chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Cough, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; little cough/cough was very minimum; This is a spontaneous report received from a contactable consumer (patient's daughter). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151; Expiration Date was not reported) via an unspecified route of ad-ministration in Arm Right on 09Apr2021 15:00, as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Multivitamins taken for an unspecified indication from an unspecified start date and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 09Apr2021, patient got the first dose. Then after the first dose, she got Covid on 21Apr2021. It has all ready been 15 days after she got Covid. Reporter asking ca she still get the second dose even if it was past the 21 days or 3 weeks, and if she just got Covid. Patient had Little cough: not really a lot of symptoms, had no fever. The same day as she noticed the positive Covid results. All of the symptoms are gone. The cough was very minimum and lasted for like 5 or 7 days at night, then it was gone. Got more exams while getting blood work for Covid. The Covid exam was a regular swab. Also had blood work that shows residues of Covid in the body. Reporter states that the results are in Spanish so was not sure how to translate that. The swab was the nose or throat and the bloodwork had a positive result. After she tested positive, she got the bloodwork to see what happened with the Covid in her body. From what she can tell, one of the components was still a little high. She has developed maybe some antibodies. She also had a chest X-ray which was clear. The blood work was from 03May 021 and the Chest X-ray was 28Apr2021. Patient gone to physician's office, just to get the whole prescriptions and care she needed and medicine. The outcome of the tested positive for Covid was unknown and for event little cough/cough was very minimum was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Decreased appetite, Nausea
Clinical narrative: Not able to eat much; Constant stomach aches; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EN6204), via an unspecified route of administration, in Left arm on 26Mar2021 at 15:30 (at the age of 65-years-old) at 2ND DOSE, single for COVID-19 immunization.  Medical history included IBD with Constipation, high cholesterol, and nickel allergy. Concomitant medications included doxycycline hyclate; lansoprazole and rosuvastatin calcium (CRESTOR) received within 2 weeks of vaccination. The patient previously took amoxicilin, azulfidine, asacol, clindamycin hydrochloride (CLEOCIN), darvocet, neomycin and experienced allergies. 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. Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at 1st dose, single for COVID-19 immunization. On 30Mar2021, since the second shot, patient's stomach has been in flux further described as not able to eat much and it was as if system needed a reboot. Additionally, the patient experienced constant stomach aches and nausea on 30Mar2021. The patient underwent lab tests and procedures which included COVID-19 test: negative on an unspecified date. The events were reported as non-serious. Patient was recommended pepto for the events but not effective at all. The outcome of the events was not recovered.  No follow-up attempts are needed. no further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fatigue
Clinical narrative: 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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program. The 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 16Apr2021, as 1st dose, single for Covid-19 immunization. Medical history and concomitant medications were not reported. On the 21Apr2021, the patient was tested positive for Covid-19. She had finished her 10 days quarantine and was symptom free. The second dose of the vaccine was scheduled on 08May2021. On an un-known date, in May2021, the outcome was recovered from the event of tested positive for Covid-19.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received the first dose of Pfizer's Covid 19 vaccine on April 22nd. That same day I started with Covid symptoms, so I took a test and it came out positive.; This is a spontaneous report from a contactable consumer. This female consumer(patient) reported for herself that:  An unspecified age of female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 22Apr2021 at single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 22Apr2021 (the day of vaccination), the patient experienced Covid symptoms, so took a test, and it came out positive. The patient recently had a PCR test, and it is negative. Her second dose scheduled for 15May2021. The outcome of event is unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Immune system disorder, Lung disorder, Thrombosis
Clinical narrative: blood clot in her lung; lung problems; bronchial asthma; may have damaged her immune system; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient, self report)  A female consumer of unspecified age, reported that she received the second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot Number and Expiration date: UNKNOWN), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Patient reported that after she received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed lung problems. She also said she had blood clot in her lung, and had bronchial asthma. Patient wants to know if there have been many reports of this nature after vaccination. She said the vaccine may have damaged her immune system, and wants to know what Pfizer can do for her. She also said the vaccine was dangerous.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: developed neuropathy in both feet; This is a spontaneous report from a contactable consumer.  This consumer (patient) of unspecified age and gender reported that received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. Medical history included shingles about 10 years before reporting. Other products were not provided. The consumer stated that developed neuropathy in both feet after receiving the Pfizer vaccine. Its been 2 months. The outcome of the event was unknown  Information on the lot/batch number has been requested
