Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Hernia, Interchange of vaccine products, Large intestinal stenosis, Urticaria chronic
Clinical narrative: After getting the vaccine, he had colon surgery for stricture; After getting the vaccine, he had colon surgery for stricture and 2 hernia surgeries, right and left.; Chronic hives started,staring at his hives on his face,hives in his arms and in various spots on his face, back and was told that it is beyond chronic and severe. He has bumps on his head and feels like he has bugs in it.; the patient received Pfizer vaccine as booster dose in vaccination schedule; the patient received Pfizer vaccine as booster dose in vaccination schedule; This spontaneous case was reported by a patient and describes the occurrence of LARGE INTESTINAL STENOSIS (After getting the vaccine, he had colon surgery for stricture), HERNIA (After getting the vaccine, he had colon surgery for stricture and 2 hernia surgeries, right and left.) and URTICARIA CHRONIC (Chronic hives started,staring at his hives on his face,hives in his arms and in various spots on his face, back and was told that it is beyond chronic and severe. He has bumps on his head and feels like he has bugs in it.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 038A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Knee operation (He is disabled have had knee, foot, spine operations before getting the vaccine.), Foot operation and Spinal operation. Concurrent medical conditions included Diabetes (Diabetes - was on medication for a while but got controlled with weight reduction; off meds currently - diagnosed before getting the vaccine).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (After getting the vaccine, he had colon surgery for stricture) (seriousness criterion medically significant), HERNIA (After getting the vaccine, he had colon surgery for stricture and 2 hernia surgeries, right and left.) (seriousness criterion medically significant), URTICARIA CHRONIC (Chronic hives started,staring at his hives on his face,hives in his arms and in various spots on his face, back and was told that it is beyond chronic and severe. He has bumps on his head and feels like he has bugs in it.) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (the patient received Pfizer vaccine as booster dose in vaccination schedule) and COVID-19 IMMUNISATION (the patient received Pfizer vaccine as booster dose in vaccination schedule). The patient was treated with OMALIZUMAB (XOLAIR) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; MONTELUKAST at an unspecified dose and frequency; DOXEPIN at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; METHOTREXATE ongoing since an unknown date at an unspecified dose and frequency; HYDROXYZINE ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; Surgery (Colon surgery for stricture) for Large intestinal stenosis and Surgery (2 hernia surgeries, right and left.) for Hernia. At the time of the report, LARGE INTESTINAL STENOSIS (After getting the vaccine, he had colon surgery for stricture), HERNIA (After getting the vaccine, he had colon surgery for stricture and 2 hernia surgeries, right and left.), INTERCHANGE OF VACCINE PRODUCTS (the patient received Pfizer vaccine as booster dose in vaccination schedule) and COVID-19 IMMUNISATION (the patient received Pfizer vaccine as booster dose in vaccination schedule) outcome was unknown and URTICARIA CHRONIC (Chronic hives started,staring at his hives on his face,hives in his arms and in various spots on his face, back and was told that it is beyond chronic and severe. He has bumps on his head and feels like he has bugs in it.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient called in to report that he had chronic hives for 2 years and recently read online that the rate of Moderna vaccine's incidence of chronic hives was higher than the rest. He had 2 doses of the Moderna vaccine in 2021. He could not tell exactly when the chronic hives started. They initially thought they were caused by bed bugs but no bed bugs were found. He initially went to his primary physician who gave him something for severe itching. The itching did not resolved so he went to see a dermatologist then 4 allergists thereafter. He stated that these hives had ruined his life and he does not like people looking at him, staring at his hives on his face. His intimacy with his wife was no more and he was ashamed of the way he looked. He does not even hug his wife and prefers not to had physical contact with anybody as he does not want to infect somebody. He stays home everyday and he stated that he was a different person now, it was not right and was very depressing. He had the hives in his arms and in various spots on his face, back and was told that it was beyond chronic and severe. He had bumps on his head and feels like he had bugs in it. It affected his sleeping. He provided the names of the 4 allergists that he consulted and the corresponding medications. He stated that the doctor spoke to him once and the 2nd time she dumped him because he got got worse.  