chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Vaccination failure
Clinical narrative: I came down with covid; I came down with covid; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, via an unspecified route of administration on 18Feb2021 (Batch/Lot number and expiration date were not reported) as dose 2, single and dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she came down with COVID (15Jul2021). What was really concerning about that was she did not know if she was super immune or was not as immune. She experienced Covid brain fog (on an unspecified date in 2021). Exactly 21 days apart she saw Health Care Professional when had COVID. The patient further stated that no one knew if you need another booster, she planned on getting the booster on 18Oct2021, eight months from my last vaccine, she did not know whether to continue to wear the mask, she did not want a cold, did not want anything, she believed the shots kept her out of the hospital, believed it could have been a lot worse. The patient questioned Where she stands on being immune, what should be done if a vaccinated person develops COVID-19? The patient stated that she didn't do a report of adverse reaction. The events I came down with covid were considered as serious (Medically Significant). The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid about 1 week ago; contracted Covid about 1 week ago; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) the first and second dose, both on unknown date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient is fully vaccinated but contracted Covid about 1 week ago before the time of reporting. Specific covid vaccine that the patient received is unknown, dated of administration are unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: On 18Aug2021 I was diagoned with Covid 19; I was exposed at my place; This is a spontaneous report received from a contactable consumer or other non HCP (patient) via Epsilon Escalation team. A patient (consumer) of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, and Batch/Lot numbers was not reported), dose 2 via an unspecified route of administration on Jun2021 (age at the time of each vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On the patient assistance program, the patient stated received both doses of the vaccine. The first dose was taken in May2021 and the second was taken in Jun2021. On 18Aug2021, the patient was diagnosed with Covid 19. The patient was exposed at the place of employment in 2021. The patient underwent lab tests and procedures which included SARS-COV-2 test, the patient was diagnosed with Covid-19 on 18Aug2021. The outcome of the event was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 28Apr2021 (at the age of 47-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included VYVANSE. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, lot number: ER2613) via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 47-year-old) as dose 1 for covid-19 immunisation. 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. The patient was not pregnant at the time of vaccination. The patient experienced Symptoms of Covid virus and positive test results on 20Aug2021 and sick for several days with sore throat, slight fever 99.9 for two days, fatigued, headache, and sinus congestion. The patient underwent lab tests which included body temperature: 99.9 and SARS-COV-2 test: positive on 20Aug2021 (Nasal Swab). The patient received treatment for the events with Hydroxychloriquine, Zithromax, and monoclonal infusion. Since the vaccination the patient was tested for COVID-19. Outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Cataracts, could not read; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis going to the lungs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced cataract, could not read. The reporter stated that the patient had got rheumatoid arthritis that went to his lungs, but the patient was fully vaccinated, after getting was just advised to be careful. The patient has had no problems with the vaccine. The rheumatoid arthritis going to the lungs was all prior to first and second COVID-19 doses. The reporter gave her COVID card to the patient, the patient could not read it and needed to get glasses. The reporter laughed and said they both have cataracts. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cataract  and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Facial paralysis, Feeling abnormal, SARS-CoV-2 test negative
Clinical narrative: foggy brain; atrial fibrillation; facial paralysis; This is a spontaneous report from a contactable Nurse. This contactable 36-year-old female Nurse (patient) reported for herself that:  A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 36-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included nervous system disorder from an unknown date, hay fever, environmental allergies, known allergies hay fever, environmental allergies. Patient had no concomitant medications. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient had not received any other vaccines within 2 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19On Mar2021 at 15:45, the patient experienced facial paralysis, foggy brain, atrial fibrillation. The patient underwent lab tests and procedures which included Nasal Swab: negative on Mar2021. The patient died on Mar2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Facial paralysis, Feeling abnormal, Atrial fibrillation cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: side effect of Covid-19 inoculation
