chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram pelvis, Cough, Dyspnoea, Heart rate, Laboratory test
Clinical narrative: Cough; heaviness to the chest; Stomach pain; Coughing so much his ribs get sore; Experiencing shortness of breath together with the cough; asthma; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 12May2021 13:00 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. There was no additional vaccine administered on same date of the BNT162B2. The patient did not receive any other vaccine within four weeks prior to the first administration date of the BNT162B2. Medical history included he had thyroid removed one time and it grew back and acid reflux. Family medical history was none. Concomitant medications included medications for an acid reflux. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 16Apr2021 around 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. The patient stated he got the COVID shot and started having problems. He stated he hadn't figured out what was the cause, clarifying he had all kinds of medical tests done, but everything came back normal. He couldn't figure out why he had the cough. He didn't have a cough until he took the last COVID shot in May2021. The patient stated if this was a side effects from the vaccine. They were thinking it might be asthma, he had never had asthma. The patient had tests on his heart. Trying to figure out if that's it or what. The patient clarified his problem as cough and heaviness to the chest in May2021 which began week after the second dose on 12May2021. The patient was coughing so much his ribs get sore in May2021. He started off as a mild, little cough. Had gotten worse. The patient was also experiencing shortness of breath together with the cough in May2021. The events required visit to emergency room and physician office. The doctor ran a chest x-ray. The patient was also having stomach pain too which began around the same time as the cough. The patient thought it was just gas and an acid reflux situation. Was on medicine for acid reflux. Then it was changed to a different medication and the stomach pain stopped. A CT of abdomen and pelvis was performed. Ultrasound of thyroid was performed. All tests performed had come back normal. He then contacted his heart doctor, who started running tests on his heart. The patient then went through the ER and was admitted to the hospital for tests. Hospital did a lung function test, which showed back normal. The patient was admitted to hospital on 29Jul2021 and was kept for 4 days. The outcome of the events Cough and heaviness to the chest was not recovered, of the event stomach pain was recovered in 2021, of the other events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pulmonary function test, Ultrasound scan
Clinical narrative: Cough; heaviness to the chest; Stomach pain; Coughing so much his ribs get sore; Experiencing shortness of breath together with the cough; asthma; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 12May2021 13:00 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. There was no additional vaccine administered on same date of the BNT162B2. The patient did not receive any other vaccine within four weeks prior to the first administration date of the BNT162B2. Medical history included he had thyroid removed one time and it grew back and acid reflux. Family medical history was none. Concomitant medications included medications for an acid reflux. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 16Apr2021 around 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. The patient stated he got the COVID shot and started having problems. He stated he hadn't figured out what was the cause, clarifying he had all kinds of medical tests done, but everything came back normal. He couldn't figure out why he had the cough. He didn't have a cough until he took the last COVID shot in May2021. The patient stated if this was a side effects from the vaccine. They were thinking it might be asthma, he had never had asthma. The patient had tests on his heart. Trying to figure out if that's it or what. The patient clarified his problem as cough and heaviness to the chest in May2021 which began week after the second dose on 12May2021. The patient was coughing so much his ribs get sore in May2021. He started off as a mild, little cough. Had gotten worse. The patient was also experiencing shortness of breath together with the cough in May2021. The events required visit to emergency room and physician office. The doctor ran a chest x-ray. The patient was also having stomach pain too which began around the same time as the cough. The patient thought it was just gas and an acid reflux situation. Was on medicine for acid reflux. Then it was changed to a different medication and the stomach pain stopped. A CT of abdomen and pelvis was performed. Ultrasound of thyroid was performed. All tests performed had come back normal. He then contacted his heart doctor, who started running tests on his heart. The patient then went through the ER and was admitted to the hospital for tests. Hospital did a lung function test, which showed back normal. The patient was admitted to hospital on 29Jul2021 and was kept for 4 days. The outcome of the events Cough and heaviness to the chest was not recovered, of the event stomach pain was recovered in 2021, of the other events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Autoimmune hepatitis, Dyspnoea, Investigation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history and family history were none. There were no concomitant medications. No additional vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccine within 4 weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), on 06Jun2021 (at the age of 69-year-old) at single dose for COVID-19 immunisation