Arthus Reaction as an Adverse Event Following Tdap Vaccination

Repeat administration of tetanus toxoid-containing vaccines has rarely been associated with Arthus phenomenon, an immune-complex reaction. In the US, since 2013, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines (Tdap) have been recommended for administration during each pregnancy. Separately, in 2019, one Tdap was approved for repeat administration in adults in the US. We aimed to describe trends in spontaneously reported Arthus reactions following Tdap in the US and to assess the risk of this phenomenon in persons receiving Tdap repeatedly. We reviewed Arthus reports in the Vaccine Adverse Events Reporting System (VAERS), 1990–2018. Reporting rates were estimated using Tdap doses distributed data. A systematic literature review was conducted in MEDLINE for any Arthus cases reported in Tdap clinical trials and observational studies published between 2000 and 2019. We found 192 Arthus reports in VAERS after any vaccine, of which 36 occurred after Tdap and none were reported during pregnancy. The Arthus reporting rate was estimated at 0.1 per million doses distributed. We identified eight published studies of Tdap administration within five years after a previous dose of tetanus toxoid-containing vaccine; no Arthus cases were reported. We conclude that Arthus reaction following Tdap is extremely rare. Increasing frequency of repeat Tdap administration in adults in the US did not result in a detectable increase in reporting rates of this phenomenon, confirming the favorable safety profile of Tdap.

Safety profile of Td vaccination in Indonesian pregnant women: a post-marketing surveillance study

BACKGROUND The Indonesian Expanded Program of Immunization has implemented tetanus and diphtheria (Td) vaccination to replace the tetanus toxoid vaccine in pregnant women since the year 2016. Td vaccine is administered to protect against diphtheria and tetanus to the mother and her baby as well. This prospective study was conducted to assess the adverse reactions after Td immunization; besides, a retrospective study was conducted to observe the presence of severe local reaction (Arthus reaction), premature birth, and low birth weight history in the medical records of pregnant women who had received Td immunization in the past year. METHODS A prospective observational study was conducted in 200 pregnant women. Local reactions and systemic events occurring within 28 days after immunization were recorded in the diary card and were confirmed by the health worker in the follow-up visit. A retrospective study was also conducted to evaluate 750 medical records of pregnant women who had received Td immunization. The study was conducted fromSeptember 2017 to January 2018. The study has been registered at ClinicalTrials.gov ID: NCT03383653. RESULTS In 185 pregnant women who completed the study, the most common local reaction was pain, occurring in 33.5% of subjects within 24 hours after vaccination. Fever, other systemic reactions, and serious adverse events were not reported during the observation. In the retrospective study, 647 medical records were validated. No Arthus reaction was observed. The prevalence of premature birth was 1.24%, and that of low birth weight was 2.63%, which were below the normal rates. CONCLUSIONS Td vaccination in pregnant women was safe and well-tolerated.