chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Orthostatic hypotension
Clinical narrative: dizziness; Orthostatic hypotension; This is a spontaneous report from a contactable Nurse (Patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number N6201) via an unspecified route of administration, administered in arm left on 14Feb2021 17:00 (age at vaccination 66 years) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dizziness and orthostatic hypotension both on 15Feb2021 06:15. It was reported as patient received the Pfizer vaccine yesterday 14Feb2021 and experienced dizziness and stated that dizziness was listed as a severe reaction to the covid 19 vaccine and wanted to know if there have been any reports of dizziness. Patient felt kind like orthostatic hypotension. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine at 16 yrs of age. Moderna approved for 18 years and older. Placed call to parent and unable to reach to establish impact to patient.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Lethargy, Seizure, Unresponsive to stimuli
Clinical narrative: passed out; hit his head; This is a spontaneous report from a contactable consumer (wife) via Pfizer-sponsored program COVAX Support (CEP 159558).   A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), via an unspecified route of administration on 29Apr2021 at 13:00 (age at the time of vaccination was 37 years) as dose 1, single for covid-19 immunisation. The patient history and Other products were reported as no. On 29Apr2021, the patient passed out and hit his head. The reporter explained that she wanted to report side effects for her and her husband. It was explained that the patient had passed out after getting the first dose of the vaccine but nothing after the second. The caller was looking for financial assistance as they have incurred medical bills due to her husband passing out after the first dose. The reporter explained they both got the vaccines at the same time. The first dose was on 29Apr2021 at around 1pm and the second dose was on 18May2021 given around 11am. The reporter said she thinks the patient was 37 years old. It was explained by the reporter that, after getting the first dose the patient passed out and was transported to the emergency room. They treated the patient that day and let him go that night, they wanted to make sure he didn't pass out again. He was there till 5 or 6pm and because it was the vaccine, they did some test because there was a concern, he hit his head. An exam related to this to be sure he was ok was done related to the concern he hit his head. She was told he was good, and they let him go home. It was reported that the report was related to a study or programme. It was reported that the lot number for the first dose, she thinks was E or S followed W0175. On 29Apr2021, patient underwent tests/exam and results were unknown. Reportedly, patient took dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18May2021 for Covid1-9 immunisation. The Lot for the second dose was BNT162B2. NDC-592671000001, no expiry. Investigation Assessment was reported as no. Therapeutic measures were taken as a result of passed out. The outcome of the event was recovered on 29Apr2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Laboratory test, Loss of consciousness
Clinical narrative: passed out; hit his head; This is a spontaneous report from a contactable consumer (wife) via Pfizer-sponsored program COVAX Support (CEP 159558).   A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), via an unspecified route of administration on 29Apr2021 at 13:00 (age at the time of vaccination was 37 years) as dose 1, single for covid-19 immunisation. The patient history and Other products were reported as no. On 29Apr2021, the patient passed out and hit his head. The reporter explained that she wanted to report side effects for her and her husband. It was explained that the patient had passed out after getting the first dose of the vaccine but nothing after the second. The caller was looking for financial assistance as they have incurred medical bills due to her husband passing out after the first dose. The reporter explained they both got the vaccines at the same time. The first dose was on 29Apr2021 at around 1pm and the second dose was on 18May2021 given around 11am. The reporter said she thinks the patient was 37 years old. It was explained by the reporter that, after getting the first dose the patient passed out and was transported to the emergency room. They treated the patient that day and let him go that night, they wanted to make sure he didn't pass out again. He was there till 5 or 6pm and because it was the vaccine, they did some test because there was a concern, he hit his head. An exam related to this to be sure he was ok was done related to the concern he hit his head. She was told he was good, and they let him go home. It was reported that the report was related to a study or programme. It was reported that the lot number for the first dose, she thinks was E or S followed W0175. On 29Apr2021, patient underwent tests/exam and results were unknown. Reportedly, patient took dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18May2021 for Covid1-9 immunisation. The Lot for the second dose was BNT162B2. NDC-592671000001, no expiry. Investigation Assessment was reported as no. Therapeutic measures were taken as a result of passed out. The outcome of the event was recovered on 29Apr2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amenorrhoea
