Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Malaise, Neck pain, Nervousness
Clinical narrative: Feeling unwell; Shoulder pain; Joint pain; Unresponsive to stimuli; Could not speak; Felt very shaky internally; Leg tightening; Burning sensation; Pain in neck; Unable to sleep; Tiredness; Severe head discomfort; Arm hurt after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after the injection), FATIGUE (Tiredness) and HEADACHE (Severe head discomfort ). On 13-Mar-2021, the patient experienced INSOMNIA (Unable to sleep). On 15-Mar-2021, the patient experienced NECK PAIN (Pain in neck). On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation) and LIMB DISCOMFORT (Leg tightening). On 18-Mar-2021, the patient experienced NERVOUSNESS (Felt very shaky internally). On 20-Mar-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant) and SPEECH DISORDER (Could not speak). On an unknown date, the patient experienced MALAISE (Feeling unwell), ARTHRALGIA (Shoulder pain) and ARTHRALGIA (Joint pain). At the time of the report, UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), SPEECH DISORDER (Could not speak), BURNING SENSATION (Burning sensation), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Arm hurt after the injection), NERVOUSNESS (Felt very shaky internally), LIMB DISCOMFORT (Leg tightening), INSOMNIA (Unable to sleep), MALAISE (Feeling unwell), FATIGUE (Tiredness), HEADACHE (Severe head discomfort ) and ARTHRALGIA (Shoulder pain) had resolved and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 203 (Inconclusive) 203.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up included updated height, weight and race of patient, outcome, additional lab information, and additional events. Case was upgraded to serious.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273.