"Notes"	"VAERS ID"	"VAERS ID Code"	"Vaccine"	"Vaccine Code"	"Vaccine Manufacturer"	"Vaccine Manufacturer Code"	Adverse Event Description
	"0904504-1"	"0904504-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Throat closure (angioedema/anaphylaxis) requiring ambulance transport to Hospital emergency room and stay IV infusion of Benedryl, solumedrol, and Pepcid with excellent results. Observed twelve hours, then discharged."
	"0916497-1"	"0916497-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient started having myalgia, chills, nausea on the next day of the vaccination. on 2nd day (12/29) patient had chest pressure which made her present to Hospital ED. She had troponin elevation to 1.14. Cardiac Catheterization was done which was negative. On Trans Thoracic Echocardiogram, patient was found to have hypokinesis of the mid and distal segment with some sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying  emotional or physical stress going on in her life or family. Till now extensive infectious as well as inflammatory work up is done to rule out any secondary causes of cardiomyopathy which till date have remained negative.  As a diagnosis of exclusion, her presentation seems to be COVID-19 vaccine induced Takotsubo Cardiomyopathy"
	"0928062-1"	"0928062-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"vomiting later on 01/05/21.  Lethargy and hypoxia in pm of 01/06/21.  Hypotension am of 01/07/21.  Hospitalized, intubated, cardiac arrest, died 01/07/21."
	"0930611-1"	"0930611-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP"
	"0933935-1"	"0933935-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine.  Clinically suspicious for ITP."
	"0934507-1"	"0934507-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Resident died suddenly and expectantly on 01/05/2021"
	"0935478-1"	"0935478-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"right after vaccine was given i got a head to toe hot flush. i thought it was just anxiety. within 2 minutes i had expolsive diarrhea, felt dizzy. looked in the mirror and saw my neck and chest covered in red rash and hives. felt hot flush again. dr came in noticed hives all over both my arms as well. felt sob and if someone was holding my neck with their hand. given benadryl and epi taken to local er."
	"0941361-1"	"0941361-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital."
	"0943010-1"	"0943010-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Peripheral neuropathy"
	"0944270-1"	"0944270-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered.   Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension.  Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
	"0944450-1"	"0944450-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp.   50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away.  Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor."
	"0953922-1"	"0953922-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"The day following the vaccine, the patient complained of throat issues and anxiety.  This was not new... however .  That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative.   On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital.  The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction."
	"0954804-1"	"0954804-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now."
	"0955945-1"	"0955945-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"a couple hours after the vaccine, I experienced a bit of rapid heart rate, which resolved after a few minutes. The following day around 3 pm I began to have chills and felt like I had the raid heart rate again.  By 5 pm I was beginning to feel really bad, I was freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove me to the emergency department.  I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday afternoon. The diagnosis was pneumonia,  I don't really believe this, as I felt fine and had  no symptoms prior to the onset of the fever."
	"0956458-1"	"0956458-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough.  Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage.  His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64.  He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged.  His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative.  Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home.  On 19-Jan-21, I contacted the State Medical Examiner's Office.  They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing."
	"0963313-1"	"0963313-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Fevers as high as 105.1F , severe chills, headaches, body aches, nausea, severe fatigue"
	"0965571-1"	"0965571-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"1/13/21 pt came into clinic for vaccine.  Had difficulty remembering age.  Called me Mon. 1/18/21 stating she was sick.  When asked what her sx were, she stated fatigue.  She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun.  I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those.  I questioned her about eating and drinking and she said she ate and drank water.  She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911.  She agreed.  Two staff from clinic called her Mon. and Tues, (1/18 and 1/19).  On Tues. she may have had sl slurred speech.  She was found deceased on"
	"0967521-1"	"0967521-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Sever abdominal pain that started 1/21 at 9pm. Persisted overnight. Went to ER at 930am on 1/22. Diagnosed with appendicitis. Appendectomy surgery performed around 7pm on 1/22/21."
	"0967802-1"	"0967802-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Chest pain, leading to STEMI"
	"0970153-1"	"0970153-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00.  The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
	"0972836-1"	"0972836-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"sudden death"
	"0974855-1"	"0974855-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the  Hospital ED asystole and pronounced dead"
	"0975065-1"	"0975065-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Dizzyness Flushed face and neck Swollen tongue Minor facial swelling around eyes Epi Pen and 50mg of Benedryl, bp remained normal, patient remained fully conscious. 911 called and transport to Emergency Dept"
	"0986526-1"	"0986526-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21."
	"0991080-1"	"0991080-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient sudden death reported by family.  No further details available at this time."
	"0991622-1"	"0991622-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Death"
	"0992338-1"	"0992338-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Pulmonary embolism, with pulmonary infarct"
	"0992864-1"	"0992864-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient was having shortness of breath, Heart rate was 111, respirations were 44, suctioned multiple times MD notified and sent to Emergency room for evaluation"
	"0993831-1"	"0993831-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
	"0997687-1"	"0997687-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"On 1/30/2021, I developed a mild headache followed by an acute change in my vision.  I went to  the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021.   My headache has resolved but I continue to have a visual field deficit.  I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization."
	"0999135-1"	"0999135-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"No trauma Got dose, works as cleaner. Received in Left deltoid. Lot 013L20A Moderna.  For first 3 days, had typical pain she would receive from influenza vaccination 3 days after started to have redness at injection site as well as swelling.  Swelling subsided but as soon as swelling improved, pain got worse radiating from shoulder down arpit and to left hand.  Numbness and tingling also radiated distally.  3 ED visits--on 1/25 and two on 1/27 giving APAP, diclofenac gel, lidocaine patch, and sling.  Workup showed mildly elevated alk phos (129), CK normal 57, WBC unremarkable with absolute eois wnl.  XR imaging unremarkable.  No DVT L upper extremity.   Today, pain in deltoid controlled with APAP 500mg x 2 along with lidocaine patch.  But biggest concern for patient is the radiating pain and numbness / tingling down her L arm that has not gone away with anything. Reports significant pain in elbow radiating to lower arm at night.  Further workup is still pending."
	"1000733-1"	"1000733-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve distribution 2 days after first vaccine. EMG demonstrated demyelinated neve with conduction velocity of 17 m/s. Loss of sensation. Motor weakness."
	"1000836-1"	"1000836-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient had an anaphylactic reaction, lips and facial swelling."
	"1006169-1"	"1006169-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID.  On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion."
	"1012078-1"	"1012078-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	""Report involves two products - COVID-19 Moderna vaccine (Moderna) and Invega Trinza (Janssen). Patient is my brother and I am company employee. Patient began Invega sustenna Dec-2016 and transitioned to Invega Trinza 2 years later. Patient has been on same dose of Invega trinza for at least a year. Regimen has been followed per prescribing instructions (per psychiatrist). Patient received first dose of Moderna COVID-10 vaccine at his place of employment on 24-Dec-2020. Last/most current dose of Invega Trinza was 15- Jan-2021. Patient then received 2nd dose of Moderna vaccine AM of 21-JAN-2021 (same location). Patient began severe pain in eyes, chills, myalgia (beginning 01:00 22-Jan-2021) and had to call in sick to work on 22-Jan-2021. Patient went for COVID-19 test on 22-Jan-2021 and result was negative. By 23/24-Jan-2021 patient began displaying symptoms of psychosis to family. Work colleagues noted that week of 25-Jan-2021 he was ""not himself"". Suicidal ideation (in emails) began 01-Feb-2021, symptoms intensified and currently 04-Feb-2021, patient is missing, endangered and in state of psychosis. Since patient is missing, I will serve as reporter in this case At the time of this report company was notified at 20:53 UTC and Moderna will be notified next after completion of this report.""
	"1014517-1"	"1014517-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey"
	"1016067-1"	"1016067-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning, she was found unresponsive and pronounced dead by paramedics."
	"1017109-1"	"1017109-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Visual problems, diplopia, concerns for left 4th cranial nerve paralysis"
	"1017156-1"	"1017156-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment."
	"1017675-1"	"1017675-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"This 96 year old resident was diagnosed with COVID on 10/28/2020. She has a significant, complicated medical history and  did not return to her pre-infection level of health. She began declining in early  January and was made care and comfort measures only on 1/2/2021.  Most of her medications were d/c'd except for those that provided comfort.  No obvious reaction to the vaccine was seen and we do not suspect that her death was vaccine related, however we were directed by Dept of Epidemiology to report her death as it was within one week of receiving the vaccine."
	"1019245-1"	"1019245-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am"
	"1019268-1"	"1019268-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"angioedema without urticaria 24h after COVID-19 vaccine (Moderna dose #1)"
	"1019768-1"	"1019768-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Started feeling unwell several days after shot.  Chills fever soaked bed sheets and had to call in sick from work.  Did telehealth visit with primary who recommended Covid test which came back negative.  Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen.  She is not recovering."
	"1024111-1"	"1024111-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Sore arm first injection as expected. 2nd more sore. Some fatigue.  Felt totally fine prior to until my husband turned onto our home street and I started to verbalize that this is not our neighborhood nor our house.  I then started to have a seizure which I was told lasted 5 minutes and was turning blue.  I was buckled at the time.  I have compression fractures of T12 to L2 He called an ambulance and I had a second one.  I had ct , mri, mra, eeg, ekg, labs.  Treated with muscle relaxants, toradol. Put on keppra.  Cannot drive for 6 months.  All new onset.  Having a lot of back spasms especially in the night My mouth and tongue are sore from biting on it During seizure Foggy thinking and decreased memory"
	"1024853-1"	"1024853-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Feb 8 states she had a cold. Feb 9 added stomach ache and nausea.  Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine.  Told to go home and rest. Feb 10 at 9:00 am found dead on the floor  in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug."
	"1026473-1"	"1026473-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with  AST/ALT in the 900s, T bili of 10, creatinine of 1.7.  CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction."
	"1026492-1"	"1026492-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21."
	"1027503-1"	"1027503-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient died on 02/08/2021"
	"1036532-1"	"1036532-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient was found unresponsive the following day and then pronounced deceased"
	"1038234-1"	"1038234-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21."
	"1039058-1"	"1039058-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Stomach pain, nausea, back pain, acute  appendicitis by 02/17/2021 appendectomy on 02/17/2021"
	"1045888-1"	"1045888-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations.  This has been occurring since after receiving the first vaccine, with increased severity after the second.  The symptoms last from 20-2 hours after exposure and then resolve."
	"1047607-1"	"1047607-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Received 1st dose Feb 3 @ 7am.  Felt minor soreness for 2 days.  Felt fine afterwards.  Feb 12 developed flu like symptoms, headache mild fever, tiredness.  Symptoms progressed Sat & Sun.  Monday she was speaking with her brother who said she wasnt making sense.  Called ambulance & brought her to hospital.   Ran CT scan, multiple MRIs and did spinal tap.  Diagnosed with HSE enciphilitis.  Has had multiple seizures.  Very confused, can barely speak, doesnt recognize or understand who people are.  Troubling motor skills."
	"1048882-1"	"1048882-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Vaccine was administered 2/1/2021 at approximately 9am.  Due to self reporting of allergic reaction (hives) to Augmentin, patient was monitored on site for 30 minutes.  After the monitoring period, she was cleared to go with no issues reported at the time.  We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021."
	"1059452-1"	"1059452-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Low platelets, thrombocytopenia, bleeding from mouth, large bruising, purpura, petechiae, rash of pinpoint-sized reddish-purple spots on lower legs. Treated with at least 2x2 units of platelets, IVIG for several days (at least), diagnosed as ITP, immune thrombocytopenia. Developed aspirational pneumonia in hospital. Admitted with platelets at 1x10^9/L; discharged on day 5 with 79x10^9/L.  Patient had ITP 10 years earlier and was recovered from it."
	"1059621-1"	"1059621-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM."
	"1059622-1"	"1059622-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died."
	"1060949-1"	"1060949-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Starting on  Saturday, 2/6/2020, four days after vaccine, elevated heart rate, 160 bpm and low blood sugar.  Before the vaccine, there was no problem with my heart rate.  Now, I am taking Labeatol 4 times a day to keep rate at least at 90.  This vaccine has doubled my heart rate.  It was 70 before the vaccine.  Now if I do not take my Labetalol, it goes up to 140.  Because my body is working so hard with that heart rate, it is making my sugar low.  So now I'm taking less insulin and this whole situation is getting confusing on how to handle this long term, adverse reaction to the Pfizer vaccine."
	"1063457-1"	"1063457-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"On date on second dose, 2/27/2021,  the pt began have fatigue and diarrhea at around 10:30 am.  This continued to the following day.  On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence.  She found him unresponsive at 5:30 pm in their bedroom.  EMS was called and the decedent was declared deceased.    The pt had his first dose on 2/9/2021.  Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose."
	"1063464-1"	"1063464-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient had the first dose of the Pfizer COVID vaccine (LOT#  EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder."
	"1064661-1"	"1064661-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within four days of the vaccine.  Doctors at hospital. Staff cannot answer what caused the seizure though they found a 4mm bleed on her brain; believed unrelated to seizure; on an MRI.  My mother has never had a seizure and noone in my family have had seizures.  I don't know if it's related to the vaccine but felt it should be reported to you."
	"1066115-1"	"1066115-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	""Moderna COVID-19 Vaccine EUA,      My legs were getting sore and tired at work. I sat down to tie my shoe and noted Pitting + 3 or 4 edema to BIL Calves.  Redness , warmth in a few areas.  R leg 1"" larger than L.  Then  I mentioned it to another nurse and  she said it could be side affect of Norvasc.  I spoke with my PA about it on 2/12 she D'C'd Norvasc and perscribed  Nefidepine 30 mg ER. I have not taken it yet I am monitoring my BP and it is WNL.   The edema less in calves however continues in ankles.  I have gotten MULTIPLE broken capillaries all over my legs.          Long short it has to be a reaction to vaccine.  And it continues almost 2 months after injection.   I can't wear most of my socks.  It is BAD.""
