Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 4479Y | SC / LA |
patient received Shingrix subcutaneous instead of intramuscular; Arm red; Arm swollen; This non-serious case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) (batch number 4479Y) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). In JAN-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient received Shingrix subcutaneous instead of intramuscular). On an unknown date, the patient experienced erythema of extremities (Verbatim: Arm red) and swelling arm (Verbatim: Arm swollen). The outcome of the intramuscular formulation administered by other route was not applicable and the outcome of the erythema of extremities and swelling arm were resolved (duration 3 weeks). It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix. It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix. Additional Information: GSK receipt date: 30-APR-2025 The nurse reported that the patient received 1stdose of Shingrix subcutaneous instead of intramuscular which led to, intramuscular formulation administered by other route. The patient said her arm was red and swollen for three weeks but did not seek medical attention. She informed the practice of it when she returned for her 2nd dose.