Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Impaired work ability, SARS-CoV-2 test
Clinical narrative: It is interfering with her work; took too much ibuprofen and now she has a stomach upset; daily headache she cannot get rid off; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 040A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Insomnia since 23-Oct-2015 and Restless leg syndrome since 23-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), Vitamin D and Vitamin B12 for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Oct-2021, HEADACHE (daily headache she cannot get rid off) had resolved. At the time of the report, IMPAIRED WORK ABILITY (It is interfering with her work) and ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient took too much ibuprofen and then she had a stomach upset.  Patient reported that the headache is right above the ears and on top of the head, it was not like a sinus headache, it was not like the headaches she had before, it was like up in her head.   Patient has been taking Lanietal 150 mg po for bipolar disorder from  23-OCT-2015 as concomitant medication.   This case was linked to MOD-2021-348352, MOD-2021-348417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-OCT-2021. Patient demographic details and medical history added. New conmeds added. Event outcome updated.