	"1066123-1"	"1066123-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Within minutes of getting the vaccine I was on the floor.  I was taken to the hospital and am still here.  I can't feel anything below my knees and have weekness in my hands.   I can't walk and have difficulty moving my legs.  Doctors are saying that they don't know if I will ever walk again."
	"1066209-1"	"1066209-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed."
	"1066784-1"	"1066784-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection.  This pain was severe visceral pain  and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg.  I need to take ibuprophen to decrease the discomfort."
	"1067083-1"	"1067083-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief,  a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms."
	"1068931-1"	"1068931-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Case passed away on 2/28/21.  During post vaccination monitoring, case did not have any adverse reactions. When writer spoke to him on 2/26/21 to schedule his second dose, he sounded well."
	"1070986-1"	"1070986-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient developed the immediate onset within 1-2 hours of  severe coughing, shortness of breath, wheezing, increased intestinal gas, sore joints, throat pain and low grade fever of 99.8. Coughing and shortness of breath continued to worsen over the day and evening and persisted for several days requiring treatment with prednisone. There were no other apparent causes for these symptoms except for the COVID-19 vaccination."
	"1071387-1"	"1071387-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Acute appendicitis and inflamed gallbladder. Required appendectomy 2.5 weeks after 2nd dose of modern covid 19 vaccine"
	"1076972-1"	"1076972-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab"
	"1077723-1"	"1077723-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient had long cardiac pauses and had to get a pacemaker. Symptoms started two days after the vaccination"
	"1079045-1"	"1079045-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Initially, a UTI developed. As the UTI resolved, double pneumonia took hold.  At the hospital they then discovered multiple clots in the legs."
	"1081471-1"	"1081471-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"This individual received the first dose of the Covid-19 Pfizer vaccine on 3/4/21 and a few days later passed away on 03/07/21."
	"1084793-1"	"1084793-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Hypotension in the 70s/40s despite IV fluid replenishment.   Per our MD DC/transfer note:  PEG displacement, ongoing sepsis, hypoglycemia.  Assess for other reason for hypotension including sepsis, cardiogenic shock, acute abdominal processes. patient was transferred to the Hospital ER where she expired"
	"1088210-1"	"1088210-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis.  She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21.  She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory.  As of this submission she has been transferred to the cardiac floor and seems to be recovering.  Symptoms started ~14d after 1st dose COVID vaccine.  She also had self limited COVID infection in early January, 2021."
	"1090382-1"	"1090382-1"	"COVID19 (COVID19 (UNKNOWN))"	"1202"	"UNKNOWN MANUFACTURER"	"000"	"Patient came to emergency department after receiving second dose of COVID-19 vaccine, unknown which manufacturer as occurred prior to emergency department visit, with worsening neck pain. Wound up being treated for possible anaphylaxis and intubated. He was intubated around 12 hours after the vaccine."
	"1094138-1"	"1094138-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"D= decedent   D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime.  ************ also mentions that there were no adverse reactions following the first dose either.   The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported."
	"1094847-1"	"1094847-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient was seen at Facility 10 minutes after his Pfizer  immunization.  He had wooziness, and hyperventilation with a breathing rate of  40.  He was transferred by wheelchair to a stretcher.  Initial Vitals:  BP  128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear  lungs.  He did not recall he had an immunization, and was uncertain of his own  age.  He did report he was on metformin for DMII.  911 was called. He was  transported to Hospital ER by EMTs."
	"1095030-1"	"1095030-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"After 1st injection (1/11/21)  experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success.  With normal blood work, chest x-ray and negative Covid test all done by 1/15.  On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism .  Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days."
	"1102228-1"	"1102228-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Nearly immediate onset of throat tightness, facial swelling, difficulty breathing. Became unable to talk. Epinephrine, benedryl and zofran were immediately administered by on-site paramedics. Was able to talk after administration of Epi. Was transported to hospital via ambulance. We later heard that he had another episode within the hour and was admitted for observation."
	"1103747-1"	"1103747-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	""Severe COVID-19 pneumonia with acute hypoxemic respiratory failure diagnosed 3/12/2021, per hospital discharge summary: On admission patient requiring 10 L nasal pendant to maintain adequate oxygenation.  She was admitted to the facility.  Chest x-ray showed diffuse interstitial thickening and mild bilateral patchy airspace opacity.  Inflammatory markers for notable for CRP of 120, D-dimer 805, ferritin 276.  She was treated with dexamethasone (and prophylactic ivermectin) and Lovenox 1 mg/kg twice daily.  Remdesivir was deferred given the onset of symptoms > 5 days PTA.  She had good response to treatment and over the next 3 days her oxygen was tapered off and she had very good symptomatic improvement.  At time of discharge she had minimal symptoms and had an ambulatory O2 sat greater than 94% on room air.""""
	"1103943-1"	"1103943-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"unexplained death"
	"1105045-1"	"1105045-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Acute stroke. Left facial droop with dysarthria. Admitted to the hospital and received tPA."
	"1105125-1"	"1105125-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient had a hemorrhagic stroke"
	"1105772-1"	"1105772-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death."
	"1105980-1"	"1105980-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred."
	"1106350-1"	"1106350-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021."
	"1107266-1"	"1107266-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown."
	"1107887-1"	"1107887-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage."
	"1111554-1"	"1111554-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Multiple strokes resulting from blood clots starting 10 days past 2nd shot. Fuzzy headed with headache prior to strokes."
	"1111791-1"	"1111791-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"My father developed a severe headache on the evening of 3/15,  followed by left sided facial paralysis, facial droop approximately 7 days after receiving the  first dose of the COVID-19 vaccine at a CVS pharmacy.  He was admitted to hospital on 3/16 for acute stroke workup given his VERY CLEAR Facial droop, slurred speech. His CT  Head was negative for acute bleed and his MRI Brain was negative for any acute stroke. He was seen by Neurologist while inpatient and was determined to have Bell Palsy and NOT an acute or subacute stroke.   Prior to taking the vaccine, he had NO facial droop. After taking the vaccine, he received no new medications nor did he travel to any other places. Additionally, he lives in a city and has not been hiking in the woods."
	"1112464-1"	"1112464-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"About six hours after receiving the vaccine I felt fatigued. Two days after receiving the shot I began having symptoms in addition to extreme fatigue, including nausea, low fever, headache, and muscle aches. Now it is 11 full days after the vaccine and symptoms have not abated at all. The doctor ordered a Covid test and blood work. They also prescribed zofran and meclazine which have not helped. It has been difficult trying to advocate for myself without coming across as an anti-vaxxer or conspiracy theorist. I wish doctors would believe me when I say this is caused by the vaccine. I am not an anti-vaxxer and was enthusiastic about getting the vaccine, but now I am frightened by my body's reaction to it."
	"1114894-1"	"1114894-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Thrombocytopenia; Vaccinators are vaccinating very high up on the shoulder; A spontaneous report was received from a nurse concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Vaccinators are vaccinating very high up on the shoulder, thrombocytopenia.  The patient's medical history, was not provided by the reporter.No Concomitant medications were  reported.  On an unknown date, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The reporter stated that Vaccinators are vaccinating very high up on the shoulder. They need to go down on the deltoid. She also reported the event of thrombocytopenia of which one involved a doctor who died.  Action taken with mRNA-1273 in response to the events was not applicable.   The  outcome of the event, vaccinators are vaccinating very high up on the shoulder was resolved . The outcome of the events thrombocytopenia is fatal.; Reporter's Comments: This report refers to a patient who experienced non-serious of vaccinating very high up on the shoulder, (Vaccine administered at inappropriate site). There were no reported AEs associated with this case of vaccine administered at inappropriate site.; Reported Cause(s) of Death: Thrombocytopenia"
	"1119393-1"	"1119393-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Systemic: Death. Unknow cause as of reporting date. -Severe, Additional Details: PT caregiver called to report that the Pt passed away on 3/8/21 2 days post vaccince, Caregiver was distrot and not very able to provided more details due to reccent nature of report."
	"1122289-1"	"1122289-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pathology confirmed: OXALATE NEPHROPATHY. Unclear trigger for abrupt onset of AKI requiring initiation of dialysis in this lady with hyperoxaluria. Her hyperoxaluria is thought due to roux-en-y bypass. But unclear why she abruptly had Cr go from 1.2 mg/dl in Dec 2020 to 11 on 3/10/21 with oliguria.  I - her attending hospitalist - am unsure what precipitated the crisis. I've attending renal pathology conference which discussed case. Some nephrologist entertained attributing it to Cdiff colitis, but the existing literature for this is very limited and her infection seems to have followed her AKI, rather than preceded it.   Although unlikely, I've considered that patient may have existed with supersaturate hyperoxaluric state  that experienced shock to equilibrium after small PEG injection of pfizer vaccine."
	"1122640-1"	"1122640-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Death 3/11/21"
	"1122739-1"	"1122739-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"3 days after 1st shot, I suffered a stroke; This is a spontaneous report from a contactable consumer (patient himself). This 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 02Feb2021 at 09:30 AM (at the age of 77-year old) at single dose for COVID-19 immunization. Relevant medical history included type 2 diabetes, kidney disease, heart failure, cutaneous T-cell lymphoma (CTCL) and allergy to lisinopril. Concomitant medications included atorvastatin (LIPITOR), metformin, losartan, potassium and acetylsalicylic acid (ASPIRIN). On 05Feb2021 at 01:30 PM, after 3 days from the first dose of vaccine, the patient experienced a stroke that resulted in hospitalization for 4 days. Treatment included CAT scan, MRI (with unknown results) and intravenous blood thinner. The outcome of the event was recovering. The event was serious due to hospitalization and life threatening illness (immediate risk of death from the event).  Information on the lot/batch number has been requested."
	"1122743-1"	"1122743-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering.   Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are  assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications."
	"1123405-1"	"1123405-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"None stated."
	"1124281-1"	"1124281-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"79 yo with HFpEF, CKD, neurogenic bladder with chronic indwelling Foley admitted to Facility 01/21/21-01/28/21 with recurrent c. difficile/sepsis.  Received COVID vaccine on 2/3/21 as outpatietn.  Readmitted to Facility on 02/16/21 with sepsis with E. coli BSI from GU source, recurrent/persistent c. difficile colitis.  Worsening sepsis.  Family transitioned goals from full code to DNR/DNI and then to CMO.  Patient expired 02/18/2021."
	"1125863-1"	"1125863-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"loss of balance, inabilty to walk or stand up. stroke ??"
	"1126281-1"	"1126281-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"unknown if related but resident Expired 3/18/21 48 hours after 2nd Covid vaccination Pfizer"
	"1127634-1"	"1127634-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"sudden hearing loss"
	"1128107-1"	"1128107-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"The evening after his appointment, he developed swelling of face and hands.   The next day, he presented to ER with complaints of  fever, chills, malaise With further evaluation including peak troponin of 8, an NSTEMI was ruled in. Patient states he has been experiencing shortness of breath after walking 3-4 mins for the past month, and had abnormal stress test done February 2020.    He was stabilized and brought to OR for coronary bypass surgery.    The vaccine reaction  exacerbated  pre existing coronary artery disease"
	"1130015-1"	"1130015-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient suffered two MIs, requiring cardiac catheterization with stenting"
	"1130974-1"	"1130974-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient had onset of  numbness in leg while driving home from vaccine appointment.  Subsequently over hours developed numbness in his face and arm.  He did not seek medical attention until 3/19/2021 because he thought this was a side effect that would resolve.  3/19/21 he was seen at Hospital and diagnosed with a CVA.  His symptoms are improved but not resolved at this time."
	"1131328-1"	"1131328-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Severe GI symptoms followed by death"
	"1131455-1"	"1131455-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Subacute fevers, cough, dyspnea for 2-3 weeks, found to be hypoxemic requiring up to max 5L nasal cannula, not responsive to coverage of community acquired pneumonia with 2 courses antibiotics. No bronch performed based on goals of care, empirically trialed on high dose steroids (soluemdrol 1000mg x3 days, then 500mg x1 day, transition to PO prednisone) as well as cefepime x7 days. Improvement to room air while continuing on steroids currently."
	"1131862-1"	"1131862-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Severe pain in right arm immediately after injection.  Weak, range of motion very limited. Pain is from my shoulder blade down to my bicep. 11 days later still in pain"
	"1134095-1"	"1134095-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Approximately 4 hours after the shot I had an intense burning sensation in my head. It felt like my brain was on fire. It lasted for about 15-20 minutes. After that I experienced tingling/numbness in the back of my neck. Now 4 days later I still have tingling/numbness in my hands and fingers and a slight twitch in my left eye."
	"1134388-1"	"1134388-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Bilateral optic disc edema R>L with vision loss in the right eye Intraretinal fluid on the right side Bilateral optic nerve enhancement on MRI Lymphocytic pleocytosis in cerebrospinal fluid Treated with IV methylprednisolone and acetozolamide"
	"1135371-1"	"1135371-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient developed myalgias and chills the day after vaccination.  Three days after vaccination, awoke from sleep wtih burning upper chest and neck pain lasting several hours.  Came to the ED.  ECG notable for lateral ST elevation.  Troponin I elevated.  CRP elevated.  COVID PCR negative x2.  Treated with aspirin and intravenous heparin infusion.  Echocardiogram revealed left ventricular systolic dysfunction (EF 48%).  Cardiac catheterzation revealed no coronary obstruction or thrombosis.  Cardiac MRI revealed late gadolinium enhancement and myocardial edema consistent with acute myocarditis.  Max temperature during hospitalization 37.4C."
