Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3J2S2 | LA |
rash/ developed a blotchy rash on her chest, left arm, back and left breast; This non-serious case was reported by a consumer via call center representative and described the occurrence of blotchy rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 3J2S2, expiry date 27-MAR-2027) for prophylaxis. The patient's past medical history included hip replacement (left hip in 2019) and shingles (3 dots on her forehead in 2009). Previously administered products included Valtrex (treated with Valtrex in 2009). Concurrent medical conditions included penicillin allergy (in 2019, her physician recommended that she could take oral penicillin but not injected penicillin). On 04-JUN-2025, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 06-JUN-2025, 2 days after receiving Shingrix, the patient experienced blotchy rash (Verbatim: rash/ developed a blotchy rash on her chest, left arm, back and left breast). On 20-JUN-2025, the outcome of the blotchy rash was resolved (duration 14 days). It was unknown if the reporter considered the blotchy rash to be related to Shingrix. It was unknown if the company considered the blotchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case for herself. The patient developed a blotchy rash on her chest, left arm, back and left breast. The patient stated that the rash resolved in 2 weeks.
Penicillin allergy (in 2019, her physician recommended that she could take oral penicillin but not injected penicillin)
Medical History/Concurrent Conditions: Hip replacement (left hip in 2019); Shingles (3 dots on her forehead in 2009)
Comments: The patient was tested for an allergy to penicillin. The results were inconclusive.