Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pneumonia aspiration, SARS-CoV-2 test
Clinical narrative: tested her for COVID-19 today (03Oct2024) and she did come out positive; patient aspirated and developed pneumonia; Illness; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested her for COVID-19 today (03Oct2024) and she did come out positive) and PNEUMONIA ASPIRATION (patient aspirated and developed pneumonia) in an 86-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 30-Sep-2024, the patient experienced PNEUMONIA ASPIRATION (patient aspirated and developed pneumonia) (seriousness criteria hospitalization and medically significant) and ILLNESS (Illness). On 03-Oct-2024, the patient experienced COVID-19 (tested her for COVID-19 today (03Oct2024) and she did come out positive) (seriousness criterion hospitalization). The patient was hospitalized on 02-Oct-2024 due to COVID-19 and PNEUMONIA ASPIRATION. At the time of the report, COVID-19 (tested her for COVID-19 today (03Oct2024) and she did come out positive), PNEUMONIA ASPIRATION (patient aspirated and developed pneumonia) and ILLNESS (Illness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2024, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter considered ILLNESS (Illness) to be not related. No further causality assessments were provided for COVID-19 (tested her for COVID-19 today (03Oct2024) and she did come out positive) and PNEUMONIA ASPIRATION (patient aspirated and developed pneumonia).    No concomitant medication was reported. Patient did not received other vaccines in the 4 weeks prior to COVID-19 vaccine. The reporter stated a patient who got the Spikevax vaccine on Sunday, had illness occurred 24 later unrelated to that vaccination. Twenty-four hours later, 30-Sep-2024, the patient aspirated and developed pneumonia, was admitted to the hospital on 02-Oct-2024, currently been treated in the hospital and tested for COVID-19 on 03-Oct-2024.  Company Comment: This is a spontaneous case concerning an 86-year-old, female patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, event of Aspiration pneumonia, the serious (due to hospitalization) unexpected event of COVID-19, and the non-serious unexpected event of Illness. The event Aspiration pneumonia occurred on the following day after the first dose of SPIKEVAX 2024-2025 KP.2 PFS, and the event COVID-19 occurred 4 days after vaccination. It was reported that the patient who got the Spikevax vaccine on 29-Sep-2024, experienced illness 24 later unrelated to that vaccination, and on the following day, she aspirated and developed pneumonia and was admitted to the hospital on 02-Oct-2024. She tested positive for COVID-19 on 03-Oct-2024. Clinical course and treatment were not provided. The outcome of the events was reported as not recovered. Age and concurrent illness post vaccination might be risk factors for aspiration. The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS vaccine is not affected by this report.