Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Muscular weakness, Pain, Paraesthesia, Sleep disorder
Clinical narrative: diagnosed with myasthenia gravis; small fiber neuropathy; she couldn't get her breath; Cramping in the muscles; muscle twitching in extremities; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (also the age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 16Mar2021 afternoon, maybe 3:00 or 4:00 pm (Lot Number: EN6208) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Pfizer Covid vaccine, first dose Lot Number / Expiry Date: EM9810 /unknown, Route, Anatomical Location: left arm on 18Feb2021 for COVID-19 immunisation (at the age of 45-years-old) and experienced sore arm. The patient called to report what happened with her because it has been an ongoing medical diagnosis since she had the vaccine. She finally had the diagnosis and knows what is going on. She had the first vaccine on 18Feb2021 and it was fine. She just had a sore arm and it was kind of expected. With the second vaccine, within a week (Mar2021), she had some muscle twitching in her extremities. She initially thought it was just muscle twitching and was no big deal. But then she was experiencing it 90 percent of her day, the twitching. On an unspecified date, there was a really sharp, shooting nerve pain everywhere, from her knees, toes, and legs. It was a sharp, shooting pain that lasted 10-20 seconds at a time. It was an excruciating pain that relax and then shoot somewhere else. On an unspecified date, left arm weakness: She is normally healthy and has worked out her whole life. She was trying to work out and exercise but, after a minute, she could barely lift her arm and was unable to extend it due to weakness. She has been going to the doctors and has had lots and lots of tests since that point. Added that after the second vaccine, finally started doing a CAT of the chest, MRI's and lots of blood work in 2021. The patient has myasthenia gravis and small fiber neuropathy on an unspecified date, all induced by the vaccine. Muscle twitching in extremities: It started at night, about a week after, probably 4 or 5 days after the vaccine. She was on vacation and was twitching. She was up all night with twitching, like little muscle twitching here and there. She was not very concerned and thought maybe it was because she was dehydrated and drank a lot of water. It progressively got worse and when she was sitting still, she could physically see it coming. Cramping in the muscles: It started within that week and a half (Mar2021). In the second week, she woke up and physically see her entire leg muscles moving. It was going to the arm, stomach, it was everywhere. The sharp nerve pain started on an unspecified date. It was an excruciating pain that would come on for 24 hours and was a shooting pain. The weakness was initially noticed most in the left arm, where she did get the vaccine. It was just like she had 3 pound weights and could barely lift it. Normally, she is ok and is healthy and works out. She is being treated and did start 2 weeks ago, for 3 days, a high dose IV steroid. The neurologist was able to confirm the diagnosis and form the treatment plan. She has been living like this for months. It is a high dose steroids. She was just approved for IVIG infusion, immunoglobulin. She will begin starting infusions on that. Seriousness for muscle twitching, cramping and nerve pain: Medically significant for sure. It has changed her life. She was diagnosed with myasthenia gravis and even doing simple things like hanging laundry, she gets tired. She can't work out or anything like that. Test results: Has had many lab tests done, lots and lots of lab tests. They did an EMG, MRI of the brain and neck with infusion, a CAT scan of the chest, a nerve conduction study. Has had multiple labs through out this time. The nerve conduction study was what determined the myasthenia gravis and the blood work. Other labs with unknown results. There were no additional vaccines administered on same date of the Pfizer. Events required a visit to Emergency Room and Physician Office. At one point, she felt like she couldn't sit still. She was still having nerve pain and it felt like she couldn't get her breath. She went to Emergency Room. She was not admitted to the hospital. It was just to the ER and they were trying to get her to definitely see neurology. Outcome of the events was unknown. Events assessed as serious.   Relatedness of drug to reaction(s)/event(s): Source of assessment: Primary Source Reporter Method of assessment: Global Introspection Drug result: Related; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on temporal relationship and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.