Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Breast cellulitis, Cellulitis, Fall, Lymphadenopathy
Clinical narrative: Spondylitis ankylosing aggravated; Stress; Fall; Meniscus injury/ tore meniscus; Pain in arm/ sore arm; Swelling arm; Breast cellulitis; Cellulitis of arm/ cellulitis on right arm and underarm; Swollen lymph nodes; 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-163-4431294-00.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of administration: Intramuscular), administration date: 12Mar2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered", described as "Pain in arm/ sore arm"; BREAST CELLULITIS (medically significant) with onset 2021, outcome "recovered"; CELLULITIS (medically significant) with onset 2021, outcome "recovered", described as "Cellulitis of arm/ cellulitis on right arm and underarm"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "recovered", described as "Swelling arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "Swollen lymph nodes"; FALL (non-serious) with onset 2022, outcome "unknown"; MENISCUS INJURY (non-serious) with onset 2022, outcome "unknown", described as "Meniscus injury/ tore meniscus"; ANKYLOSING SPONDYLITIS (medically significant), outcome "recovered", described as "Spondylitis ankylosing aggravated"; STRESS (non-serious), outcome "recovered". The action taken for adalimumab was unknown. Patient was not enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded.   Causality: 1) Swollen lymph nodes (Lymphadenopathy) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: NA  2) Meniscus injury (Meniscus injury) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: NA  3) Stress (Stress) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: NA  4) Fall (Fall) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  5) Breast cellulitis (Breast cellulitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  6) Spondylitis ankylosing aggravated (Ankylosing spondylitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  7) Pain in arm (Pain in extremity) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: NA  8) Swelling arm (Peripheral swelling) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: NA  9) Cellulitis of arm (Cellulitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: NA  The reporter's assessment of the causal relationship of "breast cellulitis", "spondylitis ankylosing aggravated", "cellulitis of arm/ cellulitis on right arm and underarm", "swollen lymph nodes", "meniscus injury/ tore meniscus", "stress", "fall", "pain in arm/ sore arm" and "swelling arm" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events and BNT162B2 is considered possible.