Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Loss of consciousness, Product dose omission issue, Seizure
Clinical narrative: received his first dose of the Covid Vaccine on 27MAY2021, and he was scheduled for his second dose yesterday, so he already missed the 21 days; lost consciousness; Faint; shaking like a seizure; shaking like a seizure; clammy; patient was hot; This is a spontaneous report from a contactable pharmacist. A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0187, expiration date: Aug2021), dose 1 via an unspecified route of administration, administered in arm left on 27May2021 (age at vaccination 15 years) as dose 1, single for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. As per she knows she did not take any vaccine prior vaccinations (within 4 weeks). On 27May2021 the patient experienced lost consciousness, faint, shaking like a seizure, clammy, received his first dose of the covid vaccine on 27May2021, and he was scheduled for his second dose yesterday, so he already missed the 21 days, patient was hot on 27May2021. Patient reported that he lost consciousness and was shaking like he had a seizure, but the pharmacist states when she saw the patient, he appeared to faint but never lost consciousness and was also clammy but not shaking at all. Also states the patient was hot and clammy and sat for half an hour after the dose and then was fine. Reporter wondering if there are any records of people fainting after receiving the vaccine. The patient had loss of consciousness, and yesterday he came back to get his second dose that was scheduled and went back to the clinic and they decided not to take the second dose, because after the first he experienced shaking with seizure. He drank some cold water and started to feel better and sat there for half an hour and they never mentioned anything about shaking or seizures. Reporter states when she saw his reaction, should thought it was not serious, but the way he describes it, it would be medically significant. The patient not visited emergency room or physician office. The patient did not receive any treatment. The outcome of event received his first dose of the COVID vaccine on 27may2021, and he was scheduled for his second dose yesterday was unknown and for other events the outcome was recovered on 27May2021. Event relatedness: Covid Vaccine: a appeared to faint but she does not think he ever lost consciousness, clammy, but not really shaky, and he was hot, shaking like a seizure, lost consciousness was related.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: The event of  is assessed as possibly related to the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association. 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.,Linked Report(s) : US-PFIZER INC-2021734134 similar report from same reporter