Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspeceted vaccination failure; shingles was in my lower back with numbness in my upper leg/pain in leg; My shingles was in my lower back with numbness in my upper leg with; The pain brought me to my knees; The pain got better but I didn't feel myself for about a month; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles was in my lower back with numbness in my upper leg/pain in leg), numbness in leg (Verbatim: My shingles was in my lower back with numbness in my upper leg with), knee pain (Verbatim: The pain brought me to my knees) and feeling abnormal (Verbatim: The pain got better but I didn't feel myself for about a month). The outcome of the vaccination failure, shingles and numbness in leg were not reported and the outcome of the knee pain was resolving and the outcome of the feeling abnormal was resolved (duration 1 month). It was unknown if the reporter considered the vaccination failure, shingles, numbness in leg, knee pain and feeling abnormal to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, numbness in leg, knee pain and feeling abnormal to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had both doses of the shingles vaccination and developed shingles in his/her lower back with numbness in his/her upper leg with nothing on his/her skin. The pain brought him/her to his/her knees, and it was awful. The pain got better but he/she did not feel his/herself for about a month. This case was considered as suspected vaccination failure since the details regarding time to onset 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 the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).