이상반응 보고
| VAERS ID | 2286184 |
|---|---|
| 성별 | 여성 |
| 나이 | 35세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | |
| 접종일 | 2021-01-10 |
| 발병일 | 2021-01-10 |
| 상태 |
증상
- 관절통(Arthralgia)
- 신체 검사(Physical examination)
- 엑스레이 사지(X-ray limb)
이환 중 질병
지병
기타 의료
INOSITOL;METFORMIN
이전 예방접종
알레르기
임상 검사
Test Date: 20220124; Test Name: Physical examination; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20220124; Test Name: X-ray shoulder; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
증상 상세
Left shoulder pain (injection site); This case was received via Agency (Reference number: IT-MINISAL02-866774) on 17-May-2022 and was forwarded to Moderna on 17-May-2022.
This regulatory authority case was reported by a physician and describes the occurrence of ARTHRALGIA (Left shoulder pain (injection site)) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.
Concomitant products included INOSITOL, METFORMIN (INOSITOL;METFORMIN) for an unknown indication.
On 10-Jan-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form.
On 10-Jan-2021, after starting mRNA-1273 (Spikevax), the patient experienced ARTHRALGIA (Left shoulder pain (injection site)) (seriousness criterion medically significant).
The patient was treated with IBUPROFEN for Shoulder pain, at a dose of 400 milligram three times a day; IBUPROFEN for Shoulder pain, at a dose of 400 milligram twice a day; IBUPROFEN for Shoulder pain, at a dose of 400 milligram once a day; RABEPRAZOLE for Shoulder pain, at a dose of 1 cp h8 for 14 days and EPERISONE HYDROCHLORIDE (EXPOSE) for Shoulder pain, at a dose of 1 capsule per day.
At the time of the report, ARTHRALGIA (Left shoulder pain (injection site)) was resolving.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, Physical examination: inconclusive (Inconclusive) Inconclusive.
On 24-Jan-2022, X-ray limb: inconclusive (Inconclusive) Inconclusive.
For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.
No Medical History information was reported.
The patient was discharged from the emergency room with indication to take ibuprofen, rabeprazole and Expose.
Company Comment: This regulatory case from Agency concerns a 35-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Arthralgia, that occurred on the same day after receiving an unspecified dose of mRNA-1273 vaccine.
Patient presented with left shoulder pain on the side of vaccination and underwent physical examination and X-ray which were both inconclusive.
Patient was discharged from the emergency room with home medication of Ibuprofen 400 mg 1 capsule 3 times daily for four days followed by tapered doses for the next 8 days and a muscle relaxant Eperisone hydrochloride (Expose) 1 capsule daily.
Outcome of the event was reported as resolving.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.
; Sender's Comments: This regulatory case from Agency concerns a 35-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Arthralgia, that occurred on the same day after receiving an unspecified dose of mRNA-1273 vaccine.
Patient presented with left shoulder pain on the side of vaccination and underwent physical examination and X-ray which were both inconclusive.
Patient was discharged from the emergency room with home medication of Ibuprofen 400 mg 1 capsule 3 times daily for four days followed by tapered doses for the next 8 days and a muscle relaxant Eperisone hydrochloride (Expose) 1 capsule daily.
Outcome of the event was reported as resolving.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.