Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4M472 | — |
Pnemonia; nail fungus; underarm rash; This serious case was reported by a consumer and described the occurrence of pneumonia in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M472) for prophylaxis. On 16-APR-2025, the patient received Shingrix .5 ml. On 16-APR-2025, less than a day after receiving Shingrix, the patient experienced pneumonia (Verbatim: Pnemonia) (serious criteria GSK medically significant), fungal infection of nail (Verbatim: nail fungus) and rash (Verbatim: underarm rash). The outcome of the pneumonia, fungal infection of nail and rash were not resolved. It was unknown if the reporter considered the pneumonia, fungal infection of nail and rash to be related to Shingrix. The company considered the pneumonia to be unrelated to Shingrix. It was unknown if the company considered the fungal infection of nail and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 03-OCT-2025 Patient needs assistance reversing persistent side effects Pneumonia, nail fungus and underarm rash. Symptoms were treated.; Sender's Comments: A case of Pneumonia, less than a day after receiving Shingrix in a 64-year-old male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.