Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Magnetic resonance imaging, Overdose, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interferes with her taking a nap or rest or concentrate at times as far as reading; Bad headaches; Sweating; Diarrhea; Vomiting; Overdose; Positive for COVID; Positive for COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group, Program ID: (159558). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, 0.5 ml single (Lot number: EK5730), in right arm and on 12Jan2021 as dose 2, 0.5 ml single (Lot number: EL0142), in right arm for covid-19 immunisation. The patient's relevant medical history included: "mild hearing loss in her right ear" (unspecified if ongoing), notes: She had noticed that 2 years prior to that between 2018 and 2019. Concomitant medication(s) included: CLONAZEPAM; PROZAC; XANAX. The following information was reported: VACCINATION FAILURE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 19May2022, outcome "recovering" and all described as "Positive for COVID"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Interferes with her taking a nap or rest or concentrate at times as far as reading"; HEADACHE (non-serious), outcome "unknown", described as "Bad headaches"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; VOMITING (non-serious), outcome "unknown"; OVERDOSE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Normal; Magnetic resonance imaging: (unspecified date) Normal; SARS-CoV-2 test: (19May2022) Positive, notes: Result: Positive for COVID; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Conclusion of Previously Completed Investigation for lot EK5730: 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/preventati ve 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 for lot EL0142: " 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 EL0142. 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. (Name Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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."  Clinical information: The patient was just now recovering from COVID, she ended up getting COVID and she is not, and she would not take the booster shot because of the problems that she had. Right now she has finished the last of the Pfizer anti inflammatory packet which she then reported as she just took the last dose of the Pfizer antiviral medicine, the 5 day pack of the antiviral they give you. She felt better once she started taking the medication because at first she was having really bad headaches and she was sweating and had problems with one day she had it from both ways: the diarrhea and the vomiting at the same time. COVID a little disabling, interferes with her taking a nap or rest or concentrate at times as far as reading. Regarding concomitant products and other medical conditions she explained she has various medical conditions, but she never suffered from tinnitus and as a nurse she didn't know when she saw on some of her patients active profile that had been in the service when they said tinnitus, she thought they just have occasional ringing in their ear; and most people, she talked to a Vet and he said that's why he always has the ear listen to music water sound. Until it happened to her she did not understand. Slightly disjointed information captured as provided by reporter.  Relatedness of drug to reaction(s)/event(s); Source of assessment: Primary Source Reporter; Method of assessment; Result of Assessment: Yes.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known Limited information in the case report a casual association between reported LOE events  with the suspect product cannot be excluded