Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Grabbing chest; sensitivity to noise; loss of short term and long term memory; inability to function daily; sore arm; Headache  that would come and go; Shake and was shivering, Teeth chattering; Feeling cold,Cold to touch; Not feeling well,Unable to lie still; Her arm itching; A rash at the injection site; Redness at site; Slightly raised that covered the whole deltoid; Fatigue; Body ache; Warm pressure from neck  up to top of  head; Red raised Rash at injection site; Warm at the injection site; Feeling disoriented; Bones are hurting; Feeling very hot; Face pale gray in color,Slight pale to pinker; Skin dry; Anxious; Irritable; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Grabbing chest) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Pollen allergy (Seasonal Allergy to Pollens) and Drug allergy (allergic to Benadryl ,Demerol, Aspirin).    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 01-Jan-2021, the patient experienced INJECTION SITE RASH (A rash at the injection site). On 01-Jan-2021 at 9:18 AM, the patient experienced INJECTION SITE PRURITUS (Her arm itching). On 08-Jan-2021, the patient experienced CHEST DISCOMFORT (Grabbing chest) (seriousness criterion hospitalization), DISORIENTATION (Feeling disoriented), IRRITABILITY (Irritable), MUSCULOSKELETAL DISCOMFORT (Warm pressure from neck  up to top of  head), RASH PAPULAR (Red raised Rash at injection site), INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE ERYTHEMA (Redness at site), INJECTION SITE SWELLING (Slightly raised that covered the whole deltoid), FATIGUE (Fatigue) and MYALGIA (Body ache). On 08-Jan-2021 at 9:25 AM, the patient experienced FEELING HOT (Feeling very hot) and VACCINATION COMPLICATION (Not feeling well,Unable to lie still). On 08-Jan-2021 at 9:29 AM, the patient experienced FEELING COLD (Feeling cold,Cold to touch). On 08-Jan-2021 at 9:31 AM, the patient experienced BONE PAIN (Bones are hurting), PALLOR (Face pale gray in color,Slight pale to pinker), DRY SKIN (Skin dry) and CHILLS (Shake and was shivering, Teeth chattering). On 08-Jan-2021 at 9:33 AM, the patient experienced ANXIETY (Anxious). On 11-Jan-2021, the patient experienced TINNITUS (sensitivity to noise), AMNESIA (loss of short term and long term memory), IMPAIRED WORK ABILITY (inability to function daily), PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache  that would come and go). The patient was treated with EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Grabbing chest), DISORIENTATION (Feeling disoriented), BONE PAIN (Bones are hurting), FEELING HOT (Feeling very hot), PALLOR (Face pale gray in color,Slight pale to pinker), DRY SKIN (Skin dry), ANXIETY (Anxious), IRRITABILITY (Irritable), VACCINATION COMPLICATION (Not feeling well,Unable to lie still), MUSCULOSKELETAL DISCOMFORT (Warm pressure from neck  up to top of  head), TINNITUS (sensitivity to noise), AMNESIA (loss of short term and long term memory), FEELING COLD (Feeling cold,Cold to touch), IMPAIRED WORK ABILITY (inability to function daily), PAIN IN EXTREMITY (sore arm), RASH PAPULAR (Red raised Rash at injection site), INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PRURITUS (Her arm itching), INJECTION SITE RASH (A rash at the injection site), INJECTION SITE ERYTHEMA (Redness at site), INJECTION SITE SWELLING (Slightly raised that covered the whole deltoid), CHILLS (Shake and was shivering, Teeth chattering), FATIGUE (Fatigue), MYALGIA (Body ache) and HEADACHE (Headache  that would come and go) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement (118-68 mmHg): 118/68 mmHg (Inconclusive) 118/68. On 08-Jan-2021, Heart rate: pulse 64 (Inconclusive) Pulse 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.   No Concomitant Medicines were provided  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Rash, injection site itching, injection site rash, injection site erythema, injection site swelling, chills, fatigue, myalgia and headache are consistent with the product known safety profile of the product.   This case was linked to US-MODERNATX, INC.-MOD-2021-005925 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: A follow up was received on 13 Apr 2021 with Outcome of the Existing Events was changed from Unknown to Not Recovered and Not Resolved.New Events Musculoskeletal Discomfort,Tinnitus,Amnesia,Rash Papular,Impaired working ability,Pain in extremity have been added.Allergic to Aspirin was added; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Rash, injection site itching, injection site rash, injection site erythema, injection site swelling, chills, fatigue, myalgia and headache are consistent with the product known safety profile of the product. US-MODERNATX, INC.-MOD-2021-005925: