Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis, Rash, Tachycardia
Clinical narrative: MULTIPLE SCLEROSIS; DEMYELINATING DISEASE; TACHYCARDIA ISSUES; BLOOD PRESSURE ABNORMAL; SKIN RASH; This spontaneous report received from a patient via a company representative, concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: unknown) dose was not reported, 1 total administered in MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple sclerosis, demyelinating disease, tachycardia issues, blood pressure abnormal and skin rash. Patient reported that - "After receiving Johnson & Johnson Vaccine in March 2021, patient had a skin rash followed by neurological problems, that have completely changed life. Primary Symptoms were Numbness off and on in extremities, Tremors, Speech issues, Tachycardia and Blood Pressure issues- possibly neurological/nervous system related, Incontinence due to numbness, Problems walking, Mild depression due to lack of things I no longer can do. On 18th October patient had a Spinal Tap followed up with Neurology and first visit with Cardiology on October 27th and 28th. The Spinal tap showed high o-band count number and patient was diagnosed with Multiple Sclerosis. Cardiology suspected autonomic nervous system (ANS) as cause of tachycardia issues. Magnetic resonance imaging (MRI) findings are indicative of Demyelinating Disease. After the diagnosis of Multiple Sclerosis insurance company denied Aubagio as well as medication to control spasticity and tremors. Patient was waiting for a different medication to help control the shaking. On 16th December, Glatiramer injections were approved and this is what patient will be taking while waiting for a better medication to be approved. This will be a 3 times weekly injection that patient will have to administer self.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin rash, tachycardia issues, blood pressure abnormal, multiple sclerosis and demyelinating disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and  ethnicity who experienced multiple sclerosis, demyelinating disease, tachycardia , abnormal blood pressure and skin rash unspecified time after vaccination. No concomitant medications were reported. Patient had a skin rash followed by neurological problems post vaccination. Primary Symptoms include on and off  numbness in extremities, tremors, Speech problems , tachycardia and blood Pressure issues, incontinence, problems walking, mild depression . Approximately 7 months after vaccination patient had neurology and first cardiology consultation .A spinal tap performed  showed high o-band count number and was diagnosed with Multiple Sclerosis. Cardiology suspected autonomic nervous system (ANS) as cause of tachycardia issues. Magnetic resonance imaging (MRI) findings are indicative of Demyelinating Disease . Approximately 9 months post vaccination patient started taking 3 times weekly self-administered  Glatiramer injections  while waiting for a better medication to be approved by the insurance. Outcome of the events has not been reported. Information is limited in this case, and the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.