Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Constipation, Dehydration, Diarrhoea, Fatigue
Clinical narrative: glaucoma; constipation; dehydrated; diarrhea/bouts of diarrhea; was resting and has been extremely tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GLAUCOMA (glaucoma) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7166B and AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Flu vaccine in September 2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 4), PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1); for Drug use for unknown indication: PAXLOVID. Past adverse reactions to the above products included No adverse event with Flu vaccine, PAXLOVID, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Gluten sensitivity and Drug allergy (Aspirin sensitivity). 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 an unknown date, the patient experienced GLAUCOMA (glaucoma) (seriousness criterion medically significant), CONSTIPATION (constipation), DEHYDRATION (dehydrated), DIARRHOEA (diarrhea/bouts of diarrhea) and FATIGUE (was resting and has been extremely tired). The patient was treated with CALCIUM CHLORIDE, GLUCOSE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE (PEDIALYTE [CALCIUM CHLORIDE;GLUCOSE;MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE;SODIUM CHLORIDE;SODIUM LACTATE]) at an unspecified dose and frequency and Surgery (Cataract procedure) for Glaucoma. At the time of the report, GLAUCOMA (glaucoma), CONSTIPATION (constipation), DEHYDRATION (dehydrated), DIARRHOEA (diarrhea/bouts of diarrhea) and FATIGUE (was resting and has been extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2023, SARS-CoV-2 test: Negative. On an unknown date, Blood test: dehydrated. On an unknown date, Laboratory test: (Negative) All test came back negative. On an unknown date, Stool analysis: dehydrated.         It was reported that patient had other vaccine in 4 weeks prior to covid-19 vaccine.  It was reported that a couple days after the shot patient came down with gastrointestinal problems which showed as diarrhea, constipation and then bouts of diarrhea which went on for a good week. They called doctor and reported this was going on and did the stool test and blood work. Reports showed patient was dehydrated and started taking Pedialyte and electrolytes. All test came back negative. In another week or week and a half the problem was still in existence and they thought they had food poisoning. She recently had a cataract procedure for glaucoma, but she was wanting to put her on antibiotics. She did not take the antibiotics because the side effects sounded terrifying. They did research and talked to her daughters. After 3 solid weeks they noticed what they had in common was the vaccine. They believe in the vaccine and they both had Covid in the past. They thought they would report for our statistics. They had been taking Kaopectate. They were going to do a computed tomography (CAT scan), but they figured it would be microscopic and ruled it out. They hope that within 30 days it would adjust.   Company Comment: This spontaneous case report concerns a 76-year-old female patient with no relevant medical history, who experienced serious (medically significant) unexpected event of Glaucoma, as well as non-serious unexpected events of Constipation, Dehydration and Diarrhoea, as well as non serious expected event of Fatigue. Reportedly, the patient developed gastrointestinal problems that showed as diarrhoea (bouts of diarrhoea) and constipation a couple days after the patient had received the mRNA-1273.222 vaccine (bivalent dose, as sixth dose in vaccination schedule). The patient also received mRNA-1273.222 vaccine as fifth dose, whereas the previous four doses were Pfizer vaccines. The patient did the stool test and blood laboratory tests which confirmed dehydration.The patient started taking Pedialyte and electrolytes. It was also stated that the patient recently had a cataract procedure for glaucoma, but the exact start date for glaucoma was not mentioned. It was also stated that the patient felt extremely tired, but the exact start date for fatigue was not provided, therefore, temporal relationship could not be determined. COVID-19 test was negative. At the time of this report, the outcome of the events was unknown. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.  This case was linked to US-MODERNATX, INC.-MOD-2023-726260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726260: