chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Influenza like illness
Clinical narrative: syncope; pleurisy; difficulty breathing; Flu-like symptoms; fever; chills; muscle and joint aches; muscle and joint aches; persistent headache; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176) in the hospital, via intramuscular route on 10Feb2021 at 10:30 at a single dose on the right arm for COVID-19 immunization.  Medical history included Non-Hodgkin's lymphoma from 2010 to 2011 and allergies to penicillin on an unknown date and unknown if ongoing. Prior to vaccination, was the patient not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: H9899) in the hospital, via intramuscular route at 01:15 PM on the left arm for COVID-19 immunization. Since the vaccination the patient has not been tested for COVID-19. It was reported that on 12Feb2021 at 08:00 PM (also reported as '3 days after injection') the patient experienced flu-like symptoms that included fever, chills, muscle and joint aches, and a persistent headache. On 13Feb2021 (also reported as 'on the 4th day', the patient developed pleurisy and difficulty breathing and had 2 syncope events the morning of 14Feb2021 (also reported as 'on the 5th day'). The patient was taken by ambulance and admitted to ER for further testing. It was determined that all symptoms likely related to the second dose of the COVID-19 vaccine recently received. Pleurisy persists one week following vaccine dose. The patient went to the emergency room/department or urgent care due to the events. As treatment for the event, the patient was monitored and given IV fluids over 12 hour stay in CDU. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects). The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship and current known drug safety profile.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pleurisy, Pyrexia, Syncope
Clinical narrative: syncope; pleurisy; difficulty breathing; Flu-like symptoms; fever; chills; muscle and joint aches; muscle and joint aches; persistent headache; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176) in the hospital, via intramuscular route on 10Feb2021 at 10:30 at a single dose on the right arm for COVID-19 immunization.  Medical history included Non-Hodgkin's lymphoma from 2010 to 2011 and allergies to penicillin on an unknown date and unknown if ongoing. Prior to vaccination, was the patient not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: H9899) in the hospital, via intramuscular route at 01:15 PM on the left arm for COVID-19 immunization. Since the vaccination the patient has not been tested for COVID-19. It was reported that on 12Feb2021 at 08:00 PM (also reported as '3 days after injection') the patient experienced flu-like symptoms that included fever, chills, muscle and joint aches, and a persistent headache. On 13Feb2021 (also reported as 'on the 4th day', the patient developed pleurisy and difficulty breathing and had 2 syncope events the morning of 14Feb2021 (also reported as 'on the 5th day'). The patient was taken by ambulance and admitted to ER for further testing. It was determined that all symptoms likely related to the second dose of the COVID-19 vaccine recently received. Pleurisy persists one week following vaccine dose. The patient went to the emergency room/department or urgent care due to the events. As treatment for the event, the patient was monitored and given IV fluids over 12 hour stay in CDU. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects). The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship and current known drug safety profile.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: may have gotten a double dose/ gave him shots in both arms/ thought they inadvertently gave him two doses of it/ unsure if he received two doses or if he only got one; both arms were sore; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age (Age: 73; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: en6200), via an unspecified route of administration on 17Feb2021 at single dose in arm for COVID-19 immunization. Medical history included Heart stents. The patient's concomitant medications were not reported. The patient previously took flu shot for immunization and experienced arms were sore. The patient reported that he may have gotten a double dose today (17Feb2021). They gave him shots in both arms, but said the first shot did not have any thing in it so they gave him another shot. He asked if a double dose was bad they said don't worry about it. Both arms were sore but not any worse than the flu shot. The consumer further reported that he got his first shot today and he thought they inadvertently gave him two doses of it. He got two shots, one in each arm and he was wondering if that's a bad thing. Caller stated they stuck him in one arm and she said "oh there was nothing in it, I'm going to give you another shot in another arm." Caller stated that he was unsure if he received two doses or if he only got one. Caller stated that the vaccination card he was provided only had one lot number and expiration date. Caller stated he was pretty sure he felt stuff go in each arm and both arms were sore, but its no more soreness than the flu shot. Caller asked if he was in danger and if he should watch out for side effects. No Covid prior vaccination. No Covid tested post vaccination. The event was non-serious per the reporter. