Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | — | — |
RSV triggered her asthma; pneumonia; RSV triggered her asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (RSV triggered her asthma), PNEUMONIA (pneumonia) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Nucala (used to be on Nucala). Past adverse reactions to the above products included No adverse effect with Nucala. Concurrent medical conditions included Allergic asthma (asthma was allergy-induced) and Allergy NOS (highly allergic to different things). On 01-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced ASTHMA (RSV triggered her asthma) (seriousness criterion hospitalization), PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) (seriousness criterion hospitalization). At the time of the report, ASTHMA (RSV triggered her asthma), PNEUMONIA (pneumonia) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) outcome was unknown. No concomitant medication was reported. The patient was currently 73 years old. She did not want to get COVID, as she had asthma and her immune system, the older she gets the more problems she had. She gets allergy shots twice a week because her asthma was allergy-induced. She used to be on Nucala but at the time of reporting, she was trying on Xolair. She wore a mask everywhere she goes because she cannot chance COVID and she cannot chance getting the RSV virus again. It was two years ago this winter, and it almost killed her. The RSV triggered her asthma, went into pneumonia and she ended up in the hospital. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2021-026563 (Patient Link).; Reporter's Comments: Company comment: Respiratory syncytial virus infection, asthma (aggravated) and pneumonia are assessed as not related considering infectious nature of events and lack of biological plausibility for causality, and underlying asthma as contributing factor. The benefit-risk relationship of product is not affected by this report.
Allergic asthma (asthma was allergy-induced); Allergy NOS (highly allergic to different things)