Reporte zur Charge 32D308N

Symptomtext

multiple Hives over entire body; Shortness of breathe; acute asthma attack(s); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:30 (Lot number: 32D308N) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vascular Ehlers-Danlos disease" (unspecified if ongoing); "hypermobility Ehlers danlos disease" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Cardiac syncopy" (unspecified if ongoing); "Bilat renal cell carcinoma" (unspecified if ongoing); "Lesions to skull bones" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: ANGIOEDEMA (medically significant, life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "multiple Hives over entire body"; DYSPNOEA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "Shortness of breathe"; ASTHMA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "acute asthma attack(s)". The events "multiple hives over entire body", "shortness of breathe" and "acute asthma attack(s)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, dyspnoea, asthma. Clinical Course: The patient did not receive any other vaccine in four weeks. The patient had not Covid prior vaccination. The patient had Covid tested post vaccination. The patient had healthcare providers not to receive the vaccine due to co morbidities but was forced to by employer or lose job. The patient had known allergies. The patient received treatment for adverse event. The physicians appt multiple inhalation thereapies.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Angioedema, Dyspnoea, Asthma and 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.