Company comment:  This spontaneous case report concerns a 75-year-old male patient with no relevant medical history, who experienced serious (medically significant) unexpected events of Large intestinal stenosis, Hernia and Chronic Urticaria. Reportedly, after getting the vaccine (unspecified dose of the mRNA-1273 vaccine), the patient had colon surgery due to stricture and 2 hernia surgeries, right and left. The exact temporal relationship between these events and administration of the mRNA-1273 vaccine could not be determined since the events' start dates were not provided. No additional details were provided. It was not also specified whether the patient was hospitalized and if yes, duration of hospitalization. Limited information precludes a meaningful medical assessment at this stage regarding these events. In addition, the patient developed chronic hives for 2 years, however, the exact start date of the event was not known. Hives were present on the patient's arms, head, face and back. Due to this event, the patient visited primary physician, dermatologist and 4 allergists thereafter. Due to reported event, the patient had difficulties in every day activities and social contact. He was told that urticaria was beyond chronic and severe. The patient was treated with: Xolair (an injectable preparation), Zyrtec, Montelukast, Doxipin and Prednisone. In addition, the patient was receiving Methotrexate, Hydroxyzine and Benadryl for the itching. Due to nature of the reported events of Hernia and Large intestinal stenosis, the company causality is assessed as not related to mRNA-1273 but most likely related to existing underlying conditions. All events were assessed as serious due to medical significance, having in mind that Large intestinal stenosis and Hernia required surgery, and on the other side, due to duration of Chronic urticaria and an impact in patient's every day activities and social contacts. Pfizer vaccine remains a confounder for chronic hives at this point, having in mind that the start date of Chronic urticaria was not specified and contributory role of the product cannot be excluded at this moment. No further details were available for medical assessment. Interchange of vaccine products and COVID-19 immunisation (revaccination with different COVI-19 vaccine) are also considered as an events in this case report, having in mind that the patient received Pfizer vaccine as booster dose in vaccination schedule. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 75-year-old male patient with no relevant medical history, who experienced serious (medically significant) unexpected events of Large intestinal stenosis, Hernia and Chronic Urticaria. Reportedly, after getting the vaccine (unspecified dose of the mRNA-1273 vaccine), the patient had colon surgery due to stricture and 2 hernia surgeries, right and left. The exact temporal relationship between these events and administration of the mRNA-1273 vaccine could not be determined since the events' start dates were not provided. No additional details were provided. It was not also specified whether the patient was hospitalized and if yes, duration of hospitalization. Limited information precludes a meaningful medical assessment at this stage regarding these events. In addition, the patient developed chronic hives for 2 years, however, the exact start date of the event was not known. Hives were present on the patient's arms, head, face and back. Due to this event, the patient visited primary physician, dermatologist and 4 allergists thereafter. Due to reported event, the patient had difficulties in every day activities and social contact. He was told that urticaria was beyond chronic and severe. The patient was treated with: Xolair (an injectable preparation), Zyrtec, Montelukast, Doxipin and Prednisone. In addition, the patient was receiving Methotrexate, Hydroxyzine and Benadryl for the itching. Due to nature of the reported events of Hernia and Large intestinal stenosis, the company causality is assessed as not related to mRNA-1273 but most likely related to existing underlying conditions. All events were assessed as serious due to medical significance, having in mind that Large intestinal stenosis and Hernia required surgery, and on the other side, due to duration of Chronic urticaria and an impact in patient's every day activities and social contacts. Pfizer vaccine remains a confounder for chronic hives at this point, having in mind that the start date of Chronic urticaria was not specified and contributory role of the product cannot be excluded at this moment. No further details were available for medical assessment. Interchange of vaccine products and COVID-19 immunisation (revaccination with different COVI-19 vaccine) are also considered as an events in this case report, having in mind that the patient received Pfizer vaccine as booster dose in vaccination schedule. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.