Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Tinnitus
Clinical narrative: got covid right now 18Nov2021 tested positive; I started to have ringing in my ears right after my 2nd dose.; got covid right now 18Nov2021 tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: Ek5730) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sudden hearing loss" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "not recovered", COVID-19 (medically significant) with onset 18Nov2021, outcome "not recovered" and all described as "got covid right now 18Nov2021 tested positive"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "I started to have ringing in my ears right after my 2nd dose.". The events "got covid right now 18nov2021 tested positive", "got covid right now 18nov2021 tested positive" and "i started to have ringing in my ears right after my 2nd dose." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19, tinnitus and included treatment with Steroid injection.  Clinical course: I started to have ringing in my ears right after my 2nd dose. The tinnitus has not improved. I got covid right now 18Nov2021 tested positive. The tinnitus has worsened. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Product Quality Group provided investigational results on [22Nov2021] for [bnt162b2]: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EK5730 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 EK5730, fill lot EK3313, and the formulated drug product lot EK3312. 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 complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL1283 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 EL1283, fill lot EL1281, and the formulated drug product lot EL1279. 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.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.