Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Depression, Fatigue, Headache
Clinical narrative: At one point slept for 24 hours; depression worsened; Symptoms have kept her off work/ I ended up being off of work for 2 months due to these symptoms; severe fatigue; Severe headache; Lack of energy; Lethargy; Side effects are significant and have gotten progressively worse; Having reoccurrence of symtoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lack of energy), LETHARGY (Lethargy), CONDITION AGGRAVATED (Side effects are significant and have gotten progressively worse), HYPERSOMNIA (At one point slept for 24 hours) and DEPRESSION (depression worsened) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015m20a and 027l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Asthma since 01-Jan-2010, Premature ventricular contractions, Hypothyroidism and Depression. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma, LAMOTRIGINE (LAMICTAL) from 20-Dec-2020 to 20-May-2021 for Depression, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, ATENOLOL from 01-Jan-2000 to an unknown date for Premature ventricular contractions.   On 06-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Lack of energy), LETHARGY (Lethargy), CONDITION AGGRAVATED (Side effects are significant and have gotten progressively worse) and SYMPTOM RECURRENCE (Having reoccurrence of symtoms). On 03-Feb-2021 at 8:00 PM, the patient experienced FATIGUE (severe fatigue) and HEADACHE (Severe headache). On an unknown date, the patient experienced HYPERSOMNIA (At one point slept for 24 hours), DEPRESSION (depression worsened) and IMPAIRED WORK ABILITY (Symptoms have kept her off work/ I ended up being off of work for 2 months due to these symptoms). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency. On 01-Apr-2021, HEADACHE (Severe headache) had resolved. On 15-May-2021, FATIGUE (severe fatigue) had resolved. At the time of the report, ASTHENIA (Lack of energy), LETHARGY (Lethargy) and CONDITION AGGRAVATED (Side effects are significant and have gotten progressively worse) had not resolved and HYPERSOMNIA (At one point slept for 24 hours), DEPRESSION (depression worsened), IMPAIRED WORK ABILITY (Symptoms have kept her off work/ I ended up being off of work for 2 months due to these symptoms) and SYMPTOM RECURRENCE (Having reoccurrence of symtoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: normal (normal) Normal.         Patient reported that her doctor put her on stimulants.  Patient stated experiencing frequent headaches as residual effects from the event severe headache.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received contains non significant information: updated AE contact information On 27-Jul-2021: Added medical history, concomitant medication added, treatment medication added, outcome of events updated