Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging normal, Muscular weakness, Pain, Suicidal ideation
Clinical narrative: became  depressed and sucidal; became  depressed and sucidal; started having visual disturbances and seeing light and objects which increased in numbers over time; eye ache; pain spreading throughout body; weakness in limbs; headache in forehead area and top of head; Initial information regarding an unsolicited valid serious case was received consumer/non- health care professional via Agency (Reference number- 00732293) and transmitted to Sanofi on 19-Aug-2021.  This case involves a 55 year old female patient who became depressed and sucidal [(suicidal ideation) and(depressed mood)], disturbances and seeing light and objects which increased in numbers over time (visual impairment), eye ache (eye pain), pain spreading throughout body (pain), weakness in limbs (muscular weakness), and headache in forehead area and top of head (headache) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  However, the patient had no pre-existing conditions prior to the FLUZONE vaccine.   On 15-Mar-2020, the patient received a first event dose (0.5 ml) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ273AB; expiry date: not reported) via intramuscular route in the left forearm for prophylactic vaccination.  On an unknown date in 2020, two weeks after receiving the vaccine, the patient developed a non-serious event reported as started having visual disturbances and seeing light and objects which increased in numbers over time (visual impairment), weakness in limbs (muscular weakness) and headache in forehead area and top of head (headache) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date in 2020, the patient developed a non-serious eye ache (eye pain) and pain spreading throughout body (pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, the patient began experiencing side effects from the vaccine approximately 2 weeks after receiving it. The patient had experienced many side effects which had progressed and required many doctor's visits and hospitalizations due to the adverse reaction to the FLUZONE vaccine. Further the reporter detailed that two weeks after receiving the vaccine the patient started having visual disturbances and seeing light and objects which increased in numbers over time. The patient began to have a headache in forehead area and top of head with weakness in limbs. The weakness was rated as 4 on a scale of 1-10 in limbs.  On 05-May-2020, the patient visited, the optometrist and the patient was given an eyedrop (not specified in this report).  On 16-Jun-2020, the patient visited a retina specialist the patient. Relevant laboratory test on 16-Jun-2020: Ophthalmological examination (eye test): [retina and vitreous were normal].  On 29-Jun-2020, again the patient visited a retina specialist, and everything looked normal.  On 30-Jun-2020, the patient's symptoms were so bad that the patient went to ER (emergency room).  Relevant laboratory test on 30-Jun-2020: Magnetic resonance imaging (MRI): [done (results not reported)].  On 04-Jul-2020, the patient visited the ER again. It was reported the patient had headache in forehead and top of head and eye ache. It was not migraine related. They could not determine cause.  On 02-AUG-2020, the patient visited a neurologist, the patient as referred to neuro-ophthalmologist.  On 28-AUG-2020, the patient visited the neurologist who ordered MRI (Magnetic resonance imaging) and ECG (Electroencephalogram).  Relevant laboratory test included:  Electroencephalogram in 2020: [no abnormalities shown] Magnetic resonance imaging: in 2020: [no abnormalities shown]  On 10-SEP-2020, the patient visited a neuro-ophthalmologist who originally thought it started in brain, but original diagnosis was incorrect.  Relevant laboratory test in Sep-2020: Lumbar puncture (spinal tap): [ruled out brain infection].  In 2020, the patient developed a serious event reported as became depressed and sucidal [(suicidal ideation) and depressed mood)] (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event suicidal ideation was assessed as medically significant.  It was reported, the patient became depressed and suicidal from symptoms and pain spreading throughout body. The patient was submitted to the psychiatric care on 20-DEC-2020.  On 07-Jan-2021, the patient had second psychiatric visit.  On 08-Feb-2021, the patient had third psychiatric visit.  On 05-Mar-2021, the patient visited psychiatrist.  On an unknown date in Apr-2021, the patient had a visit to a primary care physician.   Relevant laboratory test included:  Magnetic resonance imaging head: Magnetic resonance imaging head - in April 2021: [done (results not reported)].  Also, the patient was ordered thyroid tests.   Relevant laboratory test included: Thyroid function test (thyroid test) - in 2021: [done (results not reported)].  On 01-Jun-2021, the patient had visit to the neurologist.  On an unknown date in Jul-2021, the patient visited neurologist again.   Relevant laboratory test included: Electroencephalogram - In July 2021: [no findings in brain] Magnetic resonance imaging- In July 2021: [no findings in brain]  An unknown corrective treatment was received for the event visual impairment. It was not reported if the patient received any corrective treatment for the other events.  At the time of this report the outcome of the event was unknown.; Sender's Comments: This case concerns a 55-year-old female patient who had suicidal ideation, depressed mood, visual impairment, eye pain, pain, muscular weakness, and headache after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible for the events- visual impairment, muscular weakness and headache. Time to onset is unknown for the events- suicidal ideation, depressed mood, eye pain and pain. The patient had no pre-existing conditions prior to the vaccination. Additional information regarding medical history, other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.