Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
motor skills and lower limb strength have decreased significantly; frequently tripping; unable to stand without sitting for a length of time; lower limb strength have decreased significantly; legs hurt; injection site was red; injection site was hot to the touch; injection site was red, hot to the touch, with a rash running up and down; extreme itchiness; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves a 4 years old female patient who had motor skills and lower limb strength have decreased significantly, frequently tripping, unable to stand without sitting for a length of time, extreme itchiness, lower limb strength have decreased significantly, legs hurt, injection site was red, injection site was hot to the touch and injection site was red, hot to the touch, with a rash running up and down 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 23-Oct-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) . Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 24-OCT-2025 the patient had injection site was red (vaccination site erythema), injection site was hot to the touch (vaccination site warmth), injection site was red, hot to the touch, with a rash running up and down (vaccination site rash) and extreme itchiness (pruritus) (latency 1 day). On an unknown date in Nov 2025 the patient had motor skills and lower limb strength have decreased significantly (psychomotor skills impaired), frequently tripping (fall),unable to stand without sitting for a length of time (dysstasia),lower limb strength have decreased significantly (asthenia)and legs hurt (pain in extremity) (latency2 weeks approximately). It was reported "they were looking to order blood tests to rule out GBS (Guillain Barre syndrome), myositis, SMA (Spinal muscular atrophy), Lyme, etc. My 2year old daughter received the same vaccine at the same time without incident" Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Recovered / Resolved on 25-Oct-2025 for the events vaccination site erythema,vaccination site warmth, vaccination site rash and pruritus, unknown for other events