COVID-19 PNEUMONIA; CONFIRMED CLINICAL VACCINATION FAILURE; COUGH; DYSPNOEA; LUNG INFILTRATION; POSITIVE AIRWAY PRESSURE THERAPY; WHITE BLOOD CELL COUNT DECREASED; BLOOD BICARBONATE DECREASED; BLOOD GASES ABNORMAL; BLOOD GLUCOSE NORMAL; BLOOD PH NORMAL; LABORATORY TEST; PCO2 DECREASED; PO2 DECREASED; PROCALCITONIN INCREASED; PLATELET COUNT DECREASED; CHEST X-RAY ABNORMAL; DIARRHOEA; MALAISE; MYALGIA; NAUSEA; PYREXIA; VOMITING; SARS-COV-2 TEST NEGATIVE; This spontaneous report received from a health care professional by a Regulatory Authority (reference number 1929347) concerned a 7 decade (either 65 or 64 year) old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: Chronic obstructive pulmonary disease (COPD) and she was on 4L nasal canula (NC) at home at 76% oxygen and only wears it at night. She also had hypothyroidism and other pre-existing medical conditions included: The patient had family history of positive for COVID-19 test. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to left arm for an unspecified indication (coded as product used for unknown indication). No concomitant medications were reported.  On 28-NOV-2021, the patient was tested negative for covid (sars-cov-2 test negative). On an unspecified date, the patient was initially ill (malaise) and experienced dry cough with shortness of breath (SOB) and fever (pyrexia) to 102. She endorses Nausea, Vomiting and diarrhea. She denies loss of taste or smell. She also experienced myalgias. On 03-DEC-2021, patient arrived via emergency medical services (EMS) from home to the emergency department (ED). In the ED patient is noted to have O2 saturation was in 70s upon arrival on continuous positive airway pressure (CPAP). Patient was placed on bi-level positive airway pressure (Bipap) with improvement in O2 saturation to 90s. She was noted to be febrile to 101.5 and otherwise hemodynamically stable. Laboratory studies are significant for white blood cells (WBC) 27, platelets 122, bicarbonate 19, glucose 120, procalcitonin 01, arterial blood gases (ABG) reveals pH 7, 43 partial pressure of carbon dioxide (pCO2), 26 partial pressure of oxygen (pO2), 69 on 80 % fraction of inspired oxygen (FiO2), chest x-ray reveals diffuse bilateral alveolar infiltrates (lung infiltration) consistent with COVID-19 pneumonia. Patient was trialed on humidified, high flow nasal cannula (HHFNC) but was unable to maintain O2 saturations and was placed back on Bipap. Hospitalist service is asked for admission and patient had continued to be an inpatient. Laboratory data included: Blood bicarbonate (NR: not provided) 19 (Decreased), Blood gases (NR: not provided) abnormal, Blood glucose (NR: not provided) 120 (normal), Blood pH (NR: not provided) normal, Body temperature (NR: not provided) 101.5 F, Chest X-ray (NR: not provided) abnormal and reveals diffuse bilateral alveolar infiltrates consistent with COVID-19 pneumonia which was confirmed clinical vaccination failure, FIO2 (NR: not provided) 69, Laboratory test (NR: not provided) not reported, O2 saturation (NR: not provided) 70s, 90s, PCO2 (NR: not provided) 43 (decreased), PO2 (NR: not provided) 26 (decreased), Platelet count (NR: not provided) 122 (decreased), Procalcitonin (NR: not provided) 01 (increased), and White blood cell count (NR: not provided) 27 (decreased). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F (dose number in series: 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, intramuscular, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm for an unspecified indication (coded as product used for unknown indication). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood bicarbonate decreased, blood gases abnormal, blood glucose normal, blood ph normal, covid-19 pneumonia, chest x-ray abnormal, cough, diarrhoea, dyspnoea, laboratory test, lung infiltration, malaise, myalgia, nausea, pco2 decreased, po2 decreased, platelet count decreased, positive airway pressure therapy, procalcitonin increased, pyrexia, sars-cov-2 test negative, vomiting, white blood cell count decreased and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000209132. 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 regulatory authority evaluation/investigation performed.  Additional information was received from a regulatory authority department on 05-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: The age group of patient was changed from elderly to unknown and age at the time of vaccination was updated to 64 years from 7 decades.; Sender's Comments: V1: Follow up information updates about product quality complaint investigation result. Age group and age at the time of vaccination was updated. This information does not alter the previous causality assessment. 20211240522- covid-19 vaccine ad26.cov2.s -Confirmed 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 20211240522 -COVID-19 VACCINE AD26.COV2.S- covid-19 pneumonia, lung infiltration, malaise, myalgia, cough, diarrhoea, dyspnoea, pyrexia , nausea,  blood bicarbonate decreased, blood gases abnormal, blood glucose normal, blood ph normal, chest x-ray abnormal, laboratory test, pco2 decreased, po2 decreased, platelet count decreased, positive airway pressure therapy, procalcitonin increased, sars-cov-2 test negative, vomiting, white blood cell count decreased. 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).