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable other health care professional (HCP). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) first dose via intramuscular administered at right arm on 22Jan2021 13:30 (lot number: EL3248) (at the age of 42-year-old) and second dose via intramuscular administered at left arm on 02Feb2021 13:30 (at the age of 42-year-old) (Lot Number: EL3248) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient known allergies was unknown. Patient was not pregnant at the time of vaccination. It was unknown, if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient has been tested for COVID-19 since the vaccination. The patient had symptoms of cough and nasal congestion since 22Aug2021. The patient was diagnosed with being positive with COVID on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 23Aug2021 Post vaccination. Outcome of events was not recovered. Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the events covid19 and drug ineffective cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolisms with the vaccine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary embolism with the vaccine on an unspecified date of 2021. Caller reported having a pulmonary embolism, previously healthy, and the PE was considered unprovoked which she described as having no known cause. Caller said she found information on the VAERS sites regarding pulmonary embolisms, saying that 984 cases were reported, that it has affected 0.47% of people which is 1/200 people. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Magnetic resonance imaging, Vision blurred
Clinical narrative: blurry vision on both eyes; This is a spontaneous report from a contactable consumer (Caller reported for grandson) or other non-Healthcare Professional (HCP). A 19-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In two weeks, the patient experienced blurry vision on both eyes on an unspecified date and was hospitalized. It was reported that the patient would be getting the second dose and will be back on campus and they are making him quarantine and get tested every week. He was still having this issue up until today (as reported). They have been to the doctor. The patient underwent lab tests and procedures which included computerised tomogram: unknown results, lab test (investigation): unknown results, magnetic resonance imaging: unknown results. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: kicked in his rheumatoid arthritis; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced kicked in his rheumatoid arthritis. It was reported that the patient previously received his first dose of the vaccine on 03Mar2021 which kicked in his rheumatoid arthritis. The patient asked if he should receive the second dose of the vaccine to complete the series. The patient stated that his rheumatologist  would be sceptical to receive the second dose, PCP reported of not having enough information to guide him in his decision making. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received his 1st Pfizer covid vaccine dose on 04Aug2021 and then was diagnosed with Covid-19 on 10Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0171 and expiration date was not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 14:00 (age 42-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's relevant medical history included blood pressure high and ulcer from an unspecified date and ongoing. The concomitant medications included Hydrochlorothiazide at 25mg once daily from an unspecified date and ongoing for blood pressure high, Amlodipine at 5mg once a day from an unspecified date and ongoing for blood pressure high, Pantoprazole 1 tablet once daily from an unspecified date and ongoing for Ulcer. No prior vaccinations/other vaccinations within four weeks prior to the first administration date of the suspect vaccine was given. The patient stated that people came to his job and gave him the shot of Pfizer Covid 19 vaccine on 04Aug2021, then he got Corona, so he missed his second dose. The received his first Pfizer covid vaccine dose on 04Aug2021 and then was diagnosed with Covid-19 on 10Aug2021. Today, on 25Aug2021, he was supposed to get his second Comirnaty dose and could not be due to quarantine x 14 days plus 3 days extra. The patient asked when he could get it and if he could still get it at his job. He went to his doctor's office, who did the Covid test, which came back positive. No treatment was prescribed, he was just told to quarantine for 14 days, but he had to go an extra 3 days because his daughter got Covid too. The patient declined to provide email address. The patient underwent lab tests and procedures which included sars-cov-2 test which was found to be positive for Covid 19 on 10Aug2021. The outcome of the event was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0175, Expiry date: Unknown) via an unspecified route of administration on 07May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient tested positive post vaccination. The patient previously received bnt162b2 (lot number: EW0162) as dose 1 on 16Apr2021 for COVID-19 immunisation. The patient was not pregnant. On 23Aug2021, the patient tested positive for covid today aka breakthrough case, headache, fever, loss of smell, and body aches. The adverse event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. It was unknown if therapeutic measures were taken for the events. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0175, Expiry date: Unknown) via an unspecified route of administration on 07May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient tested positive post vaccination. The patient previously received bnt162b2 (lot number: EW0162) as dose 1 on 16Apr2021 for COVID-19 immunisation. The patient was not pregnant. On 23Aug2021, the patient tested positive for covid today aka breakthrough case, headache, fever, loss of smell, and body aches. The adverse event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. It was unknown if therapeutic measures were taken for the events. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: The shot been making my a1c going high it, in February my a1c was at 5.1 before the shot and after the shot it jumped to 9.1; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, in left arm (at the age of 50-years-old), on 05Feb2021 10:00, at dose 1, single for covid-19 immunization from health facility. Medical history included high blood pressure and known allergies to soy oil. