Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Incorrect product formulation administered, Underdose
Clinical narrative: Maternal exposure during pregnancy; No Adverse event; 6y-11y presentation wrong vaccine administered; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (6y-11y presentation wrong vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 04-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (6y-11y presentation wrong vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6y-11y presentation wrong vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse event) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (6y-11y presentation wrong vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    The patient has received 2 doses of the Pfizer vaccine, a Pfizer booster, and a Moderna booster. The Moderna booster was administered on 4OCT2022 by intramuscular injection from the 6y-11y presentation of the vaccine No additional doses, medications, or treatments had been administered at that time.  Patient had not experienced any symptoms.  Company comment: This spontaneous case of maternal exposure during pregnancy concerns a 31-year-old, female patient, with no medical history reported, who experienced the unexpected non-serious event of wrong product administered (6y-11y presentation wrong vaccine administered). The patient received the fourth (booster) dose of mRNA-1273 during pregnancy. The patient also received the first three doses (as primary vaccination and booster) of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), thus, interchange of vaccine products and COVID-19 immunization (Revaccination with different COVID-19 vaccine) were reported. Additionally, no adverse event was reported. No further relevant information, including gestational week at vaccination, course of pregnancy, diagnostic tests and treatment received, was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of maternal exposure during pregnancy concerns a 31-year-old, female patient, with no medical history reported, who experienced the unexpected non-serious event of wrong product administered (6y-11y presentation wrong vaccine administered). The patient received the fourth (booster) dose of mRNA-1273. The patient also received the first three doses (as primary vaccination and booster) of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), thus interchange of vaccine products and COVID-19 immunization (Revaccination with different COVID-19 vaccine) were reported. Additionally, no adverse event was reported. No further relevant information, including gestational week at vaccination, course of pregnancy, diagnostic tests and treatment received, was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.