Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myocardial necrosis marker
Clinical narrative: left shoulder pain; she might just have bursitis in her left shoulder.; her blood pressure was real high; left neck pain; left arm was hurting really bad; sleepy; This is a spontaneous report received from a contactable licensed nurse practitioner (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 21Apr2021 (Lot Number: EP1533) as 1ST DOSE, SINGLE for covid-19 immunisation. She stated the lot# could be either ER1533 or EP1533. She thinks it looks more like EP1533. Medical history included blood pressure. Prior Vaccinations (within 4 weeks) was none. Concomitant Products included blood pressure pills, but declines to provide the name or dosage. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that it made her sleepy but was generally fine. The caller was hospitalized from 11May2021 to 14May2021 due to left shoulder and left neck pain. She mentioned that her left arm was hurting really bad and her blood pressure was real high. Her blood pressure was up, it was 200 something over 100-something mmHg on 11May2021. She was diagnosed with possible bursitis on her left shoulder. She was given a cortisone shot for her shoulder. The doctor's thought she might be having a heart attack or a stroke, and has undergone a nuclear stress test to evaluate a possible a heart attack and stroke. Because of this, she missed her 2nd dose that was due on Thursday, 13May2021, but she couldn't get her second Covid 19 vaccine because she was in the hospital. When she was in the hospital she had blood work, they checked her heart enzymes every 3 hours, an echocardiogram, an EKG, a nuclear stress test and was injected with some dye for the stress test, she had an MRI of her left shoulder because her left shoulder and left neck were giving her a lot of pain. The doctor told her she might just have bursitis in her left shoulder. She would like to find out if the cortisone shot and nuclear stress test dye would affect the vaccine and for how long should she wait before getting it. She's asking when can she get the second Covid 19 vaccine because of what was injected during the stress test. She also had a chest x-ray and is asking if radiation affects the Covid 19 vaccine. And she had a cortisone shot in her left shoulder. She went to the emergency department on 11May2021 events left shoulder pain, left neck pain and was admitted. She personally didn't think her hospital stay had anything to do with the Covid 19 vaccine. She's PRIVACY old and had a lot of pressure in her left shoulder and thinks it was just bursitis. Her left shoulder pain started before 11May2021 but on that day, 11May2021 she had a lot of pain in her left shoulder and left neck. She reports her left shoulder is better especially since she received the cortisone injection. Her left shoulder is a lot better, she can move it and it hurts a little when she moves it certain ways. She's also taking care of her blood pressure. The outcome of left neck pain was not recovered. The patient was recovering from left shoulder pain and sleepy. The outcome of others was unknown.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the serious events cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.