Sex: M
Vaccine: COVID19
Symptoms: Abdominal hernia, Computerised tomogram, Gait disturbance, Impaired work ability, Limb injury
Clinical narrative: Foot surgery; Pelvic pain; Abdominal hernia; Difficulty in walking; Pain aggravated; The patient has been off work for 4 weeks; Left foot pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4127963-00.  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from Aug2021 (Lot number: 1143163) to Aug2021 at 40 mg (40 mg (1 in 2 wk)) and second regimen subcutaneous from Sep2021 (Lot number: 1143163) to Nov2021 at 40 mg (40 mg (1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "TOBACCO USER (CIGARETTES)", start date: 1967 (unspecified if ongoing); "Difficulty in walking", start date: Jul2021 (unspecified if ongoing); "Pain in left foot", start date: Jul2021 (unspecified if ongoing), notes: Pain in left foot; "Right side pelvic pain", start date: Nov2019 (unspecified if ongoing); "Foot surgery" (unspecified if ongoing), notes: the patient had outpatient left foot surgery on the 4th and 5th toe,. The patient took concomitant medications. The following information was reported: ABDOMINAL HERNIA (medically significant) with onset Nov2021, outcome "recovered" (16Nov2021), described as "Abdominal hernia"; GAIT DISTURBANCE (medically significant) with onset 2021, outcome "recovered" (Aug2021), described as "Difficulty in walking"; LIMB INJURY (medically significant), outcome "unknown", described as "Foot surgery"; PAIN (medically significant) with onset 2021, outcome "recovered" (Aug2021), described as "Pain aggravated"; PELVIC PAIN (medically significant), outcome "unknown", described as "Pelvic pain"; IMPAIRED WORK ABILITY (medically significant) with onset 2021, outcome "unknown", described as "The patient has been off work for 4 weeks"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Left foot pain". The event "foot surgery" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (Jul2021) unknown results, notes: The patient stated he had a Computed Tomography test performed in Jul2021,due to the reported AE's of left foot pain and difficulty in walking; ultrasound scan: (Nov2021) unknown, notes: Hernia right abdomen. The action taken for adalimumab was dosage permanently withdrawn on Nov2021. Therapeutic measures were taken as a result of abdominal hernia, limb injury. Therapeutic measures were not taken as a result of gait disturbance, pain, pelvic pain, impaired work ability, pain in extremity.  The reporter considered "abdominal hernia", "difficulty in walking", "foot surgery", "pain aggravated", "pelvic pain", "the patient has been off work for 4 weeks" and "left foot pain" not related to bnt162b2.  Additional information: The patient had pain in left foot and difficulty in walking started prior to the patient's Humira use in Jul2021 but continued to worsen causing the documented surgery. In Aug2021 or early Sep2021, the patient had outpatient left foot surgery on the 4th and 5th toe, The patient reported the physician shaved down the fourth and fifth toe and inserted a small screw in the 4th toe. The patient was discharge home with a surgical shoe and advised exercises. The patient had been off work for 4 weeks. The patient reported had difficulty in walking and left foot pain resolved in late Aug2021 or early Sep2021. On 16Nov2021, the patient had outpatient Laparoscopic Robotic Hernia Surgery. The patient reported the his Humira injections were stopped by the physician due to his documented surgeries. The patient reported that his reported Adverse events were not related to his COVID-19 Vaccinations.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of Hernia Right Abdomen, Difficulty in Walking and Worsened Pain LEFT FOOT with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of left foot surgery on the 4th and 5th toe and Right Side Pelvic Pain was not provided.  Agency opinion is that there is no reasonable possibility that the events of hernia right Abdomen, difficulty In walking, left foot surgery on the 4th and 5th toe, worsened pain left foot and right side pelvic pain are related to Humira 40mg/0.4ml(adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events abdominal hernia, limb injury, gait disturbance ,pain, pelvic pain  , impaired work ability, pain in extremity 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.