Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Body ache; Fever; This spontaneous report was received from a health professional and refers to a 54-year-old female patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date in July 2023, the patient started therapy with Dupilumab (Dupixent) 300 mg administered by subcutaneous route (anatomical location, lot number and expiration date were not reported) for the treatment of asthma. On 11-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), or with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), or Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date not reported) it was not specified which pneumococcal vaccine was administered. On the same date, the patient was vaccinated with recombinant Covid-19 vaccine (manufacturer unknown) (dose, route of administration, indication, lot number and expiration date were not reported) and with Influenza vaccine (manufacturer unknown) (dose, route of administration, anatomical location, indication, lot number and expiration date were not reported). On 06-Nov-2025, the patient developed body ache (Pain) and Fever (Pyrexia). At the reporting time, the patient was recovering from the events. The causal relationship between the events and the suspect therapies was not provided.
Dupixent (Dupilumab)