Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness postural, Essential tremor, Fall, Lethargy
Clinical narrative: Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication.     The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly.  Mild bibasilar volume loss is again seen.  Remaining lungs are clear.  No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy.  There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash.   On 26-Mar-2021, patient presented for evaluation of physical deconditioning.  Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice.  Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m.  Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor.  Patient is then to follow-up with neuro surgery and 3-4 weeks.  On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy.  Patient was discharged from the hospital 2 days ago after having a stay on swing bed.  She has multiple medical problems and was admitted following a hospitalization at Hospital.  She has generalized debilitation and advanced COPD with CO2 retention.  Patient has been instructed to utilize a BiPAP machine.  According to her family, she has been none a compliant with this and did not utilize it last night.  Patient noted this morning that she was somnolent and lethargic.  Prior to that she had been doing well since discharge.  Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors.