Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Infection, Nasal congestion, Pain in extremity
Clinical narrative: arm pain; low grade fever; Chest congestion; nasal congestion/sinus shot up; a lost sense of taste and smell; Breakthrough Infection; loss of taste; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.   On 28-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), NASAL CONGESTION (nasal congestion/sinus shot up), ANOSMIA (a lost sense of taste and smell), INFECTION (Breakthrough Infection), AGEUSIA (loss of taste) and PYREXIA (low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Chest congestion), NASAL CONGESTION (nasal congestion/sinus shot up), ANOSMIA (a lost sense of taste and smell), INFECTION (Breakthrough Infection), AGEUSIA (loss of taste), PAIN IN EXTREMITY (arm pain) and PYREXIA (low grade fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive positive (Positive) positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The primary reporter summarized the events he experienced as a breakthrough-infection with SARS-CoV 2 (confirmed by a positive covid test). The last vaccination dose was administered more than 6 months before the onset of the events. It is currently unknown for how long the vaccination by mRNA-1273 protects against SARS-CoV 2  infection. Therefore, a lack of protection due to time elapsed is a possibility. The patient´s medical condition of hypertension may be a confounding factor (established risk factor). The events experienced by the patient are rather caused by the documented Covid-19 disease than by mRNA-1273.; Sender's Comments: The primary reporter summarized the events he experienced as a breakthrough-infection with SARS-CoV 2 (confirmed by a positive covid test). The last vaccination dose was administered more than 6 months before the onset of the events. It is currently unknown for how long the vaccination by mRNA-1273 protects against SARS-CoV 2  infection. Therefore, a lack of protection due to time elapsed is a possibility.The patient´s medical condition of hypertension may be a confounding factor (established risk factor). The events experienced by the patient are rather caused by the documented Covid-19 disease than by mRNA-1273.