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; This is a spontaneous report from a Pfizer-sponsored program,  Support. A contactable male consumer (patient) of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on an unspecified date. Medical history and concomitant medications was not reported. On an unspecified date in Feb2021, after the second vaccination, the patient experienced kidney infection. His doctor prescribed antibiotics on 15Feb2021. The patient wanted to know if that will affect the efficacy of the vaccine. Event outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Friday 12th Feb was tested positive; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had her 1st dose of the vaccine on the 8th of Feb (2021), and Friday 12th Feb (2021) was tested positive. The outcome of the event was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage
Clinical narrative: Gastrointestinal? Bleeding; This is a spontaneous report from a contactable consumer (Patient's sister) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # UNKNOWN:), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose already and then had a GI (gastrointestinal)  bleeding. The clinical outcome of gastrointestinal bleeding was unknown.  Information about lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test
Clinical narrative: tested positive on the 11th; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first COVID shot last 03Feb2021. He tested negative on 10Feb2021 and tested positive on 11Feb2021 and 12Feb2021 for rapid test and lab test. On 14Feb2021, he had monoclonal antibody infusion. The patient wanted to know if he still needed to go to his second vaccine shot appointment that was scheduled on 24Feb2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness
Clinical narrative: Altered State of Consciousness.; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 16Feb2021 16:30 at single dose on left arm for Covid-19 immunisation. Medical history included breast cancer with chemo in 2004. No known allergies. The patient did not have Covid prior vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient did not have other vaccine in four weeks.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL1283) via an unspecified route of administration on Jan2021 07:00 AM on left arm for Covid-19 immunisation. The patient experienced altered state of consciousness on 17Feb2021 at 07:00. The patient felt like she was standing beside herself, removed from herself. Lightheaded and remote from her thinking or what she was saying. As if on a psychedelic drug. No flu like symptoms at all. No treatment was received for the event. The outcome of the event altered state of consciousness was recovered in Feb2021. The patient did not have covid tested post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: spure of neuropathy; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient took the first dose of the vaccine for COVID-19 immunization. On 12Feb2021 the patient experienced spure of neuropathy. Patient wanted to know if she can take prescribed "Metanx", that was prescribed before vaccine but not really taking this medication. The final outcome of the event was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Diabetic neuropathy
Clinical narrative: spure of neuropathy; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient took the first dose of the vaccine for COVID-19 immunization. On 12Feb2021 the patient experienced spure of neuropathy. Patient wanted to know if she can take prescribed "Metanx", that was prescribed before vaccine but not really taking this medication. The final outcome of the event was unknown. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Nephrolithiasis
Clinical narrative: Had kidney stones before/Developed kidney stone; Had kidney stones before/Developed kidney stone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included kidney stones. Concomitant medications were not reported. The patient developed kidney stones. She had kidney stones before. Outcome of the event was unknown.  Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Had kidney stones before/Developed kidney stone; Had kidney stones before/Developed kidney stone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included kidney stones. Concomitant medications were not reported. The patient developed kidney stones. She had kidney stones before. Outcome of the event was unknown.  Information on batch/lot number was requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Nephrolithiasis
Clinical narrative: Kidney stones; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Batch/Lot number: EL3247), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included nephrolithiasis (before getting the COVID shot). The patient's concomitant medications were not reported.  The patient experienced kidney stones on an unspecified date. The patient explained that he was scheduled for the second COVID shot on Wednesday. He noted that he has developed a kidney stone and wanted to know if it was ok to get the second dose. It was confirmed that he was used to the pain and has had a bunch of them in the past; he has a history of kidney stones before getting the COVID shot. He stated that he wanted to go ahead and get the shot, the appointments were so hard to get. Outcome of the event was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Batch/Lot number: EL3247), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included nephrolithiasis (before getting the COVID shot). The patient's concomitant medications were not reported.  The patient experienced kidney stones on an unspecified date. The patient explained that he was scheduled for the second COVID shot on Wednesday. He noted that he has developed a kidney stone and wanted to know if it was ok to get the second dose. It was confirmed that he was used to the pain and has had a bunch of them in the past; he has a history of kidney stones before getting the COVID shot. He stated that he wanted to go ahead and get the shot, the appointments were so hard to get. Outcome of the event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Computerised tomogram, Dementia, Feeling abnormal
