Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Neuropathy peripheral, Porphyria acute, Porphyria non-acute
Clinical narrative: recurring acute porphyria attacks; attacks of abdominal pain; Exacerbation of Hepatic Porphyria; Blood pressure has increased; Peripheral neuropathy; Lethargic; he has lost a lot of weight during all this; no appetite; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EP7533) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: Ulcerative colitis; "AFib" (unspecified if ongoing), notes: AFib; "Hepatic Porphyria", start date: 2012 (ongoing); "hyponatremic" (unspecified if ongoing); "hypokalemia" (unspecified if ongoing); "acute porphyria" (unspecified if ongoing); "acute abdominal pain" (unspecified if ongoing); "would notice when I went pee that it was purple" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LETHARGY (medically significant) with onset Apr2021, outcome "not recovered", described as "Lethargic"; NEUROPATHY PERIPHERAL (medically significant) with onset Apr2021, outcome "not recovered", described as "Peripheral neuropathy"; WEIGHT DECREASED (non-serious) with onset Apr2021, outcome "not recovered", described as "he has lost a lot of weight during all this"; DECREASED APPETITE (non-serious) with onset Apr2021, outcome "not recovered", described as "no appetite"; PORPHYRIA NON-ACUTE (hospitalization, medically significant, life threatening) with onset 18Apr2021, outcome "not recovered", described as "Exacerbation of Hepatic Porphyria"; ABDOMINAL PAIN (hospitalization, medically significant, life threatening) with onset 18Apr2021, outcome "unknown", described as "attacks of abdominal pain"; PORPHYRIA ACUTE (hospitalization, medically significant, life threatening) with onset 18Apr2021, outcome "unknown", described as "recurring acute porphyria attacks"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure has increased". The patient was hospitalized for abdominal pain, porphyria non-acute (start date: 18Apr2021, discharge date: 23Apr2021, hospitalization duration: 5 day(s)); for porphyria acute (hospitalization duration: 60 day(s)). The events "exacerbation of hepatic porphyria" and "recurring acute porphyria attacks" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: (unspecified date) 100s, notes: His blood glucose was always in the 100s give or take. Then one measurement was near 380m but the phlebotomist drew the blood right by the place where the dextrose was being given; (unspecified date) 89, notes: blood glucose and it was 89. Had enough insulin ready to give him to treat a blood glucose of 371; Blood potassium: (unspecified date) potassium has been lower too; Blood sodium: (unspecified date) close to 130; SARS-CoV-2 test negative: (17Mar2022) Negative. Therapeutic measures were taken as a result of porphyria acute.  Clinical Information: Reporter (Patient) stated he is calling about the Covid Vaccine; verified Pfizer Covid Vaccine. Reporter stated he is reluctant to report an drug reaction unless he is 100% sure, well unless he is more than 50% sure, but he is confused, and they have ruled everything else out and he needs help. he has been hospitalized the past 27/55 days in the hospital due to the severity. Patient spent about 35 days collectively in the hospital from 18Apr2021 through mid Aug2021 and then another 27 days in and out of the hospital collectively since 13Mar2022 until presentHepatic Porphyria has been getting a non stop attack, an exacerbation. Disabling, Hospitalization Dates when patient was in hospital for Hepatic Porphyria has been getting a non stop attack, an exacerbation. Reporter states since receiving the Covid Vaccine, he has been having an exacerbation. He stated it is an extremely rare genetic condition. he is missing an enzyme to make it and get past the 6th step. Reporter stated all the heme is produced only by one chromosome. Reporter stated he is guessing that the Pfizer vaccine, being MRNA, is it self amplifying? Reporter stated he has Hepatic Porphyria, but he has been able to manage it successfully since he discovered he had it the past decade or so, but since he took the vaccine, he has been getting a non stop attack, an exacerbation. Reporter (Patient) stated he knew he had it 10 years ago, but he was diagnosed in April. He stated so 2012, but it took that long to have another attack that was serious enough to run the test. He reports having exacerbations of his condition since being vaccinated, even reporting a hospitalization between doses. Previously, he would experience "attacks once a year, or once every-other-year", and even reports that he "was ok for 5 years". Symptoms of these attacks include "intense abdominal pain and neuro symptoms" and these symptoms have been "unrelenting, non-stop" since being vaccinated. He would like to know how long after vaccination the Pfizer-Biontech Covid19 vaccine remains in the body? Also, is there an increased demand for the production of heme anywhere in the pharmacological process for an mRNA vaccine? He stated that if there is an increased demand for heme, this would explain his symptoms. He wants to know how long he should expect the process to last or resolve?  Pharmacist (Reporter) calling to report on himself in regards to the Covid-19 vaccine. Reported an AE online. He has a rare genetic disorder called Porphyria. There are 8 different types and he possibly has a hepatic type. One of his chromosomes is not capable of sustaining life. In the heme cascade there are 8 catalytic enzymes, and he is missing the 6th one. When the demand for heme is increased by more than 50%, "all heck breaks loose" in his body, and he has extreme abdominal pain. It's unbelievable, and he cant put a number to it. Each time he got the vaccine it precipitated an attack of abdominal pain. He very rarely has attacks. They would happen once every 5 years and rarely twice in a year. However, two weeks after the first dose, the attacks started. Then, after the second dose, three weeks later, the attacks persisted. The attacks first started in Apr2021 and have persisted. He spent 35 days in and out of hospitals from Apr2021 to mid Aug2021 until it fizzled away. Believes the vaccines triggered the attacks. He was due for a booster dose in Oct2021, but his doctor said to wait. He has ulcerative colitis (UC) which flared around Aug2021 as well. The UC became a problem until mid fall 2021. Doctors started him on Cinzia, a monthly injection in Dec2021 and he was feeling better by Jan2022.  Reporter stated, I am still having attacks, they are not as frequent, but they're still severe. The frequency has decreased, I cannot wait for them to stop, because this is not pleasant at all. The attacks resemble acute porphyria." "Even before I got the vaccine, the doctors suspected I have acute porphyria, 10 years ago had a series of attacks, I would have acute abdominal pain and I would notice when I went pee that it was purple, when it got really bad my pee was red, and as soon as it hit the toilet it would turn dark, the problem is whenever I tried to get a test, the lab would compromised the sample So I had intermittent attacks, maybe once a year or one every 5 years, sometimes maybe I had 2 or 3 in a year and then nothing in years, until I got the vaccine, then I had successive attacks, more and more serious than the previous one, I've never experienced this many acute attacks before in my life. Ten years ago they were really bad but not as many, I probably spent in the past year and a half 60 days in the hospital collectively, it would make sense the vaccine will trigger a porphyria attack, because the way it works. "I wasn't expecting much porphyria is a extremely rare disorder, 1 in 5 million people, it might take a couple years to have the data if anything is even linked, I'm still waiting to confirm the diagnosis "It feels like my soul has been ripped off my body, it is so painful.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of abdominal pain, porphyria non acute,  porphyria acute, neuropathy peripheral and lethargy cannot be excluded.