Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Somnolence, Urinary tract infection, Weight increased
Clinical narrative: Could hardly stay awake; Had really weird stomach cramps like the period but it did not come/had really bad cramps; Just did not feel good; She gained 15 pounds; Felt so tired; Had a UTI a month ago/started peeing blood; Got the second dose more than 35 days after the first dose; After getting the vaccine  the patient only had 1 period and it took like 3 months for the patient to get it/The period that came, lasted only 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Could hardly stay awake), MENSTRUATION DELAYED (After getting the vaccine  the patient only had 1 period and it took like 3 months for the patient to get it/The period that came, lasted only 3 days), ABDOMINAL PAIN UPPER (Had really weird stomach cramps like the period but it did not come/had really bad cramps), URINARY TRACT INFECTION (Had a UTI a month ago/started peeing blood) and MALAISE (Just did not feel good) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MENSTRUATION DELAYED (After getting the vaccine  the patient only had 1 period and it took like 3 months for the patient to get it/The period that came, lasted only 3 days). On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose more than 35 days after the first dose). In October 2021, the patient experienced URINARY TRACT INFECTION (Had a UTI a month ago/started peeing blood). On an unknown date, the patient experienced SOMNOLENCE (Could hardly stay awake), ABDOMINAL PAIN UPPER (Had really weird stomach cramps like the period but it did not come/had really bad cramps), MALAISE (Just did not feel good), WEIGHT INCREASED (She gained 15 pounds) and FATIGUE (Felt so tired). On 16-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose more than 35 days after the first dose) had resolved. At the time of the report, SOMNOLENCE (Could hardly stay awake), MENSTRUATION DELAYED (After getting the vaccine  the patient only had 1 period and it took like 3 months for the patient to get it/The period that came, lasted only 3 days), ABDOMINAL PAIN UPPER (Had really weird stomach cramps like the period but it did not come/had really bad cramps), URINARY TRACT INFECTION (Had a UTI a month ago/started peeing blood), MALAISE (Just did not feel good), WEIGHT INCREASED (She gained 15 pounds) and FATIGUE (Felt so tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) Not pregnant.         No treatment medications were reported by the reporter.  The patient was treated with antibiotics for urinary tract infection. The patient took 8 pregnancy tests.  This is a case of Inappropriate Schedule of Product Administration concerning a 32-year-old female patient with no relevant medical history, who experienced the unexpected events of Menstruation Delayed, Urinary Tract Infection, Abdominal Pain Upper, Malaise, Somnolence and expected event of Fatigue. The event occurred approximately 1 month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Inappropriate Schedule of Product Administration concerning a 32-year-old female patient with no relevant medical history, who experienced the unexpected events of Menstruation Delayed, Urinary Tract Infection, Abdominal Pain Upper, Malaise, Somnolence and expected event of Fatigue. The event occurred approximately 1 month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.