Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dehydration, Diarrhoea, Palpitations, Pyrexia
Clinical narrative: Vomiting for 1 day; Severe diarrhea for 6 days and still now after 6 days; Fever for 4 days; Slight pressure center of chest for 4 days; Palpitations for 5 days; Severe dehydration for 5 days; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 16:00 as dose number unknown (booster), single (Lot number: C-H9702) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported and no known allergies. There were no concomitant medications. Also, no other medications in two weeks and no other vaccine in four weeks. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: PYREXIA (medically significant) with onset 10Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Fever for 4 days"; PALPITATIONS (medically significant) with onset 10Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Palpitations for 5 days"; DEHYDRATION (medically significant) with onset 10Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Severe dehydration for 5 days"; DIARRHOEA (medically significant) with onset 10Sep2022 at 06:00, outcome "not recovered", described as "Severe diarrhea for 6 days and still now after 6 days"; CHEST DISCOMFORT (medically significant) with onset 10Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Slight pressure center of chest for 4 days"; VOMITING (medically significant) with onset 10Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Vomiting for 1 day". The events "vomiting for 1 day", "severe diarrhea for 6 days and still now after 6 days", "fever for 4 days", "slight pressure center of chest for 4 days", "palpitations for 5 days" and "severe dehydration for 5 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: At hospital. Therapeutic measures were taken as a result of vomiting, diarrhoea, pyrexia, chest discomfort, palpitations, dehydration.  Clinical Course: AE treatment: IV fluids, potassium, anti-nausea. Patient did not had COVID prior vaccination. COVID was tested post vaccination.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on the available information, the reported serious events vomiting, diarrhoea, pyrexia, chest discomfort, palpitations, dehydration cannot be excluded for the suspect drug BNT162b2. The follow-up information received does not alter the previous company clinical evaluation. 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.