Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin normal, Blood urine present, Chromaturia
Clinical narrative: ALANINE AMINOTRANSFERASE INCREASED; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD BILIRUBIN NORMAL; BLOOD URINE PRESENT; FIBRIN D DIMER INCREASED; FULL BLOOD COUNT NORMAL; INFLUENZA  A VIRUS TEST NEGATIVE; MYOGLOBIN BLOOD PRESENT; PROTEIN URINE PRESENT; RENAL FUNCTION TEST NORMAL; RESPIRATORY SYNCYTIAL VIRUS TEST NEGATIVE; SARS-COV-2 TEST NEGATIVE; TROPONIN NORMAL; INFLUENZA B VIRUS TEST; CHROMATURIA; RHABDOMYOLYSIS; MYOSITIS; GAIT DISTURBANCE; MUSCULOSKELETAL PAIN; PAIN IN EXTREMITY; MYALGIA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1371923, US-VAERS-1371923-SQJT-20210917142935) and from literature: Rhabdomyolysis Following Ad26.COV2.S COVID-19 Vaccination. Vaccines 2021.  This report concerned a 49 year old male with unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had no known allergies, no history and no current illness at the time of reporting. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: unknown) dose was not reported, 1 total, drug start period 8 days, administered to left arm on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021 (8 days after vaccination), the patient experienced rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms (coded as musculoskeletal pain, myalgia, and pain in extremity), within 24 hours he was unable to walk easily (gait disturbance). The patient had no other symptoms and no physical signs of infection. The patient's urine had became dark red/brown (chromaturia) at 24 hours and the patient clinically had myositis with suspected rhabdomyolysis. On 02-JUN-2021, Laboratory data included: Alanine aminotransferase Increased, 81 (Units Unspecified), Aspartate aminotransferase Increased, 279 U/L (units per liter), Blood bilirubin Normal, Blood urine Present (Positive), Clotting time Normal, Fibrin D dimer Increased, Full blood count Normal, Influenza A virus test Negative, Influenza B virus test Negative, Myoglobin blood Positive, Protein urine Present (Positive), Respiratory syncytial virus test Negative, SARS-CoV-2 PCR (polymerase chain reaction) test Negative, Troponin Normal, and Urine analysis Dark red/brown color.  On 03-JUN-2021, Laboratory data included: Alanine aminotransferase Increased, 357 (Units Unspecified), Aspartate aminotransferase Increased, 1368 U/L, Blood urine Present (Positive), Clotting time Normal, Full blood count Normal, Protein urine Present (Positive), and Troponin Normal. On an unspecified the patient visited physician office and was hospitalized. The patient was treated with IV (Intravenous) fluids and analgesics. The patient was improving clinically but gait still disturbed at the time of reporting. It was reported that the patient had no demonstrable weakness, no neuro deficit or symptoms and no other obvious cause for acute myositis to consider. The patient was hospitalized for 1 day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin normal, blood urine present, chromaturia, fibrin d dimer increased, full blood count normal, gait disturbance, influenza a virus test negative, influenza b virus test, musculoskeletal pain, myalgia, myoglobin blood present, myositis, pain in extremity, protein urine present, renal function test normal, respiratory syncytial virus test negative, rhabdomyolysis, sars-cov-2 test negative, and troponin normal. The author emphasized, physicians should be aware of the possibility of vaccine-induced rhabdomyolysis as a potentially serious side-effect in patients complaining of myalgia following vaccination, particularly in times of mass vaccinations. Patients may be advised to monitor the color of their urine for the early detection of rhabdomyolysis. Finally, our case report suggested the need for aggressive fluid resuscitation and close monitoring for the prevention of acute kidney failure in patients with rhabdomyolysis. This report was serious (Hospitalization Caused / Prolonged). This case, from Same Literature article is linked to 20210923039, 20210543394, 20210721677, 20210639871, 20210914711, 20210528129, 20210705289, 20210702722, 20210757800, 20210762171, 20210923028, 20210924327, 20210528518, 20210922624, 20210922810, 20210922823, 20210923042, 20210925005, 20210924285 and 20210927103.  Additional information received from on 07-SEP-2021. As the follow-up Regulatory Clock Start date pre-dates the initial version Regulatory Clock start date of 13-SEP-2021, the initial version Regulatory Clock Start date has been captured within the data field to prevent an E2b failure from occurring. Upon review following information was amended: The information from literature document was incorrectly reported under (20210905291) and it was correctly added as follow up to this case (20210927643). Literature reporters, literature citation, as the patient involved was quoted in a table of similar events contained within the article.; Sender's Comments: V1: Version updates about that the information from literature document was incorrectly reported under (20210905291) and it was correctly added as follow up to this case (20210927643). This information does not alter the previous causality assessment. 20210927643-COVID-19 VACCINE AD26.COV2.S- rhabdomyolysis, myositis, chromaturia, gait disturbance, myalgia, pain in extremity, musculoskeletal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin normal, blood urine present, fibrin d dimer increased, full blood count normal, influenza-A virus test negative, influenza b virus test, myoglobin blood present, , protein urine present, renal function test normal, respiratory syncytial virus test negative, sars-cov-2 test negative, and troponin normal. 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).