이상반응 보고
| VAERS ID | 1575942 |
|---|---|
| 성별 | 여성 |
| 나이 | 31세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FE1510 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-07-30 |
| 상태 |
증상
- 피로(Fatigue)
- 사지의 통증(Pain in extremity)
- 통증(Pain)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 림프절병증(Lymphadenopathy)
- 겨드랑이 통증(Axillary pain)
- 과수면(Hypersomnia)
- 오프 라벨 사용(Off label use)
- 제품 사용 문제(Product use issue)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
이환 중 질병
Breast feeding; Pregnancy
지병
Medical History/Concurrent Conditions: Folic acid supplementation; Tiredness
기타 의료
FOLIC ACID
이전 예방접종
알레르기
임상 검사
Test Date: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
증상 상세
pain; extra sleep; Off label use/ maternal exposure via breast milk; Drug use in unapproved population/ maternal exposure via breast milk; hurt to move the arm, minor pain; Swollen lymph nodes; Armpit pain/ armpit was tender to touch; Tired all the time/tiredness; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer.
This is the first of second reports.
This is a report received from the regulatory authority.
Regulatory authority report number GB-MHRA-WEBCOVID-202108010929167140-4YZKH, Safety Report Unique Identifier GB-MHRA-ADR 25737876.
A 31-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: fe1510), dose 2 via an unspecified route of administration on 30Jul2021 09:30 (Age at Vaccination: 31Year) as dose 2, single for COVID-19 immunisation.
Medical history included fatigue from an unknown, ongoing pregnancy (currently 5 months pregnant), ongoing breast feeding, using vitamin supplementation from an unknown date.
Patient has not had symptoms associated with COVID-19.
Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported.
Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation.
It was also reported that after first dose patient had sore arm and tiredness.
On 30Jul2021 with in few hours of having vaccine the patient experienced tiredness.
On 01Aug2021 the patient experienced swollen lymph nodes and armpit pain.
On unspecified date patient had pain, extra sleep and pain in arm.
It was reported that extra sleep was resolving slowly.
In the early hours of Sunday morning patient lymph nodes began to swell under the arm that received the vaccine and the armpit was tender to the touch.
It also hurt to move the arm, minor pain.
The arm that did not get the injection was unaffected.
Patient was exposed to the medicine second-trimester (13-28 weeks).
The patient underwent lab tests and procedures which included sars-cov-2 test: (no - negative covid-19 test) on 22Jul2021.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient was not enrolled in clinical trial.
All the events were reported as medically significant.
The outcome of the event swollen lymph nodes and armpit pain was reported as not recovered, while outcome of events pain, extra sleep and tiredness was resolving.
The outcome of all other events was unknown.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : GB-PFIZER INC-202100998871 Baby case