Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she past out a second time), SYNCOPE (fainted), MALAISE (started not felling right or really good), ARTHRALGIA (night her fingers and joints were hurting), FEELING ABNORMAL (all of the sudden felt really weird, dizzy but not dizzy, really weird), FEELING HOT (like someone drop heat on her), HOT FLUSH (had  a hot flash), CONTUSION (she bang her chin on something and is  really bruise) and HEADACHE (had a little headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21a, 058h21a, 047a21a and 031l20a) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (vancomycin). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN 81), CARVEDILOL (COREG), CELECOXIB (CELEXA [CELECOXIB]), CLOPIDOGREL BISULFATE (PLAVIX), MIRTAZAPINE (REMERON), LOSARTAN POTASSIUM (COZAAR), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), NETARSUDIL MESILATE (RHOPRESSA), LATANOPROST, VITAMINS NOS, CALCIUM, FISH OIL, IRON, MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, the patient experienced MALAISE (started not felling right or really good) (seriousness criterion hospitalization), ARTHRALGIA (night her fingers and joints were hurting) (seriousness criterion hospitalization) and HEADACHE (had a little headache) (seriousness criterion hospitalization). On 02-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (she past out a second time) (seriousness criteria hospitalization and medically significant), SYNCOPE (fainted) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (all of the sudden felt really weird, dizzy but not dizzy, really weird) (seriousness criterion hospitalization), FEELING HOT (like someone drop heat on her) (seriousness criterion hospitalization) and HOT FLUSH (had  a hot flash) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONTUSION (she bang her chin on something and is really bruise) (seriousness criterion hospitalization). The patient was hospitalized from 02-Apr-2022 to 03-Apr-2022 due to ARTHRALGIA, CONTUSION, FEELING ABNORMAL, FEELING HOT, HEADACHE, HOT FLUSH, LOSS OF CONSCIOUSNESS, MALAISE and SYNCOPE. At the time of the report, LOSS OF CONSCIOUSNESS (she past out a second time), SYNCOPE (fainted), MALAISE (started not felling right or really good), ARTHRALGIA (night her fingers and joints were hurting), FEELING ABNORMAL (all of the sudden felt really weird, dizzy but not dizzy, really weird), FEELING HOT (like someone drop heat on her), HOT FLUSH (had a hot flash), CONTUSION (she bang her chin on something and is really bruise) and HEADACHE (had a little headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2022, Computerised tomogram: normal (normal) Everything was normal. On 02-Apr-2022, Electrocardiogram: normal (normal) Everything was normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had not tested positive or diagnosed with COVID-19. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient received second booster on the 31 Mar 2022 with lot number 066K21a. She stated that she was fine but on Friday afternoon started not felling right or really good, and on Friday night her fingers and joints were hurting, on Saturday morning felt pretty good did her usual morning routine and all of the sudden felt really weird, dizzy but not dizzy, really weird, like someone drop heat on her, she had a hot flash, she sat down holding the kitchen sink, and she was on the floor fainted, and call 911 to help her back on her walker seat, and she past out a second time, they took her to the hospital, and they did a CAT scan an ECG and everything was normal, she think it was the second booster. Also she stated that she bang her chin on something and is really bruise, and on Friday afternoon had a little headache. She stayed overnight on the hospital from 02 Apr 2022 until the 03 Apr 2022. No treatment information was reported. Patient gave consent to be follow by safety, and provided her doctors contact information. This case was linked to MOD-2022-533577 (Patient Link). Company Comment: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced unexpected serious events of loss of consciousness, syncope (listed in US fact sheet) (seriousness criteria hospitalization and medically significant), malaise, arthralgia, feeling abnormal, feeling hot, hot flush, contusion, headache (seriousness criteria hospitalization),which occurred 1-2 days after receiving the fourth dose (reported as second booster) of mRNA- 1273 vaccine. It is reported that patient was not feeling good and all the sudden felt weird dizzy but not dizzy, like someone drop heat on her, she had a hot flash, she sat down holding the kitchen sink, and was fainted on the floor banged her chin on something and it was bruised and had a little headache. she passed out second time after calling for the help, upon admission into the hospital, Computerised tomogram and ECG was reported as normal. She stayed overnight in the hospital. Inappropriate schedule for vaccine administration noted for the second dose. Concomitant medication carvedilol, timolol maleate could be contributory factor for the event headache. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced unexpected serious events of loss of consciousness, syncope (listed in mics. fact sheet) (seriousness criteria hospitalization and medically significant), malaise, arthralgia, feeling abnormal, feeling hot, hot flush, contusion, headache (seriousness criteria hospitalization), which occurred 1-2 days after receiving the fourth dose (reported as second booster) of mRNA- 1273 vaccine. It is reported that patient was not feeling good and all the sudden felt weird dizzy but not dizzy, like someone drop heat on her, she had a hot flash, she sat down holding the kitchen sink, and was fainted on the floor banged her chin on something and it was bruised and had a little headache. she passed out second time after calling for the help, upon admission into the hospital, Computerised tomogram and ECG was reported as normal. She stayed overnight in the hospital. Inappropriate schedule for vaccine administration noted for the second dose. Concomitant medication carvedilol, timolol maleate could be contributory factor for the event headache. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.