VAERS ID: 1761181

Description

tonic crisis, no sphincter release; Glasgow Coma Scale 9 / 7; very depressive; headache; malaise; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and fetus/baby. This is a maternal report. A 16-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: 29235BD), via intramuscular, administered in arm right on 01Sep2021 at 10:00 AM as DOSE 1, SINGLE for covid-19 immunisation at other facility. No other diagnosed illness/medical history/chronic health conditions. No allergy to any medications, food or other products. There were no concomitant medications. The patient was pregnant at the time of vaccination. Gestational period was 16 weeks. It was unknown if the patient received any other vaccines within 4 weeks prior to covid-19 vaccine. No other medications or products were taken within 2 weeks of vaccination. On 19Sep2021 at 12:00 PM, the patient was transferred from certain hospital with a history referred by the transfer physician that the patient was admitted to the hospital with tonic crisis, no sphincter release with Glasgow Coma Scale 9; medicated with diazepam one ampoule intravenous and 1 ampoule intramuscular, phenytoin 4 ampoules and came transferred. Here, patient admitted on Glasgow Coma Scale: 7 (1-2--4), mydriatic pupils, poorly photoreactive. According to the patient's mother and father, the patient has never had a convulsive seizure, was previously healthy, was pregnant for 20 weeks, with up-to-date prenatal care, but very depressed. They denied knowledge of the use of medications or drugs. Mother asked about the beginning of symptoms (malaise and headache) coincident with the Pfizer COVID vaccine, the pharmacist informed that all diagnosis are possible and it is important to let the patient stable". The event resulted in visit to emergency room/department or urgent care; hospitalization. The hospital stay was for 7 days. The patient underwent lab tests and procedures which included coma scale: 9, coma scale: 7 (1-2--4) mydriatic pupils, poorly photoreactive on an unspecified date. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient had been tested for covid-19 since the vaccination it was unknown. Therapeutic measures were taken as a result of tonic crisis, no sphincter release and glasgow coma scale 9 / 7. The outcome of the events was recovered on an unspecified date, very depressive, headache, malaise was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events of Tonic seizures and Glasgow coma scale abnormal cannot be ruled out. 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.

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