Injection site reactions with vaccination

The vaccine is well tolerated with injection site reactions and headache and fatigue occurring as commonly as in placebo groups. 

LYMErix safety data reported to the Vaccine Adverse Event Reporting System (VAERS) from 21 December 1998 to 31 October 2000 mentioned reports of adverse events associated with Lyme vaccine in prelicensure trials, including injection site reactions, transient arthralgia and myalgia within 30 days of vaccination, fever, and a flu-like illness (7). Allergic reactions were reported to the VAERS and some could have plausibly been linked to the vaccine because of the short latency between vaccination and reaction onset. No clear patterns in age, sex, time to onset, or vaccine dose were identified, although the unexpected predominance of reports of arthrosis in men might warrant further consideration. 

The question of whether revaccination with 23-valent pneumococcal polysaccharide vaccine (PPV) at least 5 years after the first vaccination is associated with more frequent or more serious adverse events than those after the first vaccination has been studied in patients aged 50-74 years who had never been vaccinated with PPV (n = 901) or who had been vaccinated once at least 5 years before enrolment (n = 513) (8). After one dose of PPV, local injection site reactions and prevaccination concentrations of type-specific antibodies were measured. Those who were re-vaccinated were more likely than those who received their first vaccinations to report a local injection site reaction of at least 10.2 cm (4 in.) in diameter within 2 days of vaccination (55/513 versus 29/ 901, or 11 versus 3%). The reactions resolved by a median of 3 days after vaccination. The highest rate was among revaccinated patients who were immune competent and did not have chronic illnesses 15% (33/228) compared with 3% (10/337) among comparable patients receiving their first vaccinations. The risk of these local reactions correlated significantly with prevaccination geometric mean antibody concentrations. The authors concluded that physicians and patients should be aware that selflimited local injection site reactions occur more often after revaccination compared with a first vaccination however, this risk does not represent a contraindication to revaccination with PPV in recommended patients. 

PPV23 safety is well documented. Local reactions occur frequently within the first 48 hours and generally are mild. Lxjcal erythema and induration (30%), local discomfort (40%), and local swelling (3%) are the side effects observed most commonly. Revaccination has been associated with self-limited injection-site reactions more commonly than after the first dose. Rarely, severe systemic reactions can occur, and they consist of weakness, myalgia, headache, photophobia, chills, and fever. Guillain-Barre syndrome has not been reported. In patients with HIV infection, pneumococcal vaccine may cause a transient increase in viral replication, but the importance of this is unknown. 

The oral typhoid vaccine is well tolerated, with rare reports of gastrointestinal discomfort, fever, headache, or rash. Local injection-site reactions are the most commonly reported adverse event following the injectable typhoid vaccine (ViCPS). Systemic symptoms, such as fever, flufike symptoms, gastrointestinal discomfort, tremor, or neck pain, are reported occasionally. Most vaccinees will report injection-site reactions after the injectable Typhoid Vaccine USP. Malaise, headache, muscle aches, and fever also may occur. Very rarely, serious adverse events, such as chest paint, hypotension, and shock, have been reported. 

S. Mutoloki, O. B. Riete, B. Brudesth, A. Tyverdal and 0. Evensen, A comparative immunopathological study of injection site reactions in salmonids following intraperitoneal injection with oil-adjuvanted vaccines. Vaccine, 2006, 24, 578-588. 

MUTOLOKi s, COOPER GA, MARJARA IS, Koop BE, EVENSEN 0. High gene expression of inflammatory markers and IL-17A correlates with severity of injection site reactions of Atlantic salmon vaccinated with oil-adjuvanted vaccines. BMC Genomics 2010,11,336... 

