이상반응 보고
| VAERS ID | 2166782 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 3 |
| 접종일 | 2021-12-08 |
| 발병일 | 2021-12-14 |
| 상태 | 입원 사망 |
증상
- 컴퓨터 단층 촬영 헤드(Computerised tomogram head)
- 신체 검사(Physical examination)
- 자기 공명 영상 목(Magnetic resonance imaging neck)
- 입원(Hospitalisation)
- 자기 공명 영상 간담도(Magnetic resonance imaging hepatobiliary)
- 사지마비(Quadriparesis)
이환 중 질병
지병
Medical History/Concurrent Conditions: Cholecystectomy; Deafness bilateral; GERD; Gout flare; Hernia hiatal; Iodine allergy; Jaundice; Loin pain (Chronic low back pain); Osteoarthritis knee (Bilateral); Pancreatic cancer (discovered at the end of summer 2021 for which the oncology department, in agreement with the patient, and in discussion with his family, had decided to abstain from any therapy except comfort care); Reduced general condition; Unintentional weight loss (loss of 6 kg in 6 months)
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20211224; Test Name: Skull and Cervical Scan; Result Unstructured Data: Test Result:results unknown; Test Date: 202112; Test Name: hepato-pancreatic MRI; Result Unstructured Data: Test Result:dilation of the intra and extra hepatic bile ducts; Comments: Suspicious mass in the head of the pancreas.
No visible liver damage.
; Test Date: 20220106; Test Name: cervical MRI; Result Unstructured Data: Test Result:results unknown; Test Date: 202112; Test Name: Clinical examination; Result Unstructured Data: Test Result:Consistent patient, calm oriented and cooperative; Comments: No sad idea.
Predominant tetraparesis in the girdles, no sensory or sphincter disorder.
No gross cerebellar or vestibular syndrome, no swallowing or phonation disorder.
No signs of heart failure, regular heart, no murmur.
No lower limb edema.
Peripheral pulses felt, calves supple.
Dry lungs.
Supple and depressible abdomen.
증상 상세
Proximal tetraparesis evolving upwards for two months; HOSPITALIZATION REPORT (FROM 06JAN2022 TO 18JAN2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from the Agency Agency-WEB.
Regulatory number: FR-AFSSAPS-CF20220386.
A 87 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 08Dec2021 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation.
Relevant medical history included: "GERD" (unspecified if ongoing); "Osteoarthritis knee" (unspecified if ongoing), notes: Bilateral; "Gout flare" (unspecified if ongoing); "Hernia hiatal" (unspecified if ongoing); "Loin pain" (unspecified if ongoing), notes: Chronic low back pain; "Cholecystectomy" (unspecified if ongoing); "Bilateral deafness" (unspecified if ongoing); "IODINE hypersensitivity" (unspecified if ongoing); "pancreatic neoplasia", start date: 2021 (unspecified if ongoing), notes: discovered at the end of summer 2021 for which the oncology department, in agreement with the patient, and in discussion with his family, had decided to abstain from any therapy except comfort care; "Unintentional weight loss" (unspecified if ongoing), notes: loss of 6 kg in 6 months; "Reduced general condition" (unspecified if ongoing); "Jaundice" (unspecified if ongoing).
The patient's concomitant medications were not reported.
Vaccination history included: Comirnaty (Dose 1, intramuscular injection, left arm, Lot ET6956), administration date: 26Apr2021, for Covid-19 immunisation; Comirnaty (Dose 2, intramuscular injection, right arm, Lot Not specified), administration date: 26May2021, for Covid-19 immunisation, reaction(s): "Guillain Barre syndrome", "Pancreatitis", "Difficulty in standing", "Gait disorder", "Upper limb motor deficit".
The following information was reported: QUADRIPARESIS (death, hospitalization) with onset 14Dec2021, outcome "fatal", described as "Proximal tetraparesis evolving upwards for two months"; HOSPITALISATION (hospitalization) with onset 06Jan2022, outcome "unknown", described as "HOSPITALIZATION REPORT (FROM 06JAN2022 TO 18JAN2022)".
