12

Injection-Related Adverse Events

The adverse events in this chapter were considered by the committee as potential consequences associated with direct trauma from the administration of various injected vaccines and not necessarily attributable to the contents of the vaccine.

COMPLEX REGIONAL PAIN SYNDROME

Epidemiologic Evidence

No studies were identified in the literature for the committee to evaluate the risk of complex regional pain syndrome (CRPS) after the injection of a vaccine.

Weight of Epidemiologic Evidence

The epidemiologic evidence is insufficient or absent to assess an association between the injection of a vaccine and CRPS.

Mechanistic Evidence

The committee identified 10 publications reporting the development or exacerbation of CRPS after receiving an injection. Eight publications described cases that did not provide evidence beyond temporality (Bensasson et al., 1977; Genc et al., 2005; Jastaniah et al., 2003; Kachko et al., 2007; Palao Sanchez et al., 1997; Pirrung, 2010; Siegfried, 1997; Steinberg et al.,



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12 Injection-Related Adverse Events The adverse events in this chapter were considered by the committee as potential consequences associated with direct trauma from the adminis- tration of various injected vaccines and not necessarily attributable to the contents of the vaccine. COMPLEX REGIONAL PAIN SYNDROME Epidemiologic Evidence No studies were identified in the literature for the committee to evalu- ate the risk of complex regional pain syndrome (CRPS) after the injection of a vaccine. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between the injection of a vaccine and CRPS. Mechanistic Evidence The committee identified 10 publications reporting the development or exacerbation of CRPS after receiving an injection. Eight publications de- scribed cases that did not provide evidence beyond temporality (Bensasson et al., 1977; Genc et al., 2005; Jastaniah et al., 2003; Kachko et al., 2007; Palao Sanchez et al., 1997; Pirrung, 2010; Siegfried, 1997; Steinberg et al., 615

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616 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY 1995). These cases did not contribute to the weight of mechanistic evidence. In addition, Kachko et al. (2007) attributed the development of CRPS to Crohn’s disease. These publications did not contribute to the weight of mechanistic evidence. Described below are publications reporting clinical, diagnostic, or ex- perimental evidence that contributed to the weight of mechanistic evidence. Jastaniah et al. (2003) described four patients who developed complex regional pain syndrome after vaccination against hepatitis B. Case 2 de- scribed a 12-year-old girl presenting with swelling, decreased temperature, discoloration, and loss of function of the left arm lasting for 1 week. Symp- tom onset developed 30 minutes after receiving the first dose of a hepatitis B vaccine in the left deltoid muscle. The same symptoms developed within minutes and lasted for 1 week after administration of the second dose of a hepatitis B vaccine in the right arm. The patient was afflicted by two ad- ditional episodes developing spontaneously; one involved the development of an urticarial rash and pain in the left foot, the second involved swell- ing, pallor, coolness, and pain in the left arm and hand. Case 4 describes a 12-year-old girl presenting with discoloration, swelling, and the inability to clench the fingers of the right hand 15 minutes after receiving the first dose of a hepatitis B vaccine in the right deltoid muscle. Past history revealed an episode of leg swelling after injection of the first dose of a diphtheria- tetanus-pertussis vaccine in the thigh; no other physical exam findings were consistent with CRPS. Subsequent pertussis vaccines were withheld and the patient tolerated other vaccinations without incident. Ali et al. (2000) conducted a study to determine if peripheral ad- ministration of physiologically relevant doses of an α-adrenergic agonist resulted in pain in patients with sympathetically maintained pain. Twelve individuals with either type I or type II CRPS affecting either an upper or a lower extremity and normal individuals were recruited to take part in the study. The participants diagnosed with CRPS previously underwent lo- cal anesthetic blocks of the sympathetic ganglia. Each participant received saline, and three concentrations of norepinephrine were administered via intradermal injection twice each. One series of injections was administered on the unaffected extremity in the mirror image region to the area on the affected extremity. Pain to each of the injections was rated by the partici- pant. Subsequently, the same series of injections were administered on the affected extremity, and the participants rated pain to each of the injections. None of the concentrations of norepinephrine elicited pain in the normal participants. Likewise, none of the concentrations of norepinephrine elic- ited significant pain in the participants diagnosed with CRPS when injected into the unaffected side. In contrast, the two highest concentrations of nor- epinephrine elicited significant pain in comparison to saline when injected in the affected extremity. Mailis-Gagnon and Bennett (2004) conducted a study using normal

