Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Chills, Fall, Hyponatraemia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell on bathroom floor and went to the emergency room/fell twice on the kitchen floor/fell twice on the kitchen floor) and HYPONATRAEMIA (had a low level of sodium of 130/had a low level of sodium of 127) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 033F21A, 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Adhesive tape allergy and Celiac disease. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced FALL (fell on bathroom floor and went to the emergency room,/fell twice on the kitchen floor/fell twice on the kitchen floor) (seriousness criterion hospitalization). 14-Apr-2022, the patient experienced HYPONATRAEMIA (had a low level of sodium of 130/had a low level of sodium of 127) (seriousness criterion hospitalization). In April 2022, the patient experienced CHILLS (was up all night with chills and a fever) and PYREXIA (was up all night with chills and a fever). On 15-Apr-2022, HYPONATRAEMIA (had a low level of sodium of 130/had a low level of sodium of 127) had resolved. At the time of the report, FALL (fell on bathroom floor and went to the emergency room/fell twice on the kitchen floor/fell twice on the kitchen floor), CHILLS (was up all night with chills and a fever,) and PYREXIA (was up all night with chills and a fever,) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood sodium: 130 (Low) Low(130) and 127 (Low) Low(127). Concomitant medications included un specified blood pressure thyroid medications. Patient height was 5 foot 2 inches. Patient stated that she was up all night with chills and a fever, and in the morning she fell on bathroom floor and went to the emergency room, and she had a low level of sodium of 130; they discharged her, and then she again felt twice on the kitchen floor, and the ambulance took her back to the ER and she had a low level of sodium of 127. She then got the sodium up and was discharge on the 15-Apr-2022. Company Comment: This spontaneous case concerns a 82 year old female patient, with reported concomitant medications included unspecified BP,  thyroid medications, who experienced Serious (hospitalization), unexpected events of fall and hyponatremia which occurred one day post vaccination with the 4th dose of mRNA-1273 vaccine. The other three doses of Covid-19 vaccine received by this patient were also mRNA-1273 with reported adverse event of Moderna rush after the 3rd dose. This was also accompanied by other non-serious , expected events of chills and fever. This patient was brought to the emergency room because of the event of fall and was noted to have decreased serum Na level at 130 and was discharged. However upon discharge, she fell twice in the kitchen floor and was brought back to the ER via ambulance and serum Na was noted at 127 she was then hospitalized to improve her serum Na levels and discharged the day after. The other details of the hospitalization like treatment information, results of other laboratories/diagnostic examinations were not reported. Outcome of all of the events was  reported as resolved. The age of this patient plus the possibility of possible blood pressure and thyroid disease (based on the concomitant medication reported are considered confounders for the events of fall and hyponatremia. The benefit -risk relationship of mRNA -1273 is not affected by this report. This case was linked to MOD-2022-544605 (Patient Link). Sender's Comments: This spontaneous case concerns a 82 year old female patient with reported concomitant medications included unspecified blood pressure, thyroid medications, who experienced Serious (hospitalization), unexpected events of fall and hyponatremia which occurred one day post vaccination with the 4th dose of mRNA-1273 vaccine. The other three doses of Covid-19 vaccine received by this patient were also mRNA-1273 with reported adverse event of Moderna rush after the third dose. This was also accompanied by other non-serious, expected events of chills and fever which occurred the night after the vaccination with the 4th dose of mRNA-1273 vaccine. This patient was brought to the emergency room because of the event of fall and was noted to have decreased serum Na level at 130 and was discharged. However upon discharge, she fell twice in the kitchen floor and was brought back to the ER via ambulance and serum Na was noted at 127 she was then hospitalized to improve her serum Na levels and discharged the day after. The other details of the hospitalization like treatment information, results of other laboratories/diagnostic examinations were not reported. Outcome of all of the events  were reported as resolved. The age of this patient plus the possibility of possible blood pressure and thyroid disease  (based on the concomitant medication reported are considered confounders for the events of fall and hyponatremia. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.