Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Pain; broke out in shingles/ lack of drug effect; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cancer (type not disclosed), chemotherapy (last chem treatment in JUL-2024) and pancreatectomy. Concurrent medical conditions included asplenia. On 28-AUG-2025, the patient received the 1st dose of Shingrix. On 31-AUG-2025, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: broke out in shingles/ lack of drug effect). On an unknown date, the patient experienced pain (Verbatim: Pain). The patient was treated with valaciclovir hydrochloride (Valtrex) and hydrocodone bitartrate;paracetamol (Norco). The outcome of the shingles and pain were not resolved. It was unknown if the reporter considered the shingles and pain to be related to Shingrix. It was unknown if the company considered the shingles and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The reporter was healthcare professional (HCP) calling on behalf of a consumer (patient) who received the first dose of Shingrix and broke out in shingles (lack of drug effect) which was ongoing. HCP stated shingles outbreak located on his side on the left. Consumer prescribed Valtrex for shingles and Norco for pain consumer was experiencing (dose/frequency unknown) in 2025. HCP stated she was calling to report on her day off from work, so she was unable to provide specific information. No further information was obtained/provided.
Asplenia
Medical History/Concurrent Conditions: Cancer (type not disclosed); Chemotherapy (last chem treatment in JUL-2024); Pancreatectomy