Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 33fd3 | IM |
Injection site lump; swollen at injection site; he felt light-headed and dizzy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 33fd3) for prophylaxis. On 08-MAR-2025, the patient received Shingrix (intramuscular) .5 ml. On 08-MAR-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site lump), injection site swelling (Verbatim: swollen at injection site) and light headedness (Verbatim: he felt light-headed and dizzy). The outcome of the injection site lump, injection site swelling and light headedness were unknown. The reporter considered the injection site lump, injection site swelling and light headedness to be related to Shingrix. The company considered the injection site lump, injection site swelling and light headedness to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The healthcare professional was the reporter. The reporter stated she administered the first dose of Shingrix to a patient on 08th March 2025. The healthcare professional reported the consumer had a lump and swelling immediately at the injection site. Approximately 5 minutes post injection the patient stated he felt light-headed and dizzy. No further information was provided/obtained.; Sender's Comments: US-GSK-US2025AMR029594:Same reporter/ different patient