Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vaccination site erythema, Vaccination site papule
Clinical narrative: Unexpected therapeutic benefit; FIRST SHORT OF COVID VACCINE RED BUMP AT THE INJECTION SITE; Vaccination site papule; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit), VACCINATION SITE ERYTHEMA (FIRST SHORT OF COVID VACCINE RED BUMP AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Vaccination site papule) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    The patient's past medical history included Nail disorder, Stomach discomfort (ERYTHROMYCIN ALLERGY MANIFESTED BY STOMACH ISSUES) and Psoriatic arthritis. Previously administered products included for Product used for unknown indication: ERYTHROMYCIN. Past adverse reactions to the above products included Stomach discomfort with ERYTHROMYCIN. Concurrent medical conditions included Allergic reaction to antibiotics (ERYTHROMYCIN ALLERGY MANIFESTED BY STOMACH ISSUES), Dust allergy, Pollen allergy, Non-tobacco user, Abstains from alcohol, Joint disorder and Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis, VITAMIN D NOS for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (FIRST SHORT OF COVID VACCINE RED BUMP AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Vaccination site papule). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2021, VACCINATION SITE ERYTHEMA (FIRST SHORT OF COVID VACCINE RED BUMP AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Vaccination site papule) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient's joint had been feeling better, but the nail was really damaged and was just before started HUMIRA and finally started to look like a regular nail. She had a softball sized red bump at the injection site with first shot of COVID. It was there for at least two weeks.  The patient had other concomitant therapy of Multivitamins and Eye vitamin.  On an unknown date in 2021 UNSPECIFIED TESTS were performed with No significant findings.  Pre-existing condition improved were considered under Therapeutic response unexpected.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of first short of covid vaccine red bump at the injection site and nail getting better/damaged before starting the humira/look like regular nail was not provided.  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.  Company comment: This spontaneous case concerns a female patient aged  60 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced unexpected non serious event of Therapeutic response unexpected that occurred on unknown date after first dose of mRNA-1273 vaccine. No further information on detailed clinical course was available in the report. On an unknown date patient experienced nail getting better and looking like a normal nail before starting Humira. Outcome of the event recovering at the time of report. Relevant medical history remains confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2021-624130 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Live-Significant follow-up appended: event added.; Sender's Comments: This spontaneous case concerns a female patient aged  60 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced unexpected non serious event of Therapeutic response unexpected that occurred on unknown date after first dose of mRNA-1273 vaccine. No further information on detailed clinical course was available in the report. On an unknown date patient experienced nail getting better and looking like a normal nail before starting Humira. Outcome of the event recovering at the time of report. Relevant medical history remains confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.