Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect incomplete
Clinical narrative: Sensation of pressure in eye; Eye pressure got worse; Drug effect incomplete; COVID-19; Blistering of mouth; Blisters/blisters on nose and corner of eyes; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Sensation of pressure in eye), CONDITION AGGRAVATED (Eye pressure got worse), ORAL MUCOSAL BLISTERING (Blistering of mouth), BLISTER (Blisters/blisters on nose and corner of eyes) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) in an adult 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included MYCOPHENOLATE MOFETIL for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In December 2021, the patient experienced ORAL MUCOSAL BLISTERING (Blistering of mouth), BLISTER (Blisters/blisters on nose and corner of eyes) and COVID-19 (COVID-19). On an unknown date, the patient experienced OCULAR DISCOMFORT (Sensation of pressure in eye), CONDITION AGGRAVATED (Eye pressure got worse) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). In March 2022, ORAL MUCOSAL BLISTERING (Blistering of mouth), BLISTER (Blisters/blisters on nose and corner of eyes) and COVID-19 (COVID-19) had resolved. At the time of the report, OCULAR DISCOMFORT (Sensation of pressure in eye) and CONDITION AGGRAVATED (Eye pressure got worse) outcome was unknown and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. The causality of Humira (adalimumab) for the events of eye pressure got worse was not provided, blister on mouth, blisters on nose and corner of eyes and covid-19 was no reasonable possibility. The reporter causality for the events of Humira was not as effective as hoped with Humira was a reasonable possibility. No treatment medications was reported.  Company comment: This spontaneous case concerns an adult female patient with medical history of rheumatoid arthritis with use of Humira (adalimumab) and concomitant use of mycophenolate mofetil,  who experienced the unexpected non serious AESI of COVID 19 and non serious events of oral mucosal blistering, blister (blistering on nose, corner of eyes), ocular discomfort, condition aggravated and therapeutic product effect incomplete (humira was not as effective as hoped). The patient received three doses of mRNA-1273, however dose administration dates were not provided and temporal relation between the three reported doses and onset of events is unclear.  No further information about the events was provided. No information about COVID 19 testing was provided. Concomitant use of mycophenolate mofetil is a confounding factor for the reported events. Causality for the event of therapeutic product effect incomplete was assessed as not related to mRNA-1273 as reported to be referring to humira use. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with medical history of rheumatoid arthritis with use of Humira (adalimumab) and concomitant use of mycophenolate mofetil,  who experienced the unexpected non serious AESI of COVID 19 and non serious events of oral mucosal blistering, blister (blistering on nose, corner of eyes), ocular discomfort, condition aggravated and therapeutic product effect incomplete (humira was not as effective as hoped). The patient received three doses of mRNA-1273, however dose administration dates were not provided and temporal relation between the three reported doses and onset of events is unclear.  No further information about the events was provided. No information about COVID 19 testing was provided. Concomitant use of mycophenolate mofetil is a confounding factor for the reported events. Causality for the event of therapeutic product effect incomplete was assessed as not related to mRNA-1273 as reported to be referring to humira use. The benefit-risk relationship of mRNA-1273 is not affected by this report.