Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7LC49 | — |
a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 7LC49, expiry date 30-JAN-2027) for prophylaxis. In JAN-2025, the patient received Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure) and inappropriate dose of vaccine administered (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 21-JAN-2025 The reporter requested data on how to proceed with a patient who received Shingrix vaccine dose with an unapproved diluent, maybe from a MMR but unsure which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter reported that Shingrix vaccine was administered between 6th January 2025 and 15th January 2025, exact date unknown. It was unknown which Shingrix vaccine in the series. The reporter stated that all the details will not be known regarding the exact patient until the clinic runs a report.