Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Platelet count, Platelet count decreased
Clinical narrative: Glaucoma; Crohn's aggravated; Platelet count decreased; Ill feeling; Illness; Confused; Blood disorder; This is a solicited report based on the information received by Pfizer [manufacturer control number: 21K-163- 3983476-00] from a  non-contactable (patient)   A 80-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE ), dose 1 intramuscular on 14Feb2021 (Batch/Lot number was not reported) SINGLE  at age of 80 years for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced glaucoma (medically significant) on an unspecified date with outcome of not recovered, Crohn's aggravated (medically significant) on an unspecified date with outcome of not recovered, confused (non-serious) on an unspecified date with outcome of unknown, blood (non-serious) on an unspecified date with outcome of not recovered, ill feeling (non-serious) on an unspecified date with outcome of not recovered, platelet count decreased (non-serious) on an unspecified date with outcome of unknown, illness (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included platelet count: decreased on unknown date. The clinical course was reported as follows: On 14Feb2021, patient received first dose Of COVID-19 Vaccine manufactured by Pfizer. The patient experienced  non-serious reactions to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced reaction to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up. Pfizer biontech covid-19 vaccine was also considered suspect. Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The action taken in response to the event(s) for adalimumab was dose not changed . Reporter's causality for Humira for Crohns aggravated was "Reasonable possibility" while for the other events was "No Reasonable possibility" Reporter's causality  for PFIZER BIONTECH COVID-19 VACCINE was not reported for all events .  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The events glaucoma, Crohn's aggravated, blood disorder, and platelet count decreased more likely represent intercurrent medical conditions in this 80 yo patient and are considered unrelated to the suspect drug. Patient was using adalimumab for Crohn's disease. Adalimumab may have contributed to decrease in platelet count and blood disorder given is known safety profile. Events malaise and illness are possibly related to the suspect drug based on known drug profile. The remaining event confusion is attributed to intercurrent or underlying conditionsin this 80 yo patient, and are considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information.