Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (It felt like the lymph nodes in both armpits were getting worse) and CONDITION AGGRAVATED (Lymph nodes in both armpits were getting worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Family history included Leukemia (Blood cancer runs in my family) since an unknown date. Concurrent medical conditions included Thalassemia and Immunocompromised. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocompromised and received 1st booster dose of Moderna Covid-19 vaccine (Monovalent)). On 17-Jun-2022, the patient experienced LYMPHADENOPATHY (It felt like the lymph nodes in both armpits were getting worse) (seriousness criterion hospitalization) and CONDITION AGGRAVATED (Lymph nodes in both armpits were getting worse) (seriousness criterion hospitalization). At the time of the report, LYMPHADENOPATHY (It felt like the lymph nodes in both armpits were getting worse) and CONDITION AGGRAVATED (Lymph nodes in both armpits were getting worse) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocompromised and received 1st booster dose of Moderna Covid-19 vaccine (Monovalent)) outcome was unknown. No concomitant medications were reported. The patient reported that her symptoms had worsened. Her doctor had done all kinds of test and blood work and said patient was fine. The patient reported that AE caused her to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment information was reported. Company Comment: This is a spontaneous case concerning a 64-year-old female patient with relevant medical history of Immunocompromised and Thalassaemia who experienced the unexpected, serious(Hospitalization) event of Lymphadenopathy(reported as It felt like the lymph nodes in both armpits were getting worse) that occurred the next day after receiving the fourth dose of mRNA-1273 Vaccine in the COVID-19 vaccination series. Additionally condition aggravated was noted. Patient had also received the first and second dose of same vaccine at an interval of 29 days and first booster dose approximately 9 months later. Patient experienced the same event after receiving second(swollen lymph nodes in right axilla) and first booster dose(swollen lymph nodes in both the axilla). Family history of Leukaemia was also noted. No further information on concomitant medications, lab results and treatment received were provided. The outcome of the event was not recovered at the time of report. Patients' history of immunocompromised, Thalassaemia and family history of leukaemia could be confounders for the event lymphadenopathy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2022-647023, MOD-2022-647027 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with relevant medical history of Immunocompromised and Thalassaemia who experienced the unexpected, serious(Hospitalization) event of Lymphadenopathy(reported as It felt like the lymph nodes in both armpits were getting worse) that occurred the next day after receiving the fourth dose of mRNA-1273 Vaccine in the COVID-19 vaccination series. Additionally condition aggravated was noted. Patient had also received the first and second dose of same vaccine at an interval of 29 days and first booster dose approximately 9 months later. Patient experienced the same event after receiving second(swollen lymph nodes in right axilla) and first booster dose(swollen lymph nodes in both the axilla). Family history of Leukaemia was also noted.  No further information on concomitant medications, lab results and treatment received were provided. The outcome of the event was not recovered at the time of report. Patients' history of immunocompromised, Thalassaemia and family history of leukaemia could be confounders for the event lymphadenopathy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.