Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Nasal oedema, Urticaria
Clinical narrative: Severe hives-large, confluent over trunk, UE and LE bilaterally, neck and face; Eyes, nose and lips swollen; Eyes, nose and lips swollen; Eyes, nose and lips swollen; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 09:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "multiple stinging insect bites", start date: 25Sep2022 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 20Sep2022 as dose number unknown, single; PREVNAR 23 taken for immunisation, on 20Sep2022 as dose number unknown, single; ESTROGEN; PROGESTERONE; CALCIUM;VITAMIN D NOS; FLAX SEED OIL. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE , Batch/Lot No: FM7553 , Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Jun2022, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Batch/Lot No: FE3590, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Oct2021, when the patient was 64-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EK4176, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 07Jan2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FH9899, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 17Dec2020, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: EYE SWELLING (life threatening), LIP SWELLING (life threatening), NASAL OEDEMA (life threatening) all with onset 04Oct2022 at 13:00, outcome "recovered" (Oct2022) and all described as "Eyes, nose and lips swollen"; URTICARIA (life threatening) with onset 04Oct2022 at 13:00, outcome "recovered" (Oct2022), described as "Severe hives-large, confluent over trunk, UE (upper extremity) and LE (upper extremity) bilaterally, neck and face". The events "severe hives-large, confluent over trunk, ue and le bilaterally, neck and face" and "eyes, nose and lips swollen" required physician office visit. Therapeutic measures were taken as a result of urticaria, eye swelling, lip swelling, nasal oedema. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies previously. Facility type vaccine was pharmacy or drug store. On 04Oct2022 13:00, the patient experienced severe hives-large, confluent over trunk, UE and LE bilaterally, neck and face, and eyes, nose and lips swollen. The patient had no respiratory difficulties. The patient received methylprednisolone (MEDROL), diphenhydramine hydrochloride (BENADRYL) for treatment.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event EYE SWELLING , LIP SWELLING, NASAL OEDEMA , URTICARIA 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.