Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Heart rate decreased, Hot flush, Irritability
Clinical narrative: Feeling disoriented; Fatigue; Body aches; Extremely anxious; Bones hurt; Looking pale/Color was from slight pale to pinker/Face pale gray in color; Went from being hot to cold and having chills/shivering/teeth chattering; experienced coldness; Experienced coldness; Not feeling well; Hot flashes; Aching at the injection site/Burning at the injection site; Itching at injection site; Injection site of the deltoid that was lacey, red; Her deltoid was swollen/slightly raised that covered the whole deltoid; Confusion; Grabbing chest and unable to lie still; Went from being hot to cold; Irritability; Skin dry; Had a rash at injection site; Headaches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Grabbing chest and unable to lie still), BONE PAIN (Bones hurt), CONFUSIONAL STATE (Confusion), HOT FLUSH (Hot flashes) and MUSCLE SWELLING (Her deltoid was swollen/slightly raised that covered the whole deltoid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Benadryl), Drug allergy (Demerol) and Drug allergy (ASA).    On 08-Jan-2021 at 9:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced CHEST DISCOMFORT (Grabbing chest and unable to lie still), CONFUSIONAL STATE (Confusion), MUSCLE SWELLING (Her deltoid was swollen/slightly raised that covered the whole deltoid), FEELING OF BODY TEMPERATURE CHANGE (Went from being hot to cold), IRRITABILITY (Irritability), DRY SKIN (Skin dry), VACCINATION SITE RASH (Had a rash at injection site), HEADACHE (Headaches) and VACCINATION SITE ERYTHEMA (Injection site of the deltoid that was lacey, red). On 08-Jan-2021 at 9:18 AM, the patient experienced VACCINATION SITE PAIN (Aching at the injection site/Burning at the injection site) and VACCINATION SITE PRURITUS (Itching at injection site). On 08-Jan-2021 at 9:25 AM, the patient experienced HOT FLUSH (Hot flashes) and MALAISE (Not feeling well). On 08-Jan-2021 at 9:29 AM, the patient experienced FEELING COLD (Experienced coldness). On 08-Jan-2021 at 9:31 AM, the patient experienced BONE PAIN (Bones hurt), PALLOR (Looking pale/Color was from slight pale to pinker/Face pale gray in color) and CHILLS (Went from being hot to cold and having chills/shivering/teeth chattering; experienced coldness). On 08-Jan-2021 at 9:33 AM, the patient experienced ANXIETY (Extremely anxious). On an unknown date, the patient experienced DISORIENTATION (Feeling disoriented), FATIGUE (Fatigue) and MYALGIA (Body aches). In January 2021, VACCINATION SITE RASH (Had a rash at injection site) had resolved. At the time of the report, CHEST DISCOMFORT (Grabbing chest and unable to lie still), BONE PAIN (Bones hurt), CONFUSIONAL STATE (Confusion), HOT FLUSH (Hot flashes), MUSCLE SWELLING (Her deltoid was swollen/slightly raised that covered the whole deltoid), PALLOR (Looking pale/Color was from slight pale to pinker/Face pale gray in color), FEELING OF BODY TEMPERATURE CHANGE (Went from being hot to cold), IRRITABILITY (Irritability), MALAISE (Not feeling well), ANXIETY (Extremely anxious), DISORIENTATION (Feeling disoriented), DRY SKIN (Skin dry), FEELING COLD (Experienced coldness), FATIGUE (Fatigue), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Went from being hot to cold and having chills/shivering/teeth chattering; experienced coldness), VACCINATION SITE ERYTHEMA (Injection site of the deltoid that was lacey, red), VACCINATION SITE PAIN (Aching at the injection site/Burning at the injection site) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 118/68 mmHg (Inconclusive) 118/68. On 08-Jan-2021, Heart rate decreased: 64 (Inconclusive) 64.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included (non-specific) IV and steroids and epinephrine pen which was administered and cold pack.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: No specific follow-up information recorded.; 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.