Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Loss of consciousness
Clinical narrative: passed out (head flew back)/her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS; HA/Headache; nausea; dizziness; elevated BP; This is a spontaneous report received from a contactable nurse from Pfizer sponsored program. This is first of three report. An 18-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8727; Expiry Date: 31Jul2021), via an unspecified route of administration on 17Jun2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 on an unknown date for COVID-19 immunisation and had no reaction. On 17Jun2021, patient experienced passed out (head flew back)/ her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS and had HA/ headache, nausea, dizziness and elevated BP. About 10 minutes after the injection, patient started complaining of a headache, nausea and dizziness. She got to the point where she had appeared to pass out when she was sitting. The observation nurse was with her when she had complained of the headache, nausea and being dizzy and then her head went back to where she appeared to of lost consciousness for about 10 seconds. After that 10 seconds she was responsive again but she was still complaining of a headache, nausea and dizziness until the EMS arrived. Reporter stated that they have been administering this particular lot number at that location for about 2 weeks now without any incidents until today all of a sudden. 2 of the patient's reactions were kind of typical reactions that they have seen in the past. No further details provided about reactions in the past. The other one (reported in report 1 of 3) that had to be treated with an epinephrine (EPIPEN) was a pretty significant reaction and they have never had multiple reactions back to back like this. Reporter seriousness for events, her head went back to where she appeared to of lost consciousness for about 10 seconds and then they called EMS, complaining of a headache, nausea and dizziness were reported as not serious. Verbatim event relatedness: COVID vaccine: her head went back to where she appeared to of lost consciousness for about 10 seconds, complaining of a headache, nausea and dizziness were unrelated. Seriousness: She would even call it a mild to moderate reaction. She thinks that she would of been fine without medical intervention. She was okay during the time in observation without actual medical intervention other than helping to calm her down and that type of thing. Causality: She doesn't think the COVID vaccine caused the reaction necessarily. She thinks it may of been anxiety induced symptoms. The outcome for events headache was unknown and for other events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship, there is reasonable possibility of causal association between the event Loss of consciousness, Headache, nausea, Dizziness, Elevated BP  and the suspect drug 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.