Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
It triggered my asthma; pneumonia and put me into the hospital; caught RSV a year and a half ago; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (It triggered my asthma), PNEUMONIA (pneumonia and put me into the hospital) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Pneumococcal vaccine for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Respiratory syncytial virus infection. Concurrent medical conditions included Asthma (acute asthma) and Immune system disorder (compromised immune system). On 03-Apr-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 03-Aug-2025, received dose of Influenza vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine (unknown route) 1 dosage form. In February 2024, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHMA (It triggered my asthma) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia and put me into the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHMA (It triggered my asthma) and PNEUMONIA (pneumonia and put me into the hospital) outcome was unknown and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) was resolving. No concomitant medication was reported. Patient was interested in receiving the RSV vaccine as she had RSV a year and a half ago. She was recovering from it. It triggered her asthma, had pneumonia and went to the hospital. Patient was up to date with every single COVID booster that the patient got. Patient was up to date with pneumonia and flu vaccines. Patient got influenza vaccine on 03-Apr-2025 and got another one 03-Aug-2025. Patient got every vaccine she needed to get only with the exception of the two that were shingles and the RSV. No additional details provided. It is unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact; Reporter's Comments: Co-suspect products Pneumococcal and Influenza vaccine; past medical history of Respiratory syncytial virus infection, asthma and Immune system disorder are contributors for the events. Due to lack of biological plausibility, the causality of the events Pneumonia and Respiratory syncytial virus infection was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Asthma (acute asthma); Immune system disorder (compromised immune system)
Medical History/Concurrent Conditions: Respiratory syncytial virus infection