Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Epistaxis, Extra dose administered
Clinical narrative: Feels exhausted,Tired; Very bad joint pain; Dry blood in each nostril; High temperature of 100.9 degrees; Nausea; Feeling dizzy; Vomiting; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Dry blood in each nostril), PYREXIA (High temperature of 100.9 degrees), NAUSEA (Nausea), DIZZINESS (Feeling dizzy), VOMITING (Vomiting), FATIGUE (Feels exhausted,Tired) and ARTHRALGIA (Very bad joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A, 012L20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus and Joint pain. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 21-Aug-2021, the patient experienced EPISTAXIS (Dry blood in each nostril) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PYREXIA (High temperature of 100.9 degrees) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization), DIZZINESS (Feeling dizzy) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), FATIGUE (Feels exhausted,Tired) (seriousness criterion hospitalization) and ARTHRALGIA (Very bad joint pain) (seriousness criterion hospitalization). The patient was hospitalized for 2 days until 21-Aug-2021 due to DIZZINESS, NAUSEA and VOMITING, and then for 2 days due to PYREXIA. On 19-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, EPISTAXIS (Dry blood in each nostril), PYREXIA (High temperature of 100.9 degrees), NAUSEA (Nausea), DIZZINESS (Feeling dizzy), VOMITING (Vomiting), FATIGUE (Feels exhausted,Tired) and ARTHRALGIA (Very bad joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree (High) High.         No treatment information was provided.  It was reported that patient had history of autoimmune disorder of Lupus with positive ANA that was diagnosed with prior to receiving the vaccine a few years. It was reported that patient's was back and had something to eat.  1st dose received on: 29Jan2021, left arm, IM injection, Lot: 012L20A, Expiration: Unknown  2nd dose received on:26Feb2021, left arm, IM injection, Lot: 003A21A, Expiration: Unknown  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, medical history of Lupus with positive ANA (LLT: Lupus erythematosus) and joint pain (LLT Joint pain) could be confounding factors for the case.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, medical history of Lupus with positive ANA (LLT: Lupus erythematosus) and joint pain (LLT Joint pain) could be confounding factors for the case.