Type 1 diabetes mellitus with hyperglycemia (HCC); Adult celiac disease; Nuclear senile cataract; Cholesteatoma of attic of right ear; Type 1 diabetes mellitus with hyperglycemia (HCC); Irritable bowel syndrome; Adenoid hypertrophy; Allergy to mold spores; Bilateral carpal tunnel syndrome; Chronic myringitis; Eustachian tube dysfunction; Nonproliferative diabetic retinopathy (HCC); Other hyperlipidemia; Tympanic membrane perforation; microalbuminuria; hypoglycemia; A1c today is down to 7.4% from the A1c at last visit of 8.1%; carbohydrate ratio deficient/correction boluses deficient; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 48 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Gluten -diarrhea" (unspecified if ongoing); "Dairy aid [Tilactase ]- GI intolerance/nausea/vomiting" (unspecified if ongoing); "Pollen extract - itching" (unspecified if ongoing); "Food Grains (Protien), Milk (Protein)" (unspecified if ongoing); "Latex" (unspecified if ongoing); "severe hypoglycemia" (unspecified if ongoing), notes: He has a history of severe hypoglycemia in the past and is wearing a Dexcom G6. The patient's concomitant medications were not reported. Past drug history included: Benzodiazepines, reaction(s): "Drug allergy", notes: Allergies: benzodiazepines - hives food - unknown; Pseudoephedrine, reaction(s): "Drug allergy"; Phenylalanine, reaction(s): "Drug allergy", notes: diarrhea , Phenylalanine - itching; Phenylalanine, reaction(s): "itching", notes: diarrhea , Phenylalanine - itching; Benzodiazepine, reaction(s): "Allergies: benzodiazepines"; Pseudoephedrine, reaction(s): "Hives". Vaccination history included: BNT162b2 (Dose: 1st, Date/Time: Date: 15Apr2021, Time: 2:52 PM, Site and Route of injection:, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0164), administration date: 15Apr2021, when the patient was 47-year-old, for COVID-19 immunisation; BNT162b2 (Dose: 2nd, Date/Time: Date: 16May2021, Time: 2:25 PM, Site and Route of injection:, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0176), administration date: 06May2021, when the patient was 47-year-old, for COVID-19 immunization; lnfluenza, administration date: 01Jan2001, when the patient was 27-year-old; tdap, administration date: 01May2013, when the patient was 39-year-old. The following information was reported: DIABETES MELLITUS (medically significant), HYPERGLYCAEMIA (non-serious), outcome "unknown" and all described as "Type 1 diabetes mellitus with hyperglycemia (HCC)"; COELIAC DISEASE (medically significant), outcome "unknown", described as "Adult celiac disease"; CATARACT NUCLEAR (medically significant), outcome "unknown", described as "Nuclear senile cataract"; CHOLESTEATOMA (medically significant), outcome "unknown", described as "Cholesteatoma of attic of right ear"; IRRITABLE BOWEL SYNDROME (non-serious), outcome "unknown"; ADENOIDAL HYPERTROPHY (non-serious), outcome "unknown", described as "Adenoid hypertrophy"; MYCOTIC ALLERGY (non-serious), outcome "unknown", described as "Allergy to mold spores"; CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Bilateral carpal tunnel syndrome"; MYRINGITIS (non-serious), outcome "unknown", described as "Chronic myringitis"; EUSTACHIAN TUBE DYSFUNCTION (non-serious), outcome "unknown"; DIABETIC RETINOPATHY (non-serious), outcome "unknown", described as "Nonproliferative diabetic retinopathy (HCC)"; HYPERLIPIDAEMIA (non-serious), outcome "unknown", described as "Other hyperlipidemia"; TYMPANIC MEMBRANE PERFORATION (non-serious), outcome "unknown"; MICROALBUMINURIA (non-serious), outcome "unknown"; HYPOGLYCAEMIA (non-serious), outcome "unknown", described as "hypoglycemia"; LABORATORY TEST ABNORMAL (non-serious), outcome "unknown", described as "A1c today is down to 7.4% from the A1c at last visit of 8.1%"; LABORATORY TEST INTERFERENCE (non-serious), outcome "unknown", described as "carbohydrate ratio deficient/correction boluses deficient". The patient did not provide information to the reporters regarding the reported adverse event(s) with the use of the product. Medications