chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Viral myocarditis
Clinical narrative: shortness of breath; coughing; Congestive heart failure; her heart had a virus; fluid under lungs and heart; fluid under lungs and heart; had a skipping heart beat; very weak; low pulse rate; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158) at the age of 63-years, via an unspecified route of administration, administered in right arm on 12Apr2021 at 12:00 at single dose for covid-19 immunisation, at pharmacy or drug store. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not pregnant at time of vaccination. There were other medications the patient received within 2 weeks of vaccination. On 09Aug2021 she had shortness of breath and coughing. Thought she had COVID again but got tested and was negative. Went to ER. Congestive heart failure. Never had a past history of any type of heart problems. After a 4 day hospital stay, she was told her heart had a virus. Still taking furosemide (LASIX) and Beta blocker to remove fluid from her under her lungs and heart. She was currently wearing a heart monitor and had a skipping heart beat. Will be seeing a EP cardiologist once reports are all in to monitor her heart. Very weak and low pulse rate. These adverse events started on 09Aug2021 at 10:00, result in emergency room/department or urgent care. The patient underwent lab tests and procedures, which included test for COVID was negative. Outcome of the events was not recovered/not resolved. The events were reported as life-threatening and hospitalization for 3 days.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Cerebral venous sinus thrombosis; received the first and second dose on the same date; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 41-year-old female patient received bnt162b2 (Pfizer COVID 19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 24Apr2021at 09:45 (at age of 41-year-old) (Batch/Lot Number: ER8729) as single dose, dose 2 via an unspecified route of administration administered in right arm on 24Apr2021 (at age of 41-year-old) (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. The medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced cerebral venous sinus thrombosis in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (from 2021), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment included Lovenox Injections twice a day. The patient received the first and second dose on the same date on 24Apr2021.  The covid test type post vaccination=Nasal Swab was negative on 2021.  The outcome of cerebral venous sinus thrombosis was not recovered, of other event was uknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Renal disorder, Renal failure
Clinical narrative: pass away/he died; couldn't breathe; kidney dialysis fail; kidney stops; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included had a stroke year before 2020 so he was weak. 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. The patient's wife called on behalf of the patient seeking compensation due to the Pfizer-BioNTech Covid-19 Vaccine. It was stated patient 19Apr2021 they had the second vaccine together. And on Tuesday 1pm (in 2021) ambulance came in and got patient cause he couldn't breathe, and they sent him to privacy hospital cause the kidney dialysis fail. They went in the morning 8'clock they go in there and they call 8:30 patient pass away in 2021. Patient had a stroke year before 2020 so he was weak they push him, and walk him, exercise and all kind of things. They didn't warn that not supposed to have a second vaccine so patient and wife went no more a week later, 2 weeks, patient and wife had first and second shot and then patient went #. When patient died and his kidney stopped. Events reported as hospitalized in 2021. The outcome of the event pass away/he died was fatal, while of the other events was unknown. 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: pass away/he died
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This person got the Covid 19 vaccine and died 3 days later; This is a spontaneous report from a contactable consumer. An 80-years-old male patient received dose of BNT162B2 (reported as 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 immunization. Medical history included prostate cancer and chemotherapy. The patient's concomitant medications were not reported. The reporter stated she knew a radiology technician who mentioned the patient that was going through chemotherapy at age 80 for prostate cancer. This patient got the Covid 19 vaccine and died 3 days later. She thought it was a bad call for this patient to get the Covid 19 vaccine. She stated some people might think that because of being immune compromised those people might succumb to the Covid 19 virus. She asked in certain patient populations, like if someone is receiving chemotherapy, is it recommended that the Covid 19 vaccine be given. The report was serious with seriousness criteria-results in death. 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: This person got the Covid 19 vaccine and died 3 days later
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender 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. Reporter's 2 family's members of hers died after receiving the pfizer biontech covid 19 vaccine on an unspecified date. 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: 2 family's members of hers died
