Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Speech disorder, Tremor
Clinical narrative: increasing symptoms of preexisting myasthenia gravis.; was unable to swallow / have gotten worse / it now takes 45 minutes to eat dinner; speech have gotten worse / speech / are still worse; speech have gotten worse / speech / are still worse; now takes 45 minutes to eat dinner; received her first dose of Shingrix and flu vaccine in same (right) arm on 13 JAN 2021; body shakes; pain racing up and down her legs; body aches; could not lift her right (injected) arm; This case was reported by a consumer via call center representative and described the occurrence of myasthenia gravis aggravated in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included herpes zoster (had shingles). Concurrent medical conditions included myasthenia gravis. Concomitant products included mycophenolic acid (Mycophenolate) and prednisone.   On 13th January 2021, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season. On 13th January 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced tremor, leg pain, general body pain, injected limb mobility decreased and vaccine administered at inappropriate site. On 1st February 2021, the patient experienced myasthenia gravis aggravated (serious criteria GSK medically significant), dysphagia aggravated, speech disorder, condition aggravated and activities of daily living impaired. On 16th January 2021, the outcome of the tremor, leg pain, general body pain and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the myasthenia gravis aggravated, dysphagia aggravated, speech disorder, condition aggravated and activities of daily living impaired were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the myasthenia gravis aggravated, tremor, leg pain, general body pain, injected limb mobility decreased, dysphagia aggravated, speech disorder, condition aggravated and activities of daily living impaired to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The reporter reported for herself. The patient received dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season in the right arm. The patient experienced body shakes, pain racing up and down her legs and body aches and could not lift her right (injected) arm. These resolved after 3 days. 2 weeks after the injection of Shingrix and flu (around 1st February 2021) the patient experienced increasing symptoms of preexisting myasthenia gravis. The patient was unable to swallow mycophenolate pills. Her swallowing and speech have gotten worse, it now takes 45 minutes to eat dinner. The prednisone dose had been increased but speech and swallowing are still worse. The patient's neurologist stated that, the patient would not get the second dose of Shingrix until all symptoms of worsening myasthenia gravis have gone away. The reporter consented to follow up.