Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram T wave peaked, Fibrin D dimer, Full blood count, Heart rate irregular, International normalised ratio normal
Clinical narrative: shortness of breath; irregular heart beat; palpitations; EKG did show PVC's; HCP at the urgent care was concerned about the T wave being peaked; left arm was sore; This is a spontaneous report from a contactable nurse practitioner (patient). A 49-year-old female patient received first dose bnt162b2(age at vaccination was 49 years) (BNT162B2, Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, in Arm Left on 12May2021 11:00 (at the age of 49years) as 1ST DOSE, SINGLE for covid-19 immunisation (reason: Civic Duty, wanting to be protected in a pandemic). Patient didn't receive other vaccination with in 4weeks prior to covid-19 vaccination patient received other products valsartan prior to vaccination. Medical history included ongoing high blood pressure (diagnosed about 2 years ago; high blood pressure related to PTSD), PTSD and palpitations (several years ago she had palpitations, but they were rare, and she wore a Holter monitor). Investigation assessment was done. Concomitant medications included valsartan (started 2 years ago, as needed) taken for high blood pressure (valsartan bottle was so small, she didn't know if she will be able to see it. Valsartan 80mg tablets). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks, no adverse events following prior vaccinations. Family medical history included dad was very sensitive to medications, she thought she will likely be following in his footsteps. The patient was calling to report her side effects or adverse reactions. On 12May2021, her left arm was sore, and then when she woke up on 13May2021 (around 7:00), she had shortness of breath, palpations and irregular heartbeat. Seriousness for shortness of breath, palpations and irregular heartbeat was assessed medically significant by reporter. The patient was supposed to play pickle ball, she was very active and didn't think that was a good idea with her side effects, so she went to the urgent care and emergency care (ER) on 13May2021 (last evening) and was evaluated at Urgent Care and ER. On 13May2021, testing included urgent care electrocardiogram (EKG), which showed PVCs and they were concerned about the T wave being peaked. On 13May2021, chest x-ray, CBC, chemistry panel, PT INR, troponin, d-dimer, PTT, urinalysis, glucose and pregnancy test, all results came back normal. She had a follow up with Cardiology next week for palpitations, irregular heart rate, and shortness of breath. The patient didn't take her supplements on 14May2021 (today), yesterday or the day before (starting 12May2021) because she didn't want them to react with anything and she hadn't taken her valsartan on 14May2021 (this morning yet). The patient stated several years ago she had palpitations, but they were rare, and she wore a Holter monitor, and she had not had them in several years. The patient will speak with her Cardiologist about the second vaccine and said no offense, but her family practice was a nurse practitioner and since her side effects were cardiac related, she will talk with him. The patient saw him last week on 05May2021. The patient was on the losartan as needed, but her blood pressure was not usually too high and it was dropping her blood pressure too low, so she reduced it to 40mg daily instead of 80mg as needed but last week he started her on it daily. The patient said she knew the vaccine was under emergency use, so she wanted to call and report to help provide data. The patient was hoping to get the shingles vaccine in July when she was eligible, as long as there was no interaction with the Covid vaccine. The patient had concerns about getting the second vaccine. The outcome of the events dyspnoea, heart rate irregular, palpitations, pain in extremity all had was recovered on 14May2021, outcome of the events ventricular extra systoles, electrocardiogram t wave peaked was unknown.  Verbatim event relatedness: Covid 19 Vaccine: didn't take her supplements today, yesterday or the day before because she didn't want them to react with anything - Related; Covid 19 Vaccine: Irregular Heartbeat - Related; Covid 19 Vaccine: Sore Left Arm  Related.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events dyspnea, palpitation and heart rate irregular and the suspect drug.  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.