Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got covid positive test home; got covid positive test home; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 (Lot number: EP7534) at the age of 64 years as dose 2, single and intramuscular, administered in arm left, administration date 10Mar2021 13:22 (Lot number: EN6204) as dose 1, single for covid-19 immunization. Relevant medical history included: "Hypertension" (ongoing), notes: Approx. Age 19; "COPD" (ongoing); "Hypercholesterolemia", start date: 1998 (ongoing); "Hypothyroidism", start date: 1994 (ongoing); "Generalized anxiety" (ongoing); "Peripheral Vascular disease", start date: 1999, stop date: 2000; "Diverticulosis", start date: 2016 (ongoing); "GERD", start date: 2005 (ongoing); "Allergic Rhinitis", start date: 2013 (ongoing), notes: Rhinoplasty, Turbinate, Reduction; "Cervical stenosis", start date: 2000 (unspecified if ongoing); "Lumbar spinal stenosis" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "ACDF", start date: 2000 (unspecified if ongoing); "Laminectomy", start date: 2001 (unspecified if ongoing); "Fibromyalgia", start date: 1990 (unspecified if ongoing); "CFS", start date: 1990 (unspecified if ongoing); "Severe osteoarthritis" (unspecified if ongoing); "Osteoporosis Severe" (unspecified if ongoing); "Mac Deg" (unspecified if ongoing); "Rhinoplasty" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). The patient took concomitant medications. Concomitant Drugs: Drug Name: All regularly prescribed drugs were taken before; hypothyroid, allergies, HTN, COPD, Asthma. Prior vaccinations were reported as none. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "got covid positive test home". The patient underwent the following laboratory tests and procedures: electromyogram: (Jul2021) unknown results, notes: Position for branchial plexopathy left arm neuritis; magnetic resonance imaging: (11Sep2021) unknown results, notes: MRI Brachial plexus; magnetic resonance imaging neck: (28Jul2021) unknown results; magnetic resonance imaging thoracic: (26Sep2021) unknown results; nerve conduction studies: (Jul2021) unknown results, notes: Position for branchial plexopathy left arm neuritis; sars-cov-2 test: (01Jan2022) positive, notes: still got covid positive test home (ON/CO) Kit, 3 weeks ago anyway. It was reported that, the pain persisted, unwavering for weeks than months. Several visits, therapy visits, a lot of facing, oral steroids x 2 rounds, antibiotics, Topiramate, Tylenol arthritis, Lyrica, steroid and IM injections shoulder, arm, neck, subscapularis. Needed assistance to dress, painful to drive, do my chores, hygiene, fix my hair, lift my arm to do anything. It's been expensive with copays for testes, visits, therapy. Stated that, no help at her home as her husband was elderly and was battling with cancer at the same time. Also still got covid positive test home (ON/CO) Kit, 3 weeks ago anyway. The report received from the product quality group provided with the investigation results. This report included that: this was a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes / Lack of Effect and have been moved to closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252. Conclusion for the Lot (CR): EN6204 of previously completed investigation of PR ID (CR): Private: The complaint for lack of effect of the Pfizer BIONTECH COVID-19 VACCINE lot EN6204 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 EN6204, fill lot EN5335 and the formulated drug product lot EN5325. 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. PR ID of previously completed Inv: Private. PR ID of previously completed Inv: Private. Conclusion for the Lot (CR): EN6204 of previously completed investigation of PR ID (CR): Private: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532 and the formulated drug product lot EP7528. A complaint sample was not returned and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. PR ID of previously completed Inv: Private. PR ID of previously completed Inv: Private.  Follow-up attempts are completed. No further information is expected.