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient reported that the vaccine shot making his a1c high. In Feb2021 his a1c was at 5.1 before the shot and it jumped to 9.1 after the shot on 01Mar2021 while his blood sugar and blood pressure were nominal. Therapeutic measures were taken as a result of the events with doctor visit. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fully vaccinated and tested positive for COVID.; Fully vaccinated and tested positive for COVID.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 23Mar2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021.  Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date in 2021. The outcome of event COVID-19 was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura, Keratosis pilaris
Clinical narrative: started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; This is a spontaneous report from a contactable consumer. A 40-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Apr2021 (age 40-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started to develop bumps on his legs and then it had morphed into basically IGA vasculitis on 19Apr2021. The patient said that he was told that when he called, he was supposed to reference a case number, that was opened by his dad. He provided that he did not know how much information was on that original case but basically on 13Apr2021 he had the first dose of the COVID vaccine and then on 19Apr2021 he started to develop bumps on his legs and then it had morphed into basically IGA vasculitis. He asked how long a safety report took and he was just trying to follow up on what his dad had already started. He was hoping that he could just get some information and feedback on the correlation of getting the COVID vaccine and cases of IGA vasculitis. He said if he could be given answers to his question as opposed to going through with a report then he would rather go to that department. The reason for no lot number of COVID vaccine, was that the caller was unwilling to complete the report. The outcome of the events was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had the first dose of the Pfizer Vaccine; Came down with Covid; This is a spontaneous report from a Pfizer Sponsored Program. This is the first case out of two cases in which the reporter is reporting for herself. A non-contactable female patient (consumer) of an unspecified age reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 02Aug2021 (Age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, she and her husband had the first dose of the Pfizer Vaccine on 02Aug2021 and they both came down with Covid on 10Aug2021. So, they were out of quarantine on the 22Aug2021 of this month and now they want to go get their second dose, but the doctor told them that they have to wait 90 days. The was transferring because of the adverse event. The patient mentioned "Correct, eight days after she got the Pfizer-BioNTech COVID-19 vaccine and she got Covid. She was no longer on the line now and no phone number was given. The patient hung up the call abruptly before warm transfer in Pfizer Drug Safety. Hence, product details (LOT#, Expiration date, NDC#, UPC#), Pharmacy details and other details could not be probed. Call back could not be done as no contact information was available. Hence, limited information was available over the call. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101105023 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Had stuffy nose,; sore throat minor aches.; sore throat minor aches; Rapid Test 24Aug21 positive.; Rapid Test 24Aug21 positive.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient did rapid test 24Aug21 result was positive and on an unspecified date the patient had stuffy nose, sore throat and minor aches. It was reported that event took place after use of products. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 24Aug2021. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Had stuffy nose,; sore throat minor aches.; sore throat minor aches; Rapid Test 24Aug21 positive.; Rapid Test 24Aug21 positive.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient did rapid test 24Aug21 result was positive and on an unspecified date the patient had stuffy nose, sore throat and minor aches. It was reported that event took place after use of products. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 24Aug2021. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a non contactable Nurse.   A 27-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL3248) via intramuscular route of administration on 03Feb2021 at 8:15 (age at the time of vaccination was 27-year-old) in right arm, as single dose for COVID-19 immunization. Medical his-tory and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3248) via intramuscular route in right arm on an unspecified date at 07:45 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was tested for COVID post vaccination. It was unknown if the patient had other vaccines in 4 weeks. On 21Aug2021, the patient experienced 8/23- live in daughter tested positive for COVID yesterday. The patient underwent lab test and procedure of SARS-CoV-2 test positive on 23Aug2021. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected. As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the product and on the conduct of the study is evaluated as part of 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, as appropriate.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure abnormal, COVID-19, Cerebrovascular accident, Death
