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Journal of Clinical and Diagnostic Research. 2019 Sep, Vol-13(9): SD01-SD02 11
DOI: 10.7860/JCDR/2019/42332.13131 Case Report
Paediatrics Section
Sterile Abscess Following Hepatitis B
Vaccination in a New Born- A Case Report
CASE REPORT
A full-term baby boy, birth weight 3.4 kg received intradermal
injection of BCG on his left arm, Hepatitis B vaccine intramuscularly
on right thigh and oral Polio vaccine 8 hours after birth. A month later
his mother noticed a lump in the right thigh at the site of Hepatitis
B injection. As the lump was asymptomatic and non-progressive,
mother waited until the 6 weeks vaccination visit to consult the
Paediatrician. After examining the lump, the paediatrician informed
the parents that the lump may disappear within a few weeks and
did not require any intervention. The baby was given subsequent
doses of Pentavalent Vaccine and Inactivated Polio Vaccine (IPV)
injections on his left thigh only. Baby completed all the recommended
vaccinations until the age of eight months.
The lump was left untreated until eight months and later started
to show progressive enlargement and became very visible. As
the lump showed progressive enlargement, mother consulted the
Paediatrician again and on examination, the baby showed no pain
response when pressure was applied on the lump. Ultra-sonogram
of the right thigh revealed a 4.3 cm × 1.5 cm irregular hypo-echoic
lesion in the subcutaneous plane with Colour Doppler showing
no internal vascularity. The lesion had a thick irregular wall and a
small tract was seen from the lesion to the skin surface. Paediatric
surgeon made a provisional diagnosis of post-injection abscess. A
tissue biopsy was obtained for culture and yielded no growth. The
medical history of the baby was not suggestive of any immuno-
deficiency status.
The final diagnosis was made as sterile abscess following vaccination.
Incision and drainage procedure was performed by the pediatric
surgeon after giving a prophylactic dose of an antibiotic, ceftriaxone
50 mg/Kg/day (intramuscular). The antibiotic was continued for
three more days along with Ibuprofen 4 mg/kg thrice daily and
mupirocin ointment twice daily for local application. The baby
recovered completely on fifth day post-drainage and no recurrence
was observed. The parents were educated about the importance of
completing the immunisation schedule. The baby was followed until
the age of one year and he received remaining vaccinations in the
same immunisation clinic without any complication. However, no
further vaccinations were given on the right thigh.
DISCUSSION
The World Health Organisation (WHO) recommends that all infants
should receive their first dose of Hepatitis B (Hep B) vaccine as soon
as possible after birth, preferably within 24 hours. The birth dose
should be followed by two more doses to complete the primary
series of Hepatitis B vaccination [1]. Adverse Events Following
Immunisation (AEFIs) may occur following any vaccination including
Hepatitis B. Abscess at the injection site has been a widely reported
AEFI in national immunisation programs. For example, a total of
40-injection site abscess cases were reported over a period of
five years from 2012 to 2017 in Netherlands’s Pharmaco-vigilance
program [2] and 12.2% (n=101) of injection site reactions including
abscess was reported to Pharmaco-vigilance Program of India over
a period of 2 years (2016 and 2017) [3]. Abscess formation following
vaccination is usually an immunisation error related reaction due to
the microbial contamination of the vaccine [4,5].
An AEFI is categorised as immunisation error related reaction
when AEFI was caused by inappropriate handling, prescribing and
administration of vaccine and thus it was preventable in nature [6].
Rarely AEFI such as sterile abscess may develop following Hepatitis
B vaccination, which is a delayed hypersensitivity reaction to
aluminium adjuvant present in the vaccine with a reported frequency
of 0.35% to 1.18% [2,7]. An investigation done using the Vaccine
Adverse Events Reporting System (VAERS) in USA, observed that
all the cases of recurrent sterile abscess following vaccination were
due to the aluminium salt added to vaccines as adjuvant [4], which
suggests that the sterile abscess could also be a vaccine product
related reaction.
Vaccine induced injection site reactions due to Hepatitis B vaccine
usually occur approximately one month after vaccination [5].
Possible explanations for injection site reactions could be either due
to previous T-cell response to a killed bacteria in a vaccine, or the
patient has a bacterial infection which can cause a T-cell response
to the vaccine [7]. The route of administration also plays a vital role
in the abscess formation, particularly Intramuscular (IM) injection.
