이상반응 보고

VAERS ID	2033960
성별	여성
나이	30세
주 코드	FR
제약회사	JANSSEN
로트 번호
예방접종 횟수	1
접종일	2021-07-26
발병일	2021-07-01
상태	입원

증상

• 발열(Pyrexia)
• 오한(Chills)
• 임신 중 노출(Exposure during pregnancy)
• 발작(Seizure)
• 아나필락시성 쇼크(Anaphylactic shock)

이환 중 질병

Abstains from alcohol; Allergy to nuts; Diabetes; Milk allergy; Pre-eclampsia; Seafood allergy; Smoker (once in a while); Thrombocytopenic purpura

지병

Comments: The patient had no drug abuse or illicit drug use.

기타 의료

INSULIN; NIFEDIPINE; PROMACTA; PREDNISONE

이전 예방접종

알레르기

임상 검사

증상 상세

ANAPHYLACTIC SHOCK; VACCINE EXPOSURE DURING PREGNANCY; CHILLS; FEVER; SEIZURES; This spontaneous pregnancy report received from a patient via a Regulatory Authority [PH-PHFDA-300095217] concerned an 30-year-old female (who is a health care professional).
The patient's height, and weight were not reported.
The patient's concurrent conditions included thrombocytopenic purpura, diabetes, pre-eclampsia, milk allergy, nut allergy, crustacean allergy, smoker (once in a while) and non-alcoholic.
The patient had no drug abuse or illicit drug use.
The patient's gravida was 1, para was 0.
The patient received covid-19 vaccine ad26.
cov2.
s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on 26-JUL-2021 on left arm for prophylactic vaccination.
All required follow up attempts have been made.
The batch number for covid-19 vaccine ad26.
cov2.
s has not been provided.
Concomitant medications included insulin for diabetes, nifedipine for pre-eclampsia, eltrombopag olamine for thrombocytopenic purpura and prednisone for thrombocytopenic purpura.
The patient was 8 months pregnant when she had vaccine (vaccine exposure during pregnancy).
The last menstrual period was on 08-NOV-2020 and expected delivery date was on 01-Aug-2021.
Obstetrician was not yet informed.
On 26-JUL-2021, she had an anaphylactic shock and received epinephrine.
She was hospitalized for unspecified number of days.
It was reported that, she still experienced fever, chills and seizures (JUL-2021).
Pregnancy was ongoing at the time of reporting.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable.
The patient had not recovered from anaphylactic shock, fever, chills, seizures and vaccine exposure during pregnancy.
This report was serious (Hospitalization Caused / Prolonged).
This case is a duplicate of 20210810710.
Additional information was received on 10-JAN-2022.
All required follow-up attempts have been made.
The batch number for COVID-19 vaccine ad26.
cov2.
s has not been provided.
Added reporter (other HCP).
Upon review following information was amended.
Corrected regulatory authority number in the narrative.
; Sender's Comments: V4: This version is created to update batch number, reporter, regulatory authority number.
This updated information does not change prior causality assessment.
20210757873-covid-19 vaccine ad26.
cov2.
s-vaccine exposure during pregnancy.
Follow-up received regarding Clinical Details.
This event(s) is considered not related.
The event(s) has a 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 20210757873-COVID-19 VACCINE AD26.
COV2.
S-Anaphylactic shock.
This event(s) is considered related.
The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible.
There is no information on any other factors potentially associated with the event(s).
20210757873-COVID-19 VACCINE AD26.
COV2.
S-Seizures.
This event(s) is considered not related.
The event(s) has a 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: MEDICAL HISTORY 20210757873-COVID-19 VACCINE AD26.
COV2.
S-Chills, fever.
This event(s) is labeled per RA and is therefore considered potentially related.