Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia, Rash, Suicidal ideation, Vaccination failure
Clinical narrative: committed himself to a mental health facility because he wanted to end his life; rash; Post herpetic neuralgia (PHN) that is extremely painful; Post herpetic neuralgia (PHN) that is extremely painful; Herpes zoster mouth; Shingles on right side of face, in mouth and lower ear; suspected vaccination failure; Shingles on lower ear; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2020, the patient received the 2nd dose of Shingrix. On 10-SEP-2020, the patient received the 1st dose of Shingrix. In FEB-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles on lower ear) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on right side of face, in mouth and lower ear) and oral herpes zoster (Verbatim: Herpes zoster mouth). On an unknown date, the patient experienced suicidal intention (Verbatim: committed himself to a mental health facility because he wanted to end his life) (serious criteria GSK medically significant), rash (Verbatim: rash), post herpetic neuralgia (Verbatim: Post herpetic neuralgia (PHN) that is extremely painful) and pain (Verbatim: Post herpetic neuralgia (PHN) that is extremely painful). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, shingles and oral herpes zoster were not reported and the outcome of the suicidal intention and rash were resolved and the outcome of the post herpetic neuralgia and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, suicidal intention, shingles, rash, post herpetic neuralgia, pain and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, suicidal intention, shingles, rash, post herpetic neuralgia, pain and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-MAY-2024 The consumer reported after the administration of both doses' patient was diagnosed with Shingles on February 2024. The patient reported he had shingles on his face, in mouth and in lower ear. He was prescribed with antiviral medication name was unknown name and the rash was now gone. The patient was now experiencing post herpetic neuralgia (PHN) that was extremely painful for which he was prescribed medication but does not know the name. The patient stated that his bout of shingles has been life altering due to the pain and he committed himself to a mental health facility because he wanted to end his life and after being discharged from the facility, he was now stable and was not thinking of ending his life. The patient stated he was misdiagnosed as having trigeminal neuralgia by a neurologist, however, after seeing a neurosurgeon his diagnosis was confirmed to be Shingles. The patient had 3 MRIs (Magnetic resonance imaging) done in order to correctly diagnose the condition.  The reporter consented to follow up.