Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bacterial test positive, COVID-19, Cerebral infarction, Chills
Clinical narrative: DEATH; TRANSFUSION; TRACHEOSTOMY; SUTURE INSERTION; HAEMOGLOBIN DECREASED; WHITE BLOOD CELL COUNT INCREASED; POST PROCEDURAL HAEMORRHAGE; RASH; SUBDURAL HAEMATOMA; COMPUTERISED TOMOGRAM HEAD ABNORMAL; RESPIRATORY FAILURE; ENDOTRACHEAL INTUBATION; MYCETOMA MYCOTIC; COMPUTERISED TOMOGRAM THORAX NORMAL; PYREXIA; CHILLS; SARS-COV-2 TEST POSITIVE; INTENSIVE CARE; BACTERIAL TEST POSITIVE; PNEUMONIA; CEREBRAL INFARCTION; THROMBOCYTOPENIA; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; LUNG DISORDER; INFECTION; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; OROPHARYNGEAL PAIN; ASTHENIA; FATIGUE; STAPHYLOCOCCAL INFECTION; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1617434), concerned a 47 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: anemia, asthma, b12 deficiency, blood transfusion, pulmonary mycobacterium avium complex mac infection, traumatic hematoma of left forearm, and methicillin-resistant staphylococcus aureus pneumonia. The patient experienced drug allergy when treated with linezolid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included clindamycin hydrochloride, cyanocobalamin, and folic acid. On 23-JUL-2021, the patient experienced asthenia, fatigue, cerebral infarction, pneumonia, thrombocytopenia, lung disorder, covid-19, loss of personal independence in daily activities, oropharyngeal pain, intensive care, bacterial test positive, staphylococcal infection and infection. Laboratory data included: Bacterial test (NR: not provided) Positive, SARS-CoV-2 test (NR: not provided) Positive (suspected clinical vaccination failure) and Platelet count (NR: not provided) Thrombocytopenia. The patient had been followed by pulmonary service for pulmonary cavitary lesions MRSA (methicillin-resistant staphylococcus aureus) and MAC (mycobacterium avium complex), the patient went to primary care provider (PCP) and told to go to emergency department to admitted to Hospital. On 24-JUL-2021, the patient was admitted to hospital due to breakthrough infection and for evaluation of progressive fatigue of 2 weeks, generalized weakness (asthenia) limiting activities of daily living (loss of personal independence in daily activities) and covid-19. The patient also noted to had fever (pyrexia) of 101, chills and sore throat. On admission the patient chest CT (computerised tomogram) with mycetoma (mycetoma mycotic) noted and given with antibiotics. Laboratory data included: Body temperature (NR: not provided) 101, computerised tomogram thorax (NR: not provided) Normal. The patient On 27-JUL-2021, the patient was performed with Bronchoalveolar lavage (BAL) and result was found to be growing methicillin-resistant staphylococcus aureus (MRSA) and put on bactrim (sulfamethoxazole/trimethoprim) which was transitioned to vancomycin, zosyn (piperacillin sodium/tazobactam sodium) and minocycline, the patient experienced with worsening thrombocytopenia, myocardial intensive care unit consulted for worsening respiratory status and was suggested to increase oxygen requirements. On 10-AUG-2021, the patient was intubated (endotracheal intubation) in the setting of respiratory failure and transferred to myocardial intensive care unit (MICU) for further management. On 12-AUG-2021, the patient was performed with computerised tomogram head and the results showed 3-4mm thickness subdural hematoma in the right frontal with occipital infarcts. On 15-AUG-2021 the patient was started on linezolid but was transitioned from zyvox (linezolid) to Bactrim (sulfamethoxazole/trimethoprim) due to developed rash, for the treatment of superimposed pneumonia with MRSA (methicillin-resistant staphylococcus aureus). On 20-AUG-2021, the patient was proceeded to tracheostomy and experience increased white blood cell count, and was placed tracheostomy with minimal blood loss, and given with 200mcg phenylephrine. On the same day patient was found to be bleeding (post procedural haemorrhage) through tracheostomy tube, surgery consulted and placed sutures (suture insertion) bleeding was slightly decreased. Laboratory data included: Hemoglobin (NR: not provided) Decreased (6, 8). On 21-AUG-2021, the patient was given with 1 unit of blood transfusion, it was reported that on the same day the patient's family members were counselled and based on the extensive discussion regarding the patients status and prognosis, family members decided to compassionately wean the patient. A Morphine drip (pressors) was started and oxygen were weaned. The patient died (death) shortly after (on 21-AUG-2021). The patient was hospitalized for 28 days. Autopsy report was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of respiratory failure, cerebral infarction, mycetoma mycotic, pneumonia, post procedural haemorrhage, staphylococcal infection, subdural haematoma, thrombocytopenia, covid-19, lung disorder, endotracheal intubation, infection, loss of personal independence in daily activities, oropharyngeal pain, chills, rash, asthenia, fatigue, pyrexia, intensive care, tracheostomy, suture insertion, transfusion, bacterial test positive, computerised tomogram head abnormal, computerised tomogram thorax normal, haemoglobin decreased, sars-cov-2 test positive and white blood cell count increased on 21-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint number 90000192506. The suspected product quality complaint has been confirmed to be not voided as the reported allegation could not be confirmed, and a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance department on 17-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V2: Additional information in this version is regarding:  Product quality complaint investigation result. This does not alter causality of previously reported events  20210908051-Covid-19 vaccine ad26.cov2.s- Death, respiratory failure, cerebral infarction, mycetoma mycotic, pneumonia, post procedural haemorrhage, staphylococcal infection, subdural haematoma, thrombocytopenia, covid-19, lung disorder, endotracheal intubation, infection, loss of personal independence in daily activities, oropharyngeal pain, intensive care, tracheostomy, suture insertion, transfusion, bacterial test positive, computerised tomogram head abnormal, computerised tomogram thorax normal, haemoglobin decreased, sars-cov-2 test positive, white blood cell count increased, chills, rash, asthenia, fatigue and pyrexia. 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).  20210908051-Covid-19 vaccine ad26.cov2.-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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH