Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Abdominal pain lower, Body temperature, COVID-19, Flatulence
Clinical narrative: treatement with paxlovid for COVID 19 post moderna covid-19 vaccination; Had gas and no relief even with normal bowel movements.; felt like I was constipated but wasn't; Felt like my uterus was contracting/lasted about 12 hours; I suffered Abdominal pain 2 inch below the belly button/the abdominal pain subsided; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Had gas and no relief even with normal bowel movements.), ABDOMINAL DISCOMFORT (felt like I was constipated but wasn't), UTERINE SPASM (Felt like my uterus was contracting/lasted about 12 hours), ABDOMINAL PAIN LOWER (I suffered Abdominal pain 2 inch below the belly button/the abdominal pain subsided) and COVID-19 (treatement with paxlovid for COVID 19 post moderna covid-19 vaccination) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Dysmenorrhea. Concurrent medical conditions included Irritable bowel syndrome, ADHD, Asthma and Drug allergy (The patent had allergy to an unknown historical drug).   On 11-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-May-2022 at 2:00 AM, the patient experienced FLATULENCE (Had gas and no relief even with normal bowel movements.), ABDOMINAL DISCOMFORT (felt like I was constipated but wasn't), UTERINE SPASM (Felt like my uterus was contracting/lasted about 12 hours) and ABDOMINAL PAIN LOWER (I suffered Abdominal pain 2 inch below the belly button/the abdominal pain subsided). On an unknown date, the patient experienced COVID-19 (treatement with paxlovid for COVID 19 post moderna covid-19 vaccination). On 18-May-2022 at 2:00 PM, UTERINE SPASM (Felt like my uterus was contracting/lasted about 12 hours) and ABDOMINAL PAIN LOWER (I suffered Abdominal pain 2 inch below the belly button/the abdominal pain subsided) had resolved. At the time of the report, FLATULENCE (Had gas and no relief even with normal bowel movements.) and ABDOMINAL DISCOMFORT (felt like I was constipated but wasn't) was resolving and COVID-19 (treatement with paxlovid for COVID 19 post moderna covid-19 vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, Body temperature: 101 (High) spike a fever of 101.         No concomitant medication was reported. No treatment information was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On day eight after beginning PAXLOVID patient suffered Abdominal pain 2 inches below the belly button and felt like she was constipated but wasn't. Had gas and no relief even with normal bowel movements. She felt like her uterus was contracting. Lasted about 12 hours. Around the time the abdominal pain subsided, she had a spike a fever of 101.  Company comment.  This spontaneous case concerns a 48  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 6 months after mRNA-1273 vaccine, reported as third dose of her COVID  19 vaccination schedule; information about previous vaccination was not provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and reported other non  serious events, for which Paxlovid could be considered as co  suspect product. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 6 months after mRNA-1273 vaccine, reported as third dose of her COVID  19 vaccination schedule; information about previous vaccination was not provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and reported other non  serious events, for which Paxlovid could be considered as co  suspect product. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.