Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dehydration, Ingrowing nail, Loss of consciousness, Pain, Swelling
Clinical narrative: Humira was not working as patient would have liked; Blacking out from the amount of pain/threw up through out the week from pain; Blacking out from the amount of pain/threw up through out the week from pain; Blacking out from the amount of pain/threw up through out the week from pain; Unevaluable event; Ingrown toe nail; Swelling and dehydrated after COVID vaccine; Swelling and dehydrated after COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4530322-00 (Abbvie).  A 41-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 20023507) at unk, (cf), subcutaneous for ankylosing spondylitis. The patient's relevant medical history included: "Blacking out from the amount of pain/threw up through out the week from pain scatter brained" (unspecified if ongoing), notes: Blacking out from the amount of pain/threw up through out the week from pain scatter brained; "Blacking out from the amount of pain/threw up through out the week from pain scatter brained" (unspecified if ongoing), notes: Blacking out from the amount of pain/threw up through out the week from pain scatter brained; "Blacking out from the amount of pain/threw up through out the week from pain scatter brained" (unspecified if ongoing), notes: Blacking out from the amount of pain/threw up through out the week from pain scatter brained; "Scatter brained" (unspecified if ongoing), notes: Scatter brained. The patient's concomitant medications were not reported. The following information was reported: SWELLING (medically significant), DEHYDRATION (medically significant) all with onset Feb2022, outcome "recovered" (2022) and all described as "Swelling and dehydrated after COVID vaccine"; INGROWING NAIL (medically significant) with onset Aug2022, outcome "recovering", described as "Ingrown toe nail"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (medically significant), outcome "not recovered", described as "Humira was not working as patient would have liked"; LOSS OF CONSCIOUSNESS (medically significant), PAIN (medically significant), VOMITING (medically significant), outcome "not recovered" and all described as "Blacking out from the amount of pain/threw up through out the week from pain"; UNEVALUABLE EVENT (medically significant), outcome "not recovered". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ingrown toe nail", "humira was not working as patient would have liked", "blacking out from the amount of pain/threw up through out the week from pain" and "unevaluable event" 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. The reporter considered "swelling and dehydrated after covid vaccine" related to BNT162b2.  Additional information: The patient felt that Humira was not working the way she would have liked. She was blacking out from the amount of pain she was in. She threw up through out the week from pain. She became scatter brained. She felt that these problems happened even before Humira and they were continuing. In Feb2022, she became very swelled up after her third COVID vaccine as well and it caused her to become dehydrated. In Aug2022, she had an ingrown toe nail removed and she was recovering.  It was unknown if she was enrolled in a COVID-19 vaccine trial.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of ingrown toe nail, blacking out from the amount of pain/threw up through out the week from pain unknown onset, blacking out from the amount of pain/threw up through out the week from pain unknown onset, blacking out from the amount of pain/threw up through out the week from pain unknown onset, swelling and dehydrated after COVID vaccine onset in Feb2022, swelling and dehydrated after COVID vaccine onset in Feb2022 and scatter brained was not provided. The reporter's causality for the event(s) of felt that Humira was not working as patient would have liked with Humira (Adalimumab) was a reasonable possibility.  Abbvie's opinion is that the event of ingrown toe nail is not assessable. Abbvie's opinion is that there is no reasonable possibility that the events of felt that Humira was not working as patient would have liked, blacking out from the amount of pain/threw up through out the week from pain unknown onset, blacking out from the amount of pain/threw up through out the week from pain unknown onset, blacking out from the amount of pain/threw up through out the week from pain unknown onset, swelling and dehydrated after COVID vaccine onset in Feb2022, swelling and dehydrated after COVID vaccine onset in Feb2022 and scatter brained are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.