Clinical narrative: started acting strange, paranoid; started acting strange, paranoid; she forgets things; dementia; This is a spontaneous report from a contactable consumer (patient's daughter)   An 82-year-old female patient received the 1st dose bnt162b2 (BNT162B2) at single dose in arm on 22Jan2021 for Covid-19 immunisation, administered a Clinic. Medical history included macular degeneration from Aug2020 and treated with Saffron and Eylea. The concomitant medications included: Saffron, an herb, started a few weeks before the vaccine was administered for macular degeneration, Eylea shot for the macular degeneration and she got a shot within a few weeks of getting one of the vaccines but this is not a new medication for her. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced dementia in Jan2021, started acting strange, paranoid on 24Jan2021, she forgets things in Jan2021. The events did not require a visit to Emergency Room or Physician Office. Course of events: About 2 days after the 1st shot she started acting strange, paranoid. Her mom lives with her daughter, son in law, and 21-year-old grandson. She though they were stealing from her, her daughter and grandson. Reporter explained she knew this sounded like classic dementia and she forgot things like everyone does but this was uncharacteristic and she was fine up until 3 days after the shot. They have called her primary care doctor who has done blood test looking for a UTI or infection and that came back good. The doctor also did a CT scan and it came back good. Caller explains that the event was about the same since it started. The outcome of dementia was unknown, of started acting strange, paranoid was not recovered. The patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose in arm on 12Feb2021 for Covid-19 immunisation, administered a Clinic.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Paranoid personality disorder
Clinical narrative: started acting strange, paranoid; started acting strange, paranoid; she forgets things; dementia; This is a spontaneous report from a contactable consumer (patient's daughter)   An 82-year-old female patient received the 1st dose bnt162b2 (BNT162B2) at single dose in arm on 22Jan2021 for Covid-19 immunisation, administered a Clinic. Medical history included macular degeneration from Aug2020 and treated with Saffron and Eylea. The concomitant medications included: Saffron, an herb, started a few weeks before the vaccine was administered for macular degeneration, Eylea shot for the macular degeneration and she got a shot within a few weeks of getting one of the vaccines but this is not a new medication for her. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced dementia in Jan2021, started acting strange, paranoid on 24Jan2021, she forgets things in Jan2021. The events did not require a visit to Emergency Room or Physician Office. Course of events: About 2 days after the 1st shot she started acting strange, paranoid. Her mom lives with her daughter, son in law, and 21-year-old grandson. She though they were stealing from her, her daughter and grandson. Reporter explained she knew this sounded like classic dementia and she forgot things like everyone does but this was uncharacteristic and she was fine up until 3 days after the shot. They have called her primary care doctor who has done blood test looking for a UTI or infection and that came back good. The doctor also did a CT scan and it came back good. Caller explains that the event was about the same since it started. The outcome of dementia was unknown, of started acting strange, paranoid was not recovered. The patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose in arm on 12Feb2021 for Covid-19 immunisation, administered a Clinic.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Streptobacillus infection
Clinical narrative: had a bout of strep throat; This is a spontaneous report from a contactable pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date in Jan2021 (3 weeks before this report) for Covid-19 immunisation, administered at a clinic as staff member.  The patient medical history and concomitant medications were not reported.  The patient experienced a bout of strep throat (mild) on an unspecified date after receiving the 1st dose and took an antibiotic in the past 24 hours. The outcome of events was unknown. The documentation stated still to give the vaccine.   Information on batch/lot number was requested.; Sender's Comments: Based on the available information, the event "a bout of strep throat" is attributed to an intercurrent medical condition that was unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart arrhythmia; This is a spontaneous report from a contactable Other Health Professional. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231), intramuscularly in Right arm on 26Jan2021 01:00 at single dose for COVID-19 immunisation. Medical history included HTN (hypertension), BPH (benign prostatic hyperplasia). Concomitant medication in two weeks included lisinopril, tamsulosin hydrochloride (TAMULOSIN), ergocalciferol (VIT D).  Facility type vaccine: Public Health Clinic/Veterans Administration facility. If other vaccine in four weeks: No. The patient previously took naproxen and experienced allergies: Naproxen.  If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced heart arrhythmia (medically significant) on 29Jan2021 12:00 with outcome of not recovered. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Holter monitor.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the event heart arrhythmia is considered as unrelated to suspect vaccine BNT162B2. The patient is most likely due to underlying cardiovascular conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body height decreased, Body temperature, Chills, Fatigue, Feeling hot
Clinical narrative: Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a contactable consumer.  An 89-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 04Feb2021 at 89-year-old at a single dose for COVID-19 immunization.  Medical history included macular degeneration from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249; left arm) for COVID-19 immunization on an unknown date.  The patient experienced the following events and outcomes: shivering (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, tiredness (non-serious) on 10Feb2021 with outcome of not recovered, fever (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, shrunk a little bit (non-serious) on an unspecified date with outcome of unknown, really hot (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021.  The patient underwent lab tests and procedures which included body temperature: highest her temperature got was 100 on an unspecified date. About six days after the patient had her second COVID shot, the patient experienced shivering and tiredness. It was reported that the patient had shrunk a little bit starting on an unspecified date.  At the time of the report, over the last 3 days, the patient experienced the side effects. "It could be from something else. She could have gotten something. She did not know." The patient also had a fever a few times. The patient would go between shivering and really hot so she would take her temperature. The patient did not normally have a fever. When the shivering came on, she was trying to cook, and could not hold the spoon in her hand. The patient did not know what was wrong, but she was cold. All she wanted to do was sleep. The only symptom she still had was being tired. The night before the report, the patient woke up so warm and was sweating; her pajamas were damp. The patient could not sleep in them, so she had to go change. The patient has not shivered since then. The tiredness was persisting. The patient slept on and off all day today, but she was feeling better in general. The patient took her temperature every day. "The highest her temperature got was 100."
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a contactable consumer.  An 89-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 04Feb2021 at 89-year-old at a single dose for COVID-19 immunization.  Medical history included macular degeneration from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249; left arm) for COVID-19 immunization on an unknown date.  The patient experienced the following events and outcomes: shivering (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, tiredness (non-serious) on 10Feb2021 with outcome of not recovered, fever (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, shrunk a little bit (non-serious) on an unspecified date with outcome of unknown, really hot (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021.  The patient underwent lab tests and procedures which included body temperature: highest her temperature got was 100 on an unspecified date. About six days after the patient had her second COVID shot, the patient experienced shivering and tiredness. It was reported that the patient had shrunk a little bit starting on an unspecified date.  At the time of the report, over the last 3 days, the patient experienced the side effects. "It could be from something else. She could have gotten something. She did not know." The patient also had a fever a few times. The patient would go between shivering and really hot so she would take her temperature. The patient did not normally have a fever. When the shivering came on, she was trying to cook, and could not hold the spoon in her hand. The patient did not know what was wrong, but she was cold. All she wanted to do was sleep. The only symptom she still had was being tired. The night before the report, the patient woke up so warm and was sweating; her pajamas were damp. The patient could not sleep in them, so she had to go change. The patient has not shivered since then. The tiredness was persisting. The patient slept on and off all day today, but she was feeling better in general. The patient took her temperature every day. "The highest her temperature got was 100."
