Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
swollen 6 in. by 2 in swelling starting just below the injection site; Very painful; Hot; Red; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included paracetamol (Tylenol) and levocabastine hydrochloride (Zyrtec). On 24-APR-2025, the patient received the 1st dose of Shingles vaccine. On 24-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: swollen 6 in. by 2 in swelling starting just below the injection site), pain (Verbatim: Very painful), feeling hot (Verbatim: Hot) and erythema (Verbatim: Red). The outcome of the injection site swelling, pain, feeling hot and erythema were not resolved. It was unknown if the reporter considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine. It was unknown if the company considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-APR-2025 This report was submitted via the online direct entry reporting system. The patient had very painful, hot red swollen 6 inch by 2 inch swelling starting just below the injection site. The patient had never before had a reaction like this to a vaccine.
TYLENOL; ZYRTEC