chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Balance disorder, Blindness, Dizziness, Impaired driving ability, Visual impairment
Clinical narrative: Everything was fine when I got the shot, but when I left I was driving home and I started to lose vision. By this time I was about to pull in to my house so I put it in park and tan inside. By this point I couldn?t see barley and I started to lose my balance from being dizzy.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac output decreased, Cardiac pacemaker insertion, Chest X-ray abnormal, Electrocardiogram abnormal
Clinical narrative: Within days, I experienced my first onset of crippling vertigo.  I went to urgent care after being extremely nauseated and still having intermittent bad vertigo.  They discovered my heart rate was 1/2 what it should be and traced the vertigo to a cardiac issue requiring a pacemaker.  Two months later I was walking on the beach and collapsed.  I was experiencing the worst vertigo where moving any part of my body moved my head.  Moving a millimeter increased the intensity of the pain making it intolerable and an ambulance transported me to the hospital.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Syncope, Vertigo
Clinical narrative: Within days, I experienced my first onset of crippling vertigo.  I went to urgent care after being extremely nauseated and still having intermittent bad vertigo.  They discovered my heart rate was 1/2 what it should be and traced the vertigo to a cardiac issue requiring a pacemaker.  Two months later I was walking on the beach and collapsed.  I was experiencing the worst vertigo where moving any part of my body moved my head.  Moving a millimeter increased the intensity of the pain making it intolerable and an ambulance transported me to the hospital.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash, Sleep disorder, Urticaria
Clinical narrative: Within an hour of receiving the vaccine, I began itching and breaking out everywhere. I suffered from extremely severe hives and itching, also with large whelps all over my body from my face all the way down to the top of my feet. Lasted 3 plus months duration in which I did not sleep well during the entire time due to the excessive itching. Was the most miserable 3 plus months of my life.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Caller reports that a dose of PROQUAD that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.  On 22-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 ml (lot number U039262, expiration date 09-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 7.7 Fahrenheit degrees for 30 minutes. It was reported that there was a previous temperature exclusion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007845: US-009507513-2206USA007693: US-009507513-2206USA007706: US-009507513-2206USA007527: US-009507513-2206USA007894: US-009507513-2206USA007547: US-009507513-2206USA007855: US-009507513-2206USA007710: US-009507513-2206USA007675: US-009507513-2206USA007717: US-009507513-2206USA007839:
Age: 56.0
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event, Product reconstitution quality issue
Clinical narrative: No side effects reported; An expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient; An expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient; This spontaneous report was received from a registered nurse referring to a 56-year-old patient of unspecified gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.  On 22-JUN-2022, the patient was administered a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis, which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (lot number S024549 has been verified to be valid, expiration date reported and established as 29-MAY-2022) (expired product administered, product reconstitution quality issue).   No side effects were reported (no adverse event). The reporter confirmed that the expired sterile diluent (MERCK STERILE DILUENT) had no temperature excursions.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2207USA000565:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered expired MMRII; This spontaneous report was received from a nurse practitioner, referring to patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent (DILUENT MRK).   On 07-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot #T020656 has been verified to be a valid lot, expiration date: 16-JUN-2022) (strength, dose regimen, and route of administration were not provided) (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE details; patient was inadvertently administered an expired vaccine; This spontaneous report was received from a physician assistance and refers to a patient of unknown age and gender. The patient's concomitant therapies included: Merck sterile diluent. The patient's concurrent conditions, medical history, allergies and drug reaction were not provided.  On 12-JUL-2022, the patient was inadvertently vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection, expiration date: 02-JUN-2022, (strength, dose, dose number, lot#, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; HBP reported an adverse event. Caller stated VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.   ?    Names of vaccines involved (including lot/exp): VARIVAX Lot U039726, E; This spontaneous report has been received from an office manager, regarding an identified patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On unspecified dates, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U039726 experienced a temperature excursion of -11.5 Celsius degrees (C) for a timeframe of 2 hour 40 minutes and 0 seconds; with a previous temperature excursion of -14 C for a timeframe of 1 hour 0 minutes and 0 seconds, and another of -13.5 C for a timeframe of 1 hour 0 minutes and 0 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 27-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U039726 confirmed to be a valid lot with expiration date reported and stablished as 15-DEC-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; HBP reported an adverse event. Caller stated VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.   ?    Names of vaccines involved (including lot/exp): VARIVAX Lot U039726, E; This spontaneous report has been received from an office manager, regarding an identified patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On unspecified dates, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U039726 experienced a temperature excursion of -13.5 Celsius degrees (C) for a timeframe of 1 hour 0 minutes and 0 seconds; no previous excursions of temperature for this lot number. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on 02-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous Injection, (lot number U039726 confirmed to be a valid lot with expiration date reported and stablished as 15-DEC-2023) administered as prophylaxis (strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; A HCP reported an AE where a dose of improperly stored ROTATEQ was administered on 22 Jun 2022. The caller provided the patient's initials, but not their full name. No adverse effects were reported. No additional information was provided at the time; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-JUN-2022, the patient was vaccinated with improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (PROQUAD) as prophylaxis (lot number: 1837116, which was determined to be valid, with an expiration date on 24-MAR-2023) (strength, dose, route and anatomical location of administration were not provided) (product storage error). Administered dose underwent a temperature excursion of above 47 degrees Fahrenheit (F) (48.7 degrees Fahrenheit) for 11 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2207USA004409:
Age: 0.58
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse event; patient was inadvertently administered a 4th dose of PEDVAX HIB.; This spontaneous report was received from a health care professional and refers to a 7-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's drug reactions or allergies.  On 16-FEB-2022, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); on 13-APR-2022, the patient was vaccinated with a second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); on 15-JUN-2022, the patient was vaccinated with a third dose of dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); On 13-JUL-2022, the patient was inadvertently vaccinated with fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, exact dose, route and site of administration, lot # and expiration date were not provided for all vaccines) for prophylaxis (extra dose administered). No additional adverse events was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004679: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 01-JUL-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 01-JUL-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004695: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004679: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: VARZOS
