Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea, Inappropriate schedule of product administration, Internal haemorrhage
Clinical narrative: Internal bleeding; Had trouble breathing; Chronic obstructive pulmonary disease; On 15Jun2021,patient received 1st dose COVID-19 Vaccine; On 25Jun2021, patient received 2nd dose COVID-19 Vaccine; This is a solicited report from a contactable consumer  (patient) based on the information received by Pfizer from agency. (manufacturer control number: 21K-163-4072803-00).   A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 25Jun2021 (Batch/Lot number was not reported) (at the age of 70-years-old) as DOSE 2, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at an unknown dose citrate free  for  moderate to severe chronic plaque psoriasis.  The patient's medical history and concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 15Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 70-years-old) for COVID-19 immunization and experienced internal bleeding, chronic obstructive pulmonary disease and trouble breathing. On unknown dates, the patient (an elderly female) experienced internal bleeding (medically significant) and non-serious chronic obstructive pulmonary disease. The patient had internal bleeding. She had trouble breathing and was diagnosed with chronic obstructive pulmonary disease. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the events internal bleeding and chronic obstructive pulmonary disease was not recovered while for the event had trouble breathing was unknown.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of internal bleeding and chronic obstructive pulmonary disease was not provided. Agency's opinion is that the events of internal bleeding and chronic obstructive pulmonary disease are not assessable.  Causality for BNT162B2 for Internal bleeding and Chronic obstructive pulmonary disease: Causality as per reporter: Possible.   The reporter's assessment of the causal relationship of the event had trouble breathing with the suspect product BNT162B2 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.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. It was noted that patient previously received the first dose of BNT162B2 vaccine and experienced internal bleeding, chronic obstructive pulmonary disease and trouble breathing. 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.