Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Inappropriate dosing schedule; injection site red; injection site warm; Injection site a little itchy; really tired; injection site a little bit sore; Injection site has the size of about 2 quarters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate dosing schedule), VACCINATION SITE PRURITUS (Injection site a little itchy), FATIGUE (really tired) and VACCINATION SITE PAIN (injection site a little bit sore) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 04021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seafood allergy (Shellfish).   On 11-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (really tired) and VACCINATION SITE PAIN (injection site a little bit sore). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site a little itchy). In January 2021, the patient experienced VACCINATION SITE SWELLING (Injection site has the size of about 2 quarters). On 20-Jan-2021 at 8:00 AM, the patient experienced VACCINATION SITE WARMTH (injection site warm) and VACCINATION SITE ERYTHEMA (injection site red). On 05-Mar-2021 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate dosing schedule). The patient was treated with Physical therapy (mix of hot and cold compresses) for Vaccination site warmth and Physical therapy (mix of hot and cold compresses) for Vaccination site erythema. On 11-Jan-2021, FATIGUE (really tired) had resolved. On 13-Jan-2021, VACCINATION SITE PAIN (injection site a little bit sore) had resolved. On 01-Feb-2021, VACCINATION SITE WARMTH (injection site warm) and VACCINATION SITE ERYTHEMA (injection site red) had resolved. On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate dosing schedule) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site a little itchy) and VACCINATION SITE SWELLING (Injection site has the size of about 2 quarters) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   The physician advised a mix of hot and cold compresses and asked to monitor body temperatures daily. Patient did not treat the events with anything, went away on their own. She is currently taking birth control pills.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up information received on 14-Apr-2021 contains information regarding patient demographics, allergy details, dosing details and action with Moderna vaccine, causality of the events injection site warmth and injection site redness, and additional event Inappropriate dosing schedule was 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.