Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Cystitis, Ear discomfort, Ear haemorrhage, Eye infection
Clinical narrative: lung infection; infections all the way from the bladder; ear exploding; mucus that was coming out of their ears; eye infection; ear exploding and bleeding; patient is still experiencing symptoms despite treatment with fluzone hd/ short period of efficacy of FLUZONE HD; Initial information received on 16-Jan-2025 regarding an unsolicited valid serious case received from a Patient.  This case involves a 75 years old female patient who experienced lung infection, infections all the way from the bladder, ear exploding and bleeding, eye infection and patient is still experiencing symptoms despite treatment / short period of efficacy of  Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  The patient's past medical history included Ear tube insertion. The patient's past medical treatment(s),  and family history were not provided. The patient has been getting flu shots since the age of 23 years (unspecified manufacturer)  At the time of the event, the patient had ongoing Hypersensitivity and Otorrhoea.   On an unknown date in 2024, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, route, strength, lot/batch number and expiration date: not provided) for Influenza immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date; patient was still experiencing symptoms despite treatment with FLUZONE HD. Patient also complained about the short period of efficacy of FLUZONE HD (therapeutic response shortened) (latency: approximately 5 months). Patient said that they were calling about the flu shot that they had. They said this year, its effects only lasted for five months and that their doctor told them not to get another one. They shared that they have four infections all the way from the bladder, (cystitis) (unknown latency) to their ear exploding (otorrhoea) (unknown latency) and bleeding (ear haemorrhage) (unknown latency), to their eyes (eye infection) (unknown latency), and lungs (pneumonia) (unknown latency). They said that they were also taking antibiotics "and all that stuff" but they said that they also needed the protection of a flu shot. They said that if it is not going to work, they wanted to know if it will also be like this next year. They said that "whatever it was" that used to work was taken out. Patient said that everybody had flu and said that the flu shots are really bad this year. After five months, their doctor told them to not go get another one. They said that they do not know what they are supposed to do. They said that they are unprotected. They said that they are a PCA (personal care assistant) and that they take care of sick people. They said that they don't know what to do multiple times. Patient said that they took another dose of FLUZONE HD after it "wore off" in eight months. They tried to get another one five months after this and was advised by their doctor to not get another one. They were frustrated that it took less time this year to not work. MIS inquired more about the blood and explosion in their ears. Patient clarified that it was actually mucus that was coming out of their ears and that the flu shots used to "take care of that." They shared that they were born in city with smog which was why they had natural allergies "and stuff." They said that mucus also got out of their ear twice when they were younger. They said that they "knew it didn't work anymore when" their ears went bad. They said that they ended up with their doctor and had tubes in their ears. They said that this was when they realized that it was the flu shot all along which made them get another one. They said that this flu shot lasted for four years. Patient said that the flu shot started lasting only a year and then eight months for the next one. Now, they are frustrated this time it only lasted for five months. They clarified that when mucus gets out of their ears, their eardrums pop and that this only happens when they don't take the flu shot. They said that the flu shots have saved their life for 40 years and now that it is not working, they are afraid because they are a PCA and that they feel like a "vat of germs." They said that they do not know if they should even be taking care of clients. They reiterated that they were a personal care assistant. They said that if the flu shots continue to not work, they might have to move "or something." Patient inquired about an RSV  (respiratory syncytial virus) shot that has recently "come out" and wanted to know if it can help control their mucus. MIS inquired about the brand name of the aforementioned RSV vaccine, then referred them to their HCP (healthcare professional). Patient was not able to confirm the brand name of the RSV vaccine. Patient said that they have plans and that they needed information. They said that they have been taking flu shots since they were 23 years old, during which it lasted for 35 years. Patient made a brief observation about how it was also in the middle of winter in their area  Action taken- not applicable for all the events  An unknown antibiotic as an corrective treatment was received for the events (eye infection, lung infection; otorrhoea; ear haemorrhage and cystitis)  At time of reporting, the outcome was  not recovered/ not resolved for otorrhoea and Unknown for all the events.  Seriousness criteria- Medically significant for Pneumonia.; Sender's Comments: Sanofi Company Comment dated 21-Jan-2025: This case involves a 75 years old female patient who experienced lung infection, after receiving Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD]. The causal role of the company suspect vaccine cannot be assessed in the absence of  information regarding temporal relevance. Further information regarding concurrent condition during vaccination, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. Additionally the role of patient's allergies; occupational exposure to infections cannot be overlooked either.