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VAERS ID: 1000276

AGE: UNK| SEX: M|State: FR

Description

Death unexplained; asymptomatic COVID-19 (with postivie PCR test); asymptomatic COVID-19 (with postivie PCR test); This is a spontaneous report from a contactable pharmacist downloaded from the database. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-DJ20210108. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular on 14Jan2021 as a single dose for COVID-19 vaccination. Medical history included severe chronic renal failure, arterial hypertension, pulmonary arterial hypertension, dyslipidemia, heart disease, permanent cardiac pacemaker insertion, prostatectomy, and chronic respiratory failure with oxygen; all from unknown dates and unknown if ongoing. Concomitant medications included fluindione (PREVISCAN), furosemide (MANUFACTURER UNKNOWN), fluticasone propionate/salmeterol xinafoate (SERETIDE), bismuth subnitrate/sterculia urens (NORMACOL BISMUTH), oxazepam (SERESTA), latanoprost (MONOPROST), morphine sulfate (ACTISKENAN), bisoprolol (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), paracetamol (DOLIPRANE), nitrous oxide/oxygen (MANUFACTURER UNKNOWN), oxygen (MANUFACTURER UNKNOWN), and macrogol (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. On 20Jan2021, the patient experienced unexplained death. The clinical course was as follows: the patient had been hospitalized since 02Dec2020 due to difficult home care (patient confined to bed) with bedsores in the heels and especially a very important sacral bedsore. It was reported that the patient had made numerous stays in this service for some time, in particular a stay from 28Aug2020 to 22Oct2020. In the afternoon of 14Jan2021, the patient was vaccinated and no signs of reactogenicity were observed after vaccination. On 18Jan2021, the COVID-19 PCR test came back positive (test carried out because other patients were positive) but the patient was not symptomatic. On 19Jan2021, he presented with a cough. On 20Jan2021 around midnight, when the nurse took her turn, the patient was sleeping, there was nothing in particular to report. When she returned to see the patient at 5:30 a.m. taking her turn, the nurse noticed that the patient was dead. The cause of death was unexplained and it was not reported if an autopsy was performed. The clinical outcome of asymptomatic COVID-19 was unknown at the time of death. Chronologically, the patient died 6 days after the COVID-19 vaccination. According to the information provided, no therapeutic modification had been made in the days preceding the occurrence of the patient's death. On the semi logical level, the COVID-19 test was positive on 18Jan2021. The other etiologies discussed with the doctor were a massive pulmonary embolism (but INR at 2.61 on 04Jan2021 and 2.42 on 09Jan2021) or septic shock on a sacral pressure ulcer with bone involvement. It should be noted that the patient did not present any particular sign of reactogenicity such as fever following the vaccination. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: unexplained death

Symptoms

Cough, Death, International normalised ratio increased, SARS-CoV-2 test positive

Vaccines

VAX DATE: 13 January 2021 | ONSET DATE: 17 January 2021 | DAYS TO ONSET: 4
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • UNK
  • OT
  • EM0477

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
19 January 2021
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
Test Date: 20210104; Test Name: INR; Result Unstructured Data: Test Result:2.61; Test Date: 20210109; Test Name: INR; Result Unstructured Data: Test Result:2.42; Test Date: 20210118; Test Name: COVID-19 virus test; Test Result: Positive
V_ADMINBY:
OTH
OTHER_MEDS:
PREVISCAN [FLUINDIONE]; FUROSEMIDE; SERETIDE; NORMACOL BISMUTH; SERESTA; MONOPROST; ACTISKENAN; BISOPROLOL; AMIODARONE; DOLIPRANE; NITROUS OXIDE;OXYGEN; OXYGEN; MACROGOL
CUR_ILL:
Hospitalization
HISTORY:
Medical History/Concurrent Conditions: Bed sore; Bedridden; Chronic respiratory failure (with oxygen); Dyslipidaemia; Heart disease, unspecified; Hospitalization (most recent of numerous stays); Hypertension arterial; Oxygen therapy; Permanent cardiac pacemaker insertion; Prostatectomy; Pulmonary arterial hypertension; Renal failure chronic (severe)
PRIOR_VAX:
SPLTTYPE:
FRPFIZER INC2021097911
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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