Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Throbbing at the site of injection/ It was burning), PAIN IN EXTREMITY (Arm was throbbing), COVID-19 (Got COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the first dose of Moderna vaccine in March 2021 and the second dose of Moderna vaccine three weeks after that) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient did not have any allergies. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the first dose of Moderna vaccine in March 2021 and the second dose of Moderna vaccine three weeks after that). On 25-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm was throbbing) and COVID-19 (Got COVID). On 23-Aug-2022, the patient experienced VACCINATION SITE PAIN (Throbbing at the site of injection/ It was burning). At the time of the report, VACCINATION SITE PAIN (Throbbing at the site of injection/ It was burning) had not resolved, PAIN IN EXTREMITY (Arm was throbbing) and COVID-19 (Got COVID) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the first dose of Moderna vaccine in March 2021 and the second dose of Moderna vaccine three weeks after that) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. The patient's arm was throbbing when the patient had COVID, but then it went away. Now, the patient felt throbbing at the site of injection. The patient's wife and patient thought that the patient had COVID again. The patient had not tested positive yet for COVID. The symptoms were reported to be worsened. The event did not cause the patient to seek medical care. Treatment medications were none. Company Comment: This is a spontaneous case concerning a 56-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result on an unknown interval (vaccination date was not provided) after receiving a dose of mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. Additionally, Inappropriate Schedule of Product Administration was reported as patient received the second dose of the mRNA-1273 vaccine three weeks after the first dose. It was reported that the outcome of the event COVID-19 has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 56-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result on an unknown interval (vaccination date was not provided) after receiving a dose of mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. Additionally, Inappropriate Schedule of Product Administration was reported as patient received the second dose of the mRNA-1273 vaccine three weeks after the first dose. It was reported that the outcome of the event COVID-19 has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.