Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy; HIVES AFTER COVID 19 VACCINE; ALLERGIC REACTION TO HANDS AS RASH; Drug rash; RASH ON HEAD/NECK; Fingers stiffness; MORE SWOLLEN IN MORNING/HANDS SWOLLEN WHEN WOKE UP; Coughing; Respiratory tract congestion; Pain in hip; RUNNY NOSE AFTER THIRD COVID-19 MODERNA VACCINE; Cough; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (RUNNY NOSE AFTER THIRD COVID-19 MODERNA VACCINE), COUGH (Cough), PRURITUS (Itchy), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion) and MUSCULOSKELETAL STIFFNESS (Fingers stiffness) in a 58-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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 01-Oct-2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On 20-Dec-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknow. On 23-Dec-2021, the patient experienced RHINORRHOEA (RUNNY NOSE AFTER THIRD COVID-19 MODERNA VACCINE) and COUGH (Cough). In 2022, the patient experienced ARTHRALGIA (Pain in hip). In July 2022, the patient experienced RESPIRATORY TRACT CONGESTION (Respiratory tract congestion) and COUGH (Coughing). On an unknown date, the patient experienced PRURITUS (Itchy), MUSCULOSKELETAL STIFFNESS (Fingers stiffness), PERIPHERAL SWELLING (MORE SWOLLEN IN MORNING/HANDS SWOLLEN WHEN WOKE UP), URTICARIA (HIVES AFTER COVID 19 VACCINE), DERMATITIS ALLERGIC (ALLERGIC REACTION TO HANDS AS RASH), DRUG ERUPTION (Drug rash) and RASH (RASH ON HEAD/NECK). In December 2021, RHINORRHOEA (RUNNY NOSE AFTER THIRD COVID-19 MODERNA VACCINE) and COUGH (Cough) had resolved. In 2022, RESPIRATORY TRACT CONGESTION (Respiratory tract congestion) and COUGH (Coughing) had resolved. At the time of the report, PRURITUS (Itchy), URTICARIA (HIVES AFTER COVID 19 VACCINE), DERMATITIS ALLERGIC (ALLERGIC REACTION TO HANDS AS RASH), DRUG ERUPTION (Drug rash) and RASH (RASH ON HEAD/NECK) had resolved, MUSCULOSKELETAL STIFFNESS (Fingers stiffness) and PERIPHERAL SWELLING (MORE SWOLLEN IN MORNING/HANDS SWOLLEN WHEN WOKE UP) had not resolved and ARTHRALGIA (Pain in hip) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of RUNNY NOSE AFTER THIRD COVID-19 MODERNA VACCINE, COUGH AFTER THIRD COVID-19 MODERNA VACCINE and RASH ON HEAD/NECK THAT DOCTOR SAID WAS FROM COVID-19 MODERNA VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ITCHY THAT DOCTOR SAID WAS FROM COVID-19 MODERNA VACCINE was not provided.  The reporter's causality for the event of Respiratory tract congestion, Cough onset in July 2022 was not provided. The reporter's causality for the event(s) of Musculoskeletal stiffness, Arthralgia, Peripheral swelling, Dermatitis allergic and Urticaria was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant follow up appended. On 31-Aug-2022: Follow-up received wherein new events added, co suspect drug information and narrative description updated.