Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Gait inability, Herpes zoster, Insomnia, Magnetic resonance imaging
Clinical narrative: Had both doses in 2018, on day 117 of shingles nerve damage/ suspected Vaccination failure; Put into AFIB (atrial fibrillation) by accident; Shingles; Nerve damage; It is just miserable, feels like a cannonball blows out the front of my chest and out the back of my ribs; Can't hardly walk; Can't keep a coherent (thought), just lose it, Can't hardly carry a thought; Severe body pain, chest, ribs, pain just spreads through all the body; Pain is always in one place in my chest; out the back of my ribs; affects nerves in entire body; Can't walk outside; one spot in your chest again; Only able to sleep about 2-3 hours per night; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2018, the patient received the 2nd dose of Shingrix .5 ml. On 22nd June 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), atrial fibrillation (serious criteria GSK medically significant), shingles, nerve damage, feeling abnormal, walking difficulty, thought process disorder, general body pain, chest pain, rib pain, post herpetic neuralgia, unable to walk, spot-like rash and insomnia. The patient was treated with pregabalin (Lyrica), amitriptyline, gabapentin and cannabis oil. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the atrial fibrillation, shingles, nerve damage, feeling abnormal, walking difficulty, thought process disorder, general body pain, chest pain, rib pain, post herpetic neuralgia, unable to walk, spot-like rash and insomnia were not recovered/not resolved.   The reporter considered the vaccination failure, atrial fibrillation, shingles, nerve damage, general body pain, chest pain, rib pain, post herpetic neuralgia and insomnia to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal, walking difficulty, thought process disorder, unable to walk and spot-like rash to be related to Shingrix. The reporter considered the vaccination failure, shingles, nerve damage, general body pain and post herpetic neuralgia to be related to Shingrix. It was unknown if the reporter considered the spot-like rash to be related to Shingrix.     Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: The patient self-reported this case.  The patient had both doses of Shingrix (50 mcg) in 2018.  The patient reported that he was in day 117 of shingles nerve damage. It was just miserable.  Right now, was one of his worse days ever.  It was from the top of head to feet, could not hardly walk.  Could hardly carry a thought. The reporter said such severe body pain it was not funny.  On the days that it gets set off it feels like a cannonball blows out the front of his chest and out the back of his ribs and all you do was try to hold body together but the pain just spreads through all the body. The patient had to at least 9 doctors for this, had blood tests for everything trying to rule out (other conditions). Pain was always in one place in his chest but then when it sets off it affects nerves in entire body. Like on the day of reporting he could not walk outside. He could not make it to barns.  When that happens it usually lasts for about 3 days then it calms down to where just hold the one spot in chest again.  This right now was clear across the front of his body, it was clear across his back, it was up and down his entire body.  When it happens could not hardly keep a coherent (thought), just lose it.  He indicated that he had been to at least 9 doctors (including an orthopedist and a rheumatologist) regarding this.  He was prescribed Lyrica, amitriptyline and gabapentin but had serious side effects from them.  He also tried cannabis oil but that sets the shingles off like crazy.  He said that he was put into AFIB (atrial fibrillation) by accident and was cardioversioned.  He said that he had an MRI (Magnetic resonance imaging) test two days ago that that seems to be had set off his shingles.  Since this happens, he was only able to sleep about 2 to 3 hours per night.  The reporter was consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as the details regarding time to onset and laboratory confirmation for shingles were unknown at the time of reporting.