Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Herpes zoster, Herpes zoster oticus, Incomplete course of vaccination, Off label use
Clinical narrative: numerous outbreaks of Ramsay-Hunt Syndrome; mild outbreaks [of shingles] (treated with prednisone); causing severe pain/pain was so intolerable; Off Label Use (valacyclovir is approved for the TREATMENT of shingles not for the prevention); it has been nearly 5 years since my 1st dose; This serious case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and valaciclovir hydrochloride (Valacyclovir) for shingles.   The patient's past medical history included stem cell transplant (Auto stem cell transplant in 2019), shingles (Initial shingles outbreak in 2017) and chemotherapy (prior chemotherapy).   On an unknown date, the patient received the 1st dose of Shingrix, did not receive the 2nd dose of Shingrix and received Valacyclovir 500 mg twice a day (1000 mg daily). On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix and Valacyclovir, the patient experienced ramsay-hunt syndrome (Verbatim: numerous outbreaks of Ramsay-Hunt Syndrome) (serious criteria GSK medically significant), shingles (Verbatim: mild outbreaks [of shingles] (treated with prednisone)), pain (Verbatim: causing severe pain/pain was so intolerable), off label use in unapproved indication (Verbatim: Off Label Use (valacyclovir is approved for the TREATMENT of shingles not for the prevention)) and incomplete course of vaccination (Verbatim: it has been nearly 5 years since my 1st dose). The patient was treated with prednisone. The action taken with Valacyclovir was unknown. The outcome of the ramsay-hunt syndrome, shingles, pain, off label use in unapproved indication and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the ramsay-hunt syndrome, shingles and pain to be related to Shingrix.     The company considered the ramsay-hunt syndrome to be unrelated to Shingrix, Shingrix and Valacyclovir. It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUN-2024 The patient self-reported this case for herself.  The patient reported that, in 2019 she had an auto stem cell transplant (using her own stem cells).  After some time, the patient received 1st Shingrix vaccine.  The patient also received many other vaccines.  The patient reported that, the during her confusion she failed to get the 2nd Shingrix vaccine.  The patient asked, what should she do. The patient had begun having numerous outbreaks of Ramsay-Hunt Syndrome (Shingles affecting the facial nerves) in recent months before reporting.  The patient had been taking 500 mg of Valcyclorir 2 times daily as a preventative since her initial outbreak in 2017.  The patient had mild outbreaks frequently that her physician treated with Prednisone 60 mg for 5 days.  The patient asked was it too late to take the 2nd dose of Shingrix since it had been nearly 5 years since her 1st dose. The patient asked should she just start the series of shots over. The patient was desperately seeking a reprieve from this pain.  The patient mentioned that the (shingles) pain was so intolerable that she wanted to blow her brains out. Suspect product start date was 2017 and suspect vaccine start date was 2019. Till the time of reporting the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments: Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingrix (1st dose and 2nd dose ) and GSK drug Valacyclovir.