Sex: U
Vaccine: UNK
Symptoms: Gastrointestinal disorder, Headache, Muscle disorder
Clinical narrative: Severe Headache; GI Symptoms; Muscle Control Issues; This case was obtained on 12NOV2020 in the review of publications.  Literature Citation:  A study participant (age, gender not reported) received the anthrax vaccine (date, dose, lot not reported) and cited several problems that occurred following injection including muscle control issues (PT: muscle disorder), GI symptoms (PT: gastrointestinal disorder), and severe headache (PT: headache). The time to onset and outcome were not reported. No further information was provided.  Literature Abstract: Most people have no problems when administered vaccines; however, as with all drugs, reported adverse effects (rAEs) do occur. There is a need to better understand the potential predictors of reported vaccine AEs (rVaxAEs), including modifiable (environmental) predictors. Individuals who have Gulf War Illness (GWI) report increased experiences of drug experiences of drug and chemical rAEs, extending to rVaxAEs. Individuals provide an opportunity to examine the relationship between their reported exposures and rAEs. Forty-one individuals with GWI and 40 healthy controls reported exposure and rAEs to exposure, including 14 vaccines. Individual and summed vaccine exposures, rVaxAEs, and reported Vaccine AE Propensity (summed rVaxAEs / Summed vaccine exposures) were compared in cases vs. controls. Exposure-outcome assessments focused on individuals, using a multivariable regression with robust standard error. More designated vaccines were reported in cases than in controls: 9.0 (2.3) vs. 3.8 (2.3), p<0.0001.  The fraction of vaccines received that led to rAEs was ten-fold higher in cases: 0.24 (0.21), vs. 0.023 (0.081), p<0.0001. Multivariable assessment confirmed that radiation and pesticides remained significant statistical predictors of reported Vaccine AE Propensity. Exposure tied to excess rVaxAEs in individuals may contribute to, or underlie, the reported link between rVaxAEs in individuals and later ill health.  Company Comment:  The information received from the article is not specific and refers to a multiple vaccinations that included anthrax vaccine as the most reactogenic and most with reported reactions comparing to other vaccines. However, there was one subject that reported headache and unspecific term of gastrointestinal and muscle disorder post injection. Headache is a known phenomenon that occur post BioThrax injection. Nausea is the only gastrointestinal disorder that has been recorded in clinical studies and postmarketing reports. The report of muscle control issue is too general to define its meaning. Just because the report says that the occurrence was post injection, it is assumed that it was temporal relationship, therefore headache is considered probable but the gastrointestinal and muscle disorder are considered possible, although being an unspecific term the relevance is missing.; Sender's Comments: The information received from the article is not specific and refers to a multiple vaccinations that included anthrax vaccine as the most reactogenic and most with reported reactions comparing to other vaccines. However, there was one subject that reported headache and unspecific term of gastrointestinal and muscle disorder post injection. Headache is a known phenomenon that occur post BioThrax injection. Nausea is the only gastrointestinal disorder that has been recorded in clinical studies and postmarketing reports. The report of muscle control issue is too general to define its meaning. Just because the report says that the occurrence was post injection, it is assumed that it was temporal relationship, therefore headache is considered probable but the gastrointestinal and muscle disorder are considered possible, although being an unspecific term the relevance is missing.