Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: splotchy rash that started on both of her arms; she was not ok, and she felt weird, and stated something feels wrong; she felt dizziness and like she needed to pass out; she felt dizziness and like she needed to pass out; her knees buckled and she lost her balance; her knees buckled and she lost her balance; hyperventilating and couldn't slow her breathing from fear; hyperventilating and couldn't slow her breathing from fear; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK5730, via an unspecified route of administration in right arm on 21Dec2020 16:30 at a single dose for COVID-19 immunization.  Medical history included bilateral mastectomy, total hysterectomy, breast cancer gene 2 (brca 2), ankylosing spondylitis (AS), allergies to penicillins and latex. The patient was not pregnant at the time of report. Concomitant medications included isotretinoin, estrogens conjugated (PREMARIN), cetirizine hydrochloride (ZYRTEC), meloxicam.  The patient previously took ciprofloxacin and experienced allergies. On 21Dec2020 at 16:45, the patient reported that she showed a nurse a splotchy rash that started on both of her arms. At that time, she also stated she was not ok, and she felt weird, and stated something feels wrong. Then she said that she felt dizziness and like she needed to pass out. The nurse asked if she could still breathe and she said "I think so."  They asked her to stand then when she did her knees buckled and she lost her balance and was dizzier and more fell back into the chair she was sitting in. Then they just lift her onto the gurney.  On the way to the emergency department, she began hyperventilating and couldn't slow her breathing from fear. Upon arrival she was asked for her name and birthdate and she slowly was able to say it. She was told she was given epinephrine, 2 rounds she thinks for her hives that had showed and her respiration was in the 39-49 range. Then they gave her methylprednisone (reported as "methypedisone"), famotidine (PEPSID), and steroids, and lorazepam (ATIVAN) to calm her breathing as well as IV fluids. Then she was able to breathe 20-35 rpm. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The patient recovered from the events.; Sender's Comments: The patient had medical history included allergies to penicillins and latex., and to ciprofloxacin. The reported events were probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. Patient's drug allergy history and nervousness may have played to contribution role to the clinical manifestations.  This case will be reassessed should additional information become available.  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.