Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Diplopia, Dysstasia
Clinical narrative: could not move / legs / had to pick up her thigh (with her arms); I could not walk 12 hours after the shot / not able to properly clean herself/ had to hold onto the wall and dresser so she could walk.; had wicked vertigo; had to urinate / and peed on the kitchen floor; She was not able to properly clean herself or the floor; muscles were so weak she could not stand/ lack of muscle strength; could not stand without assistance; she was afraid (because of this episode); still has "myalgia."; lack of energy; having urinary urgency issues / within 10 minutes she will have to urinate again; lower digestive issues / descending and sigmoid colon are making themselves known; GI upset; wasn't / diarrhea it was/ "oozing 24 hours a day 7 days a week" every time she bent over; had no solid stools during this time; stool to be black.; experiencing double vision.; This case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included multiple sclerosis (in remission for ten years). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date, for tolerance refer case US2020AMR238525). Concurrent medical conditions included immunocompromised (because of the Multiple sclerosis) and gluten sensitivity (eliminated soy, corn, and dairy from diet). Concomitant products included naltrexone.   On an unknown date, the patient received the 2nd dose of Shingrix. In November 2020, less than a year after receiving Shingrix, the patient experienced gastrointestinal upset, fecal incontinence, loose stools, black stools and double vision. On an unknown date, the patient experienced movement disorder, unable to walk, vertigo, urinary incontinence, activities of daily living impaired, muscle weakness, difficulty in standing, fear, myalgia, loss of energy, urinary urgency and lower gastrointestinal disorder. The patient was treated with bismuth subsalicylate (Pepto Bismol). On an unknown date, the outcome of the movement disorder, unable to walk, vertigo, urinary incontinence, activities of daily living impaired, difficulty in standing, fear, gastrointestinal upset, loose stools and double vision were unknown and the outcome of the muscle weakness, myalgia, loss of energy, urinary urgency and lower gastrointestinal disorder were not recovered/not resolved and the outcome of the fecal incontinence and black stools were recovered/resolved.   It was unknown if the reporter considered the movement disorder, unable to walk, vertigo, urinary incontinence, activities of daily living impaired, muscle weakness, difficulty in standing, fear, gastrointestinal upset, fecal incontinence, loose stools, black stools, double vision, myalgia, loss of energy, urinary urgency and lower gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however could be 61 or 62 years. The patient reported she had a significant adverse reaction involving multiple body systems following the 2nd vaccine and would like to discuss it with her physician at their appointment tomorrow. The reporter requested to email the list of ingredients in the vaccine and suspension solution so that they could start discussion about possible remedies. Upon follow received on 1st December 2020 it was reported that the patient had medical history of multiple sclerosis (MS) and had been in remission for ten years. The patient stated that she was immune compromised (because of the multiple sclerosis) but was not taking any immunosuppressant medications. She had gluten sensitivity and had eliminated soy, corn, and dairy from her diet. The patient was a massage therapist for 20 years. The concomitant medications included Naturethyroid, thyroid medication made for the patient by compounding pharmacy using veggie caps. The compounding pharmacy also made the patient Naltrexone low dose 4.5 mg oral (capsules). She took 1 each night and had been taking this since 2013 for her multiple sclerosis and has not had an multiple sclerosis flare in the 7 years since she has been on this product. The patient said that she could not walk 12 hours after the 2nd shot. Around 1 am she got up to go pee and had wicked vertigo. She grabbed onto the door (to stabilizer herself) and urinated quite a bit into the toilet. She said she had to hold onto the wall and dresser so she could walk. As she was trying to walk to the kitchen, to get a glass of water, she could not move her legs. She had to pick up her thigh (with her arms) to move her legs until she got to kitchen sink to get a glass water. Then she had to urinate again and peed on the kitchen floor. The patient's muscles were so weak she could not stand without assistance. She was able to reach a stool and rested on the stool for about 15 minutes. She was not able to properly clean herself or the floor. She said she was afraid because of this episode and was ready to call 911 because she lived alone. The patient eventually made it back to bed without the glass of water. From 13th November 2020 to 25th November 2020, the patient had gastrointestinal upset. She said it was not really diarrhea it was more like an oozing 24 hours a day 7 days a week every time she bent over. She went through many (urinary/sanitary) pads and took Pepto Bismol for 2 days. She would take Pepto each time after having an ooze. The patient had no solid stools during this time and said the Pepto caused her stool to be black. The patient also reported experiencing double vision. The patient was asked her how she was feeling on the day of reporting, if her symptoms had resolved and the patient said that she still had myalgia. She said she still had a lack of muscle strength and lack of energy. Those symptoms were not resolving. The patient said that her stool was no longer black now that she was off of Pepto. She was not having the 24/7 oozing anymore but she still was having some lower digestive issues and she can feel it in her descending and sigmoid colon. The patient said that her descending and sigmoid colon are making themselves known. The patient also said that she was still having urinary urgency issues which was perplexing to her. She said she will urinate and think she had fully emptied her bladder but within 10 minutes she will have to urinate again.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR238525:same patient (1st dose)