Received May 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
she has some heart problem and before she had the vaccine she did not have any; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "she has some heart problem and before she had the vaccine she did not have any". Therapeutic measures were taken as a result of cardiac disorder. Additional information: Privacy sales representative stated, "a privacy employee. He was sales representative in Privacy. One of the medical assistant in a doctor's office he called on shared that she had a side effect to the Covid vaccine (clarified as Pfizer Covid-19 Vaccine). "When probed about the side effects, privacy sales representative stated, "She said, she had some heart problem and before she had the vaccine she did not had any and then after the vaccine she had some heart issues and she had been going to see different doctors and had to get on heart medication and she shared that she had not experienced that until after she took the vaccine. "Company aware date: Privacy sales representative stated, "Just about an hour or so ago. Couple a hours ago in privacy, privacy central time around 6 o clock. A couple hours ago. He just looked at the clock and it's 8 here, so it was around 6 o clock (Company aware date clarified as 29Apr2026 hence same captured in tab). Reporter details: Name: Privacy sales representative stated, "Her name was Privacy. He did not had her last name (Privacy sales representative did not had the last name hence, only first name initial captured in patient initials tab) but she works at, He could gave you the doctor's office number. "When clarified if reporter was the patient, Privacy sales rep stated, "She was not a patient. She worked for doctor office. He was sales representative and he called on a doctor's office. "When probed to clarify that the medical assistant was also a patient who had the side effect, Privacy sales rep stated, "Correct."Reporter type(If HCP): Medical assistant. Follow up: Privacy sales rep stated, "Yes. He told her that He was going to report it and then he also gave her this number to call. "Mailing address: Privacy sales rep stated, "He had the doctor information. He did not had her but He had the doctor's information. He could gave you her phone number but He did not had her mailing address or anything like that. "Email address: Privacy sales rep stated, "No, He did not. He might had but, you know what, he was driving back to his apartment, so he thought he might had her work email address."Patient details: When probed for date of birth, height, weight, ethnicity, age at the time of event, gender, Privacy sales representative stated, "Not really. He meant, He could guess at it, but he just know she was a female, but he did not want to guess at all the other stuff. "When probed for doctor details, product details (LOT, Expiration date, NDC, UPC), vaccination facility details, Privacy sales representative stated, "No. She just mentioned that when she got it, she noticed that she started having complications afterwards and she started going to her doctor and she told them that she believed that it was from the vaccine and all of that and that she was now on two medications because of it."Privacy sales representative stated, "She said her doctor's name that she shared it with but he couldn't even remember that name. he just told her that he was going to report it and then she should report it as well. "When probed to clarify if will not be able to provide date of vaccination, dosage, indication, medical history and concomitant medication details, lab details, Privacy sales representative stated, "No. Treatment: Privacy sales representative stated, "She said she was on something, like they diagnosed her with kind of heart thing and then she said they put her on two medications. Privacy sales representative was informed that safety report had been filed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.