Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8437DA | OT / LA |
Condition aggravated; lack appetite; gained 4 to 5 pounds that came on overnight; stiff; elevated basophil count; severe inflammatory responses of very high eosinophils; feet hurt'; trouble with sleep; arm was sore; bruised; experiencing swelling in her arms, feet, and hands since receiving fluzone hd/ swelling went up my arm, over shoulder, to side of my neck; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves, a 70 years old female patient who had condition aggravated, arm was sore, bruised, feet hurt', trouble with sleep, lack appetite, severe inflammatory responses of very high eosinophils, gained 4 to 5 pounds that came on overnight, elevated basophil count, stiff and experiencing swelling in her arms, feet, and hands since receiving fluzone hd/ swelling went up her arm, over shoulder, to side of her neck after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Erythema. The patient's past vaccination(s) included Fluzone High Dose Quadrivalent on 21-Oct-2021. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Pain, Headache and Peripheral swelling. Concomitant medications included Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]) for Insomnia and Decreased appetite; and Paracetamol (Tylenol) for Pain and Fatigue. On 15-Jan-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8437DA) (unknown strength, expiry date) via intramuscular route in the left deltoid for Immunization. On 15-Jan-2025, the patient developed experiencing swelling in her arms, feet, and hands/ swelling went up her arm, over shoulder, to side of her neck (swelling), arm was sore (pain in extremity), bruised (contusion) (latency-same day); on 16-Jan-2025, the patient developed feet hurt' (pain in extremity), trouble with sleep (initial insomnia) (latency-1 day); on 28-Jan-2025, the patient developed severe inflammatory responses of very high eosinophils (eosinophil count increased), elevated basophil count (basophil count increased) (latency-13 days); on an unknown date, the patient developed lack appetite (decreased appetite), condition aggravated, stiff (musculoskeletal stiffness), gained 4 to 5 pounds that came on overnight (weight increased) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Reportedly, The caller was a nurse and the patient. She stated, '' she was looking to let people know of the reaction and ask for help with how to treat it.'' She said, she had local reactions from other vaccines and that was why she did not wanted the high-dose. With Pneumovax she reacted and was told not to take any PCV in the future. With Shingrix, the same thing. As a child ''she would miss school with arm swelling, pain and redness with DTaP shots''. Her physician's office was busy doing assessments and no one asked her which flu vaccine she wanted. They administered the injection, saying they gave it to her because she is of age. She realized after the dose that it was the high dose vaccine. In the past it was written down that she had a common reaction to a flu shot but could still receive flu shots in the future. She purposely do not get my tetanus boosters because of her history. She would only get a tetanus booster if she was actually injured.'' She was able to obtain an appointment with another physician at the office. She was told Guillain-Barre was ruled out. She was told that she had a severe inflammatory reaction. Relevant laboratory test results included: Blood test - On 28-Jan-2025: [showed severe inflammatory responses of very high eosinophils and elevated basophil count.] Weight - On 28-Jan-2025: [gained 4 to 5 pounds that came on overnight] Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Ache; Headache; Swelling arm
Medical History/Concurrent Conditions: Redness
BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; TYLENOL
Test Date: 20250128; Test Name: blood test; Result Unstructured Data: showed severe inflammatory responses of very high eosinophils and elevated basophil count.; Test Date: 20250128; Test Name: weight; Result Unstructured Data: gained 4 to 5 pounds that came on overnight