Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Somnolence, VIIIth nerve injury, Vision blurred
Clinical narrative: covid test result: Positive / covid test date: 27Dec2021; covid test result: Positive / covid test date: 27Dec2021; This is a spontaneous report received from contactable reporter(s) nurse (Other HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 18:30 (Lot number: FF2589) at the age of 45 years as dose 2, single and administered in arm left, administration date 14Sep2021 14:00 (Lot number: EW0167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "History of migraines" (unspecified if ongoing), notes: Other medical history: History of migraines; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: BUPROPION. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilauid". Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks: Bupropion 75mg daily. Patient had covid prior vaccination was unknown. The following information was reported: VACCINATION FAILURE (hospitalization, disability, medically significant), COVID-19 (hospitalization, disability, medically significant) all with onset 08Oct2021 09:00, outcome "recovering" and all described as "covid test result: Positive / covid test date: 27Dec2021". The patient was hospitalized for vaccination failure, covid-19 (hospitalization duration: 4 day(s)). The event "covid test result: positive / covid test date: 27dec2021" and "covid test result: positive / covid test date: 27dec2021" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (27Dec2021) positive, notes: Home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. AE treatment: MRI, CT scan, medications. Number of days hospitalization: 4. Conclusion of Previously Completed Investigation: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. A complaint sample was not returned. 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0167 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 EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No 6229691 6228750 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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events