Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Speech disorder
Clinical narrative: SARS-COV-2 TEST POSITIVE; SPEECH DISORDER; PYREXIA; SARS-COV-2 TEST POSITIVE; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; MOVEMENT DISORDER; COVID-19; DECREASED APPETITE; FALL; FLUID INTAKE REDUCED; FOOD REFUSAL; GAIT INABILITY; HYPOPHAGIA; HYPORESPONSIVE TO STIMULI; MOVEMENT DISORDER; SOMNOLENCE; SOMNOLENCE; MENTAL STATUS CHANGES; SPEECH DISORDER; PYREXIA; MUSCULOSKELETAL DISORDER; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; CEREBROVASCULAR ACCIDENT; MENTAL STATUS CHANGES; MUSCULOSKELETAL DISORDER; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 2368873) and concerned an 89 year old female. The patient's height, and weight were not reported. The patient's past medical history included: acute cerebrovascular accident, multiple closed fractures of pelvis with stable disruption of pelvic circle, closed head injury, facial laceration, fall, facial contusion initial encounter, and closed fracture of left distal radius, and concurrent conditions included: macular degeneration of left eye, presence of artificial eye, transient ischemic attack, vascular dementia without behavioral disturbance chronic, hyperlipidemia chronic, dementia chronic, scapholunate dissociation of left wrist, failure to thrive in adult, acute cystitis without hematuria, drug allergy (Severity Reactions (Acetaminophen, Atrovent [ipratropium Bromide], Codeine, Darvocet A500 [propoxyphene Nacetaminophen], Motrin [ibuprofen], Norco [hydrocodone-acetaminophen], (Made patient feel crazy), Propoxyphene Napsylate, Simvastatin)), penicillin allergy, influenza virus vaccine allergy (Patient had rash, she went to emergency room (ER)), red dye allergy, hypertension, and bronchial asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-FEB-2022 in left arm for an unspecified indication. Age at time of vaccination 89 years old. Concomitant medications included calcium carbonate, colecalciferol and sennosides. On 30-MAY-2022, patient was hospitalized for evaluation of decreased mentation and possible stroke (cerebrovascular accident). Patient was nonverbal (speech disorder) and followed some simple commands. The patient was admitted on 30-MAY-2022 to 01-JUN-2022, for altered mentation (mental status changes). Apparently the patient was being evaluated for seizures, however they opted not to proceed with EEG (electroencephalogram) and MRI (Magnetic resonance imaging). The patient apparently improved after fluids. Hospice was offered to the imaging was admission due to the advanced dementia, however the family refused to sign up for hospice. When patient left the hospital the son reported that patient apparently walked with full assist to about 100 feet and in fact climb a few steps of stairs, was doing fine since the discharge. On 01-JUN-2021, Wednesday, patient started having decreased appetite, refusing to be fed (food refusal) and was chest more somnolent than baseline. The son of patient also noted that the right leg was not moving at all (movement disorder and musculoskeletal disorder) despite different ways to try to encourage to move the right leg. The patient also stopped walking since Wednesday (gait inability). They apparently tried to have patient sit for a meal but patient slid off the chair with right knee going underneath the left leg. They managed to prevent patient from falling to the ground (fall). Patient was hardly responding (hyporesponsive to stimuli) and had not anything to eat or drink at all (fluid intake reduced and hypophagia). They decided to bring patient to the emergency room for further evaluation. Patient was admitted to the neurology floor. The patient was started on aspirin. Patient was considered for a statin but this was deferred due to the dietary limitations and pending hospice status. On 10-JUN-2022, patient underwent MRI (Magnetic resonance imaging) which was consistent with a CVA (cerebrovascular accident). Teleneurology was consulted given poor functional status and poor long-term prognosis family opted for hospice care. The patient had a fever (pyrexia) and tested positive for COVID-19 which delayed hospice transport 10 days waiting period for isolation concerns, recommended diet was a pureed diet. On 14-JUN-2021, Laboratory data included: SARS-CoV-2 test Positive. The patient was non-verbal and interactive with daughter present, limited intake including pocketing food. The patient was discharged to rehab. Patient was hospitalized for 10 days. Treatment medication (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cerebrovascular accident, covid-19, decreased appetite, fall, fluid intake reduced, food refusal, gait inability, hypophagia, hyporesponsive to stimuli, mental status changes, movement disorder, musculoskeletal disorder, somnolence, speech disorder, magnetic resonance imaging head abnormal, sars-cov-2 test positive, and pyrexia. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 02-AUG-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This version updates: Product quality complaint investigation result. The prior causality assessment remains unaltered with this information.   20220747042- COVID-19 VACCINE AD26.COV2.S- cerebrovascular accident, decreased appetite, fall, fluid intake reduced, food refusal, gait inability, hypophagia, hyporesponsive to stimuli, mental status changes, movement disorder, musculoskeletal disorder, somnolence, speech disorder, magnetic resonance imaging head abnormal. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.  20220747042-COVID-19 VACCINE AD26.COV2.S- COVID-19, pyrexia, SARS-COV-2 test positive. 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). Therefore, this event(s) is considered unassessable.