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Life Threatening? No
Write-up: BLOOD IN STOOL; SORENESS; DIARRHEA; VOMITING; PRICKLING IN CHEST; ACID REFLUX; SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination patient felt fine for the first few days. On an unspecified date, the patient had soreness and fever. Patient stated would estimate it was low grade fever and indicated that had a fever now. Patient had prickling in chest and stated could not eat and hold food down, it came out both ways. Patient reported vomiting for 2 days along with pooting, which patient implied as excessive bowel movements, potentially diarrhea. Patient indicated that now had bleeding when pooting. Patient also had acid reflux. Patient was concerned about the blood which was seen. The caller informed patient to seek medical attention from HCP, urgent care or ER (especially if symptoms are worsening). The caller then stated that patient was starting to get sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, fever, blood in stool, diarrhea, vomiting, prickling in chest, acid reflux, and the outcome of sick was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210544936-Covid-19 vaccine ad26.cov2.s-Blood in stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
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