Sex: M
Vaccine: COVID19
Symptoms: Blood albumin, Blood pressure measurement, Body temperature, COVID-19, Heart rate
Clinical narrative: CONFIRMED COVID-19 INFECTION; HYPOTENSION; CONFIRMED CLINICAL VACCINATION FAILURE; This solicited report received from a health care professional via non-company sponsored study, concerned a 3 decade old adult male of an unspecified ethnicity. 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: suicide attempts, and poor dentition, and concurrent conditions included: schizoaffective disorder bipolar type, violence, marijuana user, alcohol user, tobacco user, posttraumatic stress disorder (PTSD), attention-deficit/hyperactivity disorder (ADHD), suicidal ideation, and psychosis. The patient was psychiatrically admitted (date unspecified) for suicidal and homicidal threats after engaging in arson. He displayed poor insight, grandiosity, delusional thinking, and extreme paranoia; reported auditory and visual hallucinations; and was seen responding to internal stimuli. He failed multiple antipsychotics and mood stabilizers, so clozapine was started 3 months into his admission to treat his psychosis and suicidal ideation.  The patient received non-company suspect drugs included: clozapine (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for psychosis and suicidal ideation. Clozapine was titrated up to 400 mg over the following 3 months with resolution of his hallucinations and mania. He was also prescribed lithium carbonate 1,500 mg/d, gabapentin 600 mg/d, melatonin 3 mg at night, vitamin D3 2,000 IU/d, glycopyrrolate 1 mg as needed for drooling, and pantoprazole 40 mg/d. He had chronic neutrophilic leukocytosis thought to be related to his lithium and clozapine, with an average leukocyte count of 11.09 x 10*9/L (Range 7.44 to 22.12 x10*3 /mcL. Day 10 of covid illness: 7.79) and an average absolute neutrophil count of 8.13 x 10*9/L (Range 4.79 to 16.87x10*3 mcL. Day 10 of illness - 5.33) during his admission. He also suffered from poor dentition and received a single course of amoxicillin 500 mg 3 times/d shortly before the covid infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient had received the JOHNSON COVID-19 VACCINE 6 months into his admission and declined multiple offers for a Moderna booster. Nine months into the admission, he tested positive for covid-19 via a BinaxNOW nasal antigen test and had confirmed covid-19 infection and confirmed clinical vaccination failure. The patient was isolated for 10 days. On night 1 of his infection, he developed chills, hypotension (88/54 mm Hg), tachycardia (137 bpm), and hypoxia (87%), which increased to 94% on recheck, his blood pressure improved without intervention other than encouraging fluid intake. The patient's highest temperature was 99 degree F (Fahrenheit). The patient also reported a sore throat and occasional cough. On day 10 of infection, the measured COVID-19 IgG (anti-pike) was positive, though lower than expected at 31.07 index value. Laboratory data (dates unspecified) included: Albumin (NR: not provided) 3.83 g/dL (Range - 3.6 - 4.0. 1-month post illness - 4) and Protein (NR: not provided) 6.47 g/dL (Range 6.0 to 6.9. 1-month post illness - 6.5). Duration of hospitalization and discharge information were not reported. 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 hypotension, confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed covid-19 infection, hypotension, and confirmed clinical vaccination failure 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). This case, from Same Literature article is linked to 20230537421. This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20230533307- 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. 20230533307-hypotension. 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: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event is considered inconsistent with vaccine administration. 20230533307-Confirmed clinical vaccine 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.