Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Tachycardia, Vaccination failure
Clinical narrative: Shortness of breath/Shortness of breath on exertion; with chest pressure,  on exertion; Headache with sinus congestion; Headache with sinus congestion; Body aches; Diagnosed with Covid-19 virus after taking both vaccines; Diagnosed with Covid-19 virus after taking both vaccines; Tachycardic; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: 31Mar2021) on 29Dec2020 20:00 (at the age of 29-years-old) then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021) on 19Jan2021 09:00 (at the age of 29-years-old) both via an unspecified route of administration, administered in deltoid left as 0.3 mL, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included Factor V Leiden from Mar or Apr of 2017, while she was pregnant; migraine from 2011; exercise induced asthma from 2007 or 2008; all were ongoing. The patient's other family members have tested positive for Covid-19 last summer but specifies that they were not vaccinated. The patient was taking medications routinely prior to the event being reported which included Vyvanse at 20 mg by mouth once a day. She added that she does not take it every day because she works at night; and amitriptyline at 10 mg by mouth daily. On 20Apr2021, the patient was diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell; then at 3:00 am of 20Apr2021, the patient had body aches, headache with sinus congestion and cough. On 21Apr2021, the patient experienced fever. On 22Apr2021, the patient experienced shortness of breath, with chest pressure, on exertion. It was also reported that the patient's loss of taste and smell was worsened 21Apr2021 described as very noticeable. It was further reported as the patient got her first vaccine on 29Dec2020 and second vaccine on 19Jan2021 then she was diagnosed with Covid-19 on 20Apr2021. The patient stated that when she moves around, she gets short of breath and her heart rate elevates. She went to the emergency room. She had to go to the hospital because she was tachycardic described as when she came home from work, it felt like her chest was pounding; and had chest pressure from being short of breath. She was not admitted, she went to the emergency room, and was released. She cannot walk without getting short of breath. She called her primary care provider, who told her to go to the emergency room, because of her history with a clotting disorder, Factor V Leiden. The patient confirmed she has no history of having clots. Her heart rate baseline was 50 to 70 beats a minute. Shortness of breath on exertion. Loss of taste and smell started in the evening on the 20Apr2021 as her drink did not taste right, and the next day, the event was very noticeable, on the 21Apr2021. She had fever, and took Tylenol for her headache and reclarified, that it somewhat helped the headache. She also had body aches, headache with sinus congestion and cough; all on 20Apr2021 at 3:00 am. The events shortness of breath and tachycardia resulted in emergency room visit. The patient did receive additional therapies for COVID-19 which included albuterol started on 20Apr2021 as patient will take it when she was sick or has allergies; and Lovenox started on 20Apr2021 at 0.7 ml once a day, subcutaneous injection, due to her history of clotting condition. The patient underwent lab tests and procedures on 20Apr2021 which included rapid Covid-19 test: positive, no reference range provided; CBC, BMP, D-dimer: all results were normal, reference ranges not provided; Chest X-ray in emergency room: no infiltrates were noted. The events diagnosed with Covid-19 virus after taking both vaccines, tachycardic; shortness of breath, with chest pressure, on exertion; fever and headache with sinus congestion were all considered as medically significant by the reporter/patient. The outcome of the events body aches and cough was recovering while the rest of the events was not recovered. Relatedness of drug to reactions/events. Reactions assessed were diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell, fever, body aches, headache with sinus congestion and cough: Source of assessment was the primary source reporter and the method of assessment was global introspection then the drug results were unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) and the other events with BNt162b2 can not be fully excluded based on the temporal relationship.  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.