Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 2 | unknown | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure/Lack of drug effect; Neuropathy; possible Shingles; Fibromyalgia aggravated; Shivering; Shaking; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included fibromyalgia. On 27-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On an unknown date, the patient received the 1st dose of Shingrix. On 27-JUN-2025, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fibromyalgia worsened (Verbatim: Fibromyalgia aggravated), shivering (Verbatim: Shivering) and tremor (Verbatim: Shaking). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant) and shingles (Verbatim: possible Shingles). The patient was treated with pregabalin (Lyrica) and naproxen (Naprosyn). The outcome of the vaccination failure and neuropathy were not resolved and the outcome of the shingles and fibromyalgia worsened were not reported and the outcome of the shivering and tremor were resolved. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, fibromyalgia worsened, shivering and tremor to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and neuropathy to be unrelated to Shingrix. It was unknown if the company considered the shingles, fibromyalgia worsened, shivering and tremor to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The consumer stated that she was diagnosed with Fibromyalgia 10 years ago that had been controlled with exercise and over the counter pain medications. Stated this second dose of Shingrix had aggravated her fibromyalgia and now she was dealing with those symptoms. Stated she was vaccinated with her second dose of Shingrix on 27 Jun 2025 in the left arm. Consumer stated after the injection she had shivering, could not stop shaking, she was sore, and tired. Consumer stated those adverse events only lasted a few days. Consumer states after a few days she was experiencing pain on the left side of her body. Consumer stated the pain was consistent with shingles, although she had no rash. Consumer stated she wakes up in the middle of the night feeling like flesh was being ripped from her bones. Stated due to neuropathy, clothes hurt to touch her and at other times she has a feeling of being sunburned. Consumer stated if she was able to rest during the day it is possible to sleep through the night without being awakened by pain. Consumer stated she was prescribed Lyrica and Naprosyn (dose/frequency not disclosed.) Consumer stated she purchased over the counter cream called neuropaway for the neuropathy. 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.; Sender's Comments: A case of Vaccination failure and Neuropathy peripheral, unknown time and not applicable time after receiving Shingrix (Dose 1 and Dose 2) in a 52-year-old female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Fibromyalgia