Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature decreased, Chills, Cough
Clinical narrative: Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; Shortness of breath on exertion; Congestion; Cough; body aches; Chills; Headache; low grade temperature; Loss of taste; Loss of smell; Tired; This is a spontaneous report from a contactable consumer (patient, self-reported). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via Intramuscular, on 25Mar2021 (age at vaccination: 45 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date: 30Jun2021), via Intramuscular, on 03Mar2021, as a single dose for COVID-19 immunization. The patient stated that she has to call colleagues when they get Covid and in the past several days several colleagues got Covid vaccine and tested positive. She stated that she reported two yesterday without a problem and did not have reference numbers from the website from reports yesterday. She had reported two colleagues had Covid vaccine that tested positive afterwards. The colleagues called in to report this and she follows up. She has a colleague to report today that had the Covid vaccine and tested positive.The patient tested positive on 10Jul2021. Caller assumed that patient was still testing positive because she still had symptoms and rates seriousness as medically significant. Her symptoms were congestion, lost of taste and smell, shortness of breath on exertion, cough, body aches, chills, headache, low grade temperature, and tired. Her onset was 08Jul2021, but caller didn't know when each symptom came. Caller didn't know if the chills and headache were ongoing and did not have a seriousness to provide for all other symptoms. Caller stated she has not seen the patient nor examined her and didn't feel comfortable answering seriousness. She felt shortness of breath would be medically significant. The patient underwent lab tests and procedures which included body temperature decreased: not reported on 08Jul2021 and sars-cov-2 test: positive on 10Jul2021. There was a product complaint to report. The outcome of the events chills, headache, drug ineffective was reported as unknown and for all other events, it was not recovered.  QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment action was required. The complaint, its priority,and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This was a complaint for lack of effect of lot EN6203 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation was limited to the reported finished goods lot EN6203 and EL3248 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary.  Investigation Decision: Pfizer (site name withheld) reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number was valid and an investigation will be performed. Description of complaint: Covid vaccine: Tested positive for Covid 19 virus after receiving the Covid vaccine. Contain details as- IDC - Level 1: Quality, IDC - Level 2: Product Complaint, IDC - Level 3: Complaint - Function / Therapeutic Properties, (Parent) Complaint Class: Product Use Attributes, (Parent) Complaint Sub-Class: Lack Of Effect, Package Date (GMT): This was the start date when the finished product was packaged into the commercial presentation 26-Jan-2021.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 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 EL3248 and EN6203 fill lot EL3231 and EN5336, and the formulated drug product lot EL3224. 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.  Description of complaint: Consumer calling about the Pfizer COVID-19 vaccine, and says that she got the injection twice, and each time she has gotten it and gotten tested after, each test was showing positive. She says the thing was, does Pfizer have information about this, because seems to be herd immunity. Caller does not clarify this last statement. She asks if anyone else has been reporting this. She clarifies that she goes to a nursing home and was tested every 14 days when she goes to see her mom and all times prior to getting the vaccine doses she was negative. She says her first dose of the vaccine was on 26Dec, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up.She says as a medical worker she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and pay again for the test within 24 hours, which was negative too. She says then the time next she got the shot on January 16th she went to go do the shot on this past Saturday, and then she went to go get tested to go back to the nursing home and again it came back positive. Pfizer COVID-19 vaccine NDC/EXP: Caller says that the information on the card was handwritten, NDC/EXP were not written on the card. She says the card says Pfizer COVID-19, and the first dose was on December 26th of LOT: EL5738 given in her right arm. She says that the second dose was January 16th of LOT EL3248 and it was given in her left arm. Caller says that other than having positive tests for COVID she has had no symptoms. Product strength and count size dispensed: two doses. Additional lot numbers: EL3248. was a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided.  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 EL3248, fill lot EL3231, and the formulated drug product lot EL3224. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (site name withheld) 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 drug product was stored at controlled refrigeration throughout the manufacturing process and a log was maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications.