Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Hypersomnia, Hypoaesthesia, Malaise, Migraine
Clinical narrative: even taking a shower wears her out; sore throat; chest congestion; fever; Diagnosed with a viral URI with cough; Diagnosed with left facial numbness, numbness of the left side of her face & mouth; CT scan found a mucous retention polyp or cyst of the left maxillary sinus; CT scan found an 8mm calcification on the inner table of the calvarium in the left frontal region; Numbness where she couldn't feel their fingers but could feel the pressure when they checked her left arm; Subtle droopiness of the left side of her face & mouth, the left side of her mouth doesn't smile; Felt that the left side of her face had numbness and weakness, weakness of the left side of her face & mouth; Feeling sick; Chest tightness; Feeling like she couldn't breathe, shortness of breath; It felt like she had a cold; It felt like her head was clogged up; She had migraine since friday,diagnosed with a complicated migraine; She was diagnosed with bronchitis; Diagnosed with a touch of COPD with exasperation; slept since Friday; Had body aches since friday; This spontaneous case was reported by a nurse and describes the occurrence of HEMIPARESIS (Felt that the left side of her face had numbness and weakness, weakness of the left side of her face & mouth) and FACIAL PARALYSIS (Subtle droopiness of the left side of her face & mouth, the left side of her mouth doesn't smile) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MALAISE (Feeling sick), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Feeling like she couldn't breathe, shortness of breath), NASOPHARYNGITIS (It felt like she had a cold), HEAD DISCOMFORT (It felt like her head was clogged up), MIGRAINE (She had migraine since friday,diagnosed with a complicated migraine), BRONCHITIS (She was diagnosed with bronchitis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Diagnosed with a touch of COPD with exasperation), HYPERSOMNIA (slept since Friday) and MYALGIA (Had body aches since friday). On 11-Sep-2021, the patient experienced HEMIPARESIS (Felt that the left side of her face had numbness and weakness, weakness of the left side of her face & mouth) (seriousness criterion medically significant). On 12-Sep-2021, the patient experienced FACIAL PARALYSIS (Subtle droopiness of the left side of her face & mouth, the left side of her mouth doesn't smile) (seriousness criterion medically significant), UPPER RESPIRATORY TRACT INFECTION (Diagnosed with a viral URI with cough), HYPOAESTHESIA (Diagnosed with left facial numbness, numbness of the left side of her face & mouth), RETENTION CYST (CT scan found a mucous retention polyp or cyst of the left maxillary sinus), CEREBRAL CALCIFICATION (CT scan found an 8mm calcification on the inner table of the calvarium in the left frontal region) and HYPOAESTHESIA (Numbness where she couldn't feel their fingers but could feel the pressure when they checked her left arm). On an unknown date, the patient experienced ASTHENIA (even taking a shower wears her out), OROPHARYNGEAL PAIN (sore throat), RESPIRATORY TRACT CONGESTION (chest congestion) and PYREXIA (fever). At the time of the report, HEMIPARESIS (Felt that the left side of her face had numbness and weakness, weakness of the left side of her face & mouth), FACIAL PARALYSIS (Subtle droopiness of the left side of her face & mouth, the left side of her mouth doesn't smile), MALAISE (Feeling sick), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Feeling like she couldn't breathe, shortness of breath), NASOPHARYNGITIS (It felt like she had a cold), HEAD DISCOMFORT (It felt like her head was clogged up), MIGRAINE (She had migraine since friday,diagnosed with a complicated migraine), BRONCHITIS (She was diagnosed with bronchitis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Diagnosed with a touch of COPD with exasperation), UPPER RESPIRATORY TRACT INFECTION (Diagnosed with a viral URI with cough), HYPOAESTHESIA (Diagnosed with left facial numbness, numbness of the left side of her face & mouth), RETENTION CYST (CT scan found a mucous retention polyp or cyst of the left maxillary sinus), CEREBRAL CALCIFICATION (CT scan found an 8mm calcification on the inner table of the calvarium in the left frontal region), HYPOAESTHESIA (Numbness where she couldn't feel their fingers but could feel the pressure when they checked her left arm) and MYALGIA (Had body aches since friday) had not resolved and HYPERSOMNIA (slept since Friday), ASTHENIA (even taking a shower wears her out), OROPHARYNGEAL PAIN (sore throat), RESPIRATORY TRACT CONGESTION (chest congestion) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Chest X-ray: normal (normal) The lung fields are clear without evidence of pneumonia.. On 12-Sep-2021, Computerised tomogram: abnormal (abnormal) found a mucous retention polyp or cyst of the left maxillary sinus & an 8mm calcification on the inner table of the calvarium in the left frontal region.. On 12-Sep-2021, Red blood cell count: low (Low) Low. On 13-Sep-2021, Respiratory syncytial virus test: positive (Positive) POSITIVE. On 13-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given. No treatment medication was given.  Company comment: This case concerns a 51-year-old, female subject, who experienced the expected event OF FACIAL PARALYSIS and the unexpected event of HEMIPARESIS. The event hemiparesis occurred twelve days after the second dose of mRNA-1273 and the event facial paralysis occurred thirteen days after the second dose of mRNA-1273. The rechallenge was unknown as there's no information available about the first dose.The benefit-risk relationship of mRNA-1273 IS not affected by this report. Events were automatically upgraded as a Serious events as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious.; Sender's Comments: This case concerns a 51-year-old, female subject, who experienced the expected event OF FACIAL PARALYSIS and the unexpected event of HEMIPARESIS. The event hemiparesis occurred twelve days after the second dose of mRNA-1273 and the event facial paralysis occurred thirteen days after the second dose of mRNA-1273. The rechallenge was unknown as there's no information available about the first dose.The benefit-risk relationship of mRNA-1273 IS not affected by this report. Events were automatically upgraded as a Serious events as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious.