Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT |
After both Novavax vaccines, she had a sore arm at the injection site; For 24h felt less than optimal; Felt less energetic; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00232 and NOV25-00224) and concerns a 67-year-old Female who experienced "AFTER BOTH NOVAVAX VACCINES, SHE HAD A SORE ARM AT THE INJECTION SITE", "FOR 24H FELT LESS THAN OPTIMAL" and "FELT LESS ENERGETIC" on an unspecified dates in 2024 and 2025, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) first time on unspecified date in October/early November 2024 and second time on 11-Feb-2025. At the time of the report, the outcome of the Injection site pain, Feeling abnormal, Asthenia was Recovered/Resolved. A discrepancy was identified in the source document. The events reported were for both doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) received by the consumer, however, the events are only captured once in this case with the earliest onset date. On 29-Apr-2025, non-significant information was received from a consumer - No new information received. On 27-May-2025, significant information was received from a consumer via contact center (MI No. NOV25-00377) - added "She would experience a fever for a week and a half" event experienced with the mRNA vaccines in the patient past therapy.; Sender's Comments: This 67-year-old Female experienced Injection site pain, Feeling abnormal and Asthenia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Injection site pain, Feeling abnormal and Asthenia 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 Injection site pain, Feeling abnormal and Asthenia is considered Possible.
Arthritis; Drug allergy; Fruit allergy; Neurological disorder NOS; Osteoporosis; Skin disorder NOS; Vertigo positional