Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase, Aspartate aminotransferase increased
Clinical narrative: tonic-clonic seizure; ALT and AST were around 150/ they were 3 times the normal range; ALT and AST were around 150/ they were 3 times the normal range; had some shoulder soreness; soreness in arm after injection; Tired and his appetite was down; Tired and his appetite was down; This is a spontaneous report from a contactable physician via Medical Information Team. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 13Jul2021 as dose 1, single (at the age of 16-years-old) for COVID-19 immunization. Patient medical history included seizure from Apr2021 to an unknown date, seizure disorder (Epilepsy) from an unknown date and unknown if ongoing (maternal great aunt had a seizure disorder when she was tired or stressed). Physician stated that there was a family history that included maternal grandfather pancreatic cancer, paternal grandfather pancreatitis, mom had one single seizure one time. The patient did not receive any other product prior to COVID-19 vaccine. Stated that his patient, a 16-year-old male, experienced a seizure in Apr2021, but it was nothing that prompted starting medication. Patient then received the Pfizer Covid-19 vaccine on 13Jul2021 and had some shoulder soreness, soreness in arm after injection, but then on 18Jul2021 (5 days after his first dose) the patient had a tonic-clonic seizure. He stated the patient had no enlarged liver on exam. He stated the patient ALT and AST were around 150, but he is not sure of the exact value, but they were 3 times the normal range on 18Jul2021. Stated he had been searching for information on how the vaccine affects liver function or adverse effects on the liver. He stated the patient was also due for his next vaccine tomorrow. He stated he was a physician, all his searches returned no results stated he met his patient in early Apr2021, at that point he had had a brief unprovoked seizure, stated he noticed at that time he had a chemical panel that was unremarkable and with a single provoked seizure he did not usually start medication but enough information on imaging that he thought there could be something going on, stated the patient had blood work done on 27Apr2021, transaminase ALT and AST were about 20 each, prolactin level 30 something, a little high, no exact values known at this time. He stated the patient on 13Jul2021 had first Pfizer Covid shot, stated he reported a little bit of shoulder soreness not much else, stated 5 days later on 18Jul2021 the patient experienced a tonic clonic seizure, 5 days after vaccine, stated   the patient went to ER, noticed the labs they drew at this time his ALT, AST were about 150, exact values unknown, stated this was close to three times the top of normal levels, at the time of that seizure he stated he started the patient on Keppra, stated this medication did not usually change liver function or make people tired, stated the patient was complaining of being a little tired and his appetite was down on an unspecified date in 2021. He stated the patient was due for his next shot tomorrow, a chem panel today which had not been done yet, clarified it had been done but it had not been resulted yet, stated there was no information he can find about the vaccine causing any liver adverse effects, thinking it was coincidental, nothing to tell him it was not coincidental, would like any information about the vaccine and liver adverse events. The patient underwent lab tests and procedures which included alanine aminotransferase: about 150 on 18Jul2021 they were 3 times the normal range, aspartate aminotransferase: about 150 on 18Jul2021 they were 3 times the normal range. The outcome of all the events was reported as unknown at this time of the report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the event generalized tonic clonic seizure and other reported events and the suspect drug BNT162B2.   Consider also possible contributory effects from patient's pre-existing risk factors, namely, Epilepsy. 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.