Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Impaired healing, Infected bite, Inflammation
Clinical narrative: COVID-19; BODY INFLAMMATION/INFLAMMATION DUMPING IN BODY; INSECT BITES CAUSE BLISTERS AND REDNESS; OPEN SORE; BUG BITE AND TICK BITE INFECTION; bug bites/tick bites; ITCHY RED BUG BITES; PAIN; shakes; chills; Fever; UNABLE TO BEND ARM AND WRIST; INDEX FINGER PAIN ON LEFT HAND; PSORIATIC ARTHRITIS FLARE UP; PSORIASIS CAME BACK/FLARE UP; RASH, SWELLING BY RED BUG BITES,TICK BITES,BACTERIAL BUG BITES,MOSQUITO BITES/NOT HEAL FOR MORE THAN TWO WEEKS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 051F21A) 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 Psoriatic arthritis and Plaque psoriasis.    The patient's past medical history included Bilateral pneumonia from 14-Jul-2021 to 01-Aug-2021, Difficulty in walking from 10-Jul-2021 to 01-Aug-2021, Oxygen saturation decreased from 13-Jul-2021 to 28-Jul-2021, Sugar blood level increased from 13-Jul-2021 to 18-Jul-2021, Chemical burn (prescribed an unknown antibiotic) from 19-May-2019 to June 2019, Chemical burn of skin (prescribed an unknown antibiotic) from 19-May-2019 to June 2019, Arthralgia aggravated from May 2013 to 2014, Arthralgia aggravated in 2016, Arthralgia aggravated in June 2018, Infected thumb from May 2019 to June 2019 and Swollen thumb from 19-May-2019 to June 2019. Concurrent medical conditions included Psoriatic arthritis, Plaque psoriasis, Non-tobacco user and Abstains from alcohol. Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]), TRAMADOL, NAPROXEN and SULFASALAZINE for Psoriatic arthritis.   In March 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2015, the patient experienced IMPAIRED HEALING (RASH, SWELLING BY RED BUG BITES,TICK BITES,BACTERIAL BUG BITES,MOSQUITO BITES/NOT HEAL FOR MORE THAN TWO WEEKS). On 09-Jul-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 10-Jul-2021, the patient experienced PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) (seriousness criterion medically significant) and PSORIASIS (PSORIASIS CAME BACK/FLARE UP). On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (INDEX FINGER PAIN ON LEFT HAND). On 09-Nov-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (UNABLE TO BEND ARM AND WRIST). On an unknown date, the patient experienced INFLAMMATION (BODY INFLAMMATION/INFLAMMATION DUMPING IN BODY), BLISTER (INSECT BITES CAUSE BLISTERS AND REDNESS), WOUND (OPEN SORE), INFECTED BITE (BUG BITE AND TICK BITE INFECTION), ARTHROPOD BITE (bug bites/tick bites), WOUND COMPLICATION (ITCHY RED BUG BITES), PAIN (PAIN), TREMOR (shakes), CHILLS (chills) and PYREXIA (Fever). The patient was hospitalized from 14-Jul-2021 to 18-Jul-2021 due to COVID-19. The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency; DEXAMETHASONE at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; REMDESIVIR at an unspecified dose and frequency and INSULIN at an unspecified dose and frequency. In 2021, COVID-19 (COVID-19), PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) and PSORIASIS (PSORIASIS CAME BACK/FLARE UP) had resolved. In October 2021, IMPAIRED HEALING (RASH, SWELLING BY RED BUG BITES,TICK BITES,BACTERIAL BUG BITES,MOSQUITO BITES/NOT HEAL FOR MORE THAN TWO WEEKS) had resolved. At the time of the report, INFLAMMATION (BODY INFLAMMATION/INFLAMMATION DUMPING IN BODY), BLISTER (INSECT BITES CAUSE BLISTERS AND REDNESS), WOUND (OPEN SORE), ARTHROPOD BITE (bug bites/tick bites) and WOUND COMPLICATION (ITCHY RED BUG BITES) outcome was unknown, JOINT RANGE OF MOTION DECREASED (UNABLE TO BEND ARM AND WRIST), PAIN (PAIN) and PAIN IN EXTREMITY (INDEX FINGER PAIN ON LEFT HAND) had not resolved and INFECTED BITE (BUG BITE AND TICK BITE INFECTION), TREMOR (shakes), CHILLS (chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, Nasopharyngeal swab: Showed positive for Covid 19. On 12-Jul-2021, Body temperature: 103 103 F. On 13-Jul-2021, Oxygen saturation: Decreased oxygen level from 93 to 88. On 14-Jul-2021, Blood test: Showed increase in sugar level. On 14-Jul-2021, Chest X-ray: Showed double pneumonia. In September 2021, SARS-CoV-2 antibody test: Greater than 14, less than 50. In October 2021, SARS-CoV-2 antibody test: Antibody test showed 4.         