Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Sinonasal obstruction, Sinus pain, Sinusitis
Clinical narrative: chronic sinus rhinosinusitis/ chronic sinusitis unspecified; This non-serious case was reported by a consumer and described the occurrence of chronic sinusitis in a 62-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number KJ3N3, expiry date 17-APR-2026) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and fosinopril.   On 18-OCT-2024, the patient received Fluarix Tetra 2024-2025 season (left arm) .5 ml and the 2nd dose of Shingrix (left arm) .5 ml. On 25-OCT-2024, 7 days after receiving Fluarix Tetra 2024-2025 season and Shingrix, the patient experienced chronic sinusitis (Verbatim: chronic sinus rhinosinusitis/ chronic sinusitis unspecified). The patient was treated with amoxicillin;clavulanic acid, mometasone furoate (Flonase), guaifenesin (Mucinex), acetylsalicylic acid, chlorphenamine maleate (Coricidin), prednisolone (Deltasone), benzonatate (Tessalon), azelastine hydrochloride (Astelin) and doxycycline hyclate. The outcome of the chronic sinusitis was not resolved.   It was unknown if the reporter considered the chronic sinusitis to be related to Fluarix Tetra 2024-2025 season, Fluarix Tetra Pre-Filled Syringe Device and Shingrix.     It was unknown if the company considered the chronic sinusitis to be related to Fluarix Tetra 2024-2025 season, Fluarix Tetra Pre-Filled Syringe Device and Shingrix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JAN-2025 The patient self-reported this case for himself. Patient was in excellent health before the vaccine. Patient had multiple symptoms. Severe congestion, runny nose, stuffy nose, blood in mucus, occlusion, itchy eyes, pain around sinus cavities, headaches, occasional fever and more times 2.5 months and it was ongoing. Patient presented today on 17-DEC-2024 due to chronic sinusitis that had been occurring for over 2 months duration. Patient said that symptoms began in mid-October after he required a Flu and Shingles shot vaccines. Patient had been experiencing nasal congestion, cough, sinus pressure, nasal drainage. Patient stated his symptoms had been worse at night. Patient had tried several medications including Augmentin, Flonase, Mucinex, other over-the-counter antihistamines and decongestants did not appear to work since October so far in the medication that seems to be working is Coricidin HHP. Patient stated that the Augmentin he took last week was only 7-day course and have not helped with his symptomology. He took an at-home COVID test which was negative. Patient has not had any fevers. His symptoms included pain which was a 2 out of 10 with the Coricidin and a 7-8 out of 10 without the medication. The first round of antibiotics and steroids were taken sequentially did not work. Patient was currently taking a second round of antibiotics. CT scan confirmed mucous drainage with occlusions. Awaiting follow-up care with ENT. Patient experienced facial pain and nasal congestion/drainage for over 12 weeks duration of the symptomology. Patient had tenderness over the eyebrows and on lower bases of nose under her eyes following sinus pressure. Patient qualified for chronic sinus rhinosinusitis with over 12 weeks duration and also experiencing facial pain along with nasal congestion/drainage. Patient had not been experiencing any fevers or severe amounts of pain. As such ordering CT sinuses to assess sinus pressure and if there was any possibility of polyps present. Also ordered prednisone taper for 12 days duration along with Tessalon and doxycycline. Tessalon to be utilized in concurrence with the prednisone. Doxycycline to be taken if after prednisone patient was still experiencing significant symptomology. CT sinus results were received, and they showed that there was an occlusion of the frontoethmoidal drainage pathway on both sides of his face hence leading to the chronic sinus drainage, facial pressure and pain his had been feeling. As such they were going to send a referral to ENT for them to assess if intervention might be needed to help with their condition. Mucosal thickening does affect predominantly the ethmoid and frontal sinuses as mentioned above with occlusion of the frontoethmoidal drainage pathway on both sides.  The clinical indication was reported as chronic sinusitis unspecified. The reporter has alerted the CDC (centers for disease control and prevention) about his adverse reaction.