chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: denied further AE; patients were administered MMRII that underwent multiple temperature excursion; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 21-MAY-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000996: US-009507513-2108USA000995: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000999: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of herpes zoster was not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000973: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000: US-009507513-2108USA001007:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 26-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000973: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000973: US-009507513-2108USA000998: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000973: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 02-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000: US-009507513-2108USA000973:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Rash vesicular
Clinical narrative: blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 23-OCT-2017, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX), the patient suffered blisters and redness on bilateral forearms and was diagnosed with herpes zoster, varicella-like rash and drug dermatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be disabling and related to Zoster Vaccine Live(ZOSTAVAX).
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Insomnia, Muscle atrophy, Pain
Clinical narrative: total pain 24/7 non stop / Was a uncommon side effect / the pain was so bad; could not sleep at night; lost 60 to70 % of muscle tissue in my left arm; Torment; regained feeling in most of my left hand except 2 fingers little & ring finger; This case was reported by a consumer via media and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain, insomnia, muscle atrophy, stress and numbness in fingers. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the insomnia, muscle atrophy, stress and numbness in fingers were unknown.   It was unknown if the reporter considered the pain, insomnia, muscle atrophy, stress and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The patient reported that, he or she was told he/she had no choice because of his or her age by the patient's doctor and 3 years ago from reporting date, the patient received Shingrix in left arm.  The patient stated that from the moment the Shingrix vaccine was plunged into the patient's left arm, it was total pain 24/7 nonstop.  The patient stated that was an uncommon side effect from this drug that you would not get told about. Less than a day after receiving Shingrix, the patient could not sleep at night because the pain was so bad.  Less than a year after receiving Shingrix, the patient lost 60 to70 percent of muscle tissue in his or her left arm that would never come back.  The patient stated after 1 year of torment, he/she was sent to a Neurologist. The patient regained feeling in most of his or her left hand except two fingers little and ring finger but help the pain tremendously.  The patient reported that before you make the decision, find out what drug would be given to you, and google uncommon side effects.  The patient said, it was worst decision in his or her life was the shingle shot. The follow-up would not possible as no contact details were available.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Stress
Clinical narrative: total pain 24/7 non stop / Was a uncommon side effect / the pain was so bad; could not sleep at night; lost 60 to70 % of muscle tissue in my left arm; Torment; regained feeling in most of my left hand except 2 fingers little & ring finger; This case was reported by a consumer via media and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain, insomnia, muscle atrophy, stress and numbness in fingers. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the insomnia, muscle atrophy, stress and numbness in fingers were unknown.   It was unknown if the reporter considered the pain, insomnia, muscle atrophy, stress and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The patient reported that, he or she was told he/she had no choice because of his or her age by the patient's doctor and 3 years ago from reporting date, the patient received Shingrix in left arm.  The patient stated that from the moment the Shingrix vaccine was plunged into the patient's left arm, it was total pain 24/7 nonstop.  The patient stated that was an uncommon side effect from this drug that you would not get told about. Less than a day after receiving Shingrix, the patient could not sleep at night because the pain was so bad.  Less than a year after receiving Shingrix, the patient lost 60 to70 percent of muscle tissue in his or her left arm that would never come back.  The patient stated after 1 year of torment, he/she was sent to a Neurologist. The patient regained feeling in most of his or her left hand except two fingers little and ring finger but help the pain tremendously.  The patient reported that before you make the decision, find out what drug would be given to you, and google uncommon side effects.  The patient said, it was worst decision in his or her life was the shingle shot. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: mcv4 (Menveo or Menactra) vaccine to be administered. However, the medical assistant gave a dose of; Trumenba was inadvertently administered simultaneously with Bexsero/ gave a dose of Bexsero /and / Trumemba; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   In July 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. In July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and accidental overdose. On an unknown date, the outcome of the wrong vaccine administered and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient had ordered a Bexsero vaccine and an mcv4 (Menveo or Menactra) vaccine to be administered.  However, the medical assistant, inadvertently simultaneously administered a dose of Bexsero vaccine and a dose of Trumemba vaccine, which led to wrong vaccine administered and accidental overdose. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: She is allergic to flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of allergy in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included cancer (patient had Laryngeal voice box cancer), chronic obstructive pulmonary disease and drug allergy (allergic to mycins, cillins, naproxen sodium, penicillin and erythromycin).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot and had allergy. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I got the vaccine ..was allergic to it; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Shingrix and had allergic reaction. No other information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Product complaint, Syncope
Clinical narrative: new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   In August 2021, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a PQC associated, for that the health care professional was transferred to the GRC, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167017:Same reporter US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product complaint, Syncope
Clinical narrative: new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a Regulatory Authority associated, for that the health care professional was transferred, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter US-GLAXOSMITHKLINE-US2021167017:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Hot flush
Clinical narrative: hot flashes; This case was reported by a consumer via interactive digital media and described the occurrence of hot flashes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hot flashes. On an unknown date, the outcome of the hot flashes was unknown.   It was unknown if the reporter considered the hot flashes to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The reporter asked was hot flashes a symptom of the 2nd Shingrix shot. The follow-up would not possible as no contact details were available.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: first MPSV4/was given MCV4 on 7/28/2021; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA517A, expiry date 30th April 2022) for prophylaxis.   Previously administered products included MPSV4 (1st dose received on 5th October 2016 (received at the age of 11 years)).   On 28th July 2021, the patient received the 2nd dose of Menveo. On 28th July 2021, unknown after receiving Menveo, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.  Additional details were reported as follows: On 5th October 2016, the patient received 1st dose of MPSV4 vaccine at the age of 11 years. As per CDC, minimum age for vaccination for this type of Menongococcal vaccine was 16 years. On 28th July 2021, the patient received 2nd dose as a Menveo (MCV4), which led to interchange of vaccine products. The reporter consented to follow up. This case has been linked to US2020259323, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020259323:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose administered October 6, 2019, LATE 2ND DOSE; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. No reactions reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Swelling
Clinical narrative: lump the size of a goose egg; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The health care professional received the first dose of Shingrix around 4 months ago and called to inquire about the intensity of reactions compared to the first dose reactions.  Health care professional presented a lump and was in the size of a goose egg for some weeks. No exact dates were provided by health care professional regarding her own symptoms, resolution of the event or first dose administration. Reporter consented to follow-up by email.