Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Mycobacterium tuberculosis complex test
Clinical narrative: Shortness of breath; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and CHEST PAIN (Chest pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Tobacco user and Alcohol use. Previously administered products included for Product used for unknown indication: Influenza vaccine (Seasonal Influenza vaccine) in April 2020, Pneumonia vaccine (Streptococcus pneumonia vaccine) on 17-Nov-2020 and Aspirin. Past adverse reactions to the above products included No adverse event with Aspirin, Influenza vaccine and Pneumonia vaccine. Concurrent medical conditions included Crohn's disease and Drug allergy.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and CHEST PAIN (Chest pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Mycobacterium tuberculosis complex test: (Negative) Negative.         No concomitant medication was provided. Treatment medication was not provided by the reporter.   It was unknown if patient was enrolled in a COVID-19 Vaccine trial. It was reported that patient had no illicit drug use.  The reporters causality for the events of chest pain and shortness of birth was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment-This spontaneous case concerns an adult male patient of unspecified age with reported concurrent condition of Crohn's disease on Humira, experienced unexpected serious (Hospitalization) events of Dyspnoea and Chest pain on unknown dates after third dose of mRNA-1273 vaccination. Patient went to hospital three to four weeks after booster as he had difficulty in breathing and bad chest pain. Patient had received a dose JANSSEN COVID-19 VACCINE on an unknown date. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event Dyspnoea was not resolved and Chest pain was resolving at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2022: Live Significant Follow-up - Patient demographics, medical history, suspect drug information, past drug information and narrative description; Sender's Comments: This spontaneous case concerns an adult male patient of unspecified age with reported concurrent condition of Crohn's disease on Humira, experienced unexpected serious (Hospitalization) events of Dyspnoea and Chest pain on unknown dates after third dose of mRNA-1273 vaccination. Patient went to hospital three to four weeks after booster as he had difficulty in breathing and bad chest pain. Patient had received a dose JANSSEN COVID-19 VACCINE on an unknown date. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event Dyspnoea was not resolved and Chest pain was resolving at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.