Age: 68.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: complications from the appendicitis/My appendix burst/I had complications, abscesses that had to be drained; respiratory bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (complications from the appendicitis/My appendix burst/I had complications, abscesses that had to be drained) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no allergies.  The patient's past medical history included Accidental injury (bad enough after being injured in a work accident in the summer of 1980) in 1980 and Migraine (Migraines due to infected root canal). Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE, DIPHTHERIA VACCINE (I was a 5 year old and I got the diphtheria vaccine they gave out at our elementary school.), SMALLPOX VACCINE (I was a 5 year old and I got the small pox vaccine they gave out at our elementary school.), MUMPS VACCINE (I was a 5 year old and I got the  mumps vaccine they gave out at our elementary school.) and MEASLES VACCINE (I was a 5 year old and I got the measles they gave out at our elementary school.). Past adverse reactions to the above products included No adverse event with DIPHTHERIA VACCINE, INFLUENZA VACCINE, MEASLES VACCINE, MUMPS VACCINE and SMALLPOX VACCINE.    On 05-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced APPENDICITIS (complications from the appendicitis/My appendix burst/I had complications, abscesses that had to be drained) (seriousness criteria hospitalization and medically significant). In December 2022, the patient experienced BRONCHITIS (respiratory bronchitis). The patient was hospitalized for 11 days due to APPENDICITIS. The patient was treated with AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. On 01-Jan-2023, APPENDICITIS (complications from the appendicitis/My appendix burst/I had complications, abscesses that had to be drained) and BRONCHITIS (respiratory bronchitis) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient took second booster on 31-Mar-2022 with Lot number as 046L21A. It was reported that patient appendix burst on October 8th. As a direct consequence, patient had complications like abscesses that drained. Patient was in hospital for 3 days, 6, 7 days on clear liquids by himself in that room. Patient was old. He said that according to the CDC, research had shown that in the weeks followed by administration of the bivalent booster, this can happen as a side effect. He says that he felt injured. He said that he had complications from the appendicitis and had to take clear liquids for 10 days. This was very weakening for him. He says that going through this was bad. He said that he spent 11 days in the hospital due to the appendicitis. Additionally, he stated that his doctor wrote a prescription for him for physical therapy. However, he quit PT after 3 weeks because they made him do exercises that hurt his legs and he did not want to injure himself more. He also stated that he got respiratory bronchitis in Dec-2022. He stated that he was hacking, coughing, blowing snot, and phlegm" all through December of 2022. His doctor had to prescribe Zithromax for his symptoms. He stated that respiratory issues are going to be a consequence of Moderna.  Company comment: This spontaneous case concerns a 68 year old male patient with no relevant medical history, who experienced the unexpected serious (hospitalization, medically significant) event of Appendicitis, 3 days after receiving the fifth dose (additional booster) of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that the patient's appendix burst and had complications like abscesses which had to be drained. The patient was in the hospital for 11 days. He had earlier received two booster doses of Moderna vaccine. No information on risk factors and investigations was available in the report. The event resolved after about 3 months. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to MOD-2023-712991 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68 year old male patient with no relevant medical history, who experienced the unexpected serious (hospitalization, medically significant) event of Appendicitis, 3 days after receiving the fifth dose (additional booster) of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that the patient's appendix burst and had complications like abscesses which had to be drained. The patient was in the hospital for 11 days. He had earlier received two booster doses of Moderna vaccine. No information on risk factors and investigations was available in the report. The event resolved after about 3 months. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.