Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersomnia, Nausea
Clinical narrative: headache; was tired/I was exhausted; nausea; was sleeping 16 hrs/day for 3 weeks straight; felt a little off; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (was sleeping 16 hrs/day for 3 weeks straight), FEELING ABNORMAL (felt a little off), HEADACHE (headache), FATIGUE (was tired/I was exhausted) and NAUSEA (nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder NOS (She had an autoimmune issue 10 yrs ago.) and Lupus syndrome (She had had Lupus.). Concurrent medical conditions included Raynaud's disease (Her hands & feet burn.), Hyperlipidemia, Hypothyroidism, Migraine (Her allergies cause them.), Environmental allergy (they cause migraines.) and Drug allergy (it gives her headache.). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), AZELASTINE and GUAIFENESIN (MUCINEX) for Allergy, ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, LEVOTHYROXINE for Hypothyroidism.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced HYPERSOMNIA (was sleeping 16 hrs/day for 3 weeks straight), FEELING ABNORMAL (felt a little off), FATIGUE (was tired/I was exhausted) and NAUSEA (nausea). On 26-Apr-2021, the patient experienced HEADACHE (headache). In May 2021, HYPERSOMNIA (was sleeping 16 hrs/day for 3 weeks straight) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (felt a little off), FATIGUE (was tired/I was exhausted) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In the past patient saw a Rheumatologist and they did a lot of bloodwork. It was reported that patient began going to sleep at 9 pm and after waking up at 10 am in the morning she would walk the dog, then took a 2 hours nap. She wake up and did a few things, then again took another 2-4 hours nap. Again she wake up and ate dinner, then went to bed at 9 pm. Treatment information was not provided.  Company Comment: This regulatory authority case concerns a 52 year-old female patient with a history Raynaud's disease, hypothyroidism, migraine, environmental allergy, autoimmune disorder NOS, systemic lupus erythematosus who experienced the unexpected AESI of hypersomnia which occurred on an unknown date relative to the first dose of mRNA-1273 vaccine. The patient reportedly was evaluated by a Rheumatologist at an unknown time relative to the events or vaccination. No information on tests or treatments were provided. The medical history of hypothyroidism, migraine and autoimmune disorder NOS remains risk factors for the event hypersomnia. At the time of report, the event of hypersomnia was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-481382 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 52 year-old female patient with a history Raynaud's disease, hypothyroidism, migraine, environmental allergy, autoimmune disorder NOS, systemic lupus erythematosus who experienced the unexpected AESI of hypersomnia which occurred on an unknown date relative to the first dose of mRNA-1273 vaccine. The patient reportedly was evaluated by a Rheumatologist at an unknown time relative to the events or vaccination. No information on tests or treatments were provided. The medical history of hypothyroidism, migraine and autoimmune disorder NOS remains risk factors for the event hypersomnia. At the time of report, the event of hypersomnia was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.