Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Incorrect dose administered, Off label use
Clinical narrative: Patient received 5 doses of COVID 19 Vaccine and is immunocompromised.; This person has had 5 doses of the Pfizer COVID vaccine; This person has had 5 doses of the Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "severe dyspnea on exertion" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. Vaccination history included: Covid-19 vaccine (Dose 4, Manufacturer unknown), administration date: Jun2021, for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), administration date: May2021, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), administration date: Feb2021, for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), administration date: Jan2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset Sep2021, outcome "unknown" and all described as "This person has had 5 doses of the Pfizer COVID vaccine"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Patient received 5 doses of COVID 19 Vaccine and is immunocompromised." Additional information: I am a nurse practitioner inquiring about advice on a patient. This person has had 5 doses of the Pfizer COVID vaccine but the last dose was more than 6 months ago. She has multiple risk factors: age 69; obesity; an autoimmune disease; on prednisone for several years; severe dyspnea on exertion; and hypertension. The guidelines say she cannot get another dose of vaccine despite the last dose being 6+ months ago. I am not confident she was protected. Outbound call on 03:08PM ET, 22Apr2022: Reached Nurse. Response provided. Nurse added that the patient received 5 doses in total (Jan, Feb, May, Jun and Sep2021). A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine to individuals 12 years of age and older with certain kinds of immunocompromise. People who are moderately or severely immunocompromised might consider getting the second booster dose as soon as possible (i.e., 4 months after their first booster dose). Was about to continue and explain further that " Providers caring for moderately or severely immunocompromised patients may take into consideration the patient degree of immunosuppression, as well as timing issues (e.g., initiation or resumption of immunosuppressive therapies).13 Please refer to RECOMMENDATIONS section at the end of this document for further information. Please note that Pfizer is independent of these recommendations." however was interrupted. People can self-attest to their moderately or severely immunocompromised status and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19. On a case-by-case basis, providers caring for moderately or severely immunocompromised patients may administer mRNA COVID-19 vaccines outside of the FDA and CDC dosing intervals based on clinical judgment when the benefits of vaccination are deemed to outweigh the potential and unknown risks for the recipient. However, providers should not routinely administer additional doses of COVID-19 vaccine beyond those recommended in this guidance. Providers should consult treatment guidelines for use of monoclonal antibodies as pre-exposure prophylaxis for people who are moderately or severely immunocompromised and who may not mount an immune response to COVID-19 vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (22Apr2022): This is a spontaneous follow-up report received from a same contactable Nurse.   Updated information included: New Event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.