Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Orthopnoea
Clinical narrative: Unable to breath lying down/breathing related sleep disorder; Difficulty in breathing/Unable to breathe when attempting to sleep/Labored difficulty breathing; Unable to sleep because she had very severe difficulty in breathing; Somewhat unable to perform daily chores; Weakness on both legs; Subcutaneous edema/Fluid over her sternum/kind of subcutaneous edema; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Difficulty in breathing/Unable to breathe when attempting to sleep/Labored difficulty breathing), MUSCULAR WEAKNESS (Weakness on both legs), OEDEMA (Subcutaneous edema/Fluid over her sternum/kind of subcutaneous edema), BREATHING-RELATED SLEEP DISORDER (Unable to sleep because she had very severe difficulty in breathing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Somewhat unable to perform daily chores) and ORTHOPNOEA (Unable to breath lying down/breathing related sleep disorder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness on both legs) (seriousness criterion hospitalization) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Somewhat unable to perform daily chores) (seriousness criterion hospitalization). On 02-Nov-2021, the patient experienced DYSPNOEA (Difficulty in breathing/Unable to breathe when attempting to sleep/Labored difficulty breathing) (seriousness criterion hospitalization) and BREATHING-RELATED SLEEP DISORDER (Unable to sleep because she had very severe difficulty in breathing) (seriousness criterion hospitalization). On 05-Nov-2021, the patient experienced ORTHOPNOEA (Unable to breath lying down/breathing related sleep disorder) (seriousness criterion hospitalization). In November 2021, the patient experienced OEDEMA (Subcutaneous edema/Fluid over her sternum/kind of subcutaneous edema) (seriousness criterion hospitalization). The patient was hospitalized from 06-Nov-2021 to 07-Nov-2021 due to BREATHING-RELATED SLEEP DISORDER, DYSPNOEA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MUSCULAR WEAKNESS and OEDEMA. On 02-Nov-2021, MUSCULAR WEAKNESS (Weakness on both legs) outcome was unknown, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Somewhat unable to perform daily chores) had resolved. At the time of the report, DYSPNOEA (Difficulty in breathing/Unable to breathe when attempting to sleep/Labored difficulty breathing), OEDEMA (Subcutaneous edema/Fluid over her sternum/kind of subcutaneous edema), BREATHING-RELATED SLEEP DISORDER (Unable to sleep because she had very severe difficulty in breathing) and ORTHOPNOEA (Unable to breath lying down/breathing related sleep disorder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. On 02-Nov-2021 evening she retired for bedtime and was unable to sleep because she had very severe difficulty in breathing.  She did not have this issue again until Friday evening 05Nov2021 when the same symptom reoccurred: she was unable to breathe when attempting to sleep, she had labored difficulty breathing, was unable to breathe lying down.  Patient had couple of medications to her medical profile.  Company comment: This case concerns a 90-year-old, female patient with no reported medical history, who experienced the serious, unexpected events of dyspnoea, orthopnea, muscular weakness, loss of personal independence in daily activities, breathing related sleep disorder, oedema. The events muscular weakness and loss of personal independence in daily activities occurred 3 days after booster dose of mRNA-1273 vaccine. The event dyspnoea and breathing related sleep disorder occurred 4 days after booster dose of mRNA-1273 vaccine. The event orthopnea occurred 7 days after booster dose of mRNA-1273 vaccine. Time to onset was not reported from booster dose for event oedema. The rechallenge was not applicable, as no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 90-year-old, female patient with no reported medical history, who experienced the serious, unexpected events of dyspnoea, orthopnea, muscular weakness, loss of personal independence in daily activities, breathing related sleep disorder, oedema. The events muscular weakness and loss of personal independence in daily activities occurred 3 days after booster dose of mRNA-1273 vaccine. The event dyspnoea and breathing related sleep disorder occurred 4 days after booster dose of mRNA-1273 vaccine. The event orthopnea occurred 7 days after booster dose of mRNA-1273 vaccine. Time to onset was not reported from booster dose for event oedema. The rechallenge was not applicable, as no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.