Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Decreased appetite, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes; orange bowel movement; near syncope; lightheaded/lightheadness; chills; body aches; decreased appetite/poor appetite; This is a spontaneous report from a contactable Other-HCP (healthcare professional) in response to HCP letter sent in cross reference case. A 70-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EN6201) intramuscularly on 05Mar2021 (at the age of 70-years-old) as a single dose in the deltoid left for COVID-19 immunisation. Medical history included ongoing HTN (hypertension; onset date: years ago; pertinent details: well controlled) from an unspecified date and menopause from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing hydrochlorothiazide orally taken for HTN from an unspecified date, ongoing estradiol benzoate (ESTRADIOL) vaginal taken for menopause from an unspecified date and ongoing multivitamin orally taken for health maintenance from an unspecified date. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EL9261) intramuscularly on 12Feb2021 as a single dose in the deltoid left for COVID-19 immunisation and experienced sore arms and should injury. Prior vaccinations were reported as none. On 07Mar2021 the patient experienced diarrhea with blood (medically significant), sneezing, watery eyes, orange bowel movement, on 06Mar2021 the patient experienced near syncope, lightheaded/lightheadness, chills, body aches and decreased appetite/poor appetite, on 08Mar2021 the patient experienced fatigue, mild diarrhea, abdominal pain, gas and runny nose. It was reported that the event near syncope was non-serious, did not require treatment. It was also reported that the events near syncope and diarrhea with blood required a visit to the emergency room. The clinical course was reported as follows: "05Mar2021 Vax. 06Mar2021- Lightheadedness onset day after COVID vax #2. Lightheaded, chills, body aches, decreased appetite. 07Mar2021- Sneezing, watery eyes, orange bowel movement, poor appetite, diarrhea with blood. To ER. 08Mar2021- Fatigue, poor appetite, mild diarrhea, abdominal pain and gas, sneezing, runny nose. 09Mar2021- Improved." The patient underwent lab tests and procedures on 07Mar2021 that included: EKG, CBC and comprehensive metabolic panel which were all normal. The clinical outcome of the event near syncope was recovered/resolved on an unspecified date while the clinical outcomes of the events diarrhea with blood, lightheaded/lightheadness, chills, body aches, decreased appetite/poor appetite, sneezing, watery eyes, orange bowel movement, fatigue, mild diarrhea, abdominal pain, gas and runny nose were all unknown.; 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 event Diarrhea bloody cannot be 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.