Background Alopecia is associated with erenumab post-marketing, but no cases have been described. Methods We describe two patients that reported temporary hair loss and review the FDA Adverse Event Reporting System (FAERS). Results The first patient experienced alopecia within three months of starting erenumab, which did not improve with ongoing use or transition to fremanezumab. The second patient reported alopecia within two weeks of starting erenumab, which continued after transition to galcanezumab; months later, there was also recurrent hair loss within one month of starting fremanzeumab. According to FAERS (last accessed 18 August 2022), alopecia was reported most with erenumab (1158), followed by galcanezumab (554), fremanezumab (175), eptinezumab (23), rimegepant (26), ubrogepant (4), and atogepant (3). Conclusion Most events were reported in women and non-serious. The potential mechanism of alopecia with drugs targeting calcitonin gene-related peptide or its receptor possibly includes disruptions in the microvascular circulation and other homeostatic mechanisms.
Purpose of Review The aim of this review is to characterize headache as a vaccine adverse event (VAE) in clinical trials. Recent Findings Of the recent phase III vaccine RCTs (non-COVID-19), 53 studies reported on headache (13 infectious agents). The median rate (interquartile range) of headache was 15.6% ( IQR : 9.6–37.6%). Of these, 24.5% of the RCTs reported headache greater in the vaccine group compared to the placebo/control group. In the herpes zoster vaccination trials, headache was more common in all active groups: median rate 33.9% ( IQR : 29.7–40.5%) as compared to placebo: median rate 17.7% ( IQR : 15.4–23.8%). Influenza and HPV vaccination trials were the 2nd and 3rd most common to have headache as a VAE. Of the 6 widely distributed COVID-19 vaccinations, median rate of post-vaccination headache was 39% ( IQR : 28–50%). Summary Headache is a common VAE in vaccine trials. Standardized grading methods, predictors of persistence, and treatment regimens are warranted.
Objective To assess the characteristics and associated disability of headache as an adverse event following vaccination. Background According to clinical trials and post‐licensure surveillance, headache is a common symptom of vaccines, yet systematic investigations of post‐licensure reports of this adverse event are lacking. Methods This was a retrospective database analysis study. We searched the Vaccine Adverse Events Reporting System (VAERS) database completed from July 1990 to June 2020 (a 30‐year period prior to the start of COVID‐19 pandemic) to identify reports of headache. We evaluated epidemiological features, including event characteristics, patient demographics, and vaccine type. Results In those aged 3 years or older, headache was the fifth most reported adverse symptom, present in 8.1% (43,218/536,120) of all reports. Of headache reports, 96.3% (41,635/43,218) included the code “headache” not further specified. Migraine was coded in 1973 cases, although almost one‐third (12,467/41,808; 29.8%) of headache reports without a migraine code mention nausea or vomiting. The onset of symptoms was within 1 day of vaccination in over two‐thirds of cases. The majority of reports were classified as not serious; about one‐third involved emergency room or office visits. Of the 43,218 total headache reports, only a minority involved hospitalizations (2624; 6.1%) or permanent disability (1091; 2.5%), females accounted for 68.9% (29,771) and males for 29.5% (12,725), patients aged 6 to 59 years represented 67.3% (29,112), and over one‐third of cases were reported after herpes zoster (8665; 20.1%) and influenza (6748; 15.6%) vaccinations. Conclusion In a national surveillance system, headache was a commonly reported post‐vaccination adverse event; a small subset of reports was considered serious. The development of standardized vaccine‐related case definitions could be useful for better evaluating headache as an adverse event during vaccine development, and may reduce vaccine hesitancy especially in headache‐prone individuals.
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