chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; I lost consciousness; Arrhythmia; Booster; Tiredness; Arm was sore; Little bit of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Dec2021 (Lot number: FE3594) at the age of 35 years as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient had no any other vaccinations within 4 weeks. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Dec2021, outcome "unknown", described as "I lost consciousness"; ARRHYTHMIA (medically significant) with onset 22Dec2021, outcome "unknown", described as "Arrhythmia"; FATIGUE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Tiredness"; PYREXIA (non-serious) with onset 22Dec2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Dec2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was sore"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Little bit of headache". Therapeutic measure ibuprofen was taken as a result of pyrexia, pain in extremity, headache.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Immunisation
Clinical narrative: Breakthrough Covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 19Nov2021 (Lot number: FD0809) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: immunization, vaccination failure, pain, fatigue, headache, cough, nasal congestion and rhinorrhea all not recovered with onset 19Dec2021. Therapeutic measures were taken as a result of immunisation, covid-19, vaccination failure, pain, fatigue, headache, cough, nasal congestion, rhinorrhoea.   Additional information: Patient was treated with Dayquil every 4 hours. Patient was not Covid prior vaccination.  Investigational results of RA: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Polymerase chain reaction, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Breakthrough Covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 19Nov2021 (Lot number: FD0809) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: immunization, vaccination failure, pain, fatigue, headache, cough, nasal congestion and rhinorrhea all not recovered with onset 19Dec2021. Therapeutic measures were taken as a result of immunisation, covid-19, vaccination failure, pain, fatigue, headache, cough, nasal congestion, rhinorrhoea.   Additional information: Patient was treated with Dayquil every 4 hours. Patient was not Covid prior vaccination.  Investigational results of RA: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Breakthrough Covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 19Nov2021 (Lot number: FD0809) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: immunization, vaccination failure, pain, fatigue, headache, cough, nasal congestion and rhinorrhea all not recovered with onset 19Dec2021. Therapeutic measures were taken as a result of immunisation, covid-19, vaccination failure, pain, fatigue, headache, cough, nasal congestion, rhinorrhoea.   Additional information: Patient was treated with Dayquil every 4 hours. Patient was not Covid prior vaccination.  Investigational results of RA: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Immunisation, Interchange of vaccine products, Myalgia
Clinical narrative: Both Breast sore and tender; Both Breast sore and tender; Pfizer Booster; Pfizer Booster/initial COVID vaccine was J&J; muscle was sore in the arm she got injection in; 202101844781 -This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 14:00 (Lot number: FD7218) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Lumpectomy", start date: 2021 (unspecified if ongoing), notes: Lumpectomy was a month after the J&J COVID vaccine and the radiation was completed Jul2021. There were no concomitant medications. Vaccination history included: J&j vaccine (initial COVID vaccine was J&J., Batch/lot number: 206A21A, Unknown Dose. Injected in the left upper arm in the muscle.), administration date: 12Apr2021, when the patient was 66 years old, for Prevention, reaction(s): "muscle soreness in left arm". The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 14:00, outcome "unknown", described as "Pfizer Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Dec2021 14:00, outcome "unknown", described as "Pfizer Booster/initial COVID vaccine was J&J"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 20Dec2021, outcome "recovering" and all described as "Both Breast sore and tender"; MYALGIA (non-serious) with onset 19Dec2021, outcome "recovering", described as "muscle was sore in the arm she got injection in".  Additional information: She said both breast were sore and tender, but the one that she had the lumpectomy and radiation in this past spring/summer was more sore. That was prior to getting the Pfizer vaccine. Her initial COVID vaccine was J&J. The surgery and radiation was a couple of months after the J&J vaccine. She had Pfizer COVID booster shot on Sunday, 19Dec2021, so Monday, 20Dec2021, is when the breast tenderness and soreness began. On Monday and Tuesday, it was quite uncomfortable, but today is still tender when she took shower, but a little improved. Her muscle was sore in the arm she got injection in, but she thought everyone got that. Muscle soreness has improved at injection site, but it is still a little sore. She wants to be fully protected. They put a prescription number of withheld, on the J&J card. It says RX number. She then found the lot number. The only reaction was muscle soreness to left arm after that one. She is not on any other medications. The Lumpectomy was a month after the J&J COVID vaccine and the radiation was completed Jul2021. Both breast sore and tender morning and Left arm muscle soreness at injection site right after driving home.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Lymph node pain, Pain in extremity
