Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Blister lip; This non-serious case was reported by a consumer via call center representative and described the occurrence of lip blister in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac). On 03-MAR-2025 15:00, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 04-MAR-2025, 1 days after receiving Shingrix, the patient experienced lip blister (Verbatim: Blister lip). The outcome of the lip blister was not resolved. It was unknown if the reporter considered the lip blister to be related to Shingrix. It was unknown if the company considered the lip blister to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The patient received Shingrix vaccine and 18 hours later she woke up with a blister on her lower lip. The reporter did not know the lot number of the vaccine.
Anxiety
PROZAC