Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Bell's palsy, Diplopia, Drooling, Dysarthria
Clinical narrative: speaking weird/ difficulty speaking/ her voice changed/ trouble with articulation and speech; difficulty chewing and bites the inside of her mouth; right eye waters and droops; synkinesis; functionality decreased and she has drooling; bleeding behind her eyes; bells palsy; double vision; neck and headache pain; neck and headache pain; Jaw not lined up/ jaw dislocation; Pain in neck and headache that woke her up, Right side of face and forehead; Pain in neck and headache that woke her up, Right side of face and forehead; Initial information received on 05-May-2023 (live follow up processed together) regarding an unsolicited valid  serious case received from a consumer/non-hcp (non-healthcare professional).  This case is linked to case 2023SA142365(Same Patient).  This case involves a 68 years old female patient who had bleeding behind her eyes; bells palsy; pain in neck and headache that woke her up, right side of face and forehead ; double vision; jaw not lined up/ jaw dislocation; speaking weird/ difficulty speaking/ her voice changed/ trouble with articulation and speech; difficulty chewing and bites the inside of her mouth; right eye waters and droops; synkinesis; functionality decreased and she has drooling; neck and headache pain after receiving Influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Arthritis.  Concomitant medications included meloxicam for Arthritis  On 21-Nov-2019, the patient received a dose of suspect Influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UJ300AB) (with an unknown dosage, expiry date) via unknown route in unknown administration site for Immunization.  In 2019 the patient developed a serious event of  bleeding behind her eyes (eye haemorrhage) and bells palsy (bell's palsy) (latency few days approximately) following the administration of Influenza USP trival A-B high dose subvirion vaccine.   On 27-DEC-2019 the patient developed a non-serious event of pain in neck and headache that woke her up, right side of face and forehead (neck pain) (headache) 1 month 6 days following the administration of Influenza USP trival A-B high dose subvirion vaccine.   In 2019 the patient developed a non-serious event of double vision (diplopia) (latency- few days approximately) following the administration of Influenza USP trival A-B high dose subvirion vaccine  On 28-DEC-2019 the patient developed a non-serious event of  jaw not lined up/ jaw dislocation (joint dislocation) 1 month 7 days following the administration of Influenza USP trival A-B high dose subvirion vaccine.  On an unknown date the patient developed a non-serious event of speaking weird/ difficulty speaking/ her voice changed/ trouble with articulation and speech (dysphonia), difficulty chewing and bites the inside of her mouth (mastication disorder) , right eye waters and droops (lacrimation increased), synkinesis, functionality decreased and she has drooling (drooling) and neck and headache pain (neck pain) (headache)  (unknown latency) following the administration of Influenza USP trival A-B high dose subvirion vaccine.  Reportedly, Caller would like to know if Bells palsy has been associated with HD Flu vaccine. Patient states this is the first vaccination she has ever had. Pain in neck and headache that woke her up. Right side of face and forehead. She slept and the next day when she woke up she was speaking weird, Jaw not lined up Went to urgent care, she said they diagnosed her incorrectly - They gave her clindamycin. She says it made her sick as a dog. She ended up going to another urgent care that thought this could be bells palsy or Guillain-Barre.  she is bleeding behind her eyes and also had double vision. And put prism on glasses. He recommended steroids to keep inflammation down at this time her jaw dislocation was getting better perhaps because of reduced swelling 4-4.5 months later started feeling better. vision and other symptoms went away. July 2020 her voice changed looked in the mirror and her face dropped again. started antivirals and steroids. No bleeding behind eyes or dislocated jaw this time.Caller says she is currently having difficulty speaking. 3.5 months she got better. 2021 Clear no symptoms 2022 Oct started to get neck and headache pain again - next morning she had it again. She stated she did not get the COVID shot. She has had 3 episodes of Bells Palsy. She stated at present her bottom right lip is dead and doesn't move and she has a hard time talking. Her face gets tired and makes it hard to talk and talks out one side of her mouth. She stated the "functionality decreased" and she has drooling and trouble with articulation and speech. She has difficulty chewing and bites the inside of her mouth. She stated her right eye waters and droops. The first time this happened it resolved in about 4 1/2 months. During these episodes she has had inflammation in her jaw that caused her teeth to not be aligned. She has experienced nerve pain in her head and neck as well as headaches. She has been prescribed anti-virals and Prednisone in the past. HCP has now recommended that she have facial reconstructive surgery for the paralysis.  Action taken was not applicable.  A corrective treatment with antivirals and steroids was received for the events.  At time of reporting, the outcome was Unknown for the event bells palsy, pain in neck and headache that woke her up, right side of face and forehead , was Recovered / Resolved on an unknown date for the event bleeding behind her eyes, right eye waters and droops, double vision, was Recovering / Resolving for the event jaw not lined up/ jaw dislocation and speaking weird/ difficulty speaking/ her voice changed/ trouble with articulation and speech, difficulty chewing and bites the inside of her mouth, was Unknown for the event synkinesis, functionality decreased and she has drooling and neck and headache pain.  Seriousness criteria: medically significant for the events bells palsy and bleeding behind her eyes; Sender's Comments: Sanofi company comment dated 12-MAY-2023: This case involves 68 years old female patient who had bleeding behind her eyes; bells palsy after receiving Influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history and concomitant medications