Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: lot of pain; sores in her mouth; extreme sensitivity to hearing in left ear; hyper-reflexes on the left side; She has a new egg intolerance where she feels sick to her stomach upon eating eggs; She has a new egg intolerance where she feels sick to her stomach upon eating eggs; left side went numb, jaw went numb; tongue swelled; weakness; she gets unusually tired on her left side after activity, and then cannot use her left side; Initial information was received on 10-Mar-2020 regarding an unsolicited valid serious case from a consumer/non-hcp.  This case involves a 40 year old female patient who experienced lot of pain (pain), sores in her mouth (oral pain), extreme sensitivity to hearing in left ear (hyperacusis), hyper-reflexes on the left side (hyperreflexia), egg intolerance where she feels sick to her stomach upon eating eggs (food intolerance) (abdominal discomfort), left side went numb, jaw went numb (hypoaesthesia) and tongue swelled (swollen tongue), she gets unusually tired on her left side after activity, and then cannot use her left side (fatigue) and weakness (asthenia) while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  She had some slight numbness in her arm after her flu shot in 2018. The patient has received flu shots for 20 years. Medical history, medical treatment and family history were not provided.  On 13-Sep-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ212AB, expiry date-30-Jun-2020) via Unknown route in the left arm for prophylactic vaccination.  On an unknown date, within 1.5 hours, the patient's entire left side went numb (hypoaesthesia) and her tongue swelled (swollen tongue). The patient went to the emergency room (ER) three times.    On an unknown date (unknown latency), the patient had a lot of pain (pain) and her jaw went numb (hypoaesthesia). The patient was still numb on her left side.  On an unknown date (unknown latency), the patient was getting sores in her mouth (oral pain) and had extreme sensitivity to hearing in her left ear (hyperacusis).  The patient described that she had weakness (onset date and latency unknown), but her neurologist says it was not actually weakness because she does have strength. Instead, the symptoms were that she gets unusually tired on her left side after activity, and then cannot use her left side (fatigue) (onset date and latency unknown).   The patient had pain, soreness, weakness (asthenia), and numbness the next day after activity. On an unknown date (unknown latency), the patient had hyper-reflexes on the left side (hyperreflexia) and developed a new egg intolerance where she feels sick to her stomach upon eating eggs (food intolerance) (abdominal discomfort).   The patient stated that the situation was really bad.  These all events were serious due to Permanent or significant disability / incapacity.  Laboratory data:  Four or five days later, she had a spinal tap and Guillain Barre was ruled out. The patient stated that she had neurology symptoms similar to Guillain Barre, but only on her left side.  Final diagnosis was hypoaesthesia, swollen tongue, lumbar puncture, pain, oral pain, hyperacusis, asthenia, hyperreflexia, food intolerance and abdominal discomfort and fatigue.   It was not reported if the patient received a corrective treatment.  The outcome of the events were unknown at the time of report.; Sender's Comments: This case concerns 40 year old female patient who experienced hypoaesthesia, swollen tongue, lumbar puncture, pain, oral pain, hyperacusis, asthenia, hyperreflexia, food intolerance and abdominal discomfort after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible for hypoaesthesia, swollen tongue, lumbar puncture and unknown for other events. The patient has received flu shots for 20 years. Guillain Barre was ruled out. She has neurology symptoms similar to Guillain Barre, but only on her left side. Additional information regarding patient's medical history, condition at the time of vaccination, lab data would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.