Pain at the injection site is one of the most commonly reported adverse effects of vaccination. The reaction is usually mild with complaints of pain and tenderness at the injection site that may or may not be accompanied by erythema. Local reactions tend to be more frequent with repeated doses or booster doses of vaccine. The frequency and degree of the reactions appear to be related to the amount of preformed antibodies and rapid immunologic responses reflective of priming from previous doses. More serious Arthus reactions are infrequently reported. Arthus reactions are classified as type III hypersensitivity reactions, and are characterized by a massive local response involving the entire thigh or deltoid. Arthus reactions are also related to preformed antibody complexes that induce an inflammatory lesion.14... 

The most frequent adverse effect associated with TIV is soreness at the injection site that lasts for less than 48 hours. TIV may cause fever and malaise in those who have not previously been exposed to the viral antigens in the vaccine. Allergic-type reactions (hives, systemic anaphylaxis) rarely occur after influenza vaccination and are likely a result of a reaction to residual egg protein in the vaccine. 

Treatment with DNA alone, MVA alone, and in combination was well tolerated in mice. Some of the local reactions observed were considered to be related to the injection procedure rather than to the vaccine components. Other hndings were considered to be incidental in nature and not related to the vaccine treatment. Persistence was assessed by PCR, and results showed that positive signals were observed at the injection sites on both days 46 and 78. Equivocal positive results were observed in some mice (including vehicle controls) in a few other tissues, and these were most likely due to contamination and the high sensitivity of the PCR method. Since there was no persistence in any other tissue except for the injection site, no integration assays were carried out. 

In a study of adverse events after immunization in New Zealand in 1990-95 (3), reactions at the injection site after adult tetanus-diphtheria vaccine (68 reports per 100 000 immunizations) were reported five times more often than with tetanus vaccine. 

To increase immunogenicity, the hepatitis A vaccines commercially available are coupled to adjuvant aluminium phosphate or aluminium hydroxide. However, alum precipitates provoke inflammatory responses at the injection site. Immunostimulating reconstituted influenza virosomes have therefore been used as an alternative adjuvant. In 1994, a hepatitis A vaccine using the new adjuvant was licensed in Switzerland, and it was later approved for use in other countries the vaccine was well tolerated and highly immunogenic (SEDA-20,290) (SEDA-22,344). Nine people with a history of ocular sensitivity were immunized with hepatitis B, without untoward reactions. However, this result in such a small series should not be overestimated (75). There have been reports of three cases of inflammatory nodular reactions after hepatitis B immunization aluminium allergy was confirmed (76-78). 

Adverse reactions are infrequent and mUd, consisting of local soreness or localized erythema at the injection site, and systemic reactions (transient fever, headache, fatigue), lasting 1-2 days (3,4). With the quadrivalent vaccine used in Canada, fever was reported in less than 1%, local reactions in 6.3%, and rash in 1.6% among those aged 11 years or older. Local reactions were also the most reported adverse effect in other reports. 

A combined meningococcal and typhoid vaccine (Merieux) was evaluated in 158 volunteers in a singleblind study (11). Comparing the effects with those in vaccinees receiving monocomponent vaccines or the combination vaccine, there was no significant difference in the reported frequency or duration of local and systemic reactions. However, vaccinees who received the monocomponent typhoid fever vaccine alone were less likely to complain of swelling or pain at the injection site. 

Local reactions are common after DTP immnnization (40-70% of the vaccinees) bnt are nsnally self-limiting (10). A nodnle may be palpable at the injection site of adsorbed prodncts for several weeks. Abscess at the injection site has been reported (6-10 per million vaccinees). Mild to moderate fever (38.0-40.4° C) occnrs freqnently (abont 50% of vaccinated infants), generally within several honrs of administration, persisting for 1-2 days. Fever and other systemic symptoms are mnch less common following immnnization with preparations not containing the pertnssis component. Arthns-tjq)e hypersensitivity reactions occnr, particnlarly after booster doses. Rarely,... 

General malaise, headache, fever, mild lymphadenopathy, or erythema and induration at the injection site have been reported following the administration of plague vaccine (10% of vaccinees) these effects are more common with repeated injections. Sterile abscesses and hypersensitivity reactions (urticaria, asthma) occur rarely (2). 

