Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | FT95N | IM / LA |
Redness below the injection site; Itching at injection site; rash at injection site; Burning/ pain below the injection site; hot at injection site; Pain in arm/ sore arm; Shoulder pain; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number FT95N, expiry date 25-APR-2027) for prophylaxis. Concurrent medical conditions included blood pressure. Concomitant products included nebivolol hydrochloride (Nebivolol). On 25-SEP-2025 14:15, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 25-SEP-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness below the injection site), injection site itching (Verbatim: Itching at injection site), injection site rash (Verbatim: rash at injection site), injection site pain (Verbatim: Burning/ pain below the injection site), injection site warmth (Verbatim: hot at injection site), pain in arm (Verbatim: Pain in arm/ sore arm), shoulder pain (Verbatim: Shoulder pain) and headache (Verbatim: Headache). The outcome of the injection site erythema, injection site rash, injection site pain, injection site warmth, shoulder pain and headache were unknown and the outcome of the injection site itching and pain in arm were not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching, injection site rash, injection site pain, injection site warmth, pain in arm, shoulder pain and headache to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site itching, injection site rash, injection site pain, injection site warmth, pain in arm, shoulder pain and headache to be related to Shingrix. Additional Information: GSK receipt date: 02-OCT-2025 The reporter was the wife of the patient. The reporter stated, the patient received 1st dose of Shingrix at 2:15pm, in left deltoid. The patient left arm was so sore and painful and could not touch it. The reporter stated that, below the injection site, the patient had very red, burning, painful, hot, itching rash. The rash was 3 by 3 or 4 by 4 in size. The reporter stated that, the patient had pain all in his shoulder. The patient had frequent headache. The pain and itching was worse after the day of vaccination. The patient could not lay on his left side, as it was so painful. The reporter consented to follow up.
Blood pressure
Nebivolol