Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pleuritic pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Lack of drug effect; Tested positive for COVID-19; Had a cough; Her chest was hurting from coughing so much; Pleuritic chest pains; Lymphocyte disorder; Developed swollen lymph nodes on her neck near collar bone both left and right side, but more on the left side/Went to ER and was diagnosed with lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Had a cough), CHEST PAIN (Her chest was hurting from coughing so much) and PLEURITIC PAIN (Pleuritic chest pains) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Had a cough), CHEST PAIN (Her chest was hurting from coughing so much), PLEURITIC PAIN (Pleuritic chest pains), LYMPHOCYTE COUNT ABNORMAL (Lymphocyte disorder) and LYMPHADENOPATHY (Developed swollen lymph nodes on her neck near collar bone both left and right side, but more on the left side/Went to ER and was diagnosed with lymphadenopathy). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Had a cough), CHEST PAIN (Her chest was hurting from coughing so much), PLEURITIC PAIN (Pleuritic chest pains), LYMPHOCYTE COUNT ABNORMAL (Lymphocyte disorder) and LYMPHADENOPATHY (Developed swollen lymph nodes on her neck near collar bone both left and right side, but more on the left side/Went to ER and was diagnosed with lymphadenopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Treatment medications were not provided by the reporter.  Company comment: This is a spontaneous case concerning a 53-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of SARS-CoV-2 test positive and unexpected, non-serious events of drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy, and lymphocyte disorder. The patient received first, second and third dose of mRNA-1273 vaccine administration with appropriate dosage interval of 27 days for the first and second dose of administered mRNA-1273 vaccine. The events SARS-CoV-2 test positive, drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy, and lymphocyte disorder occurred 60 days after the third dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events SARS-CoV-2 test positive, drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy and lymphocyte disorder were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 53-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of SARS-CoV-2 test positive and unexpected, non-serious events of drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy, and lymphocyte disorder. The patient received first, second and third dose of mRNA-1273 vaccine administration with appropriate dosage interval of 27 days for the first and second dose of administered mRNA-1273 vaccine. The events SARS-CoV-2 test positive, drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy, and lymphocyte disorder occurred 60 days after the third dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events SARS-CoV-2 test positive, drug ineffective, cough, chest pain (chest was hurting from coughing so much), pleuritic chest pain, neck lymphadenopathy and lymphocyte disorder were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.