Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Fatigue, Pyrexia
Clinical narrative: Had a fever of 100.6; Felt tired; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an intramuscular route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included leukaemia, anaemia (ongoing), CLL (ongoing) from an unspecified date. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9261), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced had a fever of 100.6, felt tired. It was further reported that patient stated that for a half day after the second dose of the pfizer covid 19 vaccine, he had a fever of 100.6 and felt tired. Caller was number 37 in the queue and did not want to hold. He has CLL and anemia which screws up his immune system. He had an antibody test one month after his second dose and the test came back negative. He wanted to know if he was still vulnerable. He wanted to know if there were antibody test expectations after the second dose and third dose in the clinical trial. He wanted to know if he should repeat the antibody test. He wanted to know what precautions he should take. Caller wanted to know what Pfizer recommends. He wanted to know if he should repeat the second dose. He has several underlying health conditions such as leukemia and anemia and more, which he has had long time prior to getting the two Covax doses from Pfizer. Has questions though as he took an antibody test and showed no antibodies towards fighting off the Covid even after getting his two doses. His HCP is encouraging him to get a third dose. DESCRIPTION OF COMPLAINT: He stated that he has CLL and Anemia that is a problem for his immune system. He was done with the two doses of the Pfizer Covid 19 vaccine and tested negative in his antibody test. Saying his doctor is recommending a third shot for him. He was asking if we do recommend him to get a third shot of the vaccine. Date of Contact (GMT): 19Mar2021), Intake Receipt Date (GMT): 19Mar2021, Intake Due Date (GMT): 22Mar2021, Complaint Number: PQC-2021-03-0030520-US, Source System Reference Number: 00166425, Reference Number Value: 00166425, Regulatory Authority Involved: No, Product / Lot Grid 1: Complaint Record PR ID: 5775694, Product description found: Yes, Product Family API: BNT162B2, Class/Sub Class: Product use attributes lack of effect. Complainant does not have the product with them at the time of call. Special Handling: No, Medical Device: No, Combination Product: No. Original Due Date (GMT): 22Mar2021, Reporter Ref. Record: 5770472, Co-Reporter Ref. Record: Initial Response Reqd?: No. Final Response Requested/Reqd: No, Additional Information: 22Mar2021 10:37 AM (GMT4:00) (PID-215865): Notified safety via Citi. Complaint record is updated for AE reference field from "No" to "Yes"- Added safety number as 00166425. No correspondence as reporter information not provided. 22Mar2021 10:10 AM (GMT-4:00) added by (PRIVACY) (PID-215865): No correspondence as reporter information not provided. Related to Potential AE: Yes. The Pfizer receipt date (PRD) is the calendar day that the first Pfizer colleague or contingent worker first receives the AE information. Caller got a call from someone at Pfizer looking for lot numbers and he told them that he did not have them. He stated that he does now, and that he was calling back to provide them. Were any medical questions addressed by this program forwarded/referred to Medical Information: No. The patient underwent lab tests and procedures which included antibody test: negative, body temperature: 100.6 fever both done on an unspecified date. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.