chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 06-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error).         The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.  This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA003266: US-009507513-2104USA003268: US-009507513-2104USA002475: US-009507513-0503USA00121:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 07-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).        The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA002475: US-009507513-2104USA003266: US-009507513-2104USA003268: US-009507513-2104USA003265: US-009507513-0503USA00121:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 01-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).               The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA003266: US-009507513-2104USA002475: US-009507513-2104USA003265: US-009507513-0503USA00121:
Sex: U
Vaccine: HIBV, HPV9, HPV9, MMR, PPV, PPV, PPV
Symptoms: Product storage error
Clinical narrative: Medical assistant calls to report a temperature excursion that occurred on November 9, 2020 / The products were administered; No other information given at this time.; This spontaneous report was received from a medical assistant, referring to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-NOV-2021, the following vaccines experienced temperature excursion, and then on unknown dates, they were administered to unspecified number of patients: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers S007811, S029457 and S005248, expiration dates reported and validated as 14-MAR-2021, 19-SEP-2021 and 20-FEB-2021, respectively to each lot number), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers 1621929 and R025729, which has been verified to be valid, expiration dates reported and validated as 06-DEC-2021 and 18-JUN-2021, correspondingly to each lot number), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number R014263, which has been verified to valid, expiration date reported as 26-JAN-2021, but upon internal review it was established as 26-MAR-2021), and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS)  (strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported;(lot numbers S005856, S029542 and T020638, which has been verified to valid, expiration date reported and validated as 03-DEC-2020, 10-JUN-2021 and 26-FEB-2022, respectively to each lot number), all the vaccines were administered as prophylaxis. The vaccines administered experienced a temperature excursion above 47 degrees Fahrenheit (F) for a time frame of 3 hours. There was a previous temperature excursion above 47 F (47.4 F) for 1 hour and 20 minutes, 47 F (46.7 F) for 50 minutes and 47 F (47.6 F) for 40 minutes, as recorded by a data logger. No additional adverse events were reported. At the reporting time, some of the lot numbers had expired, but were not expired at the time of the administration, neither the lot numbers had expired at the time of the report.    This case has been considered non-valid due to the lack of patients' identifiers.
Sex: U
Vaccine: HIBV, HPV9, HPV9, MMR, PPV, PPV, PPV
Symptoms: Product storage error
Clinical narrative: Medical assistant calls to report a temperature excursion that occurred on November 9, 2020 / The products were administered; No other information given at this time.; This spontaneous report was received from a medical assistant, referring to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-NOV-2021, the following vaccines experienced temperature excursion, and then on unknown dates, they were administered to unspecified number of patients: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers S007811, S029457 and S005248, expiration dates reported and validated as 14-MAR-2021, 19-SEP-2021 and 20-FEB-2021, respectively to each lot number), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers 1621929 and R025729, which has been verified to be valid, expiration dates reported and validated as 06-DEC-2021 and 18-JUN-2021, correspondingly to each lot number), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number R014263, which has been verified to valid, expiration date reported as 26-JAN-2021, but upon internal review it was established as 26-MAR-2021), and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS)  (strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported;(lot numbers S005856, S029542 and T020638, which has been verified to valid, expiration date reported and validated as 03-DEC-2020, 10-JUN-2021 and 26-FEB-2022, respectively to each lot number), all the vaccines were administered as prophylaxis. The vaccines administered experienced a temperature excursion above 47 degrees Fahrenheit (F) for a time frame of 3 hours. There was a previous temperature excursion above 47 F (47.4 F) for 1 hour and 20 minutes, 47 F (46.7 F) for 50 minutes and 47 F (47.6 F) for 40 minutes, as recorded by a data logger. No additional adverse events were reported. At the reporting time, some of the lot numbers had expired, but were not expired at the time of the administration, neither the lot numbers had expired at the time of the report.    This case has been considered non-valid due to the lack of patients' identifiers. ; Sender's Comments:  US-009507513-2103USA005178:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: feeling achy; feverish; fatigued; headache; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-032321), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of pain (feeling achy), pyrexia (feverish), fatigue (fatigued) and headache in female patient of an unknown age who received apixaban (Eliquis) tablet for cerebrovascular accident prophylaxis. co-suspect products included Covid-19 Vaccine for COVID-19 immunisation. In March 2021, the patient started Eliquis (oral), 5 milligram twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). Further treatment periods at the same dose started on 26-Mar-2021. On 27-Mar-2021, the patient experienced pain (feeling achy), pyrexia (feverish), fatigue (fatigued) and headache. The action taken with Eliquis(oral) was unknown. At the time of the report, pain, pyrexia, fatigue and headache outcome was unknown. For Eliquis(oral), the reporter considered pain, pyrexia, fatigue and headache to be not related.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had gotten shot for shingles / Then shingle came on side of my neck/Suspected vaccination failure; Had gotten shot for shingles / Then shingle came on side of my neck; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingrix and the 1st dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The reporter was patient itself. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient got shot for shingles before COVID 19 shot. Then shingle came on side of the patient's neck. The patient's 2nd COVID 19 vaccination was due on Monday and asked if the patient should take another Shingrix shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. It was unknown if the reporter considered shingles to be related to Covid-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine and I still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The patient reported case for herself or himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he or she had the vaccine and still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives across both my arms and chest; This case was reported by a consumer and described the occurrence of hives in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 7th April 2021, the patient received the 2nd dose of Shingrix. On 10th April 2021, 3 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. After the 2nd dose of Shingrix, 3 days after the shot, he woke up and hives across both his arms and chest. The event lasted for 72 hours, gradually fading and then completely disappeared. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and I still got the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had the shingles vaccine shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot but I have shingles/Suspected vaccination failure; I had the shot but I have shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had the vaccination. One shot and 2 shot. Srill got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received one shot and 2 shot but still got shingles vaccine. The reporter asked if the vaccinations still work. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Bursitis, Incomplete course of vaccination, Loss of personal independence in daily activities
