Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest X-ray, Chills, Cough
Clinical narrative: she does not have an amazing immune system; left with what feels like to be fatigue and a bad cold; tested positive for Covid 19 after receiving both doses of the vaccine in Jan and Feb of this year.  Both a rapid and a PCR test were positive for Covid 19 on 15 July; tested positive for Covid 19 after receiving both doses of the vaccine in Jan and Feb of this year.  Both a rapid and a PCR test were positive for Covid 19 on 15 July; fever; constant chills; a high heart rate; just felt terrible like she had the flu; cough; having symptoms on 13Jul2021. It seemed to sinus related; had sinus pressure and a very light ticklish cough the first day, 13Jul2021; left with what feels like to be fatigue and a bad cold; This is a spontaneous report from a contactable other HCP (Nurse).   A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200; Expiration Date: 20Jun2021), dose 1 intramuscular, administered in Arm Left (Deltoid Left) on 22Jan2021 19:00 (at the age of 57-years-old) as Dose 1, Single, and dose 2 intramuscular, administered in Arm Left (Deltoid Left) on 13Feb2021, at around 11:00 or 12:00 (at the age of 57-years-old) (Batch/Lot Number: EN6200; Expiration Date: 20Jun2021) as Dose 2, Single for covid-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. The patient's concomitant medications were not reported. The patient had no other products. No additional vaccines administered on same date of the Pfizer. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient started having symptoms on 13Jul2021. It seemed to sinus related, nothing made her think COVID. She explains she had sinus pressure and a very light ticklish cough the first day, 13Jul2021. The second day on 14Jul2021, she had more sinus pressure and frequent cough. On 15Jul2021 (Thursday), she had fever, constant chills, a high heart rate and just felt terrible like she had the flu. She believes her testing positive for COVID-19 and the symptoms she experienced on Thursday are medically significant but did not require hospitalization. The caller verifies her symptoms have improved some. The fever and chills were gone after 24 hours. She was left with what feels like to be fatigue and a bad cold. The physician didn't order any treatment. The place she went to get tested was an urgent care with a physician. A physician saw her and ordered the test. It was reported that, the patient was shocked that she tested positive since she was not working in direct patient care. She asked why, she was breaking through. Wouldn't Pfizer want to know so we can track, why this happening. The patient tested positive for Covid 19 after receiving both doses of the vaccine in Jan2021 and Feb2021 of this year. Both a rapid and a polymerase chain reaction (PCR) test were positive for Covid 19 on 15Jul2021, just a few days ago. When she went to get tested for Covid, she asked if they could tell if it was a variant. She was told a special Blood test was needed. Does Pfizer recommend getting that test to see which variant she was infected with, does Pfizer track it. The one vial expired Jun2021 so that was just when it has to be used and it was given in Feb2021. She asked was Pfizer interested in getting a blood sample, she was willing to give a blood sample so Pfizer can test it. She wanted to report this information but also check with Pfizer in regard to a special blood test. She explains she asked when she got tested if they could tell if it was a variant of COVID or not and was told that it takes a special kind of blood test to determine this. The caller assumed Pfizer would want that blood test done to be able to track where the issue was. The patient does not have an amazing immune system. She hasn't had a cold in 6 or 8 years, so she was not really matching up to the other people breaking through. she was actually tested in (place name) on 15Jul2021. She flew from (place name). She was just on one flight from (place name) and then she drove from (place name). She states she went straight from the airport to an urgent care in (place name). She confirms she was deemed positive for COVID in the state of (place name). The adverse event did not required visit to emergency Room. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200was 5706482 5705159 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. When more than one investigation was found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion was blank in the table above, then the investigation record was likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6200was 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was 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. Reporter seriousness for vaccination failure, covid 19, fever, chills, a high heart rate, just felt terrible like she had the flu was reported as medically significant. The outcome of the events chills and fever was resolved in Jul2021 and outcome of all other events was unknown.