chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: I got blood clots in my lungs, both lungs about a month later; I got blood clots in my lungs, both lungs about a month later; she had a pulmonary emboli; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151, expiry date: unknown) via unspecified route of administration in right arm on 20Apr2021 as dose 2, single for Covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot: ER8730) via unspecified route of administration in right arm, on 28Mar2021, as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient stated that she got the vaccine, the Pfizer vaccine in April and got both the shots and got blood clots in her lungs less in a month and a half, both lungs about a month later, on an un-specified date in Jun2021. She ended up into an emergency room and was in the hospital for 4 days since 16Jul2021 and was on blood thinners, now and they can't find any other reason for the blood clot. She also had a pulmonary emboli, several of them actually on an unspecified date in 2021. She noticed symptoms starting 24Jun2021 but it probably started before then. The caller stated she still had the blood clots. They just give a person medication for 6 months and hope they go away. She remarked this was likely to continue, she would probably continue to get them based on how blood clots work. She doesn't know why she was even allowed to get the shots. She wanted to report the event. She could not find any data on blood clot except for the 'TTS' (not clarified) and saw that the only list confirmed cases. So, she wanted to know how was the case confirmed to be caused by the vaccine? She went to the doctor on 12Jul2021 and then had a CT scan done on 13Jul2021 and then was sent straight to emergency room but the symptoms started in June. She got Lovenox in the hospital for three days. Caller explains she was in the hospital from 13Jul2021-16Jul2021. She was put on Eliquis as treatment after leaving the hospital. She wanted them to know that several of her friends and people she has heard about who have got the shot from different manufacturers who have gotten blood clots. They have had no history or cause that was known. It was alarming that none of this was talked about and seem to be discouraged to talk about it. She hoped she saved someone's life. The patient underwent lab test for CT scan on 13Jul2021, with unknown results. The outcome of events for "I got blood clots in my lungs, both lungs about a month later" was not recovered and rest was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Pulmonary embolism, Pulmonary thrombosis, Thrombosis
Clinical narrative: I got blood clots in my lungs, both lungs about a month later; I got blood clots in my lungs, both lungs about a month later; she had a pulmonary emboli; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151, expiry date: unknown) via unspecified route of administration in right arm on 20Apr2021 as dose 2, single for Covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot: ER8730) via unspecified route of administration in right arm, on 28Mar2021, as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient stated that she got the vaccine, the Pfizer vaccine in April and got both the shots and got blood clots in her lungs less in a month and a half, both lungs about a month later, on an un-specified date in Jun2021. She ended up into an emergency room and was in the hospital for 4 days since 16Jul2021 and was on blood thinners, now and they can't find any other reason for the blood clot. She also had a pulmonary emboli, several of them actually on an unspecified date in 2021. She noticed symptoms starting 24Jun2021 but it probably started before then. The caller stated she still had the blood clots. They just give a person medication for 6 months and hope they go away. She remarked this was likely to continue, she would probably continue to get them based on how blood clots work. She doesn't know why she was even allowed to get the shots. She wanted to report the event. She could not find any data on blood clot except for the 'TTS' (not clarified) and saw that the only list confirmed cases. So, she wanted to know how was the case confirmed to be caused by the vaccine? She went to the doctor on 12Jul2021 and then had a CT scan done on 13Jul2021 and then was sent straight to emergency room but the symptoms started in June. She got Lovenox in the hospital for three days. Caller explains she was in the hospital from 13Jul2021-16Jul2021. She was put on Eliquis as treatment after leaving the hospital. She wanted them to know that several of her friends and people she has heard about who have got the shot from different manufacturers who have gotten blood clots. They have had no history or cause that was known. It was alarming that none of this was talked about and seem to be discouraged to talk about it. She hoped she saved someone's life. The patient underwent lab test for CT scan on 13Jul2021, with unknown results. The outcome of events for "I got blood clots in my lungs, both lungs about a month later" was not recovered and rest was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 33 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: unknown) dose 0.5 ml, 1 total, administered on 20-MAY-2021 on left arm  for prophylactic vaccination. There was no issue during administration of vaccine (e.g. syringe leak, needle disconnect). Patient was fully and appropriately vaccinated. No concomitant medications were reported.  