Sex: U
Vaccine: FLUR4
Symptoms: Haemolysis, Vaccination site discolouration, Vaccination site erythema, Vaccination site reaction
Clinical narrative: hemoglobin breakout; Parts of it turning even yellow; area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 cm; area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 cm; Initial information received on 26-Oct-2021 regarding an unsolicited valid serious case received from  a patient (health care professional) (under reference number: US-SA-SAC20211029001356).   This case involves an adult patient with an unknown gender who had hemoglobin breakout (haemolysis), parts of it turning even yellow (vaccination site discolouration), area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 (centimeter) cm (erythema) and (vaccination site reaction) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical treatments, concomitant medications, vaccinations and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious hemoglobin breakout (haemolysis) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   This event was assessed as medically significant.  On an unknown date the patient developed a non-serious part of it turning even yellow (vaccination site discolouration), area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 cm (erythema), (vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The reporter reported that the patient  received the Flublok and experienced an (adverse event) AE and was hoping for insights. There were no other symptoms and swelling at the site. He/ she wonder if there had been any change in the formulation for the 2021-2022 product. Something was different because the patient never had anything like that. That was remarkable, grade 3, patient had a 10 cm. Would you happen to know if we had any additional information that a reporter would provide the health care professional (HCP).  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of events was reported as unknown.; Sender's Comments: This case involves an adult patient with an unknown gender who had haemolysis, vaccination site discolouration, erythema and vaccination site reaction after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The time to onset is unknown for the events. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of suspect vaccine cannot be assessed.