Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, General physical condition abnormal, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: started vomiting, may be due to the headaches; neck has been really stiff; she has been very sick ever since then/ just feels sick; started having headaches, always has a headache now, it will not stop; developed flu-like symptoms for 3 or 4 days; including fever; has not "looked right," she has felt exhausted and goes to bed at 8:00 pm each night; muscle aches; became very weak in the legs; lost feeling in the tips of her fingers and toes; legs appear "blue-ish" in color; her blood pressure is "out of whack; Initial information received on 19-Dec-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional (patient's mother).  This case involves a 17 years old female patient who was taken to the emergency room three times, and one of those times she was kept overnight in the hospital, she has been very sick ever since then/ just feels sick, developed flu-like symptoms for 3 or 4 days, became very weak in the legs, started vomiting, may be due to the headaches, neck has been really stiff, lost feeling in the tips of her fingers and toes, legs appear blue-ish in color, her blood pressure is "out of whack, has not looked right, she has felt exhausted and goes to bed at 8:00 pm each night, started having headaches, always has a headache now, it will not stop, muscle aches and including fever after receiving Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history included unspecified problems with the unspecified flu vaccine in the past.  The patient's past medical treatment(s), vaccination(s) history and family history were not provided.   On 26-Sep-2024, the patient received a dose of suspect influenza quadrivalent recombinant vaccine lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  The following weekend, the patient developed flu-like symptoms (influenza like illness) ( latency: approximately a few days) (Onset date: 2024) for 3 or 4 days, including fever (pyrexia) ( latency: approximately a few days) (Onset date: 2024) , muscle aches (myalgia) ( latency: approximately a few days) (Onset date: 2024),exhaustion (fatigue) ( latency: approximately a few days) (Onset date: 2024), but no vomiting yet. After that, the patient started having headaches (headache) (onset date: 2024) (latency: approximately a few days), and the patient always has a headache now, it will not stop, and the patient never had a problem with headaches before. Also, the patient has not "looked right," she has felt exhausted and goes to bed at 8:00 pm each night. She has no fever now but just feels sick (malaise) (unknown onset in 2024 and unknown latency). About three weeks ago, the patient became very weak in the legs (muscular weakness)  (unknown onset in  Nov-2024 and approximately 2 months latency) and started vomiting (vomiting) (unknown date of onset in Nov-2024 and approximately 2 months latency). The vomiting may be due to the headaches. The patient's neck has been really stiff (musculoskeletal stiffness) (unknown onset in 2024 and unknown latency). The patient was taken to the emergency room three times and one of those times she was kept overnight in the hospital and released the following day. She received IV (intravenous) fluids, and was tested for influenza, Covid-19 and streptococcal infection, and all those tests were negative. ACT (computed tomography) scan and an MRI (magnetic resonance imaging) were normal. A lumbar puncture showed no meningitis. The patient is continuing to vomit. No one seems to know what is causing this illness. The patient lost feeling in the tips of her fingers and toes (sensory loss) (unknown onset in 2024 and unknown latency), and she has a neurology appointment next week.  The patient's legs appear "blueish" in color (cyanosis) (unknown onset in 2024 and unknown latency), and her blood pressure is "out of whack".  (blood pressure abnormal) (unknown onset in 2024 and unknown latency) Currently they are waiting for the results of a test for IgG and IgA antibodies.   Relevant laboratory test results included: COVID-19 - On an unknown date: Negative Computerised tomogram - On an unknown date:  [normal] Magnetic resonance imaging - On an unknown date: [normal] Streptococcal infection - On an unknown date: Negative A lumbar puncture- On an unknown date: showed no meningitis.  Action taken- not applicable.  Corrective Treatment: Unspecified IV fluids for the events influenza like illness musculoskeletal stiffness; muscular weakness; malaise; vomiting and headache. It was not reported if the patient received a corrective treatment for the events cyanosis; blood pressure abnormal and sensory loss..  At time of reporting, the outcome was not recovered/ not resolved for vomiting; headache; malaise. Recovered/ resolved for fever and unknown for the rest of the events.  Seriousness criteria: Hospitalization for the events influenza like illness and its symptoms; malaise; vomiting; headache; musculoskeletal stiffness; muscular weakness.; Sender's Comments: Sanofi Company Comment dated 25-Dec-2024: This case involves a 17 years old female patient who was taken to the emergency room three times, and one of those times she was kept overnight in the hospital, she has been very sick ever since then, developed flu-like symptoms for 3 or 4 days, became very weak in the legs, started vomiting, may be due to the headaches, neck has been really stiff, has not "looked right," she has felt exhausted and goes to bed at 8:00 pm each night, started having headaches, always has a headache now, it will not stop, muscle aches and including fever after receiving Influenza quadrivalent recombinant vaccine [Flublok]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, allergic history, are needed to fully assess this case. The lab tests done have been inconclusive which makes it hard to determine the possible etiology of the events but the patient has had history of some problems with the flu vaccine in the past as well but the exact vaccine and symptoms have not been provided. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.