Age: 78.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Severe headache; Type of arthritis; Nerve pain in feet; Rash on feet/unknown rash on both feet; Possible case of shingles after both doses/Suspected vaccination failure; Possible case of shingles, treated as such; Hip pain like the one in 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis, COVID-19 VACCINE MRNA 2V (COVID-19 BIVALENT BOOSTER) for prophylaxis and prednisone for polymyalgia rheumatica.   The patient's past medical history included pain in hip, rash, shingles, post herpetic neuralgia (nerve pain in foot) and leg pain (8 days later the pain went down his left leg to a rash on his left foot). Previously administered products included Zostavax vaccine (on 18th November 2014 received vaccine) and Antivirals (for 10 days). Concurrent medical conditions included polymyalgia rheumatica.   In January 2022, the patient received the 2nd dose of Shingrix. In July 2021, the patient received the 1st dose of Shingrix. On 9th January 2023, the patient received the 2nd dose of Flu vaccine (intramuscular). In October 2022, the patient received the 1st dose of COVID-19 BIVALENT BOOSTER (intramuscular). On an unknown date, the patient started prednisone 7.5 mg once daily (7.5 mg daily). On an unknown date, the dose was changed to 40 mg once daily. On 24th December 2022, less than a year after receiving Shingrix, between 1 and 2 years after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced pain in hip. On 18th January 2023, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the patient experienced headache, arthritis and post herpetic neuralgia. The patient was treated with valaciclovir (Valacyclovir). The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure, shingles and arthritis were unknown and the outcome of the headache and rash were recovered/resolved and the outcome of the pain in hip and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache, arthritis, pain in hip, rash and post herpetic neuralgia to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, headache, arthritis, rash and post herpetic neuralgia to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR019792   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The reporter was the wife of the patient.  The reporter reported that her husband had a possible case of shingles after receiving both doses of Shingrix.   The reporter reported she believes he received the first Shingrix vaccine in July 2021 and the second Shingrix vaccine in January 2022, in unknown arm.  The reporter reported prior to receiving Shingrix, the patient received the Zostavax vaccine.  On 2nd Jan 2020, thepatient developed left hip pain and 8 days later the pain went down his left leg to a rash on his left foot, that was diagnosed as shingles by his HCP(health care professional).  The patient was given antivirals for 10 days, and the rash resolved, the nerve pain continued in his foot. The patient had a prior history of PMR (Polymyalgia Rheumatica) and this was not associated with the foot pain per his HCP. The reporter reported that after receiving the first dose of Shingrix, the patient received bivalent Covid vaccine booster in October 2022. The patient developed a severe headache and the HCP increased his prednisone (that he takes for his PMR) from 7.5mg daily to 40mg daily and then tapered back down because it caused a type of arthritis. The patient received his Flu vaccine on 9th Jan 2023 and no problem with the flu vaccine.  On 24th DEec 2022 the patient reported hip pain like the hip pain noted in 2020 (above).  This time the hip pain was on the right hip. Twenty five days later, on 18th Jan 2023 a rash develops on both the right and left feet.  The HCP did not test for shingles but does start Valacyclovir for 7 days.  The rash has resolved but patient still had the hip pain and nerve pain in his feet. The reporter did not consent to follow up. It was unknown if the reporter considered the shingles, headache, arthritis, rash and nerve pain to be related to COVID-19 BIVALENT BOOSTER.    Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2023AMR019792:same patient