Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, COVID-19, Hypokinesia, Lymphadenopathy
Clinical narrative: pain in left breast; pain under the arm; stiffness on the upper body and around the shoulder level; couldn´t lift her arms; tested positive for Covid-19; lymph nodes swelling/ size of an egg on her neck and arm area; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in left breast), AXILLARY PAIN (pain under the arm), MUSCULOSKELETAL STIFFNESS (stiffness on the upper body and around the shoulder level), HYPOKINESIA (couldn´t lift her arms) and COVID-19 (tested positive for Covid-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Janssen Vaccine (First dose was Janssen Vaccine.) Past adverse reactions to the above products included No adverse event with Janssen Vaccine. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced LYMPHADENOPATHY (lymph nodes swelling/ size of an egg on her neck and arm area). On an unknown date, the patient experienced BREAST PAIN (pain in left breast), AXILLARY PAIN (pain under the arm), MUSCULOSKELETAL STIFFNESS (stiffness on the upper body and around the shoulder level), HYPOKINESIA (couldn´t lift her arms) and COVID-19 (tested positive for Covid-19). At the time of the report, BREAST PAIN (pain in left breast) and AXILLARY PAIN (pain under the arm) had not resolved, MUSCULOSKELETAL STIFFNESS (stiffness on the upper body and around the shoulder level), HYPOKINESIA (couldn´t lift her arms) and COVID-19 (tested positive for Covid-19) outcome was unknown and LYMPHADENOPATHY (lymph nodes swelling/ size of an egg on her neck and arm area) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date (Dec-2021), the patient experienced lymph nodes swelling a day or two after receiving the vaccine. It was the size of an egg on her neck and arm area. The patient experienced stiffness on the upper body, around the shoulder level and could not lift her arms that continued a couple of weeks. Furthermore it was reported that the patient saw the doctor and 3 weeks later the swelling came down.The patient was still experiencing pain and had a slight swelling. It was reported most bothered her was the pain under the arm and left breast. The 3 and a half weeks later tested positive for Covid-19. No Covid-19 related symptoms, just found out by accident. Concomitant medications were not provided. Treatment information included over the counter strong painkiller and warm compress on the area. Company comment: This is a spontaneous case concerning a 49-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 and unexpected non-serious events of Breast pain, Axillary pain, Musculoskeletal stiffness, Hypokinesia, and Lymphadenopathy. The event COVID-19 occurred approximately three and a half weeks after the third dose of mRNA-1273 vaccine, while the onset dates of other events were not provided. Reportedly, the first dose of vaccine was of another manufacturer, which suggests Interchange of vaccine products. Considering the previous statement, lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 49-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 and unexpected non-serious events of Breast pain, Axillary pain, Musculoskeletal stiffness, Hypokinesia, and Lymphadenopathy. The event COVID-19 occurred approximately three and a half weeks after the third dose of mRNA-1273 vaccine, while the onset dates of other events were not provided. Reportedly, the first dose of vaccine was of another manufacturer, which suggests Interchange of vaccine products. Considering the previous statement, lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.