Clinical narrative: Diagnosed with bursitis; My arm was super swollen; My arm / couldn't move it to get dress or comb my hair; Pain is back on shoulder; Have stiff neck; Feel glands are swollen; I haven't gone for second doses; This case was reported by a consumer via  interactive digital media and described the occurrence of bursitis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck, swollen glands and incomplete course of vaccination. On an unknown date, the outcome of the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands to be related to Shingles vaccine.  Additional details were reported as follows: The age group was not reported but was captured as adult as per vaccine indication. The age at the vaccination was not reported. The age at the vaccination was not applicable for the 2nd dose of Shingles vaccine. The patient received dose of shingles and arm was super swollen and couldn't move it to get dress or comb his/her hair, went to ER was diagnosed with bursitis. Doctor referred the patient to orthopedics, got a shot it lasted about one month. Pain was back on shoulder, had stiff neck and felt glands were swollen. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Diagnosed with bursitis; My arm was super swollen; My arm / couldn't move it to get dress or comb my hair; Pain is back on shoulder; Have stiff neck; Feel glands are swollen; I haven't gone for second doses; This case was reported by a consumer via  interactive digital media and described the occurrence of bursitis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck, swollen glands and incomplete course of vaccination. On an unknown date, the outcome of the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands to be related to Shingles vaccine.  Additional details were reported as follows: The age group was not reported but was captured as adult as per vaccine indication. The age at the vaccination was not reported. The age at the vaccination was not applicable for the 2nd dose of Shingles vaccine. The patient received dose of shingles and arm was super swollen and couldn't move it to get dress or comb his/her hair, went to ER was diagnosed with bursitis. Doctor referred the patient to orthopedics, got a shot it lasted about one month. Pain was back on shoulder, had stiff neck and felt glands were swollen. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I HAD THE SHOT FOR SHINGLES---GOT 'EM SHORTLY AFTER THAT/Suspected vaccination failure; I HAD THE SHOT FOR SHINGLES---GOT 'EM SHORTLY AFTER THAT; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The patient reported case for herself or himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he or she had the shot for shingles and got shingles shortly after that. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got vacinated and still got the shingles and they keep reoccuring/Suspected vaccination failure; I got vacinated and still got the shingles and they keep reoccuring; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient got vaccinated with Shingles vaccine and still got the shingles and they keep reoccurring. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: get a shingles shot because they didn't think he had gotten his second one but he had / now he had 3.; This case was reported by a consumer and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date) and Shingles vaccine (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was administered with 3rd dose of Shingles vaccine, which leads to extra dose administered. The physician did not think that the patient had gotten his 2nd dose, but he already received, so they had the patient to get a Shingles vaccine (3rd) dose. The reporter asked was that a problem, as the patient received 3 doses.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site extravasation, Injection site haemorrhage, Underdose
Clinical narrative: blood came out of the injection site; dose of Engerix-B/ 05Apr2021 / liquid and blood came out of the injection site; liquid and blood came out of the injection site.; This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 5-week-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th April 2021, immediately after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hemorrhage, injection site leaking and accidental underdose. On an unknown date, the outcome of the injection site hemorrhage and injection site leaking were recovered/resolved and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the injection site hemorrhage and injection site leaking to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a dose of Engerix-B one week ago and a small amount of liquid and blood came out of the injection site. The nurse contacted the CDC (Centers for Disease Control and Prevention) because they were concerned that the patient did not received the full dose, which led to accidental underdose and the CDC recommended to revaccinate. The reporter consented to follow up. For tolerance of revaccinated dose refer case US2021AMR082955.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082955:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Photosensitivity reaction, Rash, Urticaria
Clinical narrative: break out in hives /  a week after that had the same reaction / 2 days ago she went in to the sun / broke out again in hives broke out in hives in sun again; sensitivity to sun; Rash; severe arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th February 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 24th February 2021, the patient experienced hives, sun sensitivity and rash. The patient was treated with benadryl (nos) (Benadryl). On 22nd February 2021, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the hives, sun sensitivity and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hives, sun sensitivity and rash to be related to Shingrix.  Additional details were provided as follows: The patient had taken first dose of Shingrix on her left arm and experienced severe arm pain that eventually went away and lasted for 5 days. Also developed sensitivity to sun and break out in hives a week later on the inside of her elbows and after a week had same reaction then one week ago patient went outside in sun, broke out in hives in sun again.  The patient stated would be making an appointment to see an allergist. The reporter consented to follow up.
