Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Malaise, Mobility decreased
Clinical narrative: breathing worsen, cannot breathe/shortness of breath; dizzy/dizziness; cannot lift heavy things; felt like she was drowning; Headache; heart acceleration; Didn't feeling well/felt really bad; cannot go upstrairs; This is a solicited report based on the information received by Pfizer from Janssen (MFR Control No: 20210521779(2). A contactable consumer (patient) reported a 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 (at age of 45 years old) as single dose for COVID-19 immunization; selexipag, oral from an unspecified date and ongoing, at 1200 ug for Pulmonary Arterial Hypertension. Medical history included Breast cancer from Nov2020 (Other relevant history: Past Disease: Removed two balls on her left breast- Breast cancer (Nov2020-Unk) Continuing: No), ongoing Pulmonary Arterial Hypertension. Concomitant medications included oxygen. On Apr2021 the patient experienced breathing worsen, cannot breathe, dizzy, and cannot lift heavy things. The patient on Uptravi for 2-3 years. 1200mcg. Had covid vaccine 30Mar2021, then 2 weeks later her problem got worse. Breathing got worse and before did not have them. Bends down and get dizzy and cannot breathe. Uses the oxygen all the time now. Cannot breathe. Cannot Lift heavy things. Upon follow up it was reported that 2 weeks after she felt SOB , in 2021 headache, felt like she was drowning, dizziness, heart acceleration lasted for a month but now they are all gone. Upon follow-up the health care professional informed the oncologist that they could not sleep the patient entirely because it would be bad for her health. Patient had conversation with the doctor on 16July to talk about transplant because problem with Covid-19 vaccine Pfizer, the heart was more affected and after 2 weeks with vaccine she felt really bad, The patient had not been the same since. Before vaccine she was good. The patient could not breathe that well, shortness of breath, cannot go upstrairs, heart accelerates, dizzy and was just going to her bed all. The doctor studied and said they are the same, but she did not feel the same. The patient had electrocardiogram, blood draws. All events were medically significant. The action taken in response to the events for selexipag was dose not changed. The outcome of the events was recovered in 2021. The reporter provided no causality assessment. Company causality Between selexipag and breathing worsen, cannot breathe, dizzy, cannot lift heavy things, felt like she was drowning, headache, and heart accelerations was not related. This report was non-serious. With Breathing Worsen, Cannot Breathe; Dizzy, Dizziness; Cannot lift heavy things; Feeling like she was drowning; Headache; Heart Acceleration; Didn't feeling well; Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr.(Drug/Vaccine): Not related.  The reporter's assessment of the causal relationship of the event (cannot go upstrairs) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  The lot number for [generic name], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect product and reported events cannot be completely excluded.  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.