Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
my arm got swelled up the whole way down to my wrist; numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face; Swelling went up my neck and the back of my skull on the right side, right where my ears are; Swelling in the side of my face on the right side; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extensive swelling of vaccinated limb (Verbatim: my arm got swelled up the whole way down to my wrist), hypoesthesia (Verbatim: numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face), local swelling (Verbatim: Swelling went up my neck and the back of my skull on the right side, right where my ears are) and facial swelling (Verbatim: Swelling in the side of my face on the right side). The outcome of the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling were not reported. It was unknown if the reporter considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. It was unknown if the company considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025106918 Additional Information: GSK Receipt Date: 19-AUG-2025 The patient self-reported this case for herself. Patient explained she got a first dose of Shingles vaccine (unknown brand name or lot number) a few years ago (unknown specific date) and she got a bad reaction. And now her physician recommended to restart the series, and she got recombinant zoster vaccine (unknown brand name or lot number), but she was having a bad reaction again, exactly the same reaction than the first time, numbing of the one side of her face, and the back of her skull and down her right arm were she got the shot. The patient did tell her physician the first Shingles shot she had, she had bad reactions from and she really did not want to take the shot again, but she just said that she thought it was a very good idea if she would, she said this one was different, it might have been different but it was still the same reaction, first dose and second dose was exactly the same, she got it and her arm got swelled up the whole way down to her wrist and then it went up her neck and the back of her skull on the right side, right where her ears were and the side of her face on the right side, it was like a numbing, both her skull and the front of her face were like numb and she did not like those reactions.; Sender's Comments: US-GSK-US2025106918:same patient