Immunisation (vaccinations) side effects/contraindications
Contraindications
absolute contraindications apply to all vaccines:
- anaphylaxis following a previous dose of the relevant vaccine
- anaphylaxis following any component of the relevant vaccine
contraindications apply to live vaccines (both parenteral and oral):
- People who are significantly immunocompromised should not receive live vaccines.
- This is regardless of whether the immunocompromising condition is caused by disease or treatment.
- Active leukaemia or lymphoma, or other generalised malignancy
- Received recent chemotherapy or radiotherapy
- HIV (certain people only)
- Had a solid organ transplant or haematopoietic stem cell transplant less than 2 years ago, or are still immunocompromised or taking immunosuppressive drugs, or graft-versus-host disease
- Are taking highly immunosuppressive therapy,
- including
- bdmards (biological disease-modifying anti-rheumatic drugs
- tsdmards (targeted synthetic disease-modifying anti-rheumatic drugs)
- high-dose corticosteroids
- low-dose csDMARD(conventional synthetic DMARDs )
- methotrexate ≤0.4 mg per kg per week
- azathioprine ≤3.0 mg per kg per day
- mercaptopurine ≤1.5 mg per kg per day
- Certain autoimmune diseases, particularly if they are on highly immunosuppressive therapy
- Aplastic anaemia
- Congenital immunodeficiency
- This is regardless of whether the immunocompromising condition is caused by disease or treatment.
- Pregnant women should not receive live vaccines, in general
- women should be advised not to become pregnant within 28 days of receiving a live vaccine
Live vaccines
- BCG (bacille Calmette–Guérin) vaccine
- Some Japanese encephalitis virus vaccines
- MMR (measles-mumps-rubella) vaccine
- rotavirus vaccine
- oral typhoid vaccine
- varicella vaccine
- yellow fever vaccine
- zoster vaccine (Zostavax)
Inactivated vaccines
- that are routinely recommended in people who are immunocompromised
- People who are immunocompromised are routinely recommended to receive:
- influenza vaccine
- pneumococcal vaccine
- meningococcal vaccine
- HPV vaccine
- hepatitis B vaccine
- recombinant zoster vaccine (Shingrix)
Valid consent
the voluntary agreement by an individual to a proposed procedure, given after sufficient, appropriate and reliable information about the procedure, including the potential risks and benefits, has been conveyed to that individual
Recommended injection sites
Infants less than 12 months of age : The vastus lateralis muscle in the angerolateral thigh is the recommended site for IM vaccination in infants <12 months of age, due to its larger muscle size
Children aged 12 months or older : The deltoid muscle is the recommended site for IM or SC vaccination in children ≥12 months of age
Vaccine side effects
| ATAGI frequency term | Approx. rate | Examples |
|---|---|---|
| Very common | ≥1 in 10 doses | Sore arm, mild fever |
| Common | 1 in 10 – <1 in 100 | Mild myalgia, headache |
| Uncommon | 1 in 100 – <1 in 1 000 | High fever, extensive limb swelling |
| Rare (major) | 1 in 1 000 – <1 in 10 000 | Febrile convulsion, intussusception |
| Very-rare | <1 in 10 000 (often <1 in 100 000) | Anaphylaxis, GBS |
Sources: Australian Immunisation Handbook & NCIRS.
Minor / Expected reactions
These match your list and need no treatment other than comfort measures.
- Injection-site pain, redness, mild swelling ± small nodule
- Low-grade fever, irritability, drowsiness, tiredness
- Myalgia or headache (Influenza, HPV, MenACWY, COVID-19)
- Transient vomiting/diarrhoea ≤7 days after rotavirus
Paracetamol: prophylactic doses are only recommended for infants <2 y receiving MenB (Bexsero) with other routine vaccines.
Uncommon but usually self-resolving
| Vaccine | Uncommon AEFI | Typical rate |
|---|---|---|
| DTPa / dTpa booster | Extensive limb swelling | up to 2–6 % older children |
| DTPa-containing | Hypotonic–hyporesponsive episode (HHE) | <1 : 2 000–1 : 6 000 doses |
| MMR / MMRV | Fever >39 °C; febrile convulsion if MMRV is dose 1 (<4 y) | convulsion ≈1 : 1 000–3 000 |
| Varicella | 2–5 localised vesicles 5–26 d post-dose | ≤5 % |
Major / Rare complications
| Vaccine | Complication | Estimate |
|---|---|---|
| Rotavirus | Intussusception within 7 d of dose 1 | ≈6 excess / 100 000 infants |
| MMR | Immune thrombocytopenic purpura | ≈1 : 25 000–40 000 |
| Influenza | Febrile convulsion (6–59 m) | ≈1 : 3 000–4 000 |
| 23vPPV repeat dose | Severe cellulitis/abscess needing hospital care | <1 : 10 000 |
Very-rare but serious AEFIs
| Event | Vaccines implicated | Australian incidence |
|---|---|---|
| Anaphylaxis | Any injectable vaccine; MMR 1.8–14.4 / million doses | |
| Guillain–Barré syndrome | Influenza; possibly zoster | ≤1 / million doses |
| Brachial neuritis | Tetanus-containing | ~1 : 100 000–200 000 |
| Aseptic meningitis | Older Urabe-strain mumps (no longer used) | Exceptional |
| Vaccine-strain varicella transmission | Varicella | Isolated case reports |
| Vaccine (NIP) | Minor / Common (self-limiting) | Uncommon | Rare (major) | Very-rare / Serious |
|---|---|---|---|---|
| DTPa / dTpa | • Pain, redness, swelling ± nodule at site • Low-grade fever, irritability | • Extensive limb swelling after boosters (<2 %) The Australian Immunisation Handbook | • Hypotonic–hyporesponsive episode (≈3/100 000 doses) The Australian Immunisation Handbook | • Anaphylaxis (~1/million) The Australian Immunisation Handbook |
| Hib | Same local reactions & low fever as above The Australian Immunisation Handbook | Nil listed | None identified beyond local AEFI | Very-rare anaphylaxis |
| Hep A | Local pain/redness; mild fever The Australian Immunisation Handbook | Mild headache | None identified | Anaphylaxis (extremely rare) |
| Hep B | As for Hep A; occasional nodule The Australian Immunisation Handbook | Fatigue, myalgia | None identified | Anaphylaxis (extremely rare) |
| HPV (9-valent) | Pain/redness; mild fever; headache, nausea The Australian Immunisation Handbook | Syncope (adolescents) | Complex regional pain syndrome – causal link not proven (signal only) | Anaphylaxis (~1/million) |
| Influenza (all inactivated) | Local pain/redness; myalgia; mild fever (1–10 %) The Australian Immunisation Handbook | Higher local reactogenicity with adjuvanted & high-dose vaccines (older adults) | Febrile convulsion (4.4/1 000 with 2010 Fluvax only; vaccine now withdrawn) The Australian Immunisation Handbook | Guillain-Barré syndrome (~1/million); anaphylaxis very rare The Australian Immunisation Handbook |
| MMR / MMRV | Fever (>39 °C) ± rash, coryza 7–10 d post-dose (up to 15 %); mild gland swelling The Australian Immunisation Handbook | Arthralgia, parotitis (adults) | Febrile convulsion 1/3 000–1/4 000 doses (higher with MMRV as 1st dose) The Australian Immunisation Handbook | • Immune thrombocytopenic purpura (~1/25 000–40 000) • Encephalitis (<1/million) • Anaphylaxis 1.8–14.4/million The Australian Immunisation HandbookThe Australian Immunisation Handbook |
| MenACWY | Pain/redness; headache/myalgia; low fever The Australian Immunisation HandbookThe Australian Immunisation Handbook | Mild fever 1–10 % | Bell’s palsy signal in one study (not confirmed) The Australian Immunisation Handbook | Anaphylaxis (very rare) |
| MenB (Bexsero) | Fever ≥38 °C in 26–41 % of infants; injection-site pain; irritability → Give prophylactic paracetamol in <2 y olds The Australian Immunisation Handbook | Febrile convulsion signal (small, UK) The Australian Immunisation Handbook | None confirmed | Anaphylaxis (very rare) |
| 13vPCV / 23vPPV | Local pain/redness; low fever The Australian Immunisation Handbook | Severe local swelling with repeat 23vPPV (∼1 %) The Australian Immunisation Handbook | Severe cellulitis/abscess needing hospital care (<1/10 000) | Anaphylaxis (very rare) |
| IPV & IPV-combo | Local pain/redness; myalgia; low fever The Australian Immunisation Handbook | Nil significant | None identified | Anaphylaxis (very rare) |
| Rotavirus (oral) | Vomiting/diarrhoea ≤7 days (≤10 %) The Australian Immunisation Handbook | Mild transient fever | Intussusception: ≈6 extra cases/100 000 infants (esp. 1st dose, 0–7 d) The Australian Immunisation Handbook | Anaphylaxis extremely rare |
| Varicella | Local pain/redness; fever 5–26 d: 2–5 vesicles near site The Australian Immunisation Handbook | Generalised mild varicelliform rash | Herpes zoster from vaccine strain (rare) | Vaccine-strain transmission case reports; anaphylaxis |
| RSV (Arexvy ≥60 y) | Pain/redness; fatigue; myalgia; headache/nausea The Australian Immunisation Handbook | Lymphadenopathy | None yet identified | Anaphylaxis (very rare) |
Key counselling points
- Benefit–risk remains overwhelmingly favourable; serious AEFIs are extraordinarily uncommon.
- Observe all vaccinees ≥15 minutes; have adrenaline ready for anaphylaxis.
- Red-flag advice for carers: persistent high fever, collapse, signs of intussusception (colicky pain, red-currant jelly stool), or any severe unexpected symptom → seek urgent care and report.
- Routine paracetamol is discouraged except with MenB in infants.The Australian Immunisation Handbook