included: Elderberry take by mouth. Once daily for 1 week, once per month; Hydroxyzine Pamoate (cap) (Vistaril) at 25mg, 1 to 2 tablets twice a day as needed for anxiety or insomnia;  Insulin Aspart (Solution) (Novolog) at 100unit/ml Use in insulin pump as directed. Total daily dose upto 60 units;  Insulin Degludec (Solution Pen-injector) (Tresiba Flextouch) at 200 Unit/ml Inject under the skin. For use as a back up to insulin pump; Insulin Pen Needle (Misc) (Novofine) at 32g X 6mm Use with insulin pen QID; Insulin Pen Needle (Misc) (Insulin Pen Needle) at 30g X 8mm NovoFine 30GX8MM MISC Quantity: 200 Refills: 0 Start: 22Nov2017;  Insulin Syringe-Needle U-100 (Misc) (BD Insulin Syringe U/F) at  31GX5/16" 1ML Use for insulin administration 1-4 times per day;  Lisinopril Tab (Prinivil, Zestril) at 10mg 1 tablet daily; QUEtiapine Fumarate (Tab)(Discontinued) (SEROquel) at 25mg 1/2 to 1 tablets at night as needed for anxiety insomnia or mood ability; QUEtiapine Fumarate (Tab) (Seroquel) at 25mg 1/2 to 1 tablets at night as needed for anxiety insomnia or mood ability; Rosuvastatin Calcium (Tab) (Crestor) at 10mg One tablet daily; Tobramycin-Dexamethasone (Suspension) (Tobradex), at 0.3-0.1% Shake liquid and instill 1 drop in left eye three times daily as directed; Vitamin D take 1 capsule by mouth daily. Current Medications Are BD Insulin Syringe U/F 31G X 5/16" 1 ML Misc. Use for insulin administration 1-4 times per day. Elderberry PO Take by mouth. Once daily for 1 week, once per month; hydroxyzine pamoate (VISTARIL) 25mg capsule 1 to 2 tablets twice a day as needed for anxiety or insomnia; insulin aspart (NovoLOG) 100 unit/ml injection Use in insulin pump as directed. Total daily dose up to 60 units. Insulin degludec (Tresiba Flextouch) 200 unit/ml prefilled pen injection, Inject under the skin. For use as a back up to insulin pump; Insulin Pen Needle 30G X 8 MM misc, NovoFine 30g X 8 mm misc Start: 22Nov2017; lisinopril (PRINIVIL, ZeSTRIL) 10 mg tablet, One tablet daily; Novofine 32g X 6 mm Misc, Use with insulin pen QID; QUEtiapine (SEROquel) 25mg tablet, 1/2 to 1 tablets at night as needed for anxiety insomnia or mood ability; Rosuvastatin (Crestor) 10 mg tablet, One tablet daily; Tobramycin-dexamethasone (TOBRADEX) 0.3-0.1 % ophthalmic suspension, Shake liquid and instill 1 drop in left eye three times daily as directed, VITAMIN D PO Take 1 capsule by mouth daily; QUEtiapine (SEROquel) 25 mg tablet (Discontinued) 1/2 to 1 tablets at night as needed for anxiety insomnia or mood ability. Current Immunizations: Covid-19 MRNA Vaccine - Pfizer 12+ (Purple Cap) External: Auto Reconciled From Outside Source, Date: 23Dec2021. Problem list: as of 17Apr2023. Migrain without aura, intractable, without status migrainosus, ICD-10-CM: G43.019, Noted- Resolved: 15Jul2029-Present. Type 1 diabetes mellitus with hyperglycemia (HCC), ICD-10-CM: E10.65, Noted- Resolved: 22Apr2022-Present. Irritable bowel syndrome, ICD-10-CM: K58.9, Noted- Resolved: 09Oct2022-Present. Adenoid hypertrophy, ICD-10-CM: J35.2, Noted- Resolved: 12Oct2022 - Present. Adult celiac disease, ICD-10-CM: K90.0, Noted- Resolved: 12Oct2022 - Present. Allergy to mold spores ICD-10-CM: 291.09, Noted- Resolved: 12Oct2022 - Present. Anxiety disorder, unspecified ICD-10-CM: F41.9, Noted- Resolved: 01Mar2017 - Present. Bilateral carpal tunnel syndrome ICD-10-CM: G56.03, Noted- Resolved: 12Oct2022 - Present. Cholesteatoma of attic of right ear ICD-10-CM: H71.01 Noted- Resolved: 12Oct2022 - Present. Chronic Myringitis ICD-10-CM: H73.10 Noted- Resolved: 12Oct2022 - Present. Eustachian tube dysfunction ICD-10-CM: H69.80, Noted- Resolved: 12Oct2022 - Present. Macroalbuminuric diabetic nephropathy (HCC), ICD-10-CM: E11.21, Noted-Resolved: 18Dec2019 - Present. Last assessment and Plan: Formatting of this note might be different from the original. Patient's last urine for microalbumin Sep2019 was dated result of 239 mg/g of creatinine. He has a history of microalbuminuria and is currently on Lisinopril 10 mg daily. Blood pressure today 103/53 not much room to increase