Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Skin infection; Bunion; Rheumatoid arthritis flare up; Shingles; COVID-19; Fatigue aggravated; Myalgia aggravated; Painful feet; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 033CZ1A) 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.    The patient's past medical history included Alcohol use (ONE OR TWO DRINKS A WEEK), Tremor, Rash, Hives, Anaphylaxis, Fatigue in May 2021, Myalgia in May 2021, Exhaustion in 2020, COVID-19 in August 2020 and Surgery (bunion surgery) on 07-May-2021. Concurrent medical conditions included Drug allergy (SAVELLA ALLERGY MANIFESTED BY SEVERE TREMORS), Drug allergy (LYRICA ALLERGY MANIFESTED BY SEVERE TREMORS), Drug allergy (EMITREX ALLERGY MANIFESTED BY MIGRAINES), Allergy (BACARDI ALLERGY MANIFESTED BY MIGRAINES), Drug allergy (PROCARDIA ALLERGY MANIFESTED BY RASH AND HIVES), Drug allergy (WELLBUTRIN ALLERGY MANIFESTED BY MIGRAINES AND ANAPHYLAXIS), Migraine, Restless leg syndrome, Fibrocystic disease of breast, Depression, Anxiety, Rheumatoid arthritis, Acid reflux (oesophageal) and Hypothyroidism. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), PIROXICAM (PAXIL [PIROXICAM]) for Anxiety and Depression, ASPIRIN [ACETYLSALICYLIC ACID] for Clotting disorder, ARIPIPRAZOLE (ABILIFY) for Depression, IODINE for Fibrocystic disease of breast, LEVOTHYROXINE for Hypothyroidism, FREMANEZUMAB VFRM (AJOVY [FREMANEZUMAB VFRM]) for Migraine, MACROGOL 3350 (MIRALAX) for Restless leg syndrome, METHOTREXATE for Rheumatoid arthritis, CALCIUM and FOLIC ACID for Supplementation therapy.   In 2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 19-Jun-2021, received second 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) 40 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In June 2021, the patient experienced FATIGUE (Fatigue aggravated) and MYALGIA (Myalgia aggravated). In 2021, the patient experienced PAIN IN EXTREMITY (Painful feet). In June 2021, the patient experienced FATIGUE (Fatigue aggravated) and MYALGIA (Myalgia aggravated). In July 2021, the patient experienced COVID-19 (COVID-19). In August 2021, the patient experienced HERPES ZOSTER (Shingles). In November 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN INFECTION (Skin infection) and FOOT DEFORMITY (Bunion). The patient was treated with ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) at an unspecified dose and frequency. In 2021, HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) had resolved, FATIGUE (Fatigue aggravated) and MYALGIA (Myalgia aggravated) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and PAIN IN EXTREMITY (Painful feet) had not resolved, SKIN INFECTION (Skin infection) outcome was unknown and FOOT DEFORMITY (Bunion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Body temperature: More than 103 F fever. In August 2020, Nasopharyngeal swab: (Positive) Covid 19 positive. In 2021, Nasopharyngeal swab: (Negative) Negative for Covid 19 infection. In 2021, SARS-CoV-2 antibody test: (Positive) Positive for antibodies.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had a PARCARDIUM ALLERGY. The patient had bunion surgery on 07-May-2021 and it was very extensive. Her big toe of right foot was repositioned and tendons were removed. In Jul 2021, She had Covid virus and in Aug 2021, she had shingles. she was Humira off for five weeks due to Surgery. She was off Humira for five weeks because the surgery got postponed. The bunionectomy of right foot supposedly done on 11 Nov 2021, but in 30 Nov 2021, was rescheduled surgery. She had events of joint pain, morning stiffness, fatigue, fever, pain with or without movement, shortness of breath and cough which were subsumed under the diagnosis. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. The reporter's causality for the event(s) of WORSENED BUNION ON BOTH FEET, FATIGUE, RECURRED FATIGUE,SHINGLES, COVID VIRUS, PAIN ON BOTH FEET, RHEUMATOID ARTHRITIS FLARE UP, MUSCLE ACHES, COVID-19 and RECURRED MUSCLE ACHES with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of EXHAUSTION and SKIN INFECTION was not provided. There was no reasonable possibility that the events of WORSENED BUNION ON BOTH FEET, FATIGUE, RECURRED FATIGUE, EXHAUSTION, COVID VIRUS, PAIN ON BOTH FEET, RHEUMATOID ARTHRITIS FLARE UP, MUSCLE ACHES, COVID-19 and RECURRED MUSCLE ACHES are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). There was a reasonable possibility that the events of SKIN INFECTION and SHINGLES are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  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 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) and unexpected AESI non serious event of COVID-19. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Nasopharyngeal swab was Negative for Covid 19 infection and SARS-CoV-2 antibody test was Positive for antibodies as on unspecified date. The patient was treated with acyclovir [acyclovir], oxycodone hydrochloride, oxycodone terephthalate, paracetamol (Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol]) and the event outcome was not resolved for rheumatoid arthritis and resolved for COVID-19. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. Ongoing pandemic remains confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2021-624026 (Patient Link).; Sender's Comments: This spontaneous case concerns a 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) and unexpected AESI non serious event of COVID-19. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Nasopharyngeal swab was Negative for Covid 19 infection and SARS-CoV-2 antibody test was Positive for antibodies as on unspecified date. The patient was treated with acyclovir [acyclovir], oxycodone hydrochloride, oxycodone terephthalate, paracetamol (Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol]) and the event outcome was not resolved for rheumatoid arthritis and resolved for COVID-19. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. Ongoing pandemic remains confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.