Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Upper respiratory tract congestion
Clinical narrative: slight sore throat; GI upset; occasionally run a mild temperature; few raised areas near the injection site; fatigue/exhaustion; congestion; severe itching at the injection site and over the next hour it had spread over my entire body; entire left arm became extremely painful; Loss of apetite; Had a total body histamine response; coughing; Shaky voice; Outer body type of feeling; Numbness; itchy on her left shoulder which is the site of injection; Nausea; Body aches; swollen lymph glands; Chills; Headache; redness on her left shoulder which is the site of injection; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Loss of apetite), HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice) and AUTOSCOPY (Outer body type of feeling) in a 60-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 Allergy to antibiotic, Allergy to nuts, Allergy to nuts, Hyperparathyroidism in March 2019 and GERD in November 2020. Concomitant products included LORATADINE for Allergy, FAMOTIDINE for GERD, PARACETAMOL (TYLENOL) and IBUPROFEN for Headache, SALBUTAMOL (ALBUTEROL HFA) for Shortness of breath.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Dec-2020, the patient experienced DECREASED APPETITE (Loss of apetite), HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice), AUTOSCOPY (Outer body type of feeling), HYPOAESTHESIA (Numbness), INJECTION SITE PRURITUS (itchy on her left shoulder which is the site of injection), NAUSEA (Nausea), MYALGIA (Body aches), LYMPHADENOPATHY (swollen lymph glands), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (redness on her left shoulder which is the site of injection). On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (entire left arm became extremely painful). On 30-Dec-2020, the patient experienced PRURITUS (severe itching at the injection site and over the next hour it had spread over my entire body). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), ABDOMINAL DISCOMFORT (GI upset), PYREXIA (occasionally run a mild temperature), INJECTION SITE SWELLING (few raised areas near the injection site), FATIGUE (fatigue/exhaustion) and UPPER RESPIRATORY TRACT CONGESTION (congestion). At the time of the report, DECREASED APPETITE (Loss of apetite) outcome was unknown, HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice), AUTOSCOPY (Outer body type of feeling), HYPOAESTHESIA (Numbness), INJECTION SITE PRURITUS (itchy on her left shoulder which is the site of injection), NAUSEA (Nausea), MYALGIA (Body aches), LYMPHADENOPATHY (swollen lymph glands), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE ERYTHEMA (redness on her left shoulder which is the site of injection), OROPHARYNGEAL PAIN (slight sore throat), ABDOMINAL DISCOMFORT (GI upset), PAIN IN EXTREMITY (entire left arm became extremely painful), PYREXIA (occasionally run a mild temperature), INJECTION SITE SWELLING (few raised areas near the injection site), FATIGUE (fatigue/exhaustion) and UPPER RESPIRATORY TRACT CONGESTION (congestion) was resolving and PRURITUS (severe itching at the injection site and over the next hour it had spread over my entire body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, COVID-19: negative (Negative) Negative. On 28-Dec-2020, Influenza virus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: The patient information including medical history, concomitant medications, vaccine information and events were updated.; 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.