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617 INJECTION-RELATED ADVERSE EVENTS subjects, sympathetically independent pain (SIP) patients, and sympatheti- cally maintained pain (SMP) patients to determine if intradermal injection of phenylephrine elicits a response similar to that elicited by norepineph- rine. The SIP and SMP patients were diagnosed with either type I or type II CRPS. Intradermal injection of a placebo or 1 percent solution of phen- ylephrine were administered to the forearm, shin of the lower leg, or the suprapatellar area of the upper leg. Pain to each of the injections was rated by the participants. None of the participants reported unusual pain to the placebo. All participants reported stinging or burning pain lasting 15–90 seconds developing after intradermal injection of phenylephrine. Further- more, all SMP patients reported burning pain developing after intradermal injection of phenylephrine in the symptomatic limb. In addition, three SMP patients reported the development of pain after intradermal injection of phenylephrine administered to the unaffected limb. Weight of Mechanistic Evidence The publications, described above, presented clinical evidence sugges- tive but not sufficient for the committee to conclude that the injection of a vaccine was a contributing cause of CRPS. The clinical description in one case provided by Jastaniah et al. (2003) included evidence of vaccine rechallenge and was consistent with CRPS. Furthermore, the latency be- tween injection of a vaccine and the development of CRPS in the vaccine rechallenge case described above was 30 minutes or less, suggesting injury resulting from the injection of the vaccine. Approximately 50 percent of patients with CRPS have a history of antecedent trauma to the affected limb (Littlejohn, 2008). This is supported by controlled studies, not using vaccines, conducted by Ali and colleagues (2000) and Mailis-Ganon and Bennett (2004) in which pain was elicited after injection of norepinephrine and phenylephrine. However, the three other cases described by Jastaniah et al. (2003) and cases described by other authors (Bensasson et al., 1977; Genc et al., 2005; Jastaniah et al., 2003; Palao Sanchez et al., 1997; Pirrung, 2010) did not include convincing evidence beyond a temporal relationship between injec- tion of a vaccine and development of CRPS. The committee assesses the mechanistic evidence regarding an as- sociation between the injection of a vaccine and CRPS as low- intermediate based on experimental evidence and one case. Causality Conclusion Conclusion 12.1: The evidence is inadequate to accept or reject a causal relationship between the injection of a vaccine and CRPS.

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618 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY DELTOID BURSITIS Epidemiologic Evidence The committee reviewed one study to evaluate the risk of deltoid bur- sitis after the injection of a vaccine. This one controlled study (Black et al., 2004) contributed to the weight of epidemiologic evidence and is described below. Black et al. (2004) conducted a retrospective cohort study in pa- tients (2 years of age or older) enrolled in the Northern California Kaiser Permanente Medical Care Program. The study investigated the occurrence of bursitis/synovitis/tenosynovitis (reported as outpatient clinic visits, emer- gency room visits, and hospitalizations) after receipt of hepatitis A vaccine from April 1997 through December 1998. A total of 49,932 doses of vac- cine were administered to 14,898 children (2–17 years) and 35,034 adults (≥ 18 years) during the study. The risk period for outpatient clinic visits and emergency room visits was defined as 30 days after vaccination, whereas the risk period for hospitalizations was defined as 60 days after vaccina- tion. Two control periods were used to evaluate the risk prior to vaccine administration (31–60 or 31–90 days before vaccination) and following vaccine administration (91–120 or 91–150 days after vaccination). The two age groups (children and adults) and events following a first dose and second dose of hepatitis A vaccine were evaluated separately. The authors only reported statistically significant associations in the article, and only one analysis was listed. The relative risk of an emergency room visit for bursitis/synovitis/tenosynovitis within 30 days of administration of a sec- ond dose of hepatitis A vaccine among patients aged ≥ 18 years was 0.55 (95% CI, 0.32–0.92). The authors did not observe a consistent protective effect between the administration of hepatitis A vaccine (first or second dose) and bursitis/synovitis/tenosynovitis for either age group in the three defined settings. Weight of Epidemiologic Evidence The committee has limited confidence in the epidemiologic evi- dence, based on one study that lacked validity and precision, to assess an association between the injection of a vaccine and deltoid bursitis. Mechanistic Evidence The committee identified three publications and three Vaccine Adverse Event Reporting System (VAERS) reports describing the development of deltoid bursitis after administration of a vaccine by injection. Black and col- leagues (2004) identified cases of bursitis/synovitis/tenosynovitis developing

