Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, COVID-19, Drug interaction
Clinical narrative: COVID-19; COVID vaccination shots made Humira ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INTERACTION (COVID vaccination shots made Humira ineffective) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 041L20A and 0271121B) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    The patient's past medical history included Skin disorder, Neurological disorder NOS on 17-Oct-2017, Shunt malfunction, Injection site pain in 2017, Coma from 17-Oct-2017 to November 2021, Traumatic brain injury on 17-Oct-2017, Brain disorder NOS (BRAIN COULD NOT REGULATE THINGS) on 17-Oct-2017, Speech loss (NOT BEING ABLE TO TALK) on 17-Oct-2017, Unable to walk on 17-Oct-2017, Pain on 17-Oct-2017, Arm fracture on 17-Oct-2017, Fall (had a bad fall and went to the emergency room) on 17-Oct-2017, Arm fracture (right arm fracture due to the fall), Tonsillectomy, CSF shunt operation (shunt placed in her head), CSF shunt conversion (brain surgery and had to move the shunt to the back of her head), Cast application (clam cast), Cognitive behavioral therapy and Physical therapy (other physical therapies). Previously administered products included for Drug use for unknown indication: AMITRIPTYLINE, VICODIN, BUTALBITAL, DONEPEZIL, potassium, METHOTREXATE and MELOXICAM. Past adverse reactions to the above products included No adverse event with AMITRIPTYLINE, BUTALBITAL, DONEPEZIL, MELOXICAM, METHOTREXATE, VICODIN and potassium. Family history included Malignant hyperthermia since an unknown date. Concurrent medical conditions included Psoriatic arthritis, Drug allergy, Malignant hyperthermia, Non-smoker, Abstains from alcohol, Adhesive tape allergy (Allergy to adhesive manifestated by blisters and hives), Muscle pain, Headache, Plaque psoriasis (FLARE UP OF PLAQUE PSORIASIS), Psoriatic arthritis aggravated, Blood pressure inadequately controlled since 2017 and Plaque psoriasis. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for Blood pressure inadequately controlled, NORTRIPTYLINE for Headache, METOPROLOL for Heart disorder and Blood pressure inadequately controlled, MAGNESIUM for Muscle pain, FAMOTIDINE for Prophylaxis, FOLIC ACID and VITAMIN D3 for an unknown indication.   In 2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2018, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 09-Apr-2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 19-Nov-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 an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced DRUG INTERACTION (COVID vaccination shots made Humira ineffective). In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) and DRUG INTERACTION (COVID vaccination shots made Humira ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: Dropped.         Concomitant Famotidine was given to prevent stomach issues. Patient age was reported as 56 years. In 2015, the patient experienced painful injections/ injection burns. In 2017, she experienced blood pressure not regulated. On 17-Oct-2017, she experienced coma, traumatic brain injury, neurological issue from the fall, brain could not regulate things, not being able to talk, not being able to walk, pain and arm fracture. In 2017, the painful injections/ injection burns resolved. On an unknown date, degradation of skin from the top of head resolved. On 17-Oct-2017 she had a bad fall and went to the emergency room. she was stabilized in the emergency room and was flown by flight to another hospital. Due to fall she ended up having traumatic brain injury and was in state of coma for two and a half to three weeks. She was in the hospital from 17-Oct-2017 and stayed for two and a half to three weeks. When she went to the hospital for that fall, the doctors decided she was enough in remission and they took her off of the Humira which ended up being not a great idea because she got a lot more flares and pain from her arthritis. She did not know what tests were done. She had a shunt placed in her head. Also, she had shunt failure due to being taken off Humira, caused degradation of the skin from the top of her head to the shunt in her brain and had to have brain surgery and had to move the shunt to the back of her head. They tried to reintroduce the Humira, but it was not working for her so doctor would switch her to the Skyrizi. She had a right arm fracture due to the fall and did not need surgery but had a clam cast placed. She was in the intensive care unit and after an unknown time period, was transferred to a regular floor and then, she was transferred to a rehabilitation hospital until in Jan-2018. She had not fully recovered from the damage but her not being able to talk and walk was improved. She had also undergone series of therapies such as cognitive, vestibular, and other physical therapies. She could no longer recall the medications given to her while she was in the hospital and mentioned that while she was in the hospital, she discontinued Humira with physicians consent around in 2017. Sometime after her discharge, she had to have a shunt revision due to the shunt being exposed through the skin. Due to being off Humira, she experienced flare up of psoriatic arthritis and plaque psoriasis and she was put back on Humira around in 2018. She could not recall the dose of her Humira. The patient was treated with Amlodipine, Hydrochlorothiazide, Amitriptyline, Vicodin, Butalbital, Meloxicam, Potassium, Methotrexate and Donepezil. On 14-May-2019, the patient experienced yellow indicator observed prior to injection/removed cap one and liquid in the cap. On 15-Dec-2021, the patient experienced Humira syringe needle broken/damaged. Around early in 2021, she started noticing that Humira pen was not effective since drips of medications were remaining on her skin repeatedly. As a result of this, she was shifted from auto injector pen to prefilled syringe. She also mentioned that due to pandemic situation, she was not able to do her physical therapies. Alternative etiology of flare up of psoriatic arthritis and flare up of plaque psoriasis was reported as because of not taking Humira. Alternative etiology of dropped potassium level and muscle pain was reported as due to several unspecified blood pressure medicines. She felt that her covid vaccination shots made her Humira ineffective. In Nov-2021, the coma resolved. In May-2022, the patient experienced covid-19.  Reporter did not allow further contact  Company comment: This spontaneous case concerns a female patient with unspecified age no relevant medical history reported, who experienced the unexpected, non-serious AESI event of COVID 19 that occurred unknown days after receiving the third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient had received 1st and 2nd dose of same vaccine at an interval of 26 days and third dose approximately 9 months later. No further details on risk factors, clinical course, patient's medical history and treatment received were reported. The events outcome was unknown. Ongoing COVID 19 pandemic remains confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with unspecified age no relevant medical history reported, who experienced the unexpected, non-serious AESI event of COVID 19 that occurred unknown days after receiving the third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient had received 1st and 2nd dose of same vaccine at an interval of 26 days and third dose approximately 9 months later. No further details on risk factors, clinical course, patient's medical history and treatment received were reported. The events outcome was unknown. Ongoing COVID 19 pandemic remains confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.