Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: he had a reaction similar to when he had atorvastatin, niaspan, and dyazide.; he felt exhausted; He has bad hearing/his hearing has been decreased even more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "because of heart attacks he immediately had fibrillation in heart" (unspecified if ongoing), notes: Additional Information for Other medicines Pradaxa: been on it for years.; "because of heart attacks he immediately had fibrillation in heart" (unspecified if ongoing), notes: Additional Information for Other medicines Pradaxa: been on it for years.; "bilateral TIA like symptoms" (unspecified if ongoing), notes: The bilateral TIA like symptoms were originally discovered after open heart surgery in Jan2016; "had open heart surgery", start date: Jan2016 (unspecified if ongoing), notes: The bilateral TIA like symptoms were originally discovered after open heart surgery in Jan2016; "became unconscious", start date: 2016 (unspecified if ongoing); "His arm went numb/brain went numb/his hearing went numb", start date: 2016 (unspecified if ongoing); "had brain fog", start date: 2016 (unspecified if ongoing); "he had severe pain in legs", start date: 2016 (unspecified if ongoing); "hyperallergic to soy" (unspecified if ongoing), notes: hyperallergic to soy; "Hypermetabolism" (unspecified if ongoing). Concomitant medication(s) included: PRADAXA taken for myocardial infarction, cardiac fibrillation (ongoing); AMLODIPINE BESYLATE 10 taken for myocardial infarction (ongoing). Past drug history included: Statin, reaction(s): "he was allergic to statin", notes: That test determined that he was allergic to statin. Vaccination history included: BNT162b2 (First dose:, Date: 11Feb2021, LOT: EL926S, but he can't tell if that is really an S, EXP: unknown), administration date: 11Feb2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Second dose:, Date 04Mar2021, LOT: EN6198, NDC: unknown, EXP: unknown), administration date: 04Mar2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Pfizer Covid Vaccine Booster:, Date: 01Oct2021, LOT: SW0191 or could be EW0191 or could be FW0191, EXP: unknown), administration date: 01Oct2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Pfizer Covid Vaccine Booster:, Date: 21Apr2022, LOT: FK9894, NDC: unknown, EXP: unknown), administration date: 21Apr2022, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "he had a reaction similar to when he had atorvastatin, niaspan, and dyazide."; FATIGUE (non-serious), outcome "unknown", described as "he felt exhausted"; HYPOACUSIS (non-serious), outcome "unknown", described as "He has bad hearing/his hearing has been decreased even more". The events "he had a reaction similar to when he had atorvastatin, niaspan, and dyazide.", "he felt exhausted" and "he has bad hearing/his hearing has been decreased even more" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of drug hypersensitivity, fatigue, hypoacusis.  Additional information: Reporter did showed appreciation and stated, "He appreciated your product. He appreciated all you do and for those around the world. You folks had been wonderful. They were wonderful!" Reporter thanked Pfizer for keeping people all over the world and so many others alive due to this product.Was there any form of the preservative proline in the product or something similar.Reporter stated he had done his own research as well as with his cardiologist as he stated he had adverse reaction to medications due to his sensitivities. "Among other things, things normal people take for high blood pressure, He could not take any of those medication because he was hyper allergic to them." He accidently found out a cholesterol reducing medication, Repatha (injectable product BID), normal product for reducing cholesterol, he was hyper allergic to them. He had to discontinue - atorvastatin as he noted this product "almost killed him." Reptha which seemed to work ended up having proline, an amino acid preservative, this amino acid is essentially in significant amounts in soy, which he was hyper sensitive too. Did not reacted previously at all to the previous doses of his Pfizer COVID 19 Vaccinations however when he took the booster this time, he had a reaction similar to when he had atorvastatin, niaspan, and dyazide. Any significant soy products he also could not tolerate. Called about booster. Has had all Pfizer shots from day one. The boosters were fine, but with the last booster he had bad reaction. He was amazed because with the others he did not even know he had taken them. He wanted to let Pfizer know. He did research online. He was trying to find out if the booster, has any form of the preservative Proline in it. This preservative was for example in statins. When reporter was prescribed a statin because he was very allergic to Proline it almost killed him and took him years to get over it. Clarified booster that he had bad reaction to as Omicron Covid vaccine booster. He got it on 18Sep2022. Reporter was unique. He was a DES baby that was in his 70's. In the 40's DES was used. DES is Diethyl something, but he could not remember the whole thing. Was used in women who had miscarriage and later discontinued because it led to birth defects in children. Reporter's mother was given DES because she had a miscarriage. Reporter was not aware of birth defects in him. His DNA was screwed up and kidneys look like walnuts. Kidneys were not normal. His sinuses were not normal. Several of his bone joints had limited motion because the bone