Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: it was shingles/Suspected Vaccination Failure; it was shingles; covid outbreak; sore area; rash on the bottom part of my left arm/rash over arms; arm started hurting; arm stiffening up her thumb; stiffening up my thumb to not be able to use; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 07-APR-2020, the patient received the 2nd dose of Shingles vaccine. On 31-DEC-2019, the patient received the 1st dose of Shingles vaccine. On 28-JUL-2023, 1207 days after receiving Shingles vaccine and 1305 days after receiving Shingles vaccine, the patient experienced rash (Verbatim: rash on the bottom part of my left arm/rash over arms), pain in arm (Verbatim: arm started hurting), limbs stiffness (Verbatim: arm stiffening up her thumb) and mobility decreased (Verbatim: stiffening up my thumb to not be able to use). On an unknown date, the patient experienced vaccination failure (Verbatim: it was shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: it was shingles), covid-19 (Verbatim: covid outbreak) and pain (Verbatim: sore area). The patient was treated with prednisone. The outcome of the vaccination failure was unknown and the outcome of the shingles, pain in arm, limbs stiffness, mobility decreased, covid-19 and pain were not reported and the outcome of the rash was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain in arm, limbs stiffness, mobility decreased and pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, rash, pain in arm, limbs stiffness, mobility decreased and covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, rash, pain in arm, limbs stiffness, mobility decreased and pain to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, shingles, rash, pain in arm, limbs stiffness, mobility decreased and covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This report was submitted via the online direct entry reporting system.  The patient got the first vaccine it was at Pharmacy.  The second she went to have and they denied it for her due to covid outbreak and staff was not giving shots so she had the second one done at Pharmacy with a sore area but no big side effects.  On 28th July 2023, her arm started hurting and she broke out with a rash on the bottom part of her left arm stiffening up her thumb to not be able to use.  The reporter seriousness for rash over arms was intervention required. The walk in clinic said it was shingles.  When she went a few days later to get a mammogram done she was told that she had contaminated the area and to leave.  She never touched anything and had a jacket on covering her arms.  The administrator told her that he had no idea how they would decontaminate the area she had went into and to leave and return when the shingles was over.  The reporter asked if she had to stay confined and for how long with this.  The reporter sated that all the stuff she read said it was not contaminated. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow-up.