Adverse Event Reporting
| VAERS ID | 2013509 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FG7372 |
| Number of vaccinations | 3 |
| Vaccinated | 2021-10-13 |
| Onset | 2021-10-01 |
| Condition | Hospitalized Died |
Symptoms
- Dyspnoea
- Thrombocytopenia
- Immunisation
- Pulmonary hypertension
- Cor pulmonale acute
- Microangiopathic haemolytic anaemia
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Breast cancer metastatic (Patient with known breast cancer (right breast) with widespread skeletal metastases.); Cancer surgery (breast cancer (right breast), underwent surgery in /Jan2021); Dyslipidemia; Hypertension; Radiation therapy (breast cancer (right breast), received radiation therapy (15 fractions) in /Mar2021); Type 2 diabetes mellitus
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Cor pulmonale acute; pulmonary hypertension; Thrombocytopenia; Microangiopathic hemolytic anemia; Booster; DYSPNEA; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory-WEB.
Regulatory number: NO-NOMAADVRE-FHI-2021-U11e5g.
Other Case identifier(s): NO-NOMAADVRE-E2B_00064993.
A 64 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Oct2021 (Lot number: FG7372) as dose 3 (booster), single for covid-19 immunisation.
Relevant medical history included: "Dyslipidemia" (unspecified if ongoing); "Breast cancer metastatic" (unspecified if ongoing), notes: Patient with known breast cancer (right breast) with widespread skeletal metastases.
; "Type 2 diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Cancer surgery", start date: Jan2021 (unspecified if ongoing), notes: breast cancer (right breast), underwent surgery in /Jan2021; "Radiation therapy", start date: Mar2021 (unspecified if ongoing), notes: breast cancer (right breast), received radiation therapy (15 fractions) in /Mar2021.
The patient's concomitant medications were not reported.
Vaccination history included: Comirnaty (Dose 2, Batch/lot number: Unknown.
Intramuscular.
), administration date: 04Mar2021, for Covid-19 immunisation; Comirnaty (Dose 1, Batch/lot number: Unknown.
Intramuscular.
), administration date: 11Feb2021, for Covid-19 immunisation.
The following information was reported: IMMUNISATION (death, hospitalization) with onset 13Oct2021, outcome "fatal", described as "Booster"; DYSPNOEA (death, hospitalization) with onset Oct2021, outcome "fatal", described as "DYSPNEA"; MICROANGIOPATHIC HAEMOLYTIC ANAEMIA (death, hospitalization) with onset 11Nov2021, outcome "fatal", described as "Microangiopathic hemolytic anemia"; COR PULMONALE ACUTE (death, hospitalization) with onset 12Nov2021, outcome "fatal", described as "Cor pulmonale acute"; PULMONARY HYPERTENSION (death, hospitalization) with onset 12Nov2021, outcome "fatal", described as "pulmonary hypertension"; THROMBOCYTOPENIA (death, hospitalization) with onset 11Nov2021, outcome "fatal", described as "Thrombocytopenia".
The patient was hospitalized for immunisation, dyspnoea, microangiopathic haemolytic anaemia, cor pulmonale acute, pulmonary hypertension, thrombocytopenia (start date: 11Nov2021).
The patient date of death was 12Nov2021.
The reported cause of death was cor pulmonale acute, dyspnoea, microangiopathic haemolytic anaemia, pulmonary hypertension, thrombocytopenia.
It was not reported if an autopsy was performed.
Sender Comment: The report concerns a patient in his 60s, who developed increasing dyspnoea that started around the time of vaccination with Comirnaty.
According to the reporter, there is some uncertainty regarding when the symptoms started.
After one month, the patient was hospitalized with a rapidly declining condition and microangiopathic hemolytic anemia and thrombocytopenia were detected.
The patient developed acute cor pulmonale with significant pulmonary hypertension, and died the day after admission.
The notifier states that the notification is submitted due to the temporal coincidence between vaccination and death, and that the cause of the case is initially perceived as a cancer-related microangiopathic hemolytic anemia secondary to widespread skeletal metastasis from cancer mammae.
The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.
; Reported Cause(s) of Death: dyspnea; Microangiopathic hemolytic anemia; Pulmonary hypertension; Thrombocytopenia; COR PULMONALE ACUTE