Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: He has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May2021) and has tested positive for COVID; He has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May2021) and has tested positive for COVID; He's had flu-like symptoms; Congested; Fever; Body aches; Drowsiness; He's been sick for the 5 days. I'm at the beginning stages of diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: EW0171),expiration date-31 Aug,2021 as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in 14 May 2021) and has tested positive for COVID"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "I'm at the beginning stages of diabetes"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's had flu-like symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's been sick for the 5 days.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of influenza like illness, illness. States it flu like symptoms encompasses the following: Congested, fever, body aches, and drowsiness.congested Upon Follow-up (15Dec2021): Updated information included: Reporter address (slider 01) and Patient address. Additional information: caller patient got the vaccine but still got sick from Covid. Caller is asking how effective it is because it didn't work for him.Patient details (DOB, height, weight, ethnic group, age at vaccination). Lab test detail (test date). Dose details (dose start/stop date/time, Lot# in slider #01 & #02). Anatomical location. Best doctor/Health Care Professional information. Vaccine Facility Information. New event Congested, fever, body aches, and drowsiness. Event onset date, treatment received, event outcome (Covid-19, Flu like symptoms).Warm transfer from (name withheld) with ,: INT- # Pfizer COVID-19 Vaccine Call was transferred from (name withheld) with CEP 159558 Binax Now COVID-19 test: At home COVID-19 test made by Abbott. Positive results on 10Dec2021.History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): COVID-19 Vaccine: First dose: Date: 23Apr2021 Manufacturer: Pfizer LOT: EW0171 NDC/EXP: unknown Dose: unknown Route: injected into left arm Time: 1600 States he took 2 tablets, 200mg each of both Tylenol and Advil. States he took Tylenol before Advil.  Date Administered: Unknown; before the vaccinations Being COVID-19 positive was a shock to him. He got the vaccine and still got sick.  Agent stated caller qualifies for the booster dose. He is skeptical. How effective is it? Thought there was no way he would get COVID-19 since he got the vaccine. Confirmed he has not yet received the COVID-19 Vaccine booster dose and has no NDC/LOT/EXP to provide.   Is there a Product Complaint: Yes  Description of Product Complaint:  Description of complaint: Received two doses of Pfizer COVID-19 Vaccine. Tested positive for COVID-19 on 10Dec2021.  COVID-19 Vaccine: First dose: Date: 23Apr2021 Manufacturer: Pfizer LOT: EW0171 NDC/EXP: unknown Dose: unknown  COVID-19 PCR Test: Went to a COVID clinic for testing. Resulted positive on 10Dec2021  Second dose of COVID-19 Vaccine was in May2021. Caller recently tested positive for COVID- 19. Has had flu-like symptoms. Is taking Tylenol and Advil and cold medicine. Is just now feeling better. Been sick for 5 days. Is at the beginning stages of diabetes. The caller confirmed the details provided by the transfer agent.  Medical information: YES: Customer and/or medical inquiry forwarded or referred. Is COVID-19 Vaccine a Pfizer product? Yes   Upon Follow-up (17Dec2021): Product quality group providing investigation results Additional information:Lack of Effect has been updated by the caller for the same product ,Product Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X Lot-# (CR): EW0171 update received with complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated.A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.  Upon Follow-up (20Dec2021): Patient's clinical information received. Additional information: Patient full name, reporter name updated. Upon Follow-up (22Dec2021):product quality group providing investigation results updated, Expiration date (Slider #01 & #02).Product Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot-# (CR): EW0171. Additional information: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature,patient ID updated,Description of Complaint: Product Complaint Exchange: [50 year old male patient states that he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May2021) and has tested positive for COVID.] Initial (PRD 15Dec2021, SRD 15Dec2021) (name withheld),Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EL9267 - Lack of Effect   Reported information:The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.     Follow-up (17Dec2021):This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported : clinical investigation  Follow-up (15Dec2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported : Dose details, product details:          Follow-up (17Dec2021): This is a follow-up spontaneous report from the same contactable consumer. Clinical information received, said that he was tested positive on 10Dec2021, the first vaccination was on 23Apr2021, the second on 14May2021, the lot number for both vaccines is: EW0171, the consumer also provided his mailing address. (Address withheld).  Follow-up (20Dec2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of reporter's (patient) name. Clinical information received, patient full details, reporter details  Follow-up (22Dec2021): This is a follow-up report from product quality group providing investigation reported. Expiration date(Slider #01 & #02) received , product description and Lot number updated, expiration date-31 Aug,2021 updated, patient ID updated,Description of Complaint: Product Complaint :  Age updated, Confirmed fully vaccinated with Pfizer COVID-19 vaccine 2nd dose was in May2021) and has tested positive for COVID.] Initial (PRD 15Dec2021, SRD 15Dec2021),Lack of effect of vaccine; Sender's Comments: ~~~