and about two weeks following her first injection, she had typical reactions which included she was not feeling well for a day or two and needing to rest, her urine was dark and she got really sick/progressively ill. The patient had both shots. Approximately a week or two weeks following the second injection, the patient had extreme shortness of breath, was in afib, and very weak on 10Jul2021. She went to her family doctor she clarified as her internal medicine doctor to figure out what the problem was. She had multiple medical test. She received heart tests, lab tests, and ultrasound in 2021. When determining the problem of shortness of breath, it was found she had acute autoimmune hepatitis as a result of the chemical included in the vaccine in 2021. The outcome of the event extreme shortness of breath was recovering, of the other events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Ultrasound scan
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history and family history were none. There were no concomitant medications. No additional vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccine within 4 weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), on 06Jun2021 (at the age of 69-year-old) at single dose for COVID-19 immunisation and about two weeks following her first injection, she had typical reactions which included she was not feeling well for a day or two and needing to rest, her urine was dark and she got really sick/progressively ill. The patient had both shots. Approximately a week or two weeks following the second injection, the patient had extreme shortness of breath, was in afib, and very weak on 10Jul2021. She went to her family doctor she clarified as her internal medicine doctor to figure out what the problem was. She had multiple medical test. She received heart tests, lab tests, and ultrasound in 2021. When determining the problem of shortness of breath, it was found she had acute autoimmune hepatitis as a result of the chemical included in the vaccine in 2021. The outcome of the event extreme shortness of breath was recovering, of the other events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Feeling of body temperature change, Gait inability, Headache
Clinical narrative: feeling fatigued; feel hot/cold occasionally; ankle swollen; calve cramps for 6 days/Can't go in cold water (ocean)legs cramp; unable to walk on day one after shot; head ache; bruise on left leg above knee; PMS/cletching jaw, back stress, angry, iritable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: fc3181), via an unspecified route of administration, administered in left arm on 11Aug2021 19:00 (at the age of 56-year-old) as dose 1, single for COVID-19 immunisation. Medical history included herpes simplex (HSV) and ongoing menapausal. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included calcium carbonate (CAL), magnesium carbonate;magnesium chloride;zinc and aciclovir sodium (ZOVIRAX). The patient experienced calve cramps for 6 days, some days both, some days one calf, unable to walk on day one after shot on 12Aug2021 04:00. The patient also experienced head ache, bruise on left leg above knee, PMSing bad (patient stated she was menapausal and now had PMS again! cletching jaw, back stress, angry, iritable and she was not like this past 3 years), can't go in cold water (ocean)legs cramp, feel hot/cold occasionally on 12Aug2021 04:00. The patient stated before shot never had these and calf cramp worried her, massage therapist said ankle swollen. The patient was feeling fatigued 6 days after shot on 17Aug2021. The facility where the vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received as a result of the events. The outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscle spasms, Premenstrual syndrome
Clinical narrative: feeling fatigued; feel hot/cold occasionally; ankle swollen; calve cramps for 6 days/Can't go in cold water (ocean)legs cramp; unable to walk on day one after shot; head ache; bruise on left leg above knee; PMS/cletching jaw, back stress, angry, iritable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: fc3181), via an unspecified route of administration, administered in left arm on 11Aug2021 19:00 (at the age of 56-year-old) as dose 1, single for COVID-19 immunisation. Medical history included herpes simplex (HSV) and ongoing menapausal. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included calcium carbonate (CAL), magnesium carbonate;magnesium chloride;zinc and aciclovir sodium (ZOVIRAX). The patient experienced calve cramps for 6 days, some days both, some days one calf, unable to walk on day one after shot on 12Aug2021 04:00. The patient also experienced head ache, bruise on left leg above knee, PMSing bad (patient stated she was menapausal and now had PMS again! cletching jaw, back stress, angry, iritable and she was not like this past 3 years), can't go in cold water (ocean)legs cramp, feel hot/cold occasionally on 12Aug2021 04:00. The patient stated before shot never had these and calf cramp worried her, massage therapist said ankle swollen. The patient was feeling fatigued 6 days after shot on 17Aug2021. The facility where the vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received as a result of the events. The outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had just a little soreness for one day; This is a spontaneous report from a contactable Nurse (patient herself). A 68-years-old female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Left on 19Feb2021 (early afternoon for both, like 2-3 pm) (at age of 68 years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient's medical history (including any illness at time of vaccination) was reported as no. There was not history of all previous immunization with the Pfizer vaccine considered as suspect nor any additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced she had just a little soreness for one day on an unspecified date in Feb2021. It was reported that, patient had the first shot on 19Feb2021 in her left arm. She had just a little soreness for one day. She thought of going to an orthopedist. She looked it up, and it sounds exactly like COVID shoulder which was kind of like bursitis that goes away within 1-2 years. It Has gotten a little better but she has lost some range of motion. She had troubles shaving under her arm. Caller was unsure of the seriousness. She was worried about getting the booster.  She really did not want a cortisone shot. She did go ask the pharmacist if she could get it in her hip instead of the arm for the booster. He told her they were not trained to do that. The adverse event did not require a visit to emergency room or physician Office. There was no any relevant tests. The outcome of event was recovered on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Interstitial lung disease
Clinical narrative: Interstitial lung disease; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose number unknown, single, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had interstitial lung disease. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: After the 2nd dose of vaccine; got a brain bleed; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose 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 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation. The patient's concomitant medications were not reported.  The patient reported that after the 2nd dose of the vaccine; she got a brain bleed on an unspecified date. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My daughter received Covid Vaccine last Monday and then she got Covid; now she has Covid; My daughter received Covid Vaccine last Monday and then she got Covid; now she has Covid; This is a spontaneous report from a non-contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Aug2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's daughter received Covid vaccine last Monday and then she got covid; now she has Covid in Aug2021. The patient underwent lab tests and procedures which included Covid-19/ SARS-CoV-2 test: positive in Aug2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Woke up at midnight with severe nausea abdominal pain and diarrhea; Woke up at midnight with severe nausea abdominal pain and diarrhea; Woke up at midnight with severe nausea abdominal pain and diarrhea; Body aches; headache; arm pain; This is a spontaneous report from a contactable nurse (patient).   A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 16Aug2021 16:30 (at the age of 50-years-old) (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. Medical history included HTN (hypertension). It was unknown if patient had Covid prior vaccination. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient did not receive other vaccine in four weeks. Concomitant medications included other medications received in two weeks. The patient experienced woke up at midnight with severe nausea abdominal pain and diarrhea on 17Aug2021 00:00. The patient had several bouts of diarrhea and ongoing pain up until current time of 19:00 on 17Aug2021. Body aches, headache and arm pain were also present. All events onset on 17Aug2021 00:00. No treatment received for any events. The patient had not Covid tested post vaccination. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Woke up at midnight with severe nausea abdominal pain and diarrhea; Woke up at midnight with severe nausea abdominal pain and diarrhea; Woke up at midnight with severe nausea abdominal pain and diarrhea; Body aches; headache; arm pain; This is a spontaneous report from a contactable nurse (patient).   A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 16Aug2021 16:30 (at the age of 50-years-old) (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. Medical history included HTN (hypertension). It was unknown if patient had Covid prior vaccination. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient did not receive other vaccine in four weeks. Concomitant medications included other medications received in two weeks. The patient experienced woke up at midnight with severe nausea abdominal pain and diarrhea on 17Aug2021 00:00. The patient had several bouts of diarrhea and ongoing pain up until current time of 19:00 on 17Aug2021. Body aches, headache and arm pain were also present. All events onset on 17Aug2021 00:00. No treatment received for any events. The patient had not Covid tested post vaccination. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Impaired driving ability, Loss of personal independence in daily activities, Nausea
Clinical narrative: transient mild hearing loss; Mild dizziness; vertigo; nausea/nauseated; unable to drive; ringing in my ears; not able to perform daily activities such as a mild workout routine/perform tasks needing focus and movement; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports, for second dose. This case is serious. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 27Jun2021 17:00 (at the age of 50-years-old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included high blood pressure, heart palpitations, meniere's disease and covid prior vaccination. The patient did not receive other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); amlodipine besilate (NORVASC); hydrochlorothiazide; ethinylestradiol, etynodiol diacetate (KELNOR).  The patient previously took amoxycillin and had known allergies to amoxicillin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 06Jun2021 17:00 (at the age of 50-years-old) (Lot Number: EW0202) as single dose for covid-19 immunisation and experienced mild dizziness for the first 2 days. The patient experienced mild dizziness for the first 2 days after each vaccine. Late on 2nd day of the 2nd dose, she experienced severe vertigo and nausea which lasted several days. She was unable to drive or perform tasks needing focus and movement. After the first several days, she had experienced long term mild to moderate dizziness/vertigo along with ringing in her ears and transient mild hearing loss. The number of days experiencing this had decreased slightly but she still experienced it almost daily. Some days she felt no dizziness, other days its mild and about 1 - 2 times per week she was very dizzy and nauseated and was not able to perform daily activities such as a mild workout routine. All events onset on 29Jun2021 18:00. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included antihistamine treatment. The patient had no covid tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065738 same reporter/product/patient, different dose/similar event
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: transient mild hearing loss; Mild dizziness; vertigo; nausea/nauseated; unable to drive; ringing in my ears; not able to perform daily activities such as a mild workout routine/perform tasks needing focus and movement; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports, for second dose. This case is serious. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 27Jun2021 17:00 (at the age of 50-years-old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included high blood pressure, heart palpitations, meniere's disease and covid prior vaccination. The patient did not receive other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); amlodipine besilate (NORVASC); hydrochlorothiazide; ethinylestradiol, etynodiol diacetate (KELNOR).  The patient previously took amoxycillin and had known allergies to amoxicillin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 06Jun2021 17:00 (at the age of 50-years-old) (Lot Number: EW0202) as single dose for covid-19 immunisation and experienced mild dizziness for the first 2 days. The patient experienced mild dizziness for the first 2 days after each vaccine. Late on 2nd day of the 2nd dose, she experienced severe vertigo and nausea which lasted several days. She was unable to drive or perform tasks needing focus and movement. After the first several days, she had experienced long term mild to moderate dizziness/vertigo along with ringing in her ears and transient mild hearing loss. The number of days experiencing this had decreased slightly but she still experienced it almost daily. Some days she felt no dizziness, other days its mild and about 1 - 2 times per week she was very dizzy and nauseated and was not able to perform daily activities such as a mild workout routine. All events onset on 29Jun2021 18:00. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included antihistamine treatment. The patient had no covid tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065738 same reporter/product/patient, different dose/similar event
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable nurse. A 33-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0177 and Expiration date was not reported), via an unspecified route of administration on 18May2021 (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation. The patient also received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0171 and Expiration date: 31Aug2021), via an unspecified route of administration on 27Apr2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had other vaccine in four weeks. It was unknown if patient was diagnosed with COVID-19, prior to vaccination. On 14Aug2021, patient had been tested for the COVID-19, post vaccination by nasal swab and result was positive. On 16Aug2021, patient had symptoms included fever, chills, HA, loss of smell and taste, sinus pressure and pain and weak. Symptoms fever, chills, HA, loss of smell and taste, sinus pressure and pain and weak were recovering and treatment was unknown for the events. Patient had doctor or other healthcare professional office/clinic visit for both the events. On 19Aug2021, investigation results were reported and the complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine Injectable lot EW0171 and EW0177 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604 and lot EW0177, fill lot EP8728, and bulk formulation lot EP8609. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature. The outcome of both the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, COVID-19 and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Extra dose administered, Fall, Head injury
Clinical narrative: Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; dizzy; burning sensation throughout the body; fell; hit her head; unconscious; fainted; This is a spontaneous report from a non-contactable consumer (patient). An elderly (over 65 years old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 17:00 (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunisation. Medical history included underlying heart condition. Patient was petit. The patient's concomitant medications were not reported. The patient previously received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation.The patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug2021. At 3 am, she awoke and felt dizzy and burning sensation throughout the body and then proceeded to the bathroom and while en route fell, hit her head and fainted in Aug2021. It's unclear if fainting occurred after she hit her head or prior to. Patient fell unconscious and did not remember the whole incidence in Aug2021. Patient regained consciousness and was being evaluated by their HCPs. She appeared stable. Event took place after use of product. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Off label use, Syncope
Clinical narrative: Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; dizzy; burning sensation throughout the body; fell; hit her head; unconscious; fainted; This is a spontaneous report from a non-contactable consumer (patient). An elderly (over 65 years old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 17:00 (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunisation. Medical history included underlying heart condition. Patient was petit. The patient's concomitant medications were not reported. The patient previously received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation.The patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug2021. At 3 am, she awoke and felt dizzy and burning sensation throughout the body and then proceeded to the bathroom and while en route fell, hit her head and fainted in Aug2021. It's unclear if fainting occurred after she hit her head or prior to. Patient fell unconscious and did not remember the whole incidence in Aug2021. Patient regained consciousness and was being evaluated by their HCPs. She appeared stable. Event took place after use of product. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cough, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: heart flutters very often; I get short of breath; Immediate and continuing heartburn; headache; cough; congestion; fatigue; dizziness; nausea; Low grade fever at times.; This is a spontaneous report from a contactable consumer.  A 42-year-old female consumer (patient) reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FC3180), dose 1 via an unspecified route of administration,in Arm Right on 05Aug2021 (at the age of 42-year-old ) as single dose for covid-19 immunisation.  Medical history included Graves disease, seizure disorder, migraine, heart arrhythmia, hepatitis C, Addison's disease. The patient was not pregnant. Concomitant medications included levothyroxine sodium ( taken for an unspecified indication; simvastatin taken for an unspecified indication; levetiracetam (KEPPRA) taken for an unspecified indication and lansoprazole (PREVACID) taken for an unspecified indication.  Known allergies to Penicillin, Sulfa and Vankomiacin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 05Aug2021the patient experienced immediate and continuing heartburn and headache. She had cough, congestion, fatigue, dizziness and nausea. At the time of reporting she had heart flutters very often and she got short of breath. Low grade fever at times. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, Pyrexia
Clinical narrative: heart flutters very often; I get short of breath; Immediate and continuing heartburn; headache; cough; congestion; fatigue; dizziness; nausea; Low grade fever at times.; This is a spontaneous report from a contactable consumer.  A 42-year-old female consumer (patient) reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FC3180), dose 1 via an unspecified route of administration,in Arm Right on 05Aug2021 (at the age of 42-year-old ) as single dose for covid-19 immunisation.  Medical history included Graves disease, seizure disorder, migraine, heart arrhythmia, hepatitis C, Addison's disease. The patient was not pregnant. Concomitant medications included levothyroxine sodium ( taken for an unspecified indication; simvastatin taken for an unspecified indication; levetiracetam (KEPPRA) taken for an unspecified indication and lansoprazole (PREVACID) taken for an unspecified indication.  Known allergies to Penicillin, Sulfa and Vankomiacin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 05Aug2021the patient experienced immediate and continuing heartburn and headache. She had cough, congestion, fatigue, dizziness and nausea. At the time of reporting she had heart flutters very often and she got short of breath. Low grade fever at times. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer (reported for herself). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Feb2021 (at the age of 71-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tested positive for covid virus, after both-covid vaccines. The case assessed as serious (medically significant). The clinical course was as follows: Patient received an antibody infusion on 10Aug2021, and she contacted Medical Information to ask how long she would have to wait for a booster shot. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a non-contactable consumer.  A consumer reported that a female patient (niece) of an unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration in May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had her Pfizer vaccine in the month of May and had a stroke on an unknown date. Her neurologist said it's most probably because of the vaccine. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Off label use
Clinical narrative: she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-Year-old female patient received dose 3 [booster dose] of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3181; Expiration date: 31Oct2021) via an unspecified route of administration on 16Aug2021 as single dose for COVID-19 immunization. Medical history of the patient included cholesterol. Concomitant medications included Simvastatin 5mg started on an unspecified date [initially was on 10mg Simvastatin and then it was reduced to 5mg because of the muscle, according to patient it reduces strength in the muscle] and was ongoing for Cholesterol and regular vitamins without iron, she didn't have enough strength in her legs and she has always been very active but the last couple of years, she didn't have enough strength, so her doctor incorporated strengthening exercise and told her to take vitamins. Patient previously received first dose of Moderna (Lot number: 027L20A; Expiration date: Unknown) on 04Feb2021 in left arm for COVID-19 immunization and second dose of Moderna (Lot number: 001B21A; Expiration date: Unknown) on 04Feb2021 in left arm for COVID-19 immunization. Patient received the first dose of the Moderna vaccine last 04Feb2021 and the second dose last 10Mar2021. Caller mentioned that she was supposed to get the influenza shot at the local pharmacy, but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine by mistake last Monday 16Aug2021. Caller wanted to know if a booster shot is the same as third dose and wanted information about it. Confirms product was the Pfizer Covid 19 and confirms she received on Monday,16Aug2021. Caller states it was supposed to be a flu shot so she doesn't know anything about this because after it happened the technician shook up, so she called the pharmacist and the pharmacist refused to give her any information. She didn't know any good information from the technician, but she told her that it was called the Pfizer Covid 19 booster shot, she doesn't know what she got really, she didn't get any information from the pharmacist.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 26-years-old). Medical history included fibromyalgia, myofascial pain syndrome, and endometriosis. Concomitant medications included VIIBRYD, HAILEY 1.5/30, CLARITIN-D, and PROBIOTIC 10 taken for an unspecified indication. The patient had known allergies of took opioids (narcotic/opioid pain medications) and pregabalin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had not taken any treatment for reported events. On 15Aug2021 at 12:15 PM, the patient experienced dizziness, confusion/difficulty focusing, fever, fatigue/tiredness, weakness/fainting, fast heartbeat, muscle aches, headache, injection site pain, and bruising and hot flashes/sweating. The outcome of all the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 26-years-old). Medical history included fibromyalgia, myofascial pain syndrome, and endometriosis. Concomitant medications included VIIBRYD, HAILEY 1.5/30, CLARITIN-D, and PROBIOTIC 10 taken for an unspecified indication. The patient had known allergies of took opioids (narcotic/opioid pain medications) and pregabalin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had not taken any treatment for reported events. On 15Aug2021 at 12:15 PM, the patient experienced dizziness, confusion/difficulty focusing, fever, fatigue/tiredness, weakness/fainting, fast heartbeat, muscle aches, headache, injection site pain, and bruising and hot flashes/sweating. The outcome of all the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site bruising, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 26-years-old). Medical history included fibromyalgia, myofascial pain syndrome, and endometriosis. Concomitant medications included VIIBRYD, HAILEY 1.5/30, CLARITIN-D, and PROBIOTIC 10 taken for an unspecified indication. The patient had known allergies of took opioids (narcotic/opioid pain medications) and pregabalin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had not taken any treatment for reported events. On 15Aug2021 at 12:15 PM, the patient experienced dizziness, confusion/difficulty focusing, fever, fatigue/tiredness, weakness/fainting, fast heartbeat, muscle aches, headache, injection site pain, and bruising and hot flashes/sweating. The outcome of all the events was recovering.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: became very ill; couldn't move head because of the tremendous pain in the head; would start vomiting, even if there was nothing to vomit; This is a spontaneous report from a contactable consumer (patient). A 9-decade old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 86 years old) as dose number unknown, single for COVID-19 immunization. Medical history included pacemaker, Meniere's disease and implant in head, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient became very ill on an unspecified date in Mar2021, couldn't move head because of the tremendous pain in the head and would start vomiting, even if there was nothing to vomit on an unspecified date in 2021. The patient was hospitalized for becoming very ill on an unspecified date.  It was reported that the patient had the COVID shots in the latter part of February. On an unspecified date in March, one month to the day, she became very ill and was in the hospital. The next month, on the same day, she was in the hospital again very, very ill. The next month and 2 weeks later, she was in the hospital again; same thing, very very ill. She didn't think that she would be able to beat it if it happened again. Then it happened again and she was in the hospital for 5 days that time. She added that one minute she would be fine and the next minute she would be deathly ill. She would be woken up out of her sleep deathly ill and couldn't move her head because of the tremendous pain in her head. She would start vomiting, even if there was nothing to vomit. Her daughter would call 911 and they would come and get her and take her to the hospital. She never had the flu or colds her whole life. She gets other things that were weird. The patient also added that she has Meniere's disease. Her doctor told her that what she had happen with the shots was so different and it was not from Meniere's disease. She also has an implant in her head from her ear and her doctor said that had nothing to do with it as well. She also has a pacemaker, and the doctor says that has nothing to do with it either. The patient clarified that she has already reported her adverse events and hospitalizations after the Pfizer Covid vaccine. She was calling now to let Pfizer know that the doctors have said that her adverse events were not related to her Meniere's disease, her implant, or her pacemaker. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.