On an unspecified date patient had fever, headaches, nasal congestion, and diarrhea. The patient experienced confirmed COVID-19 infection. The patient was recovered. On 02-AUG-2021, patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive (confirmed clinical vaccination failure). On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. About gestation reporter thought patient said she had six more weeks to go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649, 20210858816. This case is associated with product quality complaint (PQC) number 90000190703. Initial information was processed along with the additional information received on 26-AUG-2021.; Sender's Comments: V0: 20210848035-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 33 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: unknown) dose 0.5 ml, 1 total, administered on 20-MAY-2021 on left arm  for prophylactic vaccination. There was no issue during administration of vaccine (e.g. syringe leak, needle disconnect). Patient was fully and appropriately vaccinated. No concomitant medications were reported.  On an unspecified date patient had fever, headaches, nasal congestion, and diarrhea. The patient experienced confirmed COVID-19 infection. The patient was recovered. On 02-AUG-2021, patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive (confirmed clinical vaccination failure). On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. About gestation reporter thought patient said she had six more weeks to go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649, 20210858816. This case is associated with product quality complaint (PQC) number 90000190703. Initial information was processed along with the additional information received on 26-AUG-2021.; Sender's Comments: V0: 20210848035-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 33 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: unknown) dose 0.5 ml, 1 total, administered on 20-MAY-2021 on left arm  for prophylactic vaccination. There was no issue during administration of vaccine (e.g. syringe leak, needle disconnect). Patient was fully and appropriately vaccinated. No concomitant medications were reported.  On an unspecified date patient had fever, headaches, nasal congestion, and diarrhea. The patient experienced confirmed COVID-19 infection. The patient was recovered. On 02-AUG-2021, patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive (confirmed clinical vaccination failure). On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. About gestation reporter thought patient said she had six more weeks to go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649, 20210858816. This case is associated with product quality complaint (PQC) number 90000190703. Initial information was processed along with the additional information received on 26-AUG-2021.; Sender's Comments: V0: 20210848035-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Cardiac function test normal, Ejection fraction normal, Myocarditis
Clinical narrative: Admitted to the hospital for presumed URI/myocarditis; (On Echocardiogram) Myocardial stress; This spontaneous case was reported by a physician and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.   The patient's past medical history included Antinuclear antibody increased.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) (seriousness criterion hospitalization) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Aug-2021 to 04-Aug-2021 due to MYOCARDITIS and UPPER RESPIRATORY TRACT INFECTION. The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency. On 04-Aug-2021, UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Brain natriuretic peptide: high (High) HIGH. On 03-Aug-2021, C-reactive protein: high (High) HIGH. On 03-Aug-2021, Echocardiogram: normal (normal) NORMAL. On 03-Aug-2021, Red blood cell sedimentation rate increased: high (High) HIGH. On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 03-Aug-2021, Troponin: high (High) HIGH.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  The patient is currently undergoing a rheumatological work up. Prior to vaccination, the patient had an elevated ANA and is being assessed for fibromyalgia versus lupus.   Laboratory data was mentioned on an unknown date patient took covid test which was negative as was the tests for respiratory pathogens.  Treatment information was mentioned as patient treated with nasal oxygen.  Company comment:  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Troponin increased
Clinical narrative: Admitted to the hospital for presumed URI/myocarditis; (On Echocardiogram) Myocardial stress; This spontaneous case was reported by a physician and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.   The patient's past medical history included Antinuclear antibody increased.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) (seriousness criterion hospitalization) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Aug-2021 to 04-Aug-2021 due to MYOCARDITIS and UPPER RESPIRATORY TRACT INFECTION. The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency. On 04-Aug-2021, UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Brain natriuretic peptide: high (High) HIGH. On 03-Aug-2021, C-reactive protein: high (High) HIGH. On 03-Aug-2021, Echocardiogram: normal (normal) NORMAL. On 03-Aug-2021, Red blood cell sedimentation rate increased: high (High) HIGH. On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 03-Aug-2021, Troponin: high (High) HIGH.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  The patient is currently undergoing a rheumatological work up. Prior to vaccination, the patient had an elevated ANA and is being assessed for fibromyalgia versus lupus.   Laboratory data was mentioned on an unknown date patient took covid test which was negative as was the tests for respiratory pathogens.  Treatment information was mentioned as patient treated with nasal oxygen.  Company comment:  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Echocardiogram, Myocarditis, Red blood cell sedimentation rate increased
