Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sleep disorder
Clinical narrative: passed out in her home; did not sleep for 3 days at all,when goes to sleep and wakes up, can't go back to sleep/sleep had been disrupted; Didn't go to work until yesterday; Still a little weak; Eyes were burning; when closed eyes, would fill with water; was wet from head to toes; really sick; cold sweats; tired from not sleeping; had a 103F fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out in her home) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 033H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot in 2005 and flu shot in 2005; for Drug use for unknown indication: hydrocodone (Cannot use hydrocodone and depo - had reaction many years ago). Past adverse reactions to the above products included Adverse reaction with hydrocodone; Sickness with flu shot; and Unwell with flu shot. Concurrent medical conditions included High cholesterol, Hypertension and Diabetes. Concomitant products included ATORVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Hypertension.   On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out in her home) (seriousness criterion medically significant), SLEEP DISORDER (did not sleep for 3 days at all,when goes to sleep and wakes up, can't go back to sleep/sleep had been disrupted), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't go to work until yesterday), ASTHENIA (Still a little weak), EYE IRRITATION (Eyes were burning), LACRIMATION INCREASED (when closed eyes, would fill with water), HYPERHIDROSIS (was wet from head to toes), ILLNESS (really sick), COLD SWEAT (cold sweats) and FATIGUE (tired from not sleeping). 04-Feb-2022, the patient experienced PYREXIA (had a 103F fever). The patient was treated with MELATONIN for Adverse event, at a dose of 5 milligram, softgel before bedtime and CHAMOMILE [MATRICARIA RECUTITA] for Adverse event, at an unspecified dose and frequency. On 14-Feb-2022, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't go to work until yesterday) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out in her home), EYE IRRITATION (Eyes were burning), LACRIMATION INCREASED (when closed eyes, would fill with water), HYPERHIDROSIS (was wet from head to toes), ILLNESS (really sick), COLD SWEAT (cold sweats), FATIGUE (tired from not sleeping) and PYREXIA (had a 103F fever) outcome was unknown, SLEEP DISORDER (did not sleep for 3 days at all,when goes to sleep and wakes up, can't go back to sleep/sleep had been disrupted) was resolving and ASTHENIA (Still a little weak) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2022, Body temperature: 103 (High) 103F fever. On 08-Feb-2022, SARS-CoV-2 test: no (Negative) No and no (Negative) No.         Concomitant medication use also included gardance 10mg once a day for diabetes   The patient received the second dose of the Moderna COVID-19 Vaccine on 03-Feb-2022.  She did not sleep for 3 days at all. Eyes were burning. When she closed her eyes, they would fill with water.  On 04-Feb-2022, the patient had a 103F fever. Believed she passed out in her home and no one knew. She was wet from head to toes and having cold sweats. She had been really sick and weak and tired from not sleeping.  Would lay down and could not sleep from Friday 04-Feb-2022 until last week Tuesday 08-Feb-2022 when she slept 4 hours. Now when went to sleep and wakes up, could not go back to sleep. Never had a sleep problem before.  On 07-Feb-2022, had a 30 minute visit with her primary care doctor who told her to go to urgent care the next day. When to Urgent Care on 08-Feb-2022, they gave her something to sleep but sleep had been disrupted. Still a little weak. Did not go to work until yesterday, 14-Feb-2022.  Company comment: This spontaneous case concerns a 65-year-old female patient with a relevant medical history of Diabetes mellitus, Hypertension and concomitant use of Hydrochlorothiazide/Losartan potassium, who experienced the serious (medically significant) unexpected event of Loss of consciousness, among other non serious events, approximately 1 day after receiving the second dose of mRNA- 1273 vaccine. The patient though she had passed out in her home, but it is uncertain if medical care was sought due to this event. Concurrent event of Pyrexia might have contributed to the event. The mentioned medical history and concomitant medication remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-483419 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with a relevant medical history of Diabetes mellitus, Hypertension and concomitant use of Hydrochlorothiazide/Losartan potassium, who experienced the serious (medically significant) unexpected event of Loss of consciousness, among other non serious events, approximately 1 day after receiving the second dose of mRNA- 1273 vaccine. The patient though she had passed out in her home, but it is uncertain if medical care was sought due to this event. Concurrent event of Pyrexia might have contributed to the event. The mentioned medical history and concomitant medication remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.