	"1137998-1"	"1137998-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Typical flu-like symptoms for 30  hours.   During that time an increasing skin sensitivity over torso and limbs.  After 36 hours, a very obvious and bad rash on hands that doctor diagnosed as dyshidrotic eczema.  Simultaneously legs were badly marked with dark red dots, especially lower legs, and much overall light red skin over upper legs and torso below neck.  The hands resolved over a few days with steroid cream.  The rest of the body continues, a month later, to feel like a sunburn.  The worst of the look of dark red dots on lower leg diminished over the first couple of weeks.  But even now, it feels like my skin is mildly burned.  I can even press it and release and see white where I pressed, surrounded by red, just like a sunburn.  Overall the skin looks mildly red, but nothing outrageous."
	"1138419-1"	"1138419-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Hemolytic anemia"
	"1139024-1"	"1139024-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching my back. My partner thought I was dying as it was much more intense and extreme then normal. I am still having increased seizures in both pain and severity daily. Typically my seizures last 20 minutes and are from 4-5 in discomfort in pain out of ten. Now they are around 7, even a week later. The first severe seizure was a 10 level pain and diabling.   I also got severe swelling in my arm of the site, extreme pain in the my arm lasting four days, and two large cold sores. Typically my cold sores small and last for two days. Mine are still active and gave me a fat lip. I also have extreme fatigue but could be caused by the increased seizures and pain of them.   I been unable to perform my normal duties and responsibilities, which my seizures typically do not interfere with."
	"1141010-1"	"1141010-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Tinnitus"
	"1141898-1"	"1141898-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"4-5 hours after vaccination he developed swelling in the back of his throat and a sensation of his throat closing. He had a change in character of his voice with hoarseness. He developed chest tightness and difficulty swallowing saliva. His uvula was edematous. He had severe throat discomfort. He was evaluated and hospitalized  and required treatment for anaphylaxis with epinephrine, famotidine , IV methylprednisolone and diphenhydramine."
	"1141989-1"	"1141989-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021.  Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive ."
	"1142141-1"	"1142141-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Tinnitus No treatment Continuing with no let up"
	"1145219-1"	"1145219-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Left-sided weakness, slurred speech"
	"1145251-1"	"1145251-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE."
	"1148204-1"	"1148204-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"My husband died on Feb 5. 2021.  I do not know if the vaccination had any effect but he died of heart attack from Coronary Artery Disease which was unknown."
	"1149490-1"	"1149490-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"I NOTICED THAT ALL OF A SUDDEN MY LEFT EYE BECAME VERY BLURRY AND IT JUST GOT WORSE. I MADE AN APPOINTMENT FOR MY YEARLY EYE EXAM AND EXPLAINED MY ISSUE WITH MY LEFT EYE. AFTER THE EXAM AND DILATION IT WAS DIAGNOSED AS A CATARACT. I HAVE SINCE MADE AN APPOINTMENT WITH A SURGEON TO HAVE THIS OPERATED ON. I AM CONCERNED WITH HOW FAST THIS OCCURED AS I THOUGHT CATARACTS STARTED AND PROGRESSED SLOWLY, THIS JUST SEEMS TO BE GETTING WORSE BY THE DAY."
	"1149738-1"	"1149738-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient presented to Medical center with right sided MCA stroke (proximal M1) occlusion.  She underwent tPA therapy and is recovering. She has a history of breast cancer that was treated in 2017. It?s unclear to us whether or not these events are related. However, given the thrombosis occurred on the same day as the vaccine was administered, we felt it was a reportable event"
	"1155002-1"	"1155002-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient died between late afternoon 3/9/21 and morning of 3/10/21. Found at a well-being check by police 3/10/21. Medical examiner declined autopsy."
	"1155633-1"	"1155633-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"cardiac arrest/vfib arrest"
	"1156227-1"	"1156227-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilateral toes that progressed to numbness and weakness of her bilateral legs. 5 days after the onset of her initial symptoms, the patient noted bilateral numbness in her fingers and her mouth, that also progressed to weakness in her bilateral arms. A few days later, the patient noticed a right-sided facial droop that brought her to the ED. Given the patient's symptoms and elevated protein in the patient's CSF (obtained via lumbar puncture), the patient's symptoms are concerning for Guillain-Barre syndrome. The patient was started today on 5 days of immune globulin (PRIVIGEN) 10 % IV infusion 25 g."
	"1163967-1"	"1163967-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Felt crummy on day one and two better on day three and on day four developed four blood clots on Coumadin with an INR of 4.5 and died the next day on 3/31/2021."
	"1164186-1"	"1164186-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"I received my second shot of the Pfizer coronavirus vaccine on Saturday, March 20th at noon.  Saturday at midnight, I woke up in full body sweats and aches.  I took two ibuprofen and tried to go back to sleep, but I would toss and turn in full body sweats and aches for the next 8 hours.  I took another 2 ibuprofen around 400am.  Sunday morning I woke up feeling OK, not great, but OK.  Sunday night ? it was very strange ? the full body chills and aches came back.  Not as bad as Saturday night, but they returned nevertheless.  I had another restless night of sleep, and I took another two rounds of ibuprofen to try and help me sleep.  Monday I woke up feeling OK again.  Monday evening, around 8:00pm, I could feel the full body chills and aches coming back again, creeping up slightly.  This time, I also felt a mild burning in my upper chest and throat.  I went to bed around 8:00pm, then woke up at 9:00pm, this time in a lot of pain.  It felt like burning and a stabbing sensation in my throat and upper chest.  I took some ibuprofen, and tried to fall asleep.  I tossed and turned in agony for the next few hours, apparently falling asleep at some point around 1:00am.  At 2:00am I woke up in severe pain again.  It was very bad, like an 8 out of a 10.  It felt like a burning and stabbing sensation in my lower throat and upper chest.  I had my wife call 911, and I was brought to hospital in an ambulance.  I would stay in the hospital for the next 3 days, getting discharged Thursday at around 5:00pm.  I had peak troponin levels of 5, so I basically had a moderate heart attack.  I had a cardiac catherization procedure done, as well as a cardiac MRI.  The cardiac catherization procedure showed I had no blockages at all in my arteries.  The cardiologists diagnosed me with myocarditis.  The cardiologists told me they believe the vaccine triggered a heavy response from my auto immune system.  The response from my auto immune system in turn caused my heart to become inflamed, giving me myocarditis.  It was a horrible experience, and my doctors are convinced that it was brought on by the second coronavirus vaccine shot that I received."
	"1164972-1"	"1164972-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Mild heart attack. Spent 2 days in hospital"
	"1167164-1"	"1167164-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"ended up with high blood pressure , diabetes , cellulitis of scrotum. Had to be transported by ambulance to hospital and spent eight days there. Currently on antibiotics , blood pressure medication , insulin and have had a catheter for 5 and 1/2 weeks."
	"1167221-1"	"1167221-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"fever18 hours later, 2 days later severe headache and light sensitivity lasting 24 hours.  Several days later asthma flared up and continues to get worse.  Pre vaccination asthma only triggered after exercising  then entering the cold weather and Hx of asthma triggered with BP medicines known to trigger asthma.  Since the 2nd vaccine asthma is getting progressively worse and having to take rescue inhaler daily."
	"1168453-1"	"1168453-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Died 4 days after shot from blood clots in my lungs. No history of clotting before this. Did have Covid asyptomatic back in January. So not sure whether having had Covid caused the clotting. Having the vaccine or being out of work with torn meniscus. They think clots started in my legs and ended up in my lungs. I was brought back after coding for 6 minutes. They seem to think Covid caused it. Not sure if vaccine contributed or not. But it did happen 4 days after the shot."
	"1168565-1"	"1168565-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Pt seen in emergency room on 4/4 for abdominal pain and vomiting that began the evening of receiving her covid vaccine.  Pt found to be in fulminant liver failure and ultimately transferred to a tertiary level care center at hospital."
	"1171746-1"	"1171746-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient vaccinated by EMS on 3/29/21,  EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21"
	"1178023-1"	"1178023-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Admitted with ischemic stroke and multiple thrombi in extremities"
	"1178391-1"	"1178391-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started receiving warm tingly feeling, lost consciousness, drifted off the road crashed my vehicle into a tree head on collision 2:45pm. Cannot hear out of my left ear."
	"1178537-1"	"1178537-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Pt was found deceased at home on 3/10/21. He had had a cough prior to, recent hospitalization for pneumonia/acute on chronic resp. failure."
	"1178571-1"	"1178571-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Pt was found deceased at home, 4/2/2021."
	"1178591-1"	"1178591-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Pt had an MI on 3/28/2021."
	"1179487-1"	"1179487-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"2 days after vaccination, patient developed acute fulminant hepatitis, acute tubular necrosis and diffuse bilateral pulmonary infiltrates consistent with hypersensitivity pneumonitis. These findings resolved rapidly and were near normal by 3/24/21"
	"1179506-1"	"1179506-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Pain in injection site . 100.2 fever chills tired. Felt like throwing up . 2 Tylenol didn't take temp down .. 2 Advil helped"
	"1179539-1"	"1179539-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"3/17 vaccination Later that evening, I got little sleep, tossing and turning. The next day I was achy, arm hurt. That night I noticed loud ringing R ear; screeching noise. As the days went on, it calmed down but there 24 hours a day. I waiting 4-5 days and then saw PCM. No infection, no blockage. Referred to ENT; hearing test. Hearing test came was fine, ears look good. No cure for Tinnitus. I did go buy a white noise machine to help sleeping at night. It is there 24 hours a day."
	"1184225-1"	"1184225-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"pt says his heart started racing, he was dizzy, had SOB, and hands were shaking.  Pt called PCP which told him to get to an ER. He went to ER. They did several test.  His heart was miss-firing.  They gave him some medication which brought heart rate down but needed to had have an electrical shock.  This brought his heart rate down to 85.  He has been referred to a Cardiologist which he will schedule appt today."
	"1186702-1"	"1186702-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"30 yo woman w/ no known PMH who was transferred for w/u of headache, AMS, found to have CSF lymphocytic pleocytosis along with elevated opening pressure and parietal and occipital infarcts in the setting of multiple recent presentations to the ED over the past several weeks for ongoing headache now status post EVD placement 4/7 intubated and sedated. She developed progressive, unrelenting headache right after the Moderna vaccine according to her mother. We are not sure if the Moderna vaccine is related at all to her current illness but the timing was suspicious and mother very worried about the timing of the vaccine and the start of her headaches. All workup has remained negative so far, but some studies are still pending. Diagnosis clinically most consistent with ADEM but unclear trigger."
	"1189587-1"	"1189587-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000.  Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count  responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment."
	"1189666-1"	"1189666-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle."
	"1190541-1"	"1190541-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21.  SHE HAD NO SIDE EFFECTS OTHER THAN SLIGHTLY SORE ARM UP TO THAT POINT.  ED MD FELT SHE HAD SIGNIFICANT CARDIAC HISTORY AND LIKELY HAD MI. MEDICAL EXAMINER DID NOT ORDER AN AUTOPSY AND SHE WAS CREMATED. I FELT THAT I SHOULD JUST REPORT IT SINCE IT WAS SO CLOSE TO RECIVING THE VACCINE."
	"1191681-1"	"1191681-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Total loss of taste on the tongue. The (very few) taste buds in the other areas of the mouth remained minimally functional. For a point of reference, I can barely taste anything when I swish mouthwash around in my mouth.  Pre-existing minimal chest pain (related to history of vaping) flared up to an extreme extent the night of the day I was vaccinated. Hurt more than the joint pain or headache I also have (but those are common side effects)."
	"1192048-1"	"1192048-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	""Prior to receiving her COVID-19 vaccine, the patient was already having symptoms from anxiety/nervousness about the vaccine. Patient was given her injection and within 1-2 minutes, she began feeling dizzy and lightheaded. The vaccine administrator came to me (pharmacist on duty) to notify me that she was not feeling well. I went to go check on her and she stated that she felt as though she was going to faint. I advised her to stay seated, asked if she would like an ice pack and water, and stepped out to get those for her while remaining vigilant (because I wanted to be in the same room as her for observation/safety). I brought her the ice pack, she held it on her chest and head and said it felt nice. After about a minute I stepped out again to ask a technician to get a water for her. When I came back, the patient was still seated but had a blank stare and her mouth was slightly open. I repeated her name out loud and nudged her shoulder several times, however the patient was unresponsive completely. I immediately looked for the red emergency kit in the consultation room but did not see one (I later found out that there was an EpiPen on the table in the room, but I did not see it at the time due to the urgency of the situation). I rushed back into the pharmacy, told the technicians to call 911, and took an EpiPen off the shelf in the pharmacy. I ran back into the room and the patient's face was very red, her eyes were bulging slightly, and it looked like she was trying to reach her hand up or move it, but was unable to. I injected her with the EpiPen immediately, and within roughly 5 seconds she came back to consciousness and looked at me and said ""I'm sorry"". EMS arrived extremely fast and was there a few minutes after using the EpiPen. She was then taken by ambulance to the hospital. Patient had a friend, with her at the store who was scheduled to receive the vaccine as well, but after the incident she decided otherwise. Later that evening I gave patient's friend a phone call to check and see how patient was doing, and to also let her know that patient's vaccination card was at the pharmacy if she wanted to pick it up. That evening around 6:30-7pm, patient's husband came to the pharmacy to get her card, he updated us that she was being discharged from the hospital and that she was okay.""
