Sex: F
Vaccine: MMR
Symptoms: Restlessness, Speech disorder, Vagus nerve disorder
Clinical narrative: Lamictal levels were 14/lamictal levels went high; It must be her Vagus Nerve stimulated because she is getting nervous; They said her levels were low; The caller was difficult ot understant at times and mumbled a lot/the caller had to be redirected multiple times in the conversation and went off track often; moving around; with Phenobarbital she will get delusions and make up delusions in her head: delusions; Getting nervous; It made her behaviorally off; It made her behaviorally off/she was repeating the same peoples names over and over; This spontaneous report was received from a 30-year-old White female patient reporting on herself. On an unspecified date, her weight was between 97 and 98 pounds. Her pertinent medical history included a memory changed to the right temporal lobe, a Chinese viral infection which caused her a fever of 104.5 (units not provided), scar tissue which was formed during the viral infection (also reported as "unsure if she was born with it"), and epilepsy for 27 years. Concomitant medications included clobazam (ONFI).  Since approximately 1994 (also reported as when she was 6-year-old), the patient started therapy with phenobarbital for epilepsy (dose, frequency, route of administration, lot number and expiration date were not reported). This was the most helpful drug to treat her epilepsy; nevertheless, its levels had gone up naturally, she was unsure of how many times she had been high on it. It was also mentioned that she had cheated on her phenobarbital treatment.   On an unknown date, therapy with lamotrigine (LAMICTAL) was started (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date of September 2018, in order to go to school, the patient was vaccinated by a student with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unknown date of September 2018 (also reported as 2 weeks after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) the patient's lamotrigine (LAMICTAL) increased to 14 (units not provided) (also reported as "her lamotrigine (LAMICTAL) went high") (anticonvulsant drug level increased) which made her behaviorally off (abnormal behavior). Consequently, the patient got to the emergency room (ER) and then she was hospitalized due to the event of anticonvulsant drug level increased. It was reported that she was repeating the same people's names over and over (repetitive speech) and she was moving around a little (restlessness). A nurse and a friend helped to calmed down her. Later, a doctor asked her if the had cheated on her phenobarbital; nevertheless, she told them that she did not this time. She explained that the difference between phenobarbital and lamotrigine (LAMICTAL) when they went up was that with phenobarbital she would get delusion and made up delusions in her head and she could remember everything; in contrast, with lamotrigine (LAMICTAL) she could not remember much (amnesia). On an unspecified day, a lab test (unspecified) was performed by some students and it was found that "her levels were low" (anticonvulsant drug level decreased); however, the patient was wondering if the students did the test correctly. The patient stated that on an unspecified date of September 2018, she had her vagus nerve stimulated since she was getting nervous (vagus nerve disorder, nervousness). On an unspecified date of September 2018, she recovered from anticonvulsant drug level increased after 7 days of hospitalization and she was discharged from the hospital on day 8.   The patient was asking if the COVID vaccine (unspecified) would interfere with her lamotrigine (LAMICTAL) phenobarbital and clobazam (ONFI) levels. She was also asking if fever is a possible side effect of the COVID vaccine (unspecified), because if the fever would be between 101-102 (units unspecified) she would propbably present seizures and would need to be hospitalized.  During the call, it was reported that the patient was difficult to understand and mumbled a lot; furthermore, many attempts of clarification had to be made and she had to be redirected multiple times in the conversation and she went off track often (speech disorder).  It was not reported if the patient received any treatment for the aforementioned adverse events.   The action taken with phenobarbital, and lamotrigine (LAMICTAL), the outcome of the event of speech disorder, repetitive speech, vagus nerve disorder, nervousness, restlessness, amnesia, and anticonvulsant drug level decreased and the causal relationship between the event and therapy with the suspect theapies were not reported.  Upon internal review, the event agus nerve disorder was considered to be medically significant (OME).