chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive Heart Failure; Information has been received regarding a case in litigation from a lawyer and refers to a 66-year-old male patient (conflicting information as it was also reported that the pt was born on a different date as reported). No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2018, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location, lot # and expiration date was not provided) as prophylaxis at a pharmacy. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in 2018, the pt was caused to suffer pain as a result of his Congestive Heart Failure, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the pt, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of Congestive Heart Failure was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Congestive Heart Failure was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vial (lot number T024557, which has been verified to be valid, the expiration date was reported and validated as 15-MAR-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 05-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 18-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 08-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 17-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T000886, which has been verified to be valid, the expiration date was reported and validated as 29-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 29-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T000886, which has been verified to be valid, the expiration date was reported and validated as 29-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036176, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: no adverse event; PROQUAD was given to a 21-year-old female; This spontaneous report was received from a medical assistant and refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 06-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 time dose for prophylaxis (exact dose, route of administration, lot# and expiration date were not reported). The reporter asked if that could be considered a valid dose. No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Pain, Rash
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 07-APR-2021. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In or around 14-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient had suffered rash under the lower left axila and pain radiating under the right breast and she was diagnosed with shingles. As a result, her symptoms resulted in physical limitations and severe, progressive permanent and incurable personal injuries not present prior to vaccination, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles to be a disabling event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was 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: T024831; expirationdate: 18-NOV-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; Sender's Comments:  US-009507513-2104USA001896: US-009507513-2104USA001895: US-009507513-2104USA001897:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 31-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was 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: T024831; expirationdate: 18-NOV-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; Sender's Comments:  US-009507513-2104USA001892: US-009507513-2104USA001896: US-009507513-2104USA001897:
Sex: U
Vaccine: HPV9
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was 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: T024831; expirationdate: 18-NOV-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; Sender's Comments:  US-009507513-2104USA001895: US-009507513-2104USA001892: US-009507513-2104USA001897:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was 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: T024831; expirationdate: 18-NOV-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; Sender's Comments:  US-009507513-2104USA001892: US-009507513-2104USA001896: US-009507513-2104USA001895:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pruritus
Clinical narrative: just the second of this new series. My husband also got the first one years ago; we're only itchy; Incomplete course of vaccination; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, pruritus and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pruritus 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 lady year got the shingles they were only 6 inches at his waist but were only itchy. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked with US2021AMR078485, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078485:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: MA mixed two Shingrix adjuvant vials and administered to this patient; Then administered the full vaccination of the adjuvant and VZV; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The MA (medical assistant) mixed two Shingrix adjuvant vials and administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The office caught it and then administered the full vaccination of the adjuvant and VZV to the patient. The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: TDaP- 0.5 ml Boostrix dose was given to 9 year old male in 2017; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The patient received Boostrix vaccine at 9 year's old age in 2017 year, with no side effects or adverse events seen but below recommended age indication, which led to inappropriate age at vaccine administration. The office manager asked if patient should receive another TDaP for 7th grade school requirement. The patient was 12 years old at the time of reporting, but had only been less than 4 years since last TDaP and was given to him. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal discomfort, Myalgia, Pain
Clinical narrative: Fever; Muscle pain; Slight headache; Shivering; Joint discomfort (toes, neck, lower back) / Discomfort in Groin area; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th April 2021, the patient received the 2nd dose of Shingles vaccine. On 6th April 2021, 1 days after receiving Shingles vaccine, the patient experienced fever, muscle pain, headache, shivering and discomfort in joints. On an unknown date, the outcome of the fever, muscle pain, headache and shivering were unknown and the outcome of the discomfort in joints was not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain, headache, shivering and discomfort in joints to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After second dose for Shingles vaccine, the patient experienced common side effects including muscle pain, slight headache, shivering and fever. However, the patient also experienced uncommon side effects such as joint discomfort (toes, neck, lower back) and discomfort in groin area. On the day of reporting, the patient was having infrequent joint discomfort while walking.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; Muscle pain; Slight headache; Shivering; Joint discomfort (toes, neck, lower back) / Discomfort in Groin area; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th April 2021, the patient received the 2nd dose of Shingles vaccine. On 6th April 2021, 1 days after receiving Shingles vaccine, the patient experienced fever, muscle pain, headache, shivering and discomfort in joints. On an unknown date, the outcome of the fever, muscle pain, headache and shivering were unknown and the outcome of the discomfort in joints was not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain, headache, shivering and discomfort in joints to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After second dose for Shingles vaccine, the patient experienced common side effects including muscle pain, slight headache, shivering and fever. However, the patient also experienced uncommon side effects such as joint discomfort (toes, neck, lower back) and discomfort in groin area. On the day of reporting, the patient was having infrequent joint discomfort while walking.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Social problem
Clinical narrative: Supposed to get the second / shot in March or February 2020 / COVID hit and he never did; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (also experienced arm hurt and felt flu like after receiving 1st dose in November 2019, refer case US2021079438) and Flu vaccine with an associated reaction of influenza like illness (received within 3 to 4 weeks of 1st dose of Shingrix in 2019, refer case US2021AMR080271). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not applicable to this report. The patient stated that he was supposed to get the 2nd dose of Shingrix in March or February 2020, but then COVID hit and he never received. The patient refused to provide any private information and did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080271:Same reporter. US-GLAXOSMITHKLINE-US2021079438:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Vaccination failure
Clinical narrative: received / Shingrix / diagnosed with shingles / 2 weeks ago/suspected vaccination failure; received / Shingrix / diagnosed with shingles / 2 weeks ago; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In March 2021, unknown after receiving 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.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was diagnosed with shingles about 2 weeks before the date of reporting. The reporter was asking if the patient should expect any adverse events. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had my first shingrix dose last fall / I am now due for the second dose / Can I get the second dose of shingrix within 10 months of the first; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on last fall in 2020). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not applicable to this report. In March 2021 (4 weeks ago), the patient received 1st dose of Covid vaccine. The patient asked was there a difference between the 1st and 2nd dose of Shingrix and could he/she get the 2nd dose of Shingrix within 10 months of 1st dose without it affecting the efficacy. The patient was now due for the 2nd dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient stated that his/her pharmacy said that he/she could not get it until 2 weeks after his/her 2nd COVID vaccine that was not until July and patient asked was this true. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her 1st Shingrix vaccination / on 09/22/2020 / has not received her 2nd Shingrix vaccination as of today 04/08/2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2020, in left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The patient did not know lot or expiration date of drug.  The patient had a question if she could still receive 2nd dose late and would planning on getting her 2nd vaccination on day of reporting.  The patient did not provide reason why she was late with second dose. The VAERS information was reported for 1st dose of vaccine. The permission to follow up was denied.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypersensitivity
Clinical narrative: possible Guillain-Barre syndrome / to Shingrix; possible allergic reaction to Shingrix; This case was reported by a physician and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of guillain-barre syndrome (the patient received 1st dose on an unknown date and experienced Guillain-Barre syndrome refer case US2021AMR079956).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the guillain barre syndrome and allergic reaction were unknown.   It was unknown if the reporter considered the guillain barre syndrome and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's colleague. The patient was also a healthcare professional. The age at vaccination was not reported. The physician reported a possible Guillain-Barre syndrome or possible allergic reaction to Shingrix for his colleague. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR079956:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix on April 7th, 2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 7th April 2021, the patient received the 3rd dose of Shingrix. On 7th April 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were reported as follows: On 7th April 2021, the patient received the 3rd dose of Shingrix, which led to extra dose administered. The healthcare professional did not reported side effects. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Neuralgia, Pain, Pain in extremity
Clinical narrative: her right foot became numb like it was asleep; felt nerve pain; pain / up her leg; pain / up her leg to her back; This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2020, 24 hrs after receiving Shingrix, the patient experienced numbness in feet, nerve pain, leg pain and pain. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the numbness in feet, nerve pain, leg pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the numbness in feet, nerve pain, leg pain and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and 24 hours after receiving the Shingrix vaccine her right foot became numb like it was asleep and as she walked around the pain when up her leg to her back and she felt nerve pain.  The healthcare professional ordered an MRI (magnetic resonance imaging) that showed nothing.  Since March 2021, the patient had received 3 steroid injections in her lower back that had only helped minimally with the pain. The patient was not sure whether or not to receive the 2nd Shingrix vaccine. The reporter did not given permission to contact healthcare professional. The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, visual
Clinical narrative: hallucinate/ saw people running for 2 days; This case was reported by a pharmacist and described the occurrence of hallucination in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 23rd September 2022) for prophylaxis.   On 7th January 2021, the patient received the 1st dose of Shingrix. On 7th January 2021, less than a day after receiving Shingrix, the patient experienced hallucination (serious criteria GSK medically significant). On an unknown date, the outcome of the hallucination was recovered/resolved.   It was unknown if the reporter considered the hallucination to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient got hallucination that she saw people running for 2 days. The reporter consented to follow up.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given a dose of Shingrix / but was 48 years old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) (batch number 39KB3, expiry date 1st April 2022) for prophylaxis.   On 8th April 2021, the patient received Shingrix. On 8th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter called for information regarding the administration of the complete dosing schedule of Shingrix to the patient that was given a dose of Shingrix but was 48 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.