Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Disorientation, Drug level, Migraine, Muscle spasms
Clinical narrative: migraines; seizure; seizure; disoriented; Muscle spasms; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration in the left arm on 07Apr2021 12:00 (Batch/Lot Number: EW0151) at the age of 21-years old as dose 1 single for covid-19 immunisation. Medical history included hereditary seizure. Concomitant medication included valproate semisodium (DEPAKOTE) taken for seizure, start and stop date were not reported. On 25Apr2021, the patient experienced seizure; migraines and muscle spasms on unspecified date in May2021. She was disoriented and unable to request an ambulance, someone drove her to the hospital. She was admitted to the hospital 25Apr2021 for observation and discharged 26Apr2021. She reported that her seizures never goes away, it is ongoing but it is improved; she is not having grand mal seizures. The patient was admitted for the second time because she was getting migraines, she was admitted for a day; maybe two weeks after the 25Apr2021 seizure, maybe in May2021, she is unsure of the exact date. Adds the migraines came after the last seizure; every time she has a seizure she has something new and this time it was migraines and muscle spasms. After the first admission they adjusted her mediation levels. At the first admission she was given 1000 mg valproic acid by IV; states it is the same as Depakote; and then she was discharged on 500mg Depakote twice daily. The second admission was because she was getting migraines; at that admission they reduced her daily dose of Depakote to 750mg and added 10mg sumatriptan; and Baclofen muscle spasms. Adds the second admission the valproic acid was pretty much an overdose so her Depakote level was a little high. It had been on average 60 to 70 but it was 120. Adds she thinks that caused the migraine. She has had it re-tested since May2021 and it is now normal at 70. The patient reported that she was scheduled to receive her second dose on 28Apr2021 however she never received it because she had a seizure on 25Apr2021. She reports that before this she has not had a seizure in about 10 years. The patient had to restart her ongoing treatment for seizures. States since she had not had a seizure for ten years she was not going to the doctor; but now she has to see a neurologist and has had to adjust her medications. Adds she has had hereditary seizures all her life. The events seizures, disoriented and migraines required emergency room and physician office visit. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Seizure, Disease recurrence, Disorientation, Migraine, and Muscle spasms and BNT162B2.  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.