Clinical narrative: Admitted to the hospital for presumed URI/myocarditis; (On Echocardiogram) Myocardial stress; This spontaneous case was reported by a physician and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.   The patient's past medical history included Antinuclear antibody increased.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) (seriousness criterion hospitalization) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Aug-2021 to 04-Aug-2021 due to MYOCARDITIS and UPPER RESPIRATORY TRACT INFECTION. The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency. On 04-Aug-2021, UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Brain natriuretic peptide: high (High) HIGH. On 03-Aug-2021, C-reactive protein: high (High) HIGH. On 03-Aug-2021, Echocardiogram: normal (normal) NORMAL. On 03-Aug-2021, Red blood cell sedimentation rate increased: high (High) HIGH. On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 03-Aug-2021, Troponin: high (High) HIGH.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  The patient is currently undergoing a rheumatological work up. Prior to vaccination, the patient had an elevated ANA and is being assessed for fibromyalgia versus lupus.   Laboratory data was mentioned on an unknown date patient took covid test which was negative as was the tests for respiratory pathogens.  Treatment information was mentioned as patient treated with nasal oxygen.  Company comment:  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Troponin, Upper respiratory tract infection
Clinical narrative: Admitted to the hospital for presumed URI/myocarditis; (On Echocardiogram) Myocardial stress; This spontaneous case was reported by a physician and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.   The patient's past medical history included Antinuclear antibody increased.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) (seriousness criterion hospitalization) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Aug-2021 to 04-Aug-2021 due to MYOCARDITIS and UPPER RESPIRATORY TRACT INFECTION. The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency. On 04-Aug-2021, UPPER RESPIRATORY TRACT INFECTION (Admitted to the hospital for presumed URI/myocarditis) and MYOCARDITIS ((On Echocardiogram) Myocardial stress) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Brain natriuretic peptide: high (High) HIGH. On 03-Aug-2021, C-reactive protein: high (High) HIGH. On 03-Aug-2021, Echocardiogram: normal (normal) NORMAL. On 03-Aug-2021, Red blood cell sedimentation rate increased: high (High) HIGH. On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 03-Aug-2021, Troponin: high (High) HIGH.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  The patient is currently undergoing a rheumatological work up. Prior to vaccination, the patient had an elevated ANA and is being assessed for fibromyalgia versus lupus.   Laboratory data was mentioned on an unknown date patient took covid test which was negative as was the tests for respiratory pathogens.  Treatment information was mentioned as patient treated with nasal oxygen.  Company comment:  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  An 88-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration on 20Jan2021 (lot number: EL1283) (age at vaccination 88-year-old) as dose 2, single for COVID-19 immunisation. The patient had allergies of iodine and diltiazem. The patient medical history included non-obstructive CAD (May2017) and unknown if ongoing, DMT2, dyslipidemia, and PAF from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Dec2020 (lot number: EL1283) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had tested positive for COVID-19. The patient had COVID-19 breakthrough infection on 23Aug2021. The patient was hospitalized due to the event for one day. The laboratory investigation included Nasal Swab COVID-19 (SARS-COV-2) PCR and result was found to be positive on 23Aug2021. Treatment was received was unknown. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  An 88-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration on 20Jan2021 (lot number: EL1283) (age at vaccination 88-year-old) as dose 2, single for COVID-19 immunisation. The patient had allergies of iodine and diltiazem. The patient medical history included non-obstructive CAD (May2017) and unknown if ongoing, DMT2, dyslipidemia, and PAF from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Dec2020 (lot number: EL1283) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had tested positive for COVID-19. The patient had COVID-19 breakthrough infection on 23Aug2021. The patient was hospitalized due to the event for one day. The laboratory investigation included Nasal Swab COVID-19 (SARS-COV-2) PCR and result was found to be positive on 23Aug2021. Treatment was received was unknown. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Blood magnesium increased, Blood potassium decreased, Cardiac arrest, Cardioversion
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Electrocardiogram abnormal, Endotracheal intubation, Intensive care
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Nausea, Troponin I increased, Ventricular fibrillation, Ventricular tachycardia
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiomyopathy, Chest discomfort, Compartment syndrome, Death, Myocarditis