There are many reports of sterile abscess following IM administration
of vaccines [8,9].
The major contributing factor for abscess formation is improper
injection technique [9,10]. Rarely, sterile abscess may be caused
by the inherent property of the vaccine itself. Aluminium salts added
as adjuvants in the vaccine cause a slow escape of antigen from
the site of injection, thereby lengthening the duration of contact
between the antigen and immune system. Hypersensitivity to a
vaccine component especially aluminium salt added as an adjuvant
can be one of the possible explanations of sterile abscess following
JISHA MYALIL LUCCA1, JUNY SEBASTIAN2, MANDYAM DHATI RAVI3, GURUMURTHY PARTHASARATHI4
Keywords: Adverse events following immunisation, Immunisation error related reaction, Program error
ABSTRACT
Vaccines may cause adverse events ranging from mild reactions like fever to serious events like seizures. Both the vaccine product
and the process of vaccination can cause adverse events. Non-sterile abscesses are usually a program error (an event caused by
an error in the transportation, storage, handling, or administration of a vaccine) that may occur due to contamination of a multi-dose
vial. Sterile abscess may occur as a delayed hypersensitivity reaction due to the presence of aluminium salt as an adjuvant in the
vaccine, and are classified as vaccine product related reactions. The Hepatitis B vaccine is recommended for all infants at birth and
for children up to 18 years. Here, authors report a case of sterile abscess in an eight-month-old baby, after the administration of first
dose of Hepatitis B Vaccination, possibly due to an error and hence classified as Immunisation error related reaction.
Jisha Myalil Lucca et al., Sterile Abscess Following Hepatitis B Vaccination www.jcdr.net
Journal of Clinical and Diagnostic Research. 2019 Sep, Vol-13(9): SD01-SD02
22
CONCLUSION
The occurrence of sterile abscess, in this case, maybe attributed to
an error in the immunisation process. In view of the high risk of VPDs
in the community, parents need to be educated and counselled to
complete the immunisation schedule with possible precautions to
avoid recurrence of AEFIs.
REFERENCES
Hepatitis B. [cited 2017 August 18]. Available from [1] http://www.who.int/
immunisation/diseases/hepatitisB/en/
Injection site abscess after administration of infarix hexa and synflorix at infant [2]
age. [online] [cited 2019 Jan 31] Available from: https://www.lareb.nl/media/3125/
signals_2017_injection-site-abscesses-after-administration-of-infanrix-hexa_.pdf
Patel H, Shah S, Desai M, Kalaiselvan V, Singh GN. Retrospective qualitative and [3]
quantitative analysis of Adverse events following immunisation. J Young Pharm
2018;10(3):326-29.
Adverse events following immunisation. Standard operating procedure. Ministry [4]
of health and family welfare. Government of India. New Delhi. 2010. [cited
2017 August 15]. Available from http://www.searo.who.int/india/topics/routine_
immunisation/AEFI_standard_operating_procedures_SOPs_2010.pdf?ua=1
[5] Klein NP, Edwards KM, Sparks RC, Dekker CL. Recurrent sterile abscesses
following aluminium adjuvant-containing vaccines. BMJ Case Rep. 2009;
bcr09.2008.0951.
Global manual on surveillance of adverse events following immunisation. World [6]
health organisation 2014. [Cited 2017 Feb 16] Available from http://www.who.
int/vaccine_safety/publications/aefi_surveillance/en/
Lauren CT, Belsito DV, Morel KD, LaRussa P. Case report of subcutaneous [7]
nodules and sterile abscess to delayed type hypersensitivity to aluminimum
containing vaccines. Pediatrics 2016;138(4):e1-5. Available from: http://
pediatrics.aappublications.org/content/pediatrics/138/4/e20141690.full.pdf
Vaccine safety basics learning manual. World health organisation 2013. [cited [8]
2014 Dec 12] Available from http://www.who.int/vaccine_safety/initiative/tech_
support/ebasic/en/
Gondal GM, Iqbal Y, Khan UM. Frequency of contributing factors in intramuscular [9]
injection abscess. P J M H S 2014;8(3):569-72.
Lauren CT, Belsito DV, Morel KD, LaRussa P. Case Report of subcutaneous [10]
nodules and sterile abscesses due to delayed type hypersensitivity to aluminum-
containing vaccines. Pediatrics 2016;138(4). Available from http://pediatrics.
aappublications.org/
Causality assessment of adverse events following immunisation user guide for [11]
revised WHO classification. World health organisation 2013. [cited 2014 Mar 13]
Available from http://www.who.int/vaccine_safety/publications/aevi_manual.pdf
Kohl KS, Ball L, Gidudu J, Hammer SJ, Halperin S, Heath P, et al. Abscess [12]
at injection site: Case definition and guidelines for collection, analysis, and
presentation of immunisation safety data. Vaccine 25(2007):5821-38.
Vargas KM, Koli A, Dethority W. Recurrent sterile abscess after immunisation [13]
with Aluminum adjuvant based vaccines. Clin Pediatr 2018;57(6):733-37.
Lehman HK, Faden HS, Fang YV, Ballow M. A case of recurrent sterile abscess [14]
following vaccination: Delayed hypersensitivity to Aluminium. Clinical and
Laboratory Observations 2018;52(1):133-35.
vaccination [4,7,8]. Aluminium containing vaccines can cause a
nodule at the injection site which can last for several weeks for 5-10%
of vaccinated persons. In rare instances, the nodule may become
inflammatory and can turn into an abscess. Nodules persisting
more than six weeks may indicate the delayed type hypersensitivity
reactions to the aluminium component in the vaccine [9,10]. Here, in
this case, the baby received Hepatitis B vaccine (each dose of 0.5 mL
contains Purified HBsAg >10 microgram, Aluminium hydroxide gel
equivalent to AL +++ 0.25 mg and Thiomersal IP 0.025 mg).
Previous studies have reported that abscess formation is commonly
noted if the quantity of aluminium present in the vaccine is more
than 0.17 mg [5] Subcutaneous administration of aluminium salt
containing vaccines can result in cyst, necrotic breakdown and
sterile abscess formation. WHO’s vaccine safety basics learning
manual suggests, to administer the aluminium containing vaccines
intramuscularly and not subcutaneously to ensure the safety
of vaccination [8,11]. The recommended primary treatment of
abscesses includes drainage of the abscess and systemic plus
local applications of antibiotics.
Causality assessment of the AEFI was performed according to the
user manual for the WHO classification [11]. This case satisfied the
eligibility criteria for AEFI, as Hepatitis B vaccine was the only vaccine
administered before the event and the diagnosis of sterile abscess
met the Brighton collaboration case definition [12]. Based on the
algorithm, causality of the event was classified as ‘consistent causal
association to vaccination’ with the sub-class ‘immunisation error
related reaction’. Sterile abscess due to a delayed hypersensitivity
reaction to aluminium salt adjuvant present in the vaccine may be
unlikely in this case, as there was no recurrence of sterile abscess
following administration of further doses of vaccines with similar
components including aluminium salt. Previously published case
reports have described the recurrence of sterile abscess following
the administration of vaccines containing aluminium salts as
adjuvants [13,14]. Hence the reaction may be an immunisation
error related reaction due to an error in the injection technique. The
possible injection technique error occurred, in this case, may be the
non-deep injection of Hepatitis B [8]. Vaccinators need to undergo
continuous education and training to minimise immunisation error
related reactions as these AEFIs may negatively influence the
parent’s confidence in immunisation.
PARTICULARS OF CONTRIBUTORS:
1. Assistant Professor, Department of Pharmacy Practice, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
2. Lecturer, Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
3. Professor, Department of Paediatrics, JSS Medical College and Hospital, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
4. Professor, Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
NAME, ADDRESS, E-MAIL ID OF THE CORRESPONDING AUTHOR:
Dr. Gurumurthy Parthasarathi,
Professor, Department of Pharmacy Practice, JSS College of Pharmacy, Jagadguru Shri Shivarathreeshwara
Academy of Higher Education and Research, S S Nagara, Mysuru-570015, Karnataka, India.
E-mail: Partha18@gmail.com
FINANCIAL OR OTHER COMPETING INTERESTS: None.
Date of Submission: Jun 28, 2019
Date of Peer Review: Jul 09, 2019
Date of Acceptance: Aug 03, 2019
Date of Publishing: Sep 01, 2019
