Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Tiredness; Lethargic; Trouble waking up; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included lymph node excision (pre-existing the Shingrix and unknown Flu Vaccine). On 02-DEC-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) and Flu vaccine (left arm). On 03-DEC-2025, 1 days after receiving Shingrix and Flu vaccine, the patient experienced tiredness (Verbatim: Tiredness), lethargy (Verbatim: Lethargic) and hard to awaken (Verbatim: Trouble waking up). The outcome of the tiredness, lethargy and hard to awaken were not resolved. It was unknown if the reporter considered the tiredness, lethargy and hard to awaken to be related to Shingrix and Flu vaccine. It was unknown if the company considered the tiredness, lethargy and hard to awaken to be related to Shingrix and Flu vaccine. Additional Information: GSK Receipt Date: 03-Dec-2025 The patient did not have any lot/expiry/NCD for either the Shingrix or the unknown Flu Vaccine. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Lymph node excision (pre-existing the Shingrix and unknown Flu Vaccine)