Clinical narrative: Uncontrollable sugar levels; stroke; heart attack; My father passed away.; Covid test date was on 06Apr2021 with result positive; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 08:00 (at age of 72-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure. No known allergies. No other vaccine in four weeks. Other medications in two weeks included diabetes injections and high blood pressure meds. The patient experienced uncontrollable sugar levels, stroke, and heart attack, all on 06Apr2021. The patient was hospitalization for 7 days. Treatment received was reported as unknown. The patient passed away on an unknown date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No covid prior vaccination. Covid was tested post vaccination, covid test type post vaccination was unknown. Covid test date was on 06Apr2021 with result positive. The event outcome for uncontrollable sugar levels, stroke was not recovered. The outcome for "Covid test date was on 06Apr2021 with result positive" was unknown. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: My father passed away
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Uncontrollable sugar levels; stroke; heart attack; My father passed away.; Covid test date was on 06Apr2021 with result positive; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 08:00 (at age of 72-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure. No known allergies. No other vaccine in four weeks. Other medications in two weeks included diabetes injections and high blood pressure meds. The patient experienced uncontrollable sugar levels, stroke, and heart attack, all on 06Apr2021. The patient was hospitalization for 7 days. Treatment received was reported as unknown. The patient passed away on an unknown date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No covid prior vaccination. Covid was tested post vaccination, covid test type post vaccination was unknown. Covid test date was on 06Apr2021 with result positive. The event outcome for uncontrollable sugar levels, stroke was not recovered. The outcome for "Covid test date was on 06Apr2021 with result positive" was unknown. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: My father passed away
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pain
Clinical narrative: first signs and symptoms for COVID; body aches; sick; This is a spontaneous report from a contactable consumer (parent). This consumer reported that an 18-year-old female patient (consumer's daughter) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Aug2021 (age 18-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter (parent) called for her 18-year-old daughter with asthma who received her first dose of the Pfizer COVID Vaccine on 07Aug2021 and showed her first signs and symptoms for COVID on 14Aug2021. She mentioned that she had body aches and other symptoms that made her sick on 14Aug2021 but did not require hospitalization. She mentioned that she seems to be okay and was herself with no symptoms as of now. She mentioned that they have also completed isolation. Her daughter was due for her second dose on 28Aug2021. She was asking when the best time for someone was who had COVID to get the vaccine's second dose because their doctor and the daughter's physician told them different things. The Physician told them to wait 60 days in which she mentioned differed from what she knew was the 42-day maximum interval. She also mentioned that some guidelines told them to wait 90 days given that people who received an infection are more protected. She wanted to know the guidance from Pfizer. Caller disconnected before survey was offered. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Formication, SARS-CoV-2 test, Vertigo
Clinical narrative: About 2 weeks after vaccine vertigo started; First week of June experienced burning sensation in arms and legs; Then crawling sensation on arms and legs; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 32-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ew0185) via an unspecified route of administration, administered in arm left on 15May2021 10:00 (at the age of 32-year-old) at dose 1, single for covid-19 immunisation. Medical history was not reported. Patient had no Known allergies. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Concomitant medication included magnesium (MAGNESIUM); paracetamol (TYLENOL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) (Other medications in two weeks), all taken for an unspecified indication, start and stop date were not reported. On 25May2021 10:00, the patient experienced about 2 weeks after vaccine vertigo started, first week of june experienced burning sensation in arms and legs, then crawling sensation on arms and legs. Clinical course of events includes; about 2 weeks after vaccine vertigo started then went away after about 2 weeks. First week of June experienced burning sensation in arms and legs. Then crawling sensation on arms and legs u tik this date. The patient underwent lab tests and procedures which included Nasal swab, PCR (sars-cov-2 test): negative on 17Aug2021. Patient received treatment with Meclizzine, prednisone, ibuprofen, flexral, gabap for the adverse events. Outcome of the events was not recovered, at the time of reporting.  No FU attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: recently died from covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter had a good friend who was fully vaccinated and didn't know which vaccine he got, who recently died from covid. The reporter knew nothing was 100%.  The patient died on an unspecified date in 2021.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: recently died from covid
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: aneurysm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender may received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Caller claimed that some guy she knows got an aneurysm and died but she was not sure if that person took the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: aneurysm
