chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. unknown if patient had Chronic or long-standing health conditions.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient age was reported as 56 years 2 months. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient age was reported as 30 years and 1 months.   It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 NDC code was reported.  No treatment drug information was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient age was reported as 27 years 10 months. No concomitant medication was reported. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code. No treatment medication was reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was provided.  Patient age was reported as 22 years and 8 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 code was reported as 80777027399.  No treatment drug information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  No treatment information was provided by the reporter.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was reported. Patient age was reported as 21 years and 6 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number code was reported as 80777027399. No treatment drug information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 31 years 1 month.  No concomitant medication was reported by reporter.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  Patient was not involved with any adverse reaction.  No treatment medication was reported by reporter.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 22 years 7 months.  No concomitant medication was reported. No treatment medication was reported.  On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  Patient was administered with a beyond use date of some lot numbers for Moderna. There was no adverse reaction noted or reported regarding this administration.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number code was reported as 80777-0273-99.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years 02 months.  Concomitant medication of the patient was not reported. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  Vaccine Ndc code was reported as 80777-0273-99.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Underdose
Clinical narrative: Vaccine that administered beyond use date after the thaw process; Third dose received 0.25 instead of 0.5; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 42 year 4 months.   No concomitant medications were reported  Patient reported no adverse reactions after the administration of vaccine. Vaccine Ndc code was reported as 80777-0273-99.  No treatment medications were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether patient has diagnosed/tested positive for COVID-19. It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 34 years and 9 months old.  No concomitant medication information was provided.  The vaccine were administered beyond use date after the thaw process. Patient received Moderna COVID-19 vaccine for dose 1. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment medication information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 37 years and 10 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code- 80777-0273-99 No treatment medication was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administrated after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number 1 NDC code was reported as 80777-0273-99.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  Patient was not involved with any adverse reaction.  No treatment medication was reported by reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a paramedic, describes the occurrence of administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 070H21A) for COVID-19 immunization. No medical history reported. On Mar 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .25 milliliter. Mar 2022, patient experienced administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered). At the time of the report, administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered) outcome unknown.  The reporter did not provide any causality assessments, concomitant medication or treatment information. The dose reported as a booster dose. It was reported that vaccine was administered beyond-use-date to patients. No adverse reaction noted or reported regarding these administrations.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 11-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: myocarditis; chest pain on exertion; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: MYOCARDITIS (medically significant), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain on exertion". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal, notes: Initial ECHO and EK were normal; Electrocardiogram: Normal, notes: Initial ECHO and EK were normal.  Clinical Information: As of 16Jun2022 This is a spontaneous follow-up report received from a non-contactable reporter(s) (Physician). It was reported that a 14-year-old male, double-vaccinated with Pfizer vaccine has recent history of chest pain on exertion. Initial ECHO and EK were normal. Proponent 22,000 increasing to 48,000 in 6 hours. Cardiac MRI with Gadolinium showed transmural enhancement consistent with myocarditis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a literature report.  A 13-year-old female 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: SEIZURE (medically significant), outcome "not recovered".  Clinical information: She was an active soccer player and a good student, now unable to play sports or attend class in person.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Loss of personal independence in daily activities, Neutrophil count, Neutrophil count increased, White blood cell count
Clinical narrative: high WBC/Neutrophil count; high WBC/Neutrophil count; bacterial infection; Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose; Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things."; BACTERIAL INFECTION (hospitalization) with onset 2022, outcome "unknown"; NEUTROPHIL COUNT INCREASED (hospitalization), WHITE BLOOD CELL COUNT INCREASED (hospitalization) all with onset 2022, outcome "unknown" and all described as "high WBC/Neutrophil count". The patient was hospitalized for neutrophil count increased, white blood cell count increased, bacterial infection (start date: 01May2022). The patient underwent the following laboratory tests and procedures: Neutrophil count: high, notes: high WBC/Neutrophil count; White blood cell count: high, notes: high WBC/Neutrophil count. Therapeutic measures were taken as a result of neutrophil count increased, white blood cell count increased, bacterial infection.  Clinical information: Caller was calling on behalf of her mother who took the second booster of COVID-19 vaccine last 26Apr2022. Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things. They observed these decline in activity and her mother was hospitalized 01May2022. Her mother already had one round of antibiotics for the high WBC/Neutrophil count. She mentioned that the antibiotics did not help with the bacterial infection. She wants to know if we have any recommendations for antibiotics or any information about bacterial infection after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: high WBC/Neutrophil count; high WBC/Neutrophil count; bacterial infection; Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose; Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things."; BACTERIAL INFECTION (hospitalization) with onset 2022, outcome "unknown"; NEUTROPHIL COUNT INCREASED (hospitalization), WHITE BLOOD CELL COUNT INCREASED (hospitalization) all with onset 2022, outcome "unknown" and all described as "high WBC/Neutrophil count". The patient was hospitalized for neutrophil count increased, white blood cell count increased, bacterial infection (start date: 01May2022). The patient underwent the following laboratory tests and procedures: Neutrophil count: high, notes: high WBC/Neutrophil count; White blood cell count: high, notes: high WBC/Neutrophil count. Therapeutic measures were taken as a result of neutrophil count increased, white blood cell count increased, bacterial infection.  Clinical information: Caller was calling on behalf of her mother who took the second booster of COVID-19 vaccine last 26Apr2022. Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things. They observed these decline in activity and her mother was hospitalized 01May2022. Her mother already had one round of antibiotics for the high WBC/Neutrophil count. She mentioned that the antibiotics did not help with the bacterial infection. She wants to know if we have any recommendations for antibiotics or any information about bacterial infection after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 11Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL oral, start date: 07Jun2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: On day 5, I tested negative; positive, notes: on day 8 and 10, I tested positive (rapid test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are required. No further information is expected; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: Paxlovid rebound - after five days of Rx tested neg x 2; Positive, notes: tested positive for COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: No other medication in 2weeks. No other medical history. This report was not related to a study or programme.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive and we were both boosted; tested positive and we were both boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 4 (booster), 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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive and we were both boosted". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative; Positive, notes: we both tested positive after eight days; Negative, notes: I tested negative on 14.  Clinical course: Both patient and her husband tested positive and they were both boosted (Unspecified vaccine), 2 boosters. Her husband was 84. He tested, since he was 84 his doctor recommended that he took Paxlovid but patient did not take it. Patient was fine and tested negative on day, they tested late because they both tested positive after eight days. So they decided to wait, so patient tested negative on 14 and her husband tested positive on 15. Today, her husband  was still positive on 19 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication(s) included: IMBRUVICA, start date: 14Nov2019, stop date: 06Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Jun2022) Negative, notes: testing Negative two days; (Jun2022) Negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Adverse event Four days after stopping paxlovid, and after testing negative two days following last dose of paxlovid, I tested positive for COVID again. Symptoms returned the following day. Patient received Paxlovid (start date: 07Jun2022, stop date: 12Jun2022) as Treatment of COVID-19. No known allergies. No treatment ae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "complex regional pain syndrome type 1" (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 May2021, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Positive, notes: Patient tested positive for covid May2021; (09Jun2022) Negative, notes: Patient then recently had onset of symptoms on 09Jun2022, negative test; (20Jun2022) Positive, notes: Patient then tested positive 20Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment. Patient has had first dose of Pfizer covid vaccine Apr2021. Patient tested positive for covid in May2021. Patient then recently had onset of symptoms on 09Jun2022, negative test. Patient received paxlovid. Patient then tested positive 20Jun2022. Adverse event start date: 08Jun2022. Patient was recovering form adverse event. If treatment adverse event: No.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hallucination, auditory, Malaise, Pyrexia
Clinical narrative: I started hearing voices; Fever; some chills; I was like feeling sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer: unknown), for COVID-19 immunization. The following information was reported: HALLUCINATION, AUDITORY (medically significant), outcome "unknown", described as "I started hearing voices"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "some chills"; MALAISE (non-serious), outcome "unknown", described as "I was like feeling sick".  Additional Information: I would expect that there would be some better phone connection from the Pfizer company that makes the Pfizer vaccine and competes against Moderna. Really that is pretty petty but compared to the report that I am about to make about my experience and side effects that I have experienced with the vaccine. Consumer stated Well, I took the vaccine and I got some side effects of the second shot, when I got the second shot. The first shot, I didn't have anything that I was aware of but then when I took the second shot. Do you know what I mean And they have no heart. It is just about money, shareholders and it just makes me sick. At least I could just say that you as a representative, working for Pfizer, I did read the story about how the mRNA vaccine was created. It is very interesting. The scientists, that they spend a technology to get approval very fast but what would you like to know, that is what I would like to know.Side effects: Consumer stated, My side effects were I had a fever, some chills, I was like feeling sick and I started hearing voices after that. Now, I don't believe in the whole microchip thing, like there is microchips in it because I don't think that would be the best interest for shareholders but I did have a fever.Is that really relevant if I am a doctor or not, if I am just calling, if I just want to make a phone call without disclosing that is that alright because I would like to see how they are treated when they call when without being given special treatment. On confirming if the consumer wants to know how the side effects are treated, Consumer statedNo, I didn't say that. What I am trying to say is that it might be hard to communicate verbally because it is a physical sensation that a patient (not clarified) of mine got and he said he called up and they gave him kind of peculiar advice how to deal with it.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Within 1-1/2 hours of taking each dose, there was a very strong metallic taste in her mouth. It went away about 2 hours prior to 2nd dose each day but then returns with each dose. The patient had no known allergies and medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.