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid increased, C-reactive protein increased, Catheterisation cardiac, Chest pain, Coronary artery disease
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Electrocardiogram ST segment elevation, Fasciotomy, Fibrin D dimer increased, General physical health deterioration
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test increased, Lung assist device therapy, Nausea, Renal replacement therapy, Serum ferritin increased
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular assist device insertion, Ventricular tachycardia, Vomiting
Clinical narrative: Patient brought to ED 8/25/2021 for chest pain, nausea and vomiting. ECG in ED showed ST elevation and patient developed incessant VT. Cardiac cath performed, which showed no significant CAD. Due to worsening status, patient was placed on VA ECMO. On 8/26, patient required CRRT. On 8/27, impella placed and patient had bilateral fasciotomies. Patient passed away on 8/28/2021.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: pt called on 9/1/2021 c/o allergic reaction and infection. hospitalized x 2 days.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Infection
Clinical narrative: pt called on 9/1/2021 c/o allergic reaction and infection. hospitalized x 2 days.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Have been to the doctor 3 times plus one trip to urgent care since receiving vaccine Extreme exhaustion-ongoing Blister rashes on body- shot of steroids by doctor Severe head and nasal congestion for a little over two weeks Blood in urine- urgent care, doctor and CT scan, treated with antibiotics. Have an appt with urologist next week for continuing pain I am still and have been exhausted everyday since receiving this vaccine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urine present, Fatigue, Head discomfort, Nasal congestion
Clinical narrative: Have been to the doctor 3 times plus one trip to urgent care since receiving vaccine Extreme exhaustion-ongoing Blister rashes on body- shot of steroids by doctor Severe head and nasal congestion for a little over two weeks Blood in urine- urgent care, doctor and CT scan, treated with antibiotics. Have an appt with urologist next week for continuing pain I am still and have been exhausted everyday since receiving this vaccine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash vesicular, Urine analysis, Urogram
Clinical narrative: Have been to the doctor 3 times plus one trip to urgent care since receiving vaccine Extreme exhaustion-ongoing Blister rashes on body- shot of steroids by doctor Severe head and nasal congestion for a little over two weeks Blood in urine- urgent care, doctor and CT scan, treated with antibiotics. Have an appt with urologist next week for continuing pain I am still and have been exhausted everyday since receiving this vaccine
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait inability, Joint swelling, Muscle spasms, Peripheral swelling
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Confusional state, Delirium, Gravitational oedema, Henoch-Schonlein purpura
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait inability, Hypersomnia, Joint swelling, Rash macular
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient experienced fever, chills, generalized weakness, and cough with sputum production.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Productive cough, Pyrexia
Clinical narrative: Patient experienced fever, chills, generalized weakness, and cough with sputum production.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling sensation on skin within 10 minutes of administration. Patient described tingling sensation throughout her body, initially starting from her legs, then to her other extremities and then all over from head to toe. The patient described the sensation lasting up to as much as 3-4 days. She did not complain of numbness or significant pain.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restlessness
Clinical narrative: Tingling sensation on skin within 10 minutes of administration. Patient described tingling sensation throughout her body, initially starting from her legs, then to her other extremities and then all over from head to toe. The patient described the sensation lasting up to as much as 3-4 days. She did not complain of numbness or significant pain.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation on skin within 10 minutes of administration. Patient described tingling sensation throughout her body, initially starting from her legs, then to her other extremities and then all over from head to toe. The patient described the sensation lasting up to as much as 3-4 days. She did not complain of numbness or significant pain.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: 5 hours after injection shivering began with extreme weakness and progressed in intensity over several hours during which fever (up to 101.7) and nausea  ensued and then muscle pains severe and unrelenting in hips bilateral with mild headache. After about 3 hours I took 300mg ibuprofen and was able to rest. The next morning and throughout the day I was exhausted. The next night I slept 12 hours. I usually sleep only 6-8 hours/night.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: 5 hours after injection shivering began with extreme weakness and progressed in intensity over several hours during which fever (up to 101.7) and nausea  ensued and then muscle pains severe and unrelenting in hips bilateral with mild headache. After about 3 hours I took 300mg ibuprofen and was able to rest. The next morning and throughout the day I was exhausted. The next night I slept 12 hours. I usually sleep only 6-8 hours/night.