	"1192054-1"	"1192054-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	""moderate heart attack; myocarditis; my heart to get inflamed; Monday evening, 22Mar, I started getting pain in my upper chest; getting pain in my upper chest and throat; I had full body chills; I had full body chills and aches; This is a spontaneous report from a contactable consumer.   A 37-years-old male patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), , administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Age at vaccination :37 years.The patient received the first dose on 27Feb2021 (Brand Pfizer,Lot number EN6203 , administration time 12:00 PM, Vaccine location Left arm).Medical history included none.     There were no concomitant medications.The clinical course was reported as follows: ""I received my second covid vaccine shot Saturday at noon, 20Mar. I had full body chills and aches Saturday and Sunday night. Monday evening, 22Mar, I started getting pain in my upper chest and throat. I woke up at 2:00am with severe chest pain. I called # and rode in an ambulance to the hospital. I spent 3 days in the hospital. I was diagnosed with myocarditis. The cardiologist believes my auto immune response to the vaccine attached my heart and caused my heart to get inflamed. I had a moderate heart attack from the vaccine"".Th Adeverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event.The patient received treatments for the events (ae treatment medication, cardiac MRI, cardiac catherization).The patient was recovered with sequel from all events.No Covid prior vaccination , No Covid tested post vaccination: Yes (covid test type post vaccination Nasal Swab on 23Mar2021:Negative)""
	"1192948-1"	"1192948-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Fever, fatigue,  12 hours after injections  Difficulty breathing 2 days after injection required 3 day hospitalization"
	"1193256-1"	"1193256-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"62 yo male Vfib arrest followed by PEA 2 days after vaccine, intubated, +MI"
	"1196995-1"	"1196995-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"On April 1,2021, patient experienced severe right arm pain up to right scapula & back, unable to move arm d/t pain & swelling, went to see provider, was sent & admitted to Hospital from 4/1-4/5/21. Diagnosed with RHABDOMYOSIS,"
	"1197962-1"	"1197962-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"29yo man who is an active swimmer presenting with persistent significant left shoulder pain, worse with activity. Coincides with getting his first covid vaccine 5-7 days earlier. Occurred the evening after his first swim after the covid vaccine. Exam notable for significant pain and shoulder instability. Worse pain was with external rotation. No evidence of impingement.  test positive. Empty can test somewhat positive. Concern for labral vs rotator cuff issues. Referred to Ortho for second opinion. x-ray ordered and will follow up with MRI."
	"1199203-1"	"1199203-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient had a large pulmonary embolism 3 weeks after receiving the vaccine.  Unclear if vaccination was the cause, but giving the timing we are reporting it.  The health care proxy also noted some palpable masses on distal L extremity, unclear if related to vaccine or what these are."
	"1200315-1"	"1200315-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"I got the vaccine on Tuesday. I had terrible headaches Wednesday, Thursday and the start of a migraine Friday. Friday night I suffered a stroke."
	"1200807-1"	"1200807-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Died within five days of receiving"
	"1201191-1"	"1201191-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"SNHL.   Hearing loss in left ear,"
	"1201981-1"	"1201981-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"7 days after the COVID vaccine, patient went into resp. arrest and died in the ER"
	"1202019-1"	"1202019-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	""This patient was under hospice care at home with Nursing Service and Hospice. He received the J&J vaccination at noon by local public health nurse on Mon 4/12/21. The patient's wife, reported to hospice team that he had been sleepy during the day and had received a dose of Ativan  earlier that morning (PRN medication at 0750). The primary hospice nurse reported wife noted he became more lethargic throughout the day after vaccination with his condition worsening at 1720; at that time his blood sugar levels were noted to be low at ""47"" but patient was alert enough to drink orange juice, eat ice cream. The patient continued to deteriorate so MD was consulted and he was transported to the ED where he later expired at 1930.""
	"1203266-1"	"1203266-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"All regular side effects on day 1 + day 2. (Fever, chills, bone and muscle aches, headache). Shortness of breath started the next day on Sunday , extreme, far beyond normal asthma or any asthma attack. Went to urgent care on Tuesday- they said it was likely a side effect of j &J and tested me for COVID, kidney disease other things, all came back negtative. Apparently I wasn?t the first person they had seen with shortness of breath. Blood in cough and spit on Wednesday after 2.5 days of  shortness of breath. Dizziness (extreme) throughout and chest pain, sternum hurt, chest tightness. Went to Er. They ran a lot of tests and they too said they had seen others with shortness of breath from j and j. They ruled out many things like pneumonia, a birth control blood clot, any lung diseases with X-rays and blood tests. I was given torkeril to ease the chest pain and tightness which it did. Blood stopped coming up in tissues. Doctor said likely inflammatory reaction to the vaccine in lungs, (I have a piece of paper proving that) and cartilage and sternum., which hurt extremely when he touched it. Blood was likely from burst capillaries from overcompensation from trying to breathe. Recommended I return if more blood came up, which it hasn?t.  Shortness of breath has not subsided. I can?t even hold a phone app without being winded. So email back, don?t call."
	"1204072-1"	"1204072-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient had an initial response 2 days after the vaccine, with general malaise,  dry mouth, headache and itching hands as well as local discomfort at the injection site that seemed to resolve spontaneously. On April 3rd he had non-specific changes in his hands that he attributed to cold weather that led to discomfort when running them under warm water. By monday APril 5th he was having worsening sensitivity in his hands and feet to heat, touch and experienced numbness. he also began to have difficulty walking. He went to the ER April 6th and was discharged April 7th after undergoing MRI of the brain and spinal cord, labs and lumbar puncture, with a presumptive diagnosis of early Guillain-barre Syndrome. His symptoms continued to worse, loss of gait was more pronounced as well as loss of balance and new off sensations in his tongue. He was admitted to the hospital, continued to undergo diagnostic workout. Results from tests on APril 6th came back positive for Anti nuclear antibodies and high protein in his CSF. He was treated with 3 days of infused Immunoglobolin therapy and was discharged on April 11th with a diagnosis of likely GBS. His symptoms continue to worsen slightly, but with less day to day decline"
	"1205103-1"	"1205103-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"On February 20, 2021 in the early evening my husband began to experience chest pain and pressure, took Tylenol, however did not relay the symptoms to me. About 6:50 AM on February 21, 2021 told me that he did not feel well, had chest pain and pressure in his chest. An ambulance was called and my husband was transported to the Hospital. I was contacted by the treating physician and was told that my husband suffered with a Pulmonary Embolysm (sp?). He was started on Heparin and admitted to the hospital. Later that evening his medication was changed to Eloquis. He was released from hospital the following evening. He has since followed up with his primary care."
	"1205224-1"	"1205224-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"specifically in the stomach area; digestive problems; bacterial infection; verry ill; debilitating symptoms; disability; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter reported behalf of his sister-in-law (patient) who had the first shot of the vaccine on 28JAN2021. The day after she became very ill and at first associated her symptoms with the vaccine. She immediately experienced debilitating symptoms after consulting her doctor, they ruled that out and said that it was a coincidence. She had fatigue and digestive problems from a bacterial infection. Symptoms were that of a bacterial infection, specifically in the stomach area. She received treatment for that and had therapy for a disability. She has yet to receive her 2nd dose. Since she experienced these symptoms, she has been afraid of getting the second dose of the vaccine. Reporter would like to know what to do since she exceeded the recommended three-week window for Pfizer, as well as the six-week window for the CDC. They have consulted with doctors, pharmacist, and was aware of the CDC 42 day window and was asking for what to do with her vaccine. The outcome of the events was unknown.   No further information is expected. Batch/Lot number is not obtained."
	"1205817-1"	"1205817-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"segment elevation myocardial infarction. Unrelenting chest pressure starting about 24h after dose 1 of the Pfizer/BioNTech vaccine. Initially unrecognized as cardiac, after 4 hours of pain he eventually called 911. He was found to have anterior STEMI, with a thrombotic proximal LAD lesion which was revascularized. He had distal embolization of thrombus to the small coronary vessels, with TIMI I-II flow and wall motion abnormality."
	"1207947-1"	"1207947-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Central Retinal Artery Occlusion, Right Eye  Occurred 4 days after vaccination Negative systemic work-up"
	"1208082-1"	"1208082-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Pt had AFIB and was on ELIQUIS 2.5 mg BID. He began to bleed, a lot. We stopped DOAC, disussed possibility pt might die form blood clot without the DOAC. He had vaccine  after stopping DOAC (stopped DOAC 2/24/21). On 3/8 he had the Janssen Vaccine. On  3/15 he awoke w weakness, inability to speak. Transferred to hospital where he was diagnosed w having major stroke, admitted to hospital. They decided NOT to use anticoagulant because he had too great a risk of bleeding."
	"1212423-1"	"1212423-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Respiratory distress, sent resident to Emergency room ; CT scan done showed a small Pulmonary EMbolism."
	"1212707-1"	"1212707-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Day after had severe gum bleeding at dentist cleaning, on February 24th had a blood nose hemmorage, needed to go to emergency department. They had to insert a nasal balloon because I wouldn't clot for about 4 hrs."
	"1212869-1"	"1212869-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient expired on 4/3/2021 after refusing dialysis x 2 weeks"
	"1212969-1"	"1212969-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient Expired"
	"1213189-1"	"1213189-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Ischemic Colitis - admitted to the hospital 3/31/21 - 4/13/21."
	"1213527-1"	"1213527-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy."
	"1219216-1"	"1219216-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakness. Treated with  high dose steroids"
	"1219824-1"	"1219824-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Profound hearing loss in L ear with slow improvement on high dose steroids"
	"1221116-1"	"1221116-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day."
	"1221916-1"	"1221916-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"blood clot in his brain; Patient collapsed on the floor at night 2 days after receiving 2nd dose; brain was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN DEATH (brain was dead), CEREBRAL THROMBOSIS (blood clot in his brain) and LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021B21A and 001821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) (seriousness criterion hospitalization prolonged). On 30-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in his brain) (seriousness criteria death and hospitalization prolonged). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, X-ray: blood clot (Positive) x-rays revealed blood clot in his brain.         No concomitant medications were reported.  After the 2nd dose, On 29Mar2021, at night, he collapsed on the floor and was taken at the hospital on same night by ambulance. So he was hospitalized on 30Mar2021 and upon doing tests and x-rays, they found blood clot in his brain. He stayed in hospital through out and transferred to hospice center on 06Apr2021 where he passed away on 08Apr2021. His brain was dead and never recovered from the clot.  Unknown treatment medications were given at the hospital.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death"
	"1223379-1"	"1223379-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Bilateral pulmonary embolism (2). DVT in lower right leg.  Blood work upon entering the hospital (3/26/21 ~ 10 pm) indicated low platelet count  (177).  Heparin drip for 2 days then Xerelto until further notice."
	"1223714-1"	"1223714-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated.  I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair.  Further investigation would be needed."
	"1223789-1"	"1223789-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed."
	"1224761-1"	"1224761-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Ear pain; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: ER2613) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021, the patient experienced ear pain and tinnitus. All the events were reported as serious, seriousness criteria as disability. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered."
	"1224928-1"	"1224928-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old non -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  at the age of 48 years, via an unspecified route of administration, administered in the left arm on 01Apr2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient has no medical history. Patient has not had Covid prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced blood clot DVT in left leg on 02Apr2021 at 09:00. Treatment for the event includes blood thinners. It was reported that the AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included nasal swab for covid test on 02Apr2021 which had a negative result. The outcome of the event was not recovered.  Information about Lot/batch number is requested."
	"1225708-1"	"1225708-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Disseminated Herpes zoster (shingles) requiring hospitalization and IV acyclovir - involving multiple dermatomes - unclear if there was CNS involvement as LP was not obtained."
	"1226944-1"	"1226944-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"4/11 Sunday afternoon fatigue and tired. 4/11 Sunday night into 4/12 Monday morning woke up with severe coughing, heart racing, and a rash. The rash was present on the right side of body, chest, arm, ribs. The rash was round bumps, raised, bright red, severe itching, and warm to touch.  The rash and itching presented for 5 days. Tuesday severe headache and body aches present in addition to other symptoms. Heart racing continues still to this day 4/18."
	"1227273-1"	"1227273-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine,  colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date.   Information about lot/batch number has been requested."
	"1229244-1"	"1229244-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU."
