Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
the patient received a total of 0.94 ml of Shingrix on a single day; received 0.44 ml; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix .5 ml and the 1st dose of Shingrix .44 ml. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced overdose (Verbatim: the patient received a total of 0.94 ml of Shingrix on a single day) and incomplete dose administered (Verbatim: received 0.44 ml). The outcome of the overdose and incomplete dose administered were not applicable. Additional Information: GSK Receipt Date: 28-MAR-2025 The pharmacist reported that what was the next steps if a patient only received 0.44 milliliter of the first dose, which led to incomplete dose administered. The product was then identified as Shingrix. She was driving at the time of the outbound call and therefore did not have the access to the patient's date of birth or other information such as the lot number. She stated that he did some research on center of disease control website and immunization organization which indicated that the dose should be re administered thus she called the patient back to the pharmacy and administer 0.5 milliliter. Therefore, the patient received a total of 0.94 milliliter of Shingrix on a single day, which led to overdose. No further information available. Pharmacist was aware that safety may follow up with her to collect more details.