chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: I had a PSA test taken,  like I do at least once a year.  The PSA number has been the same, without chance for the last 4 years, and this time it was tripled.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen
Clinical narrative: I had a PSA test taken,  like I do at least once a year.  The PSA number has been the same, without chance for the last 4 years, and this time it was tripled.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: Was unable to move hands, wrists, feet; Faint; Temp dropped to 95; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 22May2021 (14:00) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient had no relevant medical history and concomitant medications. On 22May2021 (14:00), the patient was unable to move hands, wrists and feet; fainted; and temperature dropped to 95. The events were assessed as serious (medically significant). The events had resulted into emergency room/department or urgent care). The patient did not receive any treatment for the events. The outcome of the events was recovered in May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature decreased, Movement disorder, Syncope
Clinical narrative: Was unable to move hands, wrists, feet; Faint; Temp dropped to 95; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 22May2021 (14:00) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient had no relevant medical history and concomitant medications. On 22May2021 (14:00), the patient was unable to move hands, wrists and feet; fainted; and temperature dropped to 95. The events were assessed as serious (medically significant). The events had resulted into emergency room/department or urgent care). The patient did not receive any treatment for the events. The outcome of the events was recovered in May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Illness, Myocardial infarction
Clinical narrative: Patient developed anterior myocardial infarction with complication of ventricular septal rupture requiring hospitalization, left ventricular support, and then surgical repair which was complicated by bleeding, CHF, and eventual expiration after aggressive attempt at supportive care
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Death, Interventricular septum rupture, Myocardial infarction, Procedural haemorrhage
Clinical narrative: Patient developed anterior myocardial infarction with complication of ventricular septal rupture requiring hospitalization, left ventricular support, and then surgical repair which was complicated by bleeding, CHF, and eventual expiration after aggressive attempt at supportive care
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Surgical ventricular restoration
Clinical narrative: Patient developed anterior myocardial infarction with complication of ventricular septal rupture requiring hospitalization, left ventricular support, and then surgical repair which was complicated by bleeding, CHF, and eventual expiration after aggressive attempt at supportive care
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Cough, Echocardiogram normal, Electrocardiogram PR segment depression
Clinical narrative: myocarditis with PR segment depression and a Troponin of 9000; Chest pain; This is a spontaneous report from a contactable physician. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0168), at the age of 16 years old, intramuscularly in right arm on 29May2021 14:00 at single dose for covid-19 immunisation.  Medical history included allergies to pollen. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0172), at the age of 16 years old, intramuscularly in right arm on 08May2021 12:00 at single dose for covid-19 immunisation. Shortly after the patient began experiencing a cough which has persisted until currently presentation. The patient received his second dose on 29May2021 14:00 and developed chest pain on 30May2021. Subsequently the patient experienced myocarditis with PR segment depression and a troponin of 9000. The patient was admitted to the hospital for 2 days. The patient underwent lab tests and procedures which included PR segment depression and troponin 9000 on 30May2021, SARS-CoV-2 by nucleic acid amplification (NAA) test (nasal swab) negative on 01Jun2021. The patient received treatment with scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and at present he had improvement in symptoms and troponins. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of myocarditis and chest pain.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram T wave abnormal, Myocarditis, Troponin increased
Clinical narrative: myocarditis with PR segment depression and a Troponin of 9000; Chest pain; This is a spontaneous report from a contactable physician. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0168), at the age of 16 years old, intramuscularly in right arm on 29May2021 14:00 at single dose for covid-19 immunisation.  Medical history included allergies to pollen. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0172), at the age of 16 years old, intramuscularly in right arm on 08May2021 12:00 at single dose for covid-19 immunisation. Shortly after the patient began experiencing a cough which has persisted until currently presentation. The patient received his second dose on 29May2021 14:00 and developed chest pain on 30May2021. Subsequently the patient experienced myocarditis with PR segment depression and a troponin of 9000. The patient was admitted to the hospital for 2 days. The patient underwent lab tests and procedures which included PR segment depression and troponin 9000 on 30May2021, SARS-CoV-2 by nucleic acid amplification (NAA) test (nasal swab) negative on 01Jun2021. The patient received treatment with scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and at present he had improvement in symptoms and troponins. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of myocarditis and chest pain.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram PR segment depression, Myocarditis, SARS-CoV-2 test, Troponin
Clinical narrative: myocarditis with PR segment depression and a Troponin of 9000; Chest pain; This is a spontaneous report from a contactable physician. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0168), at the age of 16 years old, intramuscularly in right arm on 29May2021 14:00 at single dose for covid-19 immunisation.  Medical history included allergies to pollen. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0172), at the age of 16 years old, intramuscularly in right arm on 08May2021 12:00 at single dose for covid-19 immunisation. Shortly after the patient began experiencing a cough which has persisted until currently presentation. The patient received his second dose on 29May2021 14:00 and developed chest pain on 30May2021. Subsequently the patient experienced myocarditis with PR segment depression and a troponin of 9000. The patient was admitted to the hospital for 2 days. The patient underwent lab tests and procedures which included PR segment depression and troponin 9000 on 30May2021, SARS-CoV-2 by nucleic acid amplification (NAA) test (nasal swab) negative on 01Jun2021. The patient received treatment with scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and at present he had improvement in symptoms and troponins. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of myocarditis and chest pain.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS LEFT AT ROOM TEMPERATURE (IN A PRE-FILLED SYRINGE) AND ADMINISTERED OUTSIDE OF THE RECOMMENDED TEMPERATURE EXCURSION LIMIT; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-MAY-2021 14:37 for prophylactic vaccination.  No concomitant medications were reported.  On 30-MAY-2021, the subject experienced vaccine was left at room temperature (in a pre-filled syringe) and administered outside of the recommended temperature excursion limit. On 30-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was left at room temperature (in a pre-filled syringe) and administered outside of the recommended temperature excursion limit and poor quality drug administered was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS LEFT AT ROOM TEMPERATURE (IN A PRE-FILLED SYRINGE) AND ADMINISTERED OUTSIDE OF THE RECOMMENDED TEMPERATURE EXCURSION LIMIT; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-MAY-2021 14:37 for prophylactic vaccination.  No concomitant medications were reported.  On 30-MAY-2021, the subject experienced vaccine was left at room temperature (in a pre-filled syringe) and administered outside of the recommended temperature excursion limit. On 30-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was left at room temperature (in a pre-filled syringe) and administered outside of the recommended temperature excursion limit and poor quality drug administered was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Angiogram normal, Blood test, Chest pain, Dyspnoea
Clinical narrative: myocarditis, aspirin, patient was observed for 24 hours in Hospital and discharged.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Full blood count
Clinical narrative: myocarditis, aspirin, patient was observed for 24 hours in Hospital and discharged.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myocarditis, Pain, Pain in extremity, Pericarditis
Clinical narrative: myocarditis, aspirin, patient was observed for 24 hours in Hospital and discharged.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: myocarditis, aspirin, patient was observed for 24 hours in Hospital and discharged.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram PR segment depression, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: myocarditis, aspirin, patient was observed for 24 hours in Hospital and discharged.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Myocarditis
Clinical narrative: the cause of death is myocarditis; This is a spontaneous report from a contactable consumer reporting for her father.    A 78-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 13May2021 (Batch/Lot Number: EX8679) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died from myocarditis  on 14May2021.   The patient died on 14May2021.  It was not reported if an autopsy was performed.  Course of the event. The woman reported that her father, who was vaccinated in out of country, died after the second dose. He got his second dose on 13May2021 and died the next day (14May2021). The cause of death is myocarditis.  Follow up information has been requested.; Reported Cause(s) of Death: the cause of death is myocarditis
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: the cause of death is myocarditis; This is a spontaneous report from a contactable consumer reporting for her father.    A 78-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 13May2021 (Batch/Lot Number: EX8679) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died from myocarditis  on 14May2021.   The patient died on 14May2021.  It was not reported if an autopsy was performed.  Course of the event. The woman reported that her father, who was vaccinated in out of country, died after the second dose. He got his second dose on 13May2021 and died the next day (14May2021). The cause of death is myocarditis.  Follow up information has been requested.; Reported Cause(s) of Death: the cause of death is myocarditis
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Blood potassium increased, Contusion, Eye haemorrhage, Thrombosis