	"1229335-1"	"1229335-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Aortic valve endocarditis with MSSA, NSTEMI, Atrial fibrillation. Patient will likely require valve replacement"
	"1232171-1"	"1232171-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"resident with acute SOB on 4/13 sent to ED dx with pneumonia. Sent to rehab. Passed away in her sleep on night of 4/20/21"
	"1232777-1"	"1232777-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"pulmonary emboli   Treatment-Xarelto  just started treatment"
	"1233421-1"	"1233421-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient received the first Moderna Covid-19 vaccine and a few weeks later he noticed jaundice and hematuria. He was admitted to the Hospital, and was noted to have dramatically elevated eosinophils (26.29 k/uL), elevated creatinine (2.36 mg/dL) and elevated LFTs (AST/AST/Alk Phos/Tbili all up, mostly direct). His eosinophils improved with pulse dose steroids and the diagnostic work up continues. There is diagnostic uncertainty about what caused this dramatic increase in eosinophilia, but it appears temporally related to getting the vaccination. Our working diagnosis is autoimmune vasculitis, but he is also being treated for possible parasitic infection, and will require very close follow-up. 61M with PMHx HTN p/w generalized fatigue, L flank pain, and decreased UOP.   He was in his usual state of health until 5 days prior to admission with onset of general fatigue/sluggishness. This was followed by a few days of dull abdominal pain, watery bowel movements, and increased frequency which spontaneously resolved, though the fatigue persisted. Yesterday evening, he noticed new L flank pain, red urine, and decreased UOP associated with mild dysuria (he describes it as needle-like pain in his urethra) which prompted him to call EMS. Denies fevers/chills/night sweats, myalgias, respiratory symptoms, melena/hematochezia. He's never had pyelonephritis or kidney stones before, no recent urinary instrumentation, antibiotic use, or hospital stays.    He recently received the first COVID vaccine and is due for the second COVID shot on Monday. He lives with his sister and works as a mechanic. He is not on any other medications or supplements. Not currently sexually active.    ED Course Vitals: Temperature: 36.7 ¦C (98 ¦F) | Heart Rate: (!) 103 | BP: (!) 169/121 | Respiratory Rate: 18  | SpO2: 96 %  |    | FIO2     | Weight: 104.3 kg (230 lb) Exam: L CVA TTP  Labs: Cr 2.34, bicarb 18, WBC 37, UA w/ 3+ blood, +1 LE, nitrates, >182 RBCs, 32 WBC, no bacteria, no casts Imaging: CT/AP with mild L hydrouretonephrosis, b/l periureteral and perinephric stranding, b/l urothelial thickening Interventions: CTX 1g, ketorolac, 1L LR, morphine    ===================== Hospital Course 4/10-4/16 ===================== #B/l Pyeloureteritis with Eosinophilia c/f Eosinophilic Pyeloureteritis  #B/l L Hydroureter/Hydronephrosis, B/l Perinephric Stranding and Pericystic Stranding #Profound Eosinophilia Pt presented with malaise, hematuria, decreased UOP and markedly leukocytosis with predominant eosinophilia to 26k and was found to have L hydroureter/hydronephrosis, b/l perinephric stranding and pericystic stranding on CT A/P (4/10). Notably has been afebrile and fairly well appearing. Symptoms were preceded by several days of watery diarrhea, cough with sputum production and subjective weight loss. Recently received moderna vaccine, and he was concerned it causes his symptoms.  Underwent extensive workup as below with involvement of multiple services including Renal, Pulm, Rheum, Allergy, ENT, and Cardiology. Had one nasal lesion biopsied by ENT, which was non-diagnostic. Renal bx prelim without clear e/o vaculitis, although obtained after steroids. Negative testing for primary hypereosinophilic syndrome. Extensive w/u notable for ANCA positive at 1:80 with  MPO only slightly elevated (20, uln 19) and PR3 wnl.  cMRI with eosinophilic cardiomyopathy, for which cards was consulted as below. Additionally, toxacara ab positive and schistosoma ab indeterminate, although per ID both schistosomiasis and toxacara infection unlikely. Per rheum, overall felt presentation 2/2 hypereosinophilic syndrome, potentially the eosinophilic stage of EGPA (given low + ANCA, low + MPO) vs.  End organ effects of idiopathic eosinophilia. Briefly received CTX 2g IV qd (4/10 - 4/12) until diagnostics returned. Treated with solumedrol 1g qd x3d (4/11-4/13) transitioned to prednisone 60 mg qd (4/14-) to be continued until rheum f/u, with rapid decline in eosinophilia. Received pre-treatment with PO ivermectin 20 mg before steroids. Treated with flonase nasal spray, symbicort and albuterol for respiratory symptoms. Deferred cyclophosphamide, with consideration of IL-5 or IL-5R targeted biologics as an outpatient. Treated with atovaquone for PCP ppx. Per ID, treated with praziquantel (for schistosomiasis) and albendazole (for toxacara) out of an abundance of caution, although low c/f visceral larva migrans given lack of compatible imaging findings and no known exposure to dogs and cats or schistosomiasis given remove travel history.  Data - CT A/P (4/10): Mild L hydroureteronephrosis with b/l periureteral and perinephric stranding and b/l urothelial thickening. Pericystic stranding. - 4/11 CT Chest with parasinus mucosal thickening and sclerotic 1 cm lesion likely benign lesion or bone island - 4/11 CT Face with parasinus mucosal thickening and small fluid levels and sclerotic ovoid 1 cm lesion in neck of right mandible potentially representing benign fibro osseous lesion or bone island - PFT with severe obstruction and elevated FeNO c/w eosinophilic infiltration - Heme review of smear with normal Eos - Echo TTE with LVH nl EF 52% - Vitamin B12 >2000 - Urine Eos undetectable after steroids - SPEP with polyclonal hypergammaglobulinemia  - Sinus Bx equivocal - ANA, ANCA (1:80; MPO 20, PR3 3), ESR (128), CRP (66), RF (<13), C3 (82, slightly low), C4 (10) - IgE 355 - Aspergillus IgG and IgE <19 - HIV non-reactive - RHP with CHIP mutation which will need f/u - FIP1L1 negative - Schistosoma ab equivocal - Strongy ab negative - Toxacara ab positive - Leptospira ab negative - Tryptase wnl - RHP notable for CHIP mutation as below - BCR-ABL negative - FIP1L1-PDGFRA negative - peripheral blood flow cytometry unremarkable   #AKI on CKD #Nephritic syndrome #Urinary retention/hydronephrosis Cr 2.34 on admission.  Baseline Cr unknown but Cr was 1.5 (OSH BI) and urine alb:Cr was elevated to 36 in 6/2018, at which time CKD was thought to be 2/2 untreated HTN. Now presented with persistent hematuria, HTN and proteinuria with UCx without e/o infection, all favoring nephritic process. Renal and urology consulted MALB/CCR 994.5. CT scan with hydronephrosis, felt to be eosinophilic pyelonephritis. Pt underwent uncomplicated renal bx 4/14 (after steroids) which showed preliminary very mild focus of interstitial nephritis with scattered eosinophils and immunofluorescence evidence suggestive of a mild immune complex-mediated disease without current activity. EM pending. He was treated with sodium bicarb 1300 mg bid. Hematuria improved but did not resolved by time of discharge. Cr on discharge 1.6, close to baseline of 1.5 in 2018.    #Sclera Icterus #CBD Dilation on CT #Elevated LFT Sclera icteric and CBD dilation on RUQUS to 1.8cm with gallbladder sludge and small gallstones. MRCP with diffuse intrahepatic and extrahepatic biliary ductal dilatation to the level of ampulla, with associated ductal and gallbladder wall edema, complex material in the gallbladder lumen and CBD, and confluent periportal lymphadenopathy. No obstructing stone or discrete mass. Findings likely represent cholangitis such as eosinophilic cholangitis in light of severe eosinophilia.. No documented LFTs here, but OSH (BI) records indicate normal LFTs and viral hepatitis studies in 6/2018. Repeat Hep B non-reactive non immune, HCV non immune, HAV non-reactive.  BIli remained stable and ALT and AST continued to rise after initiation of steroids. GI was consulted. RUQUS 4/15 with dopplers with persistently dilated CBD to 1.4 cm with sludge in CBD but with patent portal vein and hepatic veins. Anti smooth muscle ab positive on day of discharge; antimitochondrial ab pending. LFT uptrending at time of discharge, although patient declined to stay inpatient for further workup. LFT at discharge ALT 194, AST 114, ALP 262, TBili 6.3, DBili 5.3. ERCP to be considered as an outpatient.     #HTN SBP on admission 160-180. History of HTN, not on any home anti-hypertensives. Per BI records, he was prescribed amlodipine 10/valsartan 160 in 6/2019, but pt reports self-discontinuation after ~2 doses. BP remains poorly controlled. Likely related to potential nephritic syndrome or renal infiltration by eosinophils, likely with contribution of high dose steroids. While inpatient, treated with hydralazine, labetalol, carvedilol, and amlodipine. BP regimen on discharge amlodipine 10 mg qd, carvedilol 25 mg qd. Avoiding ARBs and ACEI per Renal, although will likely need to add once AKI resolved.    #Microcytic Anemia Patient with drop in Hct from 14.1 on admission to 11.4 4/14. Continues with hematuria, but denies current hematochezia. Suspect combination of blood loss and hypopoliferation given RPI 0.29, likely anemia of inflammation/acute illness given ferritin 1.010. Vitamin B12 >2000, Folate 11. Iron 151, unable to calculate TIBC. Noted to have persistently low MCV in low 70. Hemoglobin electrophoresis ordered.    #Vitamin D deficiency #HyperPTH 25-OH Vitamin D 6. No e/o hypocalcemia. Phos slightly elevated on admission, but subsequently downtrending, likely iso renal dysfunction. Treated with ergocalciferol 50,000 U weekly x12 weeks   #Right mandible lesion Sclerotic changes of the right mandible near the condyle noted on CT scan. Surgeon recommends outpatient follow-up, although patient declined.    #Hematochezia #Hemorrhoids Patient with new bloody diarrhea 4/11. Some e/o hemorrhoids on exam. CBC stable. Treated with tucks pads, dibucaine ointment and hydrocortisone cream.   #Little Medical Follow-up Pt reports that he has not seen a doctor in ~3 years.Cholesterol 124l LDL 73, HDL 10. HgbA1c 5.2. Will join Dr's panel on discharge   #CHIP mutation  RHP with DNMT3A mutation at low VAF. Will follow in cancer precursor clinic"
	"1233606-1"	"1233606-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, throbocytopenia to 70s, mild leukopenia-since 12/20); 2 recent admissions (feb march 2021) with likely etoh-induced pre-renal AKI; DM; who received 2nd dose of moderna 4/8/21.  After not being in contact with his family for several days, family sought him at his residence where he was found pulsless and apneic on the floor with some scant blood near his face.  CPR-- >transported to hospital where upon attempting to intubate profuse bleeding into larynx/pharynx noted.  Despite ongoing cpr and mechanical ventilation team in ER was unable to re-establish pulse.  He was pronounced dead at about 8 PM 4/9/21."
	"1233863-1"	"1233863-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 or 4/11) bruises began appearing on my legs. A very large round shaped swollen bruise appeared on my forearm.  I work in an elementary school and our school nurse noticed the bruise on my arm and asked how it happened. I told her it just appeared and that I had them on my legs too. She looked at them and told me I needed to get in touch with my doctor ASAP. He sent me for blood work Thursday morningat 7:00 am on 4/15/21. At 4:30 pm that same day I received a call from my PCP office telling  me to get to the ER because my platelet level was dangerously low and I was a risk for brain bleed. Got to the ER and my platelets were at 3,000. I received a platelet transfusion and platelets went to 55,000. Next day they were down to 46,000. Next day down to 24,000. Steroids started and Sunday my count was at 30, 000 and they let me go. Got blood work done today to see where I stand."
	"1234152-1"	"1234152-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th.  On Sunday, March 21st, 911 had to be called as his seizure did not end.  He had a grand male.  He was seizing for several hours.  At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily).  He passed 1 week later, March 28 at approx 6:45pm at the Clinic.  I am unable to get any information  on his medical report for that week.  Statement from his Nurologists is on second page. Additional information for Item 18:   Statement:  47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram.   Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident  Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM  Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM"
	"1234455-1"	"1234455-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"One week after taking the vaccine the patient developed numbness and tingling in his face, hands, and feet. These symptoms progressed over time and on April 18, 2021, he presented to the ER with ?weird nerve symptoms,.? He remained there overnight and was admitted the next day., He was diagnosed by lumbar puncture with Bell?s palsy of the face secondary to Guillain Barre syndrome., He is presently still an inpatient there. He?s being treated with IV immunoglobulins, with no improvement.  His eyes and facial muscles droop, and  he has difficulty chewing food. The patient has no PCP but the hospital should be able to give you medical records of his admission. The patient and I both strongly support vaccines, and we were both  eager to be vaccinated, but we don?t believe this rare illness has struck him with no precipitating event except the vaccine."
	"1238255-1"	"1238255-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation."
	"1238472-1"	"1238472-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Later on the day of the vaccine, I developed difficulty speaking and walking. My son brought me to the ER the following day. They ran  tests and ruled out stroke and other known causes of my neurological problems. I showed improvement the next day so they sent me home. My symptoms continued and worsened over a few weeks. My children called the ambulance on March 17. My body temp was 88 when I arrived at the ER and heartrate in 30s. I stayed in the hospital for 7 days but have no memory of that or the week before. As the Drs could not find a cause or remedy to symptoms, I was discharged to hospice care. I have improved at home with a lot of assistance but am not back to my pre-vaccine strength, energy, or coordination."
	"1241341-1"	"1241341-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"On day 5 started not feeling well began to run a low grade fever lasted several days. On day 3 after symptoms started patient woke up in the middle  Of the night to use the restroom something that is done every night. Patient passed out and hit his head and started having a seizure"
	"1242420-1"	"1242420-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient with cardiogenic shock due to severe myo-pericarditis, severe inflammatory response with high fever up to 104. Cardiogenic shock requiring placement of Impella support."
	"1243056-1"	"1243056-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"pt had first vaccine of moderna on 4/1 2021 and then was found to have an echocardiogram 4/16 and found to have a thrombus of left ventricle. Unclear if related but felt important to submit information"
	"1243087-1"	"1243087-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Cortical sinus thrombosis with intracerebral hemorrhage, seizures. Admitted to ICU."
	"1243207-1"	"1243207-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"pts granddaughter says she was not feeling well and a couple of weeks after taking the vax and had to call 911 on 4/16/2021. Paramedics took her to Hospital ER, in same city and state as patient, where she was admitted.  She called her granddaughter 4/18/2021 and told her she had tested positive for Covid Virus while at the hospital and that she had a blood clot on her lung.  She is being treated w/ a blood thinner."
	"1245051-1"	"1245051-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident."
	"1245290-1"	"1245290-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Multiple pulmonary embolisms in bilateral lungs with lung infart, superficial blood clot in the right groin area, significant right abdominal pain, shortness of breath, low oxygen saturation levels admitted 3 days in the hospital. 36 hours of Lovanox  injections followed by transition to Eliquis 10 mg twice per day, respiratory exercises, oxycodone given for pain Pain has diminished in lower right lung area, clotting appears to be under control"
	"1245426-1"	"1245426-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  The patient received treatment with oral Benadryl 50mg (Diphenhydramine). She was given IV push 50mg of benadryl in the ambulance. Then in the hospital, she received Epi-pen (epinephrine) and other medications. Reportedly, the patient had an anaphylactic reaction 10 minutes after the dose was administered and was sent to the emergency room. They observed her there at about 11 AM and discharged her about 5-6 PM. They gave her IV push 50 mg Benadryl and 50 mg oral Benadryl and gave her Epi-pen and other meds in the hospital. Patient does not have a HCP.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded."
