Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Feeling abnormal, Gastrointestinal inflammation, Headache, Noninfective encephalitis
Clinical narrative: Pancreas; GI inflammation; Heart palpitations; Brain swelling and inflammation; Brain swelling and inflammation; Fog; Headaches; Every organ in my body is failing; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 10:30 (Lot number: Ew7101) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: I am now after the vaccine. 28 foods including eggs" (unspecified if ongoing), notes: Known allergies: I am now after the vaccine. 28 foods including eggs; "Known allergies: I am now after the vaccine. 28 foods including eggs" (unspecified if ongoing), notes: Known allergies: I am now after the vaccine. 28 foods including eggs. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, lot number: En6206, administration time: 08:30 AM, vaccine location: Left arm), administration date: 09Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: PANCREATIC DISORDER (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "Pancreas"; GASTROINTESTINAL INFLAMMATION (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "GI inflammation"; PALPITATIONS (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "Heart palpitations"; BRAIN OEDEMA (hospitalization, disability, life threatening), NONINFECTIVE ENCEPHALITIS (hospitalization, disability, life threatening) all with onset 03May2021 16:30, outcome "not recovered" and all described as "Brain swelling and inflammation"; FEELING ABNORMAL (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "Fog"; HEADACHE (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "Headaches"; ORGAN FAILURE (hospitalization, disability, life threatening) with onset 03May2021 16:30, outcome "not recovered", described as "Every organ in my body is failing". The patient was hospitalized for pancreatic disorder, gastrointestinal inflammation, palpitations, brain oedema, noninfective encephalitis, feeling abnormal, headache, organ failure (hospitalization duration: 1 day(s)). The events "pancreas", "gi inflammation", "heart palpitations", "brain swelling and inflammation", "brain swelling and inflammation", "fog", "headaches" and "every organ in my body is failing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of pancreatic disorder, gastrointestinal inflammation, palpitations, brain oedema, noninfective encephalitis, feeling abnormal, headache, organ failure. No other vaccine in four weeks. No Other medications in two weeks.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.