Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Subcutaneous abscess, Urticaria, Vaccination failure, White blood cell count
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; EAR ABSCESS WORSENED; FACE HIVES; This solicited report received from a health care professional concerned a 5 decade old female of an unspecified ethnicity. The patient was enrolled in a non-company sponsored study. This patient was also referenced in literature. The objective of the authors was to present the cases who were vaccinated and had breakthrough infections yet demonstrated markedly decreased antibody responses during this testing sweep. The patient's height, and weight were not reported. The patient's past medical history included: right mid-lung pneumonia (treated by ceftriaxone and azithromycin), and coronary artery bypass grafting, and concurrent conditions included: major depressive disorder (with psychotic features, who was involuntarily admitted for treatment-resistant depression with a recent suicide attempt by overdose), post-traumatic stress disorder, cocaine use disorder, opioid use disorder, benzodiazepine use disorder (in sustained remission), targeting suicidal behavior, psychotic symptoms, bilateral otitis externa (right ear abscess of the pinna that was positive for methicillin-resistant staphylococcus aureus), seizure disorder, mild cognitive impairment, and attention deficit hyperactivity disorder (a remote subdural hematoma leading to a seizure disorder and mild cognitive impairment). The patient received non-company suspect drug included: clozapine (form of admin, route of admin, and batch number were not reported) 200 mg, frequency, and therapy dates were not reported, and 600 mg, 1 time every 1 day, therapy dates were not reported for targeting suicidal behavior, and psychotic symptoms at an outside hospital six months before admission. During the current admission, clozapine 600 mg/d was titrated down to 200 mg by the fourth month of hospitalization due to side effects. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date (2 months into the admission) for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, buspirone, colecalciferol, levetiracetam, metformin, metoprolol, oxcarbazepine, prazosin, rosuvastatin, venlafaxine, and cyanocobalamin (vitamin b12). The patient had repeatedly declined offers to receive a Moderna booster. Five months into the admission, the patient was tested positive for COVID-19 via BinaxNOW. The patient was isolated for 10 days. The patient experienced a few days of myalgias, pharyngitis, rhinitis, a productive cough, and a temporary loss of taste and smell but remained afebrile which confirmed covid-19 infection which leading to confirmed clinical vaccination failure. After 2 days of symptoms, the COVID-19 IgG titer was lower than expected at 1.1 index value. After the patient tested positive for COVID-19, the ear abscess worsened, and patient started on topical mupirocin ointment and a 5-day course of amoxicillin, followed by a 5-day course of prednisone 40 mg/d a month later when she developed facial hives thought to be a reaction to the topical mupirocin. On an unspecified date, the laboratory data (dates unspecified) included: Absolute neutrophil count 7.28 × 10x9/L. Range 2.49 - 15.01, Day 2 of COVID illness: 2.49 × 10x9/L. Range 2.49 - 15.01, Albumin (NR: 3.2 - 3.9) 3.6 g/dL (month prior to COVID), 3.9 g/dL, COVID-19 virus test Positive, Protein (NR: 6.4 - 7.7) 7.2 g/dL, 7.7 g/dL (month prior to COVID), SARS-CoV-2 IgG antibody test titer was lower than expected at 1.1 index value, and WBC 10.44 × 10x9 /L. Range 4.41 - 19.14, Day 2 of COVID illness: 4.41 × 10x9 /L. Range 4.41-19.14. Treatment medications (dates unspecified) included: amoxicillin, prednisone, and mupirocin. Number of days of hospitalization was not reported and it was unknown whether the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with clozapine was not reported. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure, ear abscess worsened and face hives was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed clinical vaccination failure, confirmed covid-19 infection, ear abscess worsened, and face hives was not related.  The authors concluded that if further studies confirm a risk of COVID-19 immune failure for patients on clozapine, it may be indicated to routinely monitor levels of anti-SARS-CoV-2 antibody after vaccination and screen for histories of recurrent infections to determine which patients are candidates for pre-exposure prophylaxis. This report was serious (Hospitalization Caused / Prolonged). The case was associated with product quality complaint. This case is a duplicate of 20230537421. This case, from the same reporter is linked to 20230533307.; Sender's Comments: V0: 20230543836-confirmed clinical vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration. 20230543836- confirmed covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration. 20230543836-ear abscess worsened. The event 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. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration. 20230543836-facial hives. The event has a compatible/suggestive temporal relationship, and is labeled. There are other factors more likely to be associated with the event. Specifically: CONMEDS-OTHER SUSPECT DRUGS (mupirocin). Therefore, this event is considered inconsistent with vaccine administration.