Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
Congestion pulmonary/chest congestion; Sore throat; Shivers; Muscle ache; Fatigue; Headache; Mood change; This serious case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension. Concomitant products included lisinopril. On 15-DEC-2025, the patient received the 2nd dose of Shingrix (left deltoid). On 15-DEC-2025, less than a day after receiving Shingrix, the patient experienced shivers (Verbatim: Shivers), muscle pain (Verbatim: Muscle ache), fatigue (Verbatim: Fatigue), headache (Verbatim: Headache) and mood change (Verbatim: Mood change). On 17-DEC-2025, the patient experienced lung congestion (Verbatim: Congestion pulmonary/chest congestion) (serious criteria GSK medically significant) and sore throat (Verbatim: Sore throat). The outcome of the lung congestion, shivers, muscle pain, fatigue, headache, mood change and sore throat were resolving. It was unknown if the reporter considered the lung congestion, shivers, muscle pain, fatigue, headache, mood change and sore throat to be related to Shingrix. The company considered the lung congestion to be unrelated to Shingrix. It was unknown if the company considered the shivers, muscle pain, fatigue, headache, mood change and sore throat to be related to Shingrix. Additional Information: GSK Receipt Date: 18-DEC-2025 The patient received his Shingrix vaccine. The patient stated on the night of vaccine administration he had shivers, muscle ache, fatigue, headache, and mood changes that were still ongoing but were improving. The patient stated that on 17-DEC-2025 he developed a sore throat and chest congestion that were ongoing but were improving. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Pulmonary congestion (not meeting BC Criteria), less than a day after receiving 2nd dose of Shingrix in a 64-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (hypertension).
Hypertension
LISINOPRIL