Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Muscle discomfort, Nerve injury, Pain
Clinical narrative: Burn; Tingle; Pain; pulled muscle in his back; Nerve damage; Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included The patient never had any health issues, does not take any medications, and never had COVID,.   In NOV-2021, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2021, the patient received the 1st dose of Shingrix (intramuscular, left arm). In FEB-2023, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced burn (Verbatim: Burn), tingling (Verbatim: Tingle), pain (Verbatim: Pain), muscle discomfort (Verbatim: pulled muscle in his back) and nerve damage (Verbatim: Nerve damage). The patient was treated with gabapentin. The outcome of the vaccination failure, burn, tingling and pain were unknown and the outcome of the shingles and nerve damage were not resolved and the outcome of the muscle discomfort was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burn, tingling, pain, muscle discomfort and nerve damage to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, burn, tingling, pain, muscle discomfort and nerve damage to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date:25-May-2023 The reporter stated that he received his 1st dose of Shingrix June 2021 and his 2nd dose of Shingrix November 2021, both in the left arm, and from Mid February 2023 to mid April 2023, he had a severe case of shingles that went away after 6 to 8 weeks (no specific date provided). The patient reported that he had shingles pain right away that he thought was a pulled muscle in his back because of the slow burn, and the shingles initially started as a tingle just below his right shoulder blade and came around the right side to the center of his chest.  The patient reports he could still feel the nerve and his doctor told him his nerves could be damaged. The patient saw his doctor initially after a week to 10 days ( no specific date provided) in February 2023, and was prescribed Gabapentin (unknown product information) for the pain, that did not work, and at the end of February 2023 was prescribed a different medication (pre Gab or pre Gabapentin--unknown product) because the original prescription for Gabapentin did not work.  The patient did not have the Lot and Expiry information for either dose of Shingrix. The patient felt like he was getting another case of shingles currently, but this had not been diagnosed. The reporter consented to follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not provided.