Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 342XP | LA |
Injected arm is tender to the touch; Rash on arm red and hot; Rash on arm red and hot; Rash on arm red and hot; Metallic taste in mouth after Shingrix vaccine; Low grade headache; Head felt fuzzy/did not feel like self; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 342XP, expiry date 28-APR-2027) for prophylaxis. Concurrent medical conditions included thyroid disorder and hormone replacement therapy. Concomitant products included thyroid, progesterone and estradiol. On 12-SEP-2025 12:30, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 12-SEP-2025, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Low grade headache) and fuzzy head (Verbatim: Head felt fuzzy/did not feel like self). On 12-SEP-2025 13:30, the patient experienced taste metallic (Verbatim: Metallic taste in mouth after Shingrix vaccine). On 19-SEP-2025, the patient experienced rash (Verbatim: Rash on arm red and hot), erythema of extremities (Verbatim: Rash on arm red and hot) and extremities hot feeling of (Verbatim: Rash on arm red and hot). On an unknown date, the patient experienced tenderness (Verbatim: Injected arm is tender to the touch). On 12-SEP-2025 19:00, the outcome of the taste metallic was resolved (duration 5 hrs 30 min). On 13-SEP-2025, the outcome of the headache and fuzzy head were resolved (duration 1 day). The outcome of the tenderness was not resolved and the outcome of the rash, erythema of extremities and extremities hot feeling of were not reported. It was unknown if the reporter considered the taste metallic, tenderness, headache, fuzzy head, rash, erythema of extremities and extremities hot feeling of to be related to Shingrix. It was unknown if the company considered the taste metallic, tenderness, headache, fuzzy head, rash, erythema of extremities and extremities hot feeling of to be related to Shingrix. Additional Information: GSK Receipt Date: 15-SEP-2025 and 19-SEP-2025 The same day after receiving Shingrix, the patient states she had a low grade headache, did not feel like herself and head felt fuzzy. These lasted until the next day, when she woke up, she felt fine. Patient called back to report an additional adverse event. She states that, she has developed a rash on her arm that was red and hot. It looks like a bee bite and was about 6 inches by 3 inches wide.
Hormone replacement therapy; Thyroid disorder
THYROID; PROGESTERONE; ESTRADIOL