Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain in extremity, Vaccination failure
Clinical narrative: Got both shots, currently shingles/ Suspected vaccination failure; Shingles on back of head; Arm pain; 2nd dose 8 months later; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included coronavirus infection (recovered from Covid-19). Previously administered products included Pfizer Covid-19 vaccine (Received three doses). Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy) and mepolizumab (Nucala).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) and the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Got both shots, currently shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back of head), pain in arm (Verbatim: Arm pain) and drug dose administration interval too long (Verbatim: 2nd dose 8 months later). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not resolved and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The reporter considered the pain in arm to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the pain in arm to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR063356   Additional Information: GSK Receipt Date: 28-APR-2023 The patient was self-reported this case. The patient reported that he received both doses of Shingrix vaccine which are received at same pharmacy. The patient had receipt from the pharmacy with the administration date of 10th April 2019 from batch number 353S5 and expiry date 29th May 2021 but patient was not sure whether this was for first dose or second dose. The patient reported that he experienced arm pain of the injected arm but he did not reported it because the pain was gone in a day. The patient stated that he missed the 6 month window that the Shingrix vaccine were given he believed around 8 months apart. The patient reported that he currently had a case of shingles on the back of his head. The patient had been prescribed Valtrex as a treatment. The reporter did consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule. This case had been linked with US2023AMR063356 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR063356:Same patient