Clinical narrative: Miscarriage; Sore arms and lymph nodes; Sore arms and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 14:30 (Lot number: ER8736) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 12Mar2021. The patient was 7 weeks pregnant at the time of exposure to bnt162b2. The patient is expected to deliver a baby(s) on 16Dec2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 08Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Miscarriage"; PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Sore arms and lymph nodes". The events "miscarriage", "sore arms and lymph nodes" and "sore arms and lymph nodes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abortion spontaneous, pain in extremity, lymph node pain.Clinical course: If other vaccine in four weeks was reported as no. if Covid prior vaccination and if Covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: PT HAD COVID MAY OR JUNE; Medication: PFIZER COVID VACCINE/ (Infection); This is a spontaneous report received from contactable reporter(s) (Other healthcare professional and Consumer or other non healthcare professional) for a program (054550).  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2021, outcome recovered; COVID-19 (hospitalization, medically significant) with onset May/June 2021, outcome recovered. The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 5 day(s)).  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is expected. The case will be reassessed further upon receipt of additional information.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 110772.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) at the age of 41 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The patient date of death was unknown. The reported cause of death was "passed away". It was not reported if an autopsy was performed. Addition information: it was reported that: A 41-year-old patient who had no health problems, 48 hours after receiving the vaccine, he passed away.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: passed away; felt unwell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 110772.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 05Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 06Jan2021, outcome "fatal", described as "passed away"; MALAISE (non-serious) with onset 05Jan2021, outcome "unknown", described as "felt unwell". The patient date of death was 06Jan2021. The reported cause of death was "passed away". It was not reported if an autopsy was performed.  BNT162B2 is under agreement with Biontech.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Biopsy, Blood alkaline phosphatase, Blood bilirubin, Inflammation scan
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for.  A 61-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ibuprofen (IBUPROFEN) (Batch/Lot number: unknown) at unk (x 3 days). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 31 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 765 IU/l; biopsy: lymphocytes; none normal bile ducts; blood alkaline phosphatase: 230 IU/l; blood bilirubin: 2.6 mg/dl; inflammation scan: positive, notes: Portal and lobular No interface hepatitis; international normalised ratio: 1.2; laboratory test: negative; none; viral test: negative. The action taken for ibuprofen was unknown. Therapeutic measures were not taken as a result of liver injury. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Liver injury. 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.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Laboratory test, Liver injury, Viral test
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for.  A 61-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ibuprofen (IBUPROFEN) (Batch/Lot number: unknown) at unk (x 3 days). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 31 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 765 IU/l; biopsy: lymphocytes; none normal bile ducts; blood alkaline phosphatase: 230 IU/l; blood bilirubin: 2.6 mg/dl; inflammation scan: positive, notes: Portal and lobular No interface hepatitis; international normalised ratio: 1.2; laboratory test: negative; none; viral test: negative. The action taken for ibuprofen was unknown. Therapeutic measures were not taken as a result of liver injury. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Liver injury. 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.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio, Liver injury
Clinical narrative: Liver injury following SARS-CoV-2 vaccination; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HCV" (unspecified if ongoing), notes: (treated); "Compensated Cirrhosis" (unspecified if ongoing); "cholestatic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 101 IU/l; blood alkaline phosphatase: 367 IU/l; blood bilirubin: 1.7 mg/dl; international normalised ratio: unknown results. Therapeutic measures were not taken as a result of liver injury.; 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.,Linked Report(s) : US-PFIZER INC-202101834329 same article/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antinuclear antibody, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for:  A 74 year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Extramedullary hematopoiesis" (ongoing), notes: unknown significance on prior liver biopsy. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1779 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 391 IU/l; blood bilirubin: 1.1 mg/dl; international normalised ratio: 1.0; autoimmune serologies: negative; sars-cov-2 test: negative; viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 27 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event LIVER INJURY cannot be excluded  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,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Liver injury, SARS-CoV-2 test, Viral test
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for:  A 74 year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Extramedullary hematopoiesis" (ongoing), notes: unknown significance on prior liver biopsy. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1779 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 391 IU/l; blood bilirubin: 1.1 mg/dl; international normalised ratio: 1.0; autoimmune serologies: negative; sars-cov-2 test: negative; viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 27 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event LIVER INJURY cannot be excluded  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,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio, Laboratory test
