Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood sodium, Decreased appetite, Dyspnoea, Impaired quality of life
Clinical narrative: attacks of abdominal pain; Lethargic; Peripheral neuropathy; arrhythmia; he had an episode of Afib; porphyria hepatic aggravated; has trouble breathing; he has lost a lot of weight during all this; This is affecting him at a fundamental level of life; Blood pressure has increased; 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 21Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing), notes: Ulcerative colitis; "AFib" (unspecified if ongoing), notes: AFib. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1: , LOT: EP7533, NDC and EXP: Unknown, Dose: Unknown, Location: arm), administration date: 04Apr2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Blood pressure has increased", "attacks of abdominal pain", "Exacerbation of Hepatic Porphyria", "recurring acute porphyria attacks", "Peripheral neuropathy", "Lethargic", "he has lost a lot of weight during all this", "no appetite"; BNT162b2 (Dose 2: 25Apr2021, LOT: EW0167, NDC, EXP, Dose: Unknown), administration date: 25Apr2020, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "has ulcerative colitis (UC) which flared around Aug2021 as well", "attacks of abdominal pain", "recurring acute porphyria attacks", "Exacerbation of Hepatic Porphyria", "blood glucose was always in the 100s give or take. Then one measurement was near 380m", "Lethargic", "Peripheral neuropathy", "Weight loss", "no appetite", "has ulcerative colitis (UC) which flared around Aug2021 as well". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Blood pressure has increased"; LETHARGY (medically significant) with onset 2022, outcome "not recovered", described as "Lethargic"; NEUROPATHY PERIPHERAL (medically significant) with onset 2022, outcome "not recovered", described as "Peripheral neuropathy"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 2022, outcome "unknown", described as "This is affecting him at a fundamental level of life"; ARRHYTHMIA (medically significant) with onset 2022, outcome "unknown"; ABDOMINAL PAIN (hospitalization, medically significant, life threatening) with onset 2022, outcome "unknown", described as "attacks of abdominal pain"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "has trouble breathing"; ATRIAL FIBRILLATION (medically significant) with onset 2022, outcome "unknown", described as "he had an episode of Afib"; WEIGHT DECREASED (non-serious) with onset 2022, outcome "not recovered", described as "he has lost a lot of weight during all this"; DECREASED APPETITE (non-serious) with onset 2022, outcome "not recovered", described as "no appetite"; PORPHYRIA NON-ACUTE (medically significant) with onset 2022, outcome "unknown", described as "porphyria hepatic aggravated". The patient was hospitalized for abdominal pain (start date: 17Mar2022, discharge date: 19Mar2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood potassium: Lower; Blood pressure measurement: 200/130; Blood sodium: down close to 130; SARS-CoV-2 test: never had covid. Therapeutic measures were taken as a result of abdominal pain.  Clinical course: Pharmacist calling to report on himself in regards to the Covid-19 vaccine. He had a rare genetic disorder called Porphyria. There were 8 different types and he possibly had a hepatic type. One of his chromosomes was not capable of sustaining life. In the heme cascade there were 8 catalytic enzymes, and he was missing the 6th one. When the demand for heme was increased by more than 50%, "all hell breaks loose" in his body, and he had extreme abdominal pain. It was unbelievable, and he cannot put a number to it. Each time he got the vaccine it precipitated an attack of abdominal pain. He very rarely had attacks. They would happen once every 5 years and rarely twice in a year. He was due for a booster dose in Oct2021, but his doctor said to wait. On 21Feb2022 he got his third dose (first booster) and two weeks later, he gets another attack of abdominal pain and the attacks have been relentless since then. It seems like it follows the vaccine. The vaccine definitely worked. He felt that it precipitated the attacks though. They were getting more and more powerful and frequent. The medication to treat the attacks was not as effective following each vaccine administration. After a few weeks, the attacks got really bad. Two weeks ago, he started turning the corner some. Attacks were not as frequent, but still very severe. Hate to point to the vaccine, but it seemed to mirror everything pertly. Still does not had the actual diagnosis for porphyria. He was seeing a specialist now. The key indicator was that the sunlight turns the pee purple when you have porphyria. Makes sense because the vaccine stimulate the enzyme to stimulate these inactive proteins and these proteins were activated by heme. His body was making these proteins and they were inactive, so his immune system needs to get rid of those as wells as activate for the vaccine. He submitted an online form, but could not give as much detail. Do we have any literature or information on the vaccine and people with porphyria. He had more than one hospitalization for several days at a time. He had multiple covid tests, never had covid. Does not think he would have another dose of the vaccine. He cannot tolerate these consequences which sucks because he does