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) via an unspecified route of administration on 30Jan2021 13:00 (at the age of 73-year-old), received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266) via an unspecified route of administration on 20Feb2021 12:45 (at the age of 73-year-old), both in arm left, at single dose, for COVID-19 immunisation. Medical history included Type 2 Diabetes. No Known allergies. Concomitant medications in two weeks included atorvastatin, metoprolol succinate, ramipril, and "H". The patient previously received first dose of BNT162B2 (lot number: EL9264) on 30Jan2021 01:00 PM (at the age of 73-year-old) in left arm for COVID-19 immunisation. Patient did not receive other vaccine in four weeks and did not have COVID prior vaccination. Patient tested positive for the COVID virus after receiving the 2nd dose on 03May2021 with positive result of COVID Antigen and PCR (Nasal Swab). AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for AE. The outcome of the event was recovered in May2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529304 Same reporter, event, vaccine/different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on Jan2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date in 2021, Patient stated, she received her Pfizer covid vaccine first dose in end of Jan2020 and 4 days later, she was tested positive for covid-19. Patient wanted to know about taking the second dose. she waited for 90 days and received bam therapy. Patient wanted to know about taking the second dose. She has not taken the second dose yet and wanted to know if she should. She also received antibody therapy, Bam therapy. Description of complaint: She tested positive for Covid-19 4 days after receiving her first dose of Pfizer Covid-19 Vaccine. The patient received treatment for this event. The seriousness reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 antibody test
Clinical narrative: cough; headache; tested positive for Covid-19 after first dose of vaccine; This is a spontaneous report received from a female contactable consumer (Patient herself) of 34-years-old received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number; ER8729, Expiration date: Unknown) via unspecified route of administration on 10Apr2021 (at the age of 34-years-old) in right arm at 1ST dose with unknown dosage as single for covid -19 immunization. No information of other Products. Patient medical history and concomitant medication were not reported. No Investigation Assessment was reported. Healthcare professional details were declined. On an unspecified date, patient stated that she took the Pfizer Covid vaccine on 10Apr2021 and on 13Apr2021 she tested positive for Covid and on 29Apr2021 the test was negative. Patient was asked that whether she can take the second vaccine where still she had some cough and headache. Outcome of the event for covid-19 was recovered on 29Apr2021 and cough, headache was unknown.  Description of complaint: Patient stated that she took the vaccine, the Pfizer Covid vaccine about 4 weeks ago and two days after the vaccine she tested positive for Covid, one week ago the test was negative, was supposed to take second dose last Saturday but still has some cough and headache does not know if she should get the second dose. Product Details as follows: received first dose on 10 APR 2021, NDC, expiration and dosage unknown. Product strength and count size dispensed was not provided. Additional lot numbers were not provided. No Sample of the product available to be returned if requested. Details of packaging sealed and intact were not provided.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his wife. This is the second of two reports. A female patient (consumer's wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration, administered in arm left on 30Jan2021 13:00 (lot number: EL9264) as single dose, second dose via an unspecified route of administration, administered in arm left on 20Feb2021 12:45 (Lot Number: EL9266) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that the patient was tested positive for the COVID virus after receiving the 2nd dose on 05Apr2021. Event resulted in physician office visit. No covid test prior vaccination. Covid tested post vaccination on 05Apr2021: covid test type post vaccination was nasal swab, covid test name post vaccination was antigen and polymerase chain reaction (PCR), with result positive. Therapeutic measures were taken as a result of event tested positive for the COVID virus after receiving the 2nd dose. The event outcome was recovered on an unknown date in 2021.; Sender's Comments: Linked Report(s) : PFIZER INC-2021523894 Same reporter, event, vaccine/different patient
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 antibody test
Clinical narrative: Heart attack on 04Apr2021, two weeks after second dose of vaccine; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162), via unspecified route of administration in left arm on 13Apr2021 (at the age of 58-year-old) as 2nd dose, single for COVID-19 immunization. The patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient's medical history included allergies, migraine, high blood pressure (HBP) and high cholesterol, all from unspecified date. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included aspirin, atorvastatin, cetirizine, lisinopril and met (as reported), all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6207), via unspecified route of administration in left arm on 22Mar2021 (at the age of 57-year-old) for COVID-19 immunization, and she had also received sulfamethoxazole/trimethoprim (BACTRIM), hydrochlorothiazide, both reported as known allergies. The patient experienced heart attack on 26Apr2021 22:45, two weeks after second dose of vaccine. The event resulted in emergency room/department or urgent care visit and it was reported as serious with life-threating criteria. Treatments received for the event included angioplasty and stent placement. The patient was tested for COVID post vaccination on 26Apr2021 with test type reported as blood test and negative result. The outcome of the event was resolved with sequel (reported as recovered with lasting effect).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioplasty, Blood test, Coronary arterial stent insertion, Echocardiogram, Electroencephalogram
