Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Swollen tongue, Throat tightness, Urticaria
Clinical narrative: angioedema; hives/urticaria; face, lips, tongue, eyelids swelling; throat started to close up; chest tightness; heart palpitations; legs and calves felt like they were having spasms; legs and calves felt like they were having spasms and they felt heavy like lead weights; voice starting cracking, and then patient started to lose her voice, and finally lost voice completely; Initial information regarding an unsolicited valid serious case was received from a non-healthcare professional (patient) via phone at call center as a general medication inquiry on 14-Dec-2020.  This case involved a 60-year old female patient who experienced angioedema, voice starting cracking, and then patient started to lose her voice, and finally lost voice completely (Aphonia), heart palpitations (Palpitations), chest tightness (Chest discomfort), face, lips, tongue, eyelids swelling (Swelling face), throat started to close up (Throat tightness), legs and calves felt like they were having spasms (Muscle spasms), and they felt heavy like lead weights (Limb discomfort) and hives/urticaria (Urticaria), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV).  Past medical treatment included SULFAMETHOXAZOLE/TRIMETHOPRIM (BACTRIM) on an unknown date in 1995 and experienced a bad reaction.  Past vaccination(s) included INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK) on an unknown date in 2019 at 59 years with no adverse event.  Medical history and family history were not provided.  At the time of the event, the patient had ongoing allergy to sulfa/sulfonamide antibiotics, egg allergy and the patient was more sensitive to ingredients and substances.  Concomitant medications included PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX) for restless legs syndrome. No concomitant vaccines were received.  On 09-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE pre-filled syringe 0.5 mL (lot number: UJ448AA, expiry date: unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  On 12-Oct-2020, about 3 days after the administration of the suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, the patient's voice starting cracking, and then started to lose voice, and finally lost voice completely (Aphonia).    On 20-Oct-2020, about 11 days after the administration of the suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, the patient began to experience serious events of hives/urticaria (Urticaria), angioedema, heart palpitations (Palpitations), chest tightness (Chest discomfort), face, lips, tongue, eyelids swelling (Swelling face), throat started to close up (Throat tightness). These events were assessed as medically significant.   On 20-Oct-2020, about 11 days after the administration of the suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE patient experienced non serious events such as calves felt like they were having spasms (Muscle spasms) and they felt heavy like lead weights (Limb discomfort).   Patient's physician prescribed 2 Benadryl tablets every 4 hours, and prednisone, which patient took for 2 days, but symptoms continued to progress, so that on 23-Oct-2020, the patient went to the emergency room (ER) and was treated there with intravenous medications, and Pepcid (Famotidine).   Patient was not admitted to the hospital, and the patient's symptoms have resolved, but it took another 8 days after ER visit for voice to come back.   Outcome of all adverse events was resolved on an unknown date.; Sender's Comments: This case involved a 60-year old female patient who presented with angioedema after 11 days of receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV). Time to onset is too long to suggest an allergic reaction. Although, medical history, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.