chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006064: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006064: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006064: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006064: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006064: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006064: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006064: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006064: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006064: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the shingles shot twice. Both times I got the 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 an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shot and got the shingles. The reporter stated that, shingles were one of the many side effets from the covid shot and this was the reason why the patient's doctor advised not to take the covid shot. For tolerance to the 2nd dose of shingles vaccine refer linked case US2021AMR139344, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139344:Same reporter
Sex: F
Vaccine: HPVX
Symptoms: Incomplete course of vaccination
Clinical narrative: I let my daughter get 2 of the 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   Previously administered products included HPV vaccine (received 2 doses of HPV vaccine on an unknown date).   On an unknown date, the patient received the 3rd dose of HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, 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: This patient was reporter's daughter. The age at vaccination was not applicable for this report. Till the time of reporting the patient had taken 2 doses of HPV vaccine and not taken the 3rd dose, which led to incomplete course of vaccination. This case has been linked with US2021AMR139467, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139467:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: I made mistake and took Shingrix series 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix and the 4th dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 patient reported the case for herself/himself. The age at vaccination was not reported. The patient mistakenly took Shingrix series 2 times, which led to extra dose administered. The reporter asked if he/she was ok.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received my first shot / in 2018 but never got the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot of Shingrix in 2018).   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 reported as follows: This case was reported by patient for herself/himself. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked  he/she needs to start all over and get two shots at proper interval or just get a second shot. The patient was 80 years old and also received two shots of the Moderna vaccine in March and April of this year.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Rash erythematous
Clinical narrative: administered a 11 yr old  a 3rd dose / on 6/22, (already got 2 doses of havrix ); got a rash after the 3rd dose, patient developed a  flat red rash; This case was reported by a nurse via call center representative and described the occurrence of red rash in a 11-year-old female patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix with an associated reaction of no adverse event (first dose received on 7th April 2011) and Havrix with an associated reaction of no adverse event (2nd dose received on 13th October 2011).   On 22nd June 2021, the patient received the 3rd dose of Havrix and Havrix Pre-Filled Syringe Device. In June 2021, less than a week after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced red rash. On 22nd June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the red rash and extra dose administered were unknown.   It was unknown if the reporter considered the red rash to be related to Havrix and Havrix 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: This case was reported by a Nurse. Nurse reported a medical assistant administered a  3rd dose of Havrix, which led to extra dose administered. The patient developed a flat red rash. No other complication. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: late for their second dose / within the last year most likely due to COVID but didn't have any further details; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, patient was might be two months late for their second dose of Shingrix within the last year most likely due to COVID, which led to social problem. The reporter stated that, did not have any further details. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: been 2 years since the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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. The reporter stated that, it had been 2 years since the 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, wchich led to incomplete course of vaccination. No reactions reported. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered / shingrix on 6/21/2021 / was left outside at room temperature for a week; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter stated that, patient was administered a first dose of shingrix that was left outside at room temperature for a week, which led to incorrect storage of drug. The reporter consented to follow up. The batch number of Shingrix was updated from NR55V to NR55Z as per sales data sheet.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: placing two and a half boxes of the Shingrix vaccines/ by mistake/Shingrix placed in the freezer; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number E9C7K, expiry date 14th October 2022) and (batch number 393C7, expiry date 25th October 2022) for prophylaxis.   On 20th June 2021, the patient received Shingrix. On 20th June 2021, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, placing two and a half boxes of the Shingrix vaccines by mistake. No further events were reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose one / on 07Sep2019 and forgot to return for dose two; 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 (1st dose received on 7th September 2019).   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. The reporter stated that, the patient forgot to return for dose two. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details provided on the call. Specialist forgot to ask whether pharmacist granted permission for follow up from safety.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given just the Shingrix adjuvant only (unreconstituted Shingrix); given just the Shingrix adjuvant only (unreconstituted Shingrix); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 28th October 2022) for prophylaxis.   On 12th June 2021, the patient received the 1st dose of Shingrix. On 12th June 2021, 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 details were provided as follows: The pharmacist reported that a female patient was given just the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   No symptoms reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1 dose / in October 2020 / should have gotten the 2nd dose in April 2021, but she didn't; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   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 aplicable for this report. The reporter stated that, the patient should have gotten the 2nd dose in April 2021, but she did not, so she was more than 60 days late for it. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details were provided at the time of the call. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Pallor
Clinical narrative: PALE FOR ABOUT A DAY AND HALF; COLD SWEAT; CHILLS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pale for about a day and half, cold sweat, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pale for about a day and half, cold sweat, and chills. This report was non-serious. This case, from the same reporter is linked to 20210662161.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Ear disorder, Eye disorder, Fatigue, Pain
