chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 17-SEP-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) for prophylaxis. No adverse effects was reported. There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA009967: US-009507513-1901USA009968.
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies.On an unknown date, the patient was vaccinated with her first dose of GARDASIL 9, in the gluteal region (vaccine administered at inappropriate site) intramuscular for prophylaxis (dose, lot number and expiration date were not reported). On an unspecified date, the patient's second dose of GARDASIL 9 was properly administered in the arm. The outcome of the event vaccine administered at inappropriate site was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were not provided. On 15-DEC-2018, the patient was vaccinated with a first dose of PROQUAD (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On 22-JAN-2019, the patient received a second dose of PROQUAD (lot# R020815 and expiration date: 15-JAN-2020) for prophylaxis (dose and route of administration were not reported) (inappropriate schedule of product administration). Merk sterile diluent was used to reconstitute PROQUAD (Lot number and expiration date was unknown by the reporter). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 03-DEC-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot # 1586751, expiration date: 16-FEB-2021, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23(lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 29-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date: 07-NOV-2020, thimerosal free, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 03-JAN-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB(lot # R001529, expiration date: 07-NOV-2020, thimerosal free, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date: 07-NOV-2020, thimerosal free, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATE (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored rotavirus ROTATEQ (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 12-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R018589, expiration date: 09-AUG-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 12-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R018589, expiration date: 09-AUG-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 02-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 02-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 05-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 03-JAN-2019, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments:  US-009507513-1901USA004786.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Lethargy
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative referring to a 68-year-old male patient. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 08-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On 26-NOV-2018, the patient was vaccinated with a follow up dose of PNEUMOVAX 23 (dose detail, route, lot # and expiration date were not reported) for prophylaxis. Since 26-NOV-2018, the patient had experienced extreme fatigue and lethargy. The patient notified his unspecified physician who had been referred him to an unspecified hematologist for the fatigue and lethargy. There was no treatment had been provided. At the time of the report, the patient had not recovered. The causality assessment between events and PNEUMOVAX 23 were not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) (expired product administered) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009968: US-009507513-1901USA009967: US-009507513-1901USA007603.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA009968: US-009507513-1901USA007603.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 03-DEC-2018, the patient was vaccinated with measles M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) (expired product administered) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA007603: US-009507513-1901USA009967.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number 9KT7T, expiry date 13th March 2021) for prophylaxis. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, several hours after receiving SHINGRIX, the patient experienced fever, injection site pain, joint pain, muscle pain and fatigue. On an unknown date, the outcome of the fever, injection site pain, joint pain, muscle pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, joint pain, muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: Few hours after vaccination the patient experienced fever of 101 degrees F that lasted for about 12 hours, injection site pain, joint and muscle aches and fatigue that lasted for about 36 hours. This case was linked with cases US2018GSK226652 for unspecified number of patient's. Lab Comments: on an unknown date body temperature was found to be less than 101 degree F.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in an adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was recovered/resolved. It was unknown if the reporter considered the heart rate increased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient had his heart rate increase with the SHINGRIX also back in June 2018 again from 52 to 75. The patient stated that it was resolved after about 3 days. The reporter consented to follow up. This case has been linked to case US2019GSK013004, having same patient and reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 7th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing mini-flares of shingles, so she did not get the 2nd dose until a day before the date of reporting. For tolerance dose see case ID US2019GSK013815, reported for the same patient.
Sex: F
Vaccine: MENB
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (did not experience any side effects when she had the 1st injection). On 16th January 2019, the patient received the 2nd dose of BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced fever, nausea and unwell. On an unknown date, the outcome of the fever, nausea and unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, nausea and unwell to be related to BEXSERO. Additional details were provided as follows: This case was reported by the consumer for her daughter. The age at vaccination was not reported. Yesterday from the reporting date, the patient received the booster of BEXSERO and then a couple of hours later she had a high fever, suffered nausea, and was ill. She The patient did not experience any of these side effects when she had the 1st injection. At the time of this report, on the second day of vaccination, she still had a slight temperate and still nauseous. The reporter was seeking advice how long the side effects last as their doctor advised it could be 3 to 7 days.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 30th December 2018, the patient received the 1st dose of SHINGRIX. On 16th January 2019, 17 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient broke out a day before the date of reporting yesterday (16th January 2019) and the physician confirmed that it was shingles. The reporter asked could the patient experience mild case of shingles after vaccine.
