Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Irritability, Oropharyngeal pain, Pharyngeal inflammation, Stomatitis
Clinical narrative: stomatitis; pharyngeal mucositis; the soft palate became irritable and sandy in feel; that the irritability spread down to the cheeks, to lips, and to Pharynx; mild in the discomfort level; sore throat; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via Media Information (under reference:00841105).  This case involves a 87-year-old male patient who had stomatitis, pharyngeal mucositis (pharyngeal inflammation), mild in the discomfort level (discomfort), the soft palate became irritable and sandy in feel; that the irritability spread down to the cheeks, to lips, and to pharynx (throat irritation), sore throat (oropharyngeal pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Rheumatoid arthritis.  Concomitant medications included METHOTREXATE for 3 to 4 years, with currently being on 15 mg weekly, for Rheumatoid Arthritis.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.70 mL , lot number and expiry date were not reported) via intramuscular route in the left arm for prophylactic vaccination.  On 18-Oct-2021, the patient developed non-serious stomatitis, pharyngeal mucositis (pharyngeal inflammation), mild in the discomfort level (discomfort), the soft palate became irritable and sandy in feel; that the irritability spread down to the cheeks, to lips, and to pharynx (throat irritation), sore throat (oropharyngeal pain) (on the evening of the injection) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "A consumer reporting having a bad case of stomatitis that developed into oral pharyngeal mucositis, after receiving his FLUZONE HIGH-DOSE 2021-2022 dose. The consumer reported that, on the evening of the injection, the symptoms started with sore throat; that he slept 24-hours the next day; that the following day he was able to move around even catch a performance; that, on the Thursday, 21Oct2021, the soft palate became irritable and sandy in feel; that the irritability spread down to the cheeks, to lips, and to Pharynx; that he did see an Ear, Nose, and Throat (ENT) specialist; that he was prescribed a prednisone taper with starting at a high dose of 60 mg for two days; that, on Monday, 01nov2021, the ENT added betamethasone elixir 4-times a day; that the healing is very slow and discouraging, but the issue is getting better; that he has been taking methotrexate for 3 to 4 years, with currently being on 15 mg weekly, for Rheumatoid Arthritis; that methotrexate does have this as a side effect; that the incident occurred shortly before his next dose; that he is a retired Physician and has always received the FLUZONE High-Dose since it was available; that the FLUZONE HIGH-DOSE injection this year was very mild in the discomfort level; that he never had this reaction before."  Laboratory data was not reported.  The patient was treated with PREDNISONE (prednisone taper) with starting at a high dose of 60 mg for two days and on Monday, 01-Nov-2021, Ear, Nose, and Throat (ENT)  added BETAMETHASONE elixir 4-times a day.  At time of reporting, the patient was recovering from all the events.  There will be no information on lot number for this case.