Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fainting spell; She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good; Her right arm got kind of sore; Chills; Vomiting; Nausea; Fever; Diarrhea; Dizziness; Weak; She lost 6 pounds in 3 days; Confusion; Off work X 6 days; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainting spell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Diabetes, Heart disease, unspecified and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PYREXIA (Fever), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced SYNCOPE (Fainting spell) (seriousness criterion medically significant), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), PAIN IN EXTREMITY (Her right arm got kind of sore) and CHILLS (Chills). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainting spell), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PAIN IN EXTREMITY (Her right arm got kind of sore), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication use included medications for diabetes, heart disease and high blood pressure. Specific medications were not provided by the reporter.   Treatment of the events included Zofran.   On 11Feb2021, after receiving the first dose of vaccine but before the second, the patient "had a nuclear injection" before she went on a treadmill. The patient also stated that "she had radiation that may have affected her reaction to the vaccine." No further information was provided.   Further clinical course is unknown at this time.  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.   This case was linked to MOD-2021-155323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received on 20-May-2021included additional events were added.; 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.