Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; Shingles; Vaccine exposure to pregnancy; This serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included nerve pain (took medication for the nerve pain for years). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and vaccine exposure during pregnancy (Verbatim: Vaccine exposure to pregnancy). The outcome of the vaccination failure and shingles were not reported and the outcome of the vaccine exposure during pregnancy was not applicable. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Pregnancy exposure: Pregnancy Exposure (Shingles vaccine): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 07-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 different times. Also had the shingles shot, which did not prevent shingles, but makes the episode not as bad as the first time. Took medication for the nerve pain for year. The patient was pregnant when using the product which led to Vaccine exposure during pregnancy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, an unknown time after receiving Shingles vaccine, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Nerve pain (took medication for the nerve pain for years)
Medical History/Concurrent Conditions: Shingles