Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out and I did it right when I got to my house; I felt like I was gonna pass out and I did it right when I got to my house; She was lightheaded and extremely dizzy; huge headache; arm didn't hurt when she got the shot but 30 minutes later it hurt so bad; throat hurt extremely bad; This is a spontaneous report from a contactable health professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 11Jan2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to latex, oranges, and adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), hydroxyzine and celecoxib (CELEXA). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Her arm didn't hurt when she got the shot but 30 minutes later, on 11Jan2021 at 15:30, it hurt so bad. On 18Jan2021 at 15:00 (also reported as the Monday of the vaccination), the patient experienced a feeling like she was going to pass out, at cheer practice, and did it right when she got to her house. She was lightheaded and extremely dizzy the whole time at practice and had a huge headache. Also, when she got to practice at on 18Jan2021 at 15:15, she noticed the rashes on her arm getting worse, and on her chest and then on her legs. Then, on an unknown date in Jan2021, her throat hurt extremely bad, so she gargled with salt water and it felt a little better. The patient was not treated for the events "I felt like I was gonna pass out and I did it right when I got to my house", "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad"; and was treated for "throat hurt extremely bad" as the patient gargled with salt water. Since the vaccination, the patient had been tested for COVID-19 via rapid nasal swab on 18Jan2021 with a negative result. The clinical outcome of "I felt like I was gonna pass out and I did it right when I got to my house" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad" was unknown; of "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs", "throat hurt extremely bad" was resolving.   Information on the lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of pass out cannot be fully 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. 40.~