Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Rhinorrhoea, Rotator cuff repair, Shoulder operation, Sinus disorder, Sinusitis
Clinical narrative: rotator cuff; Polyp removal; Dry eyes; Stopped up nose; COVID-19 Vaccination was interacting with Humira; Sick; Cold like symptoms; Allergy (Hypersensitivity)/ Sinus infection (Sinusitis); ears backing up; Dry eyes worse; Knee pain in both knees; Allergy to vaccine; allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose; allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose; allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose; sinus infections/sinus issue; 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-163-4369795-00.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), on 01Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1154341) at unk, citrate free, second regimen (Lot number: 1161572) at citrate free (1 in 3 wk), third regimen (Lot number: 1157583) at unk, citrate free, fourth regimen since 30Sep2019 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, citrate free), fifth regimen (ongoing) (Batch/Lot number: unknown) at unk, citrate free, sixth regimen (ongoing) (Batch/Lot number: unknown) at unk, citrate free, every 3 weeks and seventh regimen (ongoing) (Lot number: 1164301) at 40 mg (40 mg every 3 weeks, citrate free), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Moderate to Severe Adult Crohn's Disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "recovering"; NASAL CRUSTING (non-serious), MULTIPLE ALLERGIES (non-serious) all with onset 2021, outcome "unknown" and all described as "allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose"; NASAL DRYNESS (non-serious), outcome "recovering", described as "allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose"; SINUSITIS (non-serious) with onset 2021, outcome "not recovered", described as "sinus infections/sinus issue"; ROTATOR CUFF REPAIR (medically significant), outcome "unknown", described as "rotator cuff"; POLYP (medically significant), outcome "unknown", described as "Polyp removal"; ARTHRALGIA (non-serious), outcome "unknown", described as "Knee pain in both knees"; DRY EYE (non-serious), outcome "unknown", described as "Dry eyes"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Stopped up nose"; DRUG INTERACTION (non-serious), outcome "unknown", described as "COVID-19 Vaccination was interacting with Humira"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold like symptoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Allergy (Hypersensitivity)/ Sinus infection (Sinusitis)"; EAR DISORDER (non-serious), outcome "unknown", described as "ears backing up"; DRY EYE (non-serious), outcome "unknown", described as "Dry eyes worse". The patient underwent the following laboratory tests and procedures: Colonoscopy: Unknown. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of polyp.  The reporter's assessment of the causal relationship of "rotator cuff", "polyp removal", "knee pain in both knees", "dry eyes", "stopped up nose", "allergy (hypersensitivity)/ sinus infection (sinusitis)", "allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose", "ears backing up" and "dry eyes worse" 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 "allergy to vaccine", "sinus infections/sinus issue", "covid-19 vaccination was interacting with humira", "sick" and "cold like symptoms" related to BNT162b2.  Clinical course: It was reported that patient with events of non-serious knee pain in both knees, allergies/dry eyes/stopped up nose and sinus infection after COVID-19 Vaccinations with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Covid-19 vaccination was interacting with Humira, sick, knee pain in both knees, allergies/dry eyes/stopped up nose and cold like symptoms. In Feb2021, the patient experienced Sinus Infection After COVID-19 Vaccinations. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Causality for Humira (Adalimumab), The reporter's causality for the event(s) of Drug interaction, Sickness, Dry eye, Knee pain, Allergy, Sinus infection, Cold symptoms was not provided.Solicited report by a consumer of a 68-year-old male with events of non-serious COVID-19 vaccination was interacting with Humira, sick, polyp removal, allergies/reaction from the COVID 19 vaccination, dry eyes, pain in both knees, sinus infection/sinus issues and cold like symptoms with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced COVID-19 vaccination was interacting with Humira, sick, polyp removal, allergies/reaction from the COVID 19 vaccination, dry eyes, pain in both knees, sinus infection/sinus issues and cold like symptoms. In 2021, the patient experienced allergies/reaction from the COVID 19 vaccination and sinus infection/sinus issues. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(Adalimumab) The reporter's causality for the event(s) of COVID-19 vaccination was interacting with Humira, sick, polyp removal, allergies/reaction from the COVID 19 vaccination, dry eyes, pain in both knees, sinus infection/sinus issues and cold like symptoms was not provided. Change History: on 19May2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. the events of COVID-19 vaccination was interacting with Humira, sick and cold like symptoms were added. the event of allergies/dry eyes/stopped up nose was amended to dry eyes. the event of knee pain in both knees was amended to pain in both knees. the event of allergies/dry eyes/stopped up nose was amended to allergies. the event of sinus infection after COVID-19 vaccinations was amended to sinus infection/sinus issues. On 16Jun2022, received updates to reporter opinion of causality and suspect drug information. On 01Aug2022, received updates to event information, reporter opinion of causality, laboratory/diagnostic procedures and narrative description. the event of polyp removal was added. the event of allergies was amended to allergies/reaction from the COVID 19 vaccination. As per follow-up 06Dec2022, it was reported n unknown date(s), the patient experienced allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose. The reporter's causality for the event(s) of allergies/reaction from the covid 19 vaccination, cold like symptoms, covid-19 vaccination was interacting with humira, dry eyes, pain in both knees, polyp removal, sick, sinus infection/sinus issues, allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose unknown onset with Adalimumab Solution for Injection was Not Provided The reporter's causality for the event(s) of allergies/reaction from the covid 19 vaccination, cold like symptoms, covid-19 vaccination was interacting with humira, sick and sinus infection/sinus issues with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of dry eyes, pain in both knees, polyp removal, allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose unknown onset with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided opinion was that the causality for the event(s) of allergies/reaction from the covid 19 vaccination, cold like symptoms, covid-19 vaccination was interacting with humira, dry eyes, pain in both knees, polyp removal, sick, sinus infection/sinus issues, allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose unknown onset with Adalimumab Solution for Injection was Not Provided. Opinion was that the causality for the event(s) of allergies/reaction from the covid 19 vaccination, cold like symptoms, covid-19 vaccination was interacting with humira, dry eyes, pain in both knees, polyp removal, sick, sinus infection/sinus issues, allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose unknown onset with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. HUMIRA Sinus infection, cold symptoms, knee pain, Polyp removal, Allergy to vaccine Non-Health Care Professional, Introspection, Sickness, Scab, Nasal dryness, dry eye Not Reported and PFIZER BIONTECH COVID-19 VACCINE infection, cold symptom, Dry eyes, Knee pain, Allergy to vaccine, Drug interaction, sickness are possible and Polyp, Multiple allergies, removal not, scab, nasal dryness reported. HUMIRA-Allergy to vaccine, cold symptoms, knee pain, sickness, multiples allergies, scab ,Nasal dryness, drug interaction, dry eye, Polyp removal, Sinus infection. PFIZER BIONTECH COVID-19 VACCINE-Sickness, Multiple allergies, scab, nasal dryness, Allergy to vaccine, cold symptoms, knee pain, polyp removal, sinus infection, drug interaction, dry eye. Upon follow up on 15Jun2023 It was reported that patient experienced events of rotator cuff, left shoulder pain, ears backing up. Booster dose made sick and worse with Sinus infection. Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose with Adalimumab Solution for Injection, Single-Dose Pen, Adalimumab Solution for Injection, Single Dose Pen. The patient had pain in both knees and he had gel injections in his right knee in 2017. He had Allergies, dry eyes and stopped up nose. These allergies were worse from taking Humira. He had side effects from both Pfizer covid-19 vaccine, had a sinus infection, runny nose and the 2nd injection made it worse. After taking the booster got really sick and worse than the second time with Sinus infections. He had sinus issues, runny nose and sore throat. Physician felt the covid-19 vaccination was interacting with Humira and caused him to cold like symptoms. He cut his Humira back to every 3 weeks. The vaccinations caused his allergies to flare up. The 4th Covid booster really made him sick. Physician told to no more covid vaccinations. When he had his covid-19 vaccinations, his allergies were impossible and he was not taking any covid-19 vaccinations, then his allergies were manageable. He was experiencing allergies and physician told that, these might have been from the covid-19 vaccination. He had colonoscopy and had a polyp removed. Allergies caused nasal passages to get real dry and caused a crusty scab on the inside bottom of nose. Physician told to double up on allergy medicine, and nasal sprays. He had Shoulder surgery 9 weeks ago in 2023, for rotator cuff, left shoulder pain. He had allergic issues with sinuses and ears backing up. The reporter's causality for the event(s) of Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose, Cold like symptoms, Covid-19 vaccination was interacting with Humira and Covid-19 vaccine caused Sinus infection/sinus issues/Booster dose made sick and worse with Sinus infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose onset 01Jan2021, Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose unknown onset, Cold like symptoms unknown onset, Covid-19 vaccination was interacting with Humira unknown onset, Covid-19 vaccine caused Sinus infection/sinus issues/Booster dose made sick and worse with Sinus infection onset 01Jan2021, Dry eyes worse unknown onset, Pain in both knees unknown onset, Polyp unknown onset, ears backing up unknown onset, rotator cuff, left shoulder pain unknown onset with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose unknown onset, Dry eyes worse, Pain in both knees, Polyp, ears backing up, rotator