chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional advers events; Caller is a nurse reporting that a pediatric dose of VAQTA was administered to a 21 year old adult patient on 24AUG2022. No additional information provided. No additional AE reported. No PQC reported.; a pediatric dose of VAQTA was administered to a 21 year old; This spontaneous report was received from a registered nurse concerning a 21-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-AUG-2022, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, batch/lot #U102007, expiration date: 18-JAN-2023, administered as prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (incorrect dose administered). No additional adverse events were reported.   Lot number U102007 is an invalid lot number for VAQTA as confirmed by lot verification team.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: her physician has prescribed GARDASIL 9 for her and she is 65 years of age and has not been able to find a pharmacy that will administer the vaccine; No other adverse event reported; This spontaneous report has been received from a consumer referring to herself as a 65-year-old female patient. The patient's concurrent conditions included Human Papilloma Virus (HPV) 14 and on an unknown date, she had a radical hysterectomy. Her concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient's physician prescribed her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, route of administration, lot# and expiration date were not reported) (Product prescribing issue).  No adverse event was reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse reported that a dose of VARIVAX was administered to a patient after its labeled expiry date.; This spontaneous report as received from a nurse referring to a 13-month-old patient of unknown gender.      The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (strength, frequency, and route of administration were not provided) lot # T029532 and expiration date 01-SEP-2022 (expired product administered), as prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) had not experienced any temperature excursions. No additional adverse event (AE) reported, no product quality complaint involved.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Bankruptcy, Death, Guillain-Barre syndrome, Hand deformity
Clinical narrative: Guillain-Barre Syndrome/ He was paralized/ He had no balance; his hands were left in a claw like position; he passed away from a different illness; Information has been received from a lawyer and the patient's wife concerning an approximately 78-year-old male patient (pt), regarding a case in litigation. The pt's concurrent conditions, medical history, and concomitant medications were not provided. On 10-DEC-2012, at 78 years old, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, route of administration, anatomical location of the injection, lot number and expiration date were not reported) as prophylaxis. In January 2013, he suffered Guillain-Barre syndrome (GBS). He was in the hospital and rehabilitation for almost 15 months, he was completely paralyzed for most of the time. With intense physical therapy he was able to walk with the help of a walker as he had no balance; also, his hands were left in a claw like position (hand deformity). The pt's wife reported that the pt lost his small business, and both of them lost eight years of their retirement years; she had to become his caregiver, but it was too much for her to get him in and out of the car. She mentioned the pt had to claim bankruptcy for his business and personnel. The pt's wife stated that when treating physicians asked about any vaccines received prior to GBS, she and her husband did not make an association to zoster vaccine live (ZOSTAVAX) (reported as "we never put two and two together"). In January 2020, the pt passed away from an unspecified illness, not GBS, it was unknown if an autopsy was done. The outcome of the events GBS and hand deformity was considered as not recovered. The events GBS and hand deforemity were considered as related to the vaccine. The causality between the pt's death and the vaccine was not provided. The events GBS and hand deformity were considered as disabling events.  Upon internal review, the event GBS was determined to be medically significant.  Additional information was received on 07-SEP-2022 via pharmacy records, regarding a case in litigation. On 10-DEC-2012, the pt received a dose of zoster vaccine live (ZOSTAVAX) injection, single dose vial (dosing information was not provided), administered at a pharmacy.; Reported Cause(s) of Death: passed away
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Impaired work ability, Paralysis, Walking aid user
Clinical narrative: Guillain-Barre Syndrome/ He was paralized/ He had no balance; his hands were left in a claw like position; he passed away from a different illness; Information has been received from a lawyer and the patient's wife concerning an approximately 78-year-old male patient (pt), regarding a case in litigation. The pt's concurrent conditions, medical history, and concomitant medications were not provided. On 10-DEC-2012, at 78 years old, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, route of administration, anatomical location of the injection, lot number and expiration date were not reported) as prophylaxis. In January 2013, he suffered Guillain-Barre syndrome (GBS). He was in the hospital and rehabilitation for almost 15 months, he was completely paralyzed for most of the time. With intense physical therapy he was able to walk with the help of a walker as he had no balance; also, his hands were left in a claw like position (hand deformity). The pt's wife reported that the pt lost his small business, and both of them lost eight years of their retirement years; she had to become his caregiver, but it was too much for her to get him in and out of the car. She mentioned the pt had to claim bankruptcy for his business and personnel. The pt's wife stated that when treating physicians asked about any vaccines received prior to GBS, she and her husband did not make an association to zoster vaccine live (ZOSTAVAX) (reported as "we never put two and two together"). In January 2020, the pt passed away from an unspecified illness, not GBS, it was unknown if an autopsy was done. The outcome of the events GBS and hand deformity was considered as not recovered. The events GBS and hand deforemity were considered as related to the vaccine. The causality between the pt's death and the vaccine was not provided. The events GBS and hand deformity were considered as disabling events.  