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had Covid/ PCR: Nasal Swab: Positive; Had Covid/ PCR: Nasal Swab: Positive; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Feb2021 09:00 (at the age of 41-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Patient did not take concomitant medications (No other medications in two weeks). No other vaccine in four weeks. No covid prior vaccination. On 11Aug2021 (symptoms started), the patient had covid. On 15Aug2021, the patient underwent covid test post vaccination with PCR Nasal Swab test which resulted as positive. No treatment was given. The outcome of the event was recovered with lasting effects.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient's cousin). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 27Jan2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. Medical history included controlled hypotension. The patient's concomitant medications were not reported. The patient experienced pulmonary embolism on 12Feb2021. The consumer is calling about the Covid 19 vaccine, on behalf of her cousin (the patient) that used to live with her when they were children. The patient received the Covid 19 vaccine in Jan2021 and he died afterward of a pulmonary embolism. This has been a touchy subject talking to the patient's wife. The patient did not have any other health issues. He was getting ready for work and he died. The only reason he got the Covid 19 vaccine was so he could visit the caller's 97 year old mother. An autopsy was performed by the funeral home and it states cause of death, pulmonary embolism. She reports the coroner with Rolling Hills has the autopsy information. The patient only received one dose of the Pfizer Covid 19 vaccine. The caller reports that the patient was very good at going to his doctor's appointments. She reports the patient did have controlled hypertension on medications, no big deal. He wasn't overweight or diabetic or even prediabetic. His death just seems very random. She reports the date of death as 12Feb2021 early in the morning. The patient was in the bathroom getting dressed for work. The caller is glad the patient's children wanted an autopsy because the patient did not have any preexisting conditions. The evet did not require a visit to Emergency Room or Physician Office. There is no relevant tests. The patient died on 12Feb2021. An autopsy was performed, autopsy-determined cause of death was pulmonary embolism.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away after being vaccinated; This is a spontaneous report from a Pfizer sponsored program from a Non-contactable consumer (reporter's cousin). A patient of unspecified age and gender 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 for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The reporter stated his cousin pass away after being vaccinated. 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: Passed away after being vaccinated
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective
Clinical narrative: Died due to the fact he received the Covid shot; Tested Positive for Covid after Vaccine; Tested Positive for Covid after Vaccine; This is a spontaneous report from a contactable consumer (patient's friend). 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's medical history and concomitant medications were not reported.  The consumer stated she knew that a friend (the patient) died due to the fact he received the Covid shot. The consumer stated all of the patient's body and organs were spiked with proteins, and they were elevated from Covid. The patient was tested Positive for Covid after Vaccine on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of the event tested Positive for Covid was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died due to the fact he received the Covid shot
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoplastic left heart syndrome
Clinical narrative: Hypoplastic left heart syndrome; This is a spontaneous report from a contactable consumer (patient's father). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (reported as in the afternoon, after 1400) (Batch/Lot Number: EN5318) (at the age of 33-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included heart issue with her heart from an unknown date, several heart surgeries from an unknown date. There were no additional vaccines administered on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none. There was no family medical history relevant to AE. Concomitant medication included ASPIRIN [acetylsalicylic acid] tablet taken for an unspecified indication, start and stop date were not reported. The consumer stated he did not keep close contact on all her medications since she was not living with her parents. The patient experienced hypoplastic left heart syndrome on an unspecified date and died for it on 08Feb2021. The consumer was reporting that his daughter passed away after she got the first Pfizer covid shot. She passed away in February. She got her shot on a Friday and passed away Monday evening. She did have a heart issue with her heart. At the time she had been through several heart surgeries and they did not realize the covid vaccine had issues for cardiac patients. The vaccine was recommended by her doctors. He reported she had hypoplastic left heart syndrome and that was the cause of death. She died on 08Feb2021. She died in her sleep, between 12:30am and 7:30am on 08Feb2021. She did not have an autopsy done at the time. He reported she had just got the shot and he was not sure if she died from natural causes or from the shot. In his heart he felt like she had been cut up enough and did not have an autopsy done. If he knew then the information that he knew now, then he would have had an autopsy done. She received vaccine basis that of her doctor's recommendation and her mother's panic about her covid and dyeing an ugly death, she had two cardiovascular surgeons that both recommended to get the covid vaccine. There was no Emergency Room visit and no physician office visit. The patient died on 08Feb2021.  An autopsy was not performed. The outcome of the event hypoplastic left heart syndrome was fatal.; Reported Cause(s) of Death: Hypoplastic left heart syndrome
