Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry mouth, Impaired gastric emptying, Nausea, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Gastroparesis; sick to stomach; lost appetite; Had 1st booster shot when she came down with COVID/would bring up a lot of phlegm; Constipation; overall lost 27 pounds; felt nauseated; dry mouth; Didnt throw up any more but just want to eat; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) in a 74-year-old female 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) for COVID-19.    Concurrent medical conditions included Blood cholesterol increased and Sleep disorder. Concomitant products included ROSUVASTATIN for Cholesterol blood increased, ZOLPIDEM for Sleep disorder.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-May-2022, the patient experienced COVID-19 (Had 1st booster shot when she came down with COVID/would bring up a lot of phlegm). On 23-May-2022, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach) and DECREASED APPETITE (lost appetite). In 2022, the patient experienced CONSTIPATION (Constipation), WEIGHT DECREASED (overall lost 27 pounds), NAUSEA (felt nauseated), DRY MOUTH (dry mouth) and VOMITING (Didnt throw up any more but just want to eat). On 08-Aug-2022, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criterion medically significant). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Stomach discomfort, at an unspecified dose and frequency; PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for Constipation, at an unspecified dose and frequency and MACROGOL 3350 (MIRALAX) for Constipation, at an unspecified dose and frequency. In 2022, CONSTIPATION (Constipation) had resolved. At the time of the report, COVID-19 (Had 1st booster shot when she came down with COVID/would bring up a lot of phlegm), IMPAIRED GASTRIC EMPTYING (Gastroparesis), ABDOMINAL DISCOMFORT (sick to stomach), DECREASED APPETITE (lost appetite), WEIGHT DECREASED (overall lost 27 pounds), NAUSEA (felt nauseated), DRY MOUTH (dry mouth) and VOMITING (Didnt throw up any more but just want to eat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: (Positive) Positive. In 2022, Blood test: Normal. In 2022, Ultrasound scan: Normal. In 2022, Weight: Lost 27 Pounds.         Race of the patient was reported. the patient was healthy previously. Phlegm was the symptom of event COVID-19 The reporter took Paxlovid  however unsure if that was 3 times a day or twice a day but took that for 5 days, doctor should had the record for that. Zolpiden was the only other thing that the patient took while taking Paxlovid besides Rosuvastatin. The patient had gotten 3 shots Modema, does not know if those  were Pfizer shots. The patient had 1 booster shot when she came  down with Covid. She was on Paxlovid for 5 days and on the 5th day, got sick to her stomach Immediately lost her appetite. For 2 and a half months, just does not want to eat forced herself to eat cream of  wheat and chicken noodle soup. Overall, has lost 27  pounds and has just had a terrible time. The patient went to her  family doctor and then to a gastroenterologist Blood was tested and had full scale sonogram of her  intestines, stomach and all that Everything showed normal. Before she came down with Covid she had a very  healthy appetite, with no digestive problems and no  bathroom problems. She had terrible constipation during that time when she was not eating right was finally well  again, eating again and going to the bathroom.  Something really happened to her and had feeling that was Paxlovid because, her whole digestive system just  went haywire. The patient reported that she was sick to stomach, lost appetite and was diagnosed with positive Covid test. On that day, was put on Paxlovid. 5 days later from that day that the  symptoms started, so was about 23-May-2022 and was sick for about 2 months. She does not wanted to eat Felt nauseated so, her  physician put her on prescription to take, which she took once a day to help nausea go away. She had to take a lot of  things for constipation and was severely constipated. She never taken anything for constipation before. The doctor diagnosed with gastroparesis when she told all the symptoms and experiences.  Company comment: This is a spontaneous case concerning  a  74-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Impaired gastric emptying, and unexpected non-serious events of COVID-19, Adominal discomfort, Decreased appetite, Constipation, Weight decreased, Dry mouth and expected non-serious events of Nausea, Vomiting. Temporal association cannot be assessed due to lack of information on vaccination dates. Patient tested positive for  SARS-CoV-2 test, noted weight loss and other inconclusive finings. Patient reported took Paxlovid, of the dosage took for 5 days, doctor should had the record for that. The patient had gotten 3 shots Modema, does not know if those  were Pfizer shots. The patient had 1 booster shot then she tested positive for Covid. Patient took Paxlovid for 5 days and on the 5th day, got sick to her stomach, which caused lost of appetite, for 2 and a half months. It was reported that patient lost 27  pounds. Patient consulted her family doctor due to nauseate so, her  physician put her on prescription to take, which she took once a day to help nausea go away. She also consulted a gastroenterologist diagnostic test such as Blood was tested and had full scale sonogram of the intestines, stomach , results showed normal findings. Patient stated before she came down with Covid she was has a healthy appetite, with no digestive problems and no  bathroom problems. Patient also noted constipation during that time when she was not eating right was finally well again, eating again and going to the bathroom.  As per patient something really happened to her and had feeling that was Paxlovid because, her whole digestive system just  went haywire. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  74-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Impaired gastric emptying, and unexpected non-serious events of COVID-19, Adominal discomfort, Decreased appetite, Constipation, Weight decreased, Dry mouth and expected non-serious events of Nausea, Vomiting. Temporal association cannot be assessed due to lack of information on vaccination dates. Patient tested positive for  SARS-CoV-2 test, noted weight loss and other inconclusive finings. Patient reported took Paxlovid, of the dosage took for 5 days, doctor should had the record for that. The patient had gotten 3 shots Modema, does not know if those  were Pfizer shots. The patient had 1 booster shot then she tested positive for Covid. Patient took Paxlovid for 5 days and on the 5th day, got sick to her stomach, which caused lost of appetite, for 2 and a half months. It was reported that patient lost 27  pounds. Patient consulted her family doctor due to nauseate so, her  physician put her on prescription to take, which she took once a day to help nausea go away. She also consulted a gastroenterologist diagnostic test such as Blood was tested and had full scale sonogram of the intestines, stomach , results showed normal findings. Patient stated before she came down with Covid she was has a healthy appetite, with no digestive problems and no  bathroom problems. Patient also noted constipation during that time when she was not eating right was finally well again, eating again and going to the bathroom.  As per patient something really happened to her and had feeling that was Paxlovid because, her whole digestive system just  went haywire. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.