Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
Red spots diagnosed as Pityriasis rosea; This serious case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 10-JAN-2025, 8 days after receiving Shingrix, the patient experienced pityriasis rosea (Verbatim: Red spots diagnosed as Pityriasis rosea) (serious criteria GSK medically significant). The outcome of the pityriasis rosea was unknown. It was unknown if the reporter considered the pityriasis rosea to be related to Shingrix. The company considered the pityriasis rosea to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 30-JAN-2025 The patient stated that he received his dose of Shingrix. On 6th January 2025, the patient had an appointment with his dermatologist for a full body scan and he did not present with any spots or lesions. On 10th January 2025, the patient had a single red spot on his chest. Then on 16th January 2025 he reported numerous red spots on his torso (front and back) and his sides. On 28th January 2025, the patient was examined by his dermatologist and the primary care physician diagnosed his condition as pityriasis rosea. The patient was informed by the dermatologist that the antigen caused a secondary latent condition related to certain herpes virus exposures and presented as a singular red spot known as herald patch. The spots were termed daughters. The condition was known as pityriasis rosea. The herald patch was a single oval one-inch lesion. The patient was undergoing treatment for this condition that lasted for six to ten weeks. No further information was provided, including treatment of the condition.; Sender's Comments: Pityriasis rosea is an unlisted event which is considered unrelated to GSK vaccine Shingrix.