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: pre existing condition; peripheral neuropathy; and it has got a little worse; neuropathy was aggravated; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US support.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. Medical history included peripheral neuropathy (Now he has a pre-existing condition which is Peripheral Neuropathy (Medical Condition)). Concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced pre-existing condition; peripheral neuropathy; and it has got a little worse; neuropathy was aggravated. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: had a heart attack and died; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of unknown age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer Covid 19 vaccine, had a heart attack after both vaccine. The patient died due to heart attack. It was unknown if autopsy was done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: had a heart attack and died.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: tested positive after being fully vaccinated; tested positive after being fully vaccinated; This is a spontaneous report from contactable consumer (Patient wife). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in Arm Right on 27Apr2021 (Batch/Lot Number: EW0167, NDC number and Expiry Date: Unknown) as dose 1, single (Age at Time of Vaccination: 44-years-old) and dose 2 via an unspecified route of administration in Arm Right on 18May2021 (late morning) (Batch/Lot Number: EW0178, NDC number and Expiry Date: Unknown) as dose 2, single (Age at Time of Vaccination: 44-years-old) both taken for COVID-19 immunisation. Medical history included crohn's disease (Diagnosed Spring 2018) from 2018 and ongoing. Concomitant medications included infliximab dyyb (INFLECTRA [INFLIXIMAB DYYB]) taken for crohn's disease from an unspecified start date and ongoing; azathioprine taken for crohns disease from an unspecified start date and ongoing. The patient previously took remicade on an unknown date. The patient underwent lab test and procedure which included tested positive (SARS-CoV-2 test): Positive on 18Aug2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, there were no additional vaccines administered on same date of the Pfizer suspect, there were no prior vaccinations (within 4 weeks) the patient took. The vaccine was administered at Military facility. The patient did not have adverse event following prior vaccinations. The reporter stated that her husband was fully vaccinated, He had the second dose on 18May2021 and since tested positive for the virus (18Aug2021). They have 4 other friends who are fully vaccinated who tested positive. The reporter would give them the number to call and added that the phone tree was horrific to try to get through on. The patient did not go to Emergency Room and Physician Office. The events were considered as serious (Medically Significant). The outcome for events was unknown.  Follow-up attempts are completed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095815 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095813 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095814 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095816 same reporter/drug/AE, different patients.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: who are fully vaccinated who tested positive; who are fully vaccinated who tested positive; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 44-years-old) as DOSE 1, SINGLE and dose 2 bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 44-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included crohn's disease from 2018 and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Inflectra 400mg infusion every 8 weeks for crohn's disease and Azathioprine 50mg daily for crohn's disease. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient was tested positive for Covid 19. Reported as: who are fully vaccinated who tested positive. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095688 same reporter/drug/AE, different patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: who are fully vaccinated who tested positive; who are fully vaccinated who tested positive; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 (Batch/Lot Number: EW0178) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot Number: EW0167) as for covid-19 immunization. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. AEs following prior vaccinations reported as none. On 18Aug2021, the patient experienced who are fully vaccinated who tested positive (medically significant). Reporter states her husband is fully vaccinated. He had the second dose since tested positive for the virus. They have 4 other friends who are fully vaccinated who tested positive. The patient did not visit emergency room or physician office for AEs. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on an unspecified date in 2021. