Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis, Pyrexia
Clinical narrative: Liver function tests elevated; really elevated liver enzymes; elevated two times normal; Symptoms of a cold (got sick); Had a fever for a couple of days; Felt like getting over a bug; This is a spontaneous report received from a contactable consumer (patient) via a company representative. A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot no and Expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included Lambert-Eaton myas-thenic syndrome (LEMS), unspecified auto-immune disorders, asthma, abnormal cholesterol, and anxiety. Concomitant medications included firdapse (AMIFAMPRIDINE PHOSPHATE, strength: 10 mg, formulation: Tablet) from 29Jan2019 to Jun2019 at 10 mg 6 to 7 times per day (reported as 70 mg per day) orally for Lambert-Eaton myasthenic syndrome (LEMS), an unspecified cholesterol medication "statin," Klonopin (clonazepam), and omeprazole. On an unknown date in 2019 (reported as "about a month ago" relative to 12Jul2019), after starting the product, the patient's liver function tests were elevated (results not reported). Subsequently, his FIRDAPSE dosage was decreased to 10 mg daily. As of 12Jun2019, treatment with FIRDAPSE was ongoing and the status of the patient's elevated liver function tests was unknown. On 17Jul2019, it was learned that the patient's medical history included elevated liver enzymes which "he had to get down so that he could start in a FIRDAPSE study," and enrollment in a FIRDAPSE study (unknown duration and time period of enrollment). The patient was taking a 70 mg prescribed dose and he normally took 4-5 tablets per day. However, if he was going to be more active, he would take a 70 mg daily dose. On an unspecified date in 2019 (reported as "more recently" relative to 1Jul2019), that patient had some "really elevated" liver enzymes in his blood work. On an unspecified date (reported as 3 weeks ago relative to 17Jul2019), the patient's doctor had reduced the patient to taking one tablet of FIRDAPSE per day until they were able to get his liver enzymes back to "normal." As of 17Jul2019, the patient continued to take FIRDAPSE at 1 tablet a day until he can find the dosage that doid not cause elevated liver enzymes. The status of the elevated liver enzymes was not reported. On 26Sep2019, it was learned that on an unspecified date, the patient's liver enzymes were elevated to "two times normal" (previously reported as really elevated). As of 26Sep2019, the patient continued on his reduced dose of FRIDAPSE 10 MG once daily. The status of the elevated liver enzymes was not reported. On 10Dec2019, it was learned on an unspecified date in 2019, the patient's dose was decreased to FIRDAPSE 10 mg at 20 mg twice a week (on 2 separate days throughout the week). He couldn't take any more than 2 FIRDAPSE pills per week or his liver enzymes would go up. The patient's doctor was aware. As of 10Dec2019, the patient continued treatment with the product and the status of the elevated liver enzymes was not reported. The patient felt that "nothing had changed". On an unspecified date "for a time" prior to Jul2020, the patient stopped taking FIRDAPSE all together until his liver function labs came back to "normal." On an unspecified date, to make sure his muscles would not "lose function," he was put back on FIRDAPSE "like once or twice a week" as previously reported. On an un-specified date "last month" (relative to 10Aug2020), the liver functions got back to "normal" and his FIRDAPSE dose was restarted at 10 mg by mouth, 1-2 times a day. As of 10Aug2020, treatment with the product was ongoing at a dose of 10 mg, twice a day (lot number: 3185425, expiration date: Feb2022) and the status of elevated liver enzymes was improved. Liver labs would be checked in a few months (also reported as "by Oct2020"). On an unspecified date, the patient received the Pfizer COVID Vaccine and got sick afterwards, described as symptoms of a cold, "just like getting over a bug". On unspecified dates, he experienced fever for a couple of days and elevated liver enzymes. It was not known if this was the first or second dose of the vaccine. The reporter also stated elevated liver enzymes had been a problem off and on since the patient started FIRDAPSE (not further clarified but previously reported). As of 19Apr2021, the patient's treatment with FIRDAPSE continued. The outcome of the events his symptoms of a cold, feeling like he was getting over a bug, fever, and elevated liver enzymes was resolved on an unspecified date.   No follow up attempts are needed, information about lot/batch number cannot be obtained.