Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Compartment pressure test, Compartment syndrome, Electrocardiogram, Limb operation
Clinical narrative: LIMB OPERATION; COMPARTMENT PRESSURE TEST; ELECTROCARDIOGRAM; ULTRASOUND DOPPLER ABNORMAL; THROMBOSIS; NERVE CONDUCTION STUDIES; URINE ANALYSIS; BLOOD TEST; COMPARTMENT SYNDROME; PERIPHERAL SWELLING; RHABDOMYOLYSIS; This spontaneous report received from a health care professional by a Regulatory Authority concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medications, food, or other products. No other illnesses at the time of vaccination and up to one month prior. No chronic or long standing conditions. The patient did not had an adverse event following any previous vaccine. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, administered 1 in total to the right arm on 10-MAY-2021 at 11:00 for an unspecified indication. Age at time of vaccination 19 years old. Concomitant medications included (Cryselle 28) ethinylestradiol/norgestrel.  On 01-JUN-2021 at 08:00, the patient experienced compartment syndrome, and rhabdomyolysis. Patient was having persistent swelling of both arms (peripheral swelling) following release from rhabdomyolysis. On 07-JUN-2021 and 08-JUN-2021, blood work (blood test) was taken, result was not reported. Patient was hospitalized on 08-JUN-2021. The duration of hospitalization was 1 day. On 23-JUN-2021 and 18-AUG-2021, laboratory data included: Blood test (NR: not provided) Not reported. On 22-SEP-2021, Laboratory data included: Blood test and urine analysis (NR: not provided) Not reported. On 05-OCT-2021, Laboratory data included: Blood test and MRI (Magnetic resonance imaging) (NR: not provided) Not reported. On 18-OCT-2021, Laboratory data included nerve conduction studies (NR: not provided) Not reported. On 25-OCT-2021, the patient experienced thrombosis, and ultrasound Doppler test was abnormal with signs of prior blood clots in arms. On 05-NOV-2021, laboratory data included: EKG (electrocardiogram) (NR: not provided) Not reported. On 11-NOV-2021, Laboratory data included: Blood test (NR: not provided) Not reported. On 09-DEC-2021, Laboratory data included: Blood test (NR: not provided) Not reported. On 16-DEC-2021, the patient experienced compartment pressure test on right arm. Laboratory data included: Compartment pressure test (NR: not provided) Not reported. On 12-MAY-2022, Laboratory data included: Compartment pressure test on left arm (NR: not provided) Not reported. On 16-MAY-2022, the patient had limb operation (Compartment surgery on right forearm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood test, compartment pressure test, compartment syndrome, electrocardiogram, limb operation, nerve conduction studies, peripheral swelling, rhabdomyolysis, thrombosis, ultrasound doppler abnormal, and urine analysis. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).  Additional information was received from health care professional by a Regulatory Authority VAERS on 06-SEP-2022. The following information was updated and incorporated into the case narrative: patient's race, ethnic origin and pre-existing medical condition, vaccination and event time was added.; Sender's Comments: V1: This follow up adds information about patient's race, ethnic origin and pre-existing medical condition, vaccination and event time. MAC reassessed.  20220560207-COVID-19 VACCINE AD26.COV2.S-rhabdomyolysis, compartment syndrome, electrocardiogram, limb operation, nerve conduction studies, peripheral swelling, compartment pressure test, blood test, and urine analysis. 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). Therefore, this event(s) is considered unassessable.  20220560207-COVID-19 VACCINE AD26.COV2.S-thrombosis,  ultrasound doppler abnormal . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.  (patient's concomitant medication- (Cryselle 28) ethinylestradiol/norgestrel is considered as confounding factor)