Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diarrhoea, Dysgeusia, Haemorrhage, SARS-CoV-2 test
Clinical narrative: sour taste started with the second dose; Diarrhoea; got COVID / tested positive.; bleeding; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (bleeding) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.    Concurrent medical conditions included Fruit allergy (Fruits and other food items. Did not remember when it was diagnosed), Blood cholesterol abnormal (The patient did not remember when it was diagnosed), Thyroid disorder (The patient did not remember when it was diagnosed), Digestion impaired (The patient did not remember when it was diagnosed.), Stomach ache (Sometimes patient had stomach aches.) and Food allergy (Fruits and other food items. Did not remember when it was diagnosed).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) 3 dosage form twice a day. On 01-Aug-2022, the patient experienced COVID-19 (got COVID / tested positive.). On 03-Aug-2022, the patient experienced DYSGEUSIA (sour taste started with the second dose) and DIARRHOEA (Diarrhoea). In August 2022, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) in August 2022 for Diarrhoea, at an unspecified dose and frequency. On 04-Aug-2022, DIARRHOEA (Diarrhoea) had resolved. On 05-Aug-2022, DYSGEUSIA (sour taste started with the second dose) had resolved. At the time of the report, HAEMORRHAGE (bleeding) outcome was unknown and COVID-19 (got COVID / tested positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 09-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The concurrent conditions were diagnosed couple of years earlier.  The patient took COVID vaccine due to the age and underlying health issues (reported as took for preservative reasons). There were no lot numbers of COVID 19 Vaccine because Complainant did not have the product with them at the time of call.  Patient had an appointment on 02-Aug-2022 and was prescribed Paxlovid. Patient stopped Paxlovid even though the side effects mentioned liver, diarrhea, and all that. He was not sure if it was permanently discontinued  or just temporarily discontinued it. He did discontinue Paxlovid but it was not completely permanent he just had to find out what steps to take. COMPANY COMMENT: -This is an spontaneous case concerning a 58-years-old male patient with  no significant medical history reported who experienced the unexpected seriousness criterion medically significant event of haemorrhage, the unexpected  events of Covid-19 (AESI), dysgeusia and diarrhoea approximately 3 months after 4th.  dose of  mRNA-1273 vaccine.  The patient was treated with co-suspect drug PAXLOVID and suspended it due to side effects mentioned liver, diarrhea. On 01-Aug-2022, SARS-CoV-2 test Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reporting.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Non-significant follow up-Quality reference number added; Sender's Comments: COMPANY COMMENT: -This is an spontaneous case concerning a 58-years-old male patient with  no significant medical history reported who experienced the unexpected seriousness criterion medically significant event of haemorrhage, the unexpected  events of Covid-19 (AESI), dysgeusia and diarrhoea approximately 3 months after 4th.  dose of  mRNA-1273 vaccine.  The patient was treated with co-suspect drug PAXLOVID and suspended it due to side effects mentioned liver, diarrhea. On 01-Aug-2022, SARS-CoV-2 test Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reporting.