Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Suspected COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19 /  COVID-19; interchange of vaccine products; Lower abdomen cramping, like menstrual cramps or diarrhea cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Lower abdomen cramping, like menstrual cramps or diarrhea cramps), COVID-19 (Treatment of COVID-19 /  COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (Dose Number: 1 Batch/Lot No: Unknown, Location of injection: Arm Left) on 14-Mar-2021 and Dynacin since an unknown date. Past adverse reactions to the above products included Allergy NOS with Dynacin; and No adverse event with J&J. Concurrent medical conditions included Anxiety, Chronic migraine, Cleft lip and Cleft palate. Concomitant products included ESCITALOPRAM for an unknown indication.    On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022 at 7:00 AM, the patient experienced ABDOMINAL PAIN LOWER (Lower abdomen cramping, like menstrual cramps or diarrhea cramps). On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 /  COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN LOWER (Lower abdomen cramping, like menstrual cramps or diarrhea cramps) had resolved and COVID-19 (Treatment of COVID-19 /  COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            It was reported that patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 31-May-2022  No treatment medications were reported  Company comment.  This spontaneous case concerns a 32  year  old, female patient with no relevant medical history reported, who experienced the unexpected, non  serious AESI of COVID  19, among other non  serious event. The event occurred approximately 7 months after the administration of a dose of mRNA-1273 vaccine, reported as second dose of her COVID  19 immunization schedule; the patient previously had a dose of "J&J" COVID  19 vaccine (Interchange of vaccine products could be considered). The report stated that the patient received treatment with Paxlovid for COVID  19, and 3 days after starting treatment with Paxlovid, she presented lower abdomen cramping, like menstrual cramps or diarrhea cramps. 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 32  year  old, female patient with no relevant medical history reported, who experienced the unexpected, non  serious AESI of COVID  19, among other non  serious event. The event occurred approximately 7 months after the administration of a dose of mRNA-1273 vaccine, reported as second dose of her COVID  19 immunization schedule; the patient previously had a dose of "J&J" COVID  19 vaccine (Interchange of vaccine products could be considered). The report stated that the patient received treatment with Paxlovid for COVID  19, and 3 days after starting treatment with Paxlovid, she presented lower abdomen cramping, like menstrual cramps or diarrhea cramps. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.