Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Metabolic function test, Migraine, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: Non painful Blood coming from rectum; migraine headache; viral syndrome; watery diarrhea; bodyaches; nausea; vomiting; fatigue; This spontaneous case was reported by a physician and describes the occurrence of RECTAL HAEMORRHAGE (Non painful Blood coming from rectum) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, took months to recoup from symptoms), PFIZER BIONTECH COVID-19 VACCINE (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included Adverse drug reaction with PFIZER BIONTECH COVID-19 VACCINE; and No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hypothyroidism and Small intestine carcinoma. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and APPLE CIDER VINEGAR [MALUS SPP. VINEGAR EXTRACT] for an unknown indication.    On 13-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Jan-2023, the patient experienced RECTAL HAEMORRHAGE (Non painful Blood coming from rectum) (seriousness criterion medically significant), MIGRAINE (migraine headache), VIRAL INFECTION (viral syndrome), DIARRHOEA (watery diarrhea), MYALGIA (bodyaches), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). In January 2023, RECTAL HAEMORRHAGE (Non painful Blood coming from rectum) had resolved. At the time of the report, MIGRAINE (migraine headache), VIRAL INFECTION (viral syndrome), DIARRHOEA (watery diarrhea), MYALGIA (bodyaches), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2023, Weight: lost close to 20 lbs. On an unknown date, Computerised tomogram: had yearly CT for carcinoma and that was completely clear.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on unspecified medication for hypothyroidism. She never had COVID. On 14-Jan-2023, patient woke up with the usual big body ache, fatigue, nausea, vomiting, watery diarrhea, and near migraine headache. Non painful blood coming from rectum for two days that soaked through clothing, which stopped abruptly the 3rd day. Patient still had significant headaches/migraines, nausea, vomiting and watery diarrhea fatigue. Patient was taking supplements which she stopped other than multivitamin and apple cider vinegar capsules to help her tummy. She lost close to 20 lbs in this time frame. She missed work at times. Mostly forging through. She had poor quality of life. Patient wanted to know if there was anything to help her feel better.  Patient stated that symptoms from Pfizer were not nearly as bad as the symptoms from Moderna vaccine. Due to the way she felt right now, she thought of not vaccinating again for COVID. At the very least not with Moderna. It was unknown if the patient experienced any additional symptoms. No treatment information was reported.  Company Comment: This spontaneous case concerns a 55 year old female patient with concurrent Hypothyroidism and history of Small intestine carcinoma, who experienced the unexpected serious (medically significant) event of Rectal haemorrhage (non painful blood coming from rectum), on the next day of receiving the fourth dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. The patient received the previous three doses with Pfizer COVID 19 vaccine and took months to recuperate after the first dose. Thus, an interchange of vaccine products and COVID-19 immunisation (Revaccination with different COVID-19 vaccine) were also noted in the case. Patient had non painful blood coming from rectum for two days that soaked through clothing which stopped abruptly on the 3rd day. She had viral syndrome; lost close to 20 lbs in this time frame and reported to have a poor quality of life. Medical history of Small intestine carcinoma could be a risk factor for the event Rectal haemorrhage. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55 year old female patient with concurrent Hypothyroidism and history of Small intestine carcinoma, who experienced the unexpected serious (medically significant) event of Rectal haemorrhage (non painful blood coming from rectum), on the next day of receiving the fourth dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. The patient received the previous three doses with Pfizer COVID 19 vaccine and took months to recuperate after the first dose. Thus, an interchange of vaccine products and COVID-19 immunisation (Revaccination with different COVID-19 vaccine) were also noted in the case. Patient had non painful blood coming from rectum for two days that soaked through clothing which stopped abruptly on the 3rd day. She had viral syndrome; lost close to 20 lbs in this time frame and reported to have a poor quality of life. Medical history of Small intestine carcinoma could be a risk factor for the event Rectal haemorrhage. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.