Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site abscess, Injection site scab, Injection site scar, Injection site swelling
Clinical narrative: Maternal exposure during pregnancy; Brown injection site lesion\ lesion was flush with the skin surface; injection site scab; swelling of injection site & release of pus; Swelling of injection site & release of pus; sudden fatigue; injection site left a concave mark on skin; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Brown injection site lesion\ lesion was flush with the skin surface), INJECTION SITE SCAB (injection site scab), INJECTION SITE ABSCESS (Swelling of injection site & release of pus), INJECTION SITE SCAR (injection site left a concave mark on skin) and INJECTION SITE SWELLING (swelling of injection site & release of pus) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Aug-2020 to 28-Apr-2021 for an unknown indication.   On 14-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In July 2021, the patient experienced INJECTION SITE SCAR (injection site left a concave mark on skin). On 17-Jul-2021 at 8:45 AM, the patient experienced FATIGUE (sudden fatigue). On 18-Jul-2021, the patient experienced INJECTION SITE ABSCESS (Swelling of injection site & release of pus). On 18-Jul-2021 at 8:45 AM, the patient experienced INJECTION SITE SWELLING (swelling of injection site & release of pus). On 22-Jul-2021 at 8:45 AM, the patient experienced VACCINATION SITE REACTION (Brown injection site lesion\ lesion was flush with the skin surface) and INJECTION SITE SCAB (injection site scab). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 18-Jul-2021, FATIGUE (sudden fatigue) had resolved with sequelae. On 22-Jul-2021, INJECTION SITE ABSCESS (Swelling of injection site & release of pus) and INJECTION SITE SWELLING (swelling of injection site & release of pus) had resolved with sequelae. On 23-Jul-2021, INJECTION SITE SCAB (injection site scab) had resolved with sequelae. At the time of the report, VACCINATION SITE REACTION (Brown injection site lesion\ lesion was flush with the skin surface) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and INJECTION SITE SCAR (injection site left a concave mark on skin) outcome was unknown.            No treatment information was provided.  This is a case of Maternal Exposure During Pregnancy concerning a 30-year-old female patient with no relevant medical history, who experienced the unexpected events of Vaccination Site Reaction, Injection Site Scab, Injection Site Scar and expected events of Injection Site Swelling and Fatigue. The events occurred approximately 5 months after receiving the second dose of (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event Maternal Exposure During Pregnancy would need further queries and follow up as it is not clear in the source document if the patient was pregnant when she received the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Significant follow-up information received on 25-Oct-2021: reporter information was added, patient demographic details added, pregnancy information was added. events were added, product information was added.; Sender's Comments: This is a case of Maternal Exposure During Pregnancy concerning a 30-year-old female patient with no relevant medical history, who experienced the unexpected events of Vaccination Site Reaction, Injection Site Scab, Injection Site Scar and expected events of Injection Site Swelling and Fatigue. The events occurred approximately 5 months after receiving the second dose of (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event Maternal Exposure During Pregnancy would need further queries and follow up as it is not clear in the source document if the patient was pregnant when she received the vaccine.