Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Speech disorder, Spirometry, X-ray
Clinical narrative: Asthma; Condition aggravated; Dyspnoea; Headache; Loss of personal independence in daily activities; Speech disorder; This case was received via another Manufacturer (Reference number: vsafe) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021. The license partner had received the report from FDA VAERS (Reference number: 1402905).    This regulatory authority case was reported by an other health care professional and describes the occurrence of ASTHMA (Asthma), CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Dyspnoea), HEADACHE (Headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities) and SPEECH DISORDER (Speech disorder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Pre-diabetes. Concomitant products included OMALIZUMAB (XOLAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), MONTELUKAST SODIUM (SINGULAIR), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), MONTELUKAST SODIUM, ALBUTEROL SULFATE, METFORMIN, AMLODIPINE, OMEPRAZOLE (OMEP [OMEPRAZOLE]) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ASTHMA (Asthma) (seriousness criterion disability), CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion disability), DYSPNOEA (Dyspnoea) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities) (seriousness criterion disability) and SPEECH DISORDER (Speech disorder) (seriousness criterion disability). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 40 mg; PREDNISONE at a dose of 60 mg and ARFORMOTEROL TARTRATE (BROVANA) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ASTHMA (Asthma), CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Dyspnoea), HEADACHE (Headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities) and SPEECH DISORDER (Speech disorder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 14-May-2021, Computerised tomogram thorax: inconclusive (Inconclusive) Inconclusive. On 14-May-2021, Spirometry: inconclusive (Inconclusive) Breathing tests. On 14-May-2021, X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.; 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.