Received Dec 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
has been sick with diarrhea and 2 days ago he was throwing up; has been sick with diarrhea and 2 days ago he was throwing up; Initial information received on 17-Dec-2025 regarding an unsolicited valid non-serious case received from Consumer/Non-Healthcare Professional This case involves a 7 months old male patient who had been sick with diarrhea and 2 days ago he was throwing up after receiving influenza USP trival A-B subvirion NO preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Nov-2025, the patient received unknown dose of suspect influenza USP trival A-B subvirion no preservative vaccine Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Influenza immunization. Information on the batch number requested corresponding to the one at time of event occurrence. On an unknown date in DEC-2025 the patient had been sick with diarrhea and 2 days ago he was throwing up (diarrhoea) (vomiting) (unknown latency) following the administration of influenza USP trival A-B subvirion no preservative vaccine. It was reported, "reporters infant son, who was a little over 7 months old, received 1 dose of FLUZONE NP from his pediatrician last 13-Nov-2025 and is due for the booster shot today. Caregiver mentioned that she was not looking for any medical advice because she already talked to the pediatrician and knows that we cannot give that, but with her experience, doctors know very little about what's actually appropriate for vaccines, package insert, and previous research. Caregiver stated that she has 2 concerns. patient had been ill without fever for the last few days. Stated that was not the result of the vaccine because the initial dose was a little over 4 weeks ago and is due for the booster today. She was told that as long as her son did not have a fever, it is fine. However, as an adult, they are supposed to sign a waiver that they are feeling okay. Additionally, when she knows that she's not feeling okay, it has been recommended to skip the flu vaccine or boosters until she feels well. She wanted to know what research or recommendations we have if a child is not feeling well. She mentioned that her son has been sick with diarrhea and 2 days ago he was throwing up. She added that he's actually okay with the vomiting now but still has very bad diarrhea." Action taken: Not applicable. Corrective treatment: Not reported Outcome; Not Recovered / Not Resolved for the event diarrhoea and Recovering/ Resolving for the event vomiting.