Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever blister; blood in stool; abdominal pain/ abdominal cramps; Mucous stools, mucus for about 3 weeks on and off; Chills; Fever; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATOCHEZIA (blood in stool), ABDOMINAL PAIN (abdominal pain/ abdominal cramps), MUCOUS STOOLS (Mucous stools, mucus for about 3 weeks on and off), ORAL HERPES (fever blister) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B214A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urinary tract infection (Prior to the vaccine on 29-Mar-2021, prescription medication (Macrobid) provided for urinary tract infection which the patient had an allergic reaction to.) on 29-Mar-2021 and COVID-19 on 17-Nov-2020. Concurrent medical conditions included Allergy to antibiotic (Macrobid, Lymph node swelling.) since 29-Mar-2021, Spondylitis ankylosing since 05-Jan-2017 and Irritable bowel syndrome since 07-Jan-2000. Concomitant products included ESTRADIOL from 01-Apr-2021 to an unknown date for Hormone replacement therapy, FLUOXETINE for an unknown indication.    On 02-Apr-2021 at 12:31 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (body aches). On 03-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain/ abdominal cramps). 03-Apr-2021, the patient experienced MUCOUS STOOLS (Mucous stools, mucus for about 3 weeks on and off). On 08-Apr-2021, the patient experienced HAEMATOCHEZIA (blood in stool). On 09-Apr-2021, the patient experienced ORAL HERPES (fever blister). On 04-Apr-2021, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (body aches) had resolved. On 09-Apr-2021, ABDOMINAL PAIN (abdominal pain/ abdominal cramps) had resolved. At the time of the report, HAEMATOCHEZIA (blood in stool) and MUCOUS STOOLS (Mucous stools, mucus for about 3 weeks on and off) had resolved and ORAL HERPES (fever blister) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2020, SARS-CoV-2 test: postive (Positive) Positive on second Rapid test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The patient was prescribed estrogen patches (name unknown) on 01-Apr-2021. The patient has contacted gynecologist who informed that the abdominal pains can be related to the estrogen patches. At the time of report, the patient was not taking estrogen, but will restart soon.  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. Chills, myalgia and pyrexia are consistent with the product known safety profile. Some vaccines have been known to exacerbate latent herpes zoster.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Significant follow up received on 24 May 2021, updated information includes, patient demographics, relevant medical history, dosage update of concomitant medication and additional event added.; 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. Chills, myalgia and pyrexia are consistent with the product known safety profile. Some vaccines have been known to exacerbate latent herpes zoster.