Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3BD9E | — |
Shortness of Breath; Tongue Swelling; This serious case was reported by a pharmacist via sales rep and described the occurrence of shortness of breath in a female patient who received Herpes zoster (Shingrix) (batch number 3BD9E) for prophylaxis. On 22-NOV-2021, the patient received the 1st dose of Shingrix. On 22-NOV-2021, less than a day after receiving Shingrix, the patient experienced shortness of breath (Verbatim: Shortness of Breath) (serious criteria hospitalization) and swollen tongue (Verbatim: Tongue Swelling) (serious criteria hospitalization). The outcome of the shortness of breath and swollen tongue were resolved. The reporter considered the shortness of breath and swollen tongue to be related to Shingrix. The company considered the shortness of breath and swollen tongue to be related to Shingrix. Additional Information: GSK Receipt Date: 25-MAR-2025 The patient accepted the first dose of Shingrix. She waited 15 minutes in office after. The patient drove home and had tongue swelling and shortness of breath. Immediately she drove back to the hospital because of reaction.; Sender's Comments: Dyspnoea is an unlisted event, due to the following criteria (strong temporal association) is considered related to GSK vaccine Shingrix Swollen tongue is a listed event which is considered related to a GSK vaccine Shingrix