Clinical narrative: bleeding disorder; severe bruising left leg post shot 1, has large bruising on one leg; This is a spontaneous report from two contactable consumers (one was the patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 at 81 years old as 1st dose, single dose for COVID-19 immunization given in a doctor's office. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. No known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, the patient had a severe bruising left leg post shot 1, has large bruising on one leg. It was also reported that the patient developed a bleeding disorder after the doses of the Pfizer vaccine. The events required physician's office visit. The events did not result in death or life threatening condition, cause hospitalization, disability or congenital anomaly. No treatment was given. The outcome of the events was reported as not recovered.   Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: bleeding disorder; severe bruising left leg post shot 1, has large bruising on one leg; This is a spontaneous report from two contactable consumers (one was the patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 at 81 years old as 1st dose, single dose for COVID-19 immunization given in a doctor's office. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. No known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, the patient had a severe bruising left leg post shot 1, has large bruising on one leg. It was also reported that the patient developed a bleeding disorder after the doses of the Pfizer vaccine. The events required physician's office visit. The events did not result in death or life threatening condition, cause hospitalization, disability or congenital anomaly. No treatment was given. The outcome of the events was reported as not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Blood cholesterol increased, Blood creatine phosphokinase increased, Blood triglycerides increased, Low density lipoprotein increased
Clinical narrative: 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in left arm on 25May2021 at 08:00 AM as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration in left arm on 04May2021 at 11:00 AM for covid-19 immunisation. The patient's medical history included rhabdomyolysis. The patient had known allergies to Sulfa. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28May2021, 3 days post 2nd dose of covid vaccine, patient experienced muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Rhabdomyolysis, Swelling
Clinical narrative: 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in left arm on 25May2021 at 08:00 AM as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration in left arm on 04May2021 at 11:00 AM for covid-19 immunisation. The patient's medical history included rhabdomyolysis. The patient had known allergies to Sulfa. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28May2021, 3 days post 2nd dose of covid vaccine, patient experienced muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Musculoskeletal stiffness, Myalgia, Swelling
Clinical narrative: 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in left arm on 25May2021 at 08:00 AM as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration in left arm on 04May2021 at 11:00 AM for covid-19 immunisation. The patient's medical history included rhabdomyolysis. The patient had known allergies to Sulfa. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28May2021, 3 days post 2nd dose of covid vaccine, patient experienced muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: It was discovered the pfizer vaccine was not removed from the freezer to the refrigerator after 14 days in the freezer.  After contacting Pfizer, the vaccine was not viable after 17 days.  The vaccine was administered to the patient after the 17 day timeframe.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Felt sick after vaccination; This spontaneous report has been received from a lawyer, via plaintiff fact sheet from a case in litigation for zoster vaccine live (ZOSTAVAX)(MARRS # 2009USA005959), concerning to a male Elderly patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) (anatomical location, administration route, lot number and exporation date were not rpeorted) for prophylaxis.         On an unspecified date, the patient felt sick after the vaccination (malaise). The outcome of malaise was unknown.   The reporter considered malaise as an adverse reaction or side effect from the vaccination with pneumococcal vaccine, polyvalent (manufacturer unknown).; Sender's Comments:  US-009507513-2009USA005959:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse Events (AEs); Varivax and MMR II that underwent multiple temerature excursions and were administered; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On 07-MAY-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # T020652, expiration date: 16-JUN-2022 (dose, route of administration and anatomical location were not reported), and of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) injection lot # S035352, expiration date: 05-NOV-2021 (dose, route of administration and anatomical location were not reported). Both vaccines were administered as prophylaxis. Both vaccines underwent multiple temperature excursions: -14.03 Celsius degree (C) for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds; -10.3 C for 1 hour 0 minutes 0 seconds; -6.3 C for 2 hours 0 minutes 0 seconds. Prior temperature excursion was reported as -14.03 C for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds. Data logger was used to capture the temperature excursion. No additional adverse events were reported.