Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
worsening of asthma; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involved a 58 years old female patient who had worsening of asthma while receiving DUPILUMAB [DUPIXENT] via unknown medical device, INFLUENZA VACCINE, COVID-19 VACCINE, RSV vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing drug allergies to hydrochlorothiazide. Concomitant medications included Levofloxacin; LOSARTAN; Prednisone; ATORVASTATIN; CITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]; Gabapentin; Azithromycin; Naproxen; Montelukast sodium (Singulair); MULTIVITAMIN [VITAMINS NOS]; Meloxicam; Mycophenolate (International nonproprietary name unspecified) and MEPOLIZUMAB (NUCALA). On 17-Sep-2024, the patient started taking DUPILUMAB Solution for injection (strength: 300mg/ 2ml) at a dose of 300 mg subcutaneously for Unspecified asthma, uncomplicated. On 07-Oct-2025, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, on the same day, the she received a dose of suspect RSV vaccine and COVID-19 VACCINE not produced by Sanofi Pasteur (lot number, strength, expiry date, formulation not reported for all suspects) via unknown route in unknown administration site. On 08-OCT-2025 the patient developed a non-serious event "worsening of asthma" (asthma) (latency: 1 year 22 days) following the first dose intake (batch number: FW1313 and expiry date on 30-Sep-2027) of DUPILUMAB, (latency: same day) following the administration of INFLUENZA VACCINE, COVID-19 VACCINE, RSV vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "Patient got a series of vaccines (flu/ covid/rsv) on 07-Oct and noticed worsening of asthma on 08-Oct but it started to improve on 08-Oct and has improved further today so patient is not worried about it. Pharmacist advised that it could have been from all the vaccines received on the same day. Patient had no further questions or comments". Action taken: Unknown for dupilumab and therapy was ongoing and Action taken with INFLUENZA VACCINE, RSV vaccine, COVID-19 VACCINE was not applicable. Corrective Treatment: Not reported. Outcome: Recovering / Resolving for the event worsening of asthma.
Drug allergy
Levofloxacin; LOSARTAN; Prednisone; ATORVASTATIN; CITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]; Gabapentin; Azithromycin; Naproxen; Singulair; MULTIVITAMIN [VITAMINS NOS]; Meloxicam; NUCALA; DUPIXENT