chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Granuloma annulare, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Sjogren's syndrome; Lupus; granuloma annulare; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding the pt's current condition, historical condition and concomitant medication was not provided. On or about 24-SEP-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: granuloma annulare, Sjorgen's syndrome and lupus. The pt claimed damages as results of injury to themselves and economic losses. The outcome of the events was known. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, Sjogren's syndrome and lupus were considered as medically significant.
Sex: F
Vaccine: COVID19, HPV9
Symptoms: COVID-19, Herpes virus test, Oedema genital, Pain, Vaginal ulceration
Clinical narrative: she was diagnosed with COVID/ complaining of feeling tired; She bagan experiencing pain when se went to the bathroom; patient's labia was found to be swollen up to 4 times it's normal size; ulcers in her vaginal area; This spontaneous report was received from an unspecified reporter, concerning an adult female patient (around 19 or 20 years old). The patient's concurrent conditions included irritable bowel syndrome, gluten intolerance and lactose intolerance. Concomitant medications, historical conditions and drug allergies were not reported.   On an unknown date (reported as sometime in April), the patient was vaccinated with covid-19 vaccine (indication, lot number, dose, schedule, anatomical location, route of administration, and expiration date were not reported), then shortly after she was exposed to someone with covid and she was diagnosed with Covid (COVID -19). Subsequently, the patient began feeling better, but was still complaining of feeling tired. She went to her physician's office to receive her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, schedule, anatomical location, route of administration, lot number, and expiration date were not reported) on an unknown date in April (also reported as "Tuesday in April").   On Friday of the same week, the patient ran a 5 km and on Saturday, the patient's began experiencing pain when she went to the bathroom (pain), her physician found her labia swollen up to 4 times its normal size (oedema genital). Therefore, the patient received trimethoprim (+) sulfamethoxazole (BACTRIM) and another antibiotic as a treatment. It was also stated that the patient underwent a urinary tract infection test, but the results were unknown. The patient was tested for Herpes due to some ulcers in her vaginal area (vaginal ulceration) and the test was negative.  At the reporting time, the patient was fully recovered, and the symptoms pain, oedema genital, and vaginal ulceration lasted for one week.   The causal relationship between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue, Unevaluable event
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter..; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue, Unevaluable event
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter..; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003542: US-009507513-2105USA003543:
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003540: US-009507513-2105USA003543:
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003542: US-009507513-2105USA003541:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No PQC or additional AEs reported; Caller reports administration of vaccine after non-supported temperature excursion; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 24-APR-2022, the patient was vaccinated with an improperly stored dose of 0.5 milliliters (ml) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T026168 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) prefilled syringe, expiration date reported and but upon internal validation established as 04-DEC-2022) as prophylaxis (product storage error).  Since 07-APR-2021, the administered dose of the vaccine experienced intermittently a temperature excursion of 30 degrees Fahrenheit (F) for a time frame of 228 hours, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; cardiovascular event; hearing and balance problems; hearing and balance problems; herpes zoster; Information has been received from a lawyer and a female patient (pt) of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On 01-JUN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot#, expiration date and route were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered and continued to suffer from herpes zoster outbreaks, post herpetic neuralgia, a cardiovascular event, as well as hearing and balance problems. As a result of these injuries, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the events was considered as not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster outbreaks, post herpetic neuralgia, a cardiovascular event, as well as hearing and balance problems were considered as disabling by the lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Pneumonia
Clinical narrative: Pneumonia of both lower lobes; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: the prevention of shingles by an unknown health care provider (HCP). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced coughing and fatigue and was diagnosed with pneumonia of both lower lobes (pneumonia). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life; physical impairment and injury; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. At the reporting time, he was not recovered of pneumonia. The reporter considered the event pneumonia to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered pneumonia to be disabling.  Upon internal review, the event pneumonia was considered to be medically significant.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Caller states a nurse reported an expired dose of VAQT A adult was administered to a patient; This spontaneous report was received from a nurse referring to 28-year-old male patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On 17-MAY-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (concentration, number of administered dose, dosage, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number T014590 and expiration date 15-APR-2021) (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV4
Symptoms: Epilepsy
