Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Urticaria
Clinical narrative: hives; itchy; legs looked as if they were bruised; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982 and expiration date: unknown), via intramuscular route on 23Feb2021 at 09:00 (at the age of 27-years) as 2nd dose, single dose in left arm for COVID-19 immunization; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration on 05Mar2021 (Lot number: unknown), as single dose for immunization; and varicella zoster vaccine (VARICELLA VACCINE), via an unspecified route of administration on 05Mar2021 (Lot number: unknown) as single dose for immunization. The patient medical history included: attention deficit hyperactivity disorder (ADHD), gastrooesophageal reflux disease (GERD), and anxiety. No other vaccine in four weeks. Concomitant medications included: amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), sertraline hydrochloride (ZOLOFT), and omeprazole magnesium (PRILOSEC). The patient previously received first dose of BNT162B2 (lot number: EL9261) on 02Feb2021 at 09:15 (at the age of 27-years) via intramuscular route as 1st dose, single dose in left arm for COVID-19 immunisation and Bactrim for an unspecified indication and had known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 06Mar2021 at 12:00, the patient experienced hives, itchy, and legs looked as if they were bruised. The events resulted in visit to emergency room/department or urgent care. Clinical course of the events included: she got a Tdap and Chicken pox vaccine on Friday 05Mar2021 which was before the two weeks mark of her second COVID vaccine. The pharmacist did not ask if she had gotten any shots beforehand so she completely forgot that she probably should not have gotten these vaccines. She ended up having an allergic reaction to these vaccines. She broke out in hives, got itchy, and her legs looked as if they were bruised. She was told to report this by the emergency room (ER) staff and her pharmacist. The events were treated with methylprednisolone tablets. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events hives, itchy and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event contusion and the suspect drug BNT162B2 cannot be 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.