Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pyrexia, Somnolence
Clinical narrative: fever; very sleepy; hemoglobin is generally in the range of 13.8 to 14.1, but  it had dropped to 13.3; hurt her back, back injury; fell after slipping on the floor; being hit suddenly by full-blown influenza, felt like influenza; chills; Initial information received on 27-Nov-2019 regarding an unsolicited valid serious case from a consumer.  This case involves a 76 years old female patient who felt like influenza, being hit suddenly by full-blown influenza (influenza), hurt her back, back injury (back injury), fell after slipping on the floor (fall), was very sleepy (Somnolence) and hemoglobin generally in the range of 13.8 to 14.1, but it had dropped to 13.3 (Haemoglobin decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history included decreased haemoglobin when she had endometrial cancer and for which she was able to be treated only with surgery, and did not have to receive chemotherapy or radiation. Past vaccination included high-dose influenza every year without any adverse event. At the time of the vaccination, the patient had upper respiratory tract infection. Patient had no other vaccines at the time of her Fluzone High-Dose vaccination.  On 04-Oct-2019 at 4:00 pm, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ280AA and expiration date not reported) via an unknown route in an unknown administration site.  On 04-Oct-2019, around 6:00 pm, the patient being hit suddenly by full-blown influenza, felt like influenza (influenza, serious) with chills (chills) 2 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  On 06-Oct-2019, the patient fell after slipping on the floor (fall) and hurt her back, back injury (back injury) 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 08-Oct-2019, the patients hemoglobin was generally in the range of 13.8 to 14.1, but it had dropped to 13.3 (haemoglobin decreased) 4 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed non-serious fever (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On an unknown date, the patient was very sleepy (somnolence) (non-serious) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The patient stated this fall and back injury had nothing to do with the Fluzone High-Dose. She went to the emergency room (ER) on 08 Oct 2019. Patient saw her doctor again on 14 Nov 2019. The patients hemoglobin was generally in the range of 13.8 to 14.1.   Relevant laboratory test results included: On 08-Oct-2019, computerized tomogram performed however result not reported. On 08-Oct-2019, hemoglobin was 13.3 and on 22-Oct-2019 was 12.5.  Final diagnosis was influenza, somnolence and haemoglobin decreased.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.; Sender's Comments: This case concerns 76 year old female patient who presented with  Influenza, somnolence and haemoglobin decreased after vaccination with Fluzone High-Dose. The time to onset is not compatible (too short two hours). Patient's medical condition at the time of vaccination included upper respiratory tract infection and had recovered from endometrial cancer without chemotherapy or radiation. Patients concomitant medications were not reported. Based upon the reported information, the role of vaccine cannot be assessed.