Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
worsening of asthma; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of asthma aggravated in a 58-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis. Concurrent medical conditions included asthma (unspecified) and drug allergy (had ongoing drug allergies to hydrochlorothiazide). Concomitant products included dupilumab (Dupixent), levofloxacin, losartan, prednisone, atorvastatin, citalopram, aspirin, gabapentin, azithromycin, naproxen, montelukast sodium (Singulair), meloxicam, mycophenolate mofetil (Mycophenolate) and mepolizumab (Nucala). On 07-OCT-2025, the patient received RSV vaccine, Influenza vaccine and COVID-19 vaccine. On 08-OCT-2025, 1 days after receiving RSV vaccine, Influenza vaccine and COVID-19 vaccine, the patient experienced asthma aggravated (Verbatim: worsening of asthma). The outcome of the asthma aggravated was resolving. The reporter considered the asthma aggravated to be possibly related to RSV vaccine and Influenza vaccine. The company considered the asthma aggravated to be possibly related to RSV vaccine and Influenza vaccine. Additional Information: GSK Receipt Date: 20-NOV-2025 The patient's past medical history, medical treatments, vaccinations and family history were not provided. The patient received Multivitamin (Vitamin NOS) as concomitant. On 17-SEP-2024, the patient started taking Dupilumab solution for injection (strength: 300 mg/2 ml) at a dose of 300 mg subcutaneously for unspecified asthma, uncomplicated. The patient developed a non-serious event worsening of asthma, 1 year 22 days after following the first dose intake of Dupilumab and 1 days after following the administration of RSV vaccine, Influenza vaccine and COVID-19 vaccine. It was reported worsening of asthma started to improve on 08-OCT-2025 and has improved further on 09-OCT-2025, so patient was 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 was unknown for dupilumab and therapy was ongoing. The batch number was not provided and a request for this information had been made.
Asthma (unspecified); Drug allergy (had ongoing drug allergies to hydrochlorothiazide)
DUPIXENT; LEVOFLOXACIN; LOSARTAN; PREDNISONE; ATORVASTATIN; CITALOPRAM; ASPIRIN; GABAPENTIN; AZITHROMYCIN; NAPROXEN; SINGULAIR; MELOXICAM; MYCOPHENOLATE; NUCALA