Clinical narrative: Heart attack on 04Apr2021, two weeks after second dose of vaccine; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162), via unspecified route of administration in left arm on 13Apr2021 (at the age of 58-year-old) as 2nd dose, single for COVID-19 immunization. The patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient's medical history included allergies, migraine, high blood pressure (HBP) and high cholesterol, all from unspecified date. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included aspirin, atorvastatin, cetirizine, lisinopril and met (as reported), all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6207), via unspecified route of administration in left arm on 22Mar2021 (at the age of 57-year-old) for COVID-19 immunization, and she had also received sulfamethoxazole/trimethoprim (BACTRIM), hydrochlorothiazide, both reported as known allergies. The patient experienced heart attack on 26Apr2021 22:45, two weeks after second dose of vaccine. The event resulted in emergency room/department or urgent care visit and it was reported as serious with life-threating criteria. Treatments received for the event included angioplasty and stent placement. The patient was tested for COVID post vaccination on 26Apr2021 with test type reported as blood test and negative result. The outcome of the event was resolved with sequel (reported as recovered with lasting effect).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack on 04Apr2021, two weeks after second dose of vaccine; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162), via unspecified route of administration in left arm on 13Apr2021 (at the age of 58-year-old) as 2nd dose, single for COVID-19 immunization. The patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient's medical history included allergies, migraine, high blood pressure (HBP) and high cholesterol, all from unspecified date. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included aspirin, atorvastatin, cetirizine, lisinopril and met (as reported), all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6207), via unspecified route of administration in left arm on 22Mar2021 (at the age of 57-year-old) for COVID-19 immunization, and she had also received sulfamethoxazole/trimethoprim (BACTRIM), hydrochlorothiazide, both reported as known allergies. The patient experienced heart attack on 26Apr2021 22:45, two weeks after second dose of vaccine. The event resulted in emergency room/department or urgent care visit and it was reported as serious with life-threating criteria. Treatments received for the event included angioplasty and stent placement. The patient was tested for COVID post vaccination on 26Apr2021 with test type reported as blood test and negative result. The outcome of the event was resolved with sequel (reported as recovered with lasting effect).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Myocardial necrosis marker, Myocardial necrosis marker increased
Clinical narrative: elevated cardiac enzymes; left ventricular damage; This is a spontaneous report from a contactable pharmacist. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, at single for covid-19 immunisation (At the age of 16-years). Medical history was none. The patient's concomitant medications were not reported. On unspecified date, the patient was with elevated cardiac enzymes and left ventricular damage followed by a dose of product. Physicians indicate it was directly correlated and the reported was asking for specific information on this topic as to reported tissue damage especially with the EUA update age range. The patient underwent lab tests and procedures which included cardiac enzymes with results elevated on unspecified date. Outcome for all the events was unknown.   Information about batch number and lot number is requested. Further information has been expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of elevated cardiac enzymes,left ventricular damage. The case will be reassessed once new information is 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Guillain-Barre syndrome, Hypoaesthesia, Neuralgia, Palpitations
Clinical narrative: Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up thirsty with her heart racing; she fell and had a urinary incontinence.; she fell and had a urinary incontinence.; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Lot number: unknown), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient is a 29 year old female who received her 2nd dose of the Pfizer BioNTech COVID 19 Vaccine on 07May2021. It was reported that patient was admitted (hospitalized) on 08May2021 at around 5AM. As of 1:10AM today (12May2021), caller reported that the patient developed symptoms overnight. She reported nerve pain and that her legs were numb. She woke up thirsty with her heart racing and as she was getting water, she fell and had a urinary incontinence. Patient was diagnosed with Guillain Barre Syndrome, Vaccination Initial Encounter and was still hospitalized as of today. It was reported that the patient was uninsured and needs medical attention and physical therapy in order to return back home. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Urinary incontinence
Clinical narrative: Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up thirsty with her heart racing; she fell and had a urinary incontinence.; she fell and had a urinary incontinence.; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Lot number: unknown), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient is a 29 year old female who received her 2nd dose of the Pfizer BioNTech COVID 19 Vaccine on 07May2021. It was reported that patient was admitted (hospitalized) on 08May2021 at around 5AM. As of 1:10AM today (12May2021), caller reported that the patient developed symptoms overnight. She reported nerve pain and that her legs were numb. She woke up thirsty with her heart racing and as she was getting water, she fell and had a urinary incontinence. Patient was diagnosed with Guillain Barre Syndrome, Vaccination Initial Encounter and was still hospitalized as of today. It was reported that the patient was uninsured and needs medical attention and physical therapy in order to return back home. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: he was tested positive after taking the 1st dose/we vaccinated a week later we both my wife and I both got COVID; This is a spontaneous report received from a Pfizer sponsored program. A male contactable consumer (reported for himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in on 27Jan2021, as1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient took the 1st dose last on 27Jan2021. He took the 2nd dose just today 09May2021, because as per the caller he was tested positive after taking the 1st dose. Caller was advised to wait for 90 days before taking the 2nd dose. Caller was asking if he needs to start over or not. but as patient and his wife vaccinated a week later we both my wife and I both got COVID on (03Feb2021 ) and we were 3 days after that we got infusion okay, so we were told we couldn't go back for our second shot for 90 days which we just completed on this morning for the shot, so that question came up today that should be our second shot or should we stop the process over again with the first shot and that's my question to you. The out-come of the event was unknow.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : different patients
