Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Drug ineffective, SARS-CoV-2 test, Seizure
Clinical narrative: anaphylaxis; seizure; hives; Covid test date=19Jan2022, Covid test result=Positive; Covid test date=19Jan2022, Covid test result=Positive; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: Polycystic ovarian syndrome ("PCOS") (unspecified if ongoing); Gastrooesophageal reflux disease ("GERD") (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "known allergies: nuts" (unspecified if ongoing),; "known allergies: figs" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing), all notes: known allergies: shellfish, nuts, figs, pollen, eggs. Concomitant medications included: OMEPRAZOLE; METFORMIN. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "anaphylaxis"; SEIZURE (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "seizure"; URTICARIA (hospitalization, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "hives"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Covid test date=19Jan2022, Covid test result=Positive". The events "anaphylaxis", "seizure" and "hives" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasal Swab: (19Jan2022) positive. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, urticaria, which included epinephrine (EPIPEN). Clinical course: Facility type vaccine: Hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.