Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Antifungal treatment, COVID-19 pneumonia, Cardiac arrest, Cardio-respiratory arrest, Central venous catheterisation
Clinical narrative: Oxygen saturation decreased; Antifungal treatment; Central venous catheterisation; Endotracheal intubation; Haemofiltration; Renal replacement therapy; Resuscitation; Vascular catheterisation; SUSPECTED CLINICAL VACCINATION FAILURE; Cardiac arrest; Cardio-respiratory arrest; Fungaemia; Renal failure; COVID-19 pneumonia; Dyspnoea; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number 1800582) concerned a 64 year old male unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, hyperlipidemia, depression, insomnia, intellectual disability, and chronic bilateral lower extremity pain. Other pre-existing medical conditions included no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-SEP-2021, the patient was presented to hospital with worsening of shortness of breath and was diagnosed with covid-19 pneumonia. He received dexamethasone and remdesivir with vapotherm support. His saturations continued to decrease and was intubated. On 16-OCT-2021, he experienced central venous catheterization, haemofiltration, resuscitation, endotracheal intubation, vascular catheterisation, suspected clinical vaccination failure, renal failure and received peripherally inserted central catheter (PICC) line and vascular catheter for renal replacement therapy requiring CRRT (Continuous renal replacement therapy). He developed candid fungemia and given antifungal therapy, also experienced cardiac arrest and cardio-respiratory arrest for which he received 3 rounds of CPR (Cardiopulmonary resuscitation) along with calcium and epinephrine with continued asystole. He died on 16-OCT-2021 and it was unspecified if an autopsy was performed. Laboratory data included: Oxygen saturation (NR: not provided) decreased. Treatment medications (dates unspecified) included: epinephrine, remdesivir, dexamethasone, and calcium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of antifungal treatment, covid-19 pneumonia, cardiac arrest, cardio-respiratory arrest, central venous catheterisation, dyspnoea, endotracheal intubation, fungaemia, haemofiltration, oxygen saturation decreased, renal failure, renal replacement therapy, resuscitation, vascular catheterisation, and outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Life Threatening). This report was associated with product quality complaint: 90000200122. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from the Regulatory Authority on 08-NOV-2021. The following information was updated and incorporated into the case narrative: The product quality complaint investigation result was added.; Sender's Comments: V2:The following information was updated and incorporated into the case narrative: The product quality complaint investigation result was added.This added information does not alter the causality of previous reported events.  20211061611-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211061611-covid-19 vaccine ad26.cov2.s- Renal failure, covid-19 pneumonia, cardiac arrest, cardio-respiratory arrest, fungaemia, dyspnoea, oxygen saturation decreased, antifungal treatment, central venous catheterisation, endotracheal intubation, haemofiltration, renal replacement therapy, resuscitation, vascular catheterisation. This event(s) is considered unassessable. 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).; Reported Cause(s) of Death: ANTIFUNGAL TREATMENT; COVID-19 PNEUMONIA; CARDIAC ARREST; CARDIO-RESPIRATORY ARREST; CENTRAL VENOUS CATHETERISATION; DYSPNOEA; ENDOTRACHEAL INTUBATION; FUNGAEMIA; HAEMOFILTRATION; OXYGEN SATURATION DECREASED; RENAL FAILURE; RENAL REPLACEMENT THERAPY;