The patient was hospitalized for quadriparesis (start date: 14Dec2021, discharge date: 21Dec2021, hospitalization duration: 7 day(s)); for hospitalisation (start date: 06Jan2022, discharge date: 18Jan2022, hospitalization duration: 12 day(s)).
The patient underwent the following laboratory tests and procedures: computerised tomogram head: (24Dec2021) results unknown; magnetic resonance imaging hepatobiliary: (Dec2021) dilation of the intra and extra hepatic bile ducts, notes: Suspicious mass in the head of the pancreas.
No visible liver damage; magnetic resonance imaging neck: (06Jan2022) results unknown; physical examination: (Dec2021) consistent patient, calm oriented and cooperative, notes: No sad idea.
Predominant tetraparesis in the girdles, no sensory or sphincter disorder.
No gross cerebellar or vestibular syndrome, no swallowing or phonation disorder.
No signs of heart failure, regular heart, no murmur.
No lower limb edema.
Peripheral pulses felt, calves supple.
Dry lungs.
Supple and depressible abdomen.
The patient date of death was 18Jan2022.
The reported cause of death was quadriparesis.
It was not reported if an autopsy was performed.
Clinical course: 26Apr2021: Dose 1 by COVID-19 VACCINE COMIRNATY, injectable dispersion.
mRNA vaccine (modified nucleoside) against COVID-19 (IM injection left arm, Lot ET6956).
26May2021: Dose 2 by COVID-19 VACCINE COMIRNATY, injectable dispersion.
mRNA vaccine (modified nucleoside) against COVID-19 (Right arm IM injection, Lot Not specified).
Patient was vaccinated on 08Dec2021 with COVID-19 VACCINE COMIRNATY, injectable dispersion.
mRNA vaccine (modified nucleoside) against COVID-19 (3rd IM injection - Lot Not specified).
"My dad had pancreatitis 1 month after the second injection then ended up paralyzed (Guillin de Barret syndrome) was not treated the doctor wanted to give him the third injection and died on 18Jan.
" "Hospitalization in geriatric medicine from 14Dec to 21Dec2021" "Hospitalization in medicine from 06 to 18Jan2022".
"Deceased 18Jan2022.
Autopsy NOT requested by family".
Hospitalization report (from 14Dec2021 to 21Dec2021).
History of the disease: Appearance for about two months (mid Oct2021) of gait disorders, with standing becoming impossible, then motor disorders of the 2 upper limbs, predominant in the girdles.
Context of pancreatic cancer along isolated jaundice and deterioration of general condition with loss of 6 kg in 6 months: hepato-pancreatic MRI: dilation of the intra and extra hepatic bile ducts.
Suspicious mass in the head of the pancreas.
No visible liver damage.
Clinical examination : Consistent patient, calm oriented and cooperative.
No sad idea.
Predominant tetraparesis in the girdles, no sensory or sphincter disorder.
No gross cerebellar or vestibular syndrome, no swallowing or phonation disorder.
No signs of heart failure, regular heart, no murmur.
No lower limb edema.
Peripheral pulses felt, calves supple.
Dry lungs.
Supple and depressible abdomen.
Discharge diagnosis: Proximal tetraparesis evolving upwards for two months, in the course of expertise.
Evolution:Return home on 21Dec2021.
To be expected:24Dec2021: Skull and Cervical Scan.
06Jan2022: cervical MRI, hospitalization report (from 06Jan2022 TO 18Jan2022),hospitalization report not transmitted to the CRPV despite many oral and written requests to the establishment.
Solely a medical conclusion: Patient with pancreatic neoplasia discovered at the end of summer 2021 for which the oncology department, in agreement with the patient, and in discussion with his family, had decided to abstain from any therapy except comfort care.
Diagnosis of tetraparesis but Guillain Barre's diagnosis was never retained.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202200367991 same patient, different dose and AE; Reported Cause(s) of Death: Tetraparesis