Adverse Event Reporting

VAERS ID	1477211
Gender	Female
Age	89
StateCode	FR
Pharmaceutical Company	PFIZER\BIONTECH
Lot Number	EY5420
Number of vaccinations	1
Vaccinated	2021-06-15
Onset	2021-06-16
Condition	Hospitalized Died

Symptoms

Vomiting
Computerised tomogram
Oxygen saturation decreased
Blood pressure systolic
Flatulence
C-reactive protein
Blood lactate dehydrogenase
Pneumonia
Blood pressure systolic decreased
Computerised tomogram thorax
Blood creatinine
Blood urea
Oxygen saturation
Shock
Colitis ischaemic
Ileus
Gastrointestinal necrosis

Current Illness

Hyperuricaemia; Reflux oesophagitis; Sleeplessness

Preexisting Conditions

Medical History/Concurrent Conditions: Aortic valve stenosis; Atrial fibrillation; Cardiac failure chronic; Dementia; TAVI

Other Medications

LIXIANA; DIART; SPIRONOLACTONE; FEBURIC; DILTIAZEM HYDROCHLORIDE R; LANSOPRAZOLE; DAYVIGO; LUNESTA

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20210617; Test Name: Cr; Test Result: 2.
5 mg/dl; Test Date: 20210617; Test Name: Blood LDH; Result Unstructured Data: Test Result:338 IU/l; Test Date: 20210617; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:50; Comments: 6:00; Test Date: 20210617; Test Name: BUN; Test Result: 44.
2 mg/dl; Test Date: 20210617; Test Name: Abdominal CT; Result Unstructured Data: Test Result:suspected small intestinal necrosis; Comments: it was found small intestinal Ileus and images of portal, intestinal, and gas.
it was suspected small intestinal necrosis.
; Test Date: 20210617; Test Name: Chest CT; Result Unstructured Data: Test Result:pneumonia in the left lung; Test Date: 20210617; Test Name: Blood CRP; Test Result: 6.
4 mg/dl; Test Date: 20210617; Test Name: SpO2; Test Result: 85 %; Comments: O2 1L/min started

