Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dysphonia, Fall, Hip fracture, Infection
Clinical narrative: bad infection; Broke Hip; Fall; Leg and foot swell up/right leg a bit swollen; Blisters popped up on left leg; Covid/words that was trying to say was not coming out; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not Available). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4134369.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route(s) of Administration: Intramuscular), administration date: 29Mar2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Route(s) of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: DYSPHONIA (non-serious) with onset Jul2022, outcome "recovering", described as "Covid/words that was trying to say was not coming out"; BLISTER (non-serious) with onset Oct2022, outcome "unknown", described as "Blisters popped up on left leg"; HIP FRACTURE (hospitalization, medically significant) with onset Oct2022, outcome "not recovered", described as "Broke Hip"; FALL (hospitalization) with onset Oct2022, outcome "not recovered"; PERIPHERAL SWELLING (non-serious) with onset Oct2022, outcome "unknown", described as "Leg and foot swell up/right leg a bit swollen"; INFECTION (hospitalization, medically significant), outcome "not recovered", described as "bad infection". The patient was hospitalized for fall, infection, hip fracture (start date: 11Oct2022, discharge date: 15Oct2022, hospitalization duration: 5 day(s)). The action taken for adalimumab was unknown.  Clinical Course: In Jul2022, the patient had covid. She was still recovering and getting her strength back. She was throwing up at the time as well as diarrhea and headache for eight days straight. Her words that she was trying to say was not coming out. She fell and broke her hip in Oct2022. From 11Oct2022 to 15Oct2022, she was in hospital and underwent surgery. Her leg and foot swell up and right leg a bit swollen as well. Blisters popped up on her left leg. She also had bad infection. She did not agree to have the MD contacted. Causalities: The reporter's causality for the event(s) of broke hip and Fell with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of bad infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Covid/words that was trying to say was not coming out, bad infection with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of Covid/words that was trying to say was not coming out with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of broke hip, Blisters popped up on left leg, Covid/words that was trying to say was not coming out, Fell and Leg and foot swell up/right leg a bit swollen with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility. The reporter's causality for the event(s) of Blisters popped up on left leg and Leg and foot swell up/right leg a bit swollen with Adalimumab Solution for Injection was Not Provided. Agency's opinion was that the causality for the event(s) of broke hip, Blisters popped up on left leg, Covid/words that was trying to say was not coming out, Fell, Leg and foot swell up/right leg a bit swollen, bad infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of broke hip, Covid/words that was trying to say was not coming out, Fell, Leg and foot swell up/right leg a bit swollen with Adalimumab Solution for Injection was No Reasonable Possibility. Agency's opinion was that the causality for the event(s) of Blisters popped up on left leg and bad infection with Adalimumab Solution for Injection was Not Assessable. Agency's Alternative Etiology for Fell with Adalimumab Solution for Injection: More likely an accidental event in this elderly age patient with underlying crohn's disease. Agency's Alternative Etiology for broke hip with Adalimumab Solution for Injection: More likely related to injury sustained from concurrent fall. Pfizer BioNTech COVID-19 vaccine: Broken hip, Authority. Pfizer BioNTech COVID-19 vaccine: Broken hip, Non-Health Care Professional, Global Introspection, Not Related, Fall, Non-Health Care Professional, Global Introspection, Not Related. Pfizer BioNTech COVID-19 vaccine: Infection, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine: Voice disturbance, Non-Health Care Professional, Global Introspection, Not Related. Pfizer BioNTech COVID-19 vaccine: COVID-19, Non-Health Care Professional, Global Introspection, Probable. Pfizer BioNTech COVID-19 vaccine: Swelling of legs, Non-Health Care Professional, Global Introspection, Not Related. Pfizer BioNTech COVID-19 vaccine: Blisters, Non-Health Care Professional, Global Introspection, Not Related. Agency's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: Event is more likely related to SARS CoV 2 global pandemic outbreak in this elderly age patient with underlying crohn's disease. Agency's Alternative Etiology for Leg and foot swell up/right leg a bit swollen with Adalimumab Solution for Injection: More likely related to concurrent fall, musculoskeletal manifestation of underlying crohn's disease in this elderly age female patient. Agency's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: More likely related to concurrent covid infection in this elderly age patient.  The reporter considered "fall", "broke hip", "blisters popped up on left leg", "covid/words that was trying to say was not coming out" and "leg and foot swell up/right leg a bit swollen" not related to BNT162b2. The reporter's assessment of the causal relationship of "bad infection" with the suspect product(s) 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 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.,Linked Report(s) : US-ABBVIE-4134369 ABBVIE;US-PFIZER INC-202300145696 Same reporter/patient, different product/event;