Symptoms: Fibromyalgia, Herpes zoster, Neuralgia, Pain, Vaccination failure
Clinical narrative: Fibromylgia; Nerve pain is excruciating because of fibromyalgia; painful; Got the vaccine, got singles/suspected vaccination failure; shingles/Got the vaccine, got singles; 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. In June 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced fibromyalgia and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, fibromyalgia, nerve pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fibromyalgia, nerve pain and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had fibromyalgia and got the shingles vaccine last year and got shingles a month ago. The patient stated that it was still bothering him/her and was one of the most painful disease ever. The nerve pain was excruciating because of the fibromyalgia.  The patient hope it stops soon. 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. As it was not clearly whether the fibromyalgia was occurred before or after the vaccination, and follow-up was not possible due which in worst approach it was captured as event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/Had the vaccine, had a mild case; Had the vaccine, had a mild case; 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was fortunate. The patient had the vaccine and only had a very mild case. 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got my 2nd dose and boom have shingles; shingles/got my 2nd dose and boom have 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient now have had shingles from the vaccine, got his/her 2nd dose and boom had shingles. 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. As per reported narrative, the patient now had the shingles therefore partial onset date was captured.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/ have taken the shot and later still got shingles; shingles; 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: 11-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter mentioned that she personally know  many people who have taken the expensive shot and later still got shingles. The shot was expensive and did not work. The follow-up would not possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2022AMR105917 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I got shingles 2 months after getting the vaccine; shingles/I got shingles 2 months after getting the vaccine; 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, 2 months 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: 11-Jul-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient sadly stated that he/she got the shingles 2 months after getting the vaccine. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/lots of ppl that got Shingles from the vaccine; shingles/lots of ppl that got Shingles from the vaccine; 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: 11-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that the nurses caring for the patient told him/her that they know lots of people that got shingles from the vaccine. The reporter stated that yep so it was true.  The reporter stated that Shingles jabs will give shingles to people. 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. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105986:same report, other patient US-GLAXOSMITHKLINE-US2022AMR106002:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105986:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Severe rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient asked that the rash was common after a Shingrix vaccination and severe rash formed after shot. Additional supportive information: The follow-up could not be possible as no contact details were available. In worst approach, the case was kept as valid considering that the patient had severe rash after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity
Clinical narrative: Arm still very sore; Red spot size of a dollar bill; Warm spot size of a dollar bill; Hard Spot size of a dollar bill; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, erythema, feeling of warmth and induration. On an unknown date, the outcome of the pain in arm, erythema, feeling of warmth and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema, feeling of warmth and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received Shingrix shot since one week. The patient reported that arm was still very sore and red warm raised hard spot and the size of a dollar bill had formed. The reporter asked if he/she should concerned or not Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shot today, have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th July 2022, the patient received Shingles vaccine. On 8th July 2022, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot on the day of reporting and also found out that he/she have had shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Aching in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR105288   Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's comment:This case was reported by a patient via interactive digital media. The patient received 2 doses of shingles vaccine. Both the doses were month apart. Patient would not ever forgot aching in arm which lasted for days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105288:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm got very sore; still tender; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles on wrist back in October (before patient was 50)).   On 5th July 2022, the patient received Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose Shingles vaccine on Tuesday morning (the day before reporting) and arm got sore and was still tender. The patient never wants them again.  Additional supportive information: This case was linked with US2022AMR104891, reported by same reporter for different patient. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104891:tag at post
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swelling; Arm very red; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments:  The patient had arm swelling and very red from the first dose Shingrix. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivering 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 shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media.The reporter asked usually when did you feel the side effects such as shivering from the time you get vaccinated. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient got rash after Shingles shot. Additional Supportive Information: Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12th July 2022 Reporter's Comments: This case was reported via interactive digital media. The patient had redness and swelling at injection site the next day after the Shingles shot. The reporter stated that it matches with the common side effects of the vaccine. However, if someone was allergic to this vaccine, what symptoms would show. Additional Supportive Information: Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant without the active antigen; received the adjuvant without the active antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The reporter was a pharmacist.  She was regarding the administration of 3 different patients who received the Shingrix adjuvant without the active antigen component.  The reporter had limited information.  Lot numbers unknown. Additional Supportive Information:  The patient only received shingrix adjuvant without active antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR106415:Same case/same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant without the active antigen; received the adjuvant without the active antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The reporter was a pharmacist.  She was regarding the administration of 3 different patients who received the Shingrix adjuvant without the active antigen component.  The reporter had limited information.  Lot numbers unknown. Additional Supportive Information:  The patient only received shingrix adjuvant without active antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR106414:Same case/same reporter US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: She experienced pain.; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK receipt date :14-July-2022 Reporters comment: The reporter did not consent for follow-up.  Additional Supportive information:. As per source document narrative mentioned as ''she'' so patient gender captured as female. .
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shinrix and experienced extreme fatigue. Follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR107007.; Sender's Comments:  US-GSK-US2022AMR107007:same report, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Vaccine positive rechallenge
Clinical narrative: Extreme fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, for tolerance refer case US2022AMR107005).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingrix and experienced extreme fatigue. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR107005:same report, other dose