Sex: F
Vaccine: COVID19
Symptoms: Pancytopenia, Platelet count, Platelet count decreased, Product use issue, White blood cell count
Clinical narrative: she has no immune system; pancytopenic; she was bleeding from everywhere; absolute neutrophil count is zero; her platelet count was at 1; white count fluctuates between 0.6 to 1.2, but its just low.; Methotrexate and infliximab for skin condition/received monoclonal antibody drug; Methotrexate and infliximab for skin condition/received monoclonal antibody drug; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included skin disorder. Concomitant medications included methotrexate for skin condition, infliximab for skin condition, she thought the dose was 10 mg per kg but she was not quite sure, she got it once per month, IV infusion. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and experienced severe nausea and that went away on an unspecified date. She would have to try and figure out when her first dose was, she didn't remember the date but her nausea was 2 days later after the first dose and last for about 12 hours. She confirmed the nausea was recovered completely at this time. The patient was calling about the COVID vaccine. She was on REMICADE which was a monoclonal antibody drug and there was a specific question before the vaccine they asked if the patient was on a monoclonal antibody drug and she said that answer would always be yes for her. After her first COVID vaccine she had severe nausea and that went away, then when she had the second vaccine, 2 days later she was bleeding from everywhere and was pancytopenic, she had no neutrophils and she was wondering was anything being reported like this or why this could happen were there concerns of this. For event bleeding from everywhere, she did not remember what the date of the second dose was but symptoms started 2 days after the second dose. She confirmed 2 days later was when she noticed the bleeding. She said the bleeding was not happening right now (based on reporting date on 05Feb2021), she was in the hospital, she was not bleeding but she had no immune system. She said she was admitted twice so this was her second admission, the second admission was 01Feb2021 she had another admission a few days before that, she did not remember the dates of the admission but it was like an overnight stay. This was the second admission, she had been there since 01Feb2021 with this admission. She did not have her vaccine card, she could not get out of bed, the drugs they have her on made her looney and she didn't have anything she couldn't move. She said her absolute neutrophil count was zero and her platelet count was at 1. Her white count fluctuates between 0.6 to 1.2, but it's just low. She confirmed she would like to know if this had been reported with people on monoclonal antibody drugs and she just wanted to know what to do. The outcome of the event "bleeding from everywhere" was recovered on an unspecified date; of the other events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. Concurrent use of methotrexate and infliximab could be contributory. Case will be reassessed upon receipt of additional information. 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.