이상반응 보고
| VAERS ID | 2572598 |
|---|---|
| 성별 | 남성 |
| 나이 | 76세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EX3617 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-05-18 |
| 발병일 | 2021-12-21 |
| 상태 | 사망 |
증상
- 신체 검사(Physical examination)
- 코로나19 예방접종(COVID-19 immunisation)
- 백신 제품의 교환(Interchange of vaccine products)
- 간질성 폐질환(Interstitial lung disease)
이환 중 질병
지병
기타 의료
이전 예방접종
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임상 검사
Test Date: 20211221; Test Name: Physical examination; Result Unstructured Data: diagnosed with interstitial pneumonia and cardiac hypertrophy
증상 상세
Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna); Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna); Interstitial pneumonia / he was found unconscious dead in a prone position; This spontaneous case was reported by a health care professional and describes the occurrence of INTERSTITIAL LUNG DISEASE (Interstitial pneumonia / he was found unconscious dead in a prone position) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.
The occurrence of additional non-serious events is detailed below.
Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 immunisation.
No Medical History information was reported.
On 18-May-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form.
On 08-Jun-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form.
On 08-Feb-2022, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 21-Dec-2021, the patient experienced INTERSTITIAL LUNG DISEASE (Interstitial pneumonia / he was found unconscious dead in a prone position) (seriousness criteria death and medically significant).
On 08-Feb-2022, the patient experienced COVID-19 IMMUNISATION (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)) and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)).
The patient died on 27-Feb-2022.
The reported cause of death was interstitial pneumonia / dead in a prone position.
It is unknown if an autopsy was performed.
At the time of death, COVID-19 IMMUNISATION (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)) and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, Physical examination: diagnosed with interstitial pneumonia and cardiac hypertrophy.
For mRNA-1273 (Spikevax) (Unknown), the reporter considered INTERSTITIAL LUNG DISEASE (Interstitial pneumonia / he was found unconscious dead in a prone position) and COVID-19 IMMUNISATION (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)) to have an unknown relationship.
No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (Dose 1 (Pfizer) Dose 2 (Pfizer) Dose 3 (Moderna)).
About 1 month after the second vaccination, the patient experienced shortness of breath, amnesia, light-headed feeling.
Patient also had cardiac hypertrophyon 21-Dec-2021 which was medically significant and got recovered on an unknown date Severity was mild and outcome was recovered.
On 12Jan2022, patient was recovered from other symptoms.
Concomitant medications were not reported.
No treatment information was provided Reporter did not allow further contact Company comment: This spontaneous case concerns a 76-year-old, male patient with no medical history information reported, previously vaccinated with 2 dose of Comirnaty, who experienced the unexpected serious (fatal and medically significant) event of interstitial lung disease.
Interchange of vaccine product and revaccination with different COVID 19 vaccine were also noted in this case.
The event of interstitial lung disease occurred approximately 5.
5 months after the second dose of Comirnaty and 49 days prior to third dose of mRNA-1273.
As reported, about 1 month after the second vaccination, the patient experienced symptoms of shortness of breath, amnesia, light-headed feeling but recovered without particular examination.
Patient also had cardiac hypertrophy 49 days prior to 3rd dose which was medically significant.
As reported, 27 days prior to 3rd dose, patient was recovered from other symptoms and was still diagnosed with mild interstitial pneumonia.
The patient died on 19 days after 3rd dose.
The reported cause of death was interstitial pneumonia.
Patient was found unconscious and dead in a prone position.
It is unknown if an autopsy was performed.
Temporal relationship between patients death and administration of 3rd dose is present however, the event of interstitial lung disease occurred prior to 3rd dose and patient had a finding of cardiac hypertrophy suggesting longer persistence of the interstitial lung disease which was reported as the case of patient's death.
No worsening of the condition due to 3rd dose was reported, however limited information was available as patient was found dead and no detailed autopsy results or comparison of imaging findings were provided.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
; Reported Cause(s) of Death: Interstitial pneumonia / dead in a prone position