Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
PNEUMONIA; Initial information received on 24-Oct-2025 regarding a solicited valid serious case received from a physician, in the scope of company sponsored study. Study Title. This case involves Adult and unknown gender subject who experienced pneumonia, during the study participation. The subject's past medical history included Drug hypersensitivity from 2000 to 16-Oct-2025 and Nephrolithiasis on 02-Sep-2025. At the time of the event, the subject had ongoing Drug hypersensitivity since 1988, Obesity since 2005, Obstructive sleep apnoea syndrome since 2010, Asthma, Hypertension, Benign prostatic hyperplasia and Hyperlipidaemia all since 2012, Bundle branch block left since 2015, Chronic obstructive pulmonary disease since 2016, Atrial fibrillation and Hypertonic bladder both since 2020. The subject's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included valsartan and furosemide both for hypertension; atorvastatin for hyperlipidaemia; tamsulosin for benign prostatic hyperplasia; vibegron for hypertonic bladder; varenicline for smoking cessation therapy; and albuterol [salbutamol] for chronic obstructive pulmonary disease. On 16-Oct-2025, the screening/visit 1 was performed. On an unknown date, the subject received a dose of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, Solution for injection in pre-filled syringe at an unknown dose via unknown route as prophylactic vaccination. On 19-Oct-2025, unknown latency following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject had shortness of breath, chest pain and dry cough. The subject went to emergency room (ER) and was admitted. Chest x-ray was done (result not provided). The subject was diagnosed with pneumonia. The maximum intensity of the event was severe. The event was assessed as a medically attended adverse event (MAAE) but not assessed as an Adverse Event of Special Interest (AESI). Healthcare provider was contacted for the event. Action taken was not applicable with SARS-COV-2 (OMICRON JN.1) RECOMBINANT SPIKE PROTEIN. The subject received unspecified intravenous (IV) antibiotics as corrective treatment for the event (pneumonia). On 22-Oct-2025, the subject was discharged with oral antibiotics. At time of reporting, the outcome was Recovering / Resolving for the event pneumonia. The event did not cause discontinuation of the subject from the study. Pneumonia was considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE by the reporter and not reportable by the company based on company causality assessment. Rationale for final investigator causality: Possible bacterial in nature Relationship between Pneumonia and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.
Allergy to antibiotic; Asthma; Atrial fibrillation; Benign prostatic hyperplasia; COPD; Hyperlipidemia; Hypertension; Left bundle branch block; Morbid obesity; Obstructive sleep apnea; Overactive bladder
Medical History/Concurrent Conditions: Drug allergy; Kidney stone
VALSARTAN; ATORVASTATIN; TAMSULOSIN; FUROSEMIDE; VIBEGRON; VARENICLINE; ALBUTEROL [SALBUTAMOL]
Test Date: 20251019; Test Name: Chest x-ray; Result Unstructured Data: result not provided