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Catheterisation cardiac, Chills, Echocardiogram, Headache
Clinical narrative: Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization.  The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Magnetic resonance imaging, Myocardial infarction, Myocarditis, Pain
Clinical narrative: Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization.  The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization.  The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest X-ray, Dehydration, Electrocardiogram, Fatigue
Clinical narrative: overly dehydrated; high blood pressure/ blood pressure was 178/122; could not sleep entirely/she was in a semi-sleep state/having insomnia feeling like really bad; could not move or open her eyes; her head felt like exploding; her heart pounding/ heart rate 102; extreme fatigue; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 12Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization, and experienced: arm soreness, nausea, and headache, on an unspecified date. After 1 hour 30 minutes of getting the second dose on 12Feb2021, the patient felt an extreme fatigue and went to sleep. She could not sleep entirely (from an unspecified date) and woke up and went to the bathroom several times after midnight and she tried to wake up at 4 am, but she was in a semi-sleep state half aware and could not move or open her eyes no matter how hard she tried.  She described this state as she couldn't move and having insomnia feeling like really bad. When she managed to pull this up, she took her pulse and blood pressure and she was having high blood pressure, her head felt like exploding and also her heart pounding. Her blood pressure was 178/122 and her heart rate 102. She stated that her husband tried to call Pfizer that moment, but they could not get a hold of someone after 30 minutes, so they contacted 911. She was taken to the hospital, and her chest X-ray and EKG were normal (to discard a heart attack). Then they noted that she was overly dehydrated, so they prepared some IV (intravenous) solution for her. The clinical outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Heart rate, Hypertension, Hypokinesia, Insomnia
Clinical narrative: overly dehydrated; high blood pressure/ blood pressure was 178/122; could not sleep entirely/she was in a semi-sleep state/having insomnia feeling like really bad; could not move or open her eyes; her head felt like exploding; her heart pounding/ heart rate 102; extreme fatigue; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 12Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization, and experienced: arm soreness, nausea, and headache, on an unspecified date. After 1 hour 30 minutes of getting the second dose on 12Feb2021, the patient felt an extreme fatigue and went to sleep. She could not sleep entirely (from an unspecified date) and woke up and went to the bathroom several times after midnight and she tried to wake up at 4 am, but she was in a semi-sleep state half aware and could not move or open her eyes no matter how hard she tried.  She described this state as she couldn't move and having insomnia feeling like really bad. When she managed to pull this up, she took her pulse and blood pressure and she was having high blood pressure, her head felt like exploding and also her heart pounding. Her blood pressure was 178/122 and her heart rate 102. She stated that her husband tried to call Pfizer that moment, but they could not get a hold of someone after 30 minutes, so they contacted 911. She was taken to the hospital, and her chest X-ray and EKG were normal (to discard a heart attack). Then they noted that she was overly dehydrated, so they prepared some IV (intravenous) solution for her. The clinical outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: overly dehydrated; high blood pressure/ blood pressure was 178/122; could not sleep entirely/she was in a semi-sleep state/having insomnia feeling like really bad; could not move or open her eyes; her head felt like exploding; her heart pounding/ heart rate 102; extreme fatigue; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 12Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization, and experienced: arm soreness, nausea, and headache, on an unspecified date. After 1 hour 30 minutes of getting the second dose on 12Feb2021, the patient felt an extreme fatigue and went to sleep. She could not sleep entirely (from an unspecified date) and woke up and went to the bathroom several times after midnight and she tried to wake up at 4 am, but she was in a semi-sleep state half aware and could not move or open her eyes no matter how hard she tried.  She described this state as she couldn't move and having insomnia feeling like really bad. When she managed to pull this up, she took her pulse and blood pressure and she was having high blood pressure, her head felt like exploding and also her heart pounding. Her blood pressure was 178/122 and her heart rate 102. She stated that her husband tried to call Pfizer that moment, but they could not get a hold of someone after 30 minutes, so they contacted 911. She was taken to the hospital, and her chest X-ray and EKG were normal (to discard a heart attack). Then they noted that she was overly dehydrated, so they prepared some IV (intravenous) solution for her. The clinical outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death, Headache
Clinical narrative: death; severe headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program.  A male patient of an unspecified age (Age: 83, unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EH9899), intramuscularly in the left arm on 20Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously took azithromycin [MANUFACTURER UNKNOWN] and experienced allergy on an unspecified date.  On 22Jan2021, the patient experienced severe headache (non-serious). On 28Jan2021, the patient experienced death (death, medically significant); 8 days after receiving the vaccine. The patient died on 28Jan2021 due to unknown cause of death.  It was unknown if an autopsy was performed. The clinical outcome of the event, death, was fatal. The clinical outcome of the event, severe headache, was not recovered.  No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer reporting on behalf of the mother.  An approximately 81-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 23Jan2021 (Batch/lot number: EL3302). Medical history was not reported. Concomitant medications included two unspecified prescriptions. On 13Feb2021 the patient experienced stroke which required hospitalization on the same day. The reporter was not sure of the name but they did a 'CAT' where they went up and pull the clot out of the brain. Event outcome was unknown. The patient was still in the hospital at the time of report. No investigation was performed before the event.