Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal motility disorder, Suspected COVID-19, Taste disorder
Clinical narrative: Bad taste in mouth; Incomplete bowel movements; Some diarrhea; Started with COVID symptoms; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (Bad taste in mouth), GASTROINTESTINAL MOTILITY DISORDER (Incomplete bowel movements), SUSPECTED COVID-19 (Started with COVID symptoms) and DIARRHOEA (Some diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 032F21A, 040A21A and 011M20A) for COVID-19 prophylaxis.     The patient's past medical history included GERD. Concurrent medical conditions included Colitis microscopic, Interstitial lung disease, Hypertension, Hyperlipidemia, Asthma, Latex allergy, Allergy to nuts (Allergy with Pine nuts and Walnuts) and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), DILTIAZEM HYDROCHLORIDE (DILT-XR), POTASSIUM, VALACICLOVIR HYDROCHLORIDE (VALTREX), GUAIFENESIN (MUCINEX), ASPIRIN [ACETYLSALICYLIC ACID], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), TILACTASE (LACTAID), LOPERAMIDE HYDROCHLORIDE (IMODIUM), BIOTIN, CIMICIFUGA RACEMOSA EXTRACT (REMIFEMIN), COLLAGEN, GLUCOSAMINE & CHONDORITIN and SELENIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 6:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUSPECTED COVID-19 (Started with COVID symptoms). On an unknown date, the patient experienced TASTE DISORDER (Bad taste in mouth), GASTROINTESTINAL MOTILITY DISORDER (Incomplete bowel movements) and DIARRHOEA (Some diarrhea). At the time of the report, TASTE DISORDER (Bad taste in mouth), GASTROINTESTINAL MOTILITY DISORDER (Incomplete bowel movements), SUSPECTED COVID-19 (Started with COVID symptoms) and DIARRHOEA (Some diarrhea) had not resolved.            Co-suspect: On 19-APR-2022, the patient received non-company product Pfizer (Oral route) for indication Treatment of COVID-19 and Batch/lot number was reported as FY4445. It was reported that patient received Flexuron, Greens Blend, Immune Complete, Prilosec, Allegra, Advil, Cranberry, Ocuvite, Multivitamin, CQ10, Wixela 250 mg, Diazide 37.5 - 25 mg orally and Caltrate with unknown route of administration as concomitant medications. Treatment medications were not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This is a spontaneous case reported by a consumer, concerning a 72 year old female patient, with no relevant medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 about 07 days after receiving the 4 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events. Patient received the primary 2 doses and the 3 dose with Moderna with no adverse events reported. Relevant concurrent medical conditions included Interstitial lung disease, Hypertension, Hyperlipidemia and Asthma, which are risk factors for the event. It was reported that about 10 days after the 4 dose, the patient received non-company product Pfizer (Oral route) for the treatment of COVID-19. Details of  clinical course, labs, concomitant medications and other treatment details were not reported. The outcome of covid 19 was not resolved. Ongoing Covid 19 pandemia, could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 72 year old female patient, with no relevant medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 about 07 days after receiving the 4 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events. Patient received the primary 2 doses and the 3 dose with Moderna with no adverse events reported. Relevant concurrent medical conditions included Interstitial lung disease, Hypertension, Hyperlipidemia and Asthma, which are risk factors for the event. It was reported that about 10 days after the 4 dose, the patient received non-company product Pfizer (Oral route) for the treatment of COVID-19. Details of  clinical course, labs, concomitant medications and other treatment details were not reported. The outcome of covid 19 was not resolved. Ongoing Covid 19 pandemia, could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.