Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cold sweat, Decreased appetite, Faeces discoloured
Clinical narrative: Bloody stool; Stomach had an infection (in the lining); 1st dose: few days after dose, she had a viral infection; Neck and back pain; Right arm has sharp pain that goes from neck to fingers; No appetite (for a month or so); Cold sweats; Felt sick; No energy; Neck and back pain; Discoloration of stool; Body and muscle aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool), GASTRIC INFECTION (Stomach had an infection (in the lining)), VIRAL INFECTION (1st dose: few days after dose, she had a viral infection), BACK PAIN (Neck and back pain) and PAIN IN EXTREMITY (Right arm has sharp pain that goes from neck to fingers) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (Bloody stool), GASTRIC INFECTION (Stomach had an infection (in the lining)), VIRAL INFECTION (1st dose: few days after dose, she had a viral infection), BACK PAIN (Neck and back pain), PAIN IN EXTREMITY (Right arm has sharp pain that goes from neck to fingers), DECREASED APPETITE (No appetite (for a month or so)), COLD SWEAT (Cold sweats), MALAISE (Felt sick), ASTHENIA (No energy), NECK PAIN (Neck and back pain), FAECES DISCOLOURED (Discoloration of stool), MYALGIA (Body and muscle aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HAEMATOCHEZIA (Bloody stool), GASTRIC INFECTION (Stomach had an infection (in the lining)), VIRAL INFECTION (1st dose: few days after dose, she had a viral infection), BACK PAIN (Neck and back pain), PAIN IN EXTREMITY (Right arm has sharp pain that goes from neck to fingers), DECREASED APPETITE (No appetite (for a month or so)), COLD SWEAT (Cold sweats), MALAISE (Felt sick), ASTHENIA (No energy), NECK PAIN (Neck and back pain), FAECES DISCOLOURED (Discoloration of stool), MYALGIA (Body and muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were provided.  No treatment information was provided.  Company Comment: 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. Events of hematochezia and gastric infection were automatically upgraded as a Serious events as per IME list. However, based on information available and as per medical criteria they were classified as Non-serious.   This case was linked to MOD-2021-283283 (Patient Link).; 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. Events of hematochezia and gastric infection were automatically upgraded as a Serious events as per IME list. However, based on information available and as per medical criteria they were classified as Non-serious.