Sex: F
Vaccine: FLUC4
Symptoms: Feeling cold, Hypoaesthesia, Injection site pain, Injection site paraesthesia, Peripheral coldness
Clinical narrative: The patient feels coldness on her stomach, breasts; [Tingling and] burning in the patient's toes/ knees and feet; Tingling [and burning] in the patient's toes/ knees and feet; Within 45 minutes of getting the flu shot, bilateral symptoms of tinkling and burning started on the injection site; She experienced tingling all over her body; She still feels a little bit numb; She still has a lot of cold in both feet; This is a spontaneous case, reported by other non health professional (consumer) via Agency (reference number: SEQ19-05076) and initially received on 18-Oct-2019, concerning a 61-year-old, female patient.  The patient's medical history included Fluzone (influenza vaccine) that caused adverse events a couple years before. The patient's concomitant medications were not provided. The patient was not diabetic.  On 16-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, anatomical location: reported as left side', dose, route of administration, batch number and expiration date: not reported] for an unknown indication.  On the same day, 45 minutes after vaccination, the patient experienced tingling and burning that started on the injection site on the left side of the body. Symptoms migrated to the right side (bilateral) and to the knees and feet. The patient experienced tingling and burning in her toes. She also felt coldness on her stomach and breasts. It was not reported whether the corrective treatment was applied.  Afterwards, in October 2019, the patient experienced tingling all over her body. She was going to visit a neurologist in a couple of months. Also, she still felt a little bit numb and she still had a lot of cold in both feet.  On an unspecified date in October 2019, the patient was feeling better, but the outcome of the events tingling all over her body, numbness and cold feet was not recovered.  The case was assessed as non serious and the reporter did not provide the causality assessment to Flucelvax QIV.  Follow up received from other non health professional on 31-Oct-2019: historical vaccine Fluzone was added in the patient tab,  the events tab was updated with three new events, the outcome of the events was updated. Narrative was updated accordingly.  Company comment: The patient was feeling cold and experienced burning sensation, hypaesthesia, peripheral coldness, paraesthesia and vaccination site paraesthesia, all associated with administration of the suspect product, Flucelvax QIV. Chronology seems plausible. No information regarding concomitant drugs was provided. Based on provided information, causal role of the suspect product is assessed as possibly related for all events.; Reporter's Comments: The case was assessed as non serious.; Sender's Comments: The patient was feeling cold and experienced burning sensation, hypaesthesia, peripheral coldness, paraesthesia and vaccination site paraesthesia, all associated with administration of the suspect product, Flucelvax QIV. Chronology seems plausible. No information regarding concomitant drugs was provided. Based on provided information, causal role of the suspect product is assessed as possibly related for all events.