Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM |
swelling at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site). The outcome of the injection site swelling was unknown. The reporter considered the injection site swelling to be related to Shingrix. The company considered the injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter states within the past 3 months she has administered Shingrix to two patients that had swelling at the injection site. The reporter could not provide the initials, date of birth, gender or lot number for the two individuals. No further information was obtained/provided by health care professional. This was 2 of the 2 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025029066:Same reporter/ different patient