Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Fatigue, Ileus, Infection
Clinical narrative: bowel obstruction; possible ileus; infection; Upper abdominal pain; Nausea; Weakness; Diarrhea; throw up/vomited; chest pain; symptoms from his previous open heart surgery; Weight loss; trouble eating solid food; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of INTESTINAL OBSTRUCTION (bowel obstruction), ILEUS (possible ileus), INFECTION (infection), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Upper abdominal pain) and NAUSEA (Nausea) in a 61-year-old male 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 DUPILUMAB (DUPIXENT) for Atopic dermatitis.    The patient's past medical treatments, vaccinations and family history were not provided.  The patient's past medical history included Open heart surgery in 1999. Concurrent medical conditions included Atopic dermatitis and Neoplasm malignant.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 1 dosage form. In April 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion hospitalization), CARDIOVASCULAR SYMPTOM (symptoms from his previous open heart surgery), WEIGHT DECREASED (Weight loss), DYSPHAGIA (trouble eating solid food) and FATIGUE (Fatigue). On 21-Jul-2021, the patient experienced CHEST PAIN (chest pain) and VOMITING (throw up/vomited). On an unknown date, the patient experienced INTESTINAL OBSTRUCTION (bowel obstruction) (seriousness criteria hospitalization and medically significant), ILEUS (possible ileus) (seriousness criteria hospitalization and medically significant), INFECTION (infection) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Upper abdominal pain) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhea). The patient was hospitalized from 21-Jul-2021 to 26-Jul-2021 due to ABDOMINAL PAIN UPPER, ASTHENIA, ILEUS, INFECTION, INTESTINAL OBSTRUCTION and NAUSEA. The patient was treated with MORPHINE for Abdominal pain, Nausea and Diarrhea, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Ileus and Small bowel obstruction, at an unspecified dose and frequency and HYDROMORPHONE HCL for Ileus and Small bowel obstruction, at an unspecified dose and frequency. At the time of the report, INTESTINAL OBSTRUCTION (bowel obstruction), ILEUS (possible ileus), INFECTION (infection), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Upper abdominal pain), NAUSEA (Nausea), CHEST PAIN (chest pain), CARDIOVASCULAR SYMPTOM (symptoms from his previous open heart surgery), WEIGHT DECREASED (Weight loss), DYSPHAGIA (trouble eating solid food), DIARRHOEA (Diarrhea), VOMITING (throw up/vomited) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: (Inconclusive) inconclusive. In 2021, Weight: Weight loss of 17 lbs.         No concomitant medications were reported.   On 21-Jul-2021, (3 months 15 days latency after dupilumab and 3 months 27 days after MRNA vaccine), he experienced 10/10 chest pain and needed pain medication and he was heard throw up/ vomited over 20 times (vomiting) and did not come back on the phone for a while, they arrived and took over the call. The patient was hospitalized due to bowel obstruction (intestinal obstruction), due to possible ileus (ileus), due to infection, treated with NG Tube (infection), Weakness (Asthenia), Upper abdominal pain (Abdominal pain upper) and nausea. The patient was hospitalized from 21-Jul-2021 to 26-Jul-2021 (hospitalization during 5 days) for the all these events. On an unknown date in 2021, the patient experienced Weight loss of 17 lbs (weight decreased), Weakness (Asthenia), Trouble eating solid food (Dysphagia) and Fatigue (unknown latency). Reportedly, currently still experiences abdominal pain after eating, and problems with eating solid foods, able to tolerate eggs this morning, will have an appointment for upper gastric test or barium swallow test on 08-Sep-2021, then he also experiences fatigue, and did not fell after his Moderna vaccines, did go to a few specialist, had blood tests done and results were inconclusive and believes symptoms are related to the vaccines. Patient received samples, and process of resuming therapy due to financial issues, last dose was on 01-Jul-2021.  Corrective treatment included Pain medication for (chest pain); nasogastric tube was placed and two liters of fluid were removed from his stomach. Patient received treatment for events Chest pain, Abdominal pain upper, Nausea, Diarrhoea, Ileus and Intestinal obstruction.  The reporter causality was not reported for all events for dupilumab.  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 61-year-old, male patient with medical history of Open Heart surgery (1999) for unknown indication and history of co-suspect administration of Dupixent (dupilumab) for Atopic Dermatitis, who experienced the unexpected, serious (hospitalization and medically significant) events of intestinal obstruction and ileus, the unexpected, serious (hospitalization) events of infection, asthenia, abdominal pain upper and nausea, and other unexpected and expected, non-serious events.The non-serious events chest pain and vomiting occurred approximately 2 months after receiving the second dose of the mRNA-1273 vaccine. The serious event asthenia and the non-serious events cardiovascular symptom, weight decreased, dysphagia and fatigue occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that approximately 1 month after vaccination, the patient had an overnight hospital stay. No further clinical information (including details about hospitalization, symptoms, diagnostic test/s and treatment) was available for medical review. Approximately 2 months after vaccination, it was reported that the patient experienced chest pain (pain scale: 10/10) and vomiting (over 20 times). An unspecified pain medication was given for the chest pain. It was also reported that the patient was hospitalized for 6 days due to bowel obstruction, possible ileus, infection, weakness, upper abdominal pain and nausea. Morphine was given for the abdominal pain, nausea and diarrhea. Zofran (ondansetron) and Dilaudid (hydromorphone hydrochloride) were given for the ileus and small bowel obstruction. It was reported that the infection (unspecified) was treated with nasogastric tube and 2 liters of fluid were removed from the patient's stomach. On unknown dates in 2021, the patient experienced weight loss of 17 pounds, weakness, trouble eating solid food and fatigue. On unspecified dates in 2021, the patient's blood tests (unpsecified) were reported as inconclusive, however, the results were not provided. The patient was also tested for cardiovascular symptoms (not reported) from his previous Open Heart surgery, however, no details were provided. It was also reported that the patient had an appointment approximately 4 months after vaccination for upper gastric test or barium swallow, however, no details were provided. The events had not resolved at the time of the report. The medical history of Open Heart surgery remains a confounder for the event cardiovascular symptom. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old, male patient with medical history of Open Heart surgery (1999) for unknown indication and history of co-suspect administration of Dupixent (dupilumab) for Atopic Dermatitis, who experienced the unexpected, serious (hospitalization and medically significant) events of intestinal obstruction and ileus, the unexpected, serious (hospitalization) events of infection, asthenia, abdominal pain upper and nausea, and other unexpected and expected, non-serious events.The non-serious events chest pain and vomiting occurred approximately 2 months after receiving the second dose of the mRNA-1273 vaccine. The serious event asthenia and the non-serious events cardiovascular symptom, weight decreased, dysphagia and fatigue occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that approximately 1 month after vaccination, the patient had an overnight hospital stay. No further clinical information (including details about hospitalization, symptoms, diagnostic test/s and treatment) was available for medical review. Approximately 2 months after vaccination, it was reported that the patient experienced chest pain (pain scale: 10/10) and vomiting (over 20 times). An unspecified pain medication was given for the chest pain. It was also reported that the patient was hospitalized for 6 days due to bowel obstruction, possible ileus, infection, weakness, upper abdominal pain and nausea. Morphine was given for the abdominal pain, nausea and diarrhea. Zofran (ondansetron) and Dilaudid (hydromorphone hydrochloride) were given for the ileus and small bowel obstruction. It was reported that the infection (unspecified) was treated with nasogastric tube and 2 liters of fluid were removed from the patient's stomach. On unknown dates in 2021, the patient experienced weight loss of 17 pounds, weakness, trouble eating solid food and fatigue. On unspecified dates in 2021, the patient's blood tests (unpsecified) were reported as inconclusive, however, the results were not provided. The patient was also tested for cardiovascular symptoms (not reported) from his previous Open Heart surgery, however, no details were provided. It was also reported that the patient had an appointment approximately 4 months after vaccination for upper gastric test or barium swallow, however, no details were provided. The events had not resolved at the time of the report. The medical history of Open Heart surgery remains a confounder for the event cardiovascular symptom. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.