Clinical narrative: Obliteration of menses; This is a spontaneous report from a contactable nurse (patient). A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), on 23Dec2020 at 16:15 (at the age of 47-years-old), administered in the left arm, at dose 1, single for COVID-19 immunisation. Medical history was reported as none; the patient had not known allergies; prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient obliteration of menses on 11Jan2021. The event was reported as serious as resulted in disability or permanent damage; no treatment was received in response to the event. The patient had not recovered from the event.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Computerised tomogram thorax normal, Dyspnoea
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test negative, Viral test negative
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood creatine increased, Blood creatinine, Blood pressure measurement, Burning sensation
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Eructation, Fatigue
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Gastrooesophageal reflux disease, Hyperacusis, Hypertension, Investigation
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Oropharyngeal pain, Photophobia, SARS-CoV-2 test, Throat tightness
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test positive, Chest pain, Dyspnoea, Echocardiogram normal, Fatigue
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Oropharyngeal pain, Pain, Pulmonary function test abnormal
Clinical narrative: severe migraines; sensitive to light & sounds; sensitive to light & sounds; acid reflux; painful burning burps with vomit coming up; painful burning burps with vomit coming up; painful burning burps with vomit coming up; difficulty breathing/shortness of breath/gasping; extreme fatigue; chest pain; throat and stomach pains; throat and stomach pains; tightness in chest and throat; tightness in chest and throat; Unable to walk even short distances; Blood pressure has been high; Creatine and inflammation markers are high.; Creatine and inflammation markers are high.; This is a spontaneous report from a contactable consumer (patient) reported that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Apr2021 12:00 (Lot Number: EW0171, at the age of 17-year-old) as single dose  for covid-19 immunization. Medical history included skin psoriasis. Concomitant medication included adalimumab (HUMIRA). 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. Symptoms started after 24hrs on 26Apr2021 12:00 including severe migraines (sensitive to light & sounds), severe acid reflux (painful burning burps with vomit coming up), difficulty breathing, extreme fatigue, chest pain, throat and stomach pains, shortness of breath, gasping, tightness in chest and throat. Unable to walk even short distances within home. Blood pressure has been high since receiving the vaccine. Creatine and inflammation markers are high. Slightest walking brings on severe pains and all symptoms. Patient was not recovered after 4 months. Treatment received for the adverse events included emergency room (ER) visits, Consultations, Testings, medications. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. COVID-19 nasal swab test on 04May2021 was negative. The seriousness criteria for the events reported as disability. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity
Clinical narrative: arm hurt; diarrhea and some stomach issues; diarrhea and some stomach issues; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 09Feb2021 (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none (reported as Other Products: No; Patient History: No). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 as dose 1, single for covid-19 immunisation and experienced her arm hurt (little bit more than the second time). The patient experienced arm hurt on an unspecified date, having some diarrhea and some stomach issues on 15Feb2021. Therapeutic measures were taken as a result of the reported events as she took 2 Imodium. The events were not serious and seriousness criteria included none. Investigation assessment included none. Consumer received vaccines first and second doses 3 weeks apart and had zero side effects from both. It has been 6 days since she had the second dose and on the day of this report, patient was having some diarrhea and some stomach issues. Patient enquired if it would be possible that it stated from the vaccine 6 days ago or not. Consumer was informed about Pfizer Medical information department. When asked about lot number and expiration date, Consumer stated she did not have them with her. When asked about weight, Consumer stated it was probably, may be 175 pounds.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastric disorder, Pain in extremity
