Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Diabetes mellitus, Feeling abnormal, Joint stiffness
Clinical narrative: Joint stiffness; Joint pain; Nausea; diabetes; Decline in the effectiveness of Humira was not lasting the full two weeks; dehydrated; strep throat; body weight: lost 22 lbs; sinus infection; difficulty to move in the morning when it was cloudy and cold outside; Brain fog; 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-163-4257540-00, US-ABBVIE-22K-163-4257540-00.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 22Mar2019 (ongoing) (Lot number: 1155994) at 40 mg cyclic (40 mg, cyclic (every 2 weeks)) and second regimen since 22Mar2019 (ongoing) (Lot number: 1155994) at 40 mg cyclic (40 mg, cyclic (every 1 week)), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Route of administration: Intramuscular), administration date: 02Mar2021, when the patient was 56-year-old, for COVID-19 Vaccination; BNT162b2 (DOSE 2, SINGLE; Route of administration: Intramuscular), administration date: 05Apr2021, when the patient was 56-year-old, for COVID-19 Vaccination. The following information was reported: FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "not recovered", described as "Brain fog"; MOBILITY DECREASED (non-serious) with onset 17Feb2022, outcome "recovering", described as "difficulty to move in the morning when it was cloudy and cold outside"; SINUSITIS (non-serious) with onset Nov2022, outcome "recovering", described as "sinus infection"; WEIGHT DECREASED (non-serious) with onset Dec2022, outcome "unknown", described as "body weight: lost 22 lbs"; PHARYNGITIS STREPTOCOCCAL (non-serious) with onset 20Dec2022, outcome "recovered", described as "strep throat"; DEHYDRATION (non-serious) with onset 28Dec2022, outcome "recovered", described as "dehydrated"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "not recovered", described as "Decline in the effectiveness of Humira was not lasting the full two weeks"; JOINT STIFFNESS (non-serious), outcome "recovering"; ARTHRALGIA (non-serious), outcome "recovering", described as "Joint pain"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Diabetes mellitus: (unspecified date) elevated to 600, notes: Unknown Date: lab test: diabetes elevated to 600; Weight: (Dec2022) 22 lbs, notes: body weight: lost 22 lbs. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of diabetes mellitus.  The reporter's assessment of the causal relationship of "diabetes", "decline in the effectiveness of humira was not lasting the full two weeks", "difficulty to move in the morning when it was cloudy and cold outside", "joint stiffness", "joint pain", "nausea", "brain fog", "dehydrated", "strep throat", "sinus infection" and "body weight: lost 22 lbs" 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.  Clinical Information: On unknown dates, the patient experienced Joint Stiffness and Joint Pain. In Jan2022, the patient experienced COVID-19. On 17Feb2022, the patient experienced difficulty to move in the morning when it was cloudy and cold outside. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Other Relevant History was Not reported. Upon follow up on 23Nov2022 it was reported that It was unknown if patient was enrolled in COVID-19-Vaccine Trial. It was reported that the patient decline in the effectiveness of Humira was not lasting the full two weeks (Drug effect decreased) and had foggy feeling in head with Adalimumab solution for Injection, Single Dose Pen. There was no reported medical history.  Difficulty To Move In The Morning When It Was Cloudy And Cold Outside, Diabetes, Joint Stiffness, dehydrated, Decline in the effectiveness of Humira was not lasting the full two weeks, strep throat, JOINT PAIN, COVID-19, Brain fog, COVID, and sinus infection with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On Jan2022, the patient experienced COVID-19. On Jan2022, the patient experienced Brain fog. On 17Feb2022, the patient experienced Difficulty To Move In The Morning When It Was Cloudy And Cold Outside. On Nov2022, the patient experienced sinus infection. On 20Dec2022, the patient experienced strep throat. On 28Dec2022, the patient experienced dehydrated. 28Dec2022, the patient experienced COVID. On unknown date(s), the patient experienced Joint Pain, Decline in the effectiveness of Humira was not lasting the full two weeks, Joint Stiffness, diabetes. On unknown date, dehydrated recovered/resolved. On unknown date, strep throat recovered/resolved. On unknown date, COVID recovered/resolved. Pfizer BioNTech COVID-19 vaccine was also considered suspect. Treatment Drugs: The patient was treated with Jardiance.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of difficulty to move in the morning when it was cloudy and cold outside, joint stiffness, joint pain and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer Biontech Covid-19 Vaccine(Tozinameran) The reporter's causality for the event(s) of difficulty to move in the morning when it was cloudy and cold outside, joint stiffness, joint pain was not reported and COVID-19 with Humira (Adalimumab) was Possible.  Causalities: The reporter's causality for the event(s) of Covid-19, difficulty to move in the morning when it was cloudy and cold Outside, joint pain and joint stiffness with Adalimumab Solution for Injection was No Reasonable Possibility.  The reporter's causality for the event(s) of Brain fog, Decline in the effectiveness of Humira was not lasting the full two weeks and Nausea with Adalimumab Solution for Injection and with Pfizer BioNTech COVID-19 vaccine was Not Provided.  Regulatory Authority opinion was that the causality for the event(s) of Brain fog, Covid-19, difficulty to move in the morning when it was cloudy and cold outside, Decline in the effectiveness of Humira was not lasting the full two weeks, joint pain, joint stiffness and Nausea with Adalimumab Solution for Injection and with Pfizer BioNTech COVID-19 vaccine was Not provided.  