Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Gait disturbance, Head injury, Hot flush, Loss of consciousness
Clinical narrative: passed out; feeling absolutely terrible; stong surge of heat wash over me; shuffled my way to bathroom; fall; hit my head on wooden floor divider; abrasion on left knee; moaning; gurgling; dehydrated; needed to increase my electrolytes; needed to be watched closely over weekend; body getting sore and achy all over/ tender body; immediate left side felt tingly from arm up to face; little exercise; my whole body was tender to touch; body started to feel like hit by truck; feeling broken, very weak/ like someone put a straw in my head and extracted all the energy; feeling cold; shakes; hot then cold; couldn't move I hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID (VITAMIN C ACID) for Supplementation therapy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (immediate left side felt tingly from arm up to face), EXERCISE LACK OF (little exercise), TENDERNESS (my whole body was tender to touch), MALAISE (body started to feel like hit by truck), ASTHENIA (feeling broken, very weak/ like someone put a straw in my head and extracted all the energy), FEELING COLD (feeling cold), TREMOR (shakes), FEELING OF BODY TEMPERATURE CHANGE (hot then cold) and PAIN (couldn't move I hurt so bad). On 16-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling absolutely terrible), HOT FLUSH (strong surge of heat wash over me), GAIT DISTURBANCE (shuffled my way to bathroom), FALL (fall), HEAD INJURY (hit my head on wooden floor divider), SKIN ABRASION (abrasion on left knee), MOANING (moaning), ABNORMAL BEHAVIOUR (gurgling), DEHYDRATION (dehydrated), ELECTROLYTE IMBALANCE (needed to increase my electrolytes), MEDICAL OBSERVATION (needed to be watched closely over weekend) and MYALGIA (body getting sore and achy all over/ tender body). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 18-Apr-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved with sequelae. At the time of the report, PARAESTHESIA (immediate left side felt tingly from arm up to face), EXERCISE LACK OF (little exercise), TENDERNESS (my whole body was tender to touch), MALAISE (body started to feel like hit by truck), ASTHENIA (feeling broken, very weak/ like someone put a straw in my head and extracted all the energy), FEELING COLD (feeling cold), TREMOR (shakes), FEELING OF BODY TEMPERATURE CHANGE (hot then cold), PAIN (couldn't move I hurt so bad), FEELING ABNORMAL (feeling absolutely terrible), HOT FLUSH (stong surge of heat wash over me), GAIT DISTURBANCE (shuffled my way to bathroom), FALL (fall), HEAD INJURY (hit my head on wooden floor divider), SKIN ABRASION (abrasion on left knee), MOANING (moaning), ABNORMAL BEHAVIOUR (gurgling), DEHYDRATION (dehydrated), ELECTROLYTE IMBALANCE (needed to increase my electrolytes), MEDICAL OBSERVATION (needed to be watched closely over weekend) and MYALGIA (body getting sore and achy all over/ tender body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: normal (normal) normal. On 16-Apr-2021, Electrocardiogram: normal (normal) normal. On 16-Apr-2021, Urine analysis: normal (normal) normal.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.   This case was linked to MOD-2021-207690 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Vaccine adverse event reporting form Added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.