Upon internal review, the event GBS was determined to be medically significant.  Additional information was received on 07-SEP-2022 via pharmacy records, regarding a case in litigation. On 10-DEC-2012, the pt received a dose of zoster vaccine live (ZOSTAVAX) injection, single dose vial (dosing information was not provided), administered at a pharmacy.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; a dose of VARIVAX was administered after a temperature excursion; This spontaneous report was received from other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W012167, expiration date: 12-APR-2024 (strength, anatomical location, and route of administration were not provided) as prophylaxis, after experienced a temperature excursion (Product storage error) of 5.7 Fahrenheit degree during 30 minutes with a previous temperature excursion of 6 to 14 (9.1F) Fahrenheit degree for 1 hour and 6 minutes. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product dose omission issue, Refusal of vaccination
Clinical narrative: no adverse event; Customer called and reported that a consumer was about to receive a dose of ROTATEQ but then the parent refused; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The customer called and reported that on 09-SEP-2022a consumer was about to receive a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), but then the parent refused (missed dose). Limited information was provided from customer. No additional adverse event (AE) was  reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; second dose in 2019, and the last dose in july 2022; Caller is a consumer who stated that she received all three doses of GARDASIL 9, but they were all taken several years apart outside of the recommended dosage scheduling; This spontaneous report was received from a consumer reporting on herself, a 25-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in August 2015, the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, dose, anatomical location, route of administration, lot #, and expiry date were not reported).On an unspecified date in June 2019, the patient received the second dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, dose, anatomical location, route of administration, lot #, and expiry date were not reported)(Inappropriate schedule of vaccine administered). On an unknown date in July 2022, she was vaccinated with the 3rd dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, dose, anatomical location, route of administration, lot #, and expiry date were not reported), all doses were given as prophylaxis (Inappropriate schedule of vaccine administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report has been received from a non health care professional and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 06-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (dose description, vaccination scheme,  and route of administration were not provided) following a temperature excursion of 5.7 degrees Farenheit (F) for 30 minutes (product storage error), it was mentioned that previous temperature excursion did occurred between 6 F up to 14 F (9.1F) for 1 hour 6 minutes; and 6F up to 14F (10F) for 1 hour 8minutes. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; dose of VARIVAX was administered after a temperature excursion; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W002601, expiration date: 24-JAN-2024 (strength, anatomical location, and route of administration were not provided) as prophylaxis, after experienced a temperature excursion of 5.7 Fahrenheit degree during 30 minutes with a previous temperature excursion of 6 to 14 Fahrenheit degree for 1 hour and 6 minutes. No adverse event was reported.  This is one of two cases reported by the same reporter.; Sender's Comments:  US-009507513-2209USA004009:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; a dose of VARIVAX was administered after a temperature excursion; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W002601, expiration date: 24-JAN-2024 (strength, anatomical location, and route of administration were not provided) as prophylaxis, after experienced a temperature excursion of 5.7 Fahrenheit degree during 30 minutes with a previous temperature excursion of 6 to 14 Fahrenheit degree for 1 hour and 6 minutes. No adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2209USA003958:MSD
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a healthcare business professional (HBP) and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, 1 dose, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 5.7 Fahrenheit (F) for a time frame of 0 hour 30 minutes and 0 second. Additional prior excursion include 6 F up to 14 F (10 F) for 1 hour 8 minutes 0 second (on 18-JUL-2022). Previous temperature excursion included 6 F up to to 14 F (9.1 F) for 1 hour 6 minutes and 0 second.   No additional adverse event (AE) information was reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; 1 lot of VARIVAX was administered after non-supported excursion; This spontaneous report has been received from an office manager, regarding an unspecified number of patients of unknown gender and age. Information regarding the patients' historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On 19-JUL-2022, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U008181, expiration date: 16-JUN-2022 experienced 08-FEB-2023) was administered after non-supported excursion (product storage error). Temperature excursion of 10.2 Celsius degrees (C) for 182 hour. No additional adverse events (AE) reported (no adverse event).  