Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Injection site pain, Pain, Vaccination failure
Clinical narrative: Arm soreness at injection site after 2nd doses; Chills after 2nd doses; Body aches after 2nd dose; Arm soreness at injection site after 1st doses; Chills after 2nd dose; General body pain after 1st dose; a new outbreak of Shingles which started Sunday"; After both doses she experienced Shingles in March of 2021/ suspected Vaccination failure; Shingles in March 2021, chronic breakouts; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles throughout her early years).   In December 2020, the patient received the 2nd dose of Shingrix. In August 2020, the patient received the 1st dose of Shingrix. In March 2021, 3 months after receiving Shingrix and between 6 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 6th March 2022, the patient experienced shingles. On an unknown date, the patient experienced injection site pain, chills, general body pain, injection site pain, chills and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, injection site pain, chills, general body pain, injection site pain, chills and general body pain were recovered/resolved and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, chills, general body pain and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, chills, general body pain and shingles to be related to Shingrix.   Additional details were provided as follows: The reporter was the patient. The age at vaccination was unknown for 1st dose. The patient received 1st dose of Shingrix in August 2020 and less than 5 months after vaccination, had some arm soreness at the injection site, chills, and body aches which went away after 3 days or so. The patient received 2nd dose of Shingrix in December 2020 and less than 2 years after vaccination, experienced some arm soreness at the injection site, chills, and body aches which went away after 3 days or so. After receiving Shingrix, the patient experienced Shingles in March of 2021, 3 months after her second dose. That breakout lasted less than a week. The patient explained that she had chronic breakouts from shingles throughout her early years but that the breakouts had been less intense and less frequent since vaccination. The patient stated that between 1 and 2 years after vaccination with 1st and 2nd dose, she currently had a new outbreak of Shingles which started Sunday. The reporter gave permission to contact healthcare professional. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR044534:Same Reporter