Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Inflammatory bowel disease, Insomnia, Osteoarthritis
Clinical narrative: Procedural site pain; Sinus disorder; FEVER; Inflammatory bowel disease/COLONOSCOPY REVEALS INFLAMMATION/ Defecation urgency; Osteoarthritis; Dry cough; Excess sweating; Anxiety aggravated; Eyes dry; Numbness in hand; General body pain; Shortness of breath; Cholesterol high; Thyroid disorder; Insomnia; High blood pressure; Weakness; Osteopenia; Fatigue; Urinary retention; Nose bleed; Vascular rupture; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed), VASCULAR RUPTURE (Vascular rupture), ASTHENIA (Weakness), URINARY RETENTION (Urinary retention), OSTEOPENIA (Osteopenia), FATIGUE (Fatigue), RHINORRHOEA (Runny nose), PROCEDURAL PAIN (Procedural site pain), SINUS DISORDER (Sinus disorder), PYREXIA (FEVER) and INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease/COLONOSCOPY REVEALS INFLAMMATION/ Defecation urgency) in a 61-year-old 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 products included non-company products ADALIMUMAB (HUMIRA) for Colitis, ADALIMUMAB (HUMIRA) for Colitis and MESALAZINE (APRISO) for an unknown indication.    The patient's past medical history included Tobacco user from 1977 to 2020, Vascular cauterization (Nose cauterized) in August 2018, Vascular cauterization (Nose cauterized in 4 different places) on 06-Dec-2019, Vascular cauterization (Cauterized left nostril only) on 11-Dec-2019, Vascular cauterization (Nose cauterization) on 28-Jun-2021 and Vascular cauterization (Nose cauterization) on 29-Jun-2021. Previously administered products included for Product used for unknown indication: MORPHINE, ATIVAN, AUGMENTIN and ASPIRIN. Past adverse reactions to the above products included No adverse event with ASPIRIN, ATIVAN, AUGMENTIN and MORPHINE. Concurrent medical conditions included Ulcerative colitis (Moderate to severe), Arthritis (Scan showed beginning signs of arthritis) since 2018, Osteopenia (Scan showed signs of osteopenia) since 2019, Drug allergy (ASPIRIN ALLERGY MANIFESTED BY RASH), Drug allergy (MORPHINE ALLERGY MANIFESTED BY RASH AND THROAT SWELLING), Drug allergy (AUGMENTIN ALLERGY MANIFESTED BY UPSET COLON) and Drug allergy (ATIVAN ALLERGY MANIFESTED BY FEELS LIKE DID NOT KNOW WHAT DOING). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, FOLIC ACID, IRON, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA, ASCORBIC ACID (VITAMIN-C), COLECALCIFEROL (VITAMIN D3 1000), CALCIUM, ALPRAZOLAM (XANAX), LOTEPREDNOL ETABONATE (LOTEMAX), MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) and ESTRADIOL for an unknown indication.   In October 2015, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. In January 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. In 2017, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On an unknown date, the patient received first 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, ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK UNK, Citrate free. and MESALAZINE (APRISO) (unknown route) at an unspecified dose. In 2017, the patient experienced VASCULAR RUPTURE (Vascular rupture) (seriousness criterion medically significant) and RHINORRHOEA (Runny nose) (seriousness criterion medically significant). In 2018, the patient experienced EPISTAXIS (Nose bleed) (seriousness criterion medically significant). In 2019, the patient experienced URINARY RETENTION (Urinary retention) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant), OSTEOPENIA (Osteopenia) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PROCEDURAL PAIN (Procedural site pain) (seriousness criterion medically significant), SINUS DISORDER (Sinus disorder) (seriousness criterion medically significant), PYREXIA (FEVER) (seriousness criterion medically significant), INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease/COLONOSCOPY REVEALS INFLAMMATION/ Defecation urgency) (seriousness criterion medically significant), OSTEOARTHRITIS (Osteoarthritis), COUGH (Dry cough), HYPERHIDROSIS (Excess sweating), ANXIETY (Anxiety aggravated), DRY EYE (Eyes dry), HYPOAESTHESIA (Numbness in hand), PAIN (General body pain), DYSPNOEA (Shortness of breath), BLOOD CHOLESTEROL INCREASED (Cholesterol high), THYROID DISORDER (Thyroid disorder), INSOMNIA (Insomnia) and HYPERTENSION (High blood pressure). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency; ROSUVASTATIN at an unspecified dose and frequency; ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency; ALPRAZOLAM at an unspecified dose and frequency; BENZALKONIUM CHLORIDE (CLARITONE) at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Nose bleed, at an unspecified dose and frequency. At the time of the report, EPISTAXIS (Nose bleed), PYREXIA (FEVER), PAIN (General body pain), INSOMNIA (Insomnia) and HYPERTENSION (High blood pressure) had resolved, VASCULAR RUPTURE (Vascular rupture), ASTHENIA (Weakness), URINARY RETENTION (Urinary retention), OSTEOPENIA (Osteopenia), FATIGUE (Fatigue), RHINORRHOEA (Runny nose), PROCEDURAL PAIN (Procedural site pain), SINUS DISORDER (Sinus disorder), INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease/COLONOSCOPY REVEALS INFLAMMATION/ Defecation urgency), OSTEOARTHRITIS (Osteoarthritis), COUGH (Dry cough), ANXIETY (Anxiety aggravated), DRY EYE (Eyes dry), HYPOAESTHESIA (Numbness in hand), DYSPNOEA (Shortness of breath), BLOOD CHOLESTEROL INCREASED (Cholesterol high) and THYROID DISORDER (Thyroid disorder) had not resolved and HYPERHIDROSIS (Excess sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Scan: Osteopenia. In June 2020, Blood test: Good result/Antibody. On an unknown date, Blood cholesterol: High. On an unknown date, Blood pressure measurement: High blood pressure. On an unknown date, Cardiac stress test: Good result. On an unknown date, Colonoscopy: Small amount of inflamation. On an unknown date, Electrocardiogram: Good Result. On an unknown date, Scan: Beginning signs of arthritis.         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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant medical condition of ulcerative colitis, osteopenia and arthritis, and relevant medical history of nose cauterization and nicotine addiction, who experienced the unexpected and serious (due to medically significant) events of Inflammatory bowel disease, Epistaxis, Vascular rupture, Asthenia, Urinary retention, Osteopenia, Fatigue, Rhinorrhoea, Procedural pain, Sinus disorder and Pyrexia, which occurred related to the primary vaccination with mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect products included non-company products Adalimumab for Colitis, and Mesalazine. Underlying ulcerative colitis, osteopenia and arthritis, as well as medical history of nicotine addiction and nose cauterization, remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Significant live follow up (Additional event, Case narrative updated); Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant medical condition of ulcerative colitis, osteopenia and arthritis, and relevant medical history of nose cauterization and nicotine addiction, who experienced the unexpected and serious (due to medically significant) events of Inflammatory bowel disease, Epistaxis, Vascular rupture, Asthenia, Urinary retention, Osteopenia, Fatigue, Rhinorrhoea, Procedural pain, Sinus disorder and Pyrexia, which occurred related to the primary vaccination with mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect products included non-company products Adalimumab for Colitis, and Mesalazine. Underlying ulcerative colitis, osteopenia and arthritis, as well as medical history of nicotine addiction and nose cauterization, remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.