Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 27LR2 | — |
Squamous cell carcinoma; developed a blister on my back that evolved into what looked like a chickenpox; This serious case was reported by a consumer via call center representative and described the occurrence of squamous cell carcinoma in a female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (The patient received the first dose of Shingrix on 13 September 2024 (Lot number GK2AZ; expiration date 21 April 2026) Intramuscularly, in the left upper arm.The dose given was unknown). Concomitant products included ezetimibe (Zetia) and pitavastatin calcium (Livalo). On 27-FEB-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, 1 week after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed a blister on my back that evolved into what looked like a chickenpox). On an unknown date, the patient experienced squamous cell carcinoma (Verbatim: Squamous cell carcinoma) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the squamous cell carcinoma was unknown and the outcome of the chickenpox was resolved. It was unknown if the reporter considered the squamous cell carcinoma and chickenpox to be related to Shingrix. The company considered the squamous cell carcinoma and chickenpox to be unrelated to Shingrix. Additional Information: GSK receipt date: 22-MAY-2025 Consumer reported that about 1 week after receiving the second dose of Shingrix, the patient developed a blister on her back. Shortly after, a blister developed on her upper thigh. The blister on her back resolved, but the blister on her thigh developed into a mole, which grew very quickly. This mole had a hole in the center and a horn like growth coming from it. The patient had this mole biopsied in April, 2025. By the time the patient had surgery on May 6, 2025, the mole had grown back to 1cm. The mole on her thigh was Squamous Cell Carcinoma.; Sender's Comments: Squamous cell carcinoma and Varicella are unlisted events which are considered unrelated to GSK vaccine Shingrix.
ZETIA; LIVALO