Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Airway secretion clearance therapy, Allergy to vaccine, Anisocoria
Clinical narrative: INTENSIVE CARE; DYSPNOEA; HYPOTENSION; CORNEAL SCAR; IIIRD NERVE DISORDER; DEVICE OCCLUSION; INCREASED BRONCHIAL SECRETION; DRY EYE; LAGOPHTHALMOS; ENDOTRACHEAL INTUBATION; MENTAL STATUS CHANGES; EXPOSURE KERATITIS; NEUROTROPHIC KERATOPATHY; HYPOTENSION; NYSTAGMUS; IIIRD NERVE DISORDER; OXYGEN SATURATION DECREASED; INCREASED BRONCHIAL SECRETION; SACCADIC EYE MOVEMENT; OXYGEN SATURATION DECREASED; STRABISMUS; VISUAL FIELD DEFECT; PYREXIA; LAGOPHTHALMOS; BLINDNESS; SACCADIC EYE MOVEMENT; BRADYCARDIA; PYREXIA; CORNEAL NEOVASCULARISATION; ABDOMINAL DISTENSION; CORNEAL OPACITY; ABDOMINAL PAIN; PARALYSIS; INTENSIVE CARE; SEIZURE; SARS-COV-2 TEST POSITIVE; VOLVULUS; NYSTAGMUS; ABDOMINAL DISTENSION; SEIZURE; ABDOMINAL PAIN; VOLVULUS; AIRWAY SECRETION CLEARANCE THERAPY; BRONCHOALVEOLAR LAVAGE; ALLERGY TO VACCINE; BRONCHOSCOPY; ANISOCORIA; NEUROTROPHIC KERATOPATHY; BRONCHOALVEOLAR LAVAGE; BLINDNESS; BRONCHOSCOPY; BRADYCARDIA; COLOSTOMY; CORNEAL OPACITY; CONDITION AGGRAVATED; PARALYSIS; CORNEAL SCAR; AIRWAY SECRETION CLEARANCE THERAPY; DEVICE OCCLUSION; ALLERGY TO VACCINE; DRY EYE; ANISOCORIA; DYSPNOEA; COVID-19; ENDOTRACHEAL INTUBATION; COLOSTOMY; EXPOSURE KERATITIS; CONDITION AGGRAVATED; COVID-19; CORNEAL NEOVASCULARISATION; SARS-COV-2 TEST POSITIVE; MENTAL STATUS CHANGES; This spontaneous report received from a parent by a Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS) concerned a 34 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: brain damage, cervical spine fracture, colostomy, colostomy (Good stool output overall Stoma viable some retraction), hemolacria, blood clots, intracranial hemorrhage, motor vehicle accident, ocular nystagmus, headache, sigmoid volvulus subdural hematoma, seizures and paralysis (lasting 80) and concurrent conditions included: anal fistula, anisocoria, bilateral profound visual loss, sigmoid volvulus (s p end), corneal pannus of both eyes, corneal scar, opacity, depression, dry eyes bilateral, exotropia of both eyes, exposure keratopathy, gastroesophageal reflux disease, pressure ulcer, hypertropia of right eye, lagophthalmos of eyelids of both eyes, neurotrophic keratoconjunctivitis of right eye, localized visual field defect (bilateral), paralytic strabismus (associated with right partial oculomotor nerve palsy), tremor, seizure, saccadic eye movement deficiency, drug allergy (amoxicillin, ampicillin) and covid-19 ad26 vaccine allergy. The personal history of other diseases of the nervous system and sense organs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to the right arm on 10-MAR-2021 for an unspecified indication. Age at time of vaccination 33 years old. Concomitant medications included adderall (amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate), baclofen, cetirizine, senna-docusate (docusate sodium/sennoside a and b), escitalopram, guaifenesin, duo-neb (ipratropium bromide/salbutamol sulfate), lacosamide, lactulose, levetiracetam, melatonin, memantine, montelukast, oxybutynin, hypotears (retinol palmitate), eye solution, soothe eye solution, salbutamol and valproic acid. It was reported that on 10-MAR-2021, the patient had COVID-19 PCR test (sars-cov-2 test positive) which confirmed positive result (covid-19). On 23-AUG-2022, the patient experienced blindness, corneal neovascularization, corneal opacity, paralysis, seizure, volvulus, abdominal distension, abdominal pain, allergy to vaccine, anisocoria, bronchoalveolar lavage, colostomy, condition aggravated, corneal scar, device occlusion, dry eye, endotracheal intubation, exposure keratitis, iiird nerve disorder, increased bronchial secretion, lagophthalmos, neurotrophic keratopathy, nystagmus, saccadic eye movement, strabismus and visual field defect. On 23-AUG-2022, Laboratory data included: Airway secretion clearance therapy not reported, Bronchoalveolar lavage not reported, Bronchoscopy not reported, Colostomy not reported, Intubation Not reported, and Oxygen saturation (NR: not provided) 85%. It was reported that on 23-AUG-2022, the patient was presented to hospital due to worsening shortness of air (dyspnoea) and as per the patient's mother the patient became febrile (pyrexia) in the morning of admission (on 28-AUG-2022) and upon checking her oxygen saturation, it was noted to be 85% (oxygen saturation decreased). The patient was placed on 5 L home oxygen and brought to the hospital. The patient was found to have covid. She was initially admitted to the hospital medicine service, however it was noted to have decreased mentation (mental status changes) which required emergent intubation (endotracheal intubation). Post intubation the patient had a bronchoscopy with BAL performed. On 24-AUG-2022 into 25-AUG-2022, the patient became hypotensive and was given 1 liter IVF (Intravenous fluid) but remained hypotensive and was started on norepinephrine. Shortly after initiation of norepinephrine, the patient became bradycardic and therefore the patient was transitioned to epinephrine and BP and heart rate improved. The patient's mother mentioned the patient had similar issues two times prior while on norepinephrine. On 25-AUG-2022, early morning the patient was weaned off of epinephrine and extubated (device occlusion) to HFNC (High flow nasal cannula) (airway secretion clearance therapy). On 26-AUG-2022 the patient was transitioned from HFNC to 5L NC and broad spectrum abx were stopped. On 29-AUG-2022, the patient was upgraded to ICU (intensive care) status for closer monitoring. On 30-AUG-2022, the patient was hypotensive with SBP in the 70s was given 1 liter IVF (Intravenous fluid) transitioned back to HFNC (High flow nasal cannula) and repeat infectious workup was obtained. On 31-AUG-2022, the patient was transitioned back to regular NC and downgraded back to progressive care on 01-SEP-2022. On 04-SEP-2022, the patient was dropped her SpO2 (oxygen saturation) to 75%, on 4L NC NT suction was performed but catheter clogged due to secretions. The patient was placed on a NRB and SpO2 (oxygen saturation) improved to 96% and transitioned to 80% and 40L HFNC and initiated on mucomyst nebs. The patient stayed in the ICU and her oxygen was weaned down to 2L NC PRN over the past few days. The patient was continued getting mucomyst nebs, albuterol nebs, hypertonic saline nebs, chest PT (Chest physical therapy) and cough assist. These interventions due help with her secretions. It was reported that the patient's mother had all these modalities for airway clearance (airway secretion clearance therapy) at home and the patient had remained hemodynamically stable on midodrine and has tolerated RA mostly during the day with 2L PRN at night. It was reported that the patient will be discharged home with current neb treatments as well as oxygen to use PRN, home health services will resume and the team has reviewed the care plan new medications with her mother. On 04-SEP-2022, Laboratory data included: Oxygen saturation (NR: not provided) 75 %. Laboratory data (dates unspecified) included: Blood pressure improved, Heart rate improved, Oxygen saturation (NR: not provided) 80 %, 96 %, and Oxygen saturation down to 2L. The patient was hospitalized on 23-AUG-2022 for 19 days. Treatment medications (dates unspecified) included: norepinephrine, and epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blindness, bradycardia, corneal neovascularisation, corneal opacity, paralysis, seizure, volvulus, abdominal distension, abdominal pain, airway secretion clearance therapy, allergy to vaccine, anisocoria, bronchoalveolar lavage, bronchoscopy, covid-19, colostomy, condition aggravated, corneal scar, device occlusion, dry eye, dyspnoea, endotracheal intubation, exposure keratitis, iiird nerve disorder, increased bronchial secretion, intensive care, lagophthalmos, mental status changes, neurotrophic keratopathy, nystagmus, oxygen saturation decreased, sars-cov-2 test positive, saccadic eye movement, strabismus, visual field defect, and pyrexia, and had not recovered from hypotension. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000253946. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed.  Additional information received from Complaint department on 30-NOV-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2:Follow up information in this version updates, product quality complaint investigation result added.. This updated information does not change the causality of the previously reported events. 20220951222 -Covid-19 vaccine ad26.cov2.s-  Blindness ,Anisocoria ,Volvulus ,Abdominal distension, Abdominal pain, Colostomy ,Corneal scar, Corneal neovascularisation ,Corneal opacity ,Dry eye ,Exposure keratitis ,IIIrd nerve disorder ,Lagophthalmos, Neurotrophic keratopathy ,Nystagmus ,Saccadic eye movement ,Strabismus ,Visual field defect  , Bradycardia, Airway secretion clearance therapy ,Bronchoalveolar lavage., Bronchoscopy ,COVID-19,Condition aggravated ,Device occlusion, Dyspnoea, Endotracheal intubation, Hypotension, Increased bronchial secretion ,Intensive care, Mental status changes ,Oxygen saturation decreased ,SARS-CoV-2 test positive ,Pyrexia ,Allergy to vaccine . 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.  20220951222-covid-19 vaccine ad26.cov2.s- Paralysis ,Seizure . 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.