Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
Nausea; Head aching; temperature; felt like a rock in her stomacht; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 06-MAY-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Head aching), fever (Verbatim: temperature) and stomach feeling heavy (Verbatim: felt like a rock in her stomacht). The outcome of the nausea, headache and fever were not resolved and the outcome of the stomach feeling heavy was unknown. It was unknown if the reporter considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix. It was unknown if the company considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 and 07-MAY-2025 The consumer was the primary reporter. The reporter stated that she received her second dose of Shingrix on in her left arm. The reporter stated that the next morning she felt like a rock was in her stomach, nausea, head aching, and a temperature of 98.9 degree Fahrenheit and her temperature usually runs around 97.6 degree Fahrenheit. On 7 May 2025, The reporter stated that she does not have the power even to say whether aspirin Tylenol or ibuprofen are contraindicated when somebody was having a headache or something like that from the shot The reporter stated it would be awfully nice if patient had at least that much authority.
Test Name: body temperature; Result Unstructured Data: (Test Result:98.9,Unit:degree F,Normal Low:,Normal High:) usually runs around 97.6 degree Fahrenheit