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619 INJECTION-RELATED ADVERSE EVENTS after vaccination against hepatitis A using the vaccine VAQTA reported to the Kaiser Permanente Medical Care Program from April 1997 through December 1998. The location of the bursitis/synovitis/tenosynovitis was not indicated. Therefore, this publication did not contribute to the weight of mechanistic evidence. Described below are two publications and three VAERS reports provid- ing clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Atanasoff et al. (2010) identified 13 claims in the National Vaccine Injury Compensation Program (VICP) database in which injury to the shoulder was reported. All claimants were adult and 11 were women. Out of the women, eight received an influenza vaccine, two received a tetanus reduced diphtheria vaccine, and one received a human papillomavirus vac- cine. The two men received tetanus, reduced diphtheria, and reduced per- tussis vaccine. The onset of pain in the shoulder developed immediately or within 24 hours after vaccination in 54 percent and 93 percent of the cases respectively. Limited and painful range of motion was the most common finding, whereas weakness, tingling, and numbness were uncommon. Fluid collections in the deep deltoid, tendonitis, rotator cuff tears, subchondral changes in the humerus, bursitis, and increased fluid within the bursa were observed via MRI. In addition, 15 percent of the cases were found to have complete rotator cuff tears. Three VAERS reports describing shoulder dysfunction after admin- istration of influenza vaccines were identified by Vellozzi and colleagues (2009) and obtained via a Freedom of Information Act (FOIA) request (FDA, 2010). VAERS ID 28572 describes a 52-year-old woman presenting with muscle stiffness, swelling, and an arm hot to touch developing the same day after administration of an influenza vaccine. The patient reported similar symptoms accompanied by an inability to raise the arm laterally for more than 1 year after administration of an influenza vaccine 5 years earlier. VAERS ID 93764 describes a 63-year-old woman presenting with a reddened area tender to touch the size of a 25-cent piece and swelling of the arm and hand 10 minutes after administration of an influenza vaccine. The following day the patient had difficulty lifting the arm. The patient experienced similar symptoms with a previous influenza vaccine. VAERS ID 107626 describes a 55-year-old woman presenting with extreme pain and reduced range of motion 10 minutes after administration of an influ- enza vaccine. The patient reported similar symptoms after vaccination the previous year. Weight of Mechanistic Evidence The publications, described above, presented clinical evidence suffi- cient for the committee to conclude that the injection of a vaccine was a contributing cause of deltoid bursitis. The clinical descriptions provided by

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620 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Atanasoff et al. (2010) were consistent with deltoid bursitis and established a strong temporal relationship between injection of a vaccine and develop- ment of deltoid bursitis. Furthermore, the observations made by MRI by Atanasoff et al. (2010) suggest that the injection, and not the contents of the vaccine, contributed to the development of deltoid bursitis. The committee assesses the mechanistic evidence regarding an as- sociation between the injection of a vaccine and deltoid bursitis as strong based on 16 cases presenting definitive clinical evidence. Causality Conclusion Conclusion 12.2: The evidence convincingly supports a causal relationship between the injection of a vaccine and deltoid bursitis. SYNCOPE Epidemiologic Evidence The committee reviewed 21 studies to evaluate the risk of syncope after the injection of a vaccine. Eighteen studies (Bino et al., 2003; Braun et al., 1997; D’Heilly et al., 2006; Dobardzic et al., 2007; Dobson et al., 1995; D’Souza et al., 2000; DuVernoy and Braun, 2000; Ion-Nedelcu et al., 2001; Khetsuriani et al., 2010; Laribiere et al., 2005; Sejvar et al., 2005; Sever et al., 2004; Slade et al., 2009; Sri Ranganathan et al., 2003; Vahdani et al., 2005; Vika et al., 2006; Wise et al., 2004; Woo et al., 2006) were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems or self-report surveys, and lacked unvaccinated comparison populations. Three controlled studies (Bernstein et al., 2005; Beytout et al., 2009; Block et al., 2010) had very serious methodological limitations that precluded their inclusion in this assessment. Bernstein et al. (2005), Beytout et al. (2009), and Block et al. (2010) conducted double-blind, randomized controlled trials, but too few events were reported to adequately assess the risk of syncope following the injection of various vaccines. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between the injection of a vaccine and syncope. Mechanistic Evidence The committee identified 29 publications reporting syncope or syncopal seizure after receipt of an injection. Seventeen publications reported syn-

