Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Positron emission tomogram, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Possible malignant lymph nodes; Rash started: pinkish same day of the shot started itching; Rash spread around injection site; Swollen around the injection; Sore around the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Rash started: pinkish same day of the shot started itching), VACCINATION SITE LYMPHADENOPATHY (Possible malignant lymph nodes), VACCINATION SITE RASH (Rash spread around injection site), VACCINATION SITE SWELLING (Swollen around the injection) and VACCINATION SITE PAIN (Sore around the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Gastrointestinal disorder NOS. Concomitant products included PROBIOTICS NOS for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash spread around injection site), VACCINATION SITE SWELLING (Swollen around the injection) and VACCINATION SITE PAIN (Sore around the injection). On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Rash started: pinkish same day of the shot started itching). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Possible malignant lymph nodes). At the time of the report, VACCINATION SITE PRURITUS (Rash started: pinkish same day of the shot started itching), VACCINATION SITE LYMPHADENOPATHY (Possible malignant lymph nodes), VACCINATION SITE RASH (Rash spread around injection site), VACCINATION SITE SWELLING (Swollen around the injection) and VACCINATION SITE PAIN (Sore around the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) one under the arm was most likely a result of shots. The patient felt nothing in the area to cause cancer concern. On an unknown date, Positron emission tomogram: abnormal (abnormal) Noted activity in three places  Two of which had nothing to do with vaccine injections. However the third was under the arm pit of both shots..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included 2 medicines for blood pressure, Over-the-counter for intestinal issues and antidepressant.  Based on current available information and the temporal association between product use and the start date for the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-087294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: The case is non- serious per MSA.; Sender's Comments: Based on current available information and the temporal association between product use and the start date for the events a causal relationship cannot be excluded.