	"1247301-1"	"1247301-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"On 3/15 had a cardia arrest and is currently comatose"
	"1248552-1"	"1248552-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Developed severe right leg pain within two days after the vaccine. She had confirmed deep venous thrombosis on ultrasound confirmed on 4/23/21 without other known provocation."
	"1248821-1"	"1248821-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Come down with a bad case of Chingles."
	"1251456-1"	"1251456-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Vaccine was given in multiple doses aver the course of. 5 hours due to history of MCAS. Post second  dose GI manifestations of mast cell activation. Syndrome started - abdominal and esophageal pain which were treated with Pepcid ac. 48 hours post vaccine facial flushing and hives appeared all over both arms. Extreme fatigue, shaking, gi pain, etc. Mast cell activation syndrome was well controlled pre vaccine post vaccine it is out of control with increased scores. Serious anaphylaxis first occurred two days post vaccine (10 April 21) and required two epi pens to stop. since then there have been daily mast cell attacks consisting of headaches, fatigue, gipain, hives all over arms, and legs, shaking,. Patients Xolair dose was increased and Zyrtec was increased on 22 Apr 2021) to no avail. I continue to have daily debilitating mast cell symptoms. I had serious anaphylaxis again on 23 APR 2021 - full body hives, flushing, vomiting, difficulty breathing, low blood pressure is chin required epinephrine. I fear for my life and wish I had never gotten the vaccine. This is completely debilitating."
	"1251507-1"	"1251507-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	""Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care.  She reported the following:  ""She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. ""  Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.""
	"1251769-1"	"1251769-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Severe drop in blood pressure, dizziness nausea.. 48 hours after tingling in tongue, roof of mouth,gums..itching on back and legs.."
	"1251839-1"	"1251839-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Sever Headache, swollen glands, fever, chills, exhaustion, nausea."
	"1252144-1"	"1252144-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Apr-6--mild thalamic stroke confirmed by MRI and neurology consult. Apr-15, 16, and 23 -- unknown but same symptoms as thalamic stroke,  CT CAT scan scheduled for Apr-26."
	"1255637-1"	"1255637-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Diagnosed as Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 12:00 (Batch/Lot number was not reported) at the age of 50-year-old as single dose for covid-19 immunisation. The patient was health and had no medical history. The patient had no known allergy. Concomitant medication included finasteride (PROSCAR); lorazepam; hydroxyzine.  There was no other vaccine in four weeks. The patient was diagnosed as Guillain-Barre syndrome on 24Feb2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was in hospitalization for 8 days. The patient had no COVID prior vaccination and had been tested post vaccination. The patient underwent lab tests and procedures which included covid (blood test): negative on 01Mar2021. Outcome of event was recovered with sequel in 2021. The patient received IVIG Infusion therapy for 5 days for event.   Information on the lot/ batch number has been requested."
	"1255704-1"	"1255704-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Transverse Myelitis; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, at the age of 41 years, administered on the left arm on 22Mar2021 16:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced transverse myelitis on Apr2021. The patient was hospitalized for transverse myelitis (myelitis transverse) for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures (Corticosteroids) were taken as a result of transverse myelitis. The outcome of the event was recovering."
	"1256005-1"	"1256005-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"tinnitus (buzzing in the left ear) ear pain"
	"1256679-1"	"1256679-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"R sided paresthesias started at 8pm on 4/24/21 and worsened to entire R side of body on 4/25/21 am. He was evaluated and admitted to the hospital 4/25/21 and found to have left thalamic stroke. No weakness in arm noted but some R hand dysmetria along with decreased sensation."
	"1257886-1"	"1257886-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Myocarditis, started with fever and chills on 2/20-21, ultimately hospitalized on 2/27-3/6 at hospital transferred to medical center for higher level of care. Required dobutamine. Underwent R and L heart cath as well as endomyocardial biopsy, which was consistent with lymphohistiocytic myocarditis."
	"1262604-1"	"1262604-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient started to experience stroke like symptoms at 2pm after receiving his second dose of the Moderna Vaccine. He was rushed to the emergency room a 6pm. Diagnosed with stroke at 8pm. As of 4/27 patient is still at the Medical Center. He will be transferring to a Rehabilitation Center on 4/27/21 for stroke Rehabilitation."
	"1262819-1"	"1262819-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Spontaneous Coronary Artery Dissection ( SCAD) Treatment with Beta Blocker, Blood Thinners"
	"1263601-1"	"1263601-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Experienced a 100% occluded right coronary artery causing ST elevation myocardial infarction"
	"1266769-1"	"1266769-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"On the morning of Saturday, March 13th my mother had a CARDIAC ARREST,  luckily i was with her when this happened and called 911 immediately and followed an emergency/cpr protocol.  She had no pulse when the emergency team arrived and they used the defibrillator on her three times in our house before they took her in the ambulance where they used the defibrillator another time.  She was rushed to the Hospital where she was sedated and put on a breathing machine.  It did not seem as if she would survive,  the entire morning was a whirlwind and traumatizing.  In the afternoon they transferred her to the ICU unit.  Luckily after 24 hours they lowered sedation and she had no brain injury etc.,  we were all amazed she was alive. The doctors ran tests etc. to find out what caused this cardiac arrest event,  they found NOTHING - no blood clot, no clogged arteries,  nothing that could have caused this.  My mother also has had not health conditions before this that would have caused this.  She now has a defibrillator implanted and her life will never be the same,  her families either,  we will constantly worry.  I have post traumatic stress from witnessing my mother turn purple and lifeless right in front of my eyes and the emergency team working on her all morning and in the ER. Thank gosh i was with her that morning and that the emergency team arrived within a few minutes or else my mother would not be here today.   The only thing that changed leading up to her Cardiac Arrest was that she got the Pfizer Covid-19 vaccine on February 24th - we need answers,  did the vaccine have anything to do with this?"
	"1267408-1"	"1267408-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet."
	"1267942-1"	"1267942-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Received 1st dose approx 6 weeks gestation.  Fetal development stopped later same week.  Missed miscarriage discovered at 8 week 3 days.  Complete miscarriage at 8 weeks 5 days."
	"1268350-1"	"1268350-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse and on April 23, 21 was admitted into Hospital with blood clots to the left leg and to my lungs."
	"1268950-1"	"1268950-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Extreme muscle soreness, fever, sweats, chills, shortness of breath."
	"1269752-1"	"1269752-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Retinal vein occlusion; This is a spontaneous report from a contactable consumer (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 18Mar2021 13:00 as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient was not covid-19 tested post vaccination. There were concomitant medications. The patient received oral contraceptives in two weeks. The patient had no other vaccines in four weeks. On 25Mar2021, the patient experienced retinal vein occlusion. The patient received Avastin injection as treatment for the event. The event was resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event was not recovered.  It was reported that the patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 as a single dose for covid-19 immunisation.  Information on the lot/batch number has been requested."
	"1269773-1"	"1269773-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	""cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; she had no pulse; on the ground turning purple and lifeless; This is a spontaneous report received from a contactable consumer. A 53-year-old female patient (reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), administered in left arm on 24Feb2021 (at the age of 53-year-old) at single dose for COVID-19 immunisation. The vaccination facility type was reported as other. The patient was not pregnant. The patient's medical history was reported as none. No known allergies were reported. The patient had not had COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks. It was reported that on 13Mar2021 08:15 exactly 17 days after reporter's mother received her first Pfizer vaccine she had a cardiac arrest, luckily reporter was with her when this happened and he/she called immediately and followed the steps of cardiopulmonary resuscitation (CPR) etc. When the emergency team arrived she had no pulse and they used the defibrillator on her 4 times. The entire day they did not know if she would survive. She was sedated and tested, they got the news that she had survived and there was not brain damage. The doctors had no clue what the cardiac arrest was caused by, she had no prior health conditions and the tests show nothing to what could have caused this event (no blood clots, no clogged arteries etc.). The only thing that changed leading up to the event was her receiving her first vaccine. Luckily reporter was there when this happened or else she would in fact be dead. She now had a defibrillator implanted and reporter had a post-traumatic stress from the traumatic event and witnessing his/her mom on the ground turning purple and lifeless. They need answers. The events resulted in emergency room/department or urgent care. The events were reported as serious since resulted in hospitalization and life-threatening illness (immediate risk of death from the event). Treatments were received for the events and they were reported as multiple lifesaving treatments, tests, and defibrillator implant. The patient underwent lab tests and procedure which included COVID test (negative) on unspecified date post vaccination. The outcome of the events was resolved for the event ""she had no pulse"" and resolved with sequel (reported as recovered with lasting effects) for all other events.""
	"1270139-1"	"1270139-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Started experiencing extreme chest pains (stabbing feeling) between my lower right breast and upper rib cage on Saturday afternoon, especially when trying to take a big inhale. I went to the emergency room the next day after pain meds (ibprofen) did not help, and they did an EKG and X-Ray and they said it was a muscle strain. I went home and alternated between 3000 MGs of Tylenol every 24 hours, 2400 MGs of Ibuprofen, 8 hours of 4% lidocaine patch and then off for 8 hours + and a heating pad when the patch was off. The pain in my chest got worse and worse on Mon and Tue (started having spasms in the chest that caused extreme sharp shooting pain down my back up into my head) so went back into the ER Tues night. They"
	"1270988-1"	"1270988-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"After 2nd Vaccine on 3/6/21, she became ill on 3/8/21, fever and chills was in bed all day on 3/9/21 with the same symptoms.  Woke up on 3/9/21 with shingles, Her PCP was treating her with Famciclovir and Gabapentin for pain.  She no longer had the fever or chills but still didn't feel well.  On 3/17/21 she was admitted at Medical Center which she was treated for a blood clot in her lung and for pericardial effusion. She was put on blood thinners which then caused a bleed in her hip bone.  She had a surgery to put a filter in to stop more blood clots and to drain the fluid from her heart.  She died on 3/27/21 around 3:30pm."
	"1271930-1"	"1271930-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"starting have shortness of breath/difficulty breathing and back and chest pain.  light headed, pain unbearable.  Saturday April 23rd Went to er was treated for kidney stones but they could only find one small one,  Was sent home with pain medication.  Shortness of breath persisted as did bloody cough and pain in chest and all over. Went back to the er on 4/28 as pain was unbearable (chest pain)  once given a cat scan and diagnosed with blood clots in my lungs and then an ultra sound and found a blood clot in my leg (just above knee).  It is thought that I was mis-diagnosed on the original trip to the er with kidney stones.  I have been put on blood thinners and pain medication and will be following up with my doctor."
	"1272137-1"	"1272137-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient received the second dose of Moderna vaccine on 4/1/21. Approximately 5 days afterwards he began to have a headache. This lingered and progressed to the point that presented to the emergency room. A CT head revealed cerebral venous sinus thrombosis. No evidence of thrombocytopenia but notably, the patient's platelets clump."
	"1278916-1"	"1278916-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered.  No follow-up attempts are needed. No further information is expected."
	"1279432-1"	"1279432-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Diagnosed as Covid-19 positive 04Apr2021; Diagnosed as Covid-19 positive 04Apr2021; This is a spontaneous report from a contactable consumer reporting for a patient (grand mother). A 95-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination 95 years old. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient was diagnosed with covid-19 positive on 04apr2021. She is currently in the ICU (Apr2021) and end of life planning is currently under discussion. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Apr2021. Outcome of the event was unknown.  Information on the lot/ batch number has been requested."
	"1279441-1"	"1279441-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"platelet level was low; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 07Apr2021 12:30 (Batch/Lot Number: ER8737) (at the age of 52-years-old) as single dose for Covid-19 immunisation.  The patient had no medical history and had no known allergies/ The patient was not pregnant. The patient did not have Covid prior to vaccination. Concomitant medications included minerals nos, vitamins nos (CENTRUM) and cyanocobalamin (NATURE MADE B12 VITAMIN). The patient previously received the first dose of BNT162B2 on 17Mar2021 at 12:30 PM (Lot: EN6207) (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive other vaccine in four weeks. Bruises began appearing on legs weekend (10Apr2021) following dose 2. Bruises began appearing on arms. On Wednesday, 14Apr2021, the school nurse noticed a big bruise on the patient's arm and she asked how the patient got it. The patient told her she had no idea but they were on her legs too. She (nurse) looked and told the patient to call doctor ASAP. Had bloodwork done the next morning (15Apr2021) and got call from PCP office to get to the ER because platelet level was low and the patient was a brain bleed risk. Her platelets were at 3,000 at ER. Had a platelet transfusion as well as a brain scan, lung scan and leg ultrasounds. The patient was hospitalized from April 15 to 18, 2021. The patient received 4 days of dexamethasone 40 mg daily. Her platelets were decreasing again and she was now heading to (hospital name) on 28Apr2021 for potential dose of Romisplostim. The event resulted to a visit to the doctor and emergency room. The event was assessed as life threatening and requiring hospitalization by the reporter. The patient underwent nasal swab Covid test in the hospital as protocol on 15Apr2021 with negative result. The outcome of the event was not recovered."
	"1280538-1"	"1280538-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Burning back pain in the first lumbar dermatome  distribution starting on 3/10. Drop attack on 3/17 leading to Hospital admission 3/17. Episodic acute confusional state leading to readmission to Hospital 3/24 A clinical diagnosis off absence seizure made prompting beginning Keppra with no further episodes of seizure The Neurologist as noted above"
	"1281283-1"	"1281283-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient experienced extensive joint pain.  She stated the doctor diagnosed her with inflammation on the left bone marrow.  She now has stress fracture in the right foot."
