Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging spinal, Myelitis transverse, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: ENTIRE SPINAL CORD HEMORRHAGED; TRANSVERSE MYELITIS; BLOOD CLOT IN CALF MUSCLE; COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 64 year old male. Initial information was processed along with the additional information received on 28-SEP-2021, 29-SEP-2021 and 30-SEP-2021. The patient's height and weight were not reported. The patient's concurrent conditions included no alcohol use, being a non-smoker and an unspecified bladder control disorder. The patient had no history of drug abuse or illicit drug use. It was reported that the patient was 'as healthy as an ox' having previously worked and that he was paraplegic at the time of reporting. The patient had previously experienced 'whole body hurt' when treated with levofloxacin, and 'felt like a train run over him' when treated with ciprofloxacin. The patient reported having no family history of any neurological disease. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration not reported, batch number 1805020, expiry date 23-AUG-2021), 0.5 mL, once in total, administered on 05-APR-2021 into the right arm for prophylactic vaccination. Concomitant medications included a medication for bladder control, the name of which the patient could not remember. On 11-APR-2021, the patient, went to an emergency room (ER) as he reported feeling terrible, whereupon he tested positive for COVID-19 (rapid/quick COVID-19 test). The patient reported that he had no COVID-19 symptoms, but he was sent home.  On 15-APR-2021,the patient awoke at 14:00 and experienced total paralysis from the waist down (paraplegia). A blood clot was detected in his calf muscle and the reporter mentioned that the entire spinal cord had swelled and hemorrhaged. On an unspecified date, the patient was hospitalized and spent 105 days in the hospital and rehabilitation hospitals. The patient was at home for the last 2 months and was working at adjusting to his new normal life as a paraplegic. The patient reported that he aspirated on water 2 days into his hospital stay, resulting in him being transferred into the ICU (intensive care unit) ward on a ventilator for 2 weeks (14 days). He reported that the doctors had never treated anyone else with symptoms that he had, and that finally he was diagnosed with transverse myelitis. The patient reported that he was given the first dose of IVIG(Intravenous immune globulin) at either his ER visit of 11-APR-2021 or 15-APR-2021, but could not remember which. When the result for the clot was positive, IVIG was stopped. The patient reported that he had undergone various unspecified tests since APR-2021 and 'everything was fine', bar results of a spinal magnetic resonance imaging (MRI) scan which shoed his spinal cord 'looked like Swiss cheese'. On 30-SEP-2021, during a telephone call placed to the patient, he reported that total lower body paralysis was continuing. The paralysis remained at the same severity since 15-APR-2021. He reported his upper body was okay, but that his arms felt cold at times. The patient could not figure how to access his medical charts, but did verbally agree to give the company consent to obtain his records and to contact his treating physicians. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of the transverse myelitis, blood clot in calf muscle, COVID-19 test positive and entire spinal cord hemorrhaged was not reported. This report was serious (life-threatening, caused/prolonged hospitalization, other medically important condition). This report was associated with product complaint 90000194838.; Sender's Comments: V0: This spontaneous report received from a patient concerned a 64-year-old male who tested positive for COVID-19 6 days after vaccination and experienced transverse myelitis, entire spinal cord hemorrhage and a blood clot in the calf muscle 10 days after vaccine. Medical history includes unspecified bladder control disorder and drug reaction to ciprofloxacin and levofloxacin. The patient was healthy at the time of vaccination. Concomitant medications include an unspecified bladder control medication. The patient tested positive for COVID-19 on rapid test 6 days after vaccination and had no symptoms. The patient experienced paraplegia, and a blood clot in his calf muscle 10 days after vaccination. The patient was mechanically ventilated for 14 days in the ICU following an aspiration during his hospital stay. The patient spent 105 days in total in the hospital and rehabilitation centers. The patient was treated with intravenous immunoglobulin until the positive test result (unspecified test) for clot. Unspecified laboratory testing was normal but the MRI of the spinal cord showed a Swiss cheese appearance. The outcome of the events was not reported. The subject's COVID-19 infection may have increased the risk for the event(s) to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.