Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 4ab32 | RA |
Injection site soreness; Some Shivering; big red patch going down the arm; slight itching at the site of the red patch; technician told her the vaccine would be given under the skin in the fatty part of the back of her right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ab32, expiry date 27-MAR-2027) for prophylaxis. The patient's past medical history included shingles (Previous history of shingles in approximately 2014). Previously administered products included Zostavax. On 30-NOV-2025, the patient received the 1st dose of Shingrix (right arm). On 30-NOV-2025, an unknown time after receiving Shingrix, the patient experienced product administered at inappropriate site (Verbatim: technician told her the vaccine would be given under the skin in the fatty part of the back of her right arm). On an unknown date, the patient experienced injection site pain (Verbatim: Injection site soreness), shivering (Verbatim: Some Shivering), skin red (Verbatim: big red patch going down the arm) and pruritus (Verbatim: slight itching at the site of the red patch). The outcome of the injection site pain, shivering and pruritus were unknown and the outcome of the skin red was resolving and the outcome of the product administered at inappropriate site was not applicable. It was unknown if the reporter considered the injection site pain, shivering, skin red and pruritus to be related to Shingrix. It was unknown if the company considered the injection site pain, shivering, skin red and pruritus to be related to Shingrix. Additional Information: GSK receipt date 05-DEC-2025 The reporter had her first dose of Shingrix administered 30th November 2025. The reporter stated the vaccinating technician told her the vaccine would be given and under the skin in the fatty part of the back of her right arm. The reporter stated the information provided to her said that the vaccine was administered in her left deltoid. The reporter stated that she had injection site soreness and a big red patch going down the arm. The reporter stated she had some shivering and slight itching at the site of the red patch.
Medical History/Concurrent Conditions: Shingles (Previous history of shingles in approximately 2014)