Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Head injury, Headache, Heart rate increased
Clinical narrative: Feeling feverish; Lightheaded/Dizzy; Passed out / Eyes rolled up/ unconscious; Hit head; Back of head and upper neck area felt painful; too weak to be able to get up and walk; Back of head and upper neck area felt painful; HR: 112; This is a spontaneous report from a contactable physician reported for herself. A 29-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: EL3249), via intramuscular on 20Jan2021 on the left arm at a single dose for COVID-19 immunisation at the hospital. The patient medical history was not reported. The patient has no allergy to medications, food or other products. Concomitant medication included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231), on 30Dec2020 via intramuscular on the left arm at the age of 29 years for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021, patient woke up around 6am feeling feverish. Patient went to use the bathroom, and after patient washed her hands patient walked towards the bathroom door where patient felt light-headed and dizzy. Patient passed out and hit her head on the tile floor. Luckily, her parents heard the loud noise and found the patient lying on the floor with her eyes rolled up, unconscious. Patient did regain consciousness on her own. Patient drank some water, which had a bit of salt and sugar mixed in it. Patent felt too weak to be able to get up and walk, and the back of her head and upper neck area felt painful. Patient told her parents to call 911 as she wanted to make sure that there was no serious injury to her brain/neck. Patient was taken to the ER via ambulance, where her temperature was at 99.5-101F and heart rate (HR) at 112. The patient was given 2L Saline The following tests were done EKG, CT scan of head/neck/spine, bloodwork (CBC/BMP/D-dimer), 2 COVID tests (Nasal swab on 21Jan2021 with negative results and rapid antigen on 21Jan2021 with negative results), chest Xray, doppler ultrasound, Holter monitor, and Doppler ultrasound was unknown. The patient was admitted to the hospital for 1 day. The patient was given 2L Saline fluids in response to the events. The outcome of the events was recovered on an unspecified date in 2021.; Sender's Comments: Based on a compatible temporal relationship causality between reported events and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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.