Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Insomnia, Muscular weakness, Nausea
Clinical narrative: Difficulty sleeping; Numbing yet tingling sensation / Shoulders and extended down to fingertips; Numbing yet tingling sensation / Shoulders and extended down to fingertips; Chills; Tremors / Shaking; Overwhelming amount of fatigue; Nauseated; Muscles felt uncontrollable/ arms uncontrollably thrashing and flailing; Feeling dehydrated; Difficulty picking up things / Difficulty holding onto items / Lack of muscle strength; Arms uncontrollably thrashing and flailing almost like having a seizure; Feeling pulse in ears; Legs not feeling like they had strength for standing and sustaining bodyweight; Heart racing; Normal body temperature 96.6 F but it was 102.2 F; This case was reported by a consumer via call center representative and described the occurrence of seizure like phenomena in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (several years ago from Premarin). Previously administered products included Premarin. Concurrent medical conditions included fibromyalgia (40 plus years), renal disease (Stage 4 kidney disease from spironolactone) and drug allergy (Reactions and allergies to 50 to 60 prescription medications including spironolactone).   In April 2020, the patient received the 1st dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced seizure like phenomena (serious criteria GSK medically significant), pulsatile tinnitus, difficulty in standing, heart racing, fever, difficulty sleeping, tingling, numbness, chills, tremor, fatigue, nausea, involuntary muscle movement, dehydration and muscle weakness. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the seizure like phenomena, pulsatile tinnitus, difficulty in standing, heart racing, fever, difficulty sleeping, tingling, numbness, chills, tremor, fatigue, nausea, involuntary muscle movement, dehydration and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the seizure like phenomena, pulsatile tinnitus, difficulty in standing, heart racing, fever, difficulty sleeping, tingling, numbness, chills, tremor, fatigue, nausea, involuntary muscle movement, dehydration and muscle weakness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient felt severely nauseated 2 to 3 hours after dose. She tried to eat crackers but couldn't get cracker to mouth due to nausea. She experienced an overwhelming amount of fatigue.  The patient reported almost feeling limp similar to just finishing a war, being used to fatigue due to fibromyalgia and took Tylenol. She described tremors, chills and shaking that had a numbing yet tingling sensation that started at shoulders and extended down to fingertips. Her arms uncontrollably thrashing and flailing almost like having a seizure but being aware and conscious the entire time. She was placing her hands in between knees to control shaking but was unsuccessful in haltering uncontrollable shaking. Tremors and tingling sensation then went from groin and extended to tips of toes. The patient reported her normal body temperature was 96.6 F but it was 102.2 F. The patient reported heart racing and feeling pulse in ears. Cold compresses were applied to head and patient tried to drink ice water. All the reactions reportedly lasted for 24 hours. After 24 hours, the patient reported her muscles felt uncontrollable and feeling dehydrated. Her legs not feeling like they had strength for standing and sustaining bodyweight, difficulty picking up things and difficulty holding onto items. Lack of muscle strength reportedly lasted 24 hours. All symptoms reportedly resolved 48 hours after vaccination. The reporter consented to follow up.