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095688 same reporter/drug/AE, different patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: who are fully vaccinated who tested positive; who are fully vaccinated who tested positive; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received first dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0167), via an unspecified route of administration, administered in Arm Right on 27Apr2021 as single dose and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0178) via an unspecified route of administration, administered in Arm Right on 18May2021 ,as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient taking COVID Vaccine for COVID prevention. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. It was reported that relevant test was none.It was reported that  Investigation Assessment was No. Adverse event following prior vaccinations was None. It was reported that Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. It was reported that History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available) was None. Time the Vaccination Given was late morning. The patient experienced who are fully vaccinated who tested positive on 2021. It was reported that Emergency Room and Physician Office visit was no. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2021. The outcome of the events was unknown.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095688 same reporter/drug/AE, different patients.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dementia, Memory impairment, Scan brain, Urine analysis
Clinical narrative: Having memory issues after taking the Pfizer vaccination; Or if the vaccination may have triggered something in his brain to react like Dementia; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 21Jan2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer wanted to confirm, could the Pfizer vaccination cause some memory loss, her husband (patient) was having memory issues after taking the Pfizer vaccination and she was wondering if that was a possible rare side effect that may get better with time or if the vaccination may have triggered something in his brain to react like Dementia. The patient further stated that in early March the patient started having memory problems and was admitted to the hospital and he received both, the different blood test and urine test and brain scan and so far, he was being diagnosed with probable dementia. The patient was a 58 years old male and all this happened in early March after receiving the first two dose of the vaccine in January and February. The patient underwent lab tests and procedures which included blood test, scan brain and urine analysis, all unknown results on an unknown date in Mar2021. The clinical outcome for events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, International normalised ratio, Magnetic resonance imaging
Clinical narrative: short of breath; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received second dose of bnt162b2 (BNT162B2) at the age of 73-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 11:00 (Batch/Lot Number: ER2613) as dose 2, single for covid-19 immunisation. Medical history included atrial fibrillation (A Fib) from 2019 and ongoing (Pertinent details: Watchman procedure 13May2021), ongoing hypertension (High BP), diabetes from 2018 and ongoing , breast cancer from 1995 to an unknown date (Pertinent details: Lumpectomy 1995 mastectomy 2019), Lumpectomy from 1995 to an unknown date, mastectomy from 2019 to an unknown date, Left eye blindness from an unknown date and unknown if ongoing (Pertinent details: Many tests), cerebrovascular accident from 12Mar2021 to an unknown date, ongoing allergies, stroke from 12Mar202. Family medical history was none. Concomitant medications included rivaroxaban (XARELTO) Pill taken for atrial fibrillation (A Fib) from an unspecified start date to 13Mar2021; sitagliptin phosphate (JANUVIA) Pill taken for diabetes mellitus ongoing; metoprolol (METOPROLOL) taken for atrial fibrillation (A Fib) ongoing; loratadine (CLARINET) Pill taken for hypersensitivity (Allergies) ongoing. The patient previously took first dose of bnt162b2 (Batch/Lot number: EN6203 ) on 27Feb2021 10:00 AM in Right arm for covid-19 immunization and experienced Eye stroke on 12Mar2021 10PM with Seriousness criteria: Hospitalization/prolongation of hospitalization, Persistent/Significant disability/Incapacity and hospitalized for 4 Days, required visit to Emergency room and Physician office, outcome of not recovered, treatment received included many. The patient experienced short of breath on 25Mar2021 04:00 AM with outcome of recovering, required visit to Emergency room and treatment received included Heart meds. The patient was hospitalized for short of breath for 3 days. Seriousness criteria of the events was hospitalization, life threatening. The patient underwent lab tests and procedures which included blood test: many on 13Mar2021, computerised tomogram (CT Scans) : unknown results on 14Mar2021, international normalised ratio (INR ): ongoing on 14Mar2021, magnetic resonance imaging(MRI): strokes-eye and brain on 15Mar2021, sars-cov-2 test (Covid test): negative on 11May2021, ultrasound scan: unknown  results on 14Mar2021. Vaccination facility type was hospital. Prior vaccinations was none. No Autopsy information.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound scan
