TABLE 3

Crude AE Reporting Rates (per 1 Million 9vHPV Doses Distributed) in VAERS, 2014–2017

Report Type or AEn (Reporting Rate per 1 Million Doses Distributeda)
Report type
 All reports7244 (259)
 Serious reportsb186 (7)
AEc,d
 Syncope722 (26)
 POTS17 (0.6)
 Autoimmune disorders13 (0.5)
 Anaphylaxise9 (0.3)
 GBSe8 (0.3)
 Venous thromboembolism8 (0.3)
 Deathe7 (0.3)
 POI3 (N/A)f
 Stroke2 (0.07)
 ADEM2 (0.07)
 CRPS1 (0.04)
 Pancreatitis1 (0.04)
 Transverse myelitis0 (0)
 CIDP0 (0)
  • N/A, not applicable.

  • a Estimated 27 996 934 9vHPV doses distributed in the United States from 2014 through 2017 (Merck & Co, Inc, personal communication, 2018).

  • b As defined in 21CFR600.80.21

  • c A single report may contain more than 1 AE (ie, not mutually exclusive).

  • d See Supplemental Table 4 for MedDRA Preferred Terms used to identify prespecified conditions.

  • e Confirmed cases after clinical review of reports are as follows: anaphylaxis (n = 3), GBS (n = 4), death (n = 2).

  • f Not able to calculate reporting rates because of the inability to determine doses distributed for female versus male use; N/A = not available