Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Immune system disorder
Clinical narrative: Immune supressed patient; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team and a Pfizer-sponsored program. A 57-years-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8731 and Expiration date were not reported), via intramuscular in left arm on 16Apr2021 at 12:45 (vaccinated at the age of 57 years) dose 2, single for COVID-19 immunization. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8730), via Intramuscular in left arm on an 26Mar2021 at 12:15, dose 1 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included methotrexate taken for an unspecified indication, from an unknown date and ongoing. The patient previously took methotrexate, which was also ongoing. She also stated that her doctor had told her to stop taking her methotrexate 2 weeks after receiving the first dose of the vaccine as well as 2 weeks after the second dose of the vaccine, but did not stop prior to receiving either doses. It was asked if Pfizer had provided a statement on the need for a booster dose (3rd dose), and if Pfizer was investigating the need for a booster dose. The patient was wondering if she should get a third dose or booster dose. The response was that the need for a booster dose of Pfizer-Biontech COVID-19 vaccine based on duration of protection or impact of variant strains had not yet been determined. The administration of more than a 2-dose series of Pfizer Biontech COVID-19 Vaccine was not approved. Pfizer was unable to make any recommendations regarding administration of a booster dose of Pfizer-Biontech COVID-19 vaccine. The patient underwent lab tests and procedures which included antibody test negative on an unspecified date. Upon follow up on 08Jun2021, the patient stated that she already completed the COVID vaccination series and found out that there was no anti-bodies and wanted to know if she needed to go off the immune suppressants or could she start over with the vaccination series, since she was not showing any anti-bodies or both. Upon follow up on 07Jul2021, the vaccine facility type was reported as other and vaccine was not administered at military facility. No prior vaccination. The patient's medical history includes Ongoing rheumatoid arthritis from an unspecified date in 2016. Concomitant medication included methotrexate from an unspecified date in 2016 and ongoing, taken via oral for Rheumatoid arthritis; etanercept (ENBRIL) from an unspecified date in Feb2017 and ongoing, taken as injection for Rheumatoid arthritis. Took Prolia shot was over 2 weeks prior. The patient took Methotrexate, She states that her doctor told her to stop taking her Methotrexate 2 weeks after receiving the first dose of the vaccine as well as 2 weeks after the second dose of the vaccine, but did not stop prior to receiving either dose. After second dose, immune suppressed patient underwent antibody test which revealed no antibodies. The patient underwent lab tests and procedures which included antibody test: no antibodies on 02Jun2021. Outcome of the event was unknown.   Information on the batch/lot number has been requested.  Follow-up (08Jun2021): New information received from the same contactable consumer (patient herself) via the Pfizer-sponsored program includes: suspect drug (updated dose description) and clinical course details.  Information on the batch/lot number has been requested.  Follow-up (07Jul2021): New information from a contactable consumer. This 57-year-old female consumer reported in response to Non-HCP follow up letter sent which included that: Added patient age, vaccination details for both doses (date, time, route, anatomical location and batch number), medical history, concomitant medication, event (Immune supressed patient), clinical information details added.