Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: Generalised utricaria Upper torso; rash; potential anaphylactic reaction; A 74-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: El1284), via an intramuscular route of administration, administered in right arm on 16Jan2021 09:00 (at the age of 74-year-old) at single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: El 0140SCN), via an intramuscular route of administration, right arm on 27Dec2020 08:00 at single dose for COVID-19 immunization. The patient medical history included hypersensitivity. If there is a previous history of any allergies, does the patient take (or have readily available) any specific medication related to this: Adrenaline (Epipen), Antihistamine. The patient have a history of previous allergies to specific products or conditions indicative of an allergic medications were Sulfa, penicillin, ASA,  The patient did not receive any recent vaccines for any other conditions prior to the event being. The patient did not receive any recent vaccines for SARS-COV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being. The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first attempt and subsequent immunizations if dates of birth or immunizations were not available. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medications included famotidine (FAMOTIDINE), and losartan potassium (Cozzar), hydrochlorothiazide (HCTZ), levothyroxine sodium (Synthroid), omeprazole, amlodipine, taken for an unspecified indication, start and stop date were not reported, and On 11Dec2020, patient received, ibuprofen (advil) for headache (antipyretic use) as oral 23:30 after(as reported). On 16Jan2021 22:00 the patient experienced generalized urticaria upper torso and rash. It was reported that, all the signs and symptoms of the anaphylactic reaction, rash upper 10-12 hrs. The time course of the anaphylactic reaction (potential anaphylactic reaction) was 10-24 hrs after administration. Information on organ involvement: Multiorgan involvement/Dermatological/Mucosal, were  reported that, organ involvement were not respiratory, bilateral wheeze/bronchospasm, stridor, upper airway swelling, respiratory distress, tachypnoea, increased us of accessory respiratory muscle, recission, cyanosis, grunting, dry cough, hoarse voice, difficulty breathing, sensation of throat closure, sneezing, rhinorrhoea, cardiovascular, measured hypotension, shock ,tachycardia, capillary refill time, reduced central pulse volume, decreased level of consciousness, Loss of consciousness,  generalized erythema, angioedema, generalized pruritis with skin rash, generalized pruritis without skin rash, generalized pickle sensation; Localized injection site urticaria, red and itchy eyes, gastro intestinal, diarrhea, abdominal pain, nausea, vomiting. It was dermatological/mucosal generalized urticaria upper torso. The patient received for the event new medication or other treatment were benadril and avil. Treatment period completed. The reactions were not recurred on re-administration of product. It was reported that, reporter does not require medical intervention. The patient was not hospitalized and not seen in the emergency department. The patient not admitted to intensive care unit. Patient was not visited physician office. There were no any laboratory tests or diagnostic studies performed. It was reported, for lack of efficacy, provide information if not included in the initial report. It was unknown primary infection site, and culture performed. The patient provided information regarding the reported adverse event with the use of product. It was reported that considering the Pfizer product has a casual effect to the adverse event and reported that not willing to be contacted again by Pfizer on the reported adverse event. It was reported that, seriousness criteria as no. Causal relationship with the event was reported as yes. The outcome potential anaphylactic reaction generalized urticaria upper torso and rash were recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event "potential anaphylactic reaction" was related to BNT162b2 based on known drug safety profile and close temporal relationship.  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.