Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Rectal haemorrhage, Tremor
Clinical narrative: bleeding through rectum; bleeding from her GI tract; elevated blood pressure; confusion; sore throat; retaining fluid; dry throat; no tears; shaking; headache; chills/shivering; swelling of all lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding through rectum), GASTROINTESTINAL HAEMORRHAGE (bleeding from her GI tract), HYPERTENSION (elevated blood pressure), CONFUSIONAL STATE (confusion) and FLUID RETENTION (retaining fluid) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H1A, 040A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included POTASSIUM, CYANOCOBALAMIN (B12-VITAMIIN), COLECALCIFEROL (VITAMIN D3) and ALPRAZOLAM (XANAX) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding through rectum) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (bleeding from her GI tract) (seriousness criterion medically significant), HYPERTENSION (elevated blood pressure) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (sore throat), FLUID RETENTION (retaining fluid) (seriousness criterion medically significant), DRY THROAT (dry throat), LACRIMATION DECREASED (no tears), TREMOR (shaking), HEADACHE (headache), CHILLS (chills/shivering) and LYMPHADENOPATHY (swelling of all lymph nodes). At the time of the report, RECTAL HAEMORRHAGE (bleeding through rectum), GASTROINTESTINAL HAEMORRHAGE (bleeding from her GI tract), HYPERTENSION (elevated blood pressure), CONFUSIONAL STATE (confusion), OROPHARYNGEAL PAIN (sore throat), FLUID RETENTION (retaining fluid), DRY THROAT (dry throat), LACRIMATION DECREASED (no tears), TREMOR (shaking), HEADACHE (headache), CHILLS (chills/shivering) and LYMPHADENOPATHY (swelling of all lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, Blood pressure measurement: elevated blood pressure (High) elevated blood pressure. On an unknown date, General physical condition: none was found none was found.         Concomitant medication included Thyroid pill.  The patient went to her doctor and had complete physical test but none was found.  Patient had Moderna Covid19 vaccine for her first and second dose and she did not had any untoward reaction  Company Comment: This spontaneous case concerns a 58 year old female with no reported medical history,  vaccinated with primary series using mRNA-1273 vaccine for two doses with no reported adverse events , who experienced  Serious , unexpected events of Rectal hemorrhage , gastrointestinal hemorrhage, hypertension ,  fluid retention , confusional state which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . This was accompanied by other non-serious , unexpected events of oropharyngeal pain , dry throat, lacrimation decreased , tremor, lymphadenopahty and non-serious , expected events of headache and chills which also occurred on the same day post vaccination with the 3r d dose of the vaccine.  It was reported that this patient consulted her phyisian and had complete physical test but no abnormality was found . The re-challenge for this case  is not applicable since the events occurred after the 3rd dose and no additional doses will be given  and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58 year old female with no reported medical history,  vaccinated with primary series using mRNA-1273 vaccine for two doses with no reported adverse events , who experienced  Serious , unexpected events of Rectal hemorrhage , gastrointestinal hemorrhage, hypertension ,  fluid retention , confusional state which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( moderna Covid 19 vaccine ) . This was accompanied by other non-serious , unexpected events of oropharyngeal pain , dry throat, lacrimation decreased , tremor, lymphadenopahty and non-serious , expected events of headache and chills which also occurred on the same day post vaccination with the 3r d dose of the vaccine.  It was reported that this patient consulted her phyisian and had complete physical test but no abnormality was found . The re-challenge for this case  is not applicable since the events occurred after the 3rd dose and no additional doses will be given  and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.