Clinical narrative: epilepsy; Information has been received from an office manager from a medical facility via a company representative reporting on the daughter (of unknown age) of the owner of the facility. The reporter did not know the patient's concurrent conditions, medical history, or concomitant medication.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced epilepsy. It was unknown if treatment was given for the adverse event. The office manager stated that according to the owner of the facility, the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine "triggered epilepsy in their daughter," so their facility would never provide vaccinations for patients as directed by the owner of the facility.  The outcome of epilepsy and the causality between the event and the vaccine was not provided.  Upon internal review, epilepsy was considered to be medically significant.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-MAY-2021 , the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported. This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-MAY-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-MAY-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Platelet count
Clinical narrative: This case was received via VAERS (Reference number: 1194270) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt bad) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad) (seriousness criteria hospitalization). At the time of the report, FEELING ABNORMAL (felt bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Platelet count: (Low) decreased.     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.   No concomitant and treatment medications were provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: My shot hurt for about two weeks; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and it hurt for about two weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got one shot / got shingles in between but was so mild; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and got shingles in between but was so mild went back after shingles and got second shot worth it.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT is 17 . Moderna Vaccine  FOR Covid-19 is indicated FOR  18 + Older. Family WANT PATIENT to get 2nd Dose 1 PATIENT is 17 YEARS OLD. 2 Moderna Covid-19 Vaccine        is indicated FOR age 18 + OVER. 3 PATIENTS fatheR refused to allow us to contact the Primary DoctoR 4 PATIENTS Father WANTS Patient to ReciEvE the Second dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Fatigue, Oxygen saturation decreased
Clinical narrative: Patient started symptoms of fatigue, dizziness on Monday. The following day was weak / fatigued, at approximately 7:30am he fell on the floor. EMT responded. As the day progressed, the weakness increased, and patient went to ER around 2pm on Tuesday. Wednesday while in the hospital, the O2 sats have been dropping. Patient has history of COPD.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram cerebral normal, Anti-aquaporin-4 antibody, Arteriogram carotid normal, Arthralgia, Borrelia test negative
Clinical narrative: acute onset of numbness/tingling (paresthesia) and weakness involving his left upper extremity, as well as gait instability from weakness involving the left lower extremity (difficulty ambulating).  He also endorses bilateral shoulder pain and neck pain.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, HIV test negative, Hepatitis C test negative, Herpes simplex test negative, Hypoaesthesia
Clinical narrative: acute onset of numbness/tingling (paresthesia) and weakness involving his left upper extremity, as well as gait instability from weakness involving the left lower extremity (difficulty ambulating).  He also endorses bilateral shoulder pain and neck pain.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Intervertebral disc degeneration, Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: acute onset of numbness/tingling (paresthesia) and weakness involving his left upper extremity, as well as gait instability from weakness involving the left lower extremity (difficulty ambulating).  He also endorses bilateral shoulder pain and neck pain.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Myelitis transverse, Neck pain, Paraesthesia, Vertebral foraminal stenosis
Clinical narrative: acute onset of numbness/tingling (paresthesia) and weakness involving his left upper extremity, as well as gait instability from weakness involving the left lower extremity (difficulty ambulating).  He also endorses bilateral shoulder pain and neck pain.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to a person under 18 years of age
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: patient reported dizziness, and fainted 13 minutes after vaccine administered, paramedics called, helped patient sit on ground to lie down with feet elevated until help arrived, patient refused transport to hospital but had a friend pick her up to avoid driving.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to a person under 18 years of age
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dizziness, Dyspnoea, Flushing
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Injection site pain, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Vision blurred, Vitreous floaters
Clinical narrative: AFTER THE 2ND DOSE I HAD A LARGE FLOATER APPEAR IN MY LEFT EYE.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2" round, red, swollen, itchy area at injection site.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lichenoid keratosis
Clinical narrative: Lichenoid and interface dermatitis
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Walking aid user, Wheelchair user
Clinical narrative: Severe knee pain -- Arthritis flareup? I did not have this before the vaccine. It was debilitating enough I was using a cane and needed a wheel chair at times. Meloxicam has helped alleviate some symptoms, but I am still in pain
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb abnormal
Clinical narrative: Severe knee pain -- Arthritis flareup? I did not have this before the vaccine. It was debilitating enough I was using a cane and needed a wheel chair at times. Meloxicam has helped alleviate some symptoms, but I am still in pain
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Myocardial infarction, Surgery
Clinical narrative: Serious chest pains began 5 days post receiving 2nd vaccine.  3 days later ended up in hospital with massive heart attack.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature decreased, Movement disorder, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Nausea, Pain
Clinical narrative: Sore arm Rash on arm Bruising on palm of hand Severe headache Nausea Fatigue Body aches Sinus issues
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Sinus disorder
Clinical narrative: Sore arm Rash on arm Bruising on palm of hand Severe headache Nausea Fatigue Body aches Sinus issues
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Chest X-ray abnormal, Computerised tomogram thorax normal, Myocardial necrosis marker increased, Pericarditis
Clinical narrative: experienced  acute pericarditis
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast normal, Tachycardia
Clinical narrative: experienced  acute pericarditis