Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The injection site was still sore; The injection site started itching; Headache; Had a temperature of 98.4 F which is 1 degree more than her normal; The injection site became swollen; Not feeling well; Left arm was feeling sore but was not that bad,Arm is still sorebut less than previos days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Left arm was feeling sore but was not that bad,Arm is still sorebut less than previos days), VACCINATION SITE PAIN (The injection site was still sore), PYREXIA (Had a temperature of 98.4 F which is 1 degree more than her normal) and VACCINATION SITE SWELLING (The injection site became swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia since 2018, Osteopenia since 2004, Hypothyroidism since 1995, Hypercholesterolemia since 1999 and Allergy to antibiotic (sulfa). Concomitant products included SIMVASTATIN (ZOCOR) for Hypercholesterolaemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, TRAZODONE for Insomnia, CALCIUM for Osteopenia, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Left arm was feeling sore but was not that bad,Arm is still sorebut less than previos days), PYREXIA (Had a temperature of 98.4 F which is 1 degree more than her normal), VACCINATION SITE SWELLING (The injection site became swollen) and HEADACHE (Headache). On 25-Oct-2021, the patient experienced VACCINATION SITE PAIN (The injection site was still sore) and VACCINATION SITE PRURITUS (The injection site started itching). On 29-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Left arm was feeling sore but was not that bad,Arm is still sorebut less than previos days) and VACCINATION SITE PAIN (The injection site was still sore) had not resolved, PYREXIA (Had a temperature of 98.4 F which is 1 degree more than her normal) outcome was unknown and VACCINATION SITE SWELLING (The injection site became swollen) and VACCINATION SITE PRURITUS (The injection site started itching) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2021, Body temperature: 98.4 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (Left arm was feeling sore but was not that bad,Arm is still sorebut less than previos days) and HEADACHE (Headache) to be possibly related. No further causality assessments were provided for FEELING ABNORMAL (Not feeling well), VACCINATION SITE PAIN (The injection site was still sore), PYREXIA (Had a temperature of 98.4 F which is 1 degree more than her normal), VACCINATION SITE SWELLING (The injection site became swollen) and VACCINATION SITE PRURITUS (The injection site started itching).    No Treatment was reported by reporter.   This case was linked to MOD-2021-372770, MOD-2021-372786 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added Medical history, added lab data, added concomitant medications, updated event outcome, updated reporter's causality.