chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 08-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007451: US-009507513-2112USA007437: US-009507513-2112USA007438: US-009507513-2112USA007439: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007449: US-009507513-2112USA007450: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Sex: F
Vaccine: HPV9
Symptoms: Bacterial vaginosis
Clinical narrative: This spontaneous report has been received from a physician assistant referring to an adult female patient in her 40's. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. On an unspecified date, the patient experienced bacterial vaginosis. The patient sought medical attention; however, it was unknown if lab diagnostic studies were performed or if treatment was given for the event. The outcome of the event was unknown. The reporter stated that the patient thought that the bacterial vaginosis was caused by the vaccine, but her physician did not agree and did not think the event was related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter's causality assessment was not provided.
Age: 15.0
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: the patient has not had any side effects; a 15 year received PNEUMOVAX 23 by accident; This spontaneous report was received from a nurse concerning a 15-year-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 16-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis by accident (accidental exposure to product).  NO other issues or concerns were noted. The patient had not had any side effects at the reporting time.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 08-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 06-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date reported and established as 05-OCT-2022; dose, route of administration, and anatomical site of vaccination were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 53 minutes; above 9 degrees C (9.6C) for a time frame of 34 minutes; above 9 degrees C (9.5C) for a time frame of 23 minutes; and above 9 degrees C (8.5C) for a time frame of 9 minutes. It was reported that no had previous temperature excursion. No additional adverse effects reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from reporter stated as other and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 17-DEC-2021, the patient was vaccinated with an improperly store measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (strength, dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number T033814 had been verified to be a valid number with an expiration date reported and established as 05-OCT-2022) for prophylaxis (product storage error).   The vaccine underwent a temperature excursion that was reported as following: above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that the suspect vaccine did not had a previous temperature excursion. No additional adverse effect was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from reporter stated as other and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 11-OCT-2021, the patient was vaccinated with an improperly store measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (strength, dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number T033814 had been verified to be a valid number with an expiration date reported and established as 05-OCT-2022) for prophylaxis (product storage error).   The vaccine underwent a temperature excursion that was reported as following: above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that the suspect vaccine did not had a previous temperature excursion. No additional adverse effect was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from a reporter, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number T033814, expiration date reported and validated as 05-OCT-2022) as prophylaxis, that underwent a temperature excursion (product storage error). No additional adverse effect reported.  The vaccine experienced temperature excursions above 9 degrees Celsius (C) (12.4C) for 53 minutes and 0 seconds, above 9C (9.6C) for 34 minutes and 0 seconds, above 9C (9.5C) for 23 minutes and 0 seconds and above 9C (8.5C) for 9 minutes and 0 seconds. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from a reporter, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number T033814, expiration date reported and validated as 05-OCT-2022) as prophylaxis, that underwent a temperature excursion (product storage error). No additional adverse effect reported.  The vaccine experienced temperature excursions above 9 degrees Celsius (C) (12.4C) for 53 minutes and 0 seconds, above 9C (9.6C) for 34 minutes and 0 seconds, above 9C (9.5C) for 23 minutes and 0 seconds and above 9C (8.5C) for 9 minutes and 0 seconds. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2112USA007442: US-009507513-2112USA006870: US-009507513-2112USA007443:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2112USA007443: US-009507513-2112USA006870: US-009507513-2112USA007442:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2112USA007442: US-009507513-2112USA006870: US-009507513-2112USA007443:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter, concerning a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug allergies or reactions was not provided.   On 07-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II), lot number T033814, with expiration date reported and validated as 05-OCT-2022 (strength, exact dose, vaccination schedule, route of administration, anatomical site of injection were not reported) for prophylaxis that underwent a temperature excursion. No additional adverse effect reported.   The vaccine underwent a temperature above 9 degrees Celsius (12.4 degrees Celsius), for a timeframe of 0 hours 53 minutes and 0 seconds, above 9 degrees Celsius (9.6 degrees Celsius) for 0 hours and 34 minutes and 0 seconds, above 9 degrees Celsius (9.5 degrees Celsius) for 0 hours 23 minutes and 0 seconds, above 9 degrees Celsius (8.5 degrees Celsius) for 0 hours 9 minutes and 0 seconds. No previous temperature excursion (product storage error).; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007429: US-009507513-2112USA007428: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter, concerning a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug allergies or reactions was not provided.   On 26-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number T033814, with expiration date reported and validated as 05-OCT-2022 (strength, exact dose, vaccination schedule, route of administration, anatomical site of injection were not reported) for prophylaxis that underwent a temperature excursion. No additional adverse effect reported.   The vaccine underwent a temperature above 9 degrees Celsius (12.4 degrees Celsius), for a timeframe of 0 hours 53 minutes and 0 seconds, above 9 degrees Celsius (9.6 degrees Celsius) for 0 hours and 34 minutes and 0 seconds, above 9 degrees Celsius (9.5 degrees Celsius) for 0 hours 23 minutes and 0 seconds, above 9 degrees Celsius (8.5 degrees Celsius) for 0 hours 9 minutes and 0 seconds. No previous temperature excursion (product storage error).; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007429: US-009507513-2112USA007428: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from a reporter concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies were not reported.  On 29-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # T033814, expiration date 05-OCT-2022) as prophylaxis (dose, dosage schedule, route and site of administration were not reported). The vaccine was storage at 12.4 degree Celsius for 53 min, at 9.6 degree Celsius for 34 min, at 9.5 degree Celsius for 23 min, and at 8.5 degree Celsius for 9 min. No previous temperature excursion occurred (product storage error). No adverse events reported.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from a reporter concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies were not reported.  On 29-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # T033814, expiration date 05-OCT-2022) as prophylaxis (dose, dosage schedule, route and site of administration were not reported). The vaccine was stored at 12.4 degree Celsius for 53 min, at 9.6 degree Celsius for 34 min, at 9.5 degree Celsius for 23 min, and at 8.5 degree Celsius for 9 min. No previous temperature excursion occurred (product storage error). No adverse events reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 02-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 11-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, dose and route of administration were not provided), which had temperature excursions between 8.5C and 12.4C for time frames between 9 minutes and 53 minutes. The vaccine did not have previous temperature excursions and no additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007425: US-009507513-2112USA007426: US-009507513-2112USA007427: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007436: US-009507513-2112USA007437: US-009507513-2112USA007438: US-009507513-2112USA007439: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, dose and route of administration were not provided), which had temperature excursions between 8.5C and 12.4C for time frames between 9 minutes and 53 minutes. The vaccine did not have previous temperature excursions and no additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007425: US-009507513-2112USA007426: US-009507513-2112USA007427: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007436: US-009507513-2112USA007437: US-009507513-2112USA007438: US-009507513-2112USA007439: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 17-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6 C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007425: US-009507513-2112USA007436:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 23-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6 C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007437: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 30-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 13-DEC-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 15-DEC-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a male patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported. On an unknown date, the patient received a second dose of therapy with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, lot number, expiry date, anatomical location and route of administration were not provided); and he had problems (unevaluable event). The outcome of unevaluable event and the causal relationship between zoster vaccine live (ZOSTAVAX) and the aforementioned event were not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse event; Vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 14-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), (Lot number [U022726] is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)) and expiration date: 16-JAN-2023, directed as to prevent measles, mumps, rubella and varicella.  The reporter mentioned that, there was a temperature excursion involving administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccines (product storage error). No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Temperature excursion involving administered PROQUAD vaccines; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (exact dose, vaccination site, frequency, anatomical site of vaccination, lot # U022726, expiration date 16-JAN-2023) subcutaneously for prophylaxis.  On 21-DEC-2021, measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) was involved in temperature excursion (product storage error).  No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: My husband breaks out with them every 4-5 weeks has for two years he's had all the shots nothing helps with pain; My husband breaks out with them every 4-5 weeks has for two years he's had all the shots nothing helps with pain; This social media spontaneous report as received from the wife's patient via another company and refers to a male patient of unknown age.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unspecified date, the patient had been breaking out with shingles for two years. Despite of having all the shots, nothing had helped with pain. The outcome of shingles and pain was not recovered.        The causality assessment between the events and vaccine live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038177, expiration date 26-NOV-2021 (exact dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired vaccine used) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired VAQTA was given to a patient; No AEs were reported; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) syringe lot # T013204 with an expiration date on 03-DEC-2021, 0.5 milliliter once, for prophylaxis. No additional adverse events or product quality complaints were reported.
Age: 7.0
Sex: M
Vaccine: COVID19, FLUX, HEP, IPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reactions noted; 7yo male was given MMRV; This spontaneous report was received from a healthcare provider via Pfizer on 30-DEC-2021 concerning a 7-year-old male patient. No concurrent condition or medical history was reported. Concomitant therapies included hepatitis b vaccine (recombinant) (manufacturer unknown), covid-19 vaccine, polio vaccine and influenza vaccine (FLU).   On 16-DEC-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, and route were unknown; recombinant Human albumin; lot # U026799 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-FEB-2023) in the left arm for prophylaxis (product administered to patient of inappropriate age). The patient was observed for 30min and no adverse reactions noted.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-DEC-2021, the patient received incorrectly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dosage form, lot #T042014 with expiration date on 23-JUL-2023, administered for prophylaxis (route of administration were not provided). The vaccine underwent temperature excursion of 35.4 Fahrenheit degrees for 5 hours, 34.5 Fahrenheit degrees for 17 hours, 34.3 Fahrenheit degrees for 10 hours and 34.8 Fahrenheit degrees for 2 hours. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was administered an expired dose of PROQUAD; This spontaneous report has been received from other health professional (medical assistant) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, and previous drug reactions or allergies was not provided. Concomitant therapies included sterile diluent (STERILE DILUENT).     On 23-DEC-2021, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (expired product administered) (lot # T021639 has been verified to be a valid lot number, expiration date was reported and established as 21-DEC-2021; route, vaccination scheme, and anatomical site of vaccination were not reported), 0.5 milliliters for prophylaxis.   No additional AE was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Medical Assistant reports the administration of improperly stored ROTATEQ; This spontaneous report has been received from other health professional (medical assistant) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 27-DEC-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1741817 has been verified to be a valid lot number, expiration date was reported and established as 30-JUL-2022; vaccination scheme, and anatomical site of vaccination were not reported), orally, 2 milliliters for prophylaxis. The administration of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) was reported.  The vaccine was exposed to a temperature of 50.5 F, for a time frame of 57 minutes. There were no previous temperature excursions. No additional adverse event were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Medical Assistant reports the administration of improperly stored ROTATEQ.; This spontaneous report has been received from other health professional (medical assistant) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 22-DEC-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1741817 has been verified to be a valid lot number, expiration date was reported and established as 30-JUL-2022; vaccination scheme, and anatomical site of vaccination were not reported), orally, 2 milliliters for prophylaxis. The administration of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) was reported.  The vaccine was exposed to a temperature of 50.5 F, for a time frame of 57 minutes. There were no previous temperature excursions. No additional adverse event were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot# 1741817 and expiration date 30-JUL-2022) (exact dose and frequency were not reported) as prophylaxis (Product storage error). The vaccine underwent a temperature excursion of 55.5 Fahrenheit for a period of 57 minutes. There was no previous temperature excursion. No additional adverse event reported (No adverse event).