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse Events (AEs); VARIVAX and MMR II that underwent multiple temperature excursions and were administered; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On 06-MAY-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # T020652, expiration date: 16-JUN-2022 (dose, route of administration and anatomical location were not reported), and of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) injection lot # S035352, expiration date: 05-NOV-2021 (dose, route of administration and anatomical location were not reported). Both vaccines were administered as prophylaxis. Both vaccines underwent multiple temperature excursions: -14.03 Celsius degree (C) for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds; -10.3 C for 1 hour 0 minutes 0 seconds; -6.3 C for 2 hours 0 minutes 0 seconds. Previous temperature excursion was reported as -14.03 C for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds. Data logger was used to capture the temperature excursion. No additional adverse events were reported.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Customer reports a 2 month old infant was given a dose of pediatric VAQTA; No additional AE reported; This spontaneous report was received from a pharmacist, referring to a 2 month old patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with a dose of pediatric hepatitis a vaccine, inactivated (VAQTA), with lot # T018229 and expiration date on 14-DEC-2021 (route of administration was not provided) for prophylaxis. No additional adverse events were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE. No PQC. No further information available; GARDASIL 9 in 2016 when Patient was 12 years old was administered the 2nd GARDASIL 9 dose on 04/13/2021; This spontaneous report was received from a Nurse, referring to a 16 year old female patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.   In 2016, when the patient was 12 year old, she was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # L024993 and expiration date on 17-OCT-2017 (route of administration was not provided) for prophylaxis.  Subsequently, on 13-APR-2021, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration, lot # and expiration date were not provided) also for prophylaxis.  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: It was reported that a patient received the first dose of GARDASIL 9 over a year ago; No adverse event; This spontaneous report was received from a Medical Assistant, referring to an approximately 21 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      Approximately in 2020 (reported as "over a year"), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot # and expiration date were not provided) for prophylaxis.  It was reported that, at reporting time, the patient had not received any other doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination series. The patient want to be vaccinated to complete the series. No adverse events were reported.
Sex: F
Vaccine: MMR
Symptoms: Deafness, Dermatitis allergic, Hypersensitivity, Pyrexia, Rash
Clinical narrative: made her deaf; fever; scared to get the shot because of my reactions before to other vaccines / after the vaccine she had an allergic reaction (rahses); This spontaneous report was received from an 56-year-old female consumer reporting on herself.      On an unknown date, when she was born, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(MEASLES, MUMPS, AND RUBELLA (WISTAR RA 27-3) VIRUS VACC, LIVE) (dosage regimen, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, after the vaccine, the patient experienced an allergic reaction-rashes (dermatitis allergic), fever of 105 (units not provided) (pyrexia) and made her deaf (deafness)   The outcome of deafness, dermatitis allergic and pyrexia, as well as the causal relationship with the vaccination were not reported.  Upon internal review, the event of deafness was considered medically significant
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: her deltoid where the injection was given had developed redness, hardness and swelling; her deltoid where the injection was given had developed redness, hardness and swelling; her deltoid where the injection was given had developed redness, hardness and swelling; soreness at the injection site; This spontaneous report was received from a nurse via company representative referring to a female patient of unknown age.  The patient's pertinent medical history, drug reaction or allergies, concurrent conditions and concomitant therapies were unknown by the reporter.  On an unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) once intramuscularly in the deltoid region for prophylaxis (vaccination scheme, lot number and expiration date were unknown by the reporter).   Immediately after she received the dose, the patient complained of soreness at the injection site (vaccination site pain). Approximately two weeks after she received the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient's deltoid where the injection was given had developed redness (vaccination site erythema), hardness (vaccination site induration) and swelling (vaccination site swelling). It was unknown if the patient sought medical attention, underwent laboratory diagnosis or studies, or if treatment was given for the events. The outcome of the events was unknown.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; received her first dose of GARDASIL 9 at the age of 7 in 2013; inadvertently gave 7 years old a dose of Gardasil 9; This spontaneous report was received from a consumer via a company representative referring to a 7 years old female patient. The patient's concomitant medication, medical history and drug reactions or allergies were not reported.  