Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, White blood cell count, White blood cell count decreased
Clinical narrative: Acute kidney injury; Pneumocystis jirovecii pneumonia; Immunosuppression; Pneumonia; SUSPECTED CLINICAL VACCINATION FAILURE; Abnormal behaviour; Ischaemia; COVID-19; Tobacco user; Aggression; Sputum discoloured; Chest pain; Costochondritis; Cough; Dyspnoea; Productive cough; Neck pain; Overdose; Patient uncooperative; Haemoglobin decreased; Blood beta-D-glucan increased; Platelet count decreased; Haemophilus test positive; Blood urea normal; Chest X-ray abnormal; SARS-CoV-2 test positive; Sputum culture positive; Blood potassium normal; Troponin increased; Blood sodium decreased; White blood cell count decreased; Blood creatinine normal; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 57 year old male of unknown race and ethnicity.  The patient's height, and weight were not reported. The patient's past medical history included: coronary artery bypass grafting, percutaneous coronary intervention, polysubstance abuse, and fentanyl overdose, and concurrent conditions included: bipolar schizophrenia, smoker, coronary artery disease, hypertension, aids (CD4 102 on Jul-31), and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: unknown) dose was not reported, one total administered on 17-MAR-2021 at left arm for an unspecified indication. Concomitant medications included acetylsalicylic acid, amitriptyline, amlodipine, ammonium lactate, capsaicin/menthol, cetirizine, darunavir, hydroxyzine, rosuvastatin, salbutamol, terazosin, and tiotropium bromide.  It was reported that, patient did polysubstance abuse who presented with a chief complaint of dyspnea and chest pain of note patient presented for similar concerns and left against medical advice (AMA) and was also previously admitted from 31-July to 8-Aug for chest pain, fentanyl overdose and an acute kidney injury. He was evaluated by cardiology during this time who felt his elevated troponin was due to global ischemia from polysubstance abuse. Patient's chest pain was reproducible and felt to be secondary to costochondritis and chronic cough possibly from undiagnosed Chronic obstructive pulmonary disease. His chest X-ray did show interstitial infiltrates that had been present since Feb-2020 so Pneumocystis jiroveci pneumonia beta glucan and sputum cultures were obtained. Blood beta-D glucan was increased and sputum cultures eventually grew H Influenza but pneumocystis pneumonia testing was negative. Patient was discharged in stable condition. Patient was hospitalized on 09-Aug-2021 5:00 AM and discharged on 16-Aug-2021. Patient was hospitalized for 8 days. Patient was incidentally found to be COVID positive and was admitted for it. Patient did not require any oxygen and was not started on dexamethasone and Remdesivir. Patient was given regeneron on 13-Aug-21 as per ID reccs. Patient had COVID-19 infection in setting of immunosuppression and would require quarantine for 20 days and patient had suspected clinical vaccination failure. During entire hospital stay patient had extensive behavioral issues. Psychiatry was consulted and patient had been uncooperative with them patient was complaining of having persistent neck pain and was started on neurontin along with tylenol, ibuprofen and baclofen neurology was consulted who recommended MRI (magnetic resonance imaging) with further evaluation as outpatient as no acute finding present infectious disease was consulted and patient was started on geneovya, bactrim and valacyclovir during entire hospital stay patient had extensive behavioral issues he was impolite towards hospital staff was swearing and cursing at nurses had threatening attitude had frequent outbursts of profanity, he was repeatedly counseled to have nice attitude and behavior towards staff he was counseled at least three times not to leave against medical advice tried to find a place where patient could quarantine safely and not be a risk to heath of others called social services office local charities and multiple other places but were unsuccessful patient was not happy with care he was getting and was unhappy about the fact that hospital cannot arrange place for him patient was extensively counseled to complete his quarantine in hospital but was unwilling and wanted to leave he was provided with clothes list of his appointments and medication. Laboratory data included: Blood creatinine (NR: not provided) normal (1.04), platelet count decreased, Blood potassium (NR: not provided) 4.2, Normal, Blood pressure (NR: not provided) 130/90 mmHg, Blood sodium (NR: not provided) 133, Blood urea (NR: not provided) 18 (normal), Body temperature (NR: not provided) 36.8, Chest X-ray (NR: not provided) abnormal, Haemoglobin (NR: not provided) Decreased (11.5), Heart rate (NR: not provided) 90, Respiratory rate (NR: not provided) 21, SARS-CoV-2 test positive (NR: not provided) positive, Sputum culture (NR: not provided) positive, and White blood cell count (NR: not provided) decreased. Laboratory data (dates unspecified) included: Haemophilus test (NR: not provided) positive, and Troponin (NR: not provided) increased. Treatment medications (dates unspecified) included: ibuprofen, cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide fumarate, gabapentin, sulfamethoxazole/trimethoprim, baclofen, valaciclovir, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute kidney injury, pneumocystis jirovecii pneumonia, immunosuppression, pneumonia, abnormal behaviour, aggression, blood beta-d-glucan increased, blood creatinine normal, blood potassium normal, blood sodium decreased, blood urea normal, covid-19, chest X-ray abnormal, chest pain, costochondritis, cough, dyspnoea, haemoglobin decreased, haemophilus test positive, ischaemia, neck pain, overdose, patient uncooperative, platelet count decreased, productive cough, sars-cov-2 test positive, sputum culture positive, sputum discoloured, tobacco user, troponin increased, white blood cell count decreased and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193697. 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 Central Complaint Vigilance department on 21-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Follow up information received in the current version is regarding product quality complaint investigation result. This updated information does not change the prior causality assessment of reported event.   20210920765- covid-19 vaccine ad26.cov2.s-acute kidney injury, pneumonia, abnormal behavior, ischaemia, covid-19,tobacco user, aggression, sputum discoloured, chest pain, costochondritis, cough, dyspnea, productive cough, neck pain, overdose, patient uncooperative, haemoglobin decreased, blood beta-d-glucan increased, platelet count decreased, haemophilus test positive, blood urea normal, chest X-ray abnormal, sars-cov-2 test positive, sputum culture positive, blood potassium normal, troponin increased, blood sodium decreased, blood creatinine normal. 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). 20210920765- covid-19 vaccine ad26.cov2.s-pneumocystis jirovecii pneumonia, immunosuppression, white blood cell count decreased. 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: MEDICAL HISTORY. 20210920765-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