Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Anaphylaxis; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included sjogren's. Concurrent medical conditions included latex allergy (Latex allergy) and food allergy (Banana Allergy). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant). The outcome of the anaphylaxis was unknown. The reporter considered the anaphylaxis to be related to Shingrix. The company considered the anaphylaxis to be unrelated to Shingrix. Additional Information: GSK receipt date: 27-OCT-2025 Patient stated that she experienced anaphylaxis to Shingrix a few years ago. The reporter stated that it was due to the adjuvant component that had latex in it. This was her first dose of Shingrix. The patient had not received the second dose due to the anaphylaxis reaction. No other details were provided; Sender's Comments: A case of Anaphylactic reaction, on an unknown date, an unknown time after receiving Shingrix, in a 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.
Food allergy (Banana Allergy); Latex allergy (Latex allergy)
Medical History/Concurrent Conditions: Sjogren's