structures were not like normal hips and knees. Externally he seemed fine. It was after he had a heart attack and had open heart surgery they discovered because of the MRI what had happened to him. They were able to establish DES was the problem. Whatever screwed up his DNA caused him to be hyperallergic to soy and statins. He was also hyperallergic to Proline. That was why he was asking if there was any preservative in the Omicron Covid vaccine booster that might be the cause. When he looked at the chemical composition there did not seemed to be anything that would effect a DES baby that reporter could determine. They told him in the hospital he had bilateral TIA like symptoms. Reporter was thankful for Pfizer's work. He did not get sick with Covid and the vaccine was a good service. He was retired. Reporter clarified the bilateral TIA like symptoms was the bad reaction he had with a statin. The bilateral TIA like symptoms were originally discovered after he had open heart surgery in Jan2016. Approximately 6 months after that in the summer of 2016 he had the first event. He called (withheld) and became unconscious. He was a mess. He thought he was having another heart attack. His arm went numb, brain went numb and had brain fog, his hearing went numb, and he had severe pain in legs. It was described as bilateral TIA like symptoms. No one was sure what was going on. 3 months later it happened again. The hospital team assessed him and said something was going on. They did a blood test and it had to be sent to Clinic. That test determined that he was allergic to statin. They pulled it. He had been on the baby dose of the statin because of his previous history of reacting negatively to pharmaceutical. Clarified that the statin he had bad reaction and bilateral TIA like symptoms with was Atorvastatin. He forgets things now. From memory it was well within date code. He was religious about that. They told him he was allergic to Atorvastatin. Previously he had problem with Meniere's disease and had been put on Dyazide and Niaspan. Within 24 hours of taking those medications he was collapsing and was rushed to hospital. The only difference with the bad reaction he had with the Omicron Covid vaccine booster and Atorvastatin was he was not completely unconscious. He knew that something was wrong. His heart and chest were fine. He was not having heart attack. He was conscious enough to realize the symptoms. He drank a lot of water and it started getting better. Unfortunately he was out of town. Drove home and it took a week to get his act together. He called doctor about what happened. They checked him out and they said don't do that again. He had appointment last week with his general practitioner. General practitioner told reporter that reporter knew he was an odd duck and essentially if reporter thinks that was what happened that was probably what happened. It was an observation at that point. Reporter did so well with all the shots all along, but this one took him out completely. That surprised him. Reporter would visit cardiologist in about an hour. Up until that point, he did fine with all the Pfizer vaccines and did not expect to have a problem. After the first Pfizer Covid vaccine they had him wait an hour to make sure he did not have a reaction and was fine. He had first dose done at the hospital. Bad reaction: started about 16-18 hours later. The vaccine was given in afternoon and later that evening was when he was in deep trouble. It took about a week to feel normal. Within 24-48 hours he was up and about and he felt exhausted. He has bad hearing anyway, but he had been very conscious that after the event his hearing had been decreased even more. That was unusual. That was the only thing that had not fully recovered back to the average state it was. He was using hearing aid previously, but hearing has not return to his baseline. Concomitant Medications: he had taken them for years with no negative impact. He could remember on que the medication names and has to go get them. He also took some vitamins. DES he had no knowledge of the product. He was just aware his mother took it. They later found out, years later, about his deformities that they previously were not aware of. Hypermetabolism: Discovered 20 years ago. He processes food extremely fast. When he was on Dyazide for problems in ears with Meniere's they had said it will take 48-72 hours to have impact. He could not remember how much he had to take, but he took it and within 8 hours his wife found him unconscious on the floor. Cardiologist told him his blood pressure was 60/40. He was as close to being dead with out being dead. Because of that hypermetaoblism he reacts to medications differently than normal and also because of DES. He did not realize the implications until over time. Meniere's situation occurred in 2011. It was hard to say if the Meniere's is gone away because the doctor said it doesn't go away but recedes to where it was not as noticeable. He was in semi coma for 3 months. It was a terrible experience. Investigations: went for blood work and did not had results. He followed a heart healthy diet. Usually his blood work was spectacular. His total cholesterol was normally around 70. Treatment: none, continued heart healthy diet and made no changes. took him almost a week to feel semi-normal or refreshed or alive. the only thing had continued was impact on hearing. he could hear but it was 20-30% less than what it was before. Vaccine was not administered at Military Facility. Intensive Care Unit: no