Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Hip arthroplasty, Hypersensitivity, Immunisation reaction, Irritable bowel syndrome
Clinical narrative: irritable bowel syndrome; Vaccination adverse reaction; Hives; Pinched nerve; hip replacement; joint did not fit properly on the socket; increased environmental allergies; Sinus congestion; sinus drainage; Sore throat; oozing of liquid on ears/skin oozing; psoriasis scale on both ears/psoriasis in ears with Humira; plaque on thumb/ plaque on right thumb; 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): 22K-163-4236033-00.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 56 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 05Apr2012 (Batch/Lot number: unknown), in Jul2014 as 40 mg (1 in 2 wk) (Batch/Lot number: unknown), in 2017 (Batch/Lot number: unknown), on 18Sep2021 (Batch/Lot number: unknown) and on 07May2022 (ongoing) as 40 mg (1 in 2 wk) (Batch/Lot number: unknown), all subcutaneous for psoriasis. The patient's relevant medical history included: "Hip replacement", start date: 12Aug2021, stop date: 12Aug2021; "Moderate to severe chronic plaque psoriasis" (unspecified if ongoing); "Sleep apnea", start date: 1999 (unspecified if ongoing); "First left knee surgery", start date: 2015, stop date: 2015; "Abstains from alcohol" (unspecified if ongoing); "Nonsmoker" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing); "Graft allergy" (unspecified if ongoing); "Trees allergy" (unspecified if ongoing); "Molds allergy" (unspecified if ongoing); "Dove allergy" (unspecified if ongoing); "Cat allergy" (unspecified if ongoing); "Dog allergy" (unspecified if ongoing); "Fish allergy" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Shrub pollen allergy" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Meniscus injury", start date: 2018, stop date: 2018; "Fall", start date: 2018 (unspecified if ongoing); "Hip replacement", start date: Nov2021, stop date: Nov2021. Concomitant medication(s) included: XIIDRA taken for dry eye; SINGULAIR taken for hypersensitivity; MONTELUKAST SODIUM AND LEVOCETIRIZINE DIHYDROCHLORIDE; DICLOFENAC SODIUM & MISOPROSTOL taken for inflammation; DAILY VITE [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE]; FISH OIL; GLUCOSAMINE; PATADAY; REFRESH TEARS LUBRICANT; VITAMIN D3 1000; XYZAL. Vaccination history included: BNT162b2 (Dose 1, Intra-muscular, Lot number: ER8731), administration date: 18Apr2021, when the patient was 55-year-old, for Covid-19 immunisation, reaction(s): "Difficulty in walking", "Hip replacement", "Irritable bowel syndrome", "Skin oozing", "Skin plaque", "Vaccination adverse reaction", "Hives", "Pinched nerve", "Joint disorder", "Allergy aggravated", "Psoriasis", "Sinus congestion", "Nasal sinus discharge", "Sore throat"; BNT162b2 (Dose 2, Intra-muscular, Lot number: EW0185), administration date: 08May2021, when the patient was 55-year-old, for Covid-19 immunisation, reaction(s): "Difficulty in walking", "Hip replacement", "Irritable bowel syndrome", "Skin oozing", "Skin plaque", "Vaccination adverse reaction", "Hives", "Pinched nerve", "Joint disorder", "Allergy aggravated", "Sinus congestion", "Nasal sinus discharge", "Sore throat", "Psoriasis". The following information was reported: SKIN PLAQUE (medically significant) with onset 30Mar2022, outcome "recovered" (2022), described as "plaque on thumb/ plaque on right thumb"; PSORIASIS (medically significant) with onset Apr2022, outcome "not recovered", described as "psoriasis scale on both ears/psoriasis in ears with Humira"; SKIN WEEPING (medically significant) with onset May2022, outcome "unknown", described as "oozing of liquid on ears/skin oozing"; IRRITABLE BOWEL SYNDROME (medically significant), outcome "unknown"; IMMUNISATION REACTION (medically significant), outcome "recovering", described as "Vaccination adverse reaction"; URTICARIA (medically significant), outcome "unknown", described as "Hives"; NERVE COMPRESSION (medically significant), outcome "unknown", described as "Pinched nerve"; HIP ARTHROPLASTY (medically significant), outcome "recovered", described as "hip replacement"; ARTHROPATHY (medically significant), outcome "unknown", described as "joint did not fit properly on the socket"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "increased environmental allergies"; SINUS CONGESTION (medically significant), outcome "unknown"; SINUS OPERATION (medically significant), outcome "unknown", described as "sinus drainage"; OROPHARYNGEAL PAIN (medically significant), outcome "unknown", described as "Sore throat". The action taken for adalimumab was dosage not changed. The reporter considered "irritable bowel syndrome", "hip replacement", "oozing of liquid on ears/skin oozing" and "plaque on thumb/ plaque on right thumb" not related to BNT162b2. The reporter considered "vaccination adverse