Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Headache; Weakness generalized; slight malaise; Nasal congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on 27-JAN-2025, for tolerance of 1st dose of Shingrix, refer case US2025083753). On 23-JUN-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), weakness generalized (Verbatim: Weakness generalized), malaise (Verbatim: slight malaise) and nasal congestion (Verbatim: Nasal congestion). Rechallenge with Shingrix was positive. The outcome of the headache, weakness generalized, malaise and nasal congestion were resolved. It was unknown if the reporter considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix. It was unknown if the company considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix. Linked case(s) involving the same patient: US2025083753 Additional Information: GSK Receipt Date: 03-JUL-2025 The patient received Shingrix shot and he experienced slight malaise/weakness, headache, and some nasal congestion. These side effects were very minor compared to first Shingrix shot. These events resolved.; Sender's Comments: US-GSK-US2025083753:same patient/2nd dose