Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product use issue, Restlessness, Sensory disturbance, Sleep disorder
Clinical narrative: sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.