Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Glomerular filtration rate, Inflammatory marker increased, Leukocytosis
Clinical narrative: BLOOD MAGNESIUM INCREASED; BLOOD PHOSPHORUS DECREASED; BLOOD POTASSIUM NORMAL; BLOOD SODIUM DECREASED; BLOOD THYROID STIMULATING HORMONE DECREASED; BRAIN NATRIURETIC PEPTIDE NORMAL; CARBON DIOXIDE; CHEST X-RAY NORMAL; GLOMERULAR FILTRATION RATE; INFLAMMATORY MARKER INCREASED; LIPASE NORMAL; SERUM FERRITIN INCREASED; TROPONIN I NORMAL; FATIGUE; PYREXIA; COVID-19 PNEUMONIA; BLINDNESS TRANSIENT; ANION GAP; BLOOD ALBUMIN DECREASED; BLOOD LACTATE DEHYDROGENASE INCREASED; BLOOD UREA INCREASED; C-REACTIVE PROTEIN INCREASED; COUGH; COVID-19; LEUKOCYTOSIS; MENTAL STATUS CHANGES; OXYGEN SATURATION DECREASED; SARS-CoV-2 TEST POSITIVE; ALANINE AMINOTRANSFERASE NORMAL; ASPARTATE AMINOTRANSFERASE NORMAL; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BILIRUBIN NORMAL; BLOOD CHLORIDE NORMAL; BLOOD CREATININE NORMAL; BLOOD GLUCOSE NORMAL; BLOOD LACTIC ACID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1474536) concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included right leg pain- osteoarthritis/osteoarthritis of right foot, migraine with aura, allergic rhinitis, anxiety, obesity, upper airway resistance syndrome, and hypothyroidism. The patient experienced drug allergy when treated with cefazolin- rash, and ciprofloxacin- diarrhea for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included baclofen, bupropion, duloxetine, famotidine, nabumetone, pantoprazole for drug used for unknown indication, and levothyroxine for hypothyroidism.  On 12-JUL-2021, the patient experienced fever, cough, and fatigue and admitted for covid pneumonia. COVID pneumonia/altered mental status/fever. The patient presented with fever, cough, fatigue for one week and found to be covid positive in emergency department (ED) (suspected clinical vaccination failure). The patient experienced mild leukocytosis, fever 101.4, and elevated inflammatory markers. The patient received 2 L intravenous fluid (IVF), and started on Decadron (dexamethasone) 10 mg in ED given desaturation to mid 80s with ambulation. The chest x-ray shows no acute disease. The patient also experienced transient vision loss in setting of high fever (106). The patient's suspect symptoms included fever and no recurrent episode. Per neurology, no indication for further imaging or workup at this time. Given high fever 106 and tremulousness on admission concern for other etiologies of fever. The Psychology meds initially held given concern for serotonin syndrome, however by the patient's improvement with 24 hours of holding medications, and no recent dose changes and would restart. The patient had blood culture + staphylococcus simulants, initially started on vancomycin for 2 days (12-JUL-2021 to 13-JUL-2021). It was reported that the worsening leukocytosis likely was known side effect of steroid use. Inflammatory markers were down trending. Overnight the patient presented with an episode of desaturation to 87% on ambulation to bathroom, on the morning of this report, stating 94%. The treatment included Decadron 6 mg daily for total treatment 10 days from 12-JUL-2021, trend inflammatory markers every other day, lovenox 40 mg subcutaneous twice a day (SQ BID) body mass index (BMI>40) and hold for Platelet <25k, Fibrinogen <100, active bleeding.  The patient's laboratory data included sodium (NA): 134 (L), potassium (K): 3.9, L: 1.3, carbon dioxide (CO2): 21 (L), Blood urea (BUN): 21, creatinine (CREAT): 1.11, ANION GAP: 4, SERPL: 10, glucose (GLUC): 118, Troponin I: <0.02, Brain natriuretic peptide (BNP): 17, alanine aminotransferase (ALT): 21, aspartate aminotransferase (AST): 30, alkaline phosphatase (ALKP): 56, LIPASE: 42, total bilirubin (TBILI): 0.8, glomerular filtration rate (GFR-AFRAM): >60, GFR NONAFR AMER: 54 (L), lactate: 1.1,Troponin I: <0.02 lactate dehydrogenase (LDH): 289 (H),albumin (ALB): 3.2 (L), c-reactive protein(CRP) (results: not reported), total protein (TP): 6.0, 9. Chest X-ray normal, inflammatory markers increased, Oxygen saturation