Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, COVID-19 immunisation, Fibrin D dimer
Clinical narrative: Vaccine-induced rhabdomyolysis; Interchange of vaccine products; Revaccination with different COVID - 19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of RHABDOMYOLYSIS (Vaccine-induced rhabdomyolysis) in a 46-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Cystic acne, Generalised muscle aches (Patient had frequent episodes of muscle aches.), Weakness (frequent episodes of weakness) and Upper respiratory tract infection (In late 2017, patient  was admitted for rhabdomyolysis after upper respiratory tract infection. Patient reported dark urine but no rash or arthralgia. Patient had elevated CK 107,737 U/L, AST 379 U/L, and ALT 115 U/L) in 2017. Previously administered products included for Product used for unknown indication: influenza vaccine (In 2006 and 2016 and patient was hospitalized for episodes of rhabdomyolysis after receiving influenza vaccine.). Past adverse reactions to the above products included Rhabdomyolysis with influenza vaccine. Family history included Lupus erythematosus.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHABDOMYOLYSIS (Vaccine-induced rhabdomyolysis) (seriousness criteria hospitalization and medically significant), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID - 19 vaccine). At the time of the report, RHABDOMYOLYSIS (Vaccine-induced rhabdomyolysis) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID - 19 vaccine) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: current admission for rhabdomyolysis 208 U/L. On an unknown date, Aspartate aminotransferase: current admission for rhabdomyolysis 692 U/L. On an unknown date, Blood creatine phosphokinase: current admission for rhabdomyolysis 130 U/L and current admission for rhabdomyolysis 702 U/L. On an unknown date, Fibrin D dimer: current admission for rhabdomyolysis 1544 ng/mL. On an unknown date, Urine analysis: In patient's current admission for rhabdomyolysis, she presented with dark urine..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered RHABDOMYOLYSIS (Vaccine-induced rhabdomyolysis), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID - 19 vaccine) to be related.    Patient was evaluated for generalized body aches five days after receiving second dose of COVID mRNA-1273 (Moderna) vaccine. Six months prior, she received her first dose of Ad26 (Johnson & Johnson) vaccine without sequelae.  Autoimmune myositis was ruled out. Patient has never received statin medication.  In late 2017, patient's laboratory tests included  renal function, sed rate, TSH, HIV, influenza, direct Coombs, protein electrophoresis, and antinuclear antibodies were negative or within normal limits.  She was treated with IV fluids, pain medication, and discharged.  In her current admission for rhabdomyolysis, no acute renal injury was noted.  Patient was treated with intravenous crystalloids and pain medication.CK and transaminases steadily trended down. Patient was discharged as she was asymptomatic and CK had dropped significantly.   Authors concluded that mechanism of the patients reaction was unknown. The patient had elevated CK level on subsequent episodes of rhabdomyolysis fitting the pattern where a more exaggerated response of the immune system was observed every time patient was re-exposed to known insult. Genetic predisposition might have also play a role. Some patients have higher prevalence of slow acetylation and carnitine palmitoyltransferase II deficiency, a disorder of fatty acid. The myopathic form presents with high CK values. Therefore, patients should be counseled to seek medical attention when symptoms occur and physicians should consider vaccination as a possible cause.   Company comment: This literature case concerns a 46-year-old female patient, with adverse reactions of Rhabdomyolysis with influenza vaccine twice in the past and after an upper respiratory tract infection 5 years ago, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of rhabdomyolysis, after the dose of mRNA-1273 vaccine, considered as the second dose of the vaccine schedule. Previously she received a dose of JANSSEN COVID-19 VACCINE (Interchange of vaccine products & Revaccination with different COVID-19 vaccine) with no reported adverse event. The date of vaccination and the onset of the event were not reported; hence, latency cannot be properly assessed. She presented with dark urine and laboratory findings of CK 130,702 U/L, AST 692 U/L, ALT 208 U/L, and D-dimer 1,544 ng/mL. No acute renal injury was noted. Patient was treated with intravenous crystalloids and pain medication. CK and transaminases steadily trended down. She was discharged as she was asymptomatic. CK had dropped significantly. Patient´s medical history of previous rhabdomyolysis remains as a risk factor for Vaccine-induced rhabdomyolysis. The benefit-risk relationship of the mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Live follow up received by safety on 25-Aug-2022 has email with full text article and contains significant information: Reporter information, literature information, event information and treatment were updated; Sender's Comments: This literature case concerns a 46-year-old female patient, with adverse reactions of Rhabdomyolysis with influenza vaccine twice in the past and after an upper respiratory tract infection 5 years ago, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of rhabdomyolysis, after the dose of mRNA-1273 vaccine, considered as the second dose of the vaccine schedule. Previously she received a dose of JANSSEN COVID-19 VACCINE (Interchange of vaccine products & Revaccination with different COVID-19 vaccine) with no reported adverse event. The date of vaccination and the onset of the event were not reported; hence, latency cannot be properly assessed. She presented with dark urine and laboratory findings of CK 130,702 U/L, AST 692 U/L, ALT 208 U/L, and D-dimer 1,544 ng/mL. No acute renal injury was noted. Patient was treated with intravenous crystalloids and pain medication. CK and transaminases steadily trended down. She was discharged as she was asymptomatic. CK had dropped significantly. Patient´s medical history of previous rhabdomyolysis remains as a risk factor for Vaccine-induced rhabdomyolysis. The benefit-risk relationship of the mRNA-1273 is not affected by this report.