chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient.  Medical history included cystic fibrosis.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth.  The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm.  She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side.  The patient treated herself with ibuprofen and Tylenol for fever and body aches.  The patient reported she was fine on 08Feb2021.   Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Immune thrombocytopenia; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who experienced bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia.  The patient's medical history was not provided.  Concomitant product used was not provided by the reporter.  On an unspecified date, one day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: not provided) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced bruises on her arm, legs and blisters that bled inside her mouth.  On 19 Jan 2021, the patient was admitted in the hospital with a severe case of immune thrombocytopenia. The patient was given platelet transfusions along with steroids and immunoglobulins.  On 02 Feb 2021, the patient's condition slightly improved and was sent home.  Treatment for the events included platelet transfusion, steroids and immunoglobulins.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events,  bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia, were considered resolved on an unspecified date.; Reporter'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. Very limited information regarding this event has been provided at this time.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinating; A spontaneous report was received from a Physician concerning a male individual (other health care professional and colleague) who received his 2nd dose of Covid-19 vaccine and have experienced hallucinations.  The consumer's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of events, the consumer received his 2nd of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection.   According to physician, her colleague started hallucinating after his second shot. It is not known whether the patient had medical intervention or went to ER for treatment. Physician couldn't provide any further information as her head was fuzzy to answer any more questions.  Action taken with doses of Moderna Covid-19 vaccine was not applicable as the patient received both the doses.  The outcome of the event hallucinations was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong technique in device usage process
Clinical narrative: Possibly injected using 1/2 inch needle; Sore Arm; A spontaneous report was received from a PA concerning a 60 year old, female patient who experienced injection site pain after possible wrong technique in device usage process.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection while using 1/2 inch needle.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event, possible wrong technique in device usage process, was considered recovered/resolved on 05 Feb 2021.  The outcome of the event, sore arm, was not reported.; Reporter's Comments: This report refers to a case of wrong technique in device usage process for mRNA-1273 (lot unknown) with reported listed non-serious event of vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: not injected into the middle of the deltoid, but rather on the side of the arm; sore arm; swollen about 2-3 inch area, circle, red, and warm; Vaccination Site Red; A spontaneous report was received by a consumer regarding herself an 88-year-old female patient who experienced the vaccine not injected into the middle of the deltoid, but rather on the side of the arm/Incorrect route of product, sore arm/vaccination site pain, swollen about 2-3 inch area circle raised, red and warm/vaccination site swelling, and vaccination site red/vaccination site erythema.  The patient's medical history was not provided. No concomitant medications provided.   The patient received the first of two planned doses of mRNA-1273 (Batch number 030L20A) injected into the side of the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient received her vaccine, but noted that it was not given in the middle of the deltoid, but rather on the side of the arm. She also had a sore arm,  swelling reported as about a 2-3 inch circle which was red and warm. Treatment information was not provided.   Patient consented to be contacted.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vaccine not injected into the middle of the deltoid, but rather in the side of the arm, sore arm,  and a 2-3 inch circle that is raised, red and warm, was considered resolved.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. 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.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Pass away; Got COVID; A spontaneous report was received on from a consumer, concerning an 87-year-old male patient, who received Moderna's COVID-19 (mRNA 1273) vaccine and experienced pass away (death) and COVID (COVID-19).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 injection for the prophylaxis of COVID-19 infection. Two days after mRNA-1273 injection, the patient's daughter was diagnosed with COVID-19 infection. The daughter states that her mother also got infected with COVID.  On an unknown date, the patient got COVID. It was reported that he passed away. Treatment for the event was not provided.  The cause of death was not provided. The plans for an autopsy were not provided. .; Reporter's Comments: Although the onset date of COVID-19 and the fatal outcome is lacking,  Based on the natural history of COVID-19, the reported event, it is assessed as unlikely related with mRNA-1273.  The actual cause of death cannot be ascertained but assessed as not related and most likely due to the COVID-19 infection.
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site pain
Clinical narrative: some of the vaccine spilled from the syringe; pain at the injection site; This spontaneous report was received from consumer on 04-feb-2021, concerning a 84 year old male patient who was administered Moderna COVID-19 vaccine ( mRNA-1273). The patient experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm.   The patient's medical history and  Concomitant  medication was not provided.. The patient received suspect product  mRNA-1273 on 04-feb-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:029L20A)intramuscularly on the  right arm for prophylaxis of COVID-19 infection  On 11-FEB-2021 to complete his adverse reaction form and to update Moderna on how he is going to proceed. Patient will get his second injection and will have antibodies after the second Moderna Covid-19 at the direction of his Physician Action taken with the second dose of mRNA-1273  in response to the event was not reported; Reporter's Comments: This case report concerns a 84 year old male patient who was administered mRNA-1273 vaccine Lot# 029L20A and experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. (incomplete dose administered). The event of pain at the injection site is consistent with the known safety profile of mRNA-1273 and temporarily associated with the product use and a causal association cannot be excluded. The event of incomplete dose administered is assessed as not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Kidney infection
Clinical narrative: Possible kidney infection; Possible bladder infection; A spontaneous report received from a Consumer concerning, 66-year-old female patient who received first dose of the Moderna COVID-19 vaccine and experienced possible kidney infection and possible bladder infection (Cystitis)   The patient's medical history was not included. Patient's concomitant medication was not included.   On 27JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated she received her first dose of the Moderna COVID-19 vaccine on 27Jan2021. Patient stated on 30Jan2021, she started to smell an odor and believes that she has a bladder or kidney infection. Patient stated that her doctor cannot see her for several days. Patient would like to have the doctor call in a ZPack or other antibiotic but wants to know if this will interfere with the Moderna COVID-19 vaccine. Patient stated that she does not have a fever.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the events was unknown/not reported.; Reporter's Comments: This report concerns a 66--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced possible bladder and kidney infection. Very limited information regarding this event has been provided at this time.  Further information has been requested
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Flushing, Hot flush, Throat tightness
Clinical narrative: Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Pain, Rash, Skin disorder
Clinical narrative: shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now.  The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  The case will be reassessed if additional information becomes 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Pain in extremity
Clinical narrative: polymyalgia rheumatica; mild headache; upper arm and hip flexor ache; upper arm and hip flexor ache; injection site induration; left arm muscle ache; malaise; This is a spontaneous report from a contactable physician reporting for self. A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3249), via an unspecified route of administration on 23Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included hypertension, arthritis.  Concomitant medication included losartan, hctz, dabigatran. On 23Jan2021, patient experienced injection site induration, left arm muscle ache, malaise; on 30Jan2021, patient experienced mild headache, upper arm and hip flexor ache relieved by aspirin or NSAIDs for three days, and polymyalgia rheumatica. Consistent with polymyalgia rheumatica. Still the same symptoms at day 12 the milder. Outcome of events was recovering.; Sender's Comments: The serious event reported as polymyalgia rheumatica is deemed as possibly related to BNT162B2 vaccine administration based on the plausible drug-event temporal association  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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Vaccination site induration
Clinical narrative: polymyalgia rheumatica; mild headache; upper arm and hip flexor ache; upper arm and hip flexor ache; injection site induration; left arm muscle ache; malaise; This is a spontaneous report from a contactable physician reporting for self. A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3249), via an unspecified route of administration on 23Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included hypertension, arthritis.  Concomitant medication included losartan, hctz, dabigatran. On 23Jan2021, patient experienced injection site induration, left arm muscle ache, malaise; on 30Jan2021, patient experienced mild headache, upper arm and hip flexor ache relieved by aspirin or NSAIDs for three days, and polymyalgia rheumatica. Consistent with polymyalgia rheumatica. Still the same symptoms at day 12 the milder. Outcome of events was recovering.; Sender's Comments: The serious event reported as polymyalgia rheumatica is deemed as possibly related to BNT162B2 vaccine administration based on the plausible drug-event temporal association  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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, SARS-CoV-2 test
Clinical narrative: Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: She received her 1st shot of  vaccine a month ago and was diagnosed with crohn's disease after; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2 first dose on unspecified date in Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. She received her 1st shot of vaccine a month ago and was diagnosed with crohn's disease after. She just took steroids 5 mg. Her 2nd shot of our vaccine is scheduled this Saturday and she is asking if it's okay. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: passed out; light headed; This is a spontaneous report from a contactable consumer (patient's daughter).  An 82-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 25Jan2021 09:50 at single dose for covid-19 immunization. Medical history included visual problem. The patient's concomitant medications were not reported. The patient experienced passed out on 02Feb2021 and light headed in 2021. Clinical course: Consumer was calling regarding her dad who got the Pfizer COVID-19 vaccine. She said her dad had an event and she took him to his cardiologist who checked him out and suggest they call about it. She said that her dad passed out a week and a day after getting the vaccine and had been light headed. She said she was concerned that the second dose of the vaccine was supposed to be worse for effects, and she knew he was supposed to get it, but she wasn't sure that he should.  She said her dad would say to call his daughter, because he had a visual problem, which he had since before the first dose of the COVID-19 vaccine. Caller said that NDC/EXP were not provided on the handwritten card. She said it said he got his first dose 25Jan2021. She said that the report she filed online asked what time he got the vaccine dose, and she put 09:45AM since it would not let her put 09:50AM, it was really at 09:50AM. Outcome of events were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Urine analysis
Clinical narrative: The covid vaccine that has caused severe abdominal pain/severe pains; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Batch/lot number: Unknown) on 03Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that the covid vaccine that has caused severe abdominal pain (hospitalization). I round up in hospital and yesterday was severe pains and they ruled any life threatening issue out, through a CAT scan, blood work and urine specimen, so I just basically wanted to know if anybody else had the problems with the abdominal pain. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced bell's palsy 2 weeks after receiving Pfizer COVID vaccine on an unspecified date with outcome of unknown.  Event took place after use of product. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event Bell's palsy cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sepsis
Clinical narrative: died just 10 days after being given the vaccine/ put sepsis on her medical records; This is a spontaneous report from a contactable consumer report for Aunt. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history included schizophrenia and depression. The patient's concomitant medications were not reported. Consumer's aunt (patient) was housed in a facility. She was being treated for schizophrenia and depression. This was one of the facilities that chose to house Covid patients during the pandemic. Many of the patients here contracted covid19 during this time and they had to do a full facility lockdown and quarantine. The patient tested positive in Nov2020 and was quarantined to her room for 10 days. 3 weeks ago (in Jan2021), she received the Pfizer vaccine. Consumer's family was not given notice of this and we are sad to report that she died just 10 days after being given the vaccine. They put sepsis on her medical records and have not connected this to the vaccine. Consumer stated aunt was just 59 yrs old, though she was being treated for her mental illness, she was physically healthy. Consumer's family gravely concerned that this facility neglected her health by administering the vaccine without considering possible reactions from the medication she was taking, or the fact she had Covid just months prior. Patient died on an unspecified date. it was unknown if an autopsy performed.  Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: died just 10 days after being given the vaccine/ put sepsis on her medical records
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident
Clinical narrative: My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Cough, Dyspnoea, Fatigue
Clinical narrative: Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath.  The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia, Ventricular arrhythmia
Clinical narrative: Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath.  The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. 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.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021.  An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for the event.  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.; Reported Cause(s) of Death: presumed cardiac failure
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Oxygen saturation, Oxygen saturation decreased, Thrombosis, White blood cell count
Clinical narrative: White blood cells went up greatly; Blood clots in his legs; oxygen went down/oxygen levels went down; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included he had Leukemia and was on treatment. The patient's concomitant medications were not reported. The patient took first dose bnt162b2 for COVID-19 immunization. Caller says that her father got his second COVID vaccine from Pfizer. He wound up in the hospital 3 days later. His white blood cells went up greatly and he has blood clots in his legs. They do not know what is happening. They are very worried about him. He is getting a bone marrow test today (08Feb2021). His oxygen went down yesterday (07Feb2021) and is now on oxygen. She is freaking out about it. She really thinks it has to do with vaccine. It was asked if there was any information on other people with Leukemia getting the vaccine. If what research there was on this. They need all the help and information they can get. Every minute counts as everything getting worse. He is now on oxygen as his oxygen levels went down. He is getting worse every hour. The patient underwent lab tests and procedures which included oxygen saturation: his oxygen went down yesterday/oxygen levels went down on 07Feb2021, white blood cell count: his white blood cells went up greatly on an unknown date, biopsy bone marrow: unknown results on 08Feb2021. Reporter seriousness for White blood cells went and Blood clots in his legs up greatly was hospitalization. Therapeutic measures were taken as a result of oxygen went down. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: White blood cells went up greatly; Blood clots in his legs; oxygen went down/oxygen levels went down; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included he had Leukemia and was on treatment. The patient's concomitant medications were not reported. The patient took first dose bnt162b2 for COVID-19 immunization. Caller says that her father got his second COVID vaccine from Pfizer. He wound up in the hospital 3 days later. His white blood cells went up greatly and he has blood clots in his legs. They do not know what is happening. They are very worried about him. He is getting a bone marrow test today (08Feb2021). His oxygen went down yesterday (07Feb2021) and is now on oxygen. She is freaking out about it. She really thinks it has to do with vaccine. It was asked if there was any information on other people with Leukemia getting the vaccine. If what research there was on this. They need all the help and information they can get. Every minute counts as everything getting worse. He is now on oxygen as his oxygen levels went down. He is getting worse every hour. The patient underwent lab tests and procedures which included oxygen saturation: his oxygen went down yesterday/oxygen levels went down on 07Feb2021, white blood cell count: his white blood cells went up greatly on an unknown date, biopsy bone marrow: unknown results on 08Feb2021. Reporter seriousness for White blood cells went and Blood clots in his legs up greatly was hospitalization. Therapeutic measures were taken as a result of oxygen went down. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: accidental smearing of rotateq across of patient's mother's face; accidental smearing of rotateq across of patient's mother's face; no additional information; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.  On an unknown date, the patient was accidental smearing of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) across of her face (accidental exposure to product and exposure via skin contact). No additional information was provided (no adverse event ).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AEs; the patient received improperly stored vaccine; temperature between 36F and 49F with highest of 53F over 2-3 weeks period; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JAN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml injection, lot # T031820, expiration date 10-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was stored in a temperature between 36 degrees Fahrenheit (F) and 49 F with highest of 53 F for over 2 or 3 weeks. The reporter stated the data was insufficient to evaluate temperature excursion. There was no previous temperature excursion reported. Digital data logger was involved. No adverse events (AEs) were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; patient administered RECOMBIVAX HB during a temperature excursion; This spontaneous report was received from a nurse concerning a newborn male of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.    On 17-FEB-2021, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) at the dose of 0.5 ml (lot # T004378, expiration date 01-NOV-2022, route was not reported) during a temperature excursion (product storage error) as prophylaxis. The temperature was 45.5 F. The time frame was 10 hours. There was no previous temperature excursion. The call was because of data logger. No other adverse event (AE) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Redness; Pain; This case was reported by a other health professional via other manufacturer and described the occurrence of erythema in a 82-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included allergic reaction (to contrast dye), shellfish allergy and iodine allergy. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) and PNEUMONIA VACCINE.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient has allergies to shellfish and iodine.  The patient received the pneumonia shot, flu shot, and first dose of the shingles shot. After first dose of shingles shot, she experienced redness and pain. The patient was scheduled to receive the second dose of the shingles shot in January.  The patient works for a big hospital and they would like for her to receive the COVID vaccine. the patient would like to know if it would be okay to receive the COVID vaccine? The patient was unable to have an MRI (Magnetic resonance imaging) due to having an allergic reaction to contrast dye.  The patient states as a kid she had many allergies but has outgrown a lot of them like chocolate.  The patient would like to know if shellfish, iodine or contrast dye were in the covid vaccine? The patient states she would feel better if someone would contact her with more information regarding what ingredients cause people to have an allergic reaction? The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Achy (sore) arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient received the flu shot every year and experienced an achy (sore) arm at the injection site. The reporter consented to follow-up. This was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012496:Same reporter. US-GLAXOSMITHKLINE-US2021AMR013283:Same reporter. US-GLAXOSMITHKLINE-US2021AMR013283:Same reporter