Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pulmonary fibrosis, Rash
Clinical narrative: Pulmonary fibrosis; rash under the skin that spread out; SCHAMBERG'S DISEASE/STILL HAD SOME TINY SPOTS THAT LOOKS LIKE PAPRIKA; losing hair; injured the inside left forearm and back of head; injured the inside left forearm and back of head; fell from bed; This is a non-interventional study, solicited report based on the information received by Pfizer (Mfr. Report Number: 21K-163-3844962-00).   This a solicited report a contactable consumer (patient) of a 74-year-old female with events of pulmonary fibrosis and non-serious fell from bed injured the inside left forearm and back of head, schamberg's disease/still had some tiny spots that looks like paprika, rash under skin that spread out and started losing hair with adalimumab (HUMIRA). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date (at the age of 74 years) as single dose for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date at unspecified dose for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced pulmonary fibrosis, schamberg's disease/still had some tiny spots that looks like paprika, rash under skin that spread out and started losing hair. In March 2021, the patient experienced fell from bed injured the inside left forearm and back of head. COVID-19 VACCINE was also considered suspect. The patient started taking adalimumab years ago somewhere about the times of the clinical trials. She was taken off after trials ended and then diagnosed with pulmonary fibrosis. She eventually went back on adalimumab and fibrosis gotten better. The patient took COVID-19 vaccine and started noticing a rash under the skin that spread out. Her doctor had prescribed prednisone which she had weaned off of for now in 2021. She had started losing her hair as well. She had been on adalimumab for a long time and did not feel it was adalimumab related. Doctor seemed to think it was Schimberg's disease, she was still recovering from disease. Her doctor prescribed her Z-Pak, most of the part cleared up. She still had some tiny spots that look like paprika. She fell from bed about two weeks ago in Mar2021 injuring the Inside left forearm and back of her head. She went to emergency room because she was on blood thinner. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer. The patient was treated with prednisone and Z-PAK. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. On an unknown date, pulmonary fibrosis resolved with sequelae. Outcome of schamberg's disease/still had some tiny spots that looks like paprika, rash under the skin that spread out and losing hair was not recovered, of injured the inside left forearm and back of head was unknown, of fell from bed was recovering.   The reporter's assessment of the causal relationship of the events with the 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.  Causality for adalimumab: The reporter's causality for the event of pulmonary fibrosis with adalimumab was a reasonable possibility. The reporter's causality for the events of fell from bed injured the inside left forearm and back of head onset in Mar2021 and fell from bed injured the inside left forearm and back of head onset in Mar2021 was not provided. The reporter's causality for the events of schamberg's disease/still had some tiny spots that looks like paprika, fell from bed injured the inside left forearm and back of head onset in Mar2021, rash under skin that spread out and started losing hair with adalimumab was no reasonable possibility. One's opinion is that there is no reasonable possibility that the events of pulmonary fibrosis, fell from bed injured the inside left forearm and back of head onset in Mar2021, schamberg's disease/still had some tiny spots that looks like paprika, fell from bed injured the inside left forearm and back of head onset in Mar2021, fell from bed injured the inside left forearm and back of head onset in Mar2021, rash under skin that spread out and started losing hair are related to adalimumab.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Pulmonary Fibrosis, head injury and limb injury cannot be excluded. 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