Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall, Hypersomnia, Pain in extremity
Clinical narrative: she was very lethargic, slept most of the day; She had fallen/She then fell again; to get crazy, did not recall going to bed/ Trouble remembering/ Woke up at night and thought it was 9:30 in the morning, she had brain fog and confusion; she also has sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (she was very lethargic, slept most of the day), FALL (She had fallen/She then fell again), CONFUSIONAL STATE (to get crazy, did not recall going to bed/ Trouble remembering/ Woke up at night and thought it was 9:30 in the morning, she had brain fog and confusion) and PAIN IN EXTREMITY (she also has sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal surgery (removal by bile duct because of polyps in duodenum) in October 2019. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (allergies to Aleve), Drug allergy (allergies to Codeine), Drug allergy (allergies to Opioids), Blood cholesterol abnormal, Anxiety, Restless leg syndrome, Acid reflux (esophageal), Insomnia, Osteoporosis and Hypothyroidism. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROXYZINE (ATARAX [HYDROXYZINE]) for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLESEVELAM for Cholesterol and Bile duct obstruction, LEVOTHYROXINE for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (she was very lethargic, slept most of the day), FALL (She had fallen/She then fell again), CONFUSIONAL STATE (to get crazy, did not recall going to bed/ Trouble remembering/ Woke up at night and thought it was 9:30 in the morning, she had brain fog and confusion) and PAIN IN EXTREMITY (she also has sore arm). At the time of the report, HYPERSOMNIA (she was very lethargic, slept most of the day), FALL (She had fallen/She then fell again), CONFUSIONAL STATE (to get crazy, did not recall going to bed/ Trouble remembering/ Woke up at night and thought it was 9:30 in the morning, she had brain fog and confusion) and PAIN IN EXTREMITY (she also has sore arm) had resolved.            The patient stated that no changes in medical history after vaccination.  The patient confirmed all doses were moderna and had completed the vaccination series. The patient received 2 booster doses and got booster dose about 3 weeks ago.  The patient experienced events next day after the booster dose.  No treatment medications were reported.  Next day the patient felt better and had recovered. The patient felt like brain was hit with something and like her brain was gone. Company comment:This spontaneous case concerns a 73-year-old female with relevant medical history of anxiety and concomitant use of Zolpidem Tartrate for Sleep disorder, who experienced the unexpected, non-serious AESI of Hypersomnia that occurred one day after receiving a dose of mRNA-1273 as fourth (booster) dose. Additional non-serious events include lethargy, fall, memory impairment and confusional state, which may be in association with each other and with Hypersomnia. Patient's advanced age and underlying medical history of anxiety and concomitant use of Zolpidem tartrate, may be considered as contributory factors to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-553294, MOD-2022-553295, MOD-2022-553296 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old female with relevant medical history of anxiety and concomitant use of Zolpidem Tartrate for Sleep disorder, who experienced the unexpected, non-serious AESI of Hypersomnia that occurred one day after receiving a dose of mRNA-1273 as fourth (booster) dose. Additional non-serious events include lethargy, fall, memory impairment and confusional state, which may be in association with each other and with Hypersomnia. Patient's advanced age and underlying medical history of anxiety and concomitant use of Zolpidem tartrate, may be considered as contributory factors to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.