Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
severe anaphylactic reaction/another anaphylactic reaction where she was having trouble breathing; flu-like reaction; knocked out for the day; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high. On 18-NOV-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylactic reaction (Verbatim: severe anaphylactic reaction/another anaphylactic reaction where she was having trouble breathing) (serious criteria GSK medically significant), influenza-like symptoms (Verbatim: flu-like reaction) and worn out (Verbatim: knocked out for the day). The patient was treated with diphenhydramine hydrochloride (Benadryl) and epinephrine (Epipen). Rechallenge with Shingrix was positive. The outcome of the anaphylactic reaction and influenza-like symptoms were unknown and the outcome of the worn out was resolved. It was unknown if the reporter considered the anaphylactic reaction, influenza-like symptoms and worn out to be related to Shingrix. The company considered the anaphylactic reaction to be unrelated to Shingrix. It was unknown if the company considered the influenza-like symptoms and worn out to be related to Shingrix. Linked case(s) involving the same patient: US2026023696 Additional Information: GSK Receipt Date: 18-FEB-2026 The patient was released from the emergency department. The patient stated that she then carried BENADRYL liquid with her. The patient was unable to provide the dates of the emergency department visit at the time of the call. The batch number was not provided and a request for this information has been made. For the tolerance of first dose refer link case US2026023696, reported by same reporter.; Sender's Comments: A case of Anaphylactic reaction, on an unknown time after vaccination with 2nd dose of Shingrix, in an elderly female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought US-GSK-US2026023696:2nd dose: same patient
Blood pressure high