Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tenderness, Vaccination site calcification, Vaccination site discomfort, X-ray
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE CALCIFICATION (She developed a calcification in that arm/when it started to absorb, the pain came in/ still hurt her if she laid on it/it was in the tissue, not joint), TENDERNESS (She had tenderness), FEELING ABNORMAL (weird stuff that was happening), COVID-19 (Covid-19) and PAIN IN EXTREMITY (pain in her legs, not in the joint) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 018B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced VACCINATION SITE CALCIFICATION (She developed a calcification in that arm/when it started to absorb, the pain came in/ still hurt her if she laid on it/it was in the tissue, not joint), TENDERNESS (She had tenderness), FEELING ABNORMAL (weird stuff that was happening), PAIN IN EXTREMITY (pain in her legs, not in the joint), VACCINATION SITE DISCOMFORT (left arm felt like there was a wide rubber band around her arm), FATIGUE (After the booster, she was totally exhausted) and ARTHRALGIA (pain on the top of each ankle). At the time of the report, VACCINATION SITE CALCIFICATION (She developed a calcification in that arm/when it started to absorb, the pain came in/ still hurt her if she laid on it/it was in the tissue, not joint) was resolving and TENDERNESS (She had tenderness), FEELING ABNORMAL (weird stuff that was happening), COVID-19 (Covid-19), PAIN IN EXTREMITY (pain in her legs, not in the joint), VACCINATION SITE DISCOMFORT (left arm felt like there was a wide rubber band around her arm), FATIGUE (After the booster, she was totally exhausted) and ARTHRALGIA (pain on the top of each ankle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive. In February 2022, X-ray: not reported Not reported. No concomitant medications were reported. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient had both Moderna vaccines in her right arm and the booster in the left arm. After the booster, she was totally exhausted. She had tenderness but it was no big deal. She developed a calcification in that arm. She went to see someone about it, who said it was usually because your body thinks it had been injured. When it started, it did not hurt. When it started to absorb, the pain came in. She started getting a steroid shot in the back of her shoulder. It helped 75%, but it still hurt if she laid on it. She mentioned it was in the tissue, not joint. She was not sure if this was related, but she also had pain on the top of each ankle. In the left arm, it felt like there was a wide rubber band around her arm. She mentioned that it was weird stuff that was happening. She had pain in her legs, not in the joint. It would come and it would go. It did not stay sometimes. It would come back somewhere else sometimes. She mentioned that there was nothing else wrong with her arm. Company comment: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of onset was not provided, the initial two doses of mRNA-1273 were given approximately 6 months prior. It has been reported that after the booster dose, patient experienced fatigue and pain on her extremities and joints. On November 2021, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of onset was not provided, the initial two doses of mRNA-1273 were given approximately 6 months prior. It has been reported that after the booster dose, patient experienced fatigue and pain on her extremities and joints. On November 2021, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.