Adverse Event Reporting

VAERS ID 2292110
Gender Female
Age 43
StateCode FR
Pharmaceutical Company JANSSEN
Lot Number
Number of vaccinations 1
Vaccinated
Onset 2021-07-24
Condition Recovered
Symptoms
  • Exposure during pregnancy
  • Anembryonic gestation

Current Illness

Preexisting Conditions

Comments: Patient gravida 1

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

BLIGHTED OVUM; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional by a Regulatory Authority (RA, PH-PHFDA-300146449) on 19-MAY-2022 and concerned a 43 year old female of an unspecified race and ethnicity.
The patient's height, and weight were not reported.
The patient's pre-existing medical conditions included: Patient gravida 1.
The patient received covid-19 vaccine ad26.
cov2.
s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 total, dose was not reported, administered on 24-JUL-2021 for an unspecified indication.
The batch number was not reported.
The company is unable to perform follow-up to request batch/lot numbers.
Age at time of vaccination 43 years old.
No concomitant medications were reported.
On 24-JUL-2021, the patient experienced vaccine exposure during pregnancy.
The date of the patient's last menstrual period and expected delivery date were not reported.
On an unspecified date, the patient experienced blighted ovum.
On an unspecified date, the pregnancy outcome was unknown.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable.
The patient recovered from blighted ovum, and the outcome of vaccine exposure during pregnancy was not reported.
This report was serious (Other Medically Important Condition).
; Sender's Comments: V0:20220538795- covid-19 vaccine ad26.
cov2.
s - Blighted ovum.
The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility.
There is no information on any other factors potentially associated with the event(s).
Therefore, this event(s) is considered unassessable.
20220538795- covid-19 vaccine ad26.
cov2.
s -Vaccine exposure during pregnancy.
The event(s) has an compatible/suggestive 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: SPECIAL SITUATIONS.
Therefore, this event(s) is considered not related.