Clinical narrative: arm hurt; diarrhea and some stomach issues; diarrhea and some stomach issues; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 09Feb2021 (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none (reported as Other Products: No; Patient History: No). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 as dose 1, single for covid-19 immunisation and experienced her arm hurt (little bit more than the second time). The patient experienced arm hurt on an unspecified date, having some diarrhea and some stomach issues on 15Feb2021. Therapeutic measures were taken as a result of the reported events as she took 2 Imodium. The events were not serious and seriousness criteria included none. Investigation assessment included none. Consumer received vaccines first and second doses 3 weeks apart and had zero side effects from both. It has been 6 days since she had the second dose and on the day of this report, patient was having some diarrhea and some stomach issues. Patient enquired if it would be possible that it stated from the vaccine 6 days ago or not. Consumer was informed about Pfizer Medical information department. When asked about lot number and expiration date, Consumer stated she did not have them with her. When asked about weight, Consumer stated it was probably, may be 175 pounds.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus, Vaccination complication
Clinical narrative: ringing in my ear/humming in my ears; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported for herself.   A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. Medical history included tuberculosis from 1974 to an unknown date (I had tuberculosis as a child. i had tuberculosis in nineteen seventy-four and I was medically treated for that). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced some adverse reactions. It was reported that the patient had ringing in her ear, the ring like a humming like tinnitus since her second dose on 08Apr2021. Outcome of the event was reported as not recovered at this time of the report.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in my ear/humming in my ears; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported for herself.   A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. Medical history included tuberculosis from 1974 to an unknown date (I had tuberculosis as a child. i had tuberculosis in nineteen seventy-four and I was medically treated for that). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced some adverse reactions. It was reported that the patient had ringing in her ear, the ring like a humming like tinnitus since her second dose on 08Apr2021. Outcome of the event was reported as not recovered at this time of the report.   No follow up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Computerised tomogram head, Dizziness, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: loss of words; dizziness/episodes of dizziness; tingling all over; short of breath; palpitations; legs felt heavy/heaviness in legs; brain fog; headache; This is a spontaneous report from a contactable Nurse (Nurse reported for herself).   A 32-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot/Batch number, EL1284), via an unspecified route of administration, administered in Arm Right on 23Dec2020 13:15 (age at vaccination was 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Patient not received any other vaccine in four weeks. Patient not received other medications in two weeks. Patient not had covid prior to vaccination. On 23Dec2020, 13:30, the patient had dizziness, tingling all over, short of breath, palpitations, legs felt heavy, brain fog and headache. After 7months later, the patient had brain fog, loss of words, episodes of dizziness, headaches, palpitations, tingling and heaviness in legs during an episode. The events resulted in doctor or other healthcare professional office/ Emergency room and patient received meclizine. Patient underwent laboratory tests which included EKG and ECHO on an unspecified date (results were unknown). Patient was not tested covid post vaccination. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count, Headache, Metabolic function test, Paraesthesia
Clinical narrative: loss of words; dizziness/episodes of dizziness; tingling all over; short of breath; palpitations; legs felt heavy/heaviness in legs; brain fog; headache; This is a spontaneous report from a contactable Nurse (Nurse reported for herself).   A 32-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot/Batch number, EL1284), via an unspecified route of administration, administered in Arm Right on 23Dec2020 13:15 (age at vaccination was 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Patient not received any other vaccine in four weeks. Patient not received other medications in two weeks. Patient not had covid prior to vaccination. On 23Dec2020, 13:30, the patient had dizziness, tingling all over, short of breath, palpitations, legs felt heavy, brain fog and headache. After 7months later, the patient had brain fog, loss of words, episodes of dizziness, headaches, palpitations, tingling and heaviness in legs during an episode. The events resulted in doctor or other healthcare professional office/ Emergency room and patient received meclizine. Patient underwent laboratory tests which included EKG and ECHO on an unspecified date (results were unknown). Patient was not tested covid post vaccination. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: loss of words; dizziness/episodes of dizziness; tingling all over; short of breath; palpitations; legs felt heavy/heaviness in legs; brain fog; headache; This is a spontaneous report from a contactable Nurse (Nurse reported for herself).   A 32-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot/Batch number, EL1284), via an unspecified route of administration, administered in Arm Right on 23Dec2020 13:15 (age at vaccination was 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Patient not received any other vaccine in four weeks. Patient not received other medications in two weeks. Patient not had covid prior to vaccination. On 23Dec2020, 13:30, the patient had dizziness, tingling all over, short of breath, palpitations, legs felt heavy, brain fog and headache. After 7months later, the patient had brain fog, loss of words, episodes of dizziness, headaches, palpitations, tingling and heaviness in legs during an episode. The events resulted in doctor or other healthcare professional office/ Emergency room and patient received meclizine. Patient underwent laboratory tests which included EKG and ECHO on an unspecified date (results were unknown). Patient was not tested covid post vaccination. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Palpitations, Paraesthesia