The reporter's causality for the event(s) of Brain fog, Decline in the effectiveness of Humira was not lasting the full two weeks, dehydrated, diabetes, sinus infection and strep throat with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Brain fog, Difficulty To Move In The Morning When It Was Cloudy And Cold Outside, Decline in the effectiveness of Humira was not lasting the full two weeks, Joint Pain, Joint Stiffness, dehydrated, diabetes, sinus infection and strep throat with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Difficulty To Move In The Morning When It Was Cloudy And Cold Outside, Joint Pain And Joint Stiffness with Adalimumab Solution for Injection was No Reasonable Possibility Withheld name opinion was that the causality for the event(s) of Brain fog, Difficulty To Move In The Morning When It Was Cloudy And Cold Outside, Decline in the effectiveness of Humira was not lasting the full two weeks, Joint Pain, Joint Stiffness, dehydrated, diabetes, sinus infection and strep throat with Adalimumab Solution for Injection was Not Provided. Withheld opinion was that the causality for the event(s) of Brain fog, Difficulty To Move In The Morning When It Was Cloudy And Cold Outside, Decline in the effectiveness of Humira was not lasting the full two weeks, Joint Pain, Joint Stiffness, covid, dehydrated, diabetes, sinus infection and strep throat with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: HUMIRA 40MG/0.4ML Citrate free: Diabetes, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Diabetes, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Streptococcal sore throat, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Streptococcal sore throat, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Sinus infection, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Sinus infection, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Dehydration, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Dehydration, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Foggy feeling in head, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Foggy feeling in head, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: COVID-19, Market Authorization Holder (MAH), Not Related HUMIRA 40MG/0.4ML Citrate free: COVID-19, Non-Health Care Professional, Global Introspection, Not Related HUMIRA 40MG/0.4ML Citrate free: Drug effect decreased, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Drug effect decreased, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Joint pain, Non-Health Care Professional, Global Introspection, No Reasonable Possibility HUMIRA 40MG/0.4ML Citrate free: Joint pain, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Joint pain, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Joint pain, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: Joint stiffness, Non-Health Care Professional, Global Introspection, No Reasonable Possibility HUMIRA 40MG/0.4ML Citrate free: Joint stiffness, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: COVID-19, Non-Health Care Professional, Global Introspection, Possible Pfizer BioNTech COVID-19 vaccine: COVID-19, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Joint stiffness, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Joint stiffness, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Drug effect decreased, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Drug effect decreased, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: Mobility decreased, Non-Health Care Professional, Global Introspection, No Reasonable Possibility HUMIRA 40MG/0.4ML Citrate free: Mobility decreased, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Mobility decreased, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Mobility decreased, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Foggy feeling in head, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Foggy feeling in head, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: COVID-19, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: COVID-19, Non-Health Care Professional, Global Introspection, Possible Pfizer BioNTech COVID-19 vaccine: Dehydration, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Dehydration, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Sinus infection, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Sinus infection, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Diabetes, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Diabetes, Non-Health Care Professional, Global Introspection, Not Reported Pfizer BioNTech COVID-19 vaccine: Streptococcal sore throat, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Streptococcal sore throat, Non-Health Care Professional, Global Introspection, Not Reported HUMIRA 40MG/0.4ML Citrate free: COVID-19, Market Authorization Holder (MAH) HUMIRA 40MG/0.4ML Citrate free: COVID-19, Non-Health Care Professional, Global Introspection, Not Reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (28Apr2022): This is a follow-up solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No: 22K-163-4257540-00). A contactable 57-year-old male consumer (patient) reported for himself that: Update information includes: Route of administration was taken as intramuscular. Age at vaccination was added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (23Nov2022): This is a solicited follow-up report received from a Non-Interventional Study (marketing program name not available) based on information received by Pfizer from Regulatory Authority, manufacturer control number: US-ABBVIE-22K-163-4257540-00.   Updated information included: Follow-up Activities Possible was updated as No for reporter#1 and in slider#2 and postal code updated in slide #2. Vaccination dates updated for historical doses. Age at vaccination added for 2nd dose. Suspect vaccination date updated. Dose description of Humira updated as per recent follow-up. Batch number added for Humira. 'Ongoing' was ticked in dose slide #2 for Humira. New events with event details (Nausea, decline in the effectiveness of Humira was not lasting the full two weeks and 'Brain fog) were added and causalities were updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (01Mar2023): This is a solicited follow-up report from a Non-interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from Regulatory Authority. (MFR Control No.# 22K-163-4257540-00).  Updated information included: Lab data (Weight and Diabetes) product details (start date added for Humira dosage regimen slider #2), Event details (new events of Diabetes, Dehydration, Streptococcal sore throat, Sinus infection and Weight loss was added, treatment received updated as yes for Diabetes) and clinical information updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events mobility decreased, joint stiffness, arthralgia , therapeutic effect decreased (Humira), nausea, Diabetes, Dehydration, Streptococcal sore throat, Sinus infection and Weight loss and feeling abnormal 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.