Write-up

Ischaemic enterocolitis; small intestinal necrosis; small intestinal Ileus; SpO2 85 %; blood pressure systolic decreased to 50; Images of portal gas, intestinal gas, and intestinal lumen gas; Pneumonia in the left lung; vomiting; shock; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution.
The patient was a non-pregnant 89-year-old female.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
List of any other medications the patient received within 2 weeks of vaccination was included LIXIANA, DIART, Spironolactone, Feburic, Diltiazem, Lansoprazole, DAYVIGO.
The patient was not diagnosed with COVID-19 prior to vaccination.
The relevant medical history and concurrent conditions was provided as Aortic valve stenosis(after TAVI), Atrial fibrillation and Cardiac failure chronic.
The patient had no allergies to medications, food, or other products.
On 15Jun2021 at 13:30, the patient received BNT162B2 (COMIRNATY intramuscular injection, Lot number: EY5420, expiration date: 31Aug2021), via an intramuscular route of administration in arm left as DOSE 1, SINGLE for COVID-19 immunization.
The adverse event onset date was reported as on 16Jun2021 at 20:45 (1 day after the vaccination).
The course of the event was as follows: The patient started vomiting and the state of shock at the night of 16Jun2021.
Through abdominal CT, it was found small intestinal Ileus and there had Portal gas image, it was suspected small intestinal necrosis.
On 17Jun2021, the patient was transferred to PRIVACY hospital.
The event resulted in Emergency room/department or urgent care.
The outcome of the event was not recovered with treatment including Noradrenaline IV drip.
Since the vaccination, the patient had not been tested for COVID-19.
List of any other medications the patient received within 2 weeks of vaccination was included edoxaban tosilate (LIXIANA) orally from an unspecified date to 17Jun2021 for atrial fibrillation, (DIART) orally from an unspecified date to 17Jun2021 for cardiac failure chronic, spironolactone (SPIRONOLACTONE) orally from an unspecified date to 17Jun2021 for cardiac failure chronic, febuxostat (FEBURIC) orally from an unspecified date to 17Jun2021 for hyperuricaemia, diltiazem) orally from an unspecified date to 17Jun2021 for hyperuricaemia, diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE R) orally from an unspecified date to 17Jun2021 for atrial fibrillation, lansoprazole (LANSOPRAZOLE) orally from an unspecified date to 17Jun2021 for gastric ulcer prophylaxis (reflux oesophagitis), lemborexant (DAYVIGO) orally from 08May2021 to 17Jun2021 for sleeplessness, and eszopiclone (LUNESTA) orally from 08May2021 to 17Jun2021 for sleeplessness.
The relevant medical history and concurrent conditions was provided as Aortic valve stenosis (after TAVI on 17Jan2020), Atrial fibrillation, Cardiac failure chronic, dementia, ongoing hyperuricaemia, ongoing reflux oesophagitis, and ongoing sleeplessness.
It was unknown if the patient had family history.
Relevant lab tests on 17Jun2021 included blood C-reactive protein (CRP) (mg/dL, reference range 0.
0-0.
3): 6.
4, blood LDH (IU/L, reference range 110-220) 338, Blood urea (BUN) (mg/dL, reference range 8.
0-20.
0): 44.
2, creatinine (Cr) (mg/dL, reference range 0.
46-0.
8): 2.
5, Chest CT: pneumonia in the left lung, abdominal CT: images of portal gas, intestinal gas, and intestinal lumen gas.
On 17Jun2021 (2 day after the vaccination), (the event term ischaemic enterocolitis with onset date 17Jun2021 was reported).
The event ischaemic enterocolitis resulted admission to hospital (from 17Jun2021 to 24Jun2021) and intensive care unit (ICU).
On 24Jun2021 (9 day after the vaccination), the patient died.
It was unknown if an autopsy was performed.
The outcome of ischaemic enterocolitis was fatal.
The physician classified the event as serious (hospitalisation) and assessd that causality between the event ischaemic enterocolitis and BNT162B2 was unassessable (the patient was treated at another hospital).
The following was added to the course: After admission, the patient sometimes vomited after meals.
On 15Jun2021, the patient received the first dose of BNT162B2.
On 16Jun2021 at around 20:00, the patient started vomiting.
On 17Jun2021 at 6:00, the blood pressure systolic decreased to 50.
O2 administration was started.
On the CT test result, small intestinal necrosis was suspected, and the patient was emergently transferred to hospital.
it was determined to conservative treatments were given (owing to the advanced age?).
On 24Jun2021, the patient died.
Follow up questions for the event: All the signs and symptoms of the event: Vomiting, shock (blood pressure systolic 50, SpO2 85 %, for which O2 started at 1L/min).
The time course of the anaphylactic reaction: On 15Jun2021 at 13:45, the patient received vaccination of BNT162B2.
On 16Jun2021 at 20:00, the patient vomited.
On 17Jun2021, shock vitals were seen.
The patient required medical intervention with corticosteroids, IV fluids, and oxygen.
Details: On 16Jun2021 at around 20:00 IV fluids started.
On 17Jun2021 at around 9:00, hydrocortisone, O2, and dopamine were given.
It was unknown if multiorgan, cardiovascular, or other involvement was noted.
Gastrointestinal involvement was seen.
Vomiting Yes.
Details: Ischaemic enterocolitis was complicated).
There was no dermatological/Mucosal involvement.
The outcome of the rest of the events was not recovered.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: A possible contributory role of the suspect drug to the reported events "Ischaemic enterocolitis", "small intestinal necrosis", "small intestinal Ileus", "shock", "Images of portal gas, intestinal gas, and intestinal lumen gas", "Pneumonia in the left lung", "SpO2 85 %" and "blood pressure systolic decreased to 50" cannot be completely excluded based on temporal association.
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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
; Reported Cause(s) of Death: Ischaemic enterocolitis