Sex: F
Vaccine: FLU4
Symptoms: Asthenopia, Feeling hot, Malaise, Migraine, Pyrexia
Clinical narrative: migraine headache for a day and a half/ felt like my head exploded; eyes were heavy; feel warm; was very unwell; had a fever; urinary tract infection; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (Under reference 00861865).  This case involves a 70 years old female patient who had urinary tract infection, migraine headache for a day and a half/ felt like her head exploded (migraine), eyes were heavy (asthenopia), was very unwell (malaise), had a fever (pyrexia) and feel warm (feeling hot), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Influenza vaccine in 2018, Fluzone High Dose Quadrivalent (lot and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination on 07-Oct-2019 and FLUBLOK Quadrivalent (lot and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination on 02-OCT-2020.  Medical treatment(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history of Reaction to food additive.   On 27-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via unknown route in  an unknown administration site for prophylactic vaccination.  On 12-Nov-2021, the patient developed a non-serious urinary tract infection, 1 month 16 days (six and a half weeks) following the administration of vaccine.  On an unknown date in 2021, the patient was quite sick for three days following FLUZONE HIGH-DOSE QUADRIVALENT vaccine.   On an unknown date, the patient developed a non-serious migraine headache for a day and a half/ felt like my head exploded/ felt congested (migraine), eyes were heavy (asthenopia), was very unwell (malaise), had a fever (pyrexia) and feel warm (feeling hot) [unknown latency] following the administration of vaccine.  It was reported "I have been having problems since 2019. I received FLUZONE HIGH-DOSE on 07Oct2019, FLUBLOK on 02Oct2020, and FLUZONE HIGH-DOSE QUADRIVALENT on 27Sep2021. Then, about six and a half weeks after each of those flu vaccines, I had a urinary tract infection. I would like to know the exact ingredients in these flu vaccines and what has changed in them that may be causing me to have a urinary tract infection six and a half weeks after the vaccines. I believe something since 2019 is causing my problems. I have been consistent with getting flu shots because of my travels. In November of 2019, I got my ever first in my life urinary tract infection. My gynecologist said that I was lucky. I was almost 70 years old. I was traveling around that time, so I thought that maybe I was not drinking enough water or I was not having regular bathroom visits. Then in 2020, I was not going anywhere. I was at home and I again had a urinary tract infection in November. This year 2021, the same story. I had a urinary tract infection on 12Nov2021. It (urinary tract infection) is always six and a half weeks after I have the flu shot. Now, I am drawing a connection that it must be something from the flu shot that is causing this. It might be from something that has been added in 2019. My concern is the consistent urinary tract infection (each November). Each time I had urinalysis and it came back negative. I did not do one (urinalysis) in 2019. I did a urinalysis in 2020 and 2021 and the urinalysis came back negative. Something is giving me this urinary tract infection without any reason. This year, I was quite sick for three days following my FLUZONE HIGH-DOSE QUADRIVALENT injection on 27Sep2021. I had a migraine headache for a day and a half. I do get migraines but the headache on other side is rare and then it went behind. It was strange. On the third day, it felt like my head exploded, my eyes were heavy, and I was very unwell. The fourth strain in the FLUZONE HIGH-DOSE QUADRIVALENT may be too much for me. The fourth strain might have been responsible for the symptoms that I had. I felt like I had a fever and I felt congested, but it was all in my head. So, something is quite serious for me. I always have a reaction after a flu shot like I feel warm and do not feel so well but this time was worse. I know a lot of things have formaldehyde and that can also cause some liver problems. The pharmacy records only went back three years, so I do not know which flu vaccine I had in 2018. I will be seeing my doctor in two weeks and I would like to have information to be able to discuss with my doctor. I may try the FLUZONE STANDARD DOSE next year. Certain additives in processed foods bother me. I have a problem with MSG. I get headache or pains from it. No further information was provided."   Relevant laboratory test results included: Urine analysis in 2020 and 2021: Negative  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.  Follow up information was received on 22-NOV-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (Under reference 00861865).  Medical history and events (migraine, asthenopia, malaise, pyrexia and feeling hot) were added, corresponding fields and narrative was updated.