Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Product colour issue, Pyrexia, White blood cell count increased
Clinical narrative: Burning sensation in chest, nose, mouth; Tingling in head, nose, chest and mouth; Shot color was different; Chills; Fever; Aches; This is a spontaneous case from, initially received from other health professional (pharmacist) via agency (reference number: SEQ19-06465) on 11-Nov-2019, concerning a 56-year-old, male patient.   The patient's relevant medical history was not provided. The patient's concomitant medications were not reported.  On 02-Oct-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose. 0.5 ml, batch number: 261202, expiration date: 23-Jun-2020, route of administration: intramuscular and anatomical location: left deltoid] for influenza prophylaxis. It was reported that the shot colour was different [explicitly coded as Product discoloration'].  On an unspecified date, after vaccination, the patient experienced burning sensation in chest and mouth, as well as tingling in head and nose.  On 07-Oct-2019, seven days after vaccination, the patient experienced chills, fever and aches.  On 21-Oct-2019, the patient went to his doctor and was prescribed with prednisone, two tablets for two days, and then to reduce the dose, for tingling and burning sensation. The patient stated that he was feeling better while using prednisone. The patient was also prescribed with luprofen at the dose of 400 mg, for an unknown indication, and was taking over-the-counter Antacid (calcium carbonate) for tingling and burning chest pain.  On an unspecified date, the patient underwent X-ray, and the results were fine'. The patient also had blood tests done, and the result was negative, while the white blood cell count (WBC) was elevated.  At the time of this report, the patient was recovering from the events of fever, chills and pain. The patient stated it was much better '80-90%', and that he sometimes had feelings of chills. The outcome for the events of tingling and burning sensation was not reported.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Follow-up reported by other non-health professional to agency [reference number: SEQ19-06818] on 20-Nov-2019: Consumer added as a reporter. Laboratory analysis added. Flucelvax therapy tab updated [route of administration and anatomical location added]. Prednisone therapy tab updated [dosing regimen and indication provided; additional therapy tab opened]. Antacid added as a corrective treatment.  The events of chills, fever and aches updated [onset date changed to 07-Oct-2019 and outcome changed to recovering]. New non-serious events added burning sensation', tingling' and product discoloration'. Additional agency number added. Narrative amended accordingly.   Company Comment: The patient experienced pain, burning sensation, chills, pyrexia and paraesthesia after vaccination with the suspect product Flucelvax Quadrivalent. Product colour issue was also associated with Flucelvax Quadrivalent. Chronology is plausible. No medical history and concomitant medications were reported. Product colour issue is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.; Sender's Comments: The patient experienced pain, burning sensation, chills, pyrexia and paraesthesia after vaccination with the suspect product Flucelvax Quadrivalent. Product colour issue was also associated with Flucelvax Quadrivalent. Chronology is plausible. No medical history and concomitant medications were reported. Product colour issue is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.