Clinical narrative: loss of words; dizziness/episodes of dizziness; tingling all over; short of breath; palpitations; legs felt heavy/heaviness in legs; brain fog; headache; This is a spontaneous report from a contactable Nurse (Nurse reported for herself).   A 32-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot/Batch number, EL1284), via an unspecified route of administration, administered in Arm Right on 23Dec2020 13:15 (age at vaccination was 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Patient not received any other vaccine in four weeks. Patient not received other medications in two weeks. Patient not had covid prior to vaccination. On 23Dec2020, 13:30, the patient had dizziness, tingling all over, short of breath, palpitations, legs felt heavy, brain fog and headache. After 7months later, the patient had brain fog, loss of words, episodes of dizziness, headaches, palpitations, tingling and heaviness in legs during an episode. The events resulted in doctor or other healthcare professional office/ Emergency room and patient received meclizine. Patient underwent laboratory tests which included EKG and ECHO on an unspecified date (results were unknown). Patient was not tested covid post vaccination. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, International normalised ratio, Metabolic function test, Prothrombin time
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Biliary obstruction, Blood culture, Blood lactic acid
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood magnesium, C-reactive protein, Computerised tomogram abdomen, Culture urine, Differential white blood cell count
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Full blood count, Haematemesis, Hypokalaemia, Inflammation
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Lipase increased, Liver function test abnormal, Metabolic function test
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Occult blood, Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Secondary hypertension, Urine analysis, Vomiting
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal X-ray, Bile duct stone, Breast mass, Cholecystectomy, Computerised tomogram abdomen
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count, Dilatation intrahepatic duct acquired, Endoscopic retrograde cholangiopancreatography, Full blood count, International normalised ratio
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Peripheral artery occlusion
Clinical narrative: Abdominal Pain  Vomiting  Hematemesis with nausea  Right upper quadrant abdominal pain  Hypokalemia  Other secondary hypertension  Abnormal LFTs  Elevated lipase  Calculus of bile duct without cholangitis with obstruction
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest X-ray normal, Computerised tomogram normal, Depression, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration, administered in left arm on 04Apr2021 11:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Patient had no medical history. No other products taken. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 14Mar2021 05:30 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine included flu shot and never had a reaction. She was previously a healthy and active individual. After receiving the second dose, on 05Apr2021, she woke up a little dizzy in the middle of the night. She reports about a month and a half later on 16May2021, she had vision disorientation/disconnect, she did not worry about it. Then, she started to get a total dizziness, ringing in ears (on 04Jun2021), anxiety (in Jun2021), depression (in Jun2021), and different pains in her face (in Jun2021). She had been to every imaginable doctor to check everything out. She had been to the emergency room, had blood work done, had seen two different ENTs, one through had an MRI of brain/ears because she has tinnitus, ringing in the ears, she had an MRI of the spine, a CT of the brain, she went to a hearing doctor, went to a cardiologist. She could not get a deep breath (in Jun2021), she reports she was very disheartened that it came back, along with that, it also came with she could not get a deep breath and that was troublesome. She done everything to rule out anything else and the only thing it points to be the vaccine. She super healthy, she 62, she plays competitive tennis, hikes, she not on any kind of medication. She was going to an eastern medicine doctor for treatment, and they are using natural things to get her body to absorb the vaccine, but it has basically changed her life. Outcome of the event pains in face, vision disorientation and dizziness were resolving; and rest all the events were not resolved. Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.