chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Glucose tolerance impaired
Clinical narrative: fever (103F); feeling extremely tired; headache; joint pain; loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Feb2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "myasthenia gravis" (unspecified if ongoing), notes: (autoimmune disease). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (patient had a flu shot Jun2022 and then 60 days after she had the flu shot, came out of remission from her myasthenia gravis and her symptoms started up again), administration date: Jun2022. The following information was reported: CHILLS (non-serious) with onset 04Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 04Mar2023, outcome "unknown", described as "feeling extremely tired"; PYREXIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "fever (103F)"; HEADACHE (non-serious) with onset 04Mar2023, outcome "unknown"; ARTHRALGIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "joint pain"; DECREASED APPETITE (non-serious) with onset 04Mar2023, outcome "unknown", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter was a retired nurse calling on behalf of her 65-year-old daughter. Patient received a dose of Prevnar 13 on 03Feb2023 but started experiencing side effects on 04Mar2023. Reports her daughter started experiencing fever (103F); feeling extremely tired, headache, joint pain loss of appetite; chills. Patient had myasthenia gravis. Reporter thought it should not be given to someone who has an immune disease but her daughters HCP said it was ok. Reporter stated that all the tests are coming back negative. Patient was prescribed an antibiotic but it was not helping. Patient had a flu shot in Jun2022 and then 60 days after she had the flu shot, she came out of remission from her myasthenia gravis and her symptoms started up again.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Laboratory test normal, Pyrexia
Clinical narrative: fever (103F); feeling extremely tired; headache; joint pain; loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Feb2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "myasthenia gravis" (unspecified if ongoing), notes: (autoimmune disease). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (patient had a flu shot Jun2022 and then 60 days after she had the flu shot, came out of remission from her myasthenia gravis and her symptoms started up again), administration date: Jun2022. The following information was reported: CHILLS (non-serious) with onset 04Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 04Mar2023, outcome "unknown", described as "feeling extremely tired"; PYREXIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "fever (103F)"; HEADACHE (non-serious) with onset 04Mar2023, outcome "unknown"; ARTHRALGIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "joint pain"; DECREASED APPETITE (non-serious) with onset 04Mar2023, outcome "unknown", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter was a retired nurse calling on behalf of her 65-year-old daughter. Patient received a dose of Prevnar 13 on 03Feb2023 but started experiencing side effects on 04Mar2023. Reports her daughter started experiencing fever (103F); feeling extremely tired, headache, joint pain loss of appetite; chills. Patient had myasthenia gravis. Reporter thought it should not be given to someone who has an immune disease but her daughters HCP said it was ok. Reporter stated that all the tests are coming back negative. Patient was prescribed an antibiotic but it was not helping. Patient had a flu shot in Jun2022 and then 60 days after she had the flu shot, she came out of remission from her myasthenia gravis and her symptoms started up again.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. The patient received COVID-19 treatment from 01Mar2023 to 05Mar2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2021 at 12:15 as dose 1, single (Lot number: 014M20A), in left arm, on 08Apr2021 at 14:30 as dose 2, single (Lot number: 006B21A), in left arm, on 27Aug2021 at 14:30 as dose 3 (booster), single (Lot number: 045B21A), in left arm and on 08Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022 at 16:00, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: at-home test.The patient was treated with Paxlovid from 26Feb2023 to 03Mar2023.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight, X-ray
Clinical narrative: when she takes any vaccine her arm is sore for a little bit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EW0175) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot ER8729), administration date: 15Apr2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "heart started racing", "She took a test and she caught the virus", "She took a test and she caught the virus"; Flu shot (Also had a Flu shot unknown date. Manufacturer unknown.), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "when she takes any vaccine her arm is sore for a little bit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: arm soreness - when she takes any vaccine her arm is sore for a little bit and goes away. When queried what vaccines cause arm soreness caller states all booster shots, she takes she gets sore arm. Unable to clarify further. Sender's Comments: Linked Report(s): US-PFIZER INC-202300100075 same reporter/patient, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2022 as dose 2, single (Batch/Lot number: unknown), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: " Hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19".  The patient received Paxlovid from 23Feb2023 to 28Feb2023. The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107258 Same patient, same reporter, same product, different dose, different events;
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Lot number: ENG205), in left arm, on 22Mar2021 at 19:00 as dose 2, single (Lot number: ER8730), in left arm and on 09Oct2021 at 19:00 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cats" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Positive. The patient reported that symptoms (sore throat, runny nose, wheezing, headache, dry cough, cough with mucus, muscles aches, small fever) started Monday 27Feb2023. Tested positive Tuesday 28Feb2023. The patient was treated with Paxlovid from 28Feb2023 to 05Mar2023. The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Echocardiogram, Ejection fraction, Myocardial infarction, Troponin I
Clinical narrative: Myocardial Infarction; The initial case was missing the following minimum criteria: Unidentifiable patients. Upon receipt of follow-up information on (07Mar2023), this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "A CASE SERIES: SARS-COV-2 MRNA VACCINE CAUSING MYOCARDIAL INFARCTION FROM NONOBSTRUCTIVE CORONARY ARTERIES (MINOCA)".  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Angiogram: showed no angiographically significant disease, notes: in the major vessels; Echocardiogram: revealed LVEF of 55%; Ejection fraction: 55 %; Troponin I: 18.2 ng/ml.  Clinical course: Reported as, patient presented with sudden onset chest pain two days after receiving his first dose of Pfizer-BioNTech mRNA COVID vaccine. His peak troponin-I level was 18.2 ng/ml. An echocardiogram revealed LVEF of 55%, without wall motion abnormalities. Coronary angiography showed no angiographically significant disease in the major vessels.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event myocardial infarction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; He received a COVID booster and then got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US032505_NS.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "He received a COVID booster and then got COVID". Clinical course: Event: He received a COVID booster and then got COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood lactic acid, Blood pressure measurement, Body temperature, C-reactive protein
Clinical narrative: Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac index, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. 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.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Echocardiogram, Ejection fraction, Heart rate, Investigation
Clinical narrative: Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. 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.
