Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Off label use, Product use issue, Syncope
Clinical narrative: syncope within 10 min. of injection, episode; BP 70/40 P 40-30 admitted to ICU; BP 70/40 P 40-30 admitted to ICU; Adrenal Crisis; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Left arm on 19Jan2021 at single dose for COVID-19 immunization in hospital; antilymphocyte immunoglobulins (reported as immunoglobulin infusion, concentrate for solution for infusion, lot/batch number and expiration date not provided) via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication. Medical history included CVID (Immunodeficiency common variable), Addison Dx (diagnosis) and Pituitary Tumor. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had syncope within 10 minutes of injection on 19Jan2021, episode, BP (blood pressure) 70/40, P (pulse) 40-30, admitted to ICU in Jan2021, determined adverse event maybe 2nd to immunoglobulin infusion received previous day leading to Adrenal Crisis, 2nd to Addison dx / Pituitary tumor which was unknown at time of vaccination. Events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient had been hospitalized for 6 days in Jan2021. Since the vaccination, patient had not been tested for COVID-19. The action taken in response to the events for antilymphocyte immunoglobulins was unknown. Therapeutic measures were taken as result of the events syncope, BP 70/40, P 40-30 and Adrenal Crisis. The outcome of the events "syncope, BP 70/40, P 40-30, Adrenal Crisis" was recovered in 2021. Patient then received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021.  Pfizer is a marketing authorization holder of antilymphocyte immunoglobulins in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of antilymphocyte immunoglobulins has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT152B2 and antilymphocyte immunoglobulins to the events syncope, low BP and heart rate, adrenal crisis, cannot be excluded. The underlying Addison disease and Pituitary Tumor are major cofounders for the events. 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.