Clinical narrative: short of breath; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received second dose of bnt162b2 (BNT162B2) at the age of 73-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 11:00 (Batch/Lot Number: ER2613) as dose 2, single for covid-19 immunisation. Medical history included atrial fibrillation (A Fib) from 2019 and ongoing (Pertinent details: Watchman procedure 13May2021), ongoing hypertension (High BP), diabetes from 2018 and ongoing , breast cancer from 1995 to an unknown date (Pertinent details: Lumpectomy 1995 mastectomy 2019), Lumpectomy from 1995 to an unknown date, mastectomy from 2019 to an unknown date, Left eye blindness from an unknown date and unknown if ongoing (Pertinent details: Many tests), cerebrovascular accident from 12Mar2021 to an unknown date, ongoing allergies, stroke from 12Mar202. Family medical history was none. Concomitant medications included rivaroxaban (XARELTO) Pill taken for atrial fibrillation (A Fib) from an unspecified start date to 13Mar2021; sitagliptin phosphate (JANUVIA) Pill taken for diabetes mellitus ongoing; metoprolol (METOPROLOL) taken for atrial fibrillation (A Fib) ongoing; loratadine (CLARINET) Pill taken for hypersensitivity (Allergies) ongoing. The patient previously took first dose of bnt162b2 (Batch/Lot number: EN6203 ) on 27Feb2021 10:00 AM in Right arm for covid-19 immunization and experienced Eye stroke on 12Mar2021 10PM with Seriousness criteria: Hospitalization/prolongation of hospitalization, Persistent/Significant disability/Incapacity and hospitalized for 4 Days, required visit to Emergency room and Physician office, outcome of not recovered, treatment received included many. The patient experienced short of breath on 25Mar2021 04:00 AM with outcome of recovering, required visit to Emergency room and treatment received included Heart meds. The patient was hospitalized for short of breath for 3 days. Seriousness criteria of the events was hospitalization, life threatening. The patient underwent lab tests and procedures which included blood test: many on 13Mar2021, computerised tomogram (CT Scans) : unknown results on 14Mar2021, international normalised ratio (INR ): ongoing on 14Mar2021, magnetic resonance imaging(MRI): strokes-eye and brain on 15Mar2021, sars-cov-2 test (Covid test): negative on 11May2021, ultrasound scan: unknown  results on 14Mar2021. Vaccination facility type was hospital. Prior vaccinations was none. No Autopsy information.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had the breakthrough infections had had two doses of the Pfizer vaccine; had the breakthrough infections had had two doses of the Pfizer vaccine; This is a spontaneous report from a contactable physician reporting same events under the same suspect product for 10 total number patients. This is one of 10 reports.  A patient of unspecified age and gender received two doses of 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 was not reported. The patient's concomitant medications were not reported. It was reported ten patients had breakthrough infections. Local pharmacies in their area giving booster dose and the patients that had had the breakthrough infections had had two doses of the Pfizer vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID  infections  based on the known safety profile.,Linked Report(s) : US-PFIZER INC-202101058062 same reporter/SD/AE, different patient
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He was found dead in his home by friends who went looking for him after he didn't show up for work... possible suicide?
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Furuncle, Headache, Injection site reaction, Pain in extremity
Clinical narrative: Getting boil on the arm where shot was taken. Arm getting sore and little painful. Headache and weakness felt
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Subject lactating at time of vaccination on Aug 3. Baby, 7mos/M, had fever 38'C Aug 8-Aug 10. Baby recovered from fever. Infant was vaccinated with H. Influenza Jul 24 and had fever overnight.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chills, Nausea, Pyrexia
Clinical narrative: Fever developed after 7-10 hours from injection. Fever presisted for nearly 24 hours after first sign of symptoms.  Slight nausea and weakness, chills, bedridden for the duration of the fever. Fever broke after 24 hours or so, weakness and chills persisted and gradually diminished over a further 24 hours. Full recovery at 72 hours from first symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: experienced a fever after her first; headache; fatigue,; achiness; This is a spontaneous report from a contactable consumer or other non hcp.   A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 43 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Caller also states that she experienced a fever after her first does but it was "not that bad" and also reports "I had all the other symptoms that are listed in terms of headache, achiness, fatigue, and blah blah blah."  Caller is just concerned about the fever being this high and would like to know how long it is expected for this fever to last. Caller would like to know what medication would recommend to take to help with the fever, as far as Ibuprofen or Tylenol. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Hypertension, Pain, Pyrexia
