Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Magnetic resonance imaging abdominal, Magnetic resonance imaging hepatobiliary, Paralysis, Speech disorder
Clinical narrative: wasn't able to speak/was speaking and then couldn't form words; wasn't able to move her extremities/body wouldn't respond; liver enzymes were elevated; couldn't blink; This is a spontaneous report from a contactable other healthcare professional (patient's parent). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years-old, via an unspecified route of administration on 13Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years-old, via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. 5 days after the second dose of vaccine, it was while they were driving home from vacation, everything was good, the patient was talking then the patient was not able to speak but knew what she wanted to say but couldn't say what she wanted, kind of stroke like. She tried to get her to try to say a word, and she couldn't, then tried to see if she could say the letter A and she couldn't say it or other letters of the alphabet or say something and that lasted several minutes. She says it was over several minutes before, and then she became to where she was alert but her couldn't move anything for her body. She was not able to move her extremities and could not blink. After twelve hours after these complaints started, she was able to speak, blink her eyes, move her legs and arms. After thirteen hours after these complaints started, she was able to move her legs. The reporter stated that her daughter was taken to the ER and reports that her liver enzymes were elevated which lasted a couple weeks. They went to the ER, they were ruling out a stroke since that looked pretty suspect for that. The reported said that they did labs and found out her liver enzymes were very elevated, and they have no idea if one had to do with the other. She says that they did an ultrasound but couldn't find anything, and everything seems well now, she was getting better, they just want to make sure it doesn't happen again if it was related to vaccine, and she doesn't know what should be done if a booster vaccine were to be needed. The patient's labs were done in February and her liver enzymes were completely normal, no problem with it. The patient spent the night in ICU then she did get to go home the next day because she was speaking, and the movement resolved. They couldn't figure out why that was. They were supposed to follow up with other physicians and have an appointment with neurology and a GI doctor for the liver enzymes. So far they are not able to explain why this happened. The only other thing that happened that was different was that her the patient got the vaccines. The reporter would like to know if there have been any other reports for something like that, and that she almost wishes there was, because then they would have a logical explanation for what happened. The patient underwent lab tests and procedures which included CT scan, MRI, an ultrasound of the liver and abdomen, and blood work. She says those tests were done 18Jul2021 and 19Jul2021 while the patient was in the hospital. The patient has been back to normal, she was neurologically back to normal, and sees a neurologist the next day. She had additional labs drawn on 23Jul2021 and those liver enzymes were even higher than before, so they were going up. At her next appointment which she had 30Jul2021, the reporter asked for the labs to be redrawn again, and now they are significantly improved though one was still on the high side, definitely high but not near what it was. She says everything else was back to normal range, so whatever liver injury there was seems to be mending. The outcome of the event liver enzymes were elevated was recovering while other events was recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.