Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lipoma, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Fatty tumor on the  top of the shoulder of the right arm, appeared after the Moderna COVID-19 vaccination; Had a hard time taking the sweatshirt off/can be very painful; felt pain at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of LIPOMA (Fatty tumor on the  top of the shoulder of the right arm, appeared after the Moderna COVID-19 vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Tumor (family history of Fatty Tumors. Patient's Mother had fatty tumors.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced LIPOMA (Fatty tumor on the  top of the shoulder of the right arm, appeared after the Moderna COVID-19 vaccination) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time taking the sweatshirt off/can be very painful) and VACCINATION SITE PAIN (felt pain at the vaccination site). At the time of the report, LIPOMA (Fatty tumor on the  top of the shoulder of the right arm, appeared after the Moderna COVID-19 vaccination), VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time taking the sweatshirt off/can be very painful) and VACCINATION SITE PAIN (felt pain at the vaccination site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient had no adverse reactions after receiving the first dose of Moderna Covid-19 vaccine.  Company's comment: This case concerns a 74-year-old female patient with family history included tumor (Patient's Mother had fatty tumors), who experienced the unexpected event of fatty tumor on the top of the shoulder of the right arm at vaccine site, . The event occurred on an unspecified date in the same month after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The re-challenge was not applicable as the events were exclusively reported after the second dose. Causality assessment for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up contains updated narrative; Sender's Comments: This case concerns a 74-year-old female patient with family history included tumor (Patient's Mother had fatty tumors), who experienced the unexpected event of fatty tumor on the top of the shoulder of the right arm at vaccine site, . The event occurred on an unspecified date in the same month after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The re-challenge was not applicable as the events were exclusively reported after the second dose. Causality assessment for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.