Sex: F
Vaccine: COVID19
Symptoms: Saline infusion sonogram
Clinical narrative: VACCINE EXPOSURE BEFORE PREGNANCY; MORE CRAMPS AND BAD PAIN WITH MENSTRUATION; HEAVY PERIODS; MISCARRIAGE; UNABLE TO CONCEIVE; DELAYED MENSTRUATION; This spontaneous pregnancy report received from a patient concerned a 37 year old female. The patient's weight was 180 pounds, and height was 64 inches. The patient's concurrent conditions included: food allergy, non-alcoholic, and nonsmoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug usage. The patient experienced allergy when treated with clindamycin, cefadroxil, gabapentin, methylprednisolone, oxycodone, prednisone, zestoril and toradol (ketorolac tromethamine) for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium) and prenatal vitamin for unknown indication.  On 20-JUN-2021, the patient noticed the delay started from the first mensural cycle after the vaccine which was due in 3 weeks but was delayed than expected. Patient mentioned that the delayed cycles were making it difficult for her to conceive that the patient was not getting any younger and the range of delay was from 4 to 28 days. On JUN-2021, The patient mentioned that she had fertility tests saline infusion sonohysterogram (SIS) and Hysterosalpingography (HSG) to make sure no blockage of fallopian tube as well as endometrial biopsy and there were no remarkable findings. Patient mentioned that her last 3 cycles were heavier and were accompanied by more cramps and back pain at night, stated that the patient had not experienced pain that bad in 20 years. Patient stated that she had not been on birth control for 8 years. On an unspecified date in JUN-2021 and JUL-2021, the patient had 2 blood tests, and both were negative. Patient stated the dates of all her menstrual cycles after receiving the vaccine: 20-JUN-2021 to 19-JUL-2021, August (patient said, must have been pregnant date between 16-AUG-2021 to 19-AUG-2021, on 12-SEP-2021 the patient started miscarrying and on 14-SEP-2021, the fetus heartbeat stopped. Patient mentioned that, experienced 2 miscarriages first one was 7 years ago while the second one was on 14-SEP-2021. The second miscarriage happened 2 months after conception, the patient did not realize that she was pregnant until she was 6 weeks along. The patient was trying for her first baby. The patient stated that her Gynecologist suggested fertility treatment Intrauterine insemination (IUI) or In vitro fertilization (IVF) which the patient could not afford. After the miscarriage, an autopsy was done of tissues from fetus and mother to test for chromosomal abnormalities, results were normal, no reproductive issues found, no issues with the partner tests as well, her miscarriage was diagnosed as an unexplained miscarriage. The next cycle was on 17-OCT-2021, then 24-NOV-2021, then 22-DEC-2021and then 16-JAN-2022. Agent did not ask how the patient calculated the delay range which the patient mentioned before sharing the dates of her cycles to be between 4 to 28 days, but after the patient shared the dates of her mensural cycles, agent asked to confirm the range and the patient confirmed again the delay range to be from 4 to 28 days (4-28 days delay was the patient's own verbatim and as per patient own calculation). On an unspecified date, the patient experienced vaccine exposure before pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from delayed menstruation, and more cramps and bad pain with menstruation, and the outcome of miscarriage, heavy periods, unable to conceive and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220211503-covid-19 vaccine ad26.cov2.s-Miscarriage. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.   20220211503-covid-19 vaccine ad26.cov2.s- vaccine exposure before pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.