Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.; Injection site itchy; Injection site red; Very sore; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine for prophylaxis. On 06-MAR-2025, the patient received Shingrix .5 ml and the 2nd dose of Hepatitis b vaccine. On 07-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.), injection site itching (Verbatim: Injection site itchy), injection site erythema (Verbatim: Injection site red) and injection site pain (Verbatim: Very sore). The outcome of the injection site swelling, injection site itching, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAR-2025 The reporter reported that she have a 2 inch diameter red swollen area at the injection site, very sore, somewhat itchy. The reporter reported that the she had never had this reaction to a vaccine before. but, to be clear, also got her second Hep B shot at the same time.