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Chest pain, Coronary artery thrombosis, Dyspnoea, Fatigue
Clinical narrative: headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a spontaneous report from a contactable physician.  A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05May2021 as single dose for COVID-19 immunization. Medical history included chronic smoker 2 packs per day. Patient was not pregnant at the time of vaccination. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL) and ibuprofen. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Patient developed headache, fatigue, dyspnea, and chest pain for 3 days. She was admitted to hospital on 08May2021 with a completed right ventricular (RV) infarction. Angio in May2021 showed clean coronaries with the exception of a large amount of clot in the right coronary artery(RCA). Given correlation to vaccine administration, unclear if this was related (as reported). Device Date: 11May2021 (as reported). The adverse events resulted in emergency room/department or urgent care. The events were assessed as serious, hospitalization and life-threatening. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events at the time of last observation was recovering.  Information on Lot/Batch number has been requested.; Sender's Comments: As a cautionary measure and considering the drug-event temporal relationship of three days, the company cannot completely exclude a causal association between the administration of the PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 and the onset of all the reported events. Medical history of chronic smoker (2 packs per day) cannot be also excluded as contributing factor and additional information of medical history and concomitant medications concerning possible risk factors for cardiovascular diseases, should be also useful for an overall assessment of the case.  The impacts 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myocardial infarction
Clinical narrative: headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a spontaneous report from a contactable physician.  A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05May2021 as single dose for COVID-19 immunization. Medical history included chronic smoker 2 packs per day. Patient was not pregnant at the time of vaccination. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL) and ibuprofen. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Patient developed headache, fatigue, dyspnea, and chest pain for 3 days. She was admitted to hospital on 08May2021 with a completed right ventricular (RV) infarction. Angio in May2021 showed clean coronaries with the exception of a large amount of clot in the right coronary artery(RCA). Given correlation to vaccine administration, unclear if this was related (as reported). Device Date: 11May2021 (as reported). The adverse events resulted in emergency room/department or urgent care. The events were assessed as serious, hospitalization and life-threatening. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events at the time of last observation was recovering.  Information on Lot/Batch number has been requested.; Sender's Comments: As a cautionary measure and considering the drug-event temporal relationship of three days, the company cannot completely exclude a causal association between the administration of the PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 and the onset of all the reported events. Medical history of chronic smoker (2 packs per day) cannot be also excluded as contributing factor and additional information of medical history and concomitant medications concerning possible risk factors for cardiovascular diseases, should be also useful for an overall assessment of the case.  The impacts 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood cholesterol, Computerised tomogram, Myocardial infarction, Thrombosis
Clinical narrative: headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a spontaneous report from a contactable physician.  A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05May2021 as single dose for COVID-19 immunization. Medical history included chronic smoker 2 packs per day. Patient was not pregnant at the time of vaccination. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL) and ibuprofen. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Patient developed headache, fatigue, dyspnea, and chest pain for 3 days. She was admitted to hospital on 08May2021 with a completed right ventricular (RV) infarction. Angio in May2021 showed clean coronaries with the exception of a large amount of clot in the right coronary artery(RCA). Given correlation to vaccine administration, unclear if this was related (as reported). Device Date: 11May2021 (as reported). The adverse events resulted in emergency room/department or urgent care. The events were assessed as serious, hospitalization and life-threatening. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events at the time of last observation was recovering.  Information on Lot/Batch number has been requested.; Sender's Comments: As a cautionary measure and considering the drug-event temporal relationship of three days, the company cannot completely exclude a causal association between the administration of the PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 and the onset of all the reported events. Medical history of chronic smoker (2 packs per day) cannot be also excluded as contributing factor and additional information of medical history and concomitant medications concerning possible risk factors for cardiovascular diseases, should be also useful for an overall assessment of the case.  