Clinical narrative: Fever; severe Body aches; head ache; unexplained odd discomfort in uterus and Fallopian tubes; High Blood pressure; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:30 (at the age of 73-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included High BP from an unknown date and unknown if ongoing, gout from an unknown date and unknown if ongoing, Penicillin (Drug hypersensitivity) from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: 9269), via an unspecified route of administration on 10Feb2021 at 13:30 (at the age of 73-year-old) administered in Left arm as single dose for COVID-19 immunisation. It was reported that other vaccine not administered in four weeks. It was reported that Other medications was taken in two weeks. It was reported that it was unknown If patient had covid prior vaccination. Covid tested post vaccination was No. The patient experienced Fever, severe Body aches, headache and unexplained odd discomfort in uterus and Fallopian tubes and High Blood pressure on 04Mar2021 09:00. The patient did not received treatment for the event. The outcome of all event was Recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Depressed mood, Headache, Nausea
Clinical narrative: Nausea; Chills; Feelings of being "rundown"; Headache; Increased body temperature; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 26Apr2021 at 14:45(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 11:00,   roughly 20 hours after the first vaccine, the patient experienced feelings of being rundown, headache and increased body temperature. Later in the night, roughly 30 hours after the vaccine, the patient experienced a sense of nausea, chills and still had an intense headache at the time of reporting. Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feelings of being "rundown", headache, increased body temperature, nausea and chills was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection-site redness; Injection-site soreness; Injection-site swelling; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 27Apr2021 at 14:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications included loratadine (CLARITIN) and bismuth subsalicylate (PEPTO BISMOL) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 06Apr2021 at 14:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 08:30, the patient experienced injection-site redness, injection-site soreness and injection-site swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection-site redness, injection-site soreness and injection-site swelling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Fine red itchy rash over all of upper torso; Fine red itchy rash over all of upper torso; Body aches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 16Apr2021 at 10:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril/hydrochlorothiazide (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. On 17Apr2021, the patient experienced arm sore. On 18Apr2021, the patient experienced body aches. On 19Apr2021 at 00:00, the patient experienced a fine red itchy rash over all of upper torso. On 24Apr2021, the patient saw nurse practitioner due to rash increasing. The patient took off work for one week. The patient reported that had been taking zinc from pharmacy but 1 week ago switched to different brand and stopped it all together till this rash was gone. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse events and included treatment with fexofenadine (ALLEGRA) in "am", diphenhydramine (BENADRYL), oatmeal baths, and triamcinolone (MANUFACTURER UNKNOWN) ointment. The clinical outcome of the events arm sore, body aches and fine red itchy rash over all of upper torso were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Headache; Muscle pain; Joint pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 07:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Apr2021 at 07:00, the patient experienced headache, muscle pain, joint pain, and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, muscle pain, joint pain, and chills were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is excepted.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: "Approximately 1 week after, I woke up in the middle of the night and was incredibly aware that I could finally take a deep breath again. Additionally I noticed that my brain fog I had been living with had mostly cleared up."; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: "EN608") via an unspecified route of administration in the right arm on 23Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen and grass. On 11Nov2020, the patient underwent nasal swab test and the result was negative. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 02Apr2021 at 03:00, the patient had a positive effect to report and wanted to give a feedback of the experience of receding the vaccine because the patient thought it was truly a miracle. The patient understood that he was a "COVID long hauler". This term was given to the patient by his physician whom he consulted for shortness of breath and fatigue. He had a strange cold at the very beginning of the pandemic. At the time he was not wearing a mask. It was possible that got sick with the corona virus and had shortness of breath and poor mental clarity or brain fog since. After receiving the first shot of the vaccine, approximately one week after, he woke up at the middle of the night and was incredibly aware that could finally took a deep breath again after going through the majority of the last year not being able to take a deep breath. This was noticeable because the year before he was practicing cross fit and an amazing shape. Additionally the patient noticed that the brain fog had been lived with had mostly cleared up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event "approximately 1 week after, he woke up in the middle of the night and was incredibly aware that he could finally take a deep breath again. Additionally he noticed that his brain fog he had been living with had mostly cleared up" was unknown at this time of report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.