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up was received from the office manager on 09-SEP-2022. It was updated, that not properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to 16-year old female patient, and her sister. There was reported, that temperatures were misread and misrecorded, and that is why the medication error occurred. It was confirmed, that no adverse reactions were reported.; Sender's Comments:  US-009507513-2207USA008558:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from a personnel and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot #W017570, expiration date: 29-NOV-2023 (strength, dose and route of administration were not provided) for prophylaxis (Product storage error).  On an unknown date, before the administration, vaccine underwent temperature excursion at 5.7 Fahrenheit degrees (F) for 30 minutes. Previous temperature excursion occurred on an unknown date, with 6F to 14F temperature for 1 hour and 6 minutes. Another prior temperature excursion occurred on 18-JUL-2022, with 6F to 14F temperature for 1 hour and 8 minutes. No adverse events were reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's; Pharmacist reported that an expired dose of ROTATEQ was administered to a patient today, 9/12/2022.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 12-SEP-2022 (also reported as today), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot #1741381, expiration date: 04-SEP-2022, (strength, exact dose and dose number were not provided), indication was reported as: use as directed for prevention of rotavirus (expired product administered). At the time of reporting, the patient has had no reported adverse side effects. No additional adverse events (AE's) was reported (no adverse events).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported; improperly stored vaccine administered; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-AUG-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneous injection, lot #U039955, expiration date: reported as 03-OCT-2022, but determined as 14-JUN-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 9.3 degrees Fahrenheit for 5 minutes. The previous temperature excursion of the vaccine was reported as 14 up to 46 degrees Fahrenheit (25.9 degrees Fahrenheit) for 1 hour 20 minutes.  There was no adverse event reported (No adverse event).
Age: 9.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Asthma, Influenza virus test, Respiratory syncytial virus test, SARS-CoV-2 test
Clinical narrative: Dates when patient was in hospital for Asthma exacerbation: 23 Aug 2022 to 25 Aug 2022; This spontaneous report has been received from a nurse via Pfizer (manufacturer control number: 202201151170) concerning a 9-year-old male patient.   Since an unspecified date in 2015, the patient was allergic to peanuts; and also presented asthma. The patient's concomitant medications, drug reactions or allergies were not provided.   On 11-AUG-2022, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe injection, 0.5 milliliter (ml) administered intramuscularly on the left deltoid as prophylaxis (lot number U019413 has been verified to be a valid lot number with expiration date on 01-NOV-2023) (vaccination scheme was not reported). ;and also with the first dose of COVID-19 vaccine injection 0.2 milliliter administered intramuscularly (IM) in the right deltoid, lot number: FL8094 (vaccination scheme, indication, and expiration date was not provided).   On 23-AUG-2022, the patient experienced asthma exacerbation (asthma aggravated) that required him to visited the emergency room; therefore, the patient was hospitalized from  23-AUG-2022. That day, laboratories were performed such as: RSV test, influenza test, COVID-19 test, which all came negative. The patient received treatment for the event such as steroids; thus, he was going to be seen by a pulmonologist and was doing much better; therefore, on 25-AUG-2022, the patient was discharged from the hospital. On 07-SEP-2022, the second dose of COVID-19 vaccine injection 0.2 milliliter administered IM in the right deltoid, lot number: FL2757 (vaccination scheme, indication and expiration date was not provided). By the reporting time, he was recovering from the event.   Causality assessment between the suspect therapy and the events was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Caller is a medical assistant calling to report that an improperly stored dose of PROQUAD was administered to a patient on 12SEP2022.; This spontaneous report was received from a medical assistant regarding a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot #W007748, expiration date: 04-SEP-2023, administered as prophylaxis (strength, anatomical location, and route of administration were not provided) (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 52.6 degrees Fahrenheit (F) for 19 hours without previous excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient had no symptoms or adverse effects of administration.; Caller is a nurse who reports an expired dose of VARIVAX was given to a patient.; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #T029537, expiration date: 01-SEP-2022, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered); which was reconstituted with an sterile diluent, lot #U027011, expiration date: 02-MAR-2024 (strength, route of administration, anatomical location, and indication were not provided). The patient had no symptoms or adverse effects of administration. No history of temperature excursions for the administered varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired MMR II was administered to a patient today {09/12/2022); This spontaneous report has been received from a nurse concerning a 34-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 12-SEP-2022 (also reported as today), the patient was vaccinated with one expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T018892 with expiration date of 02-JUN-2022 (dosage regimen and route of administration was not reported) (Expired product administered). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: PNEUMOVAX 23 vaccine was administered to a patient.  No additional AE's; PNEUMOVAX 23 vaccine was administered to a patient.  No additional AE's; This spontaneous report was received from a nurse referring to a patient of unspecified 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 12-SEP-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T039322, for prophylaxis (strength, dose, route and site of administration were not provided). Vaccine expiration date was reported as 09-SEP-2022 (expired product administered).  The patient experienced no adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient has not experienced any side effects.; patient was accidentally administered their third dose of GARDASIL 9 three weeks after their second dose of GARDASIL 9.; This spontaneous report was received from a physician referring 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 10-SEP-2022, the patient was accidentally administered their third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), three weeks after their second dose (inappropriate schedule of product administration).  At the reporting time, the patient had not experienced any side effects.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; a patient, who was over 16 weeks of age, received their first dose of ROTATEQ; This spontaneous report was received from registered nurse and refers to a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W004501, expiration date: 20-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age).  There was no adverse event reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W010061, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 20-SEP-2023) (dose, anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature of -14 Celsius degrees [°C] up to -10°C [-14.18C] for 0 hours 15 minutes and 0 seconds) (Product storage error). The vaccine did not have previous temperature excursions.  No adverse event was reported.  This is one of three cases reported by the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 31-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W010061, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 20-SEP-2023) (dose, anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature of -14 Celsius degrees [°C] up to -10°C [-14.18C] for 0 hours 15 minutes and 0 seconds) (Product storage error). The vaccine did not have previous temperature excursions.  No adverse event was reported.  This is one of three cases reported by the same reporter.
Age: 1.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Device connection issue, Incorrect dose administered, No adverse event
Clinical narrative: No other adverse event; The caller reported the patient received a dose of VARIVAX on 9/9/2022. While the product was being injected, the needle popped off of the syringe hub and the patient only received half of the dose.; While the product was being injected, the needle popped off of the syringe hub and the patient only received half of the dose.; This spontaneous report was received from a medical assistant regarding a 12-month-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis a vaccine (+) inactivated (VAQTA) and pneumococcal vaccine conj 7v (crm197) (PREVNAR) (administered on the same day).  On 09-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W012167, expiration date: 12-APR-2024, administered subcutaneously on his right thigh (dosage regimen and strength was not provided) as prophylaxis; which was reconstituted with sterile diluent, 1 dose, administered subcutaneously on his right thigh (strength, lot #, expiry date, and indication were not provided). While the product was being injected, the needle popped off of the syringe hub (Device connection issue) and the patient only received half of the dose (Incorrect dose administered). The patient was not treated for adverse events. The reporter stated that she had reconstituted and administered varicella virus vaccine live (oka/merck) (VARIVAX) many times in the past and this had not happened. Also, she thought this might had occurred because the patient flexed his thigh as the product was being administered. No other adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: HCP reporting a patient received 2 doses of VARIVAX in 2018, but her titers taken in 2022 show the patient is not immune.; This spontaneous report was received from a registered nurse regarding a female patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2018, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.  On an unknown date in 2022, the patient's titers showed that she was not immune (Antibody test negative). At the time of reporting, the outcome of the event was not provided. She sought medical attention.   The causal relationship between antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Freezer was out of range PROQUAD was administered when it was still out of range; No additional AE reported; This spontaneous report has been received from a medical assistant concerning a 4-year-old female patient. Her concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) administered as prophylaxis on the left thigh, lot number W016358 with expiration date 16-NOV-2023 (dosage regimen and route of administration were not provided). The previously mentioned vaccine underwent a temperature excursion of 7.3 Fahrenheit (F) for 144 hours. According to the reporter the freezer was out of range and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered when it was out of range (Product storage error). The vaccine did not have previous temperature excursions. No additional adverse event was reported.  This was one of several cases received from the same reporter.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Froze the Vivotif by mistake and took it; A spontaneous report was received from a nurse on 30AUG2022. It described a female patient (unknown age) who "froze the Vivotif by mistake and took it" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3003687) before she embarked on a safari trip. It was reported that the patient froze the Vivotif by mistake and took it on an unknown date. The reporter was unsure of how many doses of Vivotif were frozen that the consumer took. Reportedly, the patient went to the clinic (last Friday as per the reporting) to get a Hepatitis B booster shot. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer froze the Vivotif by mistake and took it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer froze the Vivotif by mistake and took it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had the vaccine but still got shingles in my 6th week; Got shingles; Pain is horrendous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine but still got shingles, in his/her 6th week. The patient stated that pain was horrendous. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported narrative it was not clear whether patient was stated after vaccination in 6th week got shingles or shingles occurred and was in 6th week, therefore in worst approach time to onset was captured as unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/vaccine gave me shingles; Had it 3 times/shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that the vaccine gave the shingles. The patient had it 3 times within 6 months at same spot. That was the last vaccine he/she would ever take. The follow-up could not be possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/keeps getting them in spite of the vaccinations; keeps getting them in spite of the vaccinations; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Sept-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that the physician said in the 4 percent that just keeps getting them in spite of the vaccinations. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR129346:Same reporter
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: been vaccinated but still get them/Suspected vaccination failure; had them at least 4 times/still got them; Covid after 10 days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE BOOSTER) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure and covid-19 were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Sept-2022 Reporter's comment: The case was received from the patient via (Facebook) interactive digital media. The patient had been vaccinated but still got them. The patient have had them at least 4 times. The physician said that the patient might be in the 4 percent that just keeps getting them in spite of the vaccinations. The patient stated that they were not as bad as they were the first time. The patient had second Covid booster and got Covid 10 days later. Additional supportive information: It was unknown if the reporter considered shingles and covid to related to COVID-19 VACCINE BOOSTER. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR129342, reported by same reporter. As per narrative it was clear whether Covid booster was taken prior to the vaccine or after that, therefore in worst approach Covid booster was also captured as suspect and covid event was also coded.; Sender's Comments:  US-GSK-US2022AMR129342:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Pain
Clinical narrative: I've had it 3 times, I have my vaccine/Suspected vaccination failure; I've had it 3 times in the past few months; Pain is constant; Feel much older, makes working miserable, unbearable; Nerve pain; it makes working miserable, unbearable some days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 52-year-old 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 vaccination failure (serious criteria GSK medically significant), shingles, pain, feeling abnormal, post herpetic neuralgia and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, feeling abnormal and activities of daily living impaired were unknown and the outcome of the pain and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, feeling abnormal, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: This case was received from patient via interactive digital media. The patient had the Shingles vaccine. The patient had shingles 3 times in the past few months.  The pain was constant without the blisters/rash. The patient was only 52 years old but some days the patient felt much older, shingles makes working miserable and unbearable some days. The patient keep medication on hand, but it did not help with the nerve pain, so he/she just deal mostly. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: I've had it 3 times, I have my vaccine/Suspected vaccination failure; I've had it 3 times in the past few months; Pain is constant; Feel much older, makes working miserable, unbearable; Nerve pain; it makes working miserable, unbearable some days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 52-year-old 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 vaccination failure (serious criteria GSK medically significant), shingles, pain, feeling abnormal, post herpetic neuralgia and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, feeling abnormal and activities of daily living impaired were unknown and the outcome of the pain and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, feeling abnormal, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: This case was received from patient via interactive digital media. The patient had the Shingles vaccine. The patient had shingles 3 times in the past few months.  The pain was constant without the blisters/rash. The patient was only 52 years old but some days the patient felt much older, shingles makes working miserable and unbearable some days. The patient keep medication on hand, but it did not help with the nerve pain, so he/she just deal mostly. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: had both shots and had outbreaks/Suspected vaccination failure; after 2nd shot, continue with outbreaks; Shingles shortly after 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had both Shingrix shots and had outbreak of shingles shortly after first shot and after second shot patient was continue to had outbreaks mostly in same place on back of leg. The follow-up could not be possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.