Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Intestinal obstruction, Mass, Papule, Photophobia
Clinical narrative: Papule; Light sensitivity to eye; Difficulty sleeping; Vision decreased; Inflammation;  disease; Bowel obstruction; Injection site papule; Pain during injection; Injection site scab; Mass; Scab; Injury; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (Bowel obstruction) and VOGT-KOYANAGI-HARADA DISEASE (flare of Vogt  in a 62-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 product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Crohn's disease.    Concurrent medical conditions included Harada's disease.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 14-May-2021, the patient experienced INJECTION SITE SCAB (Injection site scab), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE PAIN (Pain during injection). In May 2021, the patient experienced MASS (Mass), SCAB (Scab) and INJURY (Injury). In November 2021, the patient experienced INTESTINAL OBSTRUCTION (Bowel obstruction) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced VOGT-KOYANAGI-HARADA DISEASE (flare of Vogt Koyanagi Harada disease) (seriousness criterion medically significant). On an unknown date, the patient experienced PAPULE (Papule), PHOTOPHOBIA (Light sensitivity to eye), INSOMNIA (Difficulty sleeping), VISUAL IMPAIRMENT (Vision decreased) and INFLAMMATION (Inflammation). At the time of the report, INTESTINAL OBSTRUCTION (Bowel obstruction), VOGT-KOYANAGI-HARADA DISEASE (flare of Vogt Koyanagi Harada disease), MASS (Mass), SCAB (Scab), PAPULE (Papule), PHOTOPHOBIA (Light sensitivity to eye), INJECTION SITE SCAB (Injection site scab), INSOMNIA (Difficulty sleeping), VISUAL IMPAIRMENT (Vision decreased), INFLAMMATION (Inflammation), INJURY (Injury), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE PAIN (Pain during injection) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient was slightly concerned about the activities, she also had different sleep pattern and wakes up much earlier than usual. She was losing more vision in eye. Stated that she cannot see five feet in front of her. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  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 62-year-old, female patient with relevant medical history of Vogt-Koyanagi-Harada syndrome, and medical history of Non-infectious Intermediate, Posterior and Panuveitis and Moderate-to-severe Crohn's disease treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of Vogt-Koyanagi-Harada disease and intestinal obstruction, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The non-serious events mass, scab, injury, injection site scab, injection site papule and injection site pain occurred unknown number of days before receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in May2021 and 14May2021 while the first dose was given on an unspecified date in Jun2021, hence, the onset latency could not be assessed. The outcomes of these events were unknown at the time the patient received the first dose and second dose of the mRNA-1273 vaccine. The events intestinal obstruction and Vogt-Koyanagi-Harada disease occurred unknown number of days after receiving the first dose and second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified date in Nov2021 and 21Nov2021, respectively, while the first dose was given on an unspecified date in Jun2021 and the second dose was given on an unspecified date in 2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided. In about a month before receiving the first dose of the mRNA-1273 vaccine, the patient experienced a little lump, scab at the injection site and painful injection. On unknown dates, it was reported that the patient experienced a bump, eye issues/more sensitivity to light, worsening eyesight, sleep irregularitie/trouble sleeping and increased inflammation. Approximately 5 months after receiving the first dose of the mRNA-1273 vaccine, the patient experienced bowel obstruction and flare of Vogt-Koyanagi-Harada disease. It was also reported that the patient was slightly concerned about the activities, and she also had a different sleep pattern and woke up much earlier than usual. She was losing more vision in the eye and cannot see 5 feet in front of her. Treatment information was not provided. The medical history of Vogt-Koyanagi-Harada syndrome remains a confounder for the event Vogt-Koyanagi-Harada disease, and for the events photophobia and visual impairment which are common symptoms of the disease. The medical history of Non-infectious Intermediate, Posterior and Panuveitis also remains a confounder for the events photophobia and visual impairment which are common symptoms of the disease. The medical history of Crohn's disease remains a confounder for the event intestinal obstruction since the disease may lead to a complication of bowel obstruction. The history of co-suspect administration of Humira also remains a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with relevant medical history of Vogt-Koyanagi-Harada syndrome, and medical history of Non-infectious Intermediate, Posterior and Panuveitis and Moderate-to-severe Crohn's disease treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of Vogt-Koyanagi-Harada disease and intestinal obstruction, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The non-serious events mass, scab, injury, injection site scab, injection site papule and injection site pain occurred unknown number of days before receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in May2021 and 14May2021 while the first dose was given on an unspecified date in Jun2021, hence, the onset latency could not be assessed. The outcomes of these events were unknown at the time the patient received the first dose and second dose of the mRNA-1273 vaccine. The events intestinal obstruction and Vogt-Koyanagi-Harada disease occurred unknown number of days after receiving the first dose and second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified date in Nov2021 and 21Nov2021, respectively, while the first dose was given on an unspecified date in Jun2021 and the second dose was given on an unspecified date in 2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided. In about a month before receiving the first dose of the mRNA-1273 vaccine, the patient experienced a little lump, scab at the injection site and painful injection. On unknown dates, it was reported that the patient experienced a bump, eye issues/more sensitivity to light, worsening eyesight, sleep irregularitie/trouble sleeping and increased inflammation. Approximately 5 months after receiving the first dose of the mRNA-1273 vaccine, the patient experienced bowel obstruction and flare of Vogt-Koyanagi-Harada disease. It was also reported that the patient was slightly concerned about the activities, and she also had a different sleep pattern and woke up much earlier than usual. She was losing more vision in the eye and cannot see 5 feet in front of her. Treatment information was not provided. The medical history of Vogt-Koyanagi-Harada syndrome remains a confounder for the event Vogt-Koyanagi-Harada disease, and for the events photophobia and visual impairment which are common symptoms of the disease. The medical history of Non-infectious Intermediate, Posterior and Panuveitis also remains a confounder for the events photophobia and visual impairment which are common symptoms of the disease. The medical history of Crohn's disease remains a confounder for the event intestinal obstruction since the disease may lead to a complication of bowel obstruction. The history of co-suspect administration of Humira also remains a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.