Adverse Event Reporting
| VAERS ID | 1133418 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EJ6136 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-01-29 |
| Onset | 2021-01-30 |
| Condition | Hospitalized Died |
Symptoms
- Troponin
- Cyanosis
- Myocardial infarction
- Pneumonia
- Troponin increased
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Body mass index low; Cardiac valve disease; Epilepsy; Heart valve incompetence (significant valvular heart disease); Hypothyroidism; Intellectual disability; Mitral regurgitation (significant valvular heart disease); Osteoporosis; Parkinson's disease; Pulmonary hypertension (significant valvular heart disease); Schizophrenia; Thrombocytopenia; Tricuspid regurgitation (significant valvular heart disease); Ventricular septal defect
Other Medications
CENTRUM ADVANCE; CETIRIZINE; QUETIAPINE; SCOPODERM [HYOSCINE HYDROBROMIDE]; IDEOS; VENLAFAXINE; LOSEC MUPS; FOLIC ACID; SINEMET PLUS; ELTROXIN; LAMICTAL; LACTULOSE; NEUPRO; SINEMET; THIAMINE
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210131; Test Name: Troponin; Result Unstructured Data: Test Result:200-450, elevated
Write-up
PNEUMONIA/lower respiratory tract infection; ELEVATED TROPONIN (200-450)/troponin rise; CYANOSED; MYOCARDIAL INFARCTION; This is a spontaneous from a contactable physician downloaded from the Regulatory Authority-WEB.
This is a report received from Regulatory Authority.
Regulatory authority report number IE-HPRA-2021-068347.
A 63-year-old female patient received first dose of bnt162b2 (COMIRNATY) (Batch/Lot Number: EJ6136), via an unspecified route of administration on 29Jan2021 as 0.
3ml single for covid-19 immunisation.
Medical history included intellectual disability, ventricular septal defect (VSD) (significant valvular heart disease: VSD with mitral regurgitation (MR), tricuspid regurgitation (TR), atrial regurgitation (AR) and pulmonary hypertension (HTN)), schizophrenia, epilepsy, thrombocytopenia, Parkinson's disease, hypothyroidism, osteoporosis, very low body mass index.
Concomitant medications included ascorbic acid, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, menadione, molybdenum, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopherol, vitamin b12 nos, vitamin d nos, xantofyl, zinc (CENTRUM ADVANCE); cetirizine; quetiapine; hyoscine hydrobromide (SCOPODERM patch); calcium carbonate/colecalciferol (IDEOS, 1250mg/0.
01mg chewable tablet); venlafaxine; omeprazole magnesium (LOSEC MUPS 20 mg gastro-resistant tablets); folic acid; carbidopa monohydrate/levodopa (SINEMET PLUS, 25mg/100mg tablet); levothyroxine sodium (ELTROXIN 100 microgram tablets); lamotrigine (LAMICTAL 50mg tablet); lactulose; rotigotine (NEUPRO, 18mg, Transdermal patch); carbidopa/levodopa (SINEMET 12.
5mg/50 mg tablets); thiamine.
Initial report received by the RA on 08Mar2021 from a healthcare professional.
On 29Jan2021, the patient was vaccinated with the first dose of bnt162b2.
On 30Jan2021, the patient became cyanosed.
The patient was admitted to hospital on 31Jan2021 and diagnosed with pneumonia, for which she was treated with intravenous antibiotics (unspecified) for three days.
It was noted on the patient's admission to hospital, that she had incidental elevated troponin (200-450, units unspecified) on 31Jan2021.
The patient was discharged on 03Feb2021 on oral antibiotics (unspecified).
The patient completed this course and was reported to be well and at her baseline.
On 19Feb2021, the patient was checked in her room and found to be unresponsive.
She underwent unsuccessful cardiopulmonary resuscitation (CPR) and passed away.
The reporter commented that it was possible the lower respiratory tract infection/pneumonia and troponin rise were contributory to her death.
The reported cause of death was myocardial infarction on a background of significant valvular heart disease, recent lower respiratory tract infection/pneumonia, elevated troponin (200-450)/troponin rise and cyanosed.
The patient died on 19Feb2021.
It was not reported if an autopsy was performed.
Event occurred in a country different from that of the reporter.
This may be a duplicate if the reporter also submitted directly to his/her local agency.
Outcome of the events was fatal.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: myocardial infarction on a background of significant valvular heart disease; recent lower respiratory tract infection/pneumonia; ELEVATED TROPONIN (200-450)/troponin rise; CYANOSED