Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Lymphadenopathy
Clinical narrative: enlarged lymph nodes under the chin/right jaw/middle of the neck and on collar bone; 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-163-4531612-00 (AbbVie).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), on 17Mar2021 as dose 2, single (Lot number: ER8727) and on 12Oct2021 as dose 3 (booster), single (Lot number: BA30125) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 0.4 ml (Batch/Lot number: unknown) and in Feb2022 (ongoing) as 0.4 unk (Batch/Lot number: unknown), all subcutaneous for ankylosing spondylitis. The patient's relevant medical history included: "Hearing Issues" (unspecified if ongoing); "Polyps Removal", start date: 2018 (unspecified if ongoing), notes: (Started 2018); "Non Tobacco User" (unspecified if ongoing); "Alcohol Use" (unspecified if ongoing), notes: Alcohol Use/Occasionally 12 Packs Of Beer Per Week. Concomitant medication(s) included: ZINC (ongoing); DICLOFENAC taken for antiinflammatory therapy (ongoing); TIZANIDINE taken for muscle relaxant therapy (ongoing); HYDROCODONE taken for pain management (ongoing); TESTOSTERONE taken for blood testosterone decreased, somnolence (ongoing). The following information was reported: LYMPHADENOPATHY (medically significant) with onset Dec2021, outcome "recovered" (Feb2022), described as "enlarged lymph nodes under the chin/right jaw/middle of the neck and on collar bone". The patient underwent the following laboratory tests and procedures: Blood test: normal result; Computerised tomogram: normal result; normal result. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of lymphadenopathy.  Clinical course: solicited report by a consumer of a 38 year old male with an event  of enlarged lymph nodes under the chin/right jaw/middle of the neck and on collar bone with humira 40mg/0.4ml (adalimumab). the patient had a relevant medical  history of polyps removal. in Dec2021, the patient experienced enlarged lymph nodes under the  chin/right jaw/middle of the neck and on collar bone. in Feb2022, the enlarged lymph nodes under the chin/right jaw/middle of the neck and on collar bone resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had stopped taking Humira due to enlarged lymph nodes that was seen under the chin from Oct2021. On 02Dec2021, three lymph nodes were removed underneath his right jaw, middle of the neck and on his collar  bone. Enlarged lymph nodes was seen under the chin up to Feb2022. An unspecified antibiotic was prescribed to  him as treatment for the enlarged lymph nodes. He had undergone CAT scan twice and blood works and it showed  normal result. His physician was not able to identify if the cause of the lymph nodes was the covid-19 vaccine  or because of Humira. The causality for removal of three lymph nodes was not related with respect to Humira and not assessable with respect to covid-19 vaccine. The outcome reported for removal of lymph node was recovered  and resolved. It was unknown if he was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded. on unknown date blood work, CAT scan normal result. Causality (Tozinameran) Regional lymphadenopathy  (Lymphadenopathy), Action(s) taken with drug: Unknown, Causality (HUMIRA) for Regional lymphadenopathy (Lymphadenopathy), Action(s) taken with drug : Dosage Decreased, Causality as per reporter (Drug/Vaccine) ; Not Related, Causality as per Mfr.(Drug/Vaccine) : Not assessable, Dechallenge : N/A. Causality as per reporter (Drug/Vaccine) ;Not assessable, Dechallenge : N/A, Causality For Humira 40mg/0.4ml(Adalimumab) the reporter's causality for the event(s) of enlarged lymph nodes under the chin/right jaw/middle of the neck  and on collar bone with humir 40mg/0.4ml(adalimumab) was no reasonable possibility. AbbVie's opinion is that the event of Enlarged Lymph Nodes Under The Chin/Right Jaw/Middle of the Neck and on Collar Bone is not assessable.  The reporter's assessment of the causal relationship of "enlarged lymph nodes under the chin/right jaw/middle of the neck and on collar bone" 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.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event of lymphadenopathy is assessed as possibly related to the suspect drug BNT162b2 based on  case context provided, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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.