Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Shivering; Fatigue; Muscle ache; Stomachache; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis. The patient's past medical history included heart disorder (Heart disorder unknown, has a pacemaker). Concomitant products included amiodarone hydrochloride (Amiodarone), hydrochlorothiazide, valsartan (Valsartan) and hydralazine hydrochloride (Hydralazine). In NOV-2023, the patient received the 1st dose of Shingrix, RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingrix, RSV vaccine and COVID-19 vaccine, the patient experienced shivering (Verbatim: Shivering), fatigue (Verbatim: Fatigue), muscle pain (Verbatim: Muscle ache) and stomach pain (Verbatim: Stomachache). The outcome of the shivering, fatigue, muscle pain and stomach pain were resolved. It was unknown if the reporter considered the shivering, fatigue, muscle pain and stomach pain to be related to Shingrix, RSV vaccine and COVID-19 vaccine. It was unknown if the company considered the shivering, fatigue, muscle pain and stomach pain to be related to Shingrix, RSV vaccine and COVID-19 vaccine. Additional Information: GSK receipt date: 25-JUL-2025 In Nov 2023, the day after receiving the Shingrix vaccine (along with the Covid and RSV vaccine at the same time) the patient experienced shivering, fatigue, muscle aches and a stomachache which all resolved in a few days.
Medical History/Concurrent Conditions: Heart disorder (Heart disorder unknown, has a pacemaker)
AMIODARONE; VALSARTAN; HYDRALAZINE