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Nasopharyngitis, Rhinorrhoea
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of weakness in a 82-year-old male patient who received TWINRIX for prophylaxis. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, 1 day after receiving TWINRIX, the patient experienced weakness, runny nose and cold symptoms. On an unknown date, the outcome of the weakness, runny nose and cold symptoms were unknown. It was unknown if the reporter considered the weakness, runny nose and cold symptoms to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. A day after vaccination, the patient experienced weakness, runny nose and cold symptoms. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site nodule, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 15-month-old male patient who received INFANRIX for prophylaxis. On 12th January 2019, the patient received INFANRIX. In January 2019, less than a week after receiving INFANRIX, the patient experienced injection site swelling, rash, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the rash, injection site lump and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site swelling, rash, injection site lump and injection site warmth to be related to INFANRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 14 or 15 months old. After vaccination, the patient experienced rash covered front of thigh with quarter size knot at injection site, hot to touch and swelling at the injection site. On 16th January 2019, the events were mostly resolved with just a bit of swelling at the injection site. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site nodule, Injection site warmth, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a male patient who received INFANRIX for prophylaxis. On 30th October 2017, the patient received INFANRIX. On an unknown date, unknown after receiving INFANRIX, the patient experienced rash, injection site lump and injection site warmth. On an unknown date, the outcome of the rash, injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the rash, injection site lump and injection site warmth to be related to INFANRIX. Additional details were reported as follows: The patient experienced a golf ball size knot at injection site, hot to touch and rash all over his thigh, front and back, which did not go below the knee. No intervention was required, a pediatrician saw it and said it was normal. The reporter agreed to follow up with GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of chest pressure in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 19th June 2018, 50 mg injection). On 16th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness. On 16th January 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the chest pressure, injection site pain, shivering, headache, fever, tiredness, feelings of weakness and drug dose administration interval too long were unknown. It was unknown if the reporter considered the chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 19th June 2018, the patient received 1st dose of SHINGRIX and on 16th January 2019, the patient received the 2nd dose of SHINGRIX, which led to lengthening of the vaccination schedule. The patient experienced terrible reaction from the 2nd injection. Sore arm where shot was given, Terrible shivering, headaches, fever, feeling tired and weak feeling. Also, pressure in chest. The reporter called Pharmacy and their pharmacist said he was sick for 2 and half days. The patient said providers in pharmacy who administer the injections should prepare people. The patient's doctors office was unprepared on the side effects. This information needed to be communicated. It was bad enough that the patient had to wait 7 months for second injection.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of chest pressure in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 19th June 2018, 50 mg injection). On 16th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness. On 16th January 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the chest pressure, injection site pain, shivering, headache, fever, tiredness, feelings of weakness and drug dose administration interval too long were unknown. It was unknown if the reporter considered the chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 19th June 2018, the patient received 1st dose of SHINGRIX and on 16th January 2019, the patient received the 2nd dose of SHINGRIX, which led to lengthening of the vaccination schedule. The patient experienced terrible reaction from the 2nd injection. Sore arm where shot was given, Terrible shivering, headaches, fever, feeling tired and weak feeling. Also, pressure in chest. The reporter called Pharmacy and their pharmacist said he was sick for 2 and half days. The patient said providers in pharmacy who administer the injections should prepare people. The patient's doctors office was unprepared on the side effects. This information needed to be communicated. It was bad enough that the patient had to wait 7 months for second injection.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Rash, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received SHINGRIX (subcutaneous) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and rash. On 15th January 2019, the patient experienced intramuscular formulation administered by other route. The patient was treated with NOS BENADRYL. On an unknown date, the outcome of the swelling, erythema, rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling, erythema and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The SHINGRIX was administered via wrong route, given subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. On 17th January 2019, it was notified to office about the patient experiencing redness, swelling, and rash. The patient was told to take BENADRYL for rash. The reporter could not describe severity or quality of any of the events. The reporter stated that, she would call MSL back with additional information needed to complete report. The reporter did not have patient's chart at time of discussion and said she would call back with more information. The reporter did not agree to follow up from GSK. This case has been linked to the case US2019GSK009270, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Feeling abnormal, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of herpes zoster (1st dose received on 7th March 2018, see case US2019GSK009212). On 16th January 2019, the patient received the 2nd dose of SHINGRIX. On 17th January 2019, 1 days after receiving SHINGRIX, the patient experienced feels awful, pain and adverse drug reaction. On an unknown date, the outcome of the feels awful and adverse drug reaction were unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the feels awful, pain and adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: She was a part of a medical cost sharing group under which vaccines were not covered. The patient did not know how long would the side effects of the SHINGRIX vaccine last. The patient got her 2nd dose of SHINGRIX a day before the date of reporting and got all the side effects. The patient knew it was to happen, but did not remember how long. The patient was glad that they qualified for patient assistance for SHINGRIX. The patient did not think to check prior to getting her doses, so did she still qualify. On the date of reporting, the patient felt awful and said she was experiencing every side effect listed. She did note that the aches were better evening compared to morning.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 61-year-old female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The patient has had a hepatitis B series before, but her titers were negative. This case had been linked with US2019008941, reported by the same reporter for the same patient. Lab Comments: On unknown date lab test was performed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day after receiving SHINGRIX, the patient experienced general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing. On an unknown date, the outcome of the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating and sleepiness were recovered/resolved and the outcome of the difficulty in standing was recovering/resolving. It was unknown if the reporter considered the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on the right arm. The next day after vaccination, the patient could hardly stand because the patient hurt from head to toe and all of her joints were stiff. The patient could not bend her toes and ankles and had trouble in walking. The patient was exhausted, slept almost all day for three days and had alternating chills and sweats. All the symptoms were lasted for three days. The patient stated that, each day the symptoms lessened in severity until they were all resolved within the three day time frame. The patient's physician told her not to receive the 2nd dose of the SHINGRIX. The reporter gave permission for her physician to be contacted. Unable to obtaine additional information. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stiffness, Mobility decreased, Pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day after receiving SHINGRIX, the patient experienced general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing. On an unknown date, the outcome of the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating and sleepiness were recovered/resolved and the outcome of the difficulty in standing was recovering/resolving. It was unknown if the reporter considered the general body pain, stiff joint, mobility decreased, walking difficulty, exhaustion, chills, sweating, sleepiness and difficulty in standing to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on the right arm. The next day after vaccination, the patient could hardly stand because the patient hurt from head to toe and all of her joints were stiff. The patient could not bend her toes and ankles and had trouble in walking. The patient was exhausted, slept almost all day for three days and had alternating chills and sweats. All the symptoms were lasted for three days. The patient stated that, each day the symptoms lessened in severity until they were all resolved within the three day time frame. The patient's physician told her not to receive the 2nd dose of the SHINGRIX. The reporter gave permission for her physician to be contacted. Unable to obtaine additional information. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 2nd June 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were received as follows: The patient reported that arm ached a bit and then resolved within a few days. The patient past due for second SHINGRIX dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.