Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 59PX7 | — |
inappropriate reconstitution technique; patient was administered only with the diluent of Shingrix second dose; pain in the arm; Fever; shivering; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 59PX7, expiry date 26-AUG-2027) for prophylaxis. On 02-MAR-2026, the patient received the 2nd dose of Shingrix. On 02-MAR-2026, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: patient was administered only with the diluent of Shingrix second dose). In MAR-2026, the patient experienced pain in arm (Verbatim: pain in the arm), fever (Verbatim: Fever) and shivering (Verbatim: shivering). The outcome of the pain in arm, fever and shivering were not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. It was unknown if the reporter considered the pain in arm, fever and shivering to be related to Shingrix. It was unknown if the company considered the pain in arm, fever and shivering to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2026 According to a nurse, the patient went to the office since he was presenting some pain in the arm, fever, and shivering as of today (on the day of reporting). The nurse wanted to know what the components of the liquid portion were and if any recommendations were available for the patient. The vaccine administration facility was the same as the primary reporter.