Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 557PZ | IM / LA |
body ache; fever; general malaise; headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 557PZ, expiry date 30-SEP-2025) for prophylaxis. On 26-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 26-FEB-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache). On 27-FEB-2025, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and general malaise (Verbatim: general malaise). On 04-MAR-2025, the outcome of the fever was resolved (duration 5 days). The outcome of the headache, general body pain and general malaise were unknown. The reporter considered the headache, general body pain, fever and general malaise to be related to Shingrix. The company considered the headache, general body pain, fever and general malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that a female patient received her second dose of Shingrix on 26-FEB- 2025 and started having a headache that same evening. The patient started also having body aches, on and off fever, and general malaise the next day, 27-FEB-2025 and the fever persisted until 4-MAR-2025. The headache, body aches and general malaise were continuing at least through Friday 7-MAR-2025, and the reporter was unsure if they persist on, 10-MAR-2025. They reported all that was provided about these adverse events.