Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Wound
Clinical narrative: Hypoxia; COVID-19; Central venous catheterisation; Endotracheal intubation; Hypophagia; Interchange of vaccine products; Mental status changes; Positive airway pressure therapy; SARS-CoV-2 test positive; Wound; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS FDA VAERS ID: 2028458) concerned a 64 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, asthma, diverticulitis, GERD (Gastroesophageal reflux disease), and ampicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: unknown) dose was not reported, 1 total, administered on 28-OCT-2021 for  an unspecified indication. No concomitant medications were reported. On 05-JAN-2022, the patient tested positive for (severe acute respiratory syndrome coronavirus 2) SARS-CoV-2  and presented to Emergency department, 3 days prior to admission, altered mental state for 2 days prior to admission, hypophagia (had poor oral intake for several days as well, as per EMS (emergency medical services) patient's initial O2 (oxygen) saturation was 50% at room air, and she was placed on was placed on CPAP (continuous positive airway pressure) which improved O2 (oxygen) saturation to 70%, patient did not tolerate the CPAP (continuous positive airway pressure) and remained persistently hypoxic and therefore intubated in emergency department. She also arrived with a right upper extremity PICC (peripherally inserted central catheter) line for outpatient antibiotics for a groin wound. The patient was hospitalized on an unspecified date for an unspecified number of days. (All events with dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 939905, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for an unspecified indication. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, central venous catheterisation, endotracheal intubation, hypophagia, hypoxia, interchange of vaccine products, mental status changes, positive airway pressure therapy, sars-cov-2 test positive and wound was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint 90000213700. 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 received from Central Complaint Vigilance department on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information in this version updates: Product quality complaint investigation result. This updated information does not alter the company causality of previously reported events. COVID-19 VACCINE AD26.COV2.S-Covid-19, central venous catheterisation, endotracheal intubation, hypophagia, hypoxia, interchange of vaccine products, mental status changes, positive airway pressure therapy, sars-cov-2 test positive and wound . 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).