Sex: M
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome, Oxygen saturation, Pulmonary arterial wedge pressure, Red blood cell sedimentation rate, Respiratory rate
Clinical narrative: Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. 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.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin, Vascular resistance systemic, White blood cell count
Clinical narrative: Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I finally tested positive for Covid in Apr2022; I finally tested positive for Covid in Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), on 28Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "I finally tested positive for Covid in Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: I finally tested positive for Covid in Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: TTOX
Symptoms: Hyperaesthesia teeth, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: On 12-Mar-2023 I received a Tetanus vaccination of which I had after effects from. I had my temperature checked in the middle of the night with a 105 degree fever (which broke by morning). I was achy and sore all over and had extremely sensitive teeth. These symptoms only lasted one day. Then the following day I noticed a very sore and swollen lymph node above my left collar bone. The sore and swollen lymph node is still in that condition at the time of this report.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Livedo reticularis
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: "marbled skin" appearance-Medium
Age: 30.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: She states that the patient has not reported any symptoms; female patient was administered Varivax 0.5 ml subcutaneous and ProQuad 0.5 ml subcutaneous on 20Feb2023; This spontaneous report was received from healthcare professional and refers to a 30-year-old female patient. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.  On 20-FEB-2023, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 0.5 milliliter, lot #W020549, expiration date: 26-DEC-2023, administered subcutaneously (SQ); and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U015684, expiration date: 18-MAY-2023, administered SQ; both for prophylaxis (Overdose). The patient had not reported any symptoms. This issue was noticed upon after discharge of the patient, and she was not notified.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: she accidently administered a dose of MMR II via intramuscular route instead of subcutaneous route. Date of administration was Mar 1, 2023. No further information provided. No additional AE reported. No PQC reported.; she accidently administered a dose of MMR II via intramuscular route instead of subcutaneous route. Date of administration was Mar 1, 2023. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.     On 01-MAR-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U039548 with expiration date of 14-DEC-2023, via intramuscular route instead of subcutaneous route (incorrect route of product administration), for prophylaxis. No additional event reported.        No further information provided.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has NOT experienced any adverse events since; a 52 year old patient was administered PROQUAD; This spontaneous report was received from a physician referring to a 52-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 06-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), once, lot # reported as WQ029553 and expiration date reported as 14-MAR-2025, which was evaluated and changed to the valid lot #W029553, with expiration date: 14-MAR-2024, (dose and route were not provided) for prophylaxis (Product administered to patient of inappropriate age). The patient had not experienced any adverse events since (No adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of vaccines involved in a temperature excursion; No additional AE reported; This spontaneous report was received from a healthcare provider and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored (product storage error) haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W021183, expiration date: 22-FEB-2025, administered for prophylaxis (dose, dose number, and route of administration were not provided). The temperature excursion was at 35.2 degrees Fahrenheit for 23 minutes. Previous excursion was at the same temperature for 9 minutes. No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare provider is reporting administration of vaccines involved in a temperature excursion. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAXHIB W021183 2/22/2025 VAQTA W028554 7/10/2024 Temperatu; No additional AE reported; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W028554, expiration date: 10-JUL-2024; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W021183, expiration date: 22-FEB-2025, administered for prophylaxis (strength, dose, and route of administration of the vaccines were not provided) (product storage error).  Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit (F) for 23 minutes. The previous temperature excursion was 35.2 F for 9 minutes. There was no adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 08-MAR-2023, the patient with vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (1 dose, lot #w008711, expiration date: 14-MAR-2024, strength and route were not reported) for prophylaxis. The vaccine was improperly stored at the temperature of -3.2 degree Celsius, and the time frame was 3 hours (product storage error). No previous temperature excursion. No additional AEs were reported (no adverse event), no further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: Bell's palsy on right side of face; This serious case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (previous history of bell's palsy on the left side of her face).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy on right side of face) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     It was unknown if the company considered the bell's palsy to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The patient reported that 10 days after she was vaccinated with the Shingrix, she developed bell's palsy on the right side of her face. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had it several times, had the Shingles Vaccine/Suspected Vaccination Failure; I've had it several times; No words can really describe the horrific pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had it several times, had the Shingles Vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I've had it several times) and pain (Verbatim: No words can really describe the horrific pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-Mar-2023. This serious case was reported by a consumer via interactive digital media.  The patent stated that no words that describe the horrific pain. The patient had shingles several times and had the vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got The Shot and still got them/ Suspected Vaccination Failure; still got them; Terrible Pain like Bees Stinging; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got The Shot and still got them/ Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still got them) and pain (Verbatim: Terrible Pain like Bees Stinging). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, the patient got the shot and still got them, terrible pain like bees stinging. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had taken the shingle shot and still had the shingles/ suspected vaccination failure; still had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had taken the shingle shot and still had the shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient had taken the shingle shot and still had the shingles but fortunately it was a light case of them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.