Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rosacea, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Rosacea; Joint pain/joint pain with humira (adalimumab); Loss of energy; Tiredness/feel a little tired after taking humira; Vaccination site warmth/bad reaction to moderna vaccination on arm felt like it was on fire; Vaccination site pruritus/bad reaction to moderna vaccination on arm felt like it was on itchy; Vaccination site erythema/bad reaction to moderna vaccination on arm felt like it was on red; Vaccination site swelling/bad reaction to moderna vaccination on arm felt like it was on swollen; Allergy/ Rash urticarial/small rash/hives on up part of back/look like little pimples/ Itching; Paraesthesia hand/tingling in her hands; Constipation/ constipated with humira; Right lower quadrant pain; Hoarseness/unusual hoarseness with humira/Hoarseness of voice; Cough/mucus in throat; Throat secretion increased; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarseness/unusual hoarseness with humira/Hoarseness of voice), COUGH (Cough/mucus in throat), INCREASED UPPER AIRWAY SECRETION (Throat secretion increased), HYPERSENSITIVITY (Allergy/ Rash urticarial/small rash/hives on up part of back/look like little pimples/ Itching) and PARAESTHESIA (Paraesthesia hand/tingling in her hands) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease, ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and VEDOLIZUMAB (ENTYVIO) for an unknown indication.    The patient's past medical history included Tissue injury, Immune thrombocytopenia, Ex-alcohol user, Bowel resection and Surgery. Concurrent medical conditions included Drug allergy and Non-smoker. Concomitant products included MESALAZINE (CANASA) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third 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 On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free., ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose and VEDOLIZUMAB (ENTYVIO) (unknown route) at an unspecified dose. In 2021, the patient experienced DYSPHONIA (Hoarseness/unusual hoarseness with humira/Hoarseness of voice), COUGH (Cough/mucus in throat) and INCREASED UPPER AIRWAY SECRETION (Throat secretion increased). In August 2021, the patient experienced ABDOMINAL PAIN LOWER (Right lower quadrant pain). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy/ Rash urticarial/small rash/hives on up part of back/look like little pimples/ Itching), PARAESTHESIA (Paraesthesia hand/tingling in her hands), CONSTIPATION (Constipation/ constipated with humira), ROSACEA (Rosacea), ARTHRALGIA (Joint pain/joint pain with humira (adalimumab)), ASTHENIA (Loss of energy), FATIGUE (Tiredness/feel a little tired after taking humira), VACCINATION SITE WARMTH (Vaccination site warmth/bad reaction to moderna vaccination on arm felt like it was on fire), VACCINATION SITE PRURITUS (Vaccination site pruritus/bad reaction to moderna vaccination on arm felt like it was on itchy), VACCINATION SITE ERYTHEMA (Vaccination site erythema/bad reaction to moderna vaccination on arm felt like it was on red) and VACCINATION SITE SWELLING (Vaccination site swelling/bad reaction to moderna vaccination on arm felt like it was on swollen). The patient was treated with MACROGOL 3350 (MIRALAX) for Constipation, at a dose of UNK UNK, qd; LORATADINE (CLARITINE) for Cough, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Cough, at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency and Surgery for Abdominal pain lower. At the time of the report, DYSPHONIA (Hoarseness/unusual hoarseness with humira/Hoarseness of voice), COUGH (Cough/mucus in throat), INCREASED UPPER AIRWAY SECRETION (Throat secretion increased), PARAESTHESIA (Paraesthesia hand/tingling in her hands), ABDOMINAL PAIN LOWER (Right lower quadrant pain), ROSACEA (Rosacea) and ARTHRALGIA (Joint pain/joint pain with humira (adalimumab)) had not resolved, HYPERSENSITIVITY (Allergy/ Rash urticarial/small rash/hives on up part of back/look like little pimples/ Itching), CONSTIPATION (Constipation/ constipated with humira), ASTHENIA (Loss of energy) and FATIGUE (Tiredness/feel a little tired after taking humira) outcome was unknown and VACCINATION SITE WARMTH (Vaccination site warmth/bad reaction to moderna vaccination on arm felt like it was on fire), VACCINATION SITE PRURITUS (Vaccination site pruritus/bad reaction to moderna vaccination on arm felt like it was on itchy), VACCINATION SITE ERYTHEMA (Vaccination site erythema/bad reaction to moderna vaccination on arm felt like it was on red) and VACCINATION SITE SWELLING (Vaccination site swelling/bad reaction to moderna vaccination on arm felt like it was on swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: no active inflammation no active inflammation. On 23-Feb-2022, Computerised tomogram: no active inflammation no active inflammation. On an unknown date, Computerised tomogram: didn't find anything didn't find anything.         The patient was not quite sure whether it was HUMIRA doing the events or not. She already saw an ear, nose and throat physician and she was given medication for the side effects. She wanted to see her ear, nose and throat physician to ask for an allergy test panel to check if hoarseness of her voice was related to allergy. She had a rash on her back area and had itching which occurred two to three months after she started taking HUMIRA. She already received unknown flu shots and was taking an unspecified eye drops, and unspecified creams for rosacea.   It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events DYSPHONIA, VACCINATION SITE ERYTHEMA, VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING and ROSACEA was a reasonable possibility, reporter's causality for the event ABDOMINAL PAIN LOWER was no reasonable possibility and was not provided for other events with HUMIRA 40MG/0.4ML(ADALIMUMAB). The reporter's causality for the events of DYSPHONIA, COUGH, ASTHENIA, PARAESTHESIA and HYPERSENSITIVITY are not assessable and was not provided for other events with HUMIRA (ADALIMUMAB) was not provided. There was no reasonable possibility that the events of VACCINATION SITE ERYTHEMA, VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING, CONSTIPATION, ABDOMINAL PAIN LOWER and ARTHRALGIA are related to HUMIRA(ADALIMUMAB). There was a reasonable possibility that the events FATIGUE, PRURITUS, ROSACEA and URTICARIA are related to HUMIRA(ADALIMUMAB). The reporter's causality for the events DYSPHONIA, and ROSACEA was related, for events HYPERSENSITIVITY, URTICARIA , PRURITUS, COUGH, INCREASED UPPER AIRWAY SECRETION, was not related and for other events was not provided with VEDOLIZUMAB (ENTYVIO).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Significant follow-up- Added event (abdominal pain lower, fatigue, paraesthesia), lab test, updated outcome of event (dysphonia), seriousness of events and suspect drugs details. On 14-Apr-2022: Significant follow-up- Updated event verbatim of event (Dysphonia), added events (increased upper airway secretion, cough, pruritus, urticaria, arthralgia) suspect drug (Entyvio), treatment drugs (Claritine, Flonase, Mucinex). On 21-Apr-2022: Significant follow-up- Added events (rosacea, hypersensitivity), medical history, drug details for suspect drug (Humira), concomitant drug (Canasa), onset year for events (dysphonia, increased upper airway secretion, cough, pruritus, urticaria) and lab results. On 26-Apr-2022: Significant follow-up- Added event (asthenia) and updated outcome of events (urticaria, cough, arthralgia). On 01-Jun-2022: Non-significant follow-up received.