Adverse Event Reporting

VAERS ID 1249208
Gender Female
Age
StateCode IL
Pharmaceutical Company JANSSEN
Lot Number 042A21A
Number of vaccinations
Vaccinated
Onset 2021-04-01
Condition Died
Symptoms
  • Blood glucose increased
  • Gastrointestinal haemorrhage
  • Blood glucose abnormal

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: Non-insulin-dependent diabetes mellitus

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Test Name: Blood sugar abnormal; Result Unstructured Data: 475 mg/dL, 475 mg/dL

Write-up

HIGH BLOOD SUGAR; GI BLEED; This spontaneous report received from a consumer concerned a 71 years old female.
The patient's height, and weight were not reported.
The patient's past medical history included NIDDM (Non-Insulin-Dependent Diabetes Mellitus Diabetes).
The patient received covid-19 vaccine ad26.
cov2.
s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 05-APR-2021 at left arm for prophylactic vaccination.
No concomitant medications were reported.
In APR-2021, the patient experienced GI (gastrointestinal) bleed.
On an unspecified date, the patient experienced high blood sugar.
It was reported that the reporter was not sure if the GI (gastrointestinal) bleed was just coincidence because the patient passed so soon after getting the covid-19 vaccine ad26.
cov2.
s.
The patient had to go to her Doctor to get an unknown shot on the day of or close to the day of the vaccine, probably insulin because the patient had a 475 blood sugar.
Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 475 mg/dL.
On an unspecified date the patient died from GI (gastrointestinal) bleed.
Patient was lying there for a while.
Patient had been bleeding when it was discovered on 11-APR-2021 that she had expired.
Coroner's report said it was from GI (gastrointestinal) bleed.
An autopsy was not performed.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable.
The patient died of GI (gastrointestinal) bleed on an unspecified date, and the outcome of high blood sugar was not reported.
This report was serious (Death).
; Sender's Comments: covid-19 vaccine ad26.
cov2.
s-GI bleed.
This event(s) is considered unassessable.
The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility.
There is no information on any other factors potentially associated with the event(s).
covid-19 vaccine ad26.
cov2.
s-high blood sugar.
This event(s) is considered not related.
The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility.
There are other factors more likely to be associated with the event(s) than the drug.
Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: GI BLEEDING