decreased, SARS-CoV-2 test positive. On 13-JUL-2021, the laboratory data included NA: 137, K: 3.8, CL: 103, CO2: 23 (L), BUN: 20, CREAT: 0.93,Anion gap: 4, SERPL: 11, Magnesium (MG): 2.2, phosphorus (PHOS): 3.4,glucose (GLUC): 140, TSH: 0.4. The laboratory data included sodium (NA): 134 (L), potassium (K): 3.9, L: 1.3, carbon dioxide (CO2): 21 (L), Blood urea (BUN): 21, creatinine (CREAT): 1.11, ANION GAP: 4, SERPL: 10, glucose (GLUC): 118, Troponin I: <0.02, Brain natriuretic peptide (BNP): 17, alanine aminotransferase (ALT): 21, aspartate aminotransferase (AST): 30, alkaline phosphatase (ALKP): 56, LIPASE: 42, total bilirubin (TBILI): 0.8, glomerular filtration rate (GFR-AFRAM): >60, GFR NONAFR AMER: 54 (L), lactate: 1.1,Troponin I: <0.02 lactate dehydrogenase (LDH): 289 (H),albumin (ALB): 3.2 (L), c-reactive protein(CRP) (results: not reported), total protein (TP): 6.0 On 13-JUL-2021, the laboratory data included NA: 137, K: 3.8, CL: 103, CO2: 23 (L), BUN: 20, CREAT: 0.93,Anion gap: 4, SERPL: 11, Magnesium (MG): 2.2, phosphorus (PHOS): 3.4,glucose (GLUC): 140, TSH: 0.4. on 13-Jul-2021 the Hypothyroidism Last thyroid stimulating hormone level (TSH) level was 0.4. and the patient will take levothyroxine 25mcg daily. On 14-JUL-2021, the laboratory data included NA: 138, K: 4.1, CL: 107, CO2: 24, BUN: 18, CREAT: 0.69, Anion gap: 4, SERPL: 7, MG: 2.2, PHOS: 2.3 (L), GLUC: 125, LDH: 265, CRP, SER QL: 11.2 (H), Ferritin: 162. On 15-JUL-2021, the laboratory data included, NA: 137, K: 3.9, CL: 105, CO2: 24, BUN: 20, CREAT: 0.71, Anion gap: 4, SERPL: 8, MG: 2.2, PHOS: 2.8V, GLUC: 108. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anion gap, blindness transient, blood albumin decreased, blood lactate dehydrogenase increased, blood urea increased, c-reactive protein increased, cough, covid-19, covid-19 pneumonia, fatigue, leukocytosis, mental status changes, oxygen saturation decreased, pyrexia, sars-cov-2 test positive, confirmed clinical vaccination failure, alanine aminotransferase normal, aspartate aminotransferase normal, blood alkaline phosphatase normal, blood bilirubin normal, blood chloride normal, blood creatinine normal, blood glucose normal, blood lactic acid, blood magnesium increased, blood phosphorus decreased, blood potassium normal, blood sodium decreased, blood thyroid stimulating hormone decreased, brain natriuretic peptide normal, carbon dioxide, chest x-ray normal, glomerular filtration rate, inflammatory marker increased, lipase normal, serum ferritin increased and troponin I normal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000187448. 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 on 02-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2.This follow up version was created to update PQMS number and PQC investigation result. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause  was not identified. Event Suspected clinical vaccination failure Is made as not related.Missing event mental status changes is added.This changes the previous causality of events.  20210751495-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  20210751495- covid-19 vaccine ad26.cov2.s - Covid-19 Pneumonia, Blindness transient,Cough,Covid-19,Anion gap,Blood albumin decreased,Blood lactate dehydrogenase increased,Blood urea increased,C-Reactive protein increased,Leukocytosis,oxygen saturation decreased,SARS-COV2-TESTpositive,Alanine aminotransferase normal,Aspartate aminotransferase normal,Blood alkaline phosphatase normal,Blood bilirubin normal,Blood chloride normal,Blood creatinine normal,Blood glucose normal,Blood lactic acid,Blood magnesium increased,Blood phosphorus decreased,Blood potassium nomal,blood sodium decreased,Blood TSH decreased,Brain natriuretic peptide normal.carbon dioxide,chest X-ray normal,Glomerular filtration rate,Inflammatory marker increased,Lipase normal,Serum ferritin increased,Troponin I normal,Mental status changes. 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).  20210751495-COVID-19 VACCINE AD26.COV2.S-Fatigue,Pyrexia. This event(s) is labeled per RSI and is therefore considered potentially related.