Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Gastrointestinal haemorrhage, Oropharyngeal blistering, Paraesthesia oral
Clinical narrative: received NIRMATRELVIR, RITONAVIR as treatment of COVID19; gastrointestinal bleeding; blisters on back of tonsils; Metal taste in mouth; tingling of tongue; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (gastrointestinal bleeding) and OROPHARYNGEAL BLISTERING (blisters on back of tonsils) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Allergy and Stent placement (five years ago). Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) and ROSUVASTATIN CALCIUM (CRESTOR) from an unknown date to 15-May-2022 for an unknown indication.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 16-May-2022, the patient experienced GASTROINTESTINAL HAEMORRHAGE (gastrointestinal bleeding) (seriousness criterion medically significant), OROPHARYNGEAL BLISTERING (blisters on back of tonsils) (seriousness criterion medically significant), DYSGEUSIA (Metal taste in mouth) and PARAESTHESIA ORAL (tingling of tongue). On an unknown date, the patient experienced COVID-19 (received NIRMATRELVIR, RITONAVIR as treatment of COVID19). At the time of the report, GASTROINTESTINAL HAEMORRHAGE (gastrointestinal bleeding), DYSGEUSIA (Metal taste in mouth) and PARAESTHESIA ORAL (tingling of tongue) was resolving, OROPHARYNGEAL BLISTERING (blisters on back of tonsils) had resolved and COVID-19 (received NIRMATRELVIR, RITONAVIR as treatment of COVID19) outcome was unknown.            Treatment medication was not reported. Company comment This spontaneous case concerns a patient of an unknown age and gender, with medical history of Stent placement (five years ago), use of ACETYLSALICYLIC ACID as concomitant medication and treatment with NIRMATRELVIR, RITONAVIR for COVID19 treatment, who experienced the unexpected serious (medically significant) events of GASTROINTESTINAL HAEMORRHAGE and OROPHARYNGEAL BLISTERING and the non-serious AESI of COVID19. Events gastrointestinal haemorrhage and oropharyngeal blistering occurred approximately 1 month and 15 days after receiving the second dose of mRNA-1273 vaccine, and on the following day after starting treatment with NIRMATRELVIR, RITONAVIR. Patient experienced Metal taste in mouth & tingling of tongue, blisters on back of tonsils which disappeared after a few days, and gastrointestinal bleeding. No further clinical or diagnostic information was disclosed. Concomitant medication with ACETYLSALICYLIC ACID could be a contributing factor for event GASTROINTESTINAL HAEMORRHAGE, and NIRMATRELVIR, RITONAVIR remains as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with medical history of Stent placement (five years ago), use of ACETYLSALICYLIC ACID as concomitant medication and treatment with NIRMATRELVIR, RITONAVIR for COVID19 treatment, who experienced the unexpected serious (medically significant) events of GASTROINTESTINAL HAEMORRHAGE and OROPHARYNGEAL BLISTERING and the non-serious AESI of COVID19. Events gastrointestinal haemorrhage and oropharyngeal blistering occurred approximately 1 month and 15 days after receiving the second dose of mRNA-1273 vaccine, and on the following day after starting treatment with NIRMATRELVIR, RITONAVIR. Patient experienced Metal taste in mouth & tingling of tongue, blisters on back of tonsils which disappeared after a few days, and gastrointestinal bleeding. No further clinical or diagnostic information was disclosed. Concomitant medication with ACETYLSALICYLIC ACID could be a contributing factor for event GASTROINTESTINAL HAEMORRHAGE, and NIRMATRELVIR, RITONAVIR remains as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.