On an unknown date in 2013, the patients was inadvertently vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (1 dosage form; strength, frequency, route, lot# and expiration date unknown) for prophylaxis (Product administered to patient of inappropriate age and inappropriate schedule of product administration). No additional adverse event or product quality concern.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 34 year old female patient received her first dose of GARDASIL 9 vaccine 13 years ago and never received another one.; No other AE information reported; This spontaneous report was received from a nurse and refers to a 34-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in June 2008 (reported as "13 years ago"), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that the patient never received another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered). There was no additional adverse event reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient fainted after receiving a dose of GARDASIL 9; This spontaneous report as received from a physician via company representative, refers to a 11-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number, expiration date were not reported) for prophylaxis.     On an unknown date, the patient experienced fainted (syncope) after receiving a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). It was unknown if laboratory/studies were performed. The patient did not receive any treatment for the event. The outcome of syncope was unknown.   The causality was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dysphonia, Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: Angioedema; Dysphonia; Dyspnoea; Swollen tongue; Throat tightness; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (Angioedema) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD, TIA, Migraine, PUD and Angioedema. Concurrent medical conditions included Diabetes mellitus and Hypertension.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), DYSPHONIA (Dysphonia), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; EPINEPHRINE at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), DYSPHONIA (Dysphonia), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of SYNCOPE (Syncope) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.  Company Comment: Very limited information regarding the event has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Arthralgia, Fatigue, Migraine, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Fatigue (minor); Tylenol 250 mg (prior to vaccine for migraine); Mild joint / aches; Mild / muscle aches; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis and paracetamol (Tylenol Tablet) tablet for migraine.   Concomitant products included levothyroxine sodium (Synthroid).   On 5th January 2021, the patient received the 2nd dose of Shingrix. On 11th February 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 21st January 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER and Tylenol Tablet 250 mg at an unknown frequency. In January 2021, less than a month after receiving Shingrix, the patient experienced migraine. On 21st January 2021, the patient experienced pain in arm and fatigue. On 11th February 2021, the patient experienced joint pain and muscle pain. The patient was treated with paracetamol (Tylenol Tablet). The action taken with Tylenol Tablet was unknown. In February 2021, the outcome of the joint pain and muscle pain were recovered/resolved. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the migraine was unknown.   It was unknown if the reporter considered the pain in arm, joint pain, muscle pain, fatigue and migraine to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient's concomitant products included Synthroid, which was ongoing since 1981. On 21st January 2021, prior to vaccination the patient received Tylenol 250 mg half tablet for migraine. The patient received Covid-19 vaccine Pfizer on an right arm. The patient had mild joint and muscle ache which was lasted for 36 hours and sore arm and minor fatigue. Less than a day after receiving 1st dose of Covid-19 vaccine Pfizer, the patient experienced sore arm and minor fatigue. Less than a day after receiving Tylenol tablet, the patient experienced minor fatigue. Less than a day after receiving 2nd dose of Covid-19 vaccine Pfizer, the patient experienced mild joint ache, muscle ache and minor fatigue. The patient experienced sore arm and minor fatigue, 16 days after receiving Shingrix, mild joint and muscle ache 37 days after receiving Shingrix and migraine, less than a month after receiving Shingrix. The patient did not receive any treatment for the adverse events and she was fine at the time of reporting. It was unknown if the reporter considered the pain in arm, joint pain, muscle pain, fatigue to be related to Covid-19 vaccine Pfizer. It was unknown if the reporter considered the fatigue to be related to Tylenol tablet. The permission to follow-up was denied. Note: The onset date for migraine was unknown, hence it was conservatively captured as an event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both doses of the vaccine, but got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both doses of Shingrix vaccine and got shingles. The patient stated did this mean the vaccine was ineffective for him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced a case of shingles; This case was reported by a consumer via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine and after 2 weeks patient experienced Shingles. The reporter consented to follow-up. No further information received.