Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: CONDITION AGGRAVATED; BLOOD LACTIC ACID; HYPOPHAGIA; LABORATORY TEST NORMAL; BLOOD CREATININE NORMAL; COVID-19; BLOOD LACTIC ACID; CONDITION AGGRAVATED; BLOOD POTASSIUM DECREASED; HYPOKALAEMIA; ELECTROLYTE SUBSTITUTION THERAPY; BLOOD POTASSIUM DECREASED; FULL BLOOD COUNT NORMAL; IMAGING PROCEDURE; PLATELET COUNT DECREASED; LABORATORY TEST NORMAL; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; ASTHENIA; CARDIAC FAILURE; BLOOD CREATININE NORMAL; HYPOKALAEMIA; IMAGING PROCEDURE; ASTHENIA; CARDIAC FAILURE; FATIGUE; ELECTROLYTE SUBSTITUTION THERAPY; COVID-19; HYPOPHAGIA; SARS-COV-2 TEST POSITIVE; FATIGUE; FLUID INTAKE REDUCED; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2447934) on 30-SEP-2022 and concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic fatigue, chronic pain, atrial fibrillation (Stable on Eliquis 5 mg BID and Simvastatin 20 mg), migraines, peripheral neuropathy, insomnia (taking PRN Trazodone 150 mg nightly at home), peptic ulcer disease / GERD (taking Pepcid 40 mg and Protonix 40 mg daily), and dry eyes (Taking Xiidra 5 percent droplets PRN at home. Patient was given liquid tears PRN in hospital), and other pre-existing medical conditions included: Patient's husband was diagnosed with covid-19 about 10 days prior to her hospitalization. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 in left arm for an unspecified indication. Age at time of vaccination 70 years old. Concomitant medications included apixaban for atrial fibrillation, simvastatin for atrial fibrillation, lifitegrast for dry eyes, famotidine for GERD, pantoprazole sodium sesquihydrate for GERD, trazodone for insomnia, gabapentin, and topiramate.  On 13-AUG-2022, the patient presented to emergency department and tested positive for covid-19. Patient was feeling increased fatigue and generalized weakness. It was significantly worsened in 48 hours prior to admission to the point where she had decreased oral intake of both food and fluids. On 15-AUG-2022 patient was admitted to the hospital for worsening of weakness and fatigue (condition aggravated). Patient had low Platelets which was 127K on admission. Patient experienced cardiac failure, hypophagia, asthenia and blood potassium decreased. Patient's complete blood cell count was remarkable in ED. Lactic acid was 1.4 and Creatinine 0.94. Patient's chest and head imaging were non-acute. She was started on 75 mL / hr. of LR and PT/OT was consulted. Patient did not require supplemental oxygen at the time of admission or throughout her stay. Patient had a baseline level of low mood, anhedonia, and decreased functionality at home. She answered many questions with "I don't know". Her potassium level dropped to 3.0 and was replete on 16-AUG-2022 (hypokalaemia). Physical therapy (PT) and occupational therapy (OT) saw the patient and recommended 2-3 days of rehab weekly for 7-10 days. The patient was approved for home health care through local service provider. Patient was discharged in stable condition after 7 days. Patient was given electrolyte substitution therapy supportive care with IV fluids and was encouraged for PO intake. PT / OT saw patient and gave recommendations for outpatient rehabilitation. She was accepted and set up with local provider for her rehab. Patient had low Platelets which was 127K on admission and decreased as low as 105K before rebounding.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac failure, covid-19, condition aggravated, hypokalaemia, hypophagia, blood creatinine normal, blood lactic acid, blood potassium decreased, electrolyte substitution therapy, fluid intake reduced, full blood count normal, imaging procedure, laboratory test normal, platelet count decreased, sars-cov-2 test positive, asthenia, and fatigue. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000254136  Additional information was received from central complaint vigilance department on 04-OCT-2022 and 05-OCT-2022. The following information was updated and incorporated into the case narrative: Batch number updated, product quality complaint number added. Sender's Comments: V1: Additional information received is regarding product quality complaint investigation result. This follow up information received does not alter the assessment of prior company causality of previously reported events.  : 20221003119-covid-19 vaccine ad26.cov2.s-  cardiac failure, hypokalemia,  covid 19, condition aggravated , hypophagia,  blood creatinine normal, blood lactic acid,  blood potassium decreased, electrolyte substitution therapy,  fluid intake reduced,  full blood count normal, imaging procedure, laboratory test normal,  platelet count decreased,  sars-cov-2 test positive, asthenia, fatigue .The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. ( Additionally, Covid 19 infection & related events are confounded by patient's recent exposure to covid infected person;  patient's medical history of atrial fibrillation is considered as confounding factor for cardiac failure)