Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
My arm is swollen above the right elbow/There's a big brown spot and huge knot that's hot that's near the injection site; My wrist and hand are numb; I'm little horse too; The doctor said it might infected; My legs were so weak and I could barely get up; My right arm is red and feels hot; My right arm is red; There's a big brown spot that's near the injection site; There is a huge knot that's hot that's near the injection site; My neck on the same side has a knot; My neck is really tight and swollen; This spontaneous case from United States, initially received on 21-Sep-2025, was reported by a non-health professional and concerns an adult female patient. Past medical history included autoimmune issues- thyroid (reports she has no thyroid), mentioned she had an oncologist, said she had shingles before. Administration of company suspect drug: On 10-Sep-2025, the patient received Flucelvax (TIV) for Flu prevention, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2025, the patient experienced My arm is swollen above the right elbow/There's a big brown spot and huge knot that's hot that's near the injection site (outcome: Not recovered / Not resolved), My wrist and hand are numb (outcome: Not recovered / Not resolved), I'm little horse too (outcome: Not recovered / Not resolved), The doctor said it might infected (outcome: Not recovered / Not resolved), My legs were so weak and I could barely get up (outcome: Not recovered / Not resolved), My right arm is red and feels hot (outcome: Not recovered / Not resolved), My right arm is red (outcome: Not recovered / Not resolved), There's a big brown spot that's near the injection site (outcome: Not recovered / Not resolved), There is a huge knot that's hot that's near the injection site (outcome: Not recovered / Not resolved), My neck on the same side has a knot (outcome: Not recovered / Not resolved), My neck is really tight and swollen (outcome: Not recovered / Not resolved). The adult patient says: She got Flucelvax on 10-Sep-2025. Her right arm was red and felt hot. Her wrist and hand were numb, and it was driving her crazy. Her arm was swollen above the right elbow. There was a big brown spot and huge knot that was hot that's near the injection site but not at the injection site. Her neck on the same side had a knot and was really tight and swollen. The doctor said it might infected. Her doctor gave her steroid cream. All of this has been going on since the evening she got the flu shot. She was a little horse too. Two different doctors told her not to get the flu shot again. She went to the Emergency room (ER) first three or four days after getting the shot because her legs were so weak and she could barely get up. She thought she must have fallen or something but she didn't fall. After that, she went to another doctor. She has follow up with her doctor in October, but she may have to go to urgent care if this numbness doesn't get better soon. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Mupirocin, Steroid cream, Antibiotics Reporter's assessment: The reporter assessed events as non-serious and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
Medical History/Concurrent Conditions: Autoimmune disorder; Shingles