Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested on Sunday and it came back positive; Tested on Sunday and it came back positive; feeling terrible/feeling bad; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, Expiration date: 30Jun2021), via an unspecified route of administration on administered in right arm 05Mar2021 (at the age of 61-years-old) as a dose 1, single; and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613, Expiration date: 31Jul2021), via an unspecified route of administration administered in right arm on 26Mar2021 (at the age of 61-year-old) as a dose 2, single; both for COVID-19 immunisation (Indication presented as reported: it was mainly so she wouldn't get it at the time. She's got grandkids, she would've been the first one to say she wouldn't have got it). Adverse events (AE) following prior vaccinations were reported as none. The family medical history relevant to AE(s) was reported as none. The patient's medical history (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. It was reported that, she got the COVID vaccine, Pfizer, back in Mar2021 and they got tested on 08Aug2021 (Sunday) and it came back positive. Stated that, the first vaccine that she had the first part was fine the second one was horrible, and she usually gets a text or email where they send her a note. It was a weekly update on how she was feeling. She had gotten one a month ago and everything was fine and then this hit. She got tested on 08Aug2021 (yesterday) and had been feeling bad/feeling terrible since 05Aug2021 (last Thursday). It started on 05Aug2021 (Thursday), in the morning, she just felt a cold coming on and thought it was a summer cold. She didn't get out. Between congestion it was worse. Stated that, she called to see whether she could get that infusion because she understands there was an infusion to shorten it. The antibody infusion was for people with underlying health conditions such as diabetes and she didn't have that. She has had a chest cough on 05Aug2021, body aches and headaches on an unspecified date in Aug2021. Stated that, she called in to her family doctor and when she said she wasn't eligible for the infusion her other daughter in law said to ask for a ZPACK or antibiotics. They are supposed to get back to her. Stated that, was there going to be a booster or once she gets covid was she still eligible to get it. The events did not result in emergency room and physician office. The reporter seriousness for the events was unspecified. On 08Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 by PCR, resulted as positive (at 10:00 AM), Swab (result came back last night at 4:25). On 10Aug2021, the reporter stated that, his wife had the COVID shots, and she tested positive for COVID 19. The outcome of the events for feeling terrible/feeling bad was not recovered while for the Covid-19 was unknown.  Conclusion (for the lot EN6206): The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion (for the lot ER2613): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER2613 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 ER2613, fill lot EP8678 and the formulated drug product lot EP8565. 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.