Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Immunodeficiency, Lymphopenia, Multiple sclerosis, Neoplasm malignant
Clinical narrative: Cancer; Multiple Sclerosis; immunocompromised; Lymphocytopenia; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Cancer), MULTIPLE SCLEROSIS (Multiple Sclerosis) and IMMUNODEFICIENCY (immunocompromised) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 042L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant), IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant) and LYMPHOPENIA (Lymphocytopenia). At the time of the report, NEOPLASM MALIGNANT (Cancer), MULTIPLE SCLEROSIS (Multiple Sclerosis), IMMUNODEFICIENCY (immunocompromised) and LYMPHOPENIA (Lymphocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called on behalf of a patient that was immunocompromised and received three full doses of the Moderna COVID19 vaccine. Last dose was in August. The patient had some lab test done (HCP did not have any supporting document for this) and said that her antibody levels are low, she did not feel protected and wanted to get a booster. Reason of immunocompromise: Cancer and Multiple Sclerosis, Lymphocytopenia. No date of diagnosis available. HCP said that patient wrote down cancer in her file after the first dose, so she did not know if this was something that she was currently under. No consent for follow up gathered.  Company Comment  This case concerns a 54-year-old female patient with no reported medical history, who experienced the serious unexpected events of Neoplasm malignant, Multiple sclerosis (AESI), and Immunodeficiency. The events occurred on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no reported medical history, who experienced the serious unexpected events of Neoplasm malignant, Multiple sclerosis (AESI), and Immunodeficiency. The events occurred on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.