Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence, Therapeutic product effect incomplete
Clinical narrative: Drug effect incomplete; was out (Sleeping); Felt bad; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (was out (Sleeping)), FEELING ABNORMAL (Felt bad) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-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) at an unspecified dose. On 23-Sep-2021, the patient experienced SOMNOLENCE (was out (Sleeping)) and FEELING ABNORMAL (Felt bad). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). In September 2021, SOMNOLENCE (was out (Sleeping)) and FEELING ABNORMAL (Felt bad) had resolved. At the time of the report, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) was resolving.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVTD19 vaccine Trial.   Causality for HUMTRA (ADALTMUMAB)   The reporter's causality for the event (s) of COVID 19 BOOSTER REACTION/ felt bad and was out possibility.   On 24 Sep 2021, received updates to event and narrative description.  The events of  getting relief with psoriasis but had information, "COVID 19 BOOSTER reaction/ felt bad and was out (sleeping) " and "was with arthritis with HUMIRA" were added.   Treatment information 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 80-years-old male patient with concurrent condition of Psoriatic arthritis treated with ADALIMUMAB (HUMIRA) and reported non serious event of Therapeutic product effect incomplete (Drug effect incomplete) along with the non-serious events of Somnolence and Feeling abnormal. The event Therapeutic product effect incomplete occurred on unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose about 1 month later and third dose 7 months after the second dose. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623400 (Patient Link).; Sender's Comments: This spontaneous case concerns 80-years-old male patient with concurrent condition of Psoriatic arthritis treated with ADALIMUMAB (HUMIRA) and reported non serious event of Therapeutic product effect incomplete (Drug effect incomplete) along with the non-serious events of Somnolence and Feeling abnormal. The event Therapeutic product effect incomplete occurred on unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose about 1 month later and third dose 7 months after the second dose. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.