Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Interchange of vaccine products, Knee operation, Nail operation, Pain
Clinical narrative: Interchange of vaccine products; paralyzed; Left knee surgery; toenail removed; poison ivy; pain in whole body; loss in energy; no appetite; chemical taste in mouth; diarrhea; weight gain; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4132344 (AbbVie).  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; immunoglobulin varicella-zoster (ZOSTER IMMUNOGLOBULIN), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient had no relevant medical history. Concomitant medication(s) included: METHOTREXATE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered"; PARALYSIS (medically significant), outcome "recovered", described as "paralyzed"; KNEE OPERATION (medically significant), outcome "recovered", described as "Left knee surgery"; NAIL OPERATION (medically significant), outcome "unknown", described as "toenail removed"; DERMATITIS CONTACT (non-serious), outcome "recovered", described as "poison ivy"; PAIN (non-serious), outcome "unknown", described as "pain in whole body"; ASTHENIA (non-serious), outcome "unknown", described as "loss in energy"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "no appetite"; DYSGEUSIA (non-serious), outcome "not recovered", described as "chemical taste in mouth"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "weight gain". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: Normal, notes: Back to normal; Weight: Gain. The action taken for adalimumab was dosage not changed.  Clinical Course: It was reported that consumer of an adult male with events of Left knee surgery, and toenail removed, and non-serious poison ivy, pain in whole body, loss in energy, no appetite, chemical taste in mouth, diarrhea, paralyzed and weight gain with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. Moderna, Pfizer/BioNTech were also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient had received shingles vaccine. He had pain in whole body after working construction. Primary reporter did not have the lot number information, because the packaging was discarded.  Causalities:  The reporter's causality for the event(s) of pain in whole body, loss in energy, weight gain, left knee surgery, no appetite, toenail removed, paralyzed, chemical taste in mouth and diarrhea with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of poison ivy with Adalimumab Solution for Injection was No Reasonable Possibility.  The reporter's causality for the event(s) of pain in whole body, loss in energy, poison ivy, left knee surgery, weight gain, no appetite, toenail removed, Paralyzed, Chemical taste in mouth and diarrhea with Moderna COVID-19 vaccine (Elasomeran) and with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  AbbVies opinion was that the causality for the event(s) of pain in whole body, loss in energy, poison ivy, weight gain, Left knee surgery, no appetite, toenail removed, Paralyzed, Chemical taste in mouth and diarrhea with Adalimumab Solution for Injection, Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: HUMIRA Loss of energy, Diarrhea, Weight gain, Knee operation, Paralyzed, General body pain, Appetite absent, Toe nail removal, Poison ivy rash and Taste chemical, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA Weight gain, Appetite absent, Toe nail removal, General body pain, Loss of energy, Poison ivy rash, Knee operation, Market Authorization Holder (MAH), Global Introspection was reported No Reasonable Possibility and Paralyzed, Taste chemical, Diarrhea, Market Authorization Holder (MAH), Global Introspection reported was Not assessable.  Moderna and Pfizer/BioNTech: Loss of energy, Paralyzed, Toe nail removal, Weight gain, General body pain, Taste chemical, Knee operation, Poison ivy rash, Appetite absent, Diarrhea, Market Authorization Holder (MAH) and Non-Health Care Professional, Global Introspection, Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of Knee operation is assessed as not related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and could be more likely due to underlying medical condition. Event Nail operation is assessed as not related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and could be an intercurrent condition. The causal association between the events Paralysis, Interchange of vaccine products, Dermatitis contact, Pain, Asthenia, Decreased appetite, Dysgeusia, Diarrhoea, Weight increased and the suspect drug BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be totally 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.