Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood creatinine
Clinical narrative: PNEUMONIA; ACUTE RESPIRATORY FAILURE; HYPOXIA; COVID-19; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; CONDITION AGGRAVATED; TACHYCARDIA; CHEST X-RAY NORMAL; SARS-COV-2 TEST POSITIVE; CARDIAC MONITORING ABNORMAL; BLOOD SODIUM INCREASED; BLOOD CREATININE INCREASED; BLOOD CREATINE PHOSPHOKINASE INCREASED; ASTHENIA; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 79 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: gammopathy, monoclonal COPD, obstructive sleep apnea, Type 2 diabetes mellitus, stage 3 chronic kidney disease, acute respiratory failure with hypoxia, hypoxia, restless leg syndrome, essential hypertension, hyperlipidemia (unspecified hyperlipidemia type), bronchiectasis without complication, chronic venous stasis dermatitis, left leg weakness, cervical stenosis of spinal canal, spinal stenosis of lumbar region without neurogenic claudication, senile nuclear cataract bilateral, myopia of both eyes, malignant neoplasm of lower lobe of right lung, chronic respiratory failure with hypoxia, systolic murmur, nicotine use disorder, on home oxygen therapy, ventral hernia without obstruction or gangrene, abdominal wall mass of right upper quadrant, dementia, late onset Alzheimer's disease without behavioral disturbance, tobacco use and pneumonia, and other pre-existing medical conditions included: The patient had no current illness at the time of vaccination. The patient experienced myalgia when treated with simvastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 06-MAY-2021 for unknown indication. The drug was associated with Batch and lot tested and found within specifications. Age at time of vaccination 79 years old. Latency period was 442 days. Concomitant medications included allopurinol, clobetasol propionate/gentamicin sulfate/miconazole nitrate, colecalciferol, fluticasone propionate, paracetamol, blood glucose monitoring supplement MISC, and salbutamol used for unknown indication. On 22-JUL-2022, the patient experienced pneumonia [J18 9] weakness [R53 1] COPD (chronic obstructive pulmonary disease) exacerbation [J44 1] Acute respiratory failure with hypoxia [J96 01] COVID-19 [U07 1]. He had a dementia who presented after he was found on the floor by daughter. Evaluation in the emergency department revealed the patient was positive for COVID-19 and Chest x-ray was negative. Patient had mild hypoxia on ambulation down to 88 percent and was placed on 2 L of oxygen. He had elevated creatinine, CPK and sodium. He was started on IV fluids and was admitted to hospital on same day for further management. Patient was started on Decadron 6 mg daily. His oxygen was weaned of quickly and creatinine improved back to his baseline chronic kidney disease stage 3. He was evaluated by PT (Physiotherapist) and OT (Occupational therapist) who recommended discharge to subacute rehab. He had a 15 minute episode of tachycardia into the 150s to 160s that reverted back to normal sinus rhythm spontaneously. Cardiac monitoring was continued and he had no further episodes of tachycardia. He was discharged to SAR in stable condition on 2 L supplemental O2 via NC (nasal cannula). He was discharged on 02-AUG-2022. Number of days of hospitalization was 11 days. Laboratory data included: Blood creatine phosphokinase increased, Blood creatinine increased, Blood sodium increased, Cardiac monitoring abnormal, Chest X-ray normal, and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute respiratory failure, asthenia, blood creatine phosphokinase increased, blood creatinine increased, blood sodium increased, covid-19, cardiac monitoring abnormal, chest x-ray normal, chronic obstructive pulmonary disease, condition aggravated, hypoxia, pneumonia, sars-cov-2 test positive, and tachycardia. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000247430. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications, the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from department on 07-SEP-2022. The following information was updated and incorporated in to the case narrative: product quality complaint investigation result.; Sender's Comments: V1:Follow up information in this version updates, product quality complaint investigation result. This updated information does not change the causality of the previously reported events. 20220844562-covid-19 vaccine ad26.cov2.s -Pneumonia, acute respiratory failure, hypoxia,  covid-19, chronic obstructive pulmonary disease, condition aggravated, tachycardia, chest x-ray normal,  sars-cov-2 test positive,  cardiac monitoring abnormal,  blood sodium increased, blood creatinine increased, blood creatine phosphokinase increased, asthenia. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.