Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a dentist and describes the occurrence of COVID-19 (COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 023M20A and 009C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (his symptoms mimicked his allergies.). Concomitant products included FLECAINIDE ACETATE and ATORVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of Over the counter; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS] (oral) at a dose of Drinking a lot of electrolyte waters. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be not related.    Height was 5 feet 10.5 inch - 5 feet 11 inch. The patient stated he was not prescribed with Paxlovid. The patient had not taken Paxlovid yet. The patient had question regarding possible side effects after taking Flecainide acetate since he was past the five to six days effectiveness. And also had question regarding Paxlovid.  The patient stated that he was taking Flecainide acetate and Atorvastatin and those medications were big no-nos with Paxlovid. He said that some statins were bad but not clarified which ones. Possible since he was taking Atorvastatin it would keep him from taking Paxlovid. The patient received total three doses of Moderna vaccine since Pfizer was not available to him, it had run out. The patient stated that symptoms started on Friday morning on 06-May-2022, He had really bad allergies and his symptoms mimicked his allergies. The patient had no clue what was going on. He woke up in the middle of the night on Monday morning, 09-May-2022, at 3:00AM with big phlegm in his throat and he could not breathe. Anywhere 2-10 days from 06-May-2022, when the patient might had picked the COVID-19 virus up. It was aggravating and was not life threatening and did not prompt a hospitalization. It was like a mild cold so far. States his major COVID-19 symptoms were congestion in the upper sinuses. Stated chest congestion, but then clarified it was not chest congestion, but was clogged up, had slight fever, but while taking temperature it said he was not having a fever. The patient also had chills, cough, and frontal headache. The patient informed that "took a home test early Monday morning, 09 May 2022, at 3:00AM. Had a PCR test done on Monday, 09 May2 022, and results came on 11 May 2022, showing positive for COVID-19."  Company Comment: This spontaneous case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 approximately 6 months and 29 days after receiving the booster dose of mRNA-1273 vaccine. Patient presented with phlegm in his throat, difficulty breathing, congestion in the upper sinuses, slight fever, chills, cough, and frontal headache. Patient treated with Guaifenesin, Paracetamol, Ibuprofen, and electrolyte solutions. Diagnosis was documented by a positive SARS-CoV-2 test. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart, the last dose of which was administered approximately 7 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 approximately 6 months and 29 days after receiving the booster dose of mRNA-1273 vaccine. Patient presented with phlegm in his throat, difficulty breathing, congestion in the upper sinuses, slight fever, chills, cough, and frontal headache. Patient treated with Guaifenesin, Paracetamol, Ibuprofen, and electrolyte solutions. Diagnosis was documented by a positive SARS-CoV-2 test. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart, the last dose of which was administered approximately 7 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.