Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: lost sense of smell; lost sense of taste; lot of congestion; bad cough; very fatigued; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19), ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), NASAL CONGESTION (lot of congestion) and COUGH (bad cough) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced COVID-19 (tested positive for covid-19). On an unknown date, the patient experienced ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), NASAL CONGESTION (lot of congestion), COUGH (bad cough) and FATIGUE (very fatigued). The patient was treated with GUAIFENESIN (MUCINEX) for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (tested positive for covid-19), ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), NASAL CONGESTION (lot of congestion), COUGH (bad cough) and FATIGUE (very fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient used OTC Mucinex and "Emergency" to alleviate covid-19 symptoms. Patient stated of taking 21 prescription drugs for blood pressure and diabetes. Patient did not want to share the list of medications.  Patient had a breakthrough case of covid-19 infection after completing the primary vaccination series. Patient was not hospitalized. Patient has completed the isolation period. Covid-19 occurred approximately 11 month 2 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine), hence not captured the LOE.  Company comment: This case concerns a 72-year-old female patient with relevant medical history of hypertension and diabetes mellitus, who experienced the unexpected non-serious (AESI) event of COVID-19 (Tested positive for covid-19). The event occurred approximately 11 month 2 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). Patient had a breakthrough case of covid-19 infection after completing the primary vaccination series (first dose on 5Feb 2021 and second dose on 5Mar 2021 respectively). Patient experienced  lost sense of smell and taste, lot of congestion, bad cough, and was very fatigued. This patient's underlying medical conditions and administration of numerous concomitant medications (not specified), may have compromised her immunity with increase susceptibility to infection. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 72-year-old female patient with relevant medical history of hypertension and diabetes mellitus, who experienced the unexpected non-serious (AESI) event of COVID-19 (Tested positive for covid-19). The event occurred approximately 11 month 2 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). Patient had a breakthrough case of covid-19 infection after completing the primary vaccination series (first dose on 5Feb 2021 and second dose on 5Mar 2021 respectively). Patient experienced  lost sense of smell and taste, lot of congestion, bad cough, and was very fatigued. This patient's underlying medical conditions and administration of numerous concomitant medications (not specified), may have compromised her immunity with increase susceptibility to infection. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.