Positive merthiolate tests were found in eight of 30 patients with suspected adverse reactions to tetanus or tick-borne encephalitis vaccine (local inflammatory reactions at the injection site, fever, lymphadenopathy, urticarial or lichenoid exanthemas) (1). 

There have been many clinical trials to assess the immunogenicity and safety of Varicella vaccine, in both healthy and immunocompromised individuals (SEDA-12, 285) (SEDA-13, 290) (SEDA-14, 285) (SEDA-15, 289) (SEDA-17, 379). The vaccine was safe and immunogenic. The reports of different investigators were similar. Mild local reactions at the injection site were the most commonly reported adverse effects, occurring in about 10% after the first and second dose. Vaccine-associated rashes about 1 month after the first dose were reported in about 6% of vaccinees, sore throat in 8%, and fever over 37.8 C in 2%. Rash and fever after the second dose of vaccine were reported by less than 1% of vaccinees. Maculopapular or papulovesicular rashes occurred much more often in vaccinees with suspended chemotherapy (42%) (4,5). 

The two recombinant hepatitis B vaccine products available in the United States (Recombivax HB, Merck Engerix-B, SmithKline Beecham) have comparable immune responses and safety profiles. The vaccines contain 5 to 40 meg HBsAg protein per milliliter adsorbed onto aluminum. Neither brand of hepatitis B vaccine contains thimerosal. The recent availability of a combined HAV and HBV vaccine allows for a more accelerated schedule for immunization. For a more detailed comparison of the potential vaccination schedules refer to the cited reference. These vaccines are some of the safest available. Side effects of the vaccine are soreness at the injection site, headache, fatigue, irritability, and fever. The number of patients experiencing adverse reactions decreases with each vaccine dose, and adverse reactions are less common in infants and children than in adults. There is no association between Guillain-Barre syndrome and the recombinant vaccine, and the vaccine does not transmit HIV. The hepatitis B vaccine is contraindicated for patients with anaphylaxis to... 

The measles vaccine has an excellent safety record. The most common side effect following vaccination is fever, which occurs in 5% to 15% of vaccinees. Transient generalized rash may occur in about 5% of vaccine recipients. These reactions generally appear 5 to 12 days postvaccination and last 2 to 5 days. Other adverse effects, such as headache, cough, sore throat, eye pain, malaise, and transient thrombocytopenia, occur less frequently. Local reactions at the injection site, while rare, may occur in subjects who have been vaccinated previously with killed vaccine. No association between MMR vaccination and the development of autism has been made following extensive study. Febrile seizures occur rarely, and there is no association between MMR vaccination and the development of a subsequent seizure disorder. ... 

Adverse reactions to RDIg include injection-site tenderness and fever. Rho(D) does not interfere with response to rubella vaccine. Rubella-seronegative women should be immunized at hospital discharge even if they received RDIg postpartum. 

Adverse reactions include pain and tenderness at the injection site (20%) and systemic side effects such as fever, headache, malaise, rash, chills, dizziness, myalgia, nausea, vomiting, and abdominal pain in 10%. In addition, there are sporadic reports of hypersensitivity reactions to the vaccine. The manifestations of this type of reaction include urticaria, angioedema, and respiratory distress. These reactions have generally occurred after a median of 12 hours after the first dose of vaccine, with 88% of reactions occurring within 3 days. After a second dose, these hypersensitivity reactions may occur 3 to 14 days after injection. 

It has been reported to stimulate humoral and cellular immune responses in combination with several subunit antigens. It has also been proven safe, and does not cause any major adverse reactions. In clinical trials it has already been used with influenza, HSV or HIV antigens, and has been marketed as part of an enhanced influenza vaccine for the elderly. MF59 does not form a depot at the injection site, but targets macrophages and dendritic cells at the site of injection and in lymph nodes. 

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