Adverse Event Reporting
| VAERS ID | 1477212 |
|---|---|
| Gender | Female |
| Age | 95 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY5420 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-16 |
| Condition | Died |
Symptoms
- Computerised tomogram
- Colitis ischaemic
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Dementia Alzheimer's type; Hypertension; Late effects of cerebral infarction; Type 2 diabetes mellitus
Other Medications
REZALTAS; BISONO; BUFFERIN [ACETYLSALICYLIC ACID]; TRAZENTA; AMLODIPINE; RISPERIDONE; MAGNESIUM OXIDE; ISOSORBIDE; LASIX [FUROSEMIDE]; SPIRONOLACTONE; BELSOMRA
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210616; Test Name: Abdominal CT; Result Unstructured Data: Test Result:large amount of gas; Comments: large amount of gas in the portal vein and pneumatosis in the small intestine and the ascending colon
Write-up
Ischaemic enterocolitis; This is a spontaneous report from a contactable physician received via the Agency.
The patient was a non-pregnant 95-year-old female.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient received olmesartan medoxomil/azelnidipine (REZALTAS), bisoprolol (BISONO tape), acetylsalicylic acid (BUFFERIN), linagliptin (TRAZENTA), amlodipine, risperidone, magnesium oxide, isosorbide (ISOSORBIDE tape), furosemide (LASIX), spironolactone, and suvorexant (BELSOMRA) within 2 weeks of vaccination.
Prior to vaccination, the patient was not diagnosed with COVID-19.
The patient had no allergies to medications, food, or other products.
Other medical history included dementia Alzheimer's type, type 2 diabetes mellitus, hypertension and late effects of cerebral infarction.
On 15Jun2021 at 09:30 (the day of vaccination), at the age of 95 years old, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital.
On 16Jun2021 at 13:30 (1 day after the vaccination), after lunch, vomiting was noted.
Abdominal CT showed large amount of gas in the portal vein and pneumatosis in the small intestine and the ascending colon which suspected necrosis of the small intestinal and the ascending colon.
The patient experienced ischaemic enterocolitis.
Treatment including drip infusion and administration of antibiotic was performed.
On 18Jun2021 (3 days after the vaccination), the patient died.
The event resulted in prolonged hospitalization/death.
The cause of death was ischaemic enterocolitis.
An autopsy was not performed.
Since the vaccination, the patient has not been tested for COVID-19.
Outcome of the event ischaemic enterocolitis was fatal.
; Sender's Comments: Based on the close temporal relationship, the association between ischemic enterocolitis with COMIRNATY use can not be fully excluded.
Advanced age may have been contributory as well.
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.
; Reported Cause(s) of Death: Ischaemic enterocolitis