Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | — |
pulmonary fibrosis; Initial information received on 21-May-2026 regarding an unsolicited valid serious case received from a consumer (non-healthcare professional). This case involves an unknown age male patient who experienced pulmonary fibrosis after receiving NVX-COV2373 (original) adjuvanted vaccine (Nuvaxovid). The patient's past medical history included gastroesophageal reflux disease. The patient's past drug history, vaccination(s), family history, and concomitant medications were not provided. At the time of the event, the patient had ongoing condition(s): gastroesophageal reflux disease. On unknown date the patient received a dose (dose: unknown, frequency: unknown) of NVX-COV2373 (original) adjuvanted vaccine dispersion for injection (batch/lot number: unknown, expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. The patient reported having also been recently diagnosed with pulmonary fibrosis (Pulmonary fibrosis, onset date: unknown, latency: unknown), so they really needed the protection of this vaccine. The caller reported trying to find a location for NUVAXOVID, the COVID vaccine, as they were unable to find it. The caller additionally reported having received, over the years, five doses of the Moderna, the mRNA, and one dose of the Pfizer, and that the last time they had the Moderna one, they had a really awful kind of reaction to it, so they were advised not to use the mRNA one again. The caller reported having had three NOVAMAX doses and had no problems with them. With the Moderna doses, the patient experienced a sore arm, a fever and joint pain. The patient's last Moderna dose was approximately seven hours after receiving it, and the patient had a three to four hour period of the worst flu-like symptoms and then it resolved, and the patient had total hearing loss of the left ear, which lasted about a week. The patient reported being due for a six-month booster, and that was why they were trying to locate the NUVAXOVID vaccine. The patient reported receiving the last booster sometime at the end of October 2025, and then prior to that was April 2025. Relevant laboratory test results included: Pathology test - On unknown date with result: underwent some lung surgery and pieces of the lung were sent to the (specialty) clinic pathology and they identified it as micro-inhalation of stomach acid. Action taken: Not applicable. Corrective treatment: Not reported. Event outcome: Unknown for pulmonary fibrosis. Seriousness criteria: Medically significant for pulmonary fibrosis.
Gastroesophageal reflux disease
Test Name: pathology; Result Unstructured Data: underwent some "lung surgery" and they sent pieces of my lung to the (specialty) clinic pathology and they identified it as "micro-inhalation of stomach acid,"