The impacts 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke approximately 3 Weeks after 2 dose; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in APR-2021 at the 56 years old at single dose for COVID-19 immunisation.  The medical history included previous heart attack 4 years ago. The concomitant medications included Other medications in two weeks. There was no other vaccine in four weeks. The Historical Vaccine was first dose BNT162B2 in Mar2021 12:00 PM at 56 years old for Covid-19 immunisation. The patient experienced Stroke approximately 3 Weeks after 2 dose on 09May2021 14:30. The patient was Hospitalized due to it from May2021 to May2021(duration 2 days). There was Emergency Room Visit, department or urgent care. There was treatment for this event.  The event was assessed as Life-threatening. There was no covid prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 09May2021: unknown. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Hypersensitivity, Pyrexia
Clinical narrative: when I have allergies my phlegm is clear and now it is yellowish green in color; dizzy shortly after dose.; This has since subsided but she the started to experience allergy like symptoms; chills; cough; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient became dizzy shortly after dose. This has since subsided but she then started to experience allergy like symptoms. She states, she was very concerned because she thought it was allergies to begin with but when she has allergies her phlegm was clear and now it was yellowish green in color. She was experiencing chills, cough, fever, and the yellowish green phlegm on an unknown date. The patient enquired whether she should take the second dose of the vaccine since she had side effects from the first dose, is the second dose the same thing as the first dose and will her side effects be worse with the second shot. The response is provided to the patient that the first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. The outcome of the event dizzy shortly after dose was recovered and the outcome of remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sputum purulent
Clinical narrative: when I have allergies my phlegm is clear and now it is yellowish green in color; dizzy shortly after dose.; This has since subsided but she the started to experience allergy like symptoms; chills; cough; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient became dizzy shortly after dose. This has since subsided but she then started to experience allergy like symptoms. She states, she was very concerned because she thought it was allergies to begin with but when she has allergies her phlegm was clear and now it was yellowish green in color. She was experiencing chills, cough, fever, and the yellowish green phlegm on an unknown date. The patient enquired whether she should take the second dose of the vaccine since she had side effects from the first dose, is the second dose the same thing as the first dose and will her side effects be worse with the second shot. The response is provided to the patient that the first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. The outcome of the event dizzy shortly after dose was recovered and the outcome of remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pharyngitis streptococcal, Pyrexia
Clinical narrative: strep throat; Experiencing streptococcus and fever.; This is a spontaneous report from a contactable consumer (father). A 18-year-old male patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0165, Expiry Date: unknown) on an unspecified date in left arm via unspecified route of administration as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the meantime, between his first and second dose of the vaccine, on 08May2021 07:38 PM, the patient had strep throat. It was reported as the patient was experiencing streptococcus and fever. The patient went to emergency room on 08May2021 and received prescription for the Antibiotics and Tylenol for the fever, got discharged from emergency room on the same day. The outcome of the event strep throat was reported as not recovered, and outcome for event fever was reported as recovering. The reporter stated that the patient is due for his second dose of vaccine on the next day and wanted to know if they need to reschedule it or could still receive the second dose on the next day of reporting date.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program COVAX US support received from a contactable consumer (patient) via medical information team. A 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date of Apr2021 (three weeks ago) (Lot number: not reported) as SINGLE DOSE, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of Apr2021, 1 day after the vaccination, the patient was tested positive for COVID 19.  The patient underwent lab tests and procedures which included COVID-19 test with result positive on an unspecified date of Apr2021. The outcome was reported as unknown at the time of reporting. The reporter was going to get his second dose of the product tomorrow and had some questions whether it was fine for him to go ahead and get his next dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Swelling face, Urticaria
Clinical narrative: severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The events 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). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021.   Information on the batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: I had thrombosis.; I felt sick; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 25Apr2021 the patient felt sick and went to the hospital where she was told she had thrombosis. The patient didn't have any risks for this disease. The patient received blood thinners as therapeutic measure of the event thrombosis and the doctor told her not to combine them with other medications. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report from a contactable consumer reporting for her uncle. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021, at single dose, for COVID-19 immunization. Medical history included COPD. Concomitant medications were not reported. A week after the patient got his COVID shot, he was dead, he had a cardiac arrest on an unspecified date in 2021, with fatal outcome. This just happened last month. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested. ; Reported Cause(s) of Death: Cardiac arrest