Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Dyspnoea, Headache, Hypersomnia
Clinical narrative: He had difficulty breathing; Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better; Terrible headache; Weak legs/legs feel like jello; Back ache; Sleeping 3-4 hours during the day; The skin on face hurt to touch, face and scalp; He states this is like myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS (He states this is like myelitis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. E01721A, 025A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included DENOSUMAB (PROLIA), INFLIXIMAB (REMICADE) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MYELITIS (He states this is like myelitis) (seriousness criterion medically significant) and PAIN OF SKIN (The skin on face hurt to touch, face and scalp). On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better) and HEADACHE (Terrible headache). On 29-Aug-2021, the patient experienced DYSPNOEA (He had difficulty breathing). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 3000 mg around the clock and TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, MYELITIS (He states this is like myelitis), MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PAIN OF SKIN (The skin on face hurt to touch, face and scalp), DYSPNOEA (He had difficulty breathing) and HEADACHE (Terrible headache) outcome was unknown and PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 101.5 to 102 (High) 101.5 to 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that the fever goes down, but spikes when the acetaminophen runs out and was not getting better. On 29 Aug 2021, patient went to urgent care. Patient tested the fever with various thermometers for confirmation. Patient took a COVID test, but the results were not available at the time of this report.  Company Comment: 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.; 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.