Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got my second shot and I got Covid; I got the rapid test and I also had home PCR test and my report came positive; I got my second shot and I got Covid; I got the rapid test and I also had home PCR test and my report came positive; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot Number: EW0162; Expiration Date: 31Jul2021, age at vaccination: 29-year-old), dose 2 via an unspecified route of administration, administered in upper Arm Left on 18Apr2021 at 14:30 as dose 2, single for covid-19 immunization. The patient previously took BNT162B2 dose 1 via an unspecified route of administration, administered in upper Arm Left on 28Mar2021 at around 1-2 PM (Batch/Lot Number: EC8730) as dose 1, single for covid-19 immunization. Medical history was not reported and concomitant medication was none. The vaccine was not administered at facility. No family Medical History Relevant to AE. The patient started feeling body ache, slight sore throat on Thursday (15Jul2021) around like 3:30 pm and then the next day, still had the same symptoms like body ache and minor sore throat. So, on Thursday, she got the rapid test and she tested positive on 16Jul2021 with rapid test and and it wasn't until Saturday (17Jul2021) that she got the fever around the afternoon and then Sunday (18Jul2021) whole day fever as well and she just took a lots of Tylenol, 'stuck to thousands milligrams' like every six hours and so and then on Sunday, she took almost '1800 grams' to break the fever. She also had it confirmed with a PCR test that was sent in on Thursday and results received on 18Jul2021. Yesterday, Monday (19Jul2021) fever was gone all day and she just had a really bad congestion and couldn't smell or taste because of the congestion. No treatment was received for the events. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No vaccines additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room and Physician Office visit due to events. The patient did not receive any prior vaccination within 4 weeks of Pfizer vaccination. Conclusion of Previously Completed Investigation. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0162 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint:# When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot EW0162. The final scope was expanded to include the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0162 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.