Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Chest Pain; Lack of drug effect; positive Covid-19 test; chills; severe coughing; headache; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), CHEST PAIN (Chest Pain), DRUG INEFFECTIVE (Lack of drug effect), COUGH (severe coughing) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 030B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to COVID-19 on 06-Nov-2021 and Travel to foreign country. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), AZELASTINE HYDROCHLORIDE (AZELASTINE HCL), VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3), ASPIRIN [ACETYLSALICYLIC ACID], PROPRANOLOL HYDROCHLORIDE (PROPRANOL), EZETIMIBE, SIMVASTATIN (EZETIMIBE/SIMVASTATIN), MONTELUKAST, ZALEPLON and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced NASAL CONGESTION (nasal congestion) and HEADACHE (headache). On 10-Nov-2021, the patient experienced COUGH (severe coughing) and CHILLS (chills). On 17-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and SARS-COV-2 TEST POSITIVE (positive Covid-19 test). On 18-Nov-2021, the patient experienced CHEST PAIN (Chest Pain). The patient was treated with HYDROXYCHLOROQUINE from 18-Nov-2021 to 19-Nov-2021 for Chest pain, at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. On 22-Nov-2021, CHEST PAIN (Chest Pain) had resolved. At the time of the report, NASAL CONGESTION (nasal congestion), COUGH (severe coughing), HEADACHE (headache) and CHILLS (chills) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) and SARS-COV-2 TEST POSITIVE (positive Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: positive (Positive) The positive test result was on 17-NOV-2021.     The patient was exposed to someone who was Covid-positive on 6-NOV-2021. Patient used an Asthma Inhaler.  Company comment: This case concerns a 60-years-old male patient, with reported medical history of Asthma, who experienced the non-serious AESI of SARS-CoV-2 test positive. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 days after the administration of the third dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses). Further information received states that the patient suffered from chest pain that did not required hospitalization and was treated with Hydroxychloroquine (for one day) and Azithromycin.  No further information was disclosed. The rechallenge is not applicable as the events occurred after the administration of the third dose of the mRNA-1273 vaccine. Reported medical history of Asthma remains as a contributing factor to the event SARS-CoV-2 test positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-411362, MOD-2021-411468 (Patient Link).; Sender's Comments: This case concerns a 60-years-old male patient, with reported medical history of Asthma, who experienced the non-serious AESI of SARS-CoV-2 test positive. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 days after the administration of the third dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses). Further information received states that the patient suffered from chest pain that did not required hospitalization and was treated with Hydroxychloroquine (for one day) and Azithromycin.  No further information was disclosed. The rechallenge is not applicable as the events occurred after the administration of the third dose of the mRNA-1273 vaccine. Reported medical history of Asthma remains as a contributing factor to the event SARS-CoV-2 test positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.