Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Dyspnoea, Eating disorder
Clinical narrative: stomach pain / cruciating pain in abdominal area" / "terrible pain around belly button area; she can not eat; fatigue; nausea; swelling of lymph node left side/tenderness and swelling of lymph node left side; injection site pain; fever over 100F than 99F; difficulty of breathing / heavy breathing; fast heartbeat; dizziness; weakness; injection site pain and inflammation; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA (difficulty of breathing / heavy breathing), HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness) and VACCINATION SITE INFLAMMATION (injection site pain and inflammation) in an 81-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.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ATENOLOL and MULTIVITAMIN & MINERAL for an unknown indication.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced DYSPNOEA (difficulty of breathing / heavy breathing), HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE INFLAMMATION (injection site pain and inflammation), PYREXIA (fever over 100F than 99F) and VACCINATION SITE PAIN (injection site pain). On 18-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain / cruciating pain in abdominal area" / "terrible pain around belly button area), EATING DISORDER (she can not eat), FATIGUE (fatigue), NAUSEA (nausea) and LYMPHADENITIS (swelling of lymph node left side/tenderness and swelling of lymph node left side). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MAALOX [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty of breathing / heavy breathing), HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE INFLAMMATION (injection site pain and inflammation), ABDOMINAL PAIN UPPER (stomach pain / cruciating pain in abdominal area" / "terrible pain around belly button area), EATING DISORDER (she can not eat), PYREXIA (fever over 100F than 99F), FATIGUE (fatigue), NAUSEA (nausea), VACCINATION SITE PAIN (injection site pain) and LYMPHADENITIS (swelling of lymph node left side/tenderness and swelling of lymph node left side) outcome was unknown.            Maalox was prescribed.  Company Comment: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Lymphadenopathy, vaccination site pain, nausea, fatigue, pyrexia are consistent with the product safety profile.; Sender's Comments: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Lymphadenopathy, vaccination site pain, nausea, fatigue, pyrexia are consistent with the product safety profile.