Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Fall, Interchange of vaccine products, Skull fracture, Syncope
Clinical narrative: fainting/fainted; Skull fracture; Fall; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting/fainted) and SKULL FRACTURE (Skull fracture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: Pfizer vaccine (1st dose) and Pfizer vaccine (2nd dose); for Shingles: Shingles Shot (Shingles Shot); for Flu: Flu shot (Flu Shot). Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer vaccine, Pfizer vaccine and Shingles Shot.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting/fainted) (seriousness criterion medically significant), SKULL FRACTURE (Skull fracture) (seriousness criterion medically significant), FALL (Fall) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SYNCOPE (fainting/fainted), SKULL FRACTURE (Skull fracture), FALL (Fall) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: Patient was red hot in echocardiogram.         No concomitant medication was reported. No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with past drug history of administration of two doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (medically significant) events of syncope and skull fracture, and an unexpected, non-serious event. The events occurred unknown number of days after receiving the booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient fainted on stage and fractured her skull. It was also reported that the patient received the booster dose '3 weeks to the day of the fall'. An Echocardiogram was done, however, the result was not provided. No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow-up received contains updated narrative.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with past drug history of administration of two doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (medically significant) events of syncope and skull fracture, and an unexpected, non-serious event. The events occurred unknown number of days after receiving the booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient fainted on stage and fractured her skull. It was also reported that the patient received the booster dose '3 weeks to the day of the fall'. An Echocardiogram was done, however, the result was not provided. No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.