Received Nov 14, 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 | — |
Suspected vaccination failure; passed out once; Shingles; nerves on my right breast/ left shoulder and my right arm/ going to nerve or pain management/ shingles can affect the nerves badly; depressed; Praying for healing daily and relief being able to sleep; Dizzy; 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: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: passed out once) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), nerve pain (Verbatim: nerves on my right breast/ left shoulder and my right arm/ going to nerve or pain management/ shingles can affect the nerves badly), depression (Verbatim: depressed), sleeplessness (Verbatim: Praying for healing daily and relief being able to sleep) and dizziness (Verbatim: Dizzy). The outcome of the vaccination failure, shingles, depression and dizziness were not reported and the outcome of the passed out was resolved and the outcome of the nerve pain and sleeplessness were not resolved. It was unknown if the reporter considered the vaccination failure, passed out, shingles, nerve pain, depression, sleeplessness and dizziness to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, nerve pain, depression, sleeplessness and dizziness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-OCT-2025 This case was reported by a patient via interactive digital media. The patient now had been suffering from the after effect of shingles for 2 years. He/she had both shots and now it was the nerves on his/her right breast where was a small keloid. Also, omega left shoulder and patient's right arm where he/she had a keloid on his/her upper arm. Some days it itches and throbs really bad. The patient was going to a dermatologist getting the needle in the arm and shoulder, he/she had to stop for a while. The patient said that shingles could affect the nerves badly. The patient prayed it would not get any worse. He/she was going to nerve or pain management soon. The patient definitely wished he/she had gotten the shingles sooner. Patient further said, those of you that prayed, please kept him/her in your prayers because sometimes, although patient prayed, he/she gets very depressed. The patient prayed daily for healing and relief, and for being able to sleep. The patient stated that check with the physician or pharmacist, if could continue medication. It had been too strong, and patient was getting dizzy and had passed out once. So, patient mentioned to be careful with pain medicine also. Shingles could be horrible and come back, and it was awful. The batch number was not provided, and unable to contact the reporter. 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: A case of Vaccination failure and Loss of consciousness, an unknown time after receiving 1st and 2nd dose of Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.