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination: A multicenter case series".  A 73-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "chronic liver disease" (unspecified if ongoing); "autoimmune hepatitis" (unspecified if ongoing), notes: in treated remission. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 6 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 813 IU/l; blood alkaline phosphatase: 114 IU/l; blood bilirubin: 0.7 mg/dl; international normalised ratio: unknown results; laboratory test: no abnormal labs, notes: for a minimum of 6 months. Therapeutic measures were taken as a result of liver injury with Oral prednisone. The patient with autoimmune hepatitis (AIH) in treated remission (i.e., no medication changes or abnormal labs for a minimum of 6 months). The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination: A multicenter case series".  A 73-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "chronic liver disease" (unspecified if ongoing); "autoimmune hepatitis" (unspecified if ongoing), notes: in treated remission. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 6 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 813 IU/l; blood alkaline phosphatase: 114 IU/l; blood bilirubin: 0.7 mg/dl; international normalised ratio: unknown results; laboratory test: no abnormal labs, notes: for a minimum of 6 months. Therapeutic measures were taken as a result of liver injury with Oral prednisone. The patient with autoimmune hepatitis (AIH) in treated remission (i.e., no medication changes or abnormal labs for a minimum of 6 months). The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antinuclear antibody, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report. A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no liver disease history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 635 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 465 IU/l; blood bilirubin: 2.8 mg/dl; international normalised ratio: 1.0; sars-cov-2 test: negative; smooth muscle antibody: 1:20; viral test: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 24 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of liver injury. 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,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Liver injury, SARS-CoV-2 test, Smooth muscle antibody, Viral test
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report. A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no liver disease history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 635 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 465 IU/l; blood bilirubin: 2.8 mg/dl; international normalised ratio: 1.0; sars-cov-2 test: negative; smooth muscle antibody: 1:20; viral test: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 24 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of liver injury. 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,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio, Laboratory test
Clinical narrative: Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury; This is a literature report.  A 37- year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered" described as "Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury." The patient underwent the following laboratory tests and procedures: ALT (alanine aminotransferase): greater than 5000 IU/l; ALP (blood alkaline phosphatase): 144 IU/l; blood bilirubin: 2.8 mg/dl; INR (international normalised ratio): 5.5; Autoimmune serologies: negative; COVID-19 test (SARS-CoV-2 test): negative; and viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. The patient received NAC infusion treatment.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is too limited to make a meaningful medical assessment of the case. However, based on the available information in the case provided, the causal association between the reported event Liver injury and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship post vaccination. 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.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Liver injury, SARS-CoV-2 test, Viral test
Clinical narrative: Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury; This is a literature report.  A 37- year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered" described as "Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury." The patient underwent the following laboratory tests and procedures: ALT (alanine aminotransferase): greater than 5000 IU/l; ALP (blood alkaline phosphatase): 144 IU/l; blood bilirubin: 2.8 mg/dl; INR (international normalised ratio): 5.5; Autoimmune serologies: negative; COVID-19 test (SARS-CoV-2 test): negative; and viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. The patient received NAC infusion treatment.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is too limited to make a meaningful medical assessment of the case. However, based on the available information in the case provided, the causal association between the reported event Liver injury and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship post vaccination. 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.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio, Liver injury
Clinical narrative: Liver injury following SARS-CoV-2 vaccination; This is a literature report.6  A 70-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Prior biliary stricture after cholecystectomy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: ALT: 96 IU/l; ALP: 140 IU/l; bili: 0.5 mg/dl; INR: unknown results. Therapeutic measures were not taken as a result of liver injury. The authors acknowledge that a series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, their report is not structured to evaluate potential causality. In their patients with prior drug exposure (amoxicillin; nitrofurantoin; non-steroidal anti-inflammatory drugs, acetaminophen), the exposures were either too short or the presentations highly atypical (by laboratory data or histopathology) to be attributed solely to the medication. Thus, DILI is not readily implicated in this patient series, although it cannot be wholly excluded. They also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event liver injury cannot be excluded.  The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.