Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Mechanical ventilation, Mental status changes, Packed red blood cell transfusion, Pneumonia bacterial
Clinical narrative: RENAL FAILURE; ACUTE MYOCARDIAL INFARCTION; ACUTE RESPIRATORY FAILURE; BLOOD LOSS ANAEMIA; COVID-19 PNEUMONIA; PNEUMONIA BACTERIAL; SEPSIS; COVID-19; DYSPNOEA; ENDOTRACHEAL INTUBATION; FIBRIN D DIMER INCREASED; HAEMODIALYSIS; INTENSIVE CARE; MECHANICAL VENTILATION; MENTAL STATUS CHANGES; PACKED RED BLOOD CELL TRANSFUSION; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional by a Regulatory Authority (Vaccine Adverse Event Reporting System) concerned a 74 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-AUG-2021 for an unspecified indication. No concomitant medications were reported. The patient was fully vaccinated and on 30-DEC-2021, the patient tested positive for Covid-19 and D dimer was elevated, 1.291. The patient was presented to hospital with shortness of breath (dyspnoea), acute mental status was changed, acute hypoxic respiratory failure in the setting of Covid-19 pneumonia as well as superimposed bacterial pneumonia (pneumonia bacterial). She was intubated and transferred to the ICU (intensive care unit) and she developed multiple complications included a non-STEMI (non-ST segment elevation myocardial infarction) (coded as acute myocardial infarction) and worsening renal failure which required hemodialysis. She also developed severe sepsis in the setting of bacterial pneumonia and received intravenous antibiotics. The patient had acute blood loss anemia in which she received multiple units of PRBCs (packed red blood cells) were transfused. Patient became ventilator dependent and was unable to be weaned off of the ventilator. She was medically stable for discharge to an LTAC (long term acute care hospitals) facility. Treatment medications included: salbutamol, remdesivir, fluticasone furoate/vilanterol trifenatate, and dexamethasone. Duration of hospitalization was 24 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myocardial infarction, acute respiratory failure, blood loss anaemia, covid-19, covid-19 pneumonia, dyspnoea, endotracheal intubation, fibrin d dimer increased, haemodialysis, intensive care, mechanical ventilation, mental status changes, packed red blood cell transfusion, pneumonia bacterial, renal failure, sars-cov-2 test positive and sepsis was not reported. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage). This report was associated with a product quality complaint: 90000217507. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed.  Additional information received from Regulatory authority on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event. 20220230489 -COVID-19 VACCINE AD26.COV2.S- Renal failure, acute myocardial infarction, acute respiratory failure, blood loss anaemia, covid-19 pneumonia, pneumonia bacterial, sepsis, covid-19,  dyspnoea, endotracheal intubation, fibrin d dimer increased, haemodialysis, intensive care, mechanical ventilation, mental status changes, packed red blood cell transfusion, sars-cov-2 test positive. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.