Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 47n3y | IM / LA |
she had an infection; Redness on left arm; she was having redness at injection site which got worsened; injection site of her left arm was hot to the touch; skin was blotchy at injection site; Fever; Bodyaches; Shivering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47n3y) for prophylaxis. On 30-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 01-APR-2025, 2 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she was having redness at injection site which got worsened), injection site warmth (Verbatim: injection site of her left arm was hot to the touch ), injection site reaction (Verbatim: skin was blotchy at injection site), fever (Verbatim: Fever), general body pain (Verbatim: Bodyaches) and shivering (Verbatim: Shivering). On 02-APR-2025, the patient experienced infection (Verbatim: she had an infection) and erythema of extremities (Verbatim: Redness on left arm). The outcome of the injection site erythema, injection site warmth, injection site reaction, general body pain, shivering, infection and erythema of extremities were not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The reporter considered the infection to be unrelated to Shingrix. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. The company considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The company considered the infection to be unrelated to Shingrix. It was unknown if the company considered the erythema of extremities to be related to Shingrix. Additional Information: GSK receipt date: 03-APR-2025 HCP was the reporter. Reporter stated 48 hours after the vaccine was administered the patient complained the injection site of her left arm was hot to the touch, her skin was blotchy at injection site, she was having redness at injection site, fever (temperature not reported) body aches, and shivering. The reporter stated the consumer went to urgent care 2 APR 2025 and was told that she had an infection. The reporter also stated the redness on the left arm at the injection site has spread to the entire left arm as of 2nd April 2025. The reporter was unable to specify where or what type of infection the consumer was diagnosed with. The reporter stated the consumer scheduled an appointment with her PCP 3rd April 2025 for evaluation and was being examined by the PCP at the time of reporting. No further information was obtained or provided.