Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid on 09Apr2021, after receiving her second dose of the Pfizer Covid Vaccine on 03Apr2021; Tested Positive for Covid on 09Apr2021, after receiving her second dose of the Pfizer Covid Vaccine on 03Apr2021; Hypoxia; Fluid in Both Lungs; Dyspnea; Fatigue; Loss of Appetite; she wasn't feeling well; Pre-existing diseases worsened during the SARS-CoV2 infection including Asthma; This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sponsored program. The nurse reported similar events for herself and her daughter. This is the second of two cases.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular route administered in arm  on 13Mar2021 (Batch/Lot Number: EN6208) as single dose (dose 1) and then via intramuscular route administered in arm on 03Apr2021 10:45 (Batch/Lot Number: ER8737) as single dose (dose 2), for COVID-19 immunization. Patient has received both doses of the Pfizer Covid Vaccine. Medical history included Down's syndrome from 15Sep1984, morbid obesity and asthma since 2011 (Diagnosed 10 years ago), all were ongoing; and not a smoker/former smoker. Ongoing concomitant medications included loratadine (CLARITIN), paroxetine hydrochloride (PAXIL) and birth control. No prior Vaccinations (within 4 weeks). On 09Apr2021, the patient tested Positive for Covid on 09Apr2021, after receiving her second dose of the Pfizer Covid Vaccine on 03Apr2021. On the same day on 09Apr2021, the patient experienced hypoxia, fatigue, fluid in both lungs, loss of appetite and she wasn't feeling well. The patient (who had Downs Syndrome not that it matters but it is a co-morbidity/ Daughter has downs) and the patient's mother (reporter) had their second doses on 03Apr2021 which was a Saturday and her daughter ended up in the hospital on Friday 09Apr2021 and tested positive for Covid. The patient was admitted with hypoxia. The patient's mother has questions for the timelines for their infections. She doesn't know if they were possibly infected before they got the second vaccine and were asymptomatic and unknown or did they get infected when got they got the vaccine thousands of other people. The patient's mother stated that it has mostly resolved now, and they were all home. It started with fatigue and loss of appetite and she wasn't feeling well, so she took her to the doctor at 08:00 and she was at the emergency room (ER) by 08:30 and hospitalized from 09Apr2021 to 13Apr2021. The events required visit to Emergency Room and Physician's office. Treatment included Remdesivir, Steroid Injection and Oxygen. Pfizer-BioNTech COVID-19 Vaccine Data Capture Aid included the following information: The patient had a positive test for SARS-CoV2. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. The patient was hospitalized from 09Apr2021 to 13Apr2021. The patient was not admitted to an Intensive Care Unit. The patient did not have SARS-CoV2 antibodies at hospital discharge. The patient displayed clinical signs at rest indicative of severe systemic illness including Oxygen Saturation on Admission was 83% on Room Air. The patient required supplemental oxygen (including high flow or ECMO). New or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening) were Respiratory: Hypoxia, Fluid in Both Lungs and Dyspnea. The patient received additional therapies for COVID-19 including 5 Doses of Remdesivir starting 09Apr2021 and ending 13Apr2021. The reporter stated that she thinks they gave her a steroid injection in the ER. The event did not require the initiation of new medication or other treatment or procedure. The patient's outcome with COVID-19 was recovering. Patient has not had a repeat test. The patient had numerous Lab work.  The patient was not a smoker/former smoker. The patient was taking medications routinely prior to the event being reported including Paxil, Claritin and Birth Control Pill. Pre-existing diseases worsened during the SARS-CoV2 infection including Asthma. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab test and procedures including a Covid Test: Positive on 09Apr2021. The relatedness of drug to the events "Tested Positive for Covid on 09Apr2021, after receiving her second dose of the Pfizer Covid Vaccine on 03Apr2021, Hypoxia, Fatigue, Fluid in Both Lungs" was unknown (Source of assessment: Primary Source Reporter/ Method of assessment: Global Introspection). Causality was unknown because she doesn't know when they were exposed to the Covid. The reporter thinks the vaccine lessened their symptoms. Reporter seriousness for "Tested Positive for Covid on 09Apr2021, after receiving her second dose of the Pfizer Covid Vaccine on 03Apr2021, Hypoxia, Fluid in Both Lungs (medically significant)" was serious (hospitalization from 09Apr2021 to 13 Apr2021). Events Fatigue and Loss of Appetite were assessed as not serious by reporter. The outcome of the events Hypoxia, Fatigue, Fluid in Both Lungs, Loss of Appetite, she wasn't feeling well, COVID-19, dyspnea and Asthma aggravated was recovering and unknown outcome for the other event.; Sender's Comments: Based on the information currently available, vaccination failure of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. Events hypoxia, pulmonary edema and dyspnea are attributed to Covid-19 infection and considered unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.,Linked Report(s) : US-PFIZER INC-2021413231 same reporter and drug, similar event, different patient