Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Chest pain, Drug ineffective, Fatigue
Clinical narrative: Chocking cough after 2nd shot; High blood pressure post Monoclonal Antibody Infusion, after 2nd shot; After the 2nd shot she was tired for a few days; Fever after 2nd shot; Chest pain post Monoclonal Antibody Infusion, after 2nd shot; Recived first dose and second dose of Moderna and had COVID-19; Severe sore throat; She states that she had COVID-19 Disease and a positive PCR Test on 19SEP2021; This spontaneous case was reported by a nurse and describes the occurrence of DRUG INEFFECTIVE (Recived first dose and second dose of Moderna and had COVID-19), OROPHARYNGEAL PAIN (Chocking cough after 2nd shot), OROPHARYNGEAL PAIN (Severe sore throat), CHEST PAIN (Chest pain post Monoclonal Antibody Infusion, after 2nd shot) and HYPERTENSION (High blood pressure post Monoclonal Antibody Infusion, after 2nd shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure high, EZETIMIBE for Cholesterol, LATANOPROST for Intraocular pressure high.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced DRUG INEFFECTIVE (Recived first dose and second dose of Moderna and had COVID-19). 19-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat) and COVID-19 (She states that she had COVID-19 Disease and a positive PCR Test on 19SEP2021). On 23-Sep-2021, the patient experienced CHEST PAIN (Chest pain post Monoclonal Antibody Infusion, after 2nd shot) and HYPERTENSION (High blood pressure post Monoclonal Antibody Infusion, after 2nd shot). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Chocking cough after 2nd shot), FATIGUE (After the 2nd shot she was tired for a few days) and PYREXIA (Fever after 2nd shot). The patient was treated with FLUTICASONE PROPIONATE (FLOVENT HFA) for Adverse event, at an unspecified dose and frequency and CEFALEXIN (CEPHALEXINE) for Adverse event, at a dose of 500 mg four times per day. On 23-Sep-2021, HYPERTENSION (High blood pressure post Monoclonal Antibody Infusion, after 2nd shot) had resolved. On 30-Sep-2021, OROPHARYNGEAL PAIN (Severe sore throat) had resolved. At the time of the report, DRUG INEFFECTIVE (Recived first dose and second dose of Moderna and had COVID-19), OROPHARYNGEAL PAIN (Chocking cough after 2nd shot), CHEST PAIN (Chest pain post Monoclonal Antibody Infusion, after 2nd shot), PYREXIA (Fever after 2nd shot) and COVID-19 (She states that she had COVID-19 Disease and a positive PCR Test on 19SEP2021) outcome was unknown and FATIGUE (After the 2nd shot she was tired for a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Chest X-ray: normal (normal) Normal .Patient did not have Pneumonia. On 19-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Patient received Monoclonal Antibody Infusion on 23Sep2021 (2.5 months ago). After the Monoclonal Antibody Infusion, she had chest pain and high blood pressure . She was in quarantine until 30Sep2021.  Company Comment: This spontaneous case concerns a 77-year-old, female patient with medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective with other associated unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient experienced fatigue for a few days post-vaccination. Treatment information was not provided. However, the event had resolved at the time of the report. On an unspecified date approximately 6 months after administration of the second dose of the Moderna mRNA-1273 vaccine, the patient experienced fever, cough and severe sore throat. She had COVID-19 disease and had a positive PCR test. The patient visited the emergency room on 19Sep2021 where she was given Flovent HFA (fluticasone propionate) inhaler. Chest X-ray done revealed that she was negative for Pneumonia. She was prescribed with Cephalexin 500 mg QID for 7 days. After 4 days, the patient received Monoclonal Antibody infusion, and experienced chest pain and high blood pressure. No further details were provided. The outcomes of the events were unknown at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient's age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old, female patient with medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective with other associated unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient experienced fatigue for a few days post-vaccination. Treatment information was not provided. However, the event had resolved at the time of the report. On an unspecified date approximately 6 months after administration of the second dose of the Moderna mRNA-1273 vaccine, the patient experienced fever, cough and severe sore throat. She had COVID-19 disease and had a positive PCR test. The patient visited the emergency room on 19Sep2021 where she was given Flovent HFA (fluticasone propionate) inhaler. Chest X-ray done revealed that she was negative for Pneumonia. She was prescribed with Cephalexin 500 mg QID for 7 days. After 4 days, the patient received Monoclonal Antibody infusion, and experienced chest pain and high blood pressure. No further details were provided. The outcomes of the events were unknown at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient's age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.