Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Pneumonia staphylococcal, Positive end-expiratory pressure, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; HYPOXIA; UNRESPONSIVE TO STIMULI; PNEUMONIA STAPHYLOCOCCAL; COVID-19; MECHANICAL VENTILATION; CONFIRMED CLINICAL VACCINATION FAILURE; ACIDOSIS; ALANINE AMINOTRANSFERASE INCREASED; ANION GAP; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD CREATINE PHOSPHOKINASE INCREASED; BLOOD CREATININE INCREASED; BLOOD GASES; BLOOD LACTIC ACID; BLOOD POTASSIUM INCREASED; BLOOD UREA INCREASED; BREATH SOUNDS ABNORMAL; COUGH; CULTURE POSITIVE; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; MENTAL STATUS CHANGES; POSITIVE END-EXPIRATORY PRESSURE; SARS-COV-2 TEST POSITIVE; VASOPRESSIVE THERAPY; WHITE BLOOD CELL COUNT INCREASED; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1778754), concerned a 52 year old male. Initial information was processed along with the additional information received from central complaint vigilance on 25-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: cellulitis, abscess of mouth, dental caries, frequency of micturition, pain in right hip, healed traumatic fracture, pneumonia, respiratory arrest of newborn, seizure, and tinea unguium and concurrent conditions included: alcohol dependence, allergic rhinitis, edema, endocrine disorder, essential primary hypertension, major depressive disorder, single episode unspecified obesity, other pulmonary embolism, acute cor pulmonale, pancreatitis, diseases of the skin and subcutaneous tissue, recurrent polyneuropathy, radiculopathy lumbar region, alcohol withdrawal, tobacco abuse counseling, type 2 diabetes mellitus, obstructive sleep apnea/sleep apnea, and alcohol abuse, patient had 02 sats in the 70's with possible seizure-like activity and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered to the left arm on 07-APR-2021 for an unspecified indication (Dose number in series 1). Concomitant medications included baclofen, diclofenac, furosemide, hydrochlorothiazide/lisinopril, modafinil, morphine, omeprazole, salbutamol, simvastatin, and sitagliptin.  It was reported that the patient presented to the ED (Emergency department) on 19-SEP-2021 for AMS (altered mental status) and the patient's family said he had been increasingly unresponsive over last 3 days and at the day of reporting he was largely unresponsive, they were unable to wake him up so they called EMS (Emergency medical services), on arrival EMS (Emergency medical services) initial blood pressure 77/46 mmHg and the patient was hypoxic so they needed to ventilate with bag-valve mask. They gave 2 mg of Narcan to which he was minimally responsive then brought to ED (emergency department) for further evaluation. The patient was found to acidotic with a VBG (Venous Blood Gas): 7,17,62,55,23 (as reported), Creatinine 5.52, Anion Gap-24 Lactate 3.2, WBC (white blood cells)15.52. The patient was intubated in the ER (emergency room) and given cefepime, flagyl and vancomycin, BP (blood pressure) was 64/40 mmHg and requiring initiation of a levophed drip. He was also found to be COVID-19 positive (confirmed clinical vaccination failure) on this admit acute hypoxic respiratory failure requiring mechanical ventilation POA (Present On Admission) COVID-19. Recent MRSA (Methicillin-resistant staphylococcus aureus) Pneumonia POA (Present On Admission) and currently on mechanical ventilation secondary to altered mental status and hypoxia. It also reported that the ventilator was adjusted to provide optimal PEEP (positive end-expiratory pressure) minimize FiO2 and lowest tidal volume to avoid lung injury and to maintain adequate minute ventilation. Continue albuterol nebulizer as needed, Cefepime, Flagyl and Vancomycin, Propofol and Dilaudid for ventilator tolerance. Spontaneous breathing trial daily when appropriate per ventilator separation protocol RESP (respiration): Symmetrical chest expansion no retractions. Breath sounds diminished bilaterally on discharge. The patient experienced COVID-19 pneumonia and he was on dexamethasone, 10 days from 20-SEP-2021 to 29-SEP-2021, no respiratory symptoms at present except slight cough Satting 90-96 percent on 2 litter oxygen and his baseline. Discharge disposition condition disposition: Home with Home Health Condition Stable and potential problems absent or manageable. The patient was concerning for septic shock with hypotension requiring vasopressors and empirically started on vancomycin and zosyn full infectious workup performed on admission with respiratory culture returned positive for MRSA pneumonia. The patient was treated with 5 days of vancomycin and zosyn but left on 16-SEP-2021, despite oxygen requirements and MICU (Medical Intensive Care Unit) team explaining that he still required medical attention. Laboratory data included: Alanine aminotransferase (NR: not provided) increased, Anion gap (NR: not provided) Not reported, Aspartate aminotransferase (NR: not provided) increased, Blood creatine phosphokinase (NR: not provided) increased, Blood creatinine (NR: not provided) increased, Blood gases (NR: not provided) not reported, Blood lactic acid (NR: not provided) Not reported, Blood potassium (NR: not provided) increased, Blood urea (NR: not provided) increased, Breath sounds (NR: not provided) abnormal, Culture (NR: not provided) positive for MRSA pneumonia, SARS-CoV-2 test (NR: not provided) positive, and White blood cell count (NR: not provided) increased. On 20-SEP-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. Treatment medications included: dexamethasone. On 22-OCT-2021, Laboratory data included: Blood pressure (NR: not provided) 77/46 mmHg. Laboratory data (dates unspecified) included: Alanine aminotransferase (NR: not provided) 166.55, Aspartate aminotransferase (NR: not provided) Not reported, Blood creatinine (NR: not provided) 6.57, Blood pressure (NR: not provided) 64/40 mmHg, Blood urea nitrogen (NR: not provided) 70, Creatine kinase (NR: not provided) 10.739, Potassium (NR: not provided) 5.6, and White blood cell count (NR: not provided) 17. Additional treatment medications (dates unspecified) included: vancomycin, hydromorphone hydrochloride, piperacillin sodium/tazobactam sodium, salbutamol, metronidazole, cefepime, norepinephrine bitartrate, propofol, and naloxone hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypoxia, unresponsive to stimuli, acidosis, acute respiratory failure, alanine aminotransferase increased, anion gap, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, blood gases, blood lactic acid, blood potassium increased, blood urea increased, breath sounds abnormal, covid-19, covid-19 pneumonia, cough, culture positive, endotracheal intubation, intensive care, mechanical ventilation, mental status changes, pneumonia staphylococcal, positive end-expiratory pressure, sars-cov-2 test positive, vasopressive therapy, and white blood cell count increased, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with a product quality complaint 90000199059. 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 was received from Central Complaint Vigilance on 03-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information in this version is regarding:  Product quality complaint investigation results. This does not alter company causality of previously reported events  20211046240-covid-19 vaccine ad26.cov2.s- acute respiratory failure, covid-19 pneumonia, hypoxia, unresponsive to stimuli, acidosis, alanine aminotransferase increased, anion gap, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, blood gases, blood lactic acid, blood potassium increased, blood urea increased, breath sounds abnormal, covid-19, cough, culture positive, endotracheal intubation, intensive care, mechanical ventilation, mental status changes, pneumonia staphylococcal, positive end-expiratory pressure, sars-cov-2 test positive, vasopressive therapy, and white blood cell count increased. 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).  20211046240-Covid-19 vaccine ad26.cov2.s- confirmed 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