Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Heart rate irregular, Inappropriate schedule of product administration, Malaise
Clinical narrative: Inappropriate schedule of product administration; Missed second dose schedule/unable to get the second Moderna vaccine /  second Moderna Vaccine was unavailable; Vaccine exposure during pregnancy; Palpitation; Heart skipping beat; Very sleepy; Felt unwell \ ill; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), HEART RATE IRREGULAR (Heart skipping beat), SOMNOLENCE (Very sleepy), MALAISE (Felt unwell \ ill) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051CZ1A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eclampsia (posteclampsia). Concomitant products included VITAMIN D3, ZINC and CALCIUM for an unknown indication.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jul-2021, the patient experienced PALPITATIONS (Palpitation), HEART RATE IRREGULAR (Heart skipping beat), SOMNOLENCE (Very sleepy), MALAISE (Felt unwell \ ill), HEADACHE (Headache) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Missed second dose schedule/unable to get the second Moderna vaccine /  second Moderna Vaccine was unavailable). On 16-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 08-Jul-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 29-Jul-2021, PRODUCT ADMINISTRATION INTERRUPTED (Missed second dose schedule/unable to get the second Moderna vaccine /  second Moderna Vaccine was unavailable) had resolved. On 16-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, PALPITATIONS (Palpitation) had resolved with sequelae and HEART RATE IRREGULAR (Heart skipping beat), SOMNOLENCE (Very sleepy), MALAISE (Felt unwell \ ill) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details provided - drink water.  lab results shows pacs and pvcs but does not show what it is.  This case involves a 35-year-old female subject with the medical history of eclampsia who experienced the non-serious unexpected adverse events of palpitations, heart rate irregular, somnolence, malaise, headache after her first vaccination with mRNA-1273 and product administration interrupted at the scheduled time of her second dose due to unavailability of the vaccine. After having received her second vaccination dose, she once again experienced palpitations (positive re-challenge).  Pregnancy exposure was also reported without any information on the date of LMP and pregnancy status.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-336369.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up document contains the information about the unavailable second dose On 29-Sep-2021: Followup received ADR form that contains patient demographics/event outcome update/ dose-2 update/preganancy status update.; Sender's Comments: This case involves a 35-year-old female subject with the medical history of eclampsia who experienced the non-serious unexpected adverse events of palpitations, heart rate irregular, somnolence, malaise, headache after her first vaccination with mRNA-1273 and product administration interrupted at the scheduled time of her second dose due to unavailability of the vaccine. After having received her second vaccination dose, she once again experienced palpitations (positive re-challenge).  Pregnancy exposure was also reported without any information on the date of LMP and pregnancy status.  The benefit-risk relationship of mRNA-1273 is not affected by this report.