이상반응 보고
| VAERS ID | 2249117 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FM3802 |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-01-11 |
| 발병일 | 2022-01-14 |
| 상태 |
증상
- 허리 통증(Back pain)
- 월경통(Dysmenorrhoea)
- 자궁 통증(Uterine pain)
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증상 상세
LOW BACK PAIN; UTERINE PAIN; SEVERE MENSTRUAL PAIN; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB.
Regulatory number: NO-NOMAADVRE-PASRAPP-2022-Vrbmkk.
Other Case identifier(s): NO-NOMAADVRE-E2B_00080831.
A 41-year-old female patient received BNT162b2 (COMIRNATY), on 11Jan2022 as dose 3 (booster), 30 ug, single (Lot number: FM3802) intramuscular, in left arm for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation.
The following information was reported: DYSMENORRHOEA (medically significant) with onset 14Jan2022, outcome "not recovered", described as "SEVERE MENSTRUAL PAIN"; BACK PAIN (non-serious), outcome "unknown", described as "LOW BACK PAIN"; UTERINE PAIN (non-serious), outcome "unknown".
Additional information: The case was downgraded from serious (Disability Or Permanent Damage) to non-serious because the report does not fulfill the criteria Disability or Permanent damage at reporting time.
The suspected product was changed from Covid-19 Vaccine Janssen to Comirnaty, and Batch/Lot No.
was added due to information available in Immunisation Registry.
Additional information on drug J07BX - Other virus vaccines -The regulatory authority did not provide a causality assessment.
No follow-up attempts are possible.
No further information is expected.