Age: 91.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Blood pressure increased, Chest pain, Dizziness, Dyspnoea
Clinical narrative: weigh loss of 20 pounds; increase in blood pressure; chest pain; shortness of breath; headache; dizziness; nausea; myalgia; weakness; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 91-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LP9HK, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for an unknown indication.   On 30th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness. On 1st January 2021, the patient experienced weight loss. On an unknown date, the outcome of the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness were not recovered/not resolved.   It was unknown if the reporter considered the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's daughter. The patient received the Fluarix vaccine the doctor's office.  Two days later, the patient experienced weakness, myalgia, nausea, dizziness, headache, shortness of breath, chest pain, increase in blood pressure, and a weigh loss of 20 pounds after 93 days. The patient went to the emergency department two days after the injection. There was nothing found that was abnormal and the patient was not admitted.  Subsequently, the symptoms continued till the day of reporting. The emergency room visit was required. The patient had blood work, X rays, computerized tomography scans, and electrocardiograms done, and all came back normal. The reporter consented to follow up.
Age: 91.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Myalgia, Nausea, Weight decreased
Clinical narrative: weigh loss of 20 pounds; increase in blood pressure; chest pain; shortness of breath; headache; dizziness; nausea; myalgia; weakness; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 91-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LP9HK, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for an unknown indication.   On 30th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness. On 1st January 2021, the patient experienced weight loss. On an unknown date, the outcome of the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness were not recovered/not resolved.   It was unknown if the reporter considered the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's daughter. The patient received the Fluarix vaccine the doctor's office.  Two days later, the patient experienced weakness, myalgia, nausea, dizziness, headache, shortness of breath, chest pain, increase in blood pressure, and a weigh loss of 20 pounds after 93 days. The patient went to the emergency department two days after the injection. There was nothing found that was abnormal and the patient was not admitted.  Subsequently, the symptoms continued till the day of reporting. The emergency room visit was required. The patient had blood work, X rays, computerized tomography scans, and electrocardiograms done, and all came back normal. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over a year ago. / was given on 13Mar2020 / second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th March 2020, vaccine powder lot no: G72Z4; expiry date:13th March 2022, adjuvant lot no:X4225, expiry date: 10th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The patient received first dose of Shingrix over a year before day of reporting. The reporter called for information regarding the administration of a late second dose of Shingrix. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The limited patient data shared due to caller having few documents at hand due to records being moved. The reporter did not consent to follow up. As per sales data sheet reported batch number of vaccine powder was changed from G7224 to G72Z4.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose / first dose was administrated on October 29 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th October 2019, batch number-5KK99 and expiration date-29th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse events were reported The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Erythema, Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: arm pain was not bad; face has been getting very red lately around the area where her face mask is specifically worn / redness around the site where the first Shingrix dose was administered; redness around the site where the first Shingrix dose was administered; small "pimple sore" the size of the head of a pin developing on her right arm / four little dots around the Shingrix injection site; small "pimple sore"; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (grandmother has shingles). Concurrent medical conditions included allergic reaction to wasp sting (patient had allergy to wasp sting).   In February 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, red face, injection site erythema, pimples and pain. On an unknown date, the outcome of the pain in arm, red face, pimples and pain were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the pain in arm, red face, injection site erythema, pimples and pain to be related to Shingrix.  Additional details were provided as follows: The patient was in early 60s. The age at vaccination was not reported. The patient stated she had a little reaction to the first Shingrix dose. The patient had small pimple sore the size of the head of a pin developing on her right arm a couple of days after receiving the first Shingrix dose. The patient further described the pimple sore as four little dots around the Shingrix injection site. This pimple sore lasted for a few weeks. The patient also reported that her face had been getting very red lately around the area where her face mask was specifically worn. She stated that this had lasted for two to three weeks. The patient also reported that she had arm pain that started the day of or the day after receiving the first Shingrix dose. This arm pain was not bad and only lasted a few days. The patient also described redness around the site where the first Shingrix dose was administered. She stated that this redness started about a week after receiving the first Shingrix dose. The patient also reported a medical history that she could not wear wool. The patient declined to provide any demographic or contact information out of privacy concerns. The patient was unable to provide the dosage and lot number/expiration date of the first Shingrix dose she received. The reporter did not consented to follow up.