	"1282407-1"	"1282407-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient developed a PE approximately 2 weeks after injection for which she was admitted to hospital."
	"1285289-1"	"1285289-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Onset of diarrhea 10 hours after the vaccine, extremely watery stool, fully liquid, followed by virtually nonstop, and rapid dehydration, continuing for a person of seven days, and still ongoing. Extreme fatigue, difficult to get out of bed, loss of appetite, affected smell, affected taste,"
	"1286194-1"	"1286194-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology"
	"1289258-1"	"1289258-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Bells Palsy, started 5/4/21. 1st dose of pfizer vaccine given on 4/14/21. Had been due for second dose on 5/5/21 but will be delayed by a couple of weeks or will switch to J&J."
	"1293311-1"	"1293311-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and slept all day. Then yesterday when she awoke she had a sense of discomfort in the left eye, and a friend who helps them at home noticed that her left eye was slightly bloodshot. Yesterday she went to see her eye doctor who dx her with an incidental small burst blood vessel but did not advise stopping eliquis and said it should resolve within weeks. She has no loss of vision. However, in the evening when at home she said she had difficulty forming words - husband did not particularly notice a problem - she ignored it basically and went to sleep . Then this morning went to the hairdresser, noticed the word finding/ speech 'garbled' slightly problem again and walked into her pcp office - she was eval'd there at approx 1140 am and sent to ER by ambulance. Code green not called given the initial deficit was last night, CT head suggested possible subacute infract. She had no chest pain or pressure, trop noted as slightly elevated at 129 , Platlets 84 Diagnosed  with Bilateral punctate infarcts throughout the brain, in cerebellum, occiput, left temporal and parietal lobes"
	"1294075-1"	"1294075-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl and Tylenol.. Event Start date and stop date updated.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: Significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded."
	"1295048-1"	"1295048-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Chills, Fever, Muscular Aches and Pain, Coughing, Nausea, and Feeling Tired."
	"1295072-1"	"1295072-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Acute renal failure, admitted to the  hospital on 4/6/21.  Underlying source never identified, died on 4/9/21."
	"1295543-1"	"1295543-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"death. Patient had inactive cirrhosis from successfully treated Hepatitis C. He had chroinically low platelet from cirrhosis and was also a clotter as evidenced several year ago with portal vein thrombosis travelling down to his mesenteric veins causing a similar lower GI bleed by clotting his colonic veins. He required several months of anticoagulants with blood thinner at that time. One week prior to his COVID-19 vaccination there ia picture of deceased with evidence of bilateral suborbital bleeding. Patient told family that he felt poorly after injection. The day he was found there was evidence of significant GI bleeding. His corpse is currenly at medical examiner's office with no plans for autopsy."
	"1297587-1"	"1297587-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Stroke, hospitalization and rehabilitation needed"
	"1301523-1"	"1301523-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"13 days following the first dose of the vaccine, the patient sustained right basal ganglia lacunar stroke."
	"1301558-1"	"1301558-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"patient admitted with impaired balance.  Found to have a left cerebellar hemisphere stroke"
	"1302344-1"	"1302344-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"In the 1-2 days after vaccine, patient had mild shoulder pain and malaise, self resolved. Two weeks after, however, developed severe unrelenting pain in the left shoulder girdle. After about one additional week, grip strength became weak and dexterity for manipulating small objects became impaired. Focused examination showed MRC grade (R/L as appropriate): trapezius 5/5, shoulder external rotation 5/5, deltoid 5/5, biceps 5/5, triceps 5/5, wrist extension 5/5, wrist flexion 5/5, finger extension 5/5-, APB 5/5-, APL 5/4-, FDI 5/4+, ADM 5/4+, FDP IV/V 5/3-, FDP II/III 5/5. Pinprick and temperature sensation were normal. Left biceps reflex was 1+; all other UE reflexes were 2+. EMG/NCS done and consistent with mild lower trunk brachial plexopathy. MRI done and shows enhancement in the scalene muscle just adjacent to lower brachial plexus. Presentation felt consistent with Parsonage Turner syndrome, brachial neuritis. He was treated with a one week prednisone taper. Over the next 3 months, he has had gradual improvement in strength and sensation. Only minimal deficits remain."
	"1303541-1"	"1303541-1"	"COVID19 (COVID19 (UNKNOWN))"	"1202"	"UNKNOWN MANUFACTURER"	"000"	"Right large pulmonary embolism"
	"1307330-1"	"1307330-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pt developed lower extremity DVT 1 week after getting the vaccine."
	"1309629-1"	"1309629-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	""ear pain in left ear; Pain worsened over 6 weeks; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 11Jan2021 (at age of 25 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, also not received other medications within 2 weeks of vaccination. The patient not diagnosed with COVID-19 prior to vaccination also not tested for COVID-19 since the vaccination. The patient experienced ear pain in left ear and pain worsened over 6 weeks on 11Jan2021 after 1st vaccine.  Have been seen by ENT. The events result Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events was serious, seriousness criteria is Life threatening. The outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events ""ear and pain worsened over 6 weeks"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.""
	"1309630-1"	"1309630-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Parotid tumor; Left sided Facial droop; This is a spontaneous report received from a contactable other HCP (patient). A 25-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 01Feb2021 (at 25 years old, not pregnant) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had her first dose of bnt162b2 vaccine on 11Jan2021 on left arm, intramuscular at 25years old for Covid-19 immunization and experienced ear pain. On 18Feb2021, 17 days after second dose, patient experienced left sided Facial droop. Have been seen by ENT and had MRI and CT done along with Biopsy of what appeared to be a parotid tumor however may not be a tumor and further testing will be done. Treatment was given for the events. The outcome of the events was not recovered. The events was assessed as life-threatening. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
	"1311758-1"	"1311758-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient is a healthy 18 year old male with no history of Covid-19. Received 1 dose Moderna vaccine 5/8/21. Felt malaise, febrile to 103.5 that evening, 5/9/21 began experiencing chest pain. 5/11/21 presented to emergency department. Diagnosed Myopericarditis of unknown origin. Cannot exclude inflammatory response from vaccine as etiology."
	"1313031-1"	"1313031-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered."
	"1321852-1"	"1321852-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	""Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21).  She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot.  She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril.   Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68.  She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range.  On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am:  132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense ""spot sign"" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right  that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss.  She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.""
	"1322176-1"	"1322176-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"patient passed away ~24-48 hours after time of vaccination"
	"1326251-1"	"1326251-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"she passed away last night; She reported no side effects other than being tired.; This is a spontaneous report from a contactable consumer. A 96-years-old female patient (reporter's mother) received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  Medical history included high blood pressure, heart disease, stent in heart. The patient was not pregnant. There was no known allergy. Concomitant medications included blood pressure and other medications. The patient previously received first dose bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation. Patient received her second Pfizer vaccine on 07May2021. She reported no side effects other than being tired. It may not be related to the vaccine, but she passed away last night. Note that she had heart issues. The adverse events resulted in Emergency room/department or urgent care. Treatment for the adverse events included CPR and other life saving measures. There was no Covid prior vaccination. The patient was not Covid tested post vaccination. Death cause was unknown; may be listed as heart attack (as reported). The outcome of event Tiredness was unknown. The patient died on 09May2021.  An autopsy was not performed.  Information about lot/batch has been requested.; Reported Cause(s) of Death: she passed away last night"
	"1326498-1"	"1326498-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"5 minutes after vaccination, patient suffered cardiac arrest in clinic.  CPR started immediately, shocked, EPI given.  EMS transported to hospital patient expired in ED."
	"1327525-1"	"1327525-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"She received her first dose on 2/6/21 around 11:30 a.m.   On 2/7/21 she was a bit tired and her arm was a little sore.  Sometime after the afternoon of 2/7/21 and the morning of 2/8/21 she was found unconscious and unresponsive on the floor.  As her dinner from the evening of 2/7/21 was still on the table unfinished and she was fully dressed we assume that whatever caused her to end up on the floor unconscious happened on 2/7/21  She was taken to the emergency room and it was determined that she was not going to survive.  She never regained consciousness and was having seizures all the way to the hospital in the back of the ambulance.  She was made comfortable and passed on 2/11/21."
	"1327725-1"	"1327725-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Bell?s palsy. Drooping of mouth on right side"
	"1327727-1"	"1327727-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"She went to the hospital, had a stroke"
	"1327978-1"	"1327978-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	""""Normal"" reaction of headache, body aches and nausea for 2-3 days. But, I believe that the vaccination cause the worst flair I have ever had with my rheumatoid arthritis. I was unable to walk or get up from a seated position on my own. The pain is now being treated with a prednisone taper for 12 days.""
	"1329227-1"	"1329227-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	""My mother was in generally good health for her age, known as the strongest woman to many.  She defied covid for over a year, despite living in an assisted living facility in one of 2020's ""hot zones"".  After taking the vaccine, she died within 2 months.  I definitely believe 100% the vaccine in the very least hastened her health as she began declining immediately after the first dose, with on/off flu like symptoms until her death.""
	"1329443-1"	"1329443-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	""extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; could not walk/she was not able to walk; she was not able to walk or sleep for two weeks due to the spasms and pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Apr2021 at 11:30 (Batch/Lot Number: ER8731) as single dose, for covid-19 immunization. Medical history included ""gluten"" (reported as past drug history), hypothyroidism, fibromyalgia, mitochondrial retrovirus and obese. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL), sertraline, colecalciferol (D3), antioxidants and ""pregneolon""; all taken from unspecified dates, for unspecified indications. Patient previously took the first dose of BNT162B2 (Batch/lot number: FR2613) on 22Mar2021 in the left arm for COVID-19 immunization. On 15Apr2021 at 10:00 (three days after the second dose), patient had extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk. Her ER visit for pain yielded a script for hydromorphone and cyclobenzaprine. Even with these drugs, she was not able to walk or sleep for two weeks due to the spasms and pain. It has been three weeks since the 2nd dose, and still have limited standing time, due to the after effects. I'd get the vaccine again, but the level of pain was extremely bad.  Information on Lot/Batch number was available. Additional information has been requested.""
	"1331202-1"	"1331202-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Vaccination 5/6 5/7 generalized myalgias 5/8 felt improved / able to golf 5/9 admitted to local hospital /  hospital transferred to another hospital acute pericarditis"
	"1332001-1"	"1332001-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"I was 22 weeks pregnant when I received the first dose of the Pfizer vaccine.  Then, 2 weeks later when I was 24 weeks pregnant, I started having vaginal bleeding. I was in the hospital for 3 days as the doctors believed I may be going into very early labor.  They suspect a partial placenta abruption. As a result, my cervix was found to be short, also indicating potential early labor coming. I was put on bed rest. Two weeks after the bleeding started, I lost much of my mucus plug (at 26 weeks). When at hospital at 24 weeks, I was given  steroids to make my baby?s lungs develop faster just in case he?s born soon. I was also prescribed progesterone which I?ve been taking nightly. I?m now also taking magnesium supplements and drinking chamomile tea.  This may be unrelated, but I have also been found to be low in iron so now I?m taking iron supplements too.   Due date is Aug 2, 2021; I?m 31 years old; I am currently 29 weeks pregnant and still have not gone into labor; This is my second pregnancy, my first pregnancy was two years prior, and it was 100% healthy."
	"1332695-1"	"1332695-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"sharp pains on my left shoulder; I can not make sudden movements; everyday things have become painful/ Im  in excruciating pain when I do it.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, Lot number: ER8733), via an unspecified route in left arm on 02Apr2021 as a single dose for covid-19 immunization. Medical history of the patient included allergies to soy, milk, peanuts and wheat. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Lot number: EN6206) in left arm on 12Mar2021 at 09:00 for Covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021 at 09:00, patient experienced sharp pains on left shoulder, I cannot make sudden movements and everyday things have become painful. I can do everything I used to do with my left arm. I am in excruciating pain when I do it. Event resulted in Disability or permanent damage. Patient did not receive any treatment for the events. Device Date was 05May2021. The clinical outcome of the events was not recovered.  Follow-up (05May2021): New information received from the same contactable male consumer (patient) includes: Details of the first and second dose added, events onset date and time added, Allergies added, clinical outcome of events updated."
	"1334117-1"	"1334117-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Started with the right arm turning purple or changing colors when elevated above the head.   This continued for a few weeks.  Then  I started to get a tingling sensation in the elbow that went into the right pinky.  I visited my primary doctor to see what was going on.  She did an evaluation, prescribed Ibuprofen and physical therapy, and had a cervical spine x-ray done.  The X-ray looked great when it came back.  I could not get an appointment with PT for several weeks so I finally went to the chiropractor on 5/13.  He worked on the shoulder area stretching it out.   By the morning of 5/15 I was being taken to urgent care and eventually the ER because the arm was swelling and fingers were turning blue.  They did blood tests, EKG, chest x-ray, and finally an ultrasound that showed a blood clot.  It was DVT in the subclavian vein.  I was given a blood thinner and sent home.  I had a more thorough ultrasound on 5/17 that sent me back to the ER and with vascular surgeons to discuss immediate surgery with lysis therapy.  It was decided that the blood clot had probably been there for weeks and the success rate of the surgery would not be as good."
	"1334510-1"	"1334510-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness of breath 3-5 days following. I didn't give it much thought, but, roughly two weeks after my dose I began to experience severe intercostal pain and sharp pain in the lower lobe of my right lung upon inhalation. I thought this was musculoskeletal at first but after it didn't abate within days, I went to the hospital and was diagnosed with several distal pulmonary emboli.   Luckily I survived and am currently on blood thinners while trying to determine the cause of this, having no history of blood clots personally or in extended family."
