Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
heart valve replacement surgery; fever; PROGRAM NAME NOT AVAILABLE This is a solicited report received from a Consumer or other non HCP from License Party, Program ID: NOT AVAILABLE. A 79-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), on 07Nov2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; dupilumab (DUPILUMAB), since 21Oct2022 (ongoing)) at 300 mg (300 mg qow), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing). Concomitant medications included Nitroglycerin; Metoprolol; Rosuvastatin; Vitamins nos (Multivitamin): Tacrolimus monohydrate (Protopic): Aspirin: Allopurinol: Lisinopril: Hydrocodone; and Clobetasol. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The course of the events was as follows: On 21Oct2022, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300mg/2mI) at a dose of 300 mg QOW subcutaneously for Atopic dermatitis. On 07Nov2023. the patient received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (with an unknown strength, route, batch number and expiration date) for Prophylactic vaccination. On 07Nov2023 the patient developed a non-serious event "experiencing a fever after receiving the covid 19 vaccine booster" (pyrexia) (latency: 1 year 17 days) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. The patient developed a non-serious event 'heart valve replacement surgery' on 02JUN2025" (cardiac valve disease) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. Action taken with DUPILUMAB (DUPIXENT) was continued for both the events. Action taken with COVID-19 VACCINE was not applicable for both the events. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Reporter causality: Unassessable for dupilumab and Related to covid-19 vaccine for pyrexia and Unassessable for cardiac valve disease for dupilumab and not reported to covid-19 vaccine. The reporter considered "fever" related to BNT162b2. The reporter's assessment of the causal relationship of "heart valve replacement surgery" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY is under agreement with BIONTECH SE.; Sender's Comments: Based on known drug safety profile, and close temporal association the event pyrexia is assessed as related to the suspect drug BNT162B2. 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. Based on known mechanism of action of the drugs, the event cardiac valve disease is assessed as not related to the suspect drug, and more likely a pre-existing cardiac valve condition unspecified in the medical history as evidenced by the patient's intake of concomitant medications such as nitroglycerin, metoprolol, and rosuvastatin which are usually given to delay that progression of a heart valve disease of decrease the workload of the heart due to the valvular heart disease. Also, the age of the patient may be a contributory factor in the development a cardiac valve disease.
Medical History/Concurrent Conditions: Atopic dermatitis
NITROGLYCERIN; METOPROLOL; PROTOPIC; ASPIRIN [ACETYLSALICYLIC ACID]; ALLOPURINOL; LISINOPRIL; HYDROCODONE; CLOBETASOL; DUPILUMAB