reaction" related to BNT162b2. The reporter's assessment of the causal relationship of "hives", "pinched nerve", "joint did not fit properly on the socket", "increased environmental allergies", "sinus congestion", "sinus drainage", "sore throat" and "psoriasis scale on both ears/psoriasis in ears with humira" 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. Solicited report by a consumer of a 52 year old male with events of hard time walking, puts pressure on the legs, torn cartilage wen patient was knocked down and hip replaced and non-serious irritable bowel syndrome, oozing of liquid on ears/skin oozing, plaque on thumb, plaque on right thumb, side effects from covid shots and booster, hives off and on possibly caused heat, pinched nerve in back, torn cartilage wen patient was knocked down, joint did not fit properly on the socket, increased environmental allergies, sinus congestion, sinus drainage, sore throat and psoriasis scale on both ears/ psoriasis in ears with Humira 40mg/0.4ml (adalimumab). Information was also received from a healthcare professional. On unknown dates, the patient experienced irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat, pinched nerve in back, joint did not fit properly on the socket, increased environmental allergies, sinus congestion, sinus drainage and sore throat. In 2018, the patient experienced torn cartilage wen patient was knocked down and torn cartilage wen patient was knocked down. In 2018, the torn cartilage wen patient was knocked down resolved. On 12Aug2021, the patient experienced hard time walking, puts pressure on the legs. In Sep2021, the hard time walking, puts pressure on the legs resolved. On 22Nov2021, the patient experienced hip replaced. On 30Mar2022, the patient experienced plaque on thumb. In Apr2022, the patient experienced psoriasis scale on both ears/ psoriasis in ears. In May2022, the patient experienced oozing of liquid on ears/ skin oozing and plaque on right thumb. In 2022, the plaque on thumb resolved. On an unknown date, hip replaced resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had second left knee surgery in 2018, the procedure was to scope the remaining cartilage that was torn when he was knocked down. He had left hip replaced on 12Aug2021, because he had difficulty walking, puts pressure on the legs. He mentioned that the joint did not fit properly on the socket. He had Irritable bowel syndrome. He had side effects from covid shots and booster. He had hives off and on possibly caused heat and Pinched nerve in back. He had to stopped Humira for six months because of a hip replacement. He also mentioned he has spinal injection every six months for the pinched nerve on his back. the alternative etiology for the event hard time walking, puts pressure on the legs was reported as pinched nerve on the back. He moved about two years ago and has been having increased environmental allergies since moving. He had sinus congestion, drainage and sore throat and had psoriasis in his ears and it had now gone away since restarting injections. His skin was cracking and oozing. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Change History: On 25May2022, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "torn cartilage wen patient was knocked down", "hip replaced", "oozing of liquid on ears", "plaque on thumb", "plaque on right thumb", "psoriasis scale on both ears", "torn cartilage wen patient was knocked down" and "joint did not fit properly on the socket" were added. The event of "left hip replaced" was amended to "hard time walking, puts pressure on the legs". On 25May2022, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "increased environmental allergies", "sinus congestion", "sinus drainage", "sore throat" and "psoriasis scale on both ears/ psoriasis in ears" were added. The event of "oozing of liquid on ears" was amended to "oozing of liquid on ears/ skin oozing". The event of "psoriasis scale on both ears" was removed. The reporter's causality for the event(s) of left hip replaced, irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back with humira (Adalimumab) was no reasonable possibility. The reporter's causality for event vaccination adverse reaction with Pfizer biontech covid-19 vaccine was possible. Drug: Humira 40mg/0.4ml (40 milligram, solution for injection in pre-filled pen) (adalimumab), 1151223, unknown, 1159670, 1159670, 1159670. Causality: Irritable bowel syndrome (Irritable bowel syndrome): Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine) and Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. Skin oozing (Skin weeping), Action(s) taken with drug: Drug discontinued. Causality as per reporter (Drug/Vaccine): Related, Causality as per Mfr. (Drug/Vaccine): Reasonable possibility. Dechallenge: No. Skin plaque (Skin plaque), Action(s) taken with drug: Drug discontinued. Causality as per reporter (Drug/Vaccine): Not related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Yes. Skin plaque, Causality as per reporter (Drug/Vaccine): Related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Yes. Vaccination adverse reaction (Immunization reaction), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. Hives (Urticaria), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge:  N/A. Pinched nerve (Nerve compression), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. Joint disorder (Arthropathy), Action(s) taken with drug:  Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk. Allergy aggravated (Hypersensitivity), Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. Sinus congestion, Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine):  Not Reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. Nasal sinus discharge (Paranasal sinus hypersecretion), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr. (Drug/Vaccine): Not assessable, Dechallenge: N/A. Causality for Humira 40MG/0.4ML (adalimumab): The reporters causality for the event(s) of hard time walking, puts pressure on the legs, torn cartilage wen patient was knocked down onset in 2018, hip replaced, irritable bowel syndrome, plaque on thumb, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporters causality for the event(s) of oozing of liquid on ears/ skin oozing and plaque on right thumb with humira 40mg/0.4ml (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of torn cartilage wen patient was knocked down onset in 2018, joint did not fit properly on the socket, increased environmental allergies, sinus congestion, sinus drainage, sore throat and psoriasis scale on both ears/ psoriasis in ears was not provided. Agency opinion is that there is no reasonable possibility that the events of hard time walking, puts pressure on the legs, torn cartilage wen patient was knocked down onset in 2018, hip replaced, irritable bowel syndrome, plaque on thumb, plaque on right thumb, side effects from covid shots and booster, hives off and on possibly caused heat, pinched nerve in back, torn cartilage wen patient was knocked down onset in 2018, joint did not fit properly on the socket, increased environmental allergies and psoriasis scale on both ears/ psoriasis in ears are related to humira 40mg/0.4ml (adalimumab). Agency opinion is that there is a reasonable possibility that the event of oozing of liquid on ears/ skin oozing is related to humira 40mg/0.4ml (adalimumab). AgencY opinion is that the events of sinus congestion, sinus drainage and sore throat are not assessable. Drug: Pfizer Biontech Covid-19 Vaccine (tozinameran) (tozinameran), ER8731, EW0185, FL3197. Causality: Irritable bowel syndrome, Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A. Skin oozing (Skin weeping), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A. Skin plaque (Skin plaque), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A. Vaccination adverse reaction (Immunization reaction), Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine): Related, Dechallenge: N/A. Hives (Urticaria), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Pinched nerve (Nerve compression), Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, Joint disorder (Arthropathy), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Allergy aggravated (Hypersensitivity), Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Sinus congestion, Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Nasal sinus discharge (Paranasal sinus hypersecretion), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Did event abate after stopping drug: NA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (01Jun2022): This is a solicited follow-up report based on the information received by Pfizer from Agency (Mfr Control No.: 22K-163-4236033-00). A contactable 56-year-old male consumer reported for himself that:  Updated Information included: Patient Details (weight, height) added. Other Relevant History (historical vaccine notes, age, RMH) added. BNT162B2 Dosage Regimens (lot number) added. Humira Substance Information (strength) added. Humira Dosage Regimens (start date, slider #02-slider#05) added. Concomitant drugs added. New events added.  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 information available, the causal relationship between the reported events (except irritable bowel syndrome", "hip replacement", "oozing of liquid on ears/skin oozing", "plaque on thumb/ plaque on right thumb" and "skin plaque (skin plaque)) and 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 Events irritable bowel syndrome", "hip replacement", "oozing of liquid on ears/skin oozing", "plaque on thumb/ plaque on right thumb" and "skin plaque (skin plaque) are considered unrelated to suspect product BNT162B2.