Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Headache, Hypertension, Magnetic resonance imaging, Pericarditis
Clinical narrative: pericarditis,slight; dehydration; headache; High blood pressure; skipped heart beat; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), on 07Jan2021 as dose 2, single (Lot number: EL1284) at the age of 73 for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2008 (not ongoing), notes: Breast cancer has resolved.; "Orthopedic issues", start date: 2004 (ongoing), notes: Orthopedic issues started in 2004. In both shoulders and both knees and now has back problems.; "bilateral mastectomy" (unspecified if ongoing), notes: She had bilateral mastectomy. She didn't need chemo or radiation because it was stage 1. There were no concomitant medications. Vaccination history included: pfizer covid19 vaccine (DOSE 1, SINGLE, LOT: EK573O), administration date: 19Dec2020, when the patient was 73-year-old, for Covid-19 Immunization. The following information was reported: HYPERTENSION (medically significant) with onset 18Jan2021, outcome "recovered", described as "High blood pressure"; HEADACHE (medically significant) with onset 18Jan2021, outcome "recovered"; EXTRASYSTOLES (medically significant) with onset 18Jan2021, outcome "recovered with sequelae", described as "skipped heart beat"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis,slight"; DEHYDRATION (non-serious), outcome "unknown". The events "headache", "high blood pressure" and "skipped heart beat" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; pericarditis, slight, notes: CT scan showed pericarditis, slight; Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Electrocardiogram ambulatory: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of headache, hypertension.  The reporter considered "headache" not related to bnt162b2.  Clinical course: Caller states she had two of the Pfizer covid 19 vaccines and it's time for her to get a booster. Caller states that the second dose caused a reaction, she ended up in the ER with high blood pressure, headache and skipped heart beat. It's time for her to have a booster, and her medical insurance doesn't cover Moderna and the literature says if you had a reaction don't have Pfizer. Caller received the second dose of the Pfizer covid 19 vaccine on 07Jan2021, she had a reaction 2 weeks later on 18Jan2021. Calling about Pfizer Covid19 Vaccine. Had injection with no reaction then with second dose had reaction a few weeks after. Had high blood pressure, headache, and skip beats. Ended up in emergency room. Doesn't want to take Pfizer again. Wants Moderna Covid Vaccine, but Name withheld doesn't offer that. She did have Moderna booster a year later with no reaction. High blood pressure: it is medicated now. She saw cardiologist who put her on blood pressure medication. She doesn't have high blood pressure now because she is on medication. Cardiologist ran all kinds of test. She had Echo, Holter monitor, EKG, and other test caller can't remember. Cardiologist did a good work up. The only thing cardiologist could pinpoint is the Covid vaccine. Headache: they gave her a liter of fluid and kept her for 8 hours and the headache went away. Seriousness Criteria: Medically Significant because she did go to hospital. Caller clarified she was not admitted to the hospital, but was in emergency room. Skip beats: still ongoing, but intermittently. The skip beats are not all the time. Investigations: she had a good work up when she had Her knee replacement in Jul2023 because of her history. Did a cat scan, MRI, and echo. CT scan showed pericarditis, slight. Adult Moderna Bivalent on 17Nov2022; Lot: AS7166V. She got the second dose of Pfizer Covid19 Vaccine in Jan2021 because work offered it. She worked at hospital and they offered her first and second. She moved out of the area and retired. Because of the reaction she chose to get Moderna after the second Pfizer Covid19 vaccine. Concomitant Medications: none that she can recall. She was not on any heart medications. Other Conditions was Yes. Vaccine was not Administered at Facility. Prior Vaccinations (within 4 weeks): only had first dose of Covid19 Vaccine on 19Dec2020. No Relevant Family Medical History to Adverse Events. Her mom died of cancer and her dad lived until 101. He was a strong dude. AE required visit to: Emergency Room, Physician Office visit (cardiologist), No Intensive Care Unit. Relatedness of drug to reaction(s)/event(s): Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Result of Assessment: Yes. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection, Result of Assessment: Yes. Causality: High Blood Pressure: Yes, because she never had it before. Headache: probably not. They said she was dehydrated and that is why they gave her a liter of fluid. Skip beats: Yes; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Hypertension , Extrasystole and the use of suspect product cannot be fully excluded.  Based on known drug safety profile and available information, the events of Headache, Pericarditis are assessed as related to suspect product. The impact of this report on the benefit/risk profile of the Pfizer product 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.