Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pain in extremity, Palpitations, Vaccination site pain
Clinical narrative: falling sleep in the parking lot/sleeping for 14-15hours; palpitations; shortness of breath; Edema; swelling in her ankles -both legs; I have pain in my hand, in the digit of my fingers; pain in the small joints in the hands; feeling extremely fatigued for 4-5 weeks/persisting fatigue; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema) and JOINT SWELLING (swelling in her ankles -both legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Patient had two open heart surgeries and had a pacemaker) and Artificial cardiac pacemaker user. Concomitant products included LOSARTAN, METOPROLOL, POTASSIUM and CALCIUM for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema), JOINT SWELLING (swelling in her ankles -both legs), PAIN IN EXTREMITY (I have pain in my hand, in the digit of my fingers), ARTHRALGIA (pain in the small joints in the hands), FATIGUE (feeling extremely fatigued for 4-5 weeks/persisting fatigue) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema), JOINT SWELLING (swelling in her ankles -both legs), FATIGUE (feeling extremely fatigued for 4-5 weeks/persisting fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved, PAIN IN EXTREMITY (I have pain in my hand, in the digit of my fingers) outcome was unknown and ARTHRALGIA (pain in the small joints in the hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per the document patient also reported Concomitant medication such as blood pressure pills, over the counter multivitamins and bunch of meds. No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up received 08-OCT-2021 event like pain in hand added.; Sender's Comments: This case concerns a 69 year-old, female with a history of heart surgeries and who is a pacemaker user , who experienced the unexpected non-serious events of  HYPERSOMNIA, PALPITATIONS, DYSPNOEA, OEDEMA, JOINT SWELLING, PAIN IN EXTREMITY, FATIGUE, ARTHRALGIA and VACCINATION SITE PAIN. The events occurred approximately 2-3 days after the first dose of mRNA-1273 Moderna vaccine.  The rechallenge is N/A (no information about 2nd dose was provided).   using a pacemaker could be a confounder for cardiac rhythm disturbance. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.