Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood creatine phosphokinase
Clinical narrative: ALANINE AMINOTRANSFERASE INCREASED; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD CREATINE PHOSPHOKINASE INCREASED; BLOOD CREATININE NORMAL; PLATELET COUNT NORMAL; PAIN IN EXTREMITY; MYALGIA; HEADACHE; RHABDOMYOLYSIS; CHROMATURIA; This spontaneous report was received from literature, in addition to information received via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), and concerned a 30 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar disease, opioid use disorder, and nicotine use disorder (vaping).The patient experienced drug allergy when treated with Demerol (pethidine hydrochloride) for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 281A21A and expiry: unknown) dose was not reported, 1 total administered at right arm on 10-APR-2021 for prophylactic vaccination. Concomitant medications included Gabapentin, Lithium carbonate, Quetiapine for unknown indication, and methadone for opioid use disorder. On 15-APR-2021 (after 5 days of vaccination), the patient experienced sore arm (pain in extremity) and headache for 2 days. Later, he developed myalgias and within few hours he was admitted in the hospital for 4 days. On 16-APR-2021, his test was done found dark urine (chromaturia), notable recent moderate exercise and over-ingestion of gabapentin. His lab test was performed which include alanine aminotransferase (ALT) was 282 (increased), aspartate aminotransferase (AST) was 779 (increased), blood creatine phosphokinase (CPK) was 95694 U/L (increase), blood creatinine (Cr) was normal and platelet count was normal. He was diagnosed with rhabdomyolysis. He did not have acute kidney failure. He received that treatment with aggressive IV hydration with improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rhabdomyolysis, pain in extremity, and headache, and the outcome of alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine normal, chromaturia, myalgia and platelet count normal was not reported. This report was serious (Hospitalization Caused / Prolonged). This case linked to 20210922810, 20210705289, 20210721677, 20210528518, 20210543394, 20210757800, 20210923028, 20210702722, 20210923039, 20210762171, 20210905291, 20210528129, 20210639871, 20210914711 and 20210639871 (Same Literature article).; Sender's Comments: V0:20210925005-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  rhabdomyolysis,alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine normal, chromaturia, platelet count  - 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). V0:20210925005 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pain in extremity, myalgia, headache, This event(s) is labeled per RSI and is therefore considered potentially related.