cuff, left shoulder pain with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. for the event(s) of Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose onset 01Jan2021, Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose unknown onset, Cold like symptoms unknown onset, Covid-19 vaccination was interacting with Humira unknown onset, Covid-19 vaccine caused Sinus infection/sinus issues/Booster dose made sick and worse with Sinus infection onset 01Jan2021, Dry eyes worse unknown onset, ears backing up unknown onset with Adalimumab Solution for Injection was Not Assessable. Opinion was that the causality for the event(s) of Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose onset 01Jan2021, Allergies/reaction from the covid 19 vaccination/Allergies caused nasal passages to get dry and caused a crusty scab on the inside bottom of nose unknown onset, Cold like symptoms, Covid-19 vaccination was interacting with Humira, Covid-19 vaccine caused Sinus infection/sinus issues/Booster dose made sick and worse with Sinus infection, Dry eyes worse, Pain in both knees, Polyp, ears backing up, rotator cuff, left shoulder pain with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Opinion was that the causality for the event(s) of Pain in both knees unknown onset, Polyp unknown onset and rotator cuff, left shoulder pain unknown onset with Adalimumab Solution for Injection was No Reasonable Possibility. Alternative Etiology for Polyp with Adalimumab Solution for Injection: More likely related to underlying Crohn's disease and age. Alternative Etiology for Pain in both knees with Adalimumab Solution for Injection: More likely related to arthritic manifestations of underlying Crohn's disease and age. Alternative Etiology for Polyp with Adalimumab Solution for Injection: More likely related to underlying Crohn's disease and age. Alternative Etiology for Pain in both knees with Adalimumab Solution for Injection: More likely related to arthritic manifestations of underlying Crohn's disease and age. Alternative Etiology for rotator cuff, left shoulder pain with Adalimumab Solution for Injection: More likely related to increased risk from arthritic manifestations of underlying Crohn's disease and age. Alternative Etiology for rotator cuff, left shoulder pain with Adalimumab Solution for Injection: More likely related to arthritic manifestations of underlying Crohn's disease and age.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (25May2022): This is a solicited follow-up report based on the information received by Pfizer (Mfr Control No.: 22K-163-4369795-00). A contactable 68-year-old male consumer reported for herself that: Updated Information included: Dose 4 information was captured. For event 'Hypersensitivity', onset date was captured. Additional events (Drug interaction, Illness, Nasopharyngitis and Allergy (Hypersensitivity)/ Sinus infection (Sinusitis)-Worsened) were added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (23Jun2022): This is a solicited follow-up report from a Non-Interventional Study (PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer, MFR Control No. 22K-163-4369795-00). A contactable 68-year-old male consumer (patient) reported for himself.  Updated information: Included was none, vaccination start date for dose 1 (previously reported as 16FEB2021) and 3 (previously reported as 01Nov2021) were updated and added dosage regimen for co-suspect. Included reporter causality for Pfizer BioNTech COVID-19 Vaccine(Tozinameran).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (05Aug2022): This is a solicited follow up report from a Non-Interventional Study (PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer, manufacturer control number: 22K-163-4369795-00. A contactable female consumer (patient) reported for herself that: Updated information included: Lab data was added. The event of polyp removal was added. The event of allergies was amended to allergies/reaction from the COVID 19 vaccination. Event Allergy to vaccine outcome updated as recovering/resolving, Humira action taken was updated  Follow-up (06Dec2022): This is a Solicited follow-up report based on the information received by Pfizer (Mfr Control No.: US-ABBVIE-22K-163-4369795-00). A contactable consumer (patient) reported for himself that: Updated information included: new reporter in reporter added. Co-suspect dosage regimens added. New events added. Event outcomes, event onset date added. for co suspect updated to dose not changed. Narrative updated accordingly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.  Follow-up (15Jun2023): This is a Solicited follow-up report based on the information received by Pfizer (Mfr Control No.US-ABBVIE-22K-163-4369795-00). A contactable consumer (patient) reported for himself that: Updated information included: New events "rotator cuff", Dry eyes worse" added, event details of sinusitis (onset date 2021) added, event outcome updated for "allergies caused nasal passages to get real dry and caused crusty scab on the inside bottom of nose" and clinical information was added  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events rotator cuff, ear disorder, sinusitis, hypersensitivity, arthralgia, dry eye, nasal congestion, drug interaction, illness, nasopharyngitis ,condition aggravated, polyp, nasal dryness, nasal crusting, multiple allergies and the use of suspect product cannot be fully excluded. The case will be reassessed once further information is available. 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.