Reporte zur Charge 022MA0N

Symptomtext

could not walk and sit up, unable to move around too much; very sleepy and drowsy; unable to move around too much, unable to stand long, have to sit back; could not get out of bed; right arm itchy; Really bad headache; little bit of fever; Fatigue; Chills; allergic reaction - could not breath, started sweating; Could not breath; Started sweating; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started sweating), GAIT DISTURBANCE (could not walk and sit up, unable to move around too much) and SOMNOLENCE (very sleepy and drowsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MA0N) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Medical history was not reported by reporter. Concomitant products included INSULIN GLARGINE (BASAGLAR), INSULIN LISPRO (HUMALOG), CLONIDINE, METFORMIN, METOPROLOL, ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), RITUXIMAB (RITUXAN) and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication. On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating). On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HYPOKINESIA (could not get out of bed), VACCINATION SITE PRURITUS (right arm itchy), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved and HYPOKINESIA (could not get out of bed) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.