that Lisinopril dose. I have reviewed these results with patient today and I recommend that he have an evaluation by nephrology to optimize therapy. Nonproliferative diabetic retinopathy (HCC), ICD-10-CM: E11.3299, Noted-Resolved: 12Oct2022 - Present. Nuclear senile cataract, ICD-10-CM: H25.10, Noted-Resolved: 12Oct2022 - Present. Other hyperlipidemia, ICD-10-CM: E78.49, Noted-Resolved: 21Oct2018 - Present. Last Assessment & Plan: Formatting of this note might be different from the original. Last lipid panel from September 2019 revealed significantly elevated LDL level of 173. He was started on Rosuvastatin 10 mg daily and reports he is tolerating it well. He agrees to repeat fasting labs before next visit. Tympanic membrane perforation, ICD-10-CM: H72.90, Noted-Resolved: 12Oct2022-Present, Type 1 diabetes mellitus (HCC), ICD-10-CM: E10.9, Noted-Resolved: 01Jun2017-Present. Uncontrolled type 1 diabetes mellitus with hyperglycemia (HCC), ICD-10-CM: E10.65, Noted-Resolved: 30May2017-Present. Last Assessment & Plan: Formatting of this note is different from the original. It was a pleasure to see (Name withheld) today for follow up of his Type 1 Diabetes which is complicated by microalbumniuria. He also has celiac dz and follows gluten free diet. He was last seen in Aug2019 and since his last visit he got started on the tandem basal IQ pump and continues to utilize the Dexcom sensor. He has a history of severe hypoglycemia in the past and is wearing a Dexcom G6. His A1c today is down to 7.4% from the A1c at last visit of 8.1%. He is pleased with the improvement. Device uploaded today and it reveals that his correction boluses in the mid-morning as well as in the evening are deficient and his post meal spikes across the day are also revealing that his carbohydrate ratio is also deficient. I have asked him to adjust his correction factor between the hours of 10 AM-12 PM down to a setting of 52, between 4 PM-12 AM to a setting of 50 and his carbohydrate ratio between the hours of 4 AM-10 AM to 11, 10 AM- 12 PM to 11, 12 PM-4 PM to 11, 4 PM-12 AM to 14. He has on hand unopened Tresiba. I will update glucagon prescription today. I have outlined the importance of continuing to work closely with diabetes education team and he is encouraged to send us a portal message if he has uploaded his pump into the tandem system. He was counseled today on how to properly treat a low blood sugar (below 70) with a simple carbohydrate like 4 ounces of juice or 3-4 glucose tablets. Repeat a blood sugar 15 minutes after treating and once above 70 consume a small meal. Carry with you a form of simple carbohydrate always. Notify this office if you have any readings below 70 as it may indicate a need for medication adjustment. Reports he has unexpired glucagon on hand. I will see him back in 3 months. Care guidelines: On statin, on ACE, UTD dilated eye exam, declines flu vaccine, UTD labs. Vitamin D deficiency. ICD-10-CM: E55.9. Noted-Resolved: 04Mar2021-Present. Social history: Tobacco history: Smoking Status: Never. Passive Exposure: Yes. Smokeless Tobacco use: Never. Alcohol history: Alcohol use status: Yes. Drinks/Week: 0 Glasses of wine, 0 Cans of beer, 0 Standard drinks or equivalent per week. Comment: 1 glass of wine per month. Drug use status: No. Sexual activity: Sexually active: Yes. Partners: Female. Birth Control/Protection: Condom, I.U.D.Comment: No multiple partners, nothing since marriage. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 130/72, notes: BP: 130/72; Body mass index: 22.04 kg/ m square, notes: BMI: 22.04 kg/ m square; Body temperature: 98.1 degree F (36.7 degree C), notes: Temp: 98.1 degree F (36.7 degree C) (Oral); Glycosylated haemoglobin: 8.1 %; 7.4 %, notes: His A1c today is down to 7.4% from the A1c at last visit of 8.1%; Heart rate: 50, notes: Pulse: 50; Resp: 17, notes: Resp: 17; Oxygen saturation: 98%, notes: SpO2 98%.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Diabetes mellitus", "Coeliac disease", "Cataract nuclear", 'Cholesteatoma" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.