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was stated that patient passed away one week after receiving the 1st Pfizer covid vaccine injection. He was young and healthy. The patient died on an unspecified date due to unknown cause of death. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died at 36 years old.; This is a spontaneous report from a non-contactable consumer.   A 36-years-old male patient received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient died at 36 years old. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died at 36 years old
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that his brother passed away after receiving the vaccine and had a stroke on an unspecified date, and there was nothing wrong with him prior to that. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter would like to know what exactly is in the shot and what the chemicals are that are in the shot. He has been recently notified that the FDA has approved the booster and wants to know what is in that one too.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Reported Cause(s) of Death: stroke
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She took her second dose and she died five days after; This is a spontaneous report from a contactable consumer. This female patient of unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient took her second dose and she died five days after on 24Aug2021. No prior health issues (further not clarified). The reporting consumer had coffee with patient that morning and she died hour and a half later. In moment reporting consumer find her on ground because of the vaccine. The reporting consumer asked how you guys can give a vaccine that kills people. Like it killed patient two days back (further not clarified) when she took it. Covid was not even that serious. The reporting consumer was going to file a huge lawsuit against you guys, a huge law site. But patient didn't have to die if you guys didn't fear among her and taking your stupid vaccine. She only died because she took up the vaccine. You know that right! because she took Pfizer. There's more than 11 thousand deaths (not clarified) because of that shit. The very system was wrong, they are probably knowing that people are dying because of your stupid vaccine. There's no way that could be approved if it is killing over 11 thousand people. The outcome of the event was fatal. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: She took her second dose and she died five days after
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Nausea, Neck pain
Clinical narrative: This is a spontaneous report from a program from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 (Batch/Lot Number: EW0181) (at the age of 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included complex regional pain syndrome from 1985 to an unknown date (Nerve reflection dystrophy bilateral hands and arms), milk allergy from an unknown date and unknown if ongoing, weight increased from an unknown date and unknown if ongoing, allergy reactions for decades and knows to what to do, mold allergy for decades, urticaria from an unknown date and unknown if ongoing (Initially she had to delay getting the vaccine because she was having hives). There were no concomitant medications. The patient previously took varicella zoster vaccine for immunization on 2021 (Ten weeks prior she had shingles vaccine). Patient stated that she experienced the same allergic reaction within 3 to 4 hours after both doses of the vaccine, initially sinus pressure, head ache that eventually involved entire head, neck, and shoulders, nausea, and congestion that resulted in a really thick heavy mucus when able to clear my sinuses. Within 4 hours of getting the first dose patient had a headache across her sinuses and over her head around the back. This lasted for 2.5 - 3 days. She had neck and shoulder pain and nausea. Described all of this as a heavy ache. Usually all of her reactions are about that long. That tells her there is a lot of mold in the vaccine (as reported). Patient took pain and other medications. Patient added with both doses she had sinus pressure and thick mucus formation. She hasn't had this in a long time. She had an onset of sinus pain. She has had a recurring headache since then. Her neighbor flooded the bathroom floor. Patient feels that there was mold between the flooring. She thinks she was currently being exposed to mold. She developed a bad headache in her forehead that went to the back and sides. This lasted for 2.5 days. She still has a headache but cannot rule out if it is related or not. She also had nausea after the second dose. Patient stated the symptoms took 4 days to resolve after the first dose and 3 to 3.5 days to resolve after the second dose. Patient stated this reaction mimics a classic reaction to mold. Patient stated she has had a mold allergy for decades. Patient stated, It has been years since I have been this sick with an allergic reaction. Patient suspects there may either be a mold component to the vaccine or that the vaccine was stored improperly resulting in microbial growth in the vial. Initially patient had to delay getting the vaccine because she was having hives. She received the second dose on 06Aug2021. It was given in her right arm. Lot: EW0181. The outcome of events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she died; This is a spontaneous report from a contactable consumer (patient was reporter's girlfriend). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she died (death, medically significant) on an unspecified date immediately, 49-year-old from Pfizer. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: she died
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-COVID-19 Vaccine, Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. COVID prior vaccination and COVID tested post vaccination was Unknown. The patient experienced tired on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.