Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
A little swollen; Very warm to the touch; Very red on the upper arm all the way to the top of the elbow; Sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included breast cancer, sentinel lymphadenectomy and lymphedema (on the right arm). On 10-OCT-2025, the patient received the 1st dose of Shingrix (left arm). In OCT-2025, more than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: A little swollen), injection site warmth (Verbatim: Very warm to the touch), injection site erythema (Verbatim: Very red on the upper arm all the way to the top of the elbow) and pain (Verbatim: Sore). The outcome of the injection site swelling, injection site warmth, injection site erythema and pain were resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and pain to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site warmth, injection site erythema and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 09-DEC-2025 The reporter mentioned that the patient mentioned she had a reaction after her first and only dose of Shingrix, the patient could not get shot on right arm as patient had lymphedema, so got the shot in the left arm. The patient was instructed that the vaccine could cause some swelling a little bit, some inflammation around the site of the shot and it could get a little red. The patient had very red on the upper arm all the way to the top of the elbow, very warm to the touch, and a little swollen, the patient was unaware whether if it was because of some lymph nodes out and maybe that was quite normal. The patient did not have any other reactions, like breathing or anything. Patient also mentioned that symptoms started on the evening after the injection or next day and lasted only for a couple days, first it was just sore, but then the patient had the other symptoms mentioned above. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Breast cancer; Lymphedema (on the right arm); Sentinel lymphadenectomy