Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Organising pneumonia, Pain in extremity
Clinical narrative: cryptogenic organizing pneumonia; soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of ORGANISING PNEUMONIA (cryptogenic organizing pneumonia) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Previous doses). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine. Concurrent medical conditions included Pneumonia.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced ORGANISING PNEUMONIA (cryptogenic organizing pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm). The patient was hospitalized on sometime in January 2024 due to ORGANISING PNEUMONIA. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ORGANISING PNEUMONIA (cryptogenic organizing pneumonia) was resolving and PAIN IN EXTREMITY (soreness in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: are showing good recovery..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  It was reported that patient was vaccinated from the very beginning with all the boosters. She reported being hospitalized with "a form of pneumonia" in January 2024 (15th or 16th of January) while she was out of the country. Once she came back to the states, patient was once more hospitalized again on 04-Feb-2024 and diagnosed by pulmonologist with cryptogenic organizing pneumonia. She reported oxygen needed at that time. Patient was on prednisone and weaning off it. She stated that her lungs are good now and the cat scans are showing good recovery. She stated her pulmonologist recommended she get COVID19 vaccine in May 2024. It was reported no previous side effects from vaccines. She mentioned she will be having an appointment with her primary physician next week and then her pulmonologist does to another scan of the lungs to make sure everything was still going in the right direction, which it is so far.  Company comment: This is a spontaneous case, concerning a 73-year-old female patient with Concurrent medical condition Pneumonia who experienced the serious (due to medically significant and hospitalization) unexpected event of organizing pneumonia that occurred approximately two months after a dose of SPIKEVAX 2023-2024 vaccine, given as an unknown dose of Covid vaccination schedule.  It was reported that she was hospitalized with "a form of pneumonia" in January 2024 (15th or 16th of January) while she was out of the country; once she came back to the states, patient was once more hospitalized again on 04-Feb-2024 and diagnosed by pulmonologist with cryptogenic organizing pneumonia. She reported oxygen needed at that time. Patient was on prednisone and weaning off it. She stated that her lungs are good now and the cat scans are showing good recovery. The outcome of the event was reported as resolving. The Concurrent medical condition Pneumonia is a contributor for the event.  The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report. Event´s seriousness assessed as reported by regulatory authority.   This case was linked to MOD-2024-774539 (Patient Link).