Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
raised bump that is red, 4 inches from injection site, size of a thumb; raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb; Swelling of injection site; hardening injection site; Fever; Headache; Fatigue; Chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-FEB-2025, the patient received Shingrix (left deltoid) .5 ml. In FEB-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: Chills). On 22-FEB-2025, the patient experienced injection site swelling (Verbatim: Swelling of injection site), injection site induration (Verbatim: hardening injection site), fever (Verbatim: Fever), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). On 28-FEB-2025, the patient experienced raised rash (Verbatim: raised bump that is red, 4 inches from injection site, size of a thumb) and feeling hot (Verbatim: raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb). The patient was treated with cetirizine hydrochloride (Zyrtec) and ibuprofen. On 25-FEB-2025, the outcome of the injection site swelling, fever, headache, fatigue and chills were resolved and the outcome of the injection site induration was resolved (duration 3 days). The outcome of the raised rash and feeling hot were not resolved. The reporter considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix. The company considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 Reporter was a pharmacist reporting for herself.