not want to get covid. Weight was 300lbs, but he had lost a lot of weight during all this. Not sure what was related to what. He had been lethargic, cannot get excited about much, does not even want to eat ice cream. He cannot wait for this to pass. The worst part was the attacks of abdominal pain. The emergency room gives him 2mg of IV Dilaudid and that barely works. He had trouble breathing from the pain and does not want to experience this again. Everything got quiet until the booster on 21Feb2022. After that he was hospitalized on 17Mar2022-19Mar2022. This hospitalization wasn't his first attack of the abdominal pain after the booster dose though. They were treating him with panhematin. The heme process was one of the most conserved processes in nature. All life that uses oxygen uses this process including plants. The only difference was that every enzyme was identical except the final one. This was affecting him at a fundamental level of life. it was complete agony. It feels like his soul is being ripped from his body. Not blaming the Pfizer vaccines. He was a huge proponent. Nobody questioned polio when it came out, Attacks of abdominal pain was ongoing. Outcome was Unpredictable. Expecting it to last a few more weeks before it fizzles out. Peripheral neuropathy: In hands and feet and more pronounced now. He had it in his feet, but had just recently noticed it in his hands. Losing weight: Does not know why he was losing the weight. Blood pressure had increased: It was not always high, but during acute attacks it will go to 200/130. Cardiologist had increased blood pressure medicine. Takes Toprol and had experienced an arrhythmia with his abdominal pain attack. Doesn't think he experienced arrhythmias during the time he's had the vaccines. Arrhythmia had not been associated with the vaccines for him. Cannot take second dose of Toprol because his pulse was too low. Left a message with doctor and was waiting to hear back from him on what to do about that. It had captured his rhythm and in Jan he had an episode of Afib and before that it was like 10-15 years ago since the last episode. He had a loop recorder. Cardiologist called him in Jan2022 about that arrhythmia. Caller had missed a dose of Toprol and does not think it had anything to do with the other problems. His mood had been so off. Lethargic was the best way to describe it. Just the pain associated with porphyria. Caller also had ulcerative colitis. There is a weak correlation between porphyria and ulcerative colitis or lupus. Causality: Indirectly related. If the vaccine triggered the porphyria than yes there was relation there. Still trying to diagnose the porphyria. Its hard to diagnose. They were about 95% certain at this point. He was seeing a specialist now. There are only 5 specialists in the country. His electrolytes were off as well. He was hyponatremic and hypokalemia. Presumable why he had Afib. His sodium went below 130 10 years ago. Now it had gotten down close to 130, but hasn't gone below that threshold of 130. His potassium has been lower too. Had plenty reserve with his weight. He wants to lose weight but not this way withheld was the specialist he was seeing now. Caller requested information on how the Pfizer Covid 19 vaccine affects people with porphyria, he stated: "The doctors suspect that he have acute hepatic porphyria, hereditary coproporphyria. After he had the Pfizer Covid 19 vaccine, it triggered a series of attacks that lasted a few months. Then he got the booster in Feb and it happened again about two weeks after that, they keep getting more severe. He still having attacks, they were not as frequent, but they were still severe. The frequency had decreased, he cannot wait for them to stop, because this was not pleasant at all. The attacks resemble acute porphyria." "Even before he got the vaccine, the doctors suspected have acute porphyria, 10 years ago had a series of attacks, he would have acute abdominal pain and he would notice when he went pee that it was purple, when it got really bad pee was red, and as soon as it hit the toilet it would turn dark, the problem was whenever he tried to get a test, the lab would compromised the sample. So, had intermittent attacks, might be once a year or one every 5 years, sometimes might be had 2 or 3 in a year and then nothing in years, until got the vaccine, then had successive attacks, more and more serious than the previous one, never experienced this many acute attacks before in life. Ten years ago they were really bad but not as many, he probably spent in the past year and a half 60 days in the hospital collectively, it would make sense the vaccine would trigger a porphyria attack, because the way it works. " He wasn't expecting much porphyria was a extremely rare disorder, 1 in 5 million people, it might take a couple years to have the data if anything is even linked, still waiting to confirm the diagnosis "It feels like soul had been ripped off body, it was so painful".; Sender's Comments: As there is limited information in the case provided, the causal association between the event Adnominal pain, Lethargic, peripheral neuropathy, arrythmia, atrial fibrillation, porphyria non acute, breathing difficult, weight loss, impaired quality of life, blood pressure increased, decreased appetite and the suspect drug cannot be excluded. The case will be reassessed once new information is available.