Section 9: Reporting Adverse Events Following Immunization (AEFI) in Canada – AEFI details

Section 9.
AEFI Details

Indicate the details of the AEFI being reported by checking all that apply. All additional pertinent details (e.g., results of medical investigations, laboratory test, treatment, etc.) should be provided in section 10. For convenience and consistency, high level definitions have been provided for most events listed in section 9. However, if an asterisk (*) is present beside an AEFI term, this specific event should be diagnosed by a physician. If not, sufficient information should be provided (in section 10) to support the selection(s). For all AEFIs, indicate the time to onset or interval (time from immunization to onset of first symptom/sign), and the duration (time from onset of first symptom/sign to resolution of all of signs and symptoms). For each AEFI where a Brighton Collaboration Case Definition (BCCD) exists, the most current published version of the case definition has been cited.

• Time to onset/interval and duration of signs and symptoms: The time to onset/interval and the duration of the signs and symptoms of the specified AEFI should be documented using the most appropriate time unit: Days, Hours, or Minutes.

• If the time to onset/interval or the time to resolution is less than one (1) hour, record in minutes.
• If the time to onset/interval or the time to resolution is greater than or equal to one (1) hour, but less than one (1) day, record in hours.
• If the time to onset/interval or the time to resolution is greater than or equal to one (1) day, record in days.

Section 9A) Local Reaction at or Near Vaccination Site

Any description of morphological or physiological change at or near the vaccination site.
(BCCD: Vaccine 26 (2008) 6800-6813).

Indicate, by choosing all that apply any local reactions at or near the vaccination site, as described below:

• Infected Abscess: A localized collection of pus in a cavity formed by the disintegration of tissue, usually caused by microorganisms that invade the tissues. (Note presence of any of the following by ticking the appropriate box on the form: erythema, pain, tenderness, warmth, spontaneous/surgical drainage, palpable fluctuance, fluid collection shown by imaging technique, lymphangitic streaking, regional lymphadenopathy and microbial results; if fever present check box in section 9d; use section 10 for additional details. If treated with antibiotics indicate if resolution/improvement was temporally related to treatment). (BCCD: Vaccine 25 (2007) 5821-5838)
• Sterile Abscess: A localized collection of non-purulent fluid which is not caused by pyogenic bacteria. (Note presence of any of the following by ticking the appropriate box on the form: erythema, pain, tenderness, warmth, spontaneous/surgical drainage, palpable fluctuance, fluid collection shown by imaging technique, lymphangitic streaking, regional lymphadenopathy and microbial results; if fever present check box in section 9d; use section 10 for additional details. If treated with antibiotics indicate if resolution/improvement was temporally related to treatment). (BCCD: Vaccine 25 (2007) 5821-5838)
• Cellulitis: A diffuse inflammatory process within solid tissues, characterized by edema, redness, pain, and interference with function, usually caused by infection with streptococci, staphylococci, or similar organisms. (Note presence of any of the following by ticking the appropriate box on the form: swelling, pain, tenderness, erythema, warmth, induration, lymphangitic streaking, regional lymphadenopathy and microbial results; if fever present check box in section 9d; use section 10 for additional details). (BCCD: Vaccine 25 (2007) 5803-5820)
• Nodule: Discrete, well demarcated soft tissue mass or lump at the vaccination site that has a firm texture and is not accompanied by erythema, warmth or abscess formation. (BCCD: Vaccine 22 (2004) 575-585).
• Reaction crosses joint: Reaction extending past at least one joint adjacent to the site of vaccine administration.
• Lymphadenitis: Inflammation of one or more lymph nodes, draining the site of vaccination.
• Other: Specify all details of the vaccination site reaction in section 10 that are not already captured in section 9A above. Examples of “other” local reactions that may be reported here include necrosis, papule etc.

For all local reactions at or near the vaccination site, describe the signs and symptoms by checking all that apply from the list below. Provide any additional details in section 10:

• Swelling: Visible enlargement of the site of injection of an injected limb that is assessed by any person. (BCCD: Vaccine 25 (2007) 5858-5874).
• Pain: An unpleasant sensation occurring in varying degrees of severity that could be described as discomfort, distress or agony.
• Tenderness: Abnormal sensitivity to touch or release of pressure.
• Erythema: Abnormal redness of the skin.
• Warmth: A sensation/perception of an increase in temperature.
• Induration: Palpable thickening, firmness or hardening of soft tissue (subcutaneous tissue, fat, fