Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388474 | — |
It's travelling up my neck, the tightness; Perhaps some of the fluid leaked into the tissue; It's like my muscles are paralyzed; Motion difficulty in the arm that took the needle; Restriction in the movements of my arm / can't put my arm over my head; Restriction in the movements of my arm / it's like an ache, not a pain, it's not a 10 it's more like an 8; Fingers are getting numb on my left side; Slight headaches; Malaise; Injection site sore; This spontaneous case, initially received on 27-Jan-2025, was reported by a non health professional and concerns an elderly female patient. No medical history or concomitant medications were reported. Administration of company suspect drug: On 07-Jan-2025, the patient received Fluad (TIV) for an unknown indication, dose, anatomical location and route of administration: not reported. Lot number: 388474. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Jan-2025, the patient experienced , Injection site sore (outcome: Recovered / Resolved). On 10-Jan-2025, the patient experienced Restriction in the movements of my arm / can't put my arm over my head (outcome: Not recovered / Not resolved), Restriction in the movements of my arm / it's like an ache, not a pain, it's not a 10 it's more like an 8 (outcome: Not recovered / Not resolved),It's like my muscles are paralyzed (Medically Significant, outcome: Not recovered / Not resolved), Motion difficulty in the arm that took the needle (outcome: Not recovered / Not resolved), Fingers are getting numb on my left side (outcome: Not recovered / Not resolved), Slight headaches (outcome: Not recovered / Not resolved), Malaise (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced It's travelling up my neck, the tightness (outcome: Not recovered / Not resolved), Perhaps some of the fluid leaked into the tissue (outcome: Not recovered / Not resolved). Patient reported that recently got the Fluad and has been having some reactions in terms of motion difficulty in the arm that took the needle. She took the injection on 07-Jan-2025, and got the injection site sore, and that went away, and then by 09-Jan-2025 or 10-Jan-2025 started to notice restriction in the movements of her arm. It was like an ache, not a pain, it was not a 10 it was more like an 8. She couldn't put her arm over her head. Her fingers were getting numb on her left side. It was like her muscles were paralyzed, it was weird. And she was also getting slight headaches and malaise. She called her immunologist a couple of days after, and he said that of course it was going to be sore, he advised intermittent ice and anti-inflammatory. Called him back at the 14-Jan-2025 and he said it could still take a while. But what she was noticing was that it was not getting better, it was travelling up her neck, the tightness. Referred that was taking the anti-inflammatory as needed, and that never experienced any kind of allergic reaction to any other vaccine. Added that it made she wonder on the administration of the shot, like it went into the muscle, but perhaps some of the fluid leaked into the tissue, she did not know, but this one hurt. Fluad (TIV) action taken: Not Applicable Treatment medication: ice and unspecified anti-inflammatory Reporter assessment: the reporter considered the seriousness as unknown and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purpose. Related for injection site events, administration site movement pain due to anatomic proximity. Related for the rest of the events due to plausible temporal relationship of around 3 days post vaccination.
Comments: None