Adverse Event Reporting
| VAERS ID | 2558223 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | NC |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | |
| Onset | 2022-11-15 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Pulmonary embolism
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Penicillin allergy (Drug allergies: PCN); Sulfonamide allergy (Drug allergies: Sulfa)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Bilateral Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP).
A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.
4-5 (BNT162B2, BNT162B2 OMI BA.
4-5), in 2022 (2-3 weeks prior to 15Nov2022) as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history included: "Drug allergies: PCN" (unspecified if ongoing), notes: Drug allergies: PCN; "Drug allergies: Sulfa" (unspecified if ongoing), notes: Drug allergies: Sulfa.
The patient had no drug or alcohol abuse.
The patient had no related family history.
The patient's concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer Unknown), for COVID-19 immunization.
The following information was reported: PULMONARY EMBOLISM (caused and prolonged hospitalization, disability, medically significant, life threatening, congenital anomaly (as reported)) with onset 15Nov2022, outcome "recovering", described as "Bilateral Pulmonary embolism".
The patient was hospitalized and prolonged hospitalization for pulmonary embolism (start date: Nov2022, discharge date: 21Nov2022, hospitalization duration: 6 day(s)).
The event "bilateral pulmonary embolism" required physician office visit.
Therapeutic measures were taken as a result of pulmonary embolism with anticoagulants.
Patient was low risk for blood clot so BNT162b2, BNT162b2 omi ba.
4-5 also suspected.
The vaccine may have increased her risk or caused the clots.
The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.
4-5 has been requested and will be submitted if and when received.
; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event pulmonary embolism with the suspect drug BNT162b2, BNT162b2 omi ba.
4-5 cannot be excluded.
The case will be reassessed once new information is available.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.