Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Computerised tomogram, Diverticulitis, Escherichia test positive
Clinical narrative: Looked like he was in sepsis; thrombus occluding his IMV protruding into part of the SMV; Thrombocytopenia; Bacteremia with E. Coli; Unable to tolerate diet; Abdominal pain; Nausea; Vomiting; Muscle aches; Chills; Fever; This is a spontaneous report from a contactable physician.   A 36-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 06Apr2021 at 10:00, at the age of 36 years old, for COVID-19 immunization. The patient's medical history included diverticulitis ongoing since 05Nov2018. Concomitant drugs included escitalopram oxalate (LEXAPRO) ongoing since an unspecified date. There were no other vaccinations 4 weeks prior to receiving BNT162b2. Two days after vaccination, on 08Apr2021, the patient developed nausea, vomiting, muscle aches, chills, and fever. The patient continued to have these symptoms and then developed abdominal pain on 11Apr2021, so the patient went to ER. Nausea, vomiting, muscle aches, chills, fever, and abdominal pain were reported as medically significant events. A CT of the abdomen and pelvis was performed on 11Apr2021, which seemed at that time to reveal only uncomplicated diverticulitis. Therefore, the patient was sent home with oral antibiotics. Then, the patient presented back to ER on 14Apr2021: the patient couldn't tolerate his diet and was experiencing worsening of abdominal pain. Another CT of abdomen and pelvis was therefore done on 14Apr2021, which this time revealed a thrombus occluding his IMV protruding into part of the SMV and the portal vein. In light of this finding, on 14Apr2021 the medical staff retroactively looked at the patient's CT scan from 11Apr2021 and they found that the thrombus was already present but less evident than on 14Apr2021. The patient also looked like he was in sepsis, so the medical team was performing a full septic work-up and the patient was hospitalized on 14Apr2021. The patient was terrified, and the medical staff were ruling out acute mesenteric ischemia. On 14Apr2021, blood work showed thrombocytopenia, and a bacteria blood test showed bacteremia with E. Coli. The event thrombus was reported as serious since medically significant, life threatening, and requiring hospitalization. No information regarding seriousness was provided for thrombocytopenia and bacteremia. Treatment with heparin drip was started (ongoing at the time of the reporting) and the patient improved. However, the reporter stated that at the time of the last reporting, all of the patient's symptoms were ongoing, that all of the patient's symptoms had worsened. At the time of the last reporting the patient was in the ICU. The patient had not recovered from the all reported events. The reporter did not know if the reported events were related to BNT162b2, however she added that diverticulitis could also cause all the patient's side effects.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the thrombosis, sepsis and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including MRI of abdomen and vascular angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.