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621 INJECTION-RELATED ADVERSE EVENTS cope developing after vaccination but either did not provide a time frame between the two events or the time frame provided was nonspecific (Bino et al., 2003; D’Heilly et al., 2006; Dobardzic et al., 2007; Dobson et al., 1995; DuVernoy and Braun, 2000; Ion-Nedelcu et al., 2001; Khetsuriani et al., 2010; Reisinger et al., 2010; Rivera Medina et al., 2010; Schnatz et al., 2010; Sejvar et al., 2005; Sever et al., 2004; Southern et al., 2006; Sri Ranganathan et al., 2003; Vahdani et al., 2005; Wise et al., 2004; Woo et al., 2006). These publications did not contribute to the weight of mecha- nistic evidence. Described below are 12 publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Buttery et al. (2008) identified adverse events following vaccination against human papillomavirus. The adverse events were reported to Sur- veillance of Adverse Events following Vaccination in the Community (SAFEVIC) in Australia in April 2007. The authors identified cases of syn- cope developing within 2 hours after vaccination. One case presented with a second episode of syncope 2 days later. D’Souza et al. (2000) identified adverse events developing after adminis- tration of a measles, mumps, and rubella vaccine reported to the vaccine pro- viders participating in the Measles Control Campaign (MCC), to the Serious Adverse Events Following Vaccination Surveillance Scheme (SAFEVSS), and to the Adverse Drug Reactions Advisory Committee (ADRAC) in Australia from August to November 1998. The authors identified 29 cases of syncope or syncopal seizure developing after vaccination. Twenty-one of the 29 cases developed within 1 hour after vaccination. Similarly, 21 of the 29 cases did not require medical attention. Keyserling et al. (2005) conducted a randomized, double-blind trial at 11 clinical centers in the United States where meningococcal vaccines were administered to 881 individuals ranging from 11 to 18 years of age. Two participants experienced a vasovagal episode within 30 minutes after receiving a meningococcal vaccine. Medical intervention was not required. Labribière et al. (2005) conducted a prospective study using surveys completed by physicians and families to study adverse events reported after administration of meningococcal vaccines in France. The authors identified 10 cases of seizures or tonic-clonic movements during syncope. In addition, the authors described one case of syncope in some detail. An 11-year-old boy presented with loss of consciousness, hypotension, bradypnea, and bradycardia 3 minutes after vaccination. The patient experienced two ad- ditional episodes within 1 hour. Meyer et al. (2001) describe a 10-year-old boy presenting with loss of consciousness for 30 seconds after feeling dizzy and experiencing optic sensations a few minutes after receiving a vaccine against tick-borne en- cephalitis. The patient had a similar episode 4 months later after receiving a measles, mumps, and rubella vaccine. In addition, the patient had previ-

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622 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY ously become pale, lost consciousness, and developed a seizure 2 minutes after venipuncture. Twenty seconds after venipuncture the patient’s heart rate decreased from 110 to 50 beats per minute followed by 6 seconds of asystole. The patient recovered in less than 30 seconds. Braun et al. (1997) analyzed reports to VAERS from its inception through October 1995. The authors identified 697 reports of syncope developing within 12 hours after vaccination. Of the 697 reports 323 oc- curred within 5 minutes, 454 occurred within 15 minutes, 500 occurred within 30 minutes, and 511 occurred within 1 hour after vaccination. Of the 697 reports, 67 required hospitalization. Six cases were described in detail. Case 1 describes a 17-year-old boy who developed syncope 10 min- utes after receiving tetanus-diphtheria and measles, mumps, and rubella vaccines. The patient suffered a linear skull fracture and bilateral fronto- temporal contusions. Case 2 describes a 12-year-old boy who developed syncope 10 to 15 minutes after receiving a measles, mumps, and rubella vaccine. The patient suffered frontal cerebral contusions. Case 3 describes a 26-year-old man who developed syncope less than 3 minutes after receiving tetanus-diphtheria and measles, mumps, and rubella vaccines. The patient suffered a linear nondepressed skull fracture and contusions of the frontal and temporal regions. Depression and cognitive deficits continued through a follow-up 2 years after injury. Case 4 describes a 28-year-old man who developed syncope within 1 minute after receiving a measles vaccine. The patient suffered from a subdural and epidural hematoma compressing the right lateral ventricle. The patient experienced months of cognitive, behav- ioral, speech, and language problems after the injury. Case 5 describes a 15-year-old boy who developed syncope less than 10 minutes after receiv- ing a tetanus-diphtheria vaccine. The patient suffered a massive cerebral hemorrhage from a lacerated middle meningeal artery. Two years after the injury the patient had a right hemiparesis. Case 6 describes an 18-year-old girl who developed syncope 5 minutes after receiving a tetanus-diphtheria vaccine. The patient suffered a skull fracture, cerebral contusions, and a right frontal hematoma. Miller and Woo (2006) describe a teenage boy who experienced vaso- vagal syncope a few minutes after receiving the third dose of a hepatitis B vaccine. The patient fell striking his head. Upon regaining consciousness the patient developed seizures and cardiopulmonary arrest after complaining of pain in the chest and arms. Resuscitation attempts failed and the patient died. Frontal lobe contusions, edema, and cerebral hemorrhage were ob- served during autopsy. The fall and resulting head injuries were determined to be the cause of death. In addition, the authors identified 2,366 reports of syncope submitted to VAERS since 1990. Slade et al. (2009) analyzed reports of adverse events developing after

