Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
Low back pain (without radiation); Nausea; Fatigue; Ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of nausea (Received 1st dose of Shingrix vaccine on 12-APR-2025). On 22-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On 22-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Ache). On 23-JUL-2025, the patient experienced nausea (Verbatim: Nausea) and fatigue (Verbatim: Fatigue). On 24-JUL-2025, the patient experienced low back pain (Verbatim: Low back pain (without radiation)). Rechallenge with Shingrix was positive. On 24-JUL-2025, the outcome of the nausea and fatigue were resolved (duration 1 day). The outcome of the low back pain and pain were not resolved. It was unknown if the reporter considered the nausea, fatigue, low back pain and pain to be related to Shingrix. It was unknown if the company considered the nausea, fatigue, low back pain and pain to be related to Shingrix. Additional Information: GSK receipt date: 25-JUL-2025 The patient received her second dose of Shingrix on 22-Jul-2025 and the following day she experienced nausea and fatigue along with overall achiness. The nausea and fatigue have subsided but on the day of reporting (today) she awoke with low back pain. Please refer case US2025096096 for the tolerance of the first dose.; Sender's Comments: US-GSK-US2025096096:1st dose