Sex: F
Vaccine: COVID19, UNK
Symptoms: Autoimmune disorder, Product use issue
Clinical narrative: autoimmune disease; patient received cortisone injections the same day that she received her second dose of the Pfizer BioNTech COVID-19 vaccine.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date: not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for covid-19 immunization; hydrocortisone (CORTISONE [HYDROCORTISONE]), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. Concomitant medications included prednisone 10 mg taken daily from an unknown date for an unspecified indication. Previously the patient received first dose of bnt162b2 (Lot number not reported), via an unspecified route of administration on an unknown date for covid-19 immunization. In Mar2021, the patient received cortisone injections on the same day she received her second dose of the Pfizer BioNTech COVID-19 vaccine. She has a lot of autoimmune and was getting cortisone injections. Her rheumatologist was not aware at that time. She drained her knee and did a Cortisone injection and she just carried on. She did not know it would affect this. She told her to just get the shot in. Her Primary Care Provider would like her to get third dose now as she had no antibodies and had no injections or infusions. As she also had an autoimmune disease and discussed her situation with her HCP, but nobody is ready to give her the third dose. So a response was provided for her regarding the third dose that 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 25Feb2021, 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. The clinical outcome of the events was unknown.  Information related to batch/Lot no. was requested.