Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Haematochezia, Hyperhidrosis, Interchange of vaccine products
Clinical narrative: Bleeding in the toilet; Extreme constipation; arm got sore; sweating; Super achy; chills; fever; nauseous; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bleeding in the toilet), CONSTIPATION (Extreme constipation), PAIN IN EXTREMITY (arm got sore), HYPERHIDROSIS (sweating) and MYALGIA (Super achy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Attention deficit disorder. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 03-Nov-2021, the patient experienced HAEMATOCHEZIA (Bleeding in the toilet), CONSTIPATION (Extreme constipation), PAIN IN EXTREMITY (arm got sore), HYPERHIDROSIS (sweating), MYALGIA (Super achy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MIDOL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. On 03-Nov-2021, CONSTIPATION (Extreme constipation) had resolved. At the time of the report, HAEMATOCHEZIA (Bleeding in the toilet), PAIN IN EXTREMITY (arm got sore), HYPERHIDROSIS (sweating), MYALGIA (Super achy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseous) was resolving.            It was reported that patient received the Johnson and Johnson vaccine on 05April2021 first and then got the Moderna booster on 02November2021. Patient offered  to give blood because she received the Johnson and Johnson vaccine and Moderna. Company Comment : This case concerns a 24 year-old, female patient with no relevant medical history, who experienced the non serious unexpected events of Haematochezia, Pain in extremity, constipation and Hyperhidrosis. The events occurred approximately 1 day after the booster dose of Moderna COVID-19 vaccine. Interchange of vaccine products was considered as an additional event. The patient received one dose of Janssen vaccine and 7 months after a booster dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the booster dose and no additional dose will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event Haematochezia was automatically upgraded as serious as per IME list. However, based on reporter´s assessment, information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.; Sender's Comments: This case concerns a 24 year-old, female patient with no relevant medical history, who experienced the non serious unexpected events of Haematochezia, Pain in extremity, constipation and Hyperhidrosis. The events occurred approximately 1 day after the booster dose of Moderna COVID-19 vaccine. Interchange of vaccine products was considered as an additional event. The patient received one dose of Janssen vaccine and 7 months after a booster dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the booster dose and no additional dose will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event Haematochezia was automatically upgraded as serious as per IME list. However, based on reporter´s assessment, information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.