Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Platelet count, Rectal haemorrhage
Clinical narrative: rectal bleeding; tingling brain; nose bleed; felt tired; legs felt like elephant trunks; nausea; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RECTAL HAEMORRHAGE (rectal bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac valve leak (leaky mitral valve pre-condition) and Infrared therapy (Started Lifewave patches infrared therapy thru physical therapy recently and thought tingling might be due to that). Concurrent medical conditions included Drug allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]), MULTIVITAMINS [VITAMINS NOS], MAGNESIUM, COLECALCIFEROL (VITAMIN D 3), OMEGA-3 [OMEGA-3 NOS], PROBIOTICS NOS and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 30-Apr-2021, the patient experienced LIMB DISCOMFORT (legs felt like elephant trunks), FATIGUE (felt tired) and NAUSEA (nausea). On 01-May-2021, the patient experienced EPISTAXIS (nose bleed). On 11-May-2021, the patient experienced RECTAL HAEMORRHAGE (rectal bleeding) (seriousness criterion medically significant) and PARAESTHESIA (tingling brain). On 30-Apr-2021, HEADACHE (headache) and NAUSEA (nausea) had resolved. On 01-May-2021, LIMB DISCOMFORT (legs felt like elephant trunks), EPISTAXIS (nose bleed) and FATIGUE (felt tired) had resolved. At the time of the report, RECTAL HAEMORRHAGE (rectal bleeding) and PARAESTHESIA (tingling brain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Platelet count: normal (normal) Normal.         It was reported by the patient that they started Lifewave patches infrared therapy thru physical therapy recently and thought tingling might be due to that. She called them and they never heard of those symptoms.  It was reported on 01May2021 caller had a nose bleed and was concerned about brain hemorrhage. Called cardiologist and got blood test and platelet counts which were normal.  Patient reported cardiologist ordered another/additionally blood test & stool test.  Tylenol was reported as treatment for headache.   Action taken with the drug in response to the event(s) was not applicable.   This case was linked to MOD-2021-117920, MOD21-089543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The cardiologist suggested another blood test and stool test for the patient.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.