	"1334690-1"	"1334690-1"	"COVID19 (COVID19 (UNKNOWN))"	"1202"	"UNKNOWN MANUFACTURER"	"000"	"Suspected vaccine-induced thrombocytopenia; required ICU level of care, treated with IV steroids; platelet nadir 11 on 5/19/21"
	"1340339-1"	"1340339-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (fetus's mother). This consumer reported information for both mother and fetus. This is the fetus report. A patient (fetus) mother (35-years-old ) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 09:15 (Batch/Lot Number: EW0164) at the age of 35-years-old as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 15:00 (Batch/Lot Number: Er8732) at the age of 35-years-old as single dose for covid-19 immunisation. Route of the administration for fetus was provided as Transplacental. The patient's mother medical history was not reported. The patient's mother's concomitant medication included estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The baby experienced maternal exposure during pregnancy, first trimester from 28Mar2021 15:00. On 23Apr2021, 14:00, the mother experienced miscarriage, the baby stopped growing 5 days after shot 23Apr2021 14:00, confirmed with ultrasounds 26Apr2021 and 06May2021, the event resulted in doctor or other healthcare professional office/clinic visit, there was no treatment for event. Mother's Last menstrual date was 10Mar2021. The outcome of the events was fatal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509131 mother case; Reported Cause(s) of Death: Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester"
	"1340397-1"	"1340397-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"This is a spontaneous report from a contactable Nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number is either EW0158 or EWD158), intramuscular, administered in Arm Left on 15Apr2021 as 1ST dose, single for COVID-19 immunization. Medical history included Lumpectomy over 20 years ago, High cholesterol over 20 years ago, seasonal allergy and asthma. She gets flu shot every year and has never had any issue with vaccines. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were none. Concomitant products included tocopherol (VITAMIN E); ascorbic acid (VITAMIN C) for the past six months to prevent COVID; colecalciferol (VITAMIN D); and acetylsalicylic acid (BABY ASPIRIN) for the cholesterol thing, takes it every day and has been on it about a year. She uses an inhaler for asthma she has had. Caller had experienced hypertension post first dose. Caller would like to know if she can or should get the second dose of vaccine on 20May2021. Caller has consulted with her PCP and states that she was not able to get answers. She had her first Pfizer COVID19 vaccine on 15Apr2021.That same week she was diagnosed with COVID. She had mild symptoms initially. She started having symptoms that afternoon and didn't know if was related to the vaccine. She had arm soreness, fatigue, foggy memory, and was not feeling right. She went to her internist on that Friday who said she was exhibiting symptoms of COVID. They tested her. She had been tested twice the week before for traveling and was negative. So she was tested a week before she boarded and five days before she left. On the afternoon of 15Apr2021 she had chills and didn't feel well and the symptoms were so similar she didn't known if it was coincidental. The did COVID test on Friday and got the results on Saturday morning. She got sick with fever, chills, malaise, and all of those things. She was in quarantine. Her blood pressure started escalating. She is very fit and an avid walker. She walks 7 to 8 miles per day. She had no issues before the vaccine with blood pressure. Her blood pressure runs 110/60 and heart rate in 60s in Apr 2021, but since the vaccine she has been hypertensive. She ended up in the ER last week because she was having chest tightness probably from COVID and shortness of breath. She went to urgent care because the chest tightness got severe. They said her lungs looked good and she had resolving pneumonia. Her blood pressure was almost 170/110 in Apr 2021. It was very up and down and all over the place. They had said maybe it was related to chest tightness and shortness of breath. She is very concerned because of her blood pressure and she is still having some shortness of breath and tightness of chest. They said that could linger a while. All other symptoms are better, but the shortness of breath has not gotten better. Her blood pressure will be better, but if she walks it immediately shoots up. They had made a mistake and scheduled her to get her second vaccine on 05May2021. Callers internist said that they recommend waiting a little longer and there were lots of cases where patients get COVID in between vaccines. They said to wait until 20May2021 to get the second dose of the COVID19 vaccine. Should she get the vaccine if she is still having hypertension? She can't live like this if it is secondary to vaccine. Caller had EKG and all her cardio was good. She was checked for clots because post COVID people get clots. Her dimer was good and all of her results. She had no evidence of clots in the lungs. Caller runs a little high cholesterol. It has always been that way, but her other levels are good. Due to COVID caller cant be on statin. Caller clarified that she had never been on a statin for her cholesterol. The doctor never wanted to start on her a statin because her other levels were good. Her cholesterol is not causing the issue with her blood pressure. She dont know if she should get the second vaccine. She is in her 60's and looks like she is in her 40s. Caller knows the vaccine is directly related to the hypertension. It is not from COVID. The doctor said because she is over the other symptoms except shortness of breath and a little tightness. Her blood pressure is up and down. She knows she can get anxious if she continues to check it. In the morning she has pressure in the neck that she didn't have before. The elevated blood pressure happens all over the day. She didnt check it yesterday. Right now it is 130/80 and that is high for her. Her heart rate is in the 80s currently and usually she has a low pulse. She is getting back to trying to walk a little bit. She is pacing herself. Overall, she feels ok. Her appetite is still not better. She lost 7 to 8 pounds since COVID. She is about 119 pounds, but feels like it is muscle loss because she is not exercising. Can she safely take the other vaccine that is scheduled for 20May2021? Has it been long enough now? She knows she shouldn't do it before the 14th. Is this going to go away? Are there other reported cases? She did not want to go on blood pressure medication. She is in good health and just turned 63. She never had medical issues. The only issue she had was a lumpectomy over 20 years ago. weight: around 118 pounds. She was in the upper 120s, but since COVID she has not been able to get back to walking 7 to 8 miles per day. Caller was sick, but not as most cases. She didn't end up in the hospital from COVID. She went to hospital because of chest tightness and shortness of breath. Her blood pressure was up when she went to urgent care. All the other symptoms were gone. She is currently still having shortness of breath, chest tightness, and elevated blood pressure. Sometimes the blood pressure will stabilize in the 120s. She is finally sleeping better. She wakes up with a stiff neck, but it is not the bed because she has a nice bed and pillow. As a medical professional and after discussing it with her family that are medical professionals, she feels that it is a result form Pfizer. She just needs to know if it is safe for her to get it. Does she need it since she has antibodies from the first one? Arm soreness: it lasted a week. When she feels her arm now it is tender in the spot. The fatigue and foggy memory were disabling and she couldn't do anything. Hypertensive: Seriousness is hospitalization. She was in the ER for six or seven hours. After they removed her IV the discharge nurse checked her blood pressure again manually and it was 168 over 100. She asked if it was safe to send her home. They said that everything else looked good and that it was related to being cold and being in the hospital. They had ruled the other things out. She was still symptomatic and was still having shortness of breath and chest tightness when she was leaving the ER. The blood pressure hovered a lot in the 140s when she was laying in the bed. Her O2 sats were good, 98 or 99. Her blood pressure would shoot up to the 160s or 170s. The time they have for caller to go back is 05May2021 which is not 30 days. It is completely messed up. First, she went to the Urgent care on 30Apr2021 and they did x-ray. They couldn't check her for clots. She was having shortness of breath, chest tightness, and elevated blood pressure. They sent her to the ER on 30Apr2021. Her main question is the hypertension. Blood pressure is related to the vaccine itself and is not from COVID. Does she need the second vaccine since she already had the first one and has antibodies from COVID? Is it safe to do the second vaccine having hypertension from the first? She doesn't want to escalate this more and have it linger for several months. She has to get to work and do her job. With hypertension she gets tightness in chest. They said her lungs look good except for the area of resolving pneumonia. When she gets short of breath it is related to high blood pressure and tightness of chest. Is it safe to get second vaccine? She is very concerned about getting the second vaccine. What will happen with her blood pressure being all over the place? Her blood pressure is not steady and stable. The chest tightness is still there and has not gone away. It has improved some. It wasn't even 30 days. Is it ok to take the second dose with the blood pressure issues? The onset date of events was Apr 2021. The outcome of the events was unknown. The nurse considered the COVID19 Vaccine was related to arm soreness, hypertensive, foggy memory and not feeling right. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination with BNT162B2 played a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities."
	"1343026-1"	"1343026-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"heart attack; stent put in; awaiting further treatment"
	"1343238-1"	"1343238-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient began experiencing some shortness of breath 15 minutes after the injection with audible wheezing.  This nurse assessed her and found the following: LS tight/rhonci  whole L side w/wheezing in bilat upper lungs, O2 sat 96% on RA, skin pink/warm, no change in color, no diaphoresis noted, HR regular/98. Patient was able to converse. 911 was activated, paramedics heard air movement throughout lungs, still 96% on RA, BP 141/92. Taken by ambulance to ED due to long history of asthma and no recue inhaler on her person."
	"1347839-1"	"1347839-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Syncope on 5/20, found to have acute myocarditis with acute systolic heart failure"
	"1353503-1"	"1353503-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Central retinal vein occlusion of right eye; Fewer; headache; pain throughout body; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 16:00 as 2nd dose, single for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161) administered in left arm on 16Apr2021 00:00 for COVID-19 Immunization. There is no other vaccine in four weeks, no other medications in four weeks, no covid prior vaccination, no covid tested post vaccination, no known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced central retinal vein occlusion of right eye, Fewer, headache, pain through-out body, fatigue on 08May2021. The adverse event resulted in emergency room/department or urgent care, disability or permanent damage. The outcome of the events was recovered with lasting effects (resolved with Sequel).   No follow-up attempts are possible. No further information is expected."
	"1353752-1"	"1353752-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021"
	"1354136-1"	"1354136-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Patient had been complaining of worsening LE edema 3 days prior to event. She was seen at the clinic and given medication for it. Patient apparently developed high BP at home ( worsening HTN ?) and passed away at home 5 days after vaccination (05/11). No further info."
	"1354953-1"	"1354953-1"	"COVID19 (COVID19 (JANSSEN))"	"1203"	"JANSSEN"	"592"	"Patient had SOB, upper chest and back pain, diagnosed with small pulmonary embolism in right upper lung"
	"1355128-1"	"1355128-1"	"COVID19 (COVID19 (MODERNA))"	"1201"	"MODERNA"	"591"	"Fainted in apartment parking lot, on morning of April 3; transported to ER,, via ambulance.  Hospital stay for several days, moved to Rehab, sent back to ER with a cough, trouble breathing, and swallowing. Diagnosed with pneumonia. Went into coma on 4/18. Passed away on 4/22/2021."
	"1357347-1"	"1357347-1"	"COVID19 (COVID19 (PFIZER-BIONTECH))"	"1200"	"PFIZER\BIONTECH"	"590"	"Pulmonary embolism; Two massive bilateral clots; This is a spontaneous report received from a contactable physician (patient). A 75 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 23Feb2021 (Lot Number: EL9204) as single dose for covid-19 immunization. Medical history included, chronic obstructive pulmonary disease (COPD), history of cancers. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 02Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. The patient experienced pulmonary embolism on 19Apr2021, two massive bilateral clots on 19Apr2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for all events for 6 days. The patient underwent lab tests and procedures which included Nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of pulmonary embolism, two massive bilateral clots and included Heparin and Xarelta. The outcome of the events was recovered with Seroquel in 2021.; Sender's Comments: Based on the temporal relation, the association between pulmonary embolism, thrombosis and vaccination with BNT162B2 cannot be completely ruled out. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate."
"---"
"Dataset: The Vaccine Adverse Event Reporting System (VAERS)"
"Query Parameters:"
"Date Report Completed: 2019; 2020; 2021; Unknown Date"
"Event Category: Death; Life Threatening; Permanent Disability"
"State / Territory: Massachusetts"
"Vaccine Products: COVID19 VACCINE (COVID19)"
"VAERS ID: All"
"Group By: VAERS ID; Vaccine; Vaccine Manufacturer"
"Show Totals: False"
"Show Zero Values: Disabled"
"---"
"Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information."
"---"
"Query Date: Jun 10, 2021 10:08:46 AM"
"---"
"Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Jun 10, 2021 10:08:46 AM"
"---"
Messages:
"1. The full results are too long to be displayed, only non-zero rows are available."
"2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week."
"3. These results are for 283 total events."
"4. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to"
"restore them, if you wish."
"5. Click on a VAERS ID to see a report containing detailed information for the event."
"---"
Footnotes:
"1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse"
"event (possible side effect)."
"---"
Caveats:
"1. <p> VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine"
"manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports"
"alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain"
"information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they"
"are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports"
"should always be interpreted with these limitations in mind. </p> <p> The strengths of VAERS are that it is national in scope"
"and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to"
"post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events,"
"also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as"
"the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have"
"the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine."
"</p> <p> Key considerations and limitations of VAERS data: <ul><li> Vaccine providers are encouraged to report any clinically"
"significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause. </li><li>"
"Reports may include incomplete, inaccurate, coincidental and unverified information. </li><li> The number of reports alone"
"cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated"
"with vaccines. </li><li> VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date"
"for which data are available. </li><li> VAERS data do not represent all known safety information for a vaccine and should be"
"interpreted in the context of other scientific information. </li></ul> </p>"
"2."
"3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and"
"Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total"
"number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%"
"in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many"
"reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to"
"unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress."
"4. Data contains VAERS reports processed as of 05/28/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system"
"receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or"
"reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting."
"5. Values of Event Category field vary in their availability over time due to changes in the reporting form. The ""Emergency"
"Room/Office Visit"" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The"
"""Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit"" values are available only for events reported"
"using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for"
"these categories."
"6. For more information on how many persons have been vaccinated in the US for COVID19 to date, see"
"https://covid.cdc.gov/covid-data-tracker/#vaccinations/"