Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Coma, Condition aggravated, Confusional state, Dehydration
Clinical narrative: RHABDOMYOLYSIS; INTENSIVE CARE; COMA; TYPE 1 DIABETES MELLITUS; SARS-COV-2 TEST POSITIVE; LOSS OF CONSCIOUSNESS; DEVICE INFUSION ISSUE; DIABETIC KETOACIDOSIS; BLISTER; ISCHAEMIC HEPATITIS; CONFUSIONAL STATE; BLISTER; RHABDOMYOLYSIS; CONDITION AGGRAVATED; TYPE 1 DIABETES MELLITUS; CONFUSIONAL STATE; LOSS OF CONSCIOUSNESS; DEHYDRATION; DIABETIC KETOACIDOSIS; DEVICE INFUSION ISSUE; ISCHAEMIC HEPATITIS; INTENSIVE CARE; CONDITION AGGRAVATED; LIVER FUNCTION TEST INCREASED; DEHYDRATION; SARS-COV-2 TEST POSITIVE; LIVER FUNCTION TEST INCREASED; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 2425263), FDA Inbound Unit) and concerned a 58 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 13-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: Latex allergy, abilify allergy, adhesive allergy, dilaudid allergy, morphine allergy, vancomycin allergy, chronic obstructive pulmonary disease, chronic hypothyroidism, renal insufficiency, bipolar ii disorder, chronic hyperlipidemia, gastroesophageal reflux disease, neuropathy, hypertension, smoker, diabetes type 1 (controlled dx 1989), overweight, insulin pump in place, diabetic retinopathy associated with type 1 diabetes mellitus, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1802068 expiry: UNKNOWN) dose was not reported, administered 1 in total on 05-APR-2021 for an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported.  On 21-AUG-2022, the patient was brought to hospital since the patient was unconscious at home, Initially thought to suffer from pump failure but later it was discovered that patients pump's battery died and she had actually ignored 2 warnings about line obstruction and low battery.  It is plausible that patient had suffered covid-19 encephalopathy and due to the confusion was not able to manage her insulin pump and so it powered down causing her to go into DKA (Diabetic ketoacidosis) and coma. Patient was initially managed in ICU (intensive care unit) and is now stable on the floors. Rhabdomyolysis was resolved and improved with IV fluid hydration. Encourage continued hydration T1DM (type 1 diabetes mellitus). Patient is confident she is capable of managing her insulin pump.  Patient was managed here with basal and prandial insulin. Plan is to go home and set up her pump. Home care ordered to check on the patient tomorrow to make sure patients insulin is set up with her pump. Patient was not having any COVID-19 sign of respiratory distress. No indication for covid-19 directed therapy. Patient was continued with supportive care. Superficial blisters on back and right butt cheek, blister on head local wound care was given, patients LFT's (liver function test) was Elevate unclear etiology  may be due to shock in liver from dehydration. Hepatitis panel ordered. Patient was hospitalized for 6 days. date of discharge was not reported. Latency was 503 days. On 21-AUG-2022, the patient experienced rhabdomyolysis, coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, blister, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased, sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 PCR (polymerase chain reaction) test Positive. Liver function test Elevate. Patient has an appointment with endocrinology on 01-SEP-2022.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rhabdomyolysis, coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, blister, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000251280 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 PQC evaluation/investigation performed.  Additional information was received from central complaint vigilance department on 04-OCT-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1: This follow up version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events.  20220922861-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Blister, sars-cov-2 test positive. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.(Event of rhadomyolysis reported around 16 months post vaccination and the patient experienced covid-19 encephalopathy which precipitated Rhabdomyolysis in patient with multiple co-morbidities,  provides more plausible explanation) 20220922861-covid-19 vaccine ad26.cov2.s- coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased. 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.