Clinical narrative: VERTIGO; CAN NOT OPEN JAW; BODY ACHE; FEELING REALLY TIRED; LACK OF FOCUS; EYE DISORDER; EAR DISORDER; This spontaneous report received from a parent concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included defibrillator, and concurrent conditions included muscular dystrophy, atrial fibrillation, and cardio myopathy. The patient experienced drug allergy when treated with fentanyl, and meclozine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced lack of focus. On APR-2021, the subject experienced eye disorder. On APR-2021, the subject experienced ear disorder. On 01-APR-2021, the subject experienced body ache. On 01-APR-2021, the subject experienced feeling really tired. On 02-APR-2021, the subject experienced vertigo. On 02-APR-2021, the subject experienced can not open jaw. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and feeling really tired on 04-APR-2021, was recovering from can not open jaw, had not recovered from vertigo, and the outcome of lack of focus, eye disorder and ear disorder was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Trismus, Vertigo
Clinical narrative: VERTIGO; CAN NOT OPEN JAW; BODY ACHE; FEELING REALLY TIRED; LACK OF FOCUS; EYE DISORDER; EAR DISORDER; This spontaneous report received from a parent concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included defibrillator, and concurrent conditions included muscular dystrophy, atrial fibrillation, and cardio myopathy. The patient experienced drug allergy when treated with fentanyl, and meclozine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced lack of focus. On APR-2021, the subject experienced eye disorder. On APR-2021, the subject experienced ear disorder. On 01-APR-2021, the subject experienced body ache. On 01-APR-2021, the subject experienced feeling really tired. On 02-APR-2021, the subject experienced vertigo. On 02-APR-2021, the subject experienced can not open jaw. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and feeling really tired on 04-APR-2021, was recovering from can not open jaw, had not recovered from vertigo, and the outcome of lack of focus, eye disorder and ear disorder was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Pyrexia
Clinical narrative: FELT DIZZY; COLD; MILD FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced felt dizzy, cold, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizzy, cold, and mild fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media and company representative concerned a patient of unspecified sex, age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666714-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: I have been in and out of hospital because of being dehydrated after vaccine.; Diarrhea; I had watery diarrhea and couldn't eat anything because this continued happened; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DEHYDRATION (I have been in and out of hospital because of being dehydrated after vaccine.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome. Concurrent medical conditions included Sleep disorder.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DECREASED APPETITE (I had watery diarrhea and couldn't eat anything because this continued happened). On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced DEHYDRATION (I have been in and out of hospital because of being dehydrated after vaccine.) (seriousness criterion medically significant). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DEHYDRATION (I have been in and out of hospital because of being dehydrated after vaccine.) and DECREASED APPETITE (I had watery diarrhea and couldn't eat anything because this continued happened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication also included unspecified IV fluids and fodmap diet. Concomitant medication included unspecified medicine to sleep at night  Company Comment:  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-225401 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Hyperacusis, Photophobia
Clinical narrative: Severe headache in upper right side of head with light and sound sensitivity followed by a shingles outbreak on right side of face and head.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Oropharyngeal pain
Clinical narrative: sore throat, fatigue, upset stomach
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dysphonia, Feeling abnormal, Myalgia, Swelling
Clinical narrative: Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are  tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Vision blurred
Clinical narrative: Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are  tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncopal episode within 5 minutes of administration of second dosage of Moderna Covid-19 vaccination, patient was unconscious less than 30 seconds, spontaneously awoken, and was fully recovered within 15 minutes.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncopal episode within 5 minutes of administration of second dosage of Moderna Covid-19 vaccination, patient was unconscious less than 30 seconds, spontaneously awoken, and was fully recovered within 15 minutes.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Urinary incontinence
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild, Additional Details: Patient received vaccine (2nd dose) on left arm, felt dizzy while waiting in the observation area. Suddenly peed himself, and walked away. When we talked to him afterwards, he reports he thinks he might have had a seizure. Patient did not fall, said he had no history of seizure in the past. Patient declined to be sent to the ER or urgent care. Unsure exactly if it was a seizure or not. He said he did not have any reaction when he got his first dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Allergy test, Cold sweat, Fatigue, Headache
Clinical narrative: Headache, body ache, cold sweats, fatigue. ACNE!!  Two days after my second dose I got a bunch of small pimples on my left cheek. Ever since April 9th, the acne has only gotten worse. It started as small closed bumps on my cheeks and forehead and spread to my neck, chest, and back. I?ve gone to the dermatologist and allergist to see what I am allergic to, only to find out that I?m allergic to a few things but nothing in any products I use or come into contact daily. The acne had progressed from small bumps, looking like almost clogged pores, to full acne. It is getting worse and not going away. I am going to be scheduled a biopsy with my dermatologist to send to a pathologist to see exactly what type of acne/cells it is and also go to a gynecologist to check my hormones.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Headache, body ache, cold sweats, fatigue. ACNE!!  Two days after my second dose I got a bunch of small pimples on my left cheek. Ever since April 9th, the acne has only gotten worse. It started as small closed bumps on my cheeks and forehead and spread to my neck, chest, and back. I?ve gone to the dermatologist and allergist to see what I am allergic to, only to find out that I?m allergic to a few things but nothing in any products I use or come into contact daily. The acne had progressed from small bumps, looking like almost clogged pores, to full acne. It is getting worse and not going away. I am going to be scheduled a biopsy with my dermatologist to send to a pathologist to see exactly what type of acne/cells it is and also go to a gynecologist to check my hormones.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Additional Details: pt had s few rash and was itchy on both arms
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling
Clinical narrative: Systemic: See details below-Medium, Additional Details: Patient stated she is continueously having sore throat, allergy symptoms and, swellings on hands, fingers, and feet since next day of the vaccine administration. She tried several OTCs including Claritin, Benadryl, Tylenol, Aleve, sore throat spray, and Halls lozenges. None of those helps. She also takes HCTZ and will have PCP appt on 07/01/21. In the meantime, suggested her to discuss with PCP and withold the second dose until adverse reactions are being resolved.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest discomfort, Chest pain, Heart rate increased, Lymphadenopathy
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Tachycardia-Mild, Additional Details: pt mom called 4 days post vaccination. i recommended going to urgent care or er. she said chest and armpit swollen with pain and pt thought heart was beating faster than normal.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Tachycardia-Mild, Additional Details: pt mom called 4 days post vaccination. i recommended going to urgent care or er. she said chest and armpit swollen with pain and pt thought heart was beating faster than normal.