Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, COVID-19, Constipation, Diarrhoea, Stool analysis
Clinical narrative: came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning; came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning; This spontaneous case was reported by a patient and describes the occurrence of CONSTIPATION (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning) and DIARRHOEA (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Flu vaccine in sep2022 in September 2022 and PFIZER BIONTECH COVID-19 VACCINE (4 Pfizer vaccines); for Drug use for unknown indication: PAXLOVID. Past adverse reactions to the above products included No adverse event with Flu vaccine in sep2022, PAXLOVID and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Food allergy, Pollen allergy, Allergy to plants (Rye and Oak), Wheat allergy, Oat allergy and Birch pollen allergy. Concomitant products included ATTAPULGITE (KAOPECTATE [ATTAPULGITE]) for an unknown indication. On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 02-May-2023, the patient experienced CONSTIPATION (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning) and DIARRHOEA (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Diarrhea and Constipation, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning) and DIARRHOEA (came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea /they thought they had food poisoning) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2023, COVID-19: Negative. On an unknown date, Blood test: Negative. On an unknown date, COVID-19: Positive. On an unknown date, Stool analysis: Negative. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. It was reported that in another week or week and a half the problem was still in existence and they thought they had food poisoning. After 3 solid weeks they noticed what they had in common was the vaccine. Patient's wife and he believed in the vaccine and they both have had Covid in the past. Caller hope was within 30 days it will adjust. Treatment drug reported as electrolytes. This case was linked to US-MODERNATX, INC.-MOD-2023-726263 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2023-726263: