Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Pruritus, Rash, Sensitive skin, Sleep disorder
Clinical narrative: Suspected vaccination failure; diagnosed with 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) (batch number 4Z43X, expiry date 22-FEB-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had as a kid) and shingles (previously had shingles about 5 years ago).   On 19-NOV-2020, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In SEP-2020, the patient received the 1st dose of Shingrix. On 12-NOV-2024, 1454 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with Shingles). The patient was treated with valaciclovir (Valacyclovir), triamcinolone and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 21-NOV-2024 The patient self-reported this case for himself. The patient reported that he received the first dose of Shingrix at his physician's office. The patient reported that he received his second dose of Shingrix at his pharmacy.  The patient reported that on Tuesday, 12th November 2024, he started having burning and itching around his waist. The patient went to see his physician on Thursday, 14th November 2024 and was diagnosed with Shingles. The patient reported that he had a 7- to 8-inch-wide area of redness, burning and itching almost 180 degrees around his waist or the center of his body that was very severe.  The patient reported this area around his waist was very sore and sensitive.  The patient reported that the sensitivity has subsided as of today (on the day of reporting), 21- NOV-2024, but the tenderness on his skin was still there as of today. The patient reported he still has itching on the day of reporting.  The patient also reported that he now had spots and other eruptions up and down his left arm that he was feeling last night, 20th November 2024.  The patient reported these spots on his arm look like little pimples and rash like, itch like crazy and woke him up in the middle of the night last night, 20th November 2024.  The patient also reported that he had a small spot on his left thigh that started as a couple of spots, but then made a long line, that itch and were still there on the day of reporting.  The patient reported that he previously had shingles about 5 years ago (no specific date provided-preexisting Shingrix). The patient reported this second outbreak of shingles, after having received both doses of Shingrix, was worse than the first outbreak of shingles.  The patient reports that his physician gave him three medications for his outbreak of shingles. First was Valacyclovir 1gm, 1 tablet three times a day for 7 days, second was a Triamcinolone 0.5 Cream, apply topically two times a day, patient applied three times a day because he could not stop itching and third one was a Gabapentin 100mg, one capsule three times a day.  No further information provided about any of the three products the patient was taking for his shingles outbreak. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information s regarding laboratory confirmation of disease, h/o chickenpox and shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).