Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine, Blood pressure measurement, Body temperature, CD4 lymphocytes, CD4/CD8 ratio
Clinical narrative: tachypneic; Severe COVID-19; Vaccine Breakthrough infection; This literature-study case was reported in a literature article and describes the occurrence of TACHYPNOEA (tachypneic) and COVID-19 (Severe COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: A case of severe COVID-19 despite full vaccination with mRNA-1273 SARS-CoV-2 Vaccine (Moderna) in a kidney transplant recipient. Transpl Infect Dis. 2021     The patient's past medical history included Renal transplant on 10-Feb-2020 and Immunosuppressant drug therapy since an unknown date. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Hypertension and Acute kidney injury. Concomitant products included PREDNISONE, MYCOPHENOLATE MOFETIL and TACROLIMUS for Immunosuppressant drug therapy.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYPNOEA (tachypneic) (seriousness criterion hospitalization prolonged), COVID-19 (Severe COVID-19) (seriousness criterion hospitalization prolonged) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection). The patient was hospitalized until 07-Jun-2021 due to COVID-19 and TACHYPNOEA. The patient was treated with DEXAMETHASONE (intravenous) at a dose of 6 milligram and REMDESIVIR (intravenous) at an unspecified dose and frequency. At the time of the report, TACHYPNOEA (tachypneic), COVID-19 (Severe COVID-19) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Lymphocyte count (1-3.30): 1.01 k/ul (normal) two months prior to admission showed an absolute lymphocyte count of 1.01 k/uL. On 02-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Apr-2021, White blood cell count (3.80-10.50): 5.62 k/ul (normal) two months prior to admission showed a white blood cell count of 5.62 k/uL. On 31-May-2021, SARS-CoV-2 antibody test: negative (Negative) Antibody tests against the SARS-CoV-2 nucleocapsid and receptor-binding domain (RBD) of the spike protein using the anti-SARS-CoV-2 S enzyme immunoassay (Roche Elecsys) were both negative. On 31-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Jun-2021, CD4 lymphocytes (30-56): 66 (High) one week after hospitalization showed 66% and 384/ul (normal) one week after hospitalization, showed absolute CD4+ T cell count of 384/uL. On 05-Jun-2021, CD4/CD8 ratio (0.86-4.14): 4.38 (High) CD4/CD8 ratio of 4.38. On 05-Jun-2021, CD8 lymphocytes (30-56): 15% (Low) one week after hospitalization showed CD8 percentage of 15% and 88/ul (Low) one week after hospitalization showed absolute CD8+ T cell count of 88/uL. In 2021, Blood creatine (1.25-1.96): high (High) serum creatine increased from baseline 1.25 to 1.96 mg/dL. In 2021, Blood pressure measurement: 97/55 mmhg (Low) blood pressure 97/55 mmHg. In 2021, Body temperature: 36.9°c (normal) temperature 36.9°C. In 2021, Computerised tomogram thorax: abnormal (abnormal) extensive bilateral patchy interstitial and nodular ground glass opacities, consistent with the findings of COVID-19.. In 2021, Glycosylated haemoglobin: 8.4% % (abnormal) insulin-dependent diabetes mellitus with a hemoglobin A1c level of 8.4%. In 2021, Heart rate: 100 (abnormal) 100 beats per minute. In 2021, Lymphocyte count (1-3.30): 0.11 k/ul (abnormal) absolute lymphocyte count 0.11 k/uL on admission noted lymphopenia. In 2021, Oxygen saturation: 92% (normal) oxygen saturation 92% while breathing ambient air and 94% to 99% (normal) was started on supplemental oxygen, delivered by nasal cannula at 2 L/minute, which improved his oxygen saturation values to 94 to 99%. In 2021, Respiratory rate: 35 breaths/min (abnormal) On examination, the patient appeared to be tachypneic. In 2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal swab tested positive for SARS-CoV-2 by real-time reverse transcriptasepolymerase-chain-reaction (rRT-PCR) assay. In 2021, White blood cell count (3.80-10.50): 11.74 k/ul (High) white blood cell count 11.74 k/uL on admission noted leukocytosis. On 06-Jul-2021, SARS-CoV-2 antibody test: negative (Negative) A month after discharge the SARS-CoV-2 nucleocapsid antibody remained negative (COI=0.18, reference range = 0.99) and the anti-spike RBD protein antibody turned positive with a low titer of 2.31 U/mL (reference range = 0.79 U/mL)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TACHYPNOEA (tachypneic), COVID-19 (Severe COVID-19) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection) to be possibly related.    Race of the patient reported.  The patient presented to our emergency department (ED) on 29-May-2021, with decreased oral intake, nausea, lethargy, and progressive shortness of breath and cough for two weeks.  On examination, the patient appeared to be tachypneic.  In patient daily tacrolimus levels ranged between 3.8 to 6.0 ng/mL. Patient received intravenous (IV) remdesivir for 4 days but it was discontinued one day early due to acute kidney injury (serum creatine increased from baseline 1.25 to 1.96 mg/dL).   After completing 10 days of IV dexamethasone 6 mg/day, patient was discharged home 07-Jun-2021.  Patient's serum creatine had normalized to his baseline at the time of discharge and two weeks post-discharge his tacrolimus level had fallen to 2.2 ng/mL  "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"; Sender's Comments: "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"