Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Chills, Hidradenitis, Sensation of foreign body, Therapeutic response shortened
Clinical narrative: hidradenitis suppurativa boils reappered five to six days prior to humira injection with Humira (adalimumab); FELT LIKE SOMETHING FOREIGN WAS IN BODY AND FREAKED OUT; Wearing off effect; ANXIETY REACTION TO SECOND MODERNA VACCINE INJECTION; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa boils reappered five to six days prior to humira injection with Humira (adalimumab)), SENSATION OF FOREIGN BODY (FELT LIKE SOMETHING FOREIGN WAS IN BODY AND FREAKED OUT), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ANXIETY (ANXIETY REACTION TO SECOND MODERNA VACCINE INJECTION) and CHILLS (Chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa boils reappered five to six days prior to humira injection with Humira (adalimumab)), SENSATION OF FOREIGN BODY (FELT LIKE SOMETHING FOREIGN WAS IN BODY AND FREAKED OUT), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ANXIETY (ANXIETY REACTION TO SECOND MODERNA VACCINE INJECTION) and CHILLS (Chills). At the time of the report, HIDRADENITIS (hidradenitis suppurativa boils reappered five to six days prior to humira injection with Humira (adalimumab)) had not resolved, SENSATION OF FOREIGN BODY (FELT LIKE SOMETHING FOREIGN WAS IN BODY AND FREAKED OUT) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown and ANXIETY (ANXIETY REACTION TO SECOND MODERNA VACCINE INJECTION) and CHILLS (Chills) had resolved.            No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (adalimumab): The reporters causality for the events feeling of foreign body, Chills, Anxiety reaction, Hidradenitis suppurativa was not provided. No treatment medications were provided by the reporter.  Company Comment: This spontaneous case concerns a female unknown-years-old patient, with  medical history of Co-suspect product included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa who experienced the unexpected events of sensation of hidradenitis,  foreign body, therapeutic response shortened, anxiety and other expected event unknown days after 2nd. dose of mRNA-1273 vaccine. The medical history of ADALIMUMAB and Hidradenitis suppurativa are confounders for hidradenitis event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a female unknown-years-old patient, with  medical history of Co-suspect product included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa who experienced the unexpected events of sensation of hidradenitis,  foreign body, therapeutic response shortened, anxiety and other expected event unknown days after 2nd. dose of mRNA-1273 vaccine. The medical history of ADALIMUMAB and Hidradenitis suppurativa are confounders for hidradenitis event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.