Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Dyspnoea, Feeling cold, Tremor, White blood cell count
Clinical narrative: He is now diagnosed with a heart condition; He spent 2 days with an uncontrolable shaking; he was freezing; he experienced difficult breathing/he had his breathing affected; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISORDER (He is now diagnosed with a heart condition), TREMOR (He spent 2 days with an uncontrolable shaking), FEELING COLD (he was freezing) and DYSPNOEA (he experienced difficult breathing/he had his breathing affected) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid - 19 Vaccine (011M20A: First Dose) on 13-Feb-2021, Moderna covid - 19 Vaccine (0021321A: Second dose) on 14-Mar-2021, MODERNA COVID-19 VACCINE (012F21A: Third Dose) on 27-Oct-2021, MODERNA COVID-19 VACCINE (033K: Fourth Dose) on 05-Apr-2022 and MODERNA COVID-19 VACCINE (Fifth Dose) on 09-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, Moderna covid - 19 Vaccine and Moderna covid - 19 Vaccine. Concurrent medical conditions included COPD.    On 07-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, the patient experienced CARDIAC DISORDER (He is now diagnosed with a heart condition) (seriousness criterion hospitalization), TREMOR (He spent 2 days with an uncontrolable shaking) (seriousness criterion hospitalization), FEELING COLD (he was freezing) (seriousness criterion hospitalization) and DYSPNOEA (he experienced difficult breathing/he had his breathing affected) (seriousness criterion hospitalization). The patient was hospitalized from 17-May-2023 to 18-May-2023 due to CARDIAC DISORDER, DYSPNOEA, FEELING COLD and TREMOR. At the time of the report, CARDIAC DISORDER (He is now diagnosed with a heart condition), TREMOR (He spent 2 days with an uncontrolable shaking), FEELING COLD (he was freezing) and DYSPNOEA (he experienced difficult breathing/he had his breathing affected) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2023, White blood cell count: High.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Doctors found his white count high and he was diagnosed with SEPSIS but then they couldn´t find any infection, he didn´t have SEPSIS. Doctors were blaming the vaccine. The caller stated her husband was not sick before the Covid vaccine. That was bringing him down fast. He was then diagnosed with a heart condition: ACIP. He never experienced something like that. No treatment information was reported.  Company comment:  This is a spontaneous case concerning a 74-year-old, male patient with Chronic obstructive pulmonary disease, previously vaccinated with 5 doses of mRNA-1273 .222 vaccine, who experienced the unexpected serious (Hospitalization) events of Cardiac disorder, dyspnoea, tremor and feeling cold. The events occurred about 10 days after the administration of mRNA-1273 .222 (Original/Omicron BA.4/5) vaccine, used as a sixth dose.  Patient developed uncontrollable shaking, feeling as freezing and difficult breathing. A blood test revealed white blood cells high which initially lead to a diagnosis of sepsis, but later it was ruled out and now diagnosed with a heart condition which was not specified. No further information on clinical course, investigations and treatment received was available in the report. Patient medical condition of COPD is a confounder for the events. The benefit-risk relationship of mRNA-1273 .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.