Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM |
pregnant patient received Shingrix vaccine; Nerve pain; suspected vaccination failure; At this time the neuropathy diagnosis was ruled out and she was diagnosed with shingles; This serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included INFLUENZA VACCINE, metformin and insulin glargine (Toujeo). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). In SEP-2024, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At this time the neuropathy diagnosis was ruled out and she was diagnosed with shingles). In OCT-2024, the patient experienced post herpetic neuralgia (Verbatim: Nerve pain). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Shingrix vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was not resolved and the outcome of the vaccine exposure during pregnancy was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Pregnancy exposure: Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 15-MAY-2025 The reporter was the husband of the patient. The patient had received both doses of Shingrix in late 2022. He remarked that they had received a flu shot about one month before the Shingrix vaccine. He did not know which flu shot or manufacturer it was. In September 2024, the patient experienced her "first ever" fever blister, which lasted about four days. In October 2024, she began feeling pain in her back that radiated down her right leg. She also began feeling less energetic at that time and complained of pain in her side. There was no rash at that time. In November 2024, she was originally diagnosed with neuropathy caused by her diabetes until two "dots" appeared on her back near her rib cage and on her buttock. At that point, the neuropathy diagnosis was ruled out, and she was diagnosed with shingles. The dots went away about two to three weeks later. The dot on her ribcage appeared like a blister that had popped. The patient reported that her ongoing intermittent pain occurred between the dot location on her ribcage and the dot location on her buttock. She continued to complain of intermittent pain when clothing touched her skin. The HCP noted in the report was her Primary Care Physician. His wife was her gynecologist. They shared the same office contact information. The pregnant patient received Shingrix vaccine which led to, vaccine exposure during pregnancy. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Diabetes
INFLUENZA VACCINE; METFORMIN; TOUJEO