Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in an 83-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Patient had received all the COVID-19 vaccines from Moderna since the earliest days of the pandemic). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in 2025 to sometime in 2025 due to PNEUMONIA. In 2025, PNEUMONIA (pneumonia) had resolved. No concomitant medications were reported. Patient had received all the COVID-19 vaccines from Moderna since the earliest days of the pandemic. However, when the time came in the spring of 2025 for the patient to get the second dose of the Spikevax vaccine for 2024-25, she was in the hospital with pneumonia. Then, the patient just waited longer to get her a second dose. Eventually, in Aug-2025, the reporter began to search for a pharmacy that still had some 2024-25 COVID-19 vaccines left. The reporter was able to find a pharmacy that had some Pfizer vaccines left for 2024-25. Since reporter did not know when the new vaccines would be available, the patient went ahead and got a second dose of a 2024-25 COVID vaccine (this time from Pfizer vaccine) in August. The reporter raised concern about how long the patient must wait before getting the 2025-26 COVID-19 vaccine from Moderna. It was reported that one local pharmacist described the time interval as 3 months, and another pharmacist described the time interval as 6 months, and reporter then asked about which one was correct. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The event of Pneumonia was assessed as not related to suspected vaccine due to lack of biological plausibility. Patient's advanced age was assessed as a confounding factor. The benefit-risk relationship of product is not affected by this report.