Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Suspected vaccination failure; shingles under her breast the first time in 2023; Shingles under her left breast; sore rash at the injection site; sore rash at the injection site; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included lumpectomy (had a Lumpectomy in her right breast). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, left arm). On 08-MAR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced shingles (Verbatim: Shingles under her left breast). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles under her breast the first time in 2023), injection site pain (Verbatim: sore rash at the injection site) and injection site rash (Verbatim: sore rash at the injection site). The patient was treated with valaciclovir (Valacyclovir) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the shingles was resolved and the outcome of the injection site pain and injection site rash were resolved (duration 2 weeks). It was unknown if the reporter considered the vaccination failure, shingles, shingles, injection site pain and injection site rash to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles, injection site pain and injection site rash to be related to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had both shots and still had shingles. She had both doses of Shingrix in 2023 and had shingles twice since receiving both doses. The patient had shingles under her breast the first time in 2023, after receiving both doses of Shingrix, but could not provide any further details of this event. The patient had shingles again now, 11-MAR-2025, that started on Saturday, 8-MAR-2025, again as breaking out under her left breast. The patient was taking Valacyclovir 1gm, 1 Tablet every 8 hours, prescribed by her physician on 9-MAR-2025, and Gabapentin 300mg, 1 Capsule at bedtime for the pain. The patient also reported that after the second dose of Shingrix, her left arm broke out in a big, sore rash at the injection site, that started the day after receiving the second dose. The patient reported that the soreness and the rash both lasted for a couple of weeks. The patient received both doses in her left arm. The patient reported both doses of Shingrix were given by her pharmacist at Pharmacy in 2023. The patient reported she had a Lumpectomy in her right breast pre-existing dose of Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Medical History/Concurrent Conditions: Lumpectomy (had a Lumpectomy in her right breast)