Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Lethargy, Loss of consciousness, Loss of personal independence in daily activities, Nausea
Clinical narrative: Suspected vaccination failure; Almost passed out because my back, side, and hip were covered with blisters; Severe case of shingles; Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae); Blisters broke out; Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae); Could not walk; Could hardly breathe; Could not do (my normal activities); Chills; Nausea; Brain fog; Total lethargy; Fatigue; Right TFL is still firing; Lumbar pain; Abdominal pain; Groin pain; Knee pain; Debilitating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Extremely healthy- no medical issues, take no medications, take no (over-the-counter) drugs did not even take aspirin. The patient teach exercise and wellness classes. She was near perfect health wasn't overly stressed. had a relaxed life. She was very strong and healthy and did not get sick. She had a super immune system. The patient never had Covid. she didn't get flu last year or this year. she had good immunity.  On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: Almost passed out because my back, side, and hip were covered with blisters) (serious criteria GSK medically significant), shingles (Verbatim: Severe case of shingles), post herpetic neuralgia (Verbatim: Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae)), blister (Verbatim: Blisters broke out), pain (Verbatim: Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae)), unable to walk (Verbatim: Could not walk), difficulty breathing (Verbatim: Could hardly breathe), activities of daily living impaired (Verbatim: Could not do (my normal activities)), chills (Verbatim: Chills), nausea (Verbatim: Nausea), brain fog (Verbatim: Brain fog), lethargy (Verbatim: Total lethargy), fatigue (Verbatim: Fatigue), burning sensation (Verbatim: Right TFL is still firing), lumbar pain (Verbatim: Lumbar pain), abdominal pain (Verbatim: Abdominal pain), groin pain (Verbatim: Groin pain), knee pain (Verbatim: Knee pain) and debility (Verbatim: Debilitating). The patient was treated with acyclovir and gabapentin. The outcome of the vaccination failure was unknown and the outcome of the passed out, shingles, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, nausea, lethargy, lumbar pain, abdominal pain, groin pain, knee pain and debility were resolving and the outcome of the chills, brain fog and fatigue were not reported and the outcome of the burning sensation was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the company considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received both the doses of Shingrix vaccine in 2019. The patient did not have the exact dates of the shots but did provide the pharmacy contact information who should have the dates (and lot numbers) on file. A couple of months ago patient came down with a severe case of shingles in 2023 which has not fully resolved. Patient reported that she started having neuralgia pain in right hip down into my groin area. The patient thought she had a hip problem or pulled a muscle because she was active.  This started several months before the blisters broke out. When the blisters broke out she had no warning. She was washing her back and she almost passed out because her back, side, and hip were covered with blisters.  The pain became unbearable, then it was in the right TFL (Tensor Fasciae Latae) area and across her lumbar region, right lower quadrant of abdomen felt like she was having appendicitis. Pain was deep in right groin and radiated into right knee.  Patient husband took her to the emergency room because her was doubled over in pain and could not walk, could hardly breathe.  As soon as they saw the blisters they diagnosed patient with shingles.  Patient did two rounds of acyclovir and they prescribed gabapentin for a month.  The Physician's Assistant told me to cancel everything for the next 3 to 6 weeks and he was correct. It was debilitating.  Patient could not do (normal activities) for almost 2 months. But things were better now the patient was back to teaching, she could mow the lawn, could hike with the dogs. The patient still on the gabapentin.  The patient was much better but still had a shadow of the neuralgia pain and her right TFL was still firing. The blisters cleared up.  They dried up and they just have marks were they were. She also said that during the shingles outbreak she had chills, was under piles of blankets, could not get warm. The shingles outbreak caused her to have chills, nausea, brain fog, and total lethargy.  The reporter asked her if these events had resolved. She said that she still does get chills once in a while.  She gets brain fog and fatigue occasionally, but she could function now. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.