Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: Arm Pain after first dose of the Covid Vaccine/Arm pain after the second dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 17:30 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 72 years as dose 2, single and administration date 25Jan2021 (Lot number: EL9262, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polymyalgia rheumatica", start date: 2012 (ongoing); "Coronary artery disease", start date: 2019 (ongoing); "Cardiomyopathy", start date: 2019 (ongoing); "Heart failure", start date: 2019 (ongoing); "Vestibular Dysfunction", start date: 2008 (ongoing); "Sjogren's syndrome", start date: 2008 (ongoing); "Stent placement", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE ACETATE] taken for polymyalgia rheumatica, start date: 2013 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Jan2021, outcome "recovered" (Feb2021), described as "Arm Pain after first dose of the Covid Vaccine/Arm pain after the second dose of the Covid Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call reports having the first dose of the Pfizer covid vaccine on 25Jan2021 and the second dose on 15Feb2021. She had routine blood work done on 13Apr2021, and her antibodies were negative. She takes Medrol 3 to 4mg a day, since 2013, for polymyalgia rheumatica. she also has Sjogren's - doesn't know if because of medication or auto immune disorder had anything to do with this. Her doctor is recommending that she have a third vaccine. Caller states, "They are seeing negative results in patients with immuno suppressive drugs. Caller reads a statement from her doctor's office, "In our practice at Physicians, we have had a few patients on immuno suppressant medication test negative on antibody test after vaccination of the covid vaccine. Our physicians are now recommending revaccination of a third dose. Before doing this, they want you to test again to confirm that this is negative." Question: Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose? Response: The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Note to frontline: This FAQ should only be used if someone specifically asks about the Pfizer statement on booster doses. For all other general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Question: Are you recommending for immunocompromised people to have this Booster more readily than the rest of the population Response: Explained that the Government and Local state authorities determine who receives the vaccine Referred to HCP.  No follow-up attempts are possible. No further information is expected.