Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep deficit, Syncope
Clinical narrative: she tried to stand 2 additional time and fainted each time, resulting in 3 total/ "the fainting type."; Felt a warm sensation on the back of my neck; Sweat; I felt like a fever was coming/ temperature was 100.6°F/fever; sore arm again starting a few hours after /my arm hurt; I didn't sleep very well; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (she tried to stand 2 additional time and fainted each time, resulting in 3 total/ "the fainting type.") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Faint and Stroke (The patient had a history of stroke occurring 2 years ago.). Concomitant products included IBANDRONATE SODIUM (IBANDRONATE) for Bone disorder, SIMVASTATIN for Hyperlipidemia, ASPIRIN [ACETYLSALICYLIC ACID], CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH and LEVOTHYROXINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced SLEEP DEFICIT (I didn't sleep very well) and PAIN IN EXTREMITY (sore arm again starting a few hours after /my arm hurt). On 27-Mar-2021, the patient experienced SYNCOPE (she tried to stand 2 additional time and fainted each time, resulting in 3 total/ "the fainting type.") (seriousness criterion medically significant), FEELING HOT (Felt a warm sensation on the back of my neck), HYPERHIDROSIS (Sweat) and PYREXIA (I felt like a fever was coming/ temperature was 100.6°F/fever). On 28-Mar-2021, SYNCOPE (she tried to stand 2 additional time and fainted each time, resulting in 3 total/ "the fainting type."), FEELING HOT (Felt a warm sensation on the back of my neck), SLEEP DEFICIT (I didn't sleep very well), HYPERHIDROSIS (Sweat), PAIN IN EXTREMITY (sore arm again starting a few hours after /my arm hurt) and PYREXIA (I felt like a fever was coming/ temperature was 100.6°F/fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Blood pressure normal. On an unknown date, Body temperature: 100.6 f (normal) 100.6 F Fever.         After the second dose of vaccine, patient experienced a sore arm again starting a few hours after and resolving after a few days. The sore arm prevented from sleeping very well that night. The next day (27MAR2021) the patient felt felt a warm sensation on the back of her neck, like a fever was coming on, started to sweat, and fainted. Upon returning to consciousness, she tried to stand 2 additional time and fainted each time, resulting in 3 total fainting episode. patient stated it was "the fainting type." patient fainted a few times prior in her life, when she was 9 years old and on her honeymoon when she was 26 years old. patient never took any treatments specific to her experience with the vaccine.  Company comment This case concerns a female patient with unknown age and relevant medical history of syncope (SD: She states she is "the fainting type." She has fainted a few times prior in her life, when she was 9 years old and on her honeymoon when she was 26 years old), who experienced the serious unexpected event of Syncope, non-serious unexpected events of feeling hot, sleep deficit, hyperhidrosis, pain in extremity, non-serious expected event of pyrexia. The events syncope, feeling hot, hyperhidrosis and pyrexia occurred the day after the second dose of mRNA-1273. The events occurred the same day after the second dose of mRNA-1273. The medical history of syncope remains a confounder. The rechallenge was assessed as not applicable as the AEs occurred after the second dose and we are not expecting another dose. The benefit -risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-345174 (Patient Link).; Sender's Comments: This case concerns a female patient with unknown age and relevant medical history of syncope (SD: She states she is "the fainting type." She has fainted a few times prior in her life, when she was 9 years old and on her honeymoon when she was 26 years old), who experienced the serious unexpected event of Syncope, non-serious unexpected events of feeling hot, sleep deficit, hyperhidrosis, pain in extremity, non-serious expected event of pyrexia. The events syncope, feeling hot, hyperhidrosis and pyrexia occurred the day after the second dose of mRNA-1273. The events occurred the same day after the second dose of mRNA-1273. The medical history of syncope remains a confounder. The rechallenge was assessed as not applicable as the AEs occurred after the second dose and we are not expecting another dose. The benefit -risk relationship of mRNA-1273 is not affected by this report.