Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Eructation, Fatigue, Headache, Pain in extremity
Clinical narrative: collagenous colitis is back; Terrible pain in left arm; burping all the time; More severe and more frequent  headaches; Little tired; This spontaneous case was reported by a nurse and describes the occurrence of COLITIS (collagenous colitis is back), PAIN IN EXTREMITY (Terrible pain in left arm), ERUCTATION (burping all the time), HEADACHE (More severe and more frequent  headaches) and FATIGUE (Little tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 026L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL for an unknown indication.    The patient's past medical history included Cancer, Colitis collagenous and Migraine.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PARACETAMOL (Oral) at an unspecified dose. On 20-Feb-2021, the patient experienced FATIGUE (Little tired). On 24-Feb-2021, the patient experienced COLITIS (collagenous colitis is back), PAIN IN EXTREMITY (Terrible pain in left arm), ERUCTATION (burping all the time) and HEADACHE (More severe and more frequent  headaches). At the time of the report, COLITIS (collagenous colitis is back), PAIN IN EXTREMITY (Terrible pain in left arm) and HEADACHE (More severe and more frequent  headaches) had not resolved and ERUCTATION (burping all the time) and FATIGUE (Little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter (a nurse) was also the patient. Concomitant product use was not provided. Her past medical history included "other serious health issues". The patient saw a gastrointestinal specialist for terrible pains in stomach and due to her burping all the time. Treatment included paracetamol.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-053223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: The patient reported she "didn't feel so good taking the vaccines" and she was currently dealing with post-injection problems/post-vaccination syndrome; added collagenous colitis to med history; migraine and post-injection problems/post-vaccination syndrome added as events; outcome of collagenous colitis is back, terrible pain in left arm, and headache changed to not resolved; removed inappropriate schedule of vaccine administration as event; major narrative update. On 07-May-2021: NNI; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 015M20A with associated AEs aggravated colitis, abdominal pain, eructation, fatigue, pain, headaches.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded