Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF01A | OT / LA |
I can't smell flowers strongly, like my food, I can taste it but I can't really smell it; I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke; I started to developed smell, like cigarette smell and I don't smoke; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via Novavax Medical Information (AE Number: NOV25-00106) and concerns a 60 year-old female who experienced "I STARTED TO DEVELOPED SMELL, LIKE CIGARETTE SMELL AND I DON'T SMOKE" and "I CAN'T SMELL FLOWERS STRONGLY, LIKE MY FOOD, I CAN TASTE IT BUT I CAN'T REALLY SMELL IT" on an unknown date, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) at unknown latency. At the time of the report, the outcome of the Parosmia, Hyposmia was Not Recovered/Not Resolved/Ongoing. On 25-Mar-2025, non-significant information was received from a consumer via a query response - No new information was received. Gitelman's was spelled correctly in the previous version. On 19-Apr-2025, non-significant information was received from a consumer via a query response - Consent for follow-up was withdrawn. No new information was received. On 07-May-2025 and 14-May-2025, significant information was received from a consumer via query response and via the Novavax Medical Information (MI No. NOV25-00314) - Lot/Batch number of Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) was reported as 6024MF01A with expiry date of 30-Nov-2024. Updated the event reported term to "I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke". The consumer confirmed that vaccine was administered intramuscularly on her left deltoid. The event of Parosmia started about two weeks after Novavax vaccine.; Sender's Comments: This 60-year-old female experienced Parosmia and Hyposmia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Parosmia and Hyposmia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Parosmia and Hyposmia is considered Possible.
Anxiety (75 mg of Effexor for mid anxiety); Fish allergy; Gitelman's syndrome (diagnosed at 18); Shellfish allergy
Medical History/Concurrent Conditions: Depression (75 mg of Effexor for mid anxiety for depression)
EFFEXOR; KLOR CON; ALDACTONE; MAGNESIUM
Test Date: 202501; Test Name: COVID-19 TEST; Test Result: Negative ; Test Date: 202501; Test Name: FLU TEST; Test Result: Negative ; Test Date: 202501; Test Name: ANV TEST; Test Result: Negative ; Comments: Avian Nephritis virus test.