Age: 87.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Swelling
Clinical narrative: intoxicated; sleepy and drowsy; jittery; her teeth turn the other way; arm immobile, shoulder is becoming immobilized; unable to do any of her previous activities; Hematomas; becoming depressed, feeling like she cannot go on living this way; Fentanyl patch, paracetamol, Lidocaine pathches have not relieved pain, it has zero effect on her pain; a hard lump developed at the injection site; a purple bruise at the injection site; the top half of her arm above the injection site had swollen up, was red, painful to touch and warm; the top half of her arm above the injection site had swollen up, was red, painful to touch and warm; pain was radiating into the chest and across the shoulder and out of the arm; Upon second medical examination of the case during internal review, a significant correction was performed on 15-Dec-2020 to correct suspect product coding (LIDOCAINE) to non-company from company.  Initial information regarding an unsolicited valid serious case was received from the non-healthcare professionals (patient's husband and daughter) via Information (Reference number- 00368249) and transmitted to Sanofi on 23-Nov-2020.  This case involves an 87 year old female patient who experienced pain radiating into the chest, across the shoulder and out of the arm (pain), hematoma, her arm and shoulder became immobilized (mobility decreased), sleepy and drowsy (somnolence), jittery (feeling jittery), her teeth turn the other way (tooth disorder), unable to do any of her previous activities (loss of personal independence in daily activities), the top half of her arm above the injection site had swollen up, was red, painful to touch and warm (inflammation and vaccination site reaction), a hard lump at the injection site (vaccination site induration), a purple bruise at the injection site (vaccination site bruising), she was becoming depressed, feeling like she could not go on living this way (depression) and was intoxicated (poisoning), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and while treated with ACETAMINOPHEN [PARACETAMOL], LIDOCAINE and FENTANYL.  The patient had received flu shots in the past for prophylactic vaccination without adverse event.  The patient's past medical treatment(s) and family history were not reported.  At the time of the event, the patient had ongoing Hiatus hernia.  The reporter was not sure, but it was her impression that the patient did not receive any other vaccines concomitantly.  Before the vaccination the patient was a very vibrant and able to cook and was very busy and active.  On 13-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot number and expiration date were not reported) via an intramuscular route in the left arm for prophylactic vaccination.  On either 13 or 14-Sep-2020, the patient experienced that the top half of her arm above the injection site had swollen up, was red, painful to touch and warm (inflammation and vaccination site reaction), within 24 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The redness went away within a week, but the pain was still there. The swollen area was the size of a grapefruit, very painful and hot to the touch. Pain level gradually increased to ten in the left arm.  On an unknown date of Sep-2020, the patient developed non-serious a hard lump and a purple bruise at the injection site (vaccination site induration and vaccination site bruising), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  At one point on an unknown date of Sep-2020, the pain was radiating into the chest, across the shoulder and out of the arm (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient and her family were concerned about infection. They went to the emergency room on an unknown date of Sep-2020.   An MRI (Magnetic Resonance Imaging) and doppler scan of blood flow were done and the results did not support infection and instead it looked like just a reaction which confirmed hematoma, (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   On an unknown date, the patient had been through gamut of pain relief, including acetaminophen (APAP) through all codones, lidocaine patches and a shot in the arm by a pain specialist on the shoulder joint. There had been no relief. These things made her sleepy, drowsy (somnolence) and intoxicated (poisoning) but had not relieved her pain, (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and dose intake of PARACETAMOL and LIDOCAINE.  The event of poisoning was assessed as medically significant.  Also, this was a case of lack of drug effect (drug ineffective) as the patient had acetaminophen(paracetamol), applied lidocaine and Fentanyl patch, but it did not relieve her pain, had zero effect on her pain.   On an unknown date, the patient complained that the Fentanyl patch made her jittery (feeling jittery) and her teeth turned the other way (tooth disorder),(unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and dose intake of PARACETAMOL, LIDOCAINE and FENTANYL.  On an unknown date, at a second visit to the emergency room she was given a Morphine shot in her arm for pain.   On an unknown date, her arm shoulder became immobilized (mobility decreased) and the bruising was coming out more. The only pain relief was a high dose of gabapentin with acetaminophen and that provided only a tiny bit of short-lived relief of maybe one hour.  However, as the patient had complication of a hiatal hernia, she could not tolerate many medications.   On an unknown date, the patient was unable to do any of her previous activities (loss of personal independence in daily activities) and was becoming depressed, feeling like she could not go on living this way (depression), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and dose intake of PARACETAMOL, LIDOCAINE and FENTANYL.  The patients husband then removed the patch as it was causing too many side effects.  The action taken with suspect drugs was not reported at the time of reporting.  At the time of reporting, the patient had not recovered from the events (It was reported that, patient was reaching the end of her rope).  As per the reporter, these events were either due to an improper shot and/or an adverse reaction to the vaccine.  Information on the batch number was requested.  Addendum: a significant correction was performed on 15-Dec-2020 to correct suspect product coding (LIDOCAINE) to non-company from company.; Sender's Comments: This case concerns an 87 year old patient who experienced  pain, hematoma, mobility decreased, loss of personal independence in daily activities, inflammation, vaccination site reaction, vaccination site induration and vaccination site bruising, after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT and experienced somnolence, feeling jittery, tooth disorder, poisoning and drug ineffectiveness, after treatment with ACETAMINOPHEN, LIDOCAINE and FENTANYL. The time to onset is compatible for inflammation, vaccination site reaction, vaccination site induration, vaccination site bruising, pain and unknown for other events.  The patient had ongoing hiatus hernia. The patient's allergy history and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual product cannot be assessed.