Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Hypersensitivity, Nasal congestion, Pulmonary congestion
Clinical narrative: Mild COVID-19 disease after 2nd vaccine; Lack of drug effect; Thought it was allergies after 2nd vaccine; Mild Congestion Lungs after 2nd vaccine; Mild Congested Head after 2nd vaccine; Mild Stuffy Nose after 2nd vaccine; Lost sense of taste after 2nd vaccine; Lost sense of smell after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Mild Congestion Lungs after 2nd vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced PULMONARY CONGESTION (Mild Congestion Lungs after 2nd vaccine) (seriousness criterion medically significant), HEAD DISCOMFORT (Mild Congested Head after 2nd vaccine), NASAL CONGESTION (Mild Stuffy Nose after 2nd vaccine), AGEUSIA (Lost sense of taste after 2nd vaccine), ANOSMIA (Lost sense of smell after 2nd vaccine) and HYPERSENSITIVITY (Thought it was allergies after 2nd vaccine). On 12-Sep-2021, the patient experienced COVID-19 (Mild COVID-19 disease after 2nd vaccine) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, PULMONARY CONGESTION (Mild Congestion Lungs after 2nd vaccine), COVID-19 (Mild COVID-19 disease after 2nd vaccine), HEAD DISCOMFORT (Mild Congested Head after 2nd vaccine), NASAL CONGESTION (Mild Stuffy Nose after 2nd vaccine), AGEUSIA (Lost sense of taste after 2nd vaccine), ANOSMIA (Lost sense of smell after 2nd vaccine), DRUG INEFFECTIVE (Lack of drug effect) and HYPERSENSITIVITY (Thought it was allergies after 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Coronavirus test: positive (Positive) Positive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company comment: This case concerns a 63-year-old male subject who experienced the serious event of pulmonary congestion and non-serious events of COVID-19, head discomfort, nasal congestion, ageusia, anosmia, drug ineffective  and hypersensitivity. The patient's medical history was not provided. The events occurred approximately 6 months 25 days after the first dose, and 5 months 25 days  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 63-year-old male subject who experienced the serious event of pulmonary congestion and non-serious events of COVID-19, head discomfort, nasal congestion, ageusia, anosmia, drug ineffective  and hypersensitivity. The patient's medical history was not provided. The events occurred approximately 6 months 25 days after the first dose, and 5 months 25 days  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.