Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nerve conduction studies, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 04Jan2021 at 10:00 as dose 1, single (Lot number: EL0142), in right arm, on 26Jan2021 at 14:00 as dose 2, single (Lot number: El8a82), in right arm and on 20Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 66 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occlusion", start date: 01Aug2018 (ongoing), notes: Illness/AE: Retinal vein occlusion, eye inje 4 to 6 weeks; "High blood pressure" (ongoing), notes: metoprolol succinate 100 mg 1x a day. The patient's family history included: "Thyroid" (ongoing), notes: Onset date: 10 years ago, Levothyroxine sodium 25 mcg; "stroke" (unspecified if ongoing); "Alzheimers" (unspecified if ongoing); "RA" (unspecified if ongoing); "eye disease" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension; LEVOTHYROXINE SODIUM taken for thyroid disorder. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "not recovered" and all described as "got covid". The patient underwent the following laboratory tests and procedures: Nerve conduction studies: (01Oct2022) highly arthritic, notes: I have had a nerve conduction test for carpal tunnel syndrome yet highly arthritic No CT, Arthritis; SARS-CoV-2 test: (26Dec2021) Positive, notes: Still got covid.  Conclusion of the Investigational results reported for the lot GH9703, EL0142,EP8736. This is 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. Refer to the below table for details. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID (see File attachment in this investigation record). The complaint for a positive COVID test after vaccination of "Pfizer Biontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9703, EL0142, lot EW0186, fill lot EP8736, and bulk formulation lot EP8617. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical course: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccine Administered at private Facility was no. Prior Vaccinations (within 4 weeks) was none. Vaccination Facility Type was Hospital for 3rd dose/booster and 01 dose. On all four injection sites patient had knots underneath skin. Patient had a nerve conduction test for carpal tunnel syndrome yet highly arthritic. Patient got covid on birthday and it felt more like flu. Patient doc tested and patient was positive. (hubby was too) patient was willing to be followed for research since patient was concerned of having lasting effect. Patient have had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 and 26Jan2021. Then two Pfizer boosters on 20Aug2021 and 01Oct2022. Patient right upper arm where two of the injections were given stay sore along with pain on occasion traveling down patient arm into right thumb. This has been ongoing for quite awhile and patient thought it was her side sleeping but bought a spinal alignment pillow and it still persists. The pain was not severe but is there. Patient was 66 years old (ethnicity) female and am concerned.