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623 INJECTION-RELATED ADVERSE EVENTS vaccination with the quadrivalent human papillomavirus vaccine Gardasil received by VAERS from June 2006 through December 2008. The authors identified 1,896 cases reporting syncope. Syncope developed on the same day of vaccination in 90 percent of the cases reporting a time interval be- tween the onset of symptoms and vaccination. Fifty percent of the cases occurring on the day of vaccination developed within 15 minutes after vac- cination. Of the 1,896 reports of syncope, 293 resulted in a fall of which 200 resulted in a head injury. One VAERS report describing syncope after administration of an influ- enza vaccine was identified by Vellozzi and colleagues (2009) and obtained via a FOIA request (FDA, 2010). VAERS ID 212825 describes a 49-year-old man presenting with brief syncope after vaccination. The patient’s blood pressure was initially 80/60, and after 5 minutes it was reported to be 100/60. The patient experienced a similar episode after a previous influenza vaccination. Konkel et al. (1993) and Wiersbitzky et al. (1993) describe a 6-year-old presenting with loss of consciousness, generalized tonic-clonic seizures, and enuresis 10 minutes after administration of a measles, mumps, and rubella vaccine. Zimmerman et al. (2010) conducted a randomized trial of an alternate human papillomavirus vaccine administration schedule and received 114 and 95 reports of adverse events in the standard schedule group and the al- ternate schedule group, respectively. One case of syncope was reported and described in some detail. The patient developed syncope, which resolved without complications, immediately after receiving a dose of the quadriva- lent human papillomavirus vaccine. The patient was on the examination table at the time. Weight of Mechanistic Evidence The publications described above presented clinical evidence sufficient for the committee to conclude that the injection of a vaccine was a con- tributing cause of syncope. The clinical descriptions provided in many publications establish a strong temporal relationship between injection of a vaccine and development of syncope. Furthermore, the prodromal symptoms, including dizziness and pallor, described in some publications, are consistent with those developing before vasovagal syncope. Also, one patient experienced a decreased heart rate seconds after venipuncture and before fainting suggesting vasovagal syncope. This patient developed two additional episodes of syncope after injection of two different vaccines, sug- gesting that the injection, and not the contents of the vaccine, contributed to the development of syncope.

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624 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY The latency, of 15 minutes or less, between injection of a vaccine and the development of syncope in many of the cases described above suggests vasovagal syncope as the mechanism. The committee assesses the mechanistic evidence regarding an as- sociation between the injection of a vaccine and syncope as strong based on 35 cases1 presenting definitive clinical evidence. Causality Conclusion Conclusion 12.3: The evidence convincingly supports a causal re- lationship between the injection of a vaccine and syncope. CONCLUDING SECTION Table 12-1 provides a summary of the epidemiologic assessments, mechanistic assessments, and causality conclusions for injection-related adverse events. 1 In addition, hundreds of cases have been reported to passive surveillance systems; however, it is not possible to know how many represent unique cases or were reported elsewhere.

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TABLE 12-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Injection-Related Adverse Events Studies Contributing Cases Contributing Epidemiologic to the Epidemiologic Mechanistic to the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion Injection-Related Event Complex Regional Insufficient None Low-Intermediate 1 Inadequate Pain Syndrome Injection-Related Event Deltoid Bursitis Limited 1 Strong 16 Convincingly Supports Injection-Related Event Syncope Insufficient None Strong 35* Convincingly Supports *In addition, hundreds of cases have been reported to passive surveillance systems; however, it is not possible to known how many represent unique cases or were reported elsewhere. 625

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