Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol abnormal, Blood pressure measurement, Hypertension, Laboratory test, Renal disorder
Clinical narrative: My blood pressure is around 187 over 95. Blood pressure was 200/113; Starting to affect her kidneys; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Past drug history included: Claritin d for Sinus migraines. Vaccination history included: BNT162b2 (Dose number 2), administration date: 03Apr2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Stroke"; Bnt162b2 (Dose number 1), for COVID-19 immunization; Bnt162b2 (Dose number 3), for COVID-19 immunization.  The following information was reported: HYPERTENSION (medically significant), outcome "unknown", described as "My blood pressure is around 187 over 95. Blood pressure was 200/113"; RENAL DISORDER (non-serious), outcome "unknown", described as "Starting to affect her kidneys". The patient underwent the following laboratory tests and procedures: Blood cholesterol abnormal: Low; Blood pressure measurement: 187 over 95; 120s / high 70s-low 80s; 200/113; 159/89; Tests: Unknown result, notes: they did all kinds of tests, they just never found a medical reason. Therapeutic measures were taken as a result of hypertension. Clinical course: Caller is a consumer (Patient). Patient reported high blood pressure after receiving the Pfizer bivalent booster and wanted to know if we do have recommendations. She said that she's calling to check if this has been reported before and what medication they took to lower their blood pressure. She also said, "I've been on 4 different (blood pressure) medications, nothing is working, my blood pressure is around 187 over 95." Patient also stated that she read on the website (maybe another website) that high blood pressure (3.8%) was reported after getting the Pfizer vaccine. Sinus migraines She takes Claritin D, but because of the time of year, she can't confirm if she was taking Claritin D at that time. Usually in the winter, she doesn't take Claritin D. COVID-19 Vaccine, booster shot: high blood pressure. A year went by, she pretty much recovered from the stroke. She got the booster shot for the COVID-19. The reason she's getting the shots regardless of her health is because her husband has heart problems and cancer. Husband is on drugs for both of those conditions and he has a very low immune system. Patient was in the hospital. She never had high blood pressure. She was usually 120s / high 70s-low 80s. When she got the booster shot, all of a sudden she had high blood pressure. Went to the doctor one month later for a physical and had high blood, like really high blood pressure. Blood pressure was 200/113. States it is now Jan2023, which is five months later and she has tried 4 different medications: Valsartan, Amlodipine, Lisinopril and now is on metoprolol. None of these medications work for her. She took 50mg of Metoprolol this morning, and her blood pressure is 159/89, which pretty much is as low as she can get it unless she does cardio exercises. She sees Pfizer is running tests and trying to figure it out. Maybe there might be some recommendation she doesn't know about for treating the high blood pressure. A lot of people said it was temporary when reading the report Pfizer has, but she doesn't know how long she can do this, stating the medication is starting to affect her kidneys. Last month she had liver, but she got that straightened out. The medication is starting to affect other areas. Patient does not specify what exactly happened to her liver. COVID-19 Vaccine, booster shot: high blood pressure: Happened right after the booster dose. Never in her life has she had high blood pressure. Everyone keeps saying she's getting old, but high blood pressure doesn't just appear, something is causing it. Her being 70-year-old doesn't give her a lot of credibility in the medical field. She crawls around on the floor and has mobility like a 30-year-old, she plays street hockey. She is not just sitting up in her rocking chair folding up and dying. The worst problem beside the drugs for the high blood pressure medications not working is the side effect where all of her muscles just roll up in a big, huge ball and she has to un-ball them every morning. Clarifies she has to exercise before she even goes to the bathroom, she can hardly get up. She doesn't understand it, before the stroke happened there was absolutely nothing wrong with her, except she had hypothyroidism and has been taking thyroid medication for 30 years. The only pill she took was levothyroxine. COVID-19 Vaccine: All doses were manufactured by Pfizer. Stated her hospital records says she has had 4 total COVID-19 Vaccines. But if she has had 4, she never endorsed the last one, it must have been snuck in with her flu shot. Does not have vaccine record card at time of call to provide NDCs/LOTs/EXPs or other product details. Amlodipine: Manufacturer: Unknown. She was taking it along with all of the other ones. She would either take Amlodipine and 1 Valsartan or Amlodipine and 1 Lisinopril. Formulation: 5mg tablet. Dose: take 1 tablet by mouth once daily. Packaged in a pharmacy bottle. NDC/LOT/EXP: not probed as non-Pfizer product, Valsartan: Manufacturer: MacLeod's Pharmaceutical, Drug Formulation: Capsule, Dose: 320mg once a day, NDC/LOT/EXP: not probed as non-Pfizer product, Packaged in a pharmacy bottle. Could only take it once because the side effects got worse. Clarified as the muscle pain. Starts in lower part of back, radiates down to thighs and up in shoulders. Lisinopril: Manufacturer: Lupin pharmaceuticals, it was underneath the label. Drug Formulation: tablet, Dose: 20mg once a day, Confirms it's packaged in a pharmacy bottle. NDC/LOT/EXP: not probed as non-Pfizer product, Metoprolol, Manufacturer: Doctor Reddy Oval. Caller confirms manufacturer and it is documented as provided by caller. Drug Formulation: capsule, Dose: 50mg once a day, Packaged in a pharmacy bottle. NDC/LOT/EXP: not probed as non-Pfizer product, Investigations: Doesn't know, they did all kinds of tests, they just never found a medical reason. Is there a product complaint to report? Yes, Description of Product Complaint: PC not on suspect product: Description of complaint: Medications did not work for high blood pressure. Valsartan: Manufacturer: MacLeod's Pharmaceutical, Drug Formulation: Capsule, Dose: 320mg once a day, NDC/LOT/EXP: not probed as non-Pfizer product, Packaged in a pharmacy bottle. Could only take it once because the side effects got worse. Clarified as the muscle pain. Starts in lower part of back, radiates down to thighs and up in shoulders, Lisinopril: Manufacturer: Lupin pharmaceuticals, it was underneath the label. Drug Formulation: tablet, Dose: 20mg once a day, Confirms it's packaged in a pharmacy bottle. NDC/LOT/EXP: not probed as non-Pfizer product, Metoprolol, Manufacturer: Doctor Reddy Oval. Caller confirms manufacturer and it is documented as provided by caller. Drug Formulation: capsule, Dose: 50mg once a day, Packaged in a pharmacy bottle. NDC/LOT/EXP: not probed as non-Pfizer product, Below questions were not queried as products are non-Pfizer products. Product strength and count size dispensed: Additional lot numbers: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact?  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.