It was unknown if patient was enrolled in a covid-19 vaccine trial   On unknown dates, He experienced insect bites cause blisters and redness, itchy red bug bites, pain, open sore, bug bite and tick bite infection, body inflammation and after covid vaccine he had shakes/chills/fever. He was getting insect bites that would not heal easily. he described the bug bites and tick bites that he had while on humira swell up for a month like big rashes and would not heal for more than two weeks. The longer he was on humira the longer it would take for the bug bites and tick bites to heal.   On 04-Jul-2021, He had cough, From 06-Jul-2021, had fatigue. From 08-Jul 2021, had changed in smell, taste, From 10-Jul-2021, had cough, From 12-Jul-2021, had fever and From 13-Jul-2021, he had heavy breathing. Treated with two milliliter oxygen daily. he clarified the adverse event sick was his diagnosis of covid-19. fever was recovered on 16-Jul-2021. Changes in taste, cough were recovered on 01-Aug-2021. While off humira experienced flare up on both his psoriasis and psoriatic arthritis where all of his joints from his head to toe are inflamed and swelled up. Had pain in his index finger on the left hand and prescribed an epipen but he never administered.   Reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event with humira (adalimumab) for events covid-19 psoriasis flare-up, wound healing delayed, psoriatic arthritis aggravated was possible. For insect bite nos, pain, shaking, chills, pyrexia was no reasonable possibility, for blisters, wound erythema, pain in fingers, joint range of motion decreased was not related and for arthropod bite, wound, infected bite causality was not 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  Company comment: This spontaneous case concerns a 36 year old male patient with concurrent  Psoriatic arthritis and Plaque psoriasis, who experienced the unexpected serious (hospitalized) AESI of COVID-19 and unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthropathy) , about 3 months and 13 days prior to receiving the first dose of mRNA-1273 vaccine. His blood test showed increase in sugar level, temperature was 103 degree F; Chest X-ray showed double pneumonia; nasopharyngeal swab was positive for COVID 19; Oxygen saturation decreased from 93 to 88; SARS-CoV-2 antibody test was greater than 14 and less than 50 which further reduced to 4 in two months. The events resolved. Co-suspect adalimumab could be a risk factor for the event COVID 19. Concurrent  Psoriatic arthritis and Plaque psoriasis could be confounding for Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36 year old male patient with concurrent  Psoriatic arthritis and Plaque psoriasis, who experienced the unexpected serious (hospitalized) AESI of COVID-19 and unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthropathy) , about 3 months and 13 days prior to receiving the first dose of mRNA-1273 vaccine. His blood test showed increase in sugar level, temperature was 103 degree F; Chest X-ray showed double pneumonia; nasopharyngeal swab was positive for COVID 19; Oxygen saturation decreased from 93 to 88; SARS-CoV-2 antibody test was greater than 14 and less than 50 which further reduced to 4 in two months. The events resolved. Co-suspect adalimumab could be a risk factor for the event COVID 19. Concurrent  Psoriatic arthritis and Plaque psoriasis could be confounding for Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.