Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Induration, Malaise, Nausea, Pyrexia
Clinical narrative: arm is hard very very red and hot to touch; arm is hard very very red and hot to touch, oozing in the middle of the night; progressively ill-er with a temperature 101.2; severe chills; nausea; vomiting turned to purely vomiting blood; did not feel very well; diarrhea; chest pain; Cervical dystonia and tremors which has gotten visibly worse; Cervical dystonia and tremors which has gotten visibly worse; arm is hard very very red and hot to touch; arm is hard very very red and hot to touch; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (vomiting turned to purely vomiting blood) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Cervical dystonia and Tremor.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HAEMATEMESIS (vomiting turned to purely vomiting blood) (seriousness criterion medically significant), MALAISE (did not feel very well), DIARRHOEA (diarrhea), CHEST PAIN (chest pain), TORTICOLLIS (Cervical dystonia and tremors which has gotten visibly worse), TREMOR (Cervical dystonia and tremors which has gotten visibly worse), ERYTHEMA (arm is hard very very red and hot to touch), INDURATION (arm is hard very very red and hot to touch), SKIN WEEPING (arm is hard very very red and hot to touch, oozing in the middle of the night), PYREXIA (progressively ill-er with a temperature 101.2), CHILLS (severe chills) and NAUSEA (nausea). On an unknown date, the patient experienced SKIN WARM (arm is hard very very red and hot to touch). At the time of the report, HAEMATEMESIS (vomiting turned to purely vomiting blood), MALAISE (did not feel very well), CHEST PAIN (chest pain), TREMOR (Cervical dystonia and tremors which has gotten visibly worse), ERYTHEMA (arm is hard very very red and hot to touch), INDURATION (arm is hard very very red and hot to touch), SKIN WARM (arm is hard very very red and hot to touch), SKIN WEEPING (arm is hard very very red and hot to touch, oozing in the middle of the night), PYREXIA (progressively ill-er with a temperature 101.2) and CHILLS (severe chills) outcome was unknown and DIARRHOEA (diarrhea), TORTICOLLIS (Cervical dystonia and tremors which has gotten visibly worse) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.2 (High) progressively iller.         Concomitant medications were not provided. Action taken with m-RNA in respect to the events was not applicable. Per report, On 08-Apr-2021 the patient was admitted to the emergency room (ER). While in the ER, the patient received an EKG, chest x-ray, basic metabolic panel, complete blood count  with differentials, hepatic function test, troponin and urinalysis (test results were not provided). Her diagnosis was systemic adverse effect of COVID 19 vaccine. Treatment included Ketorolac, Theraflu (Acetaminophen, Chlorpheniramine, Dextromethorphan, and Pseudoephedrine ), and anti-nausea medications.  Company Comment: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Fever, chills and nausea are consistent with the product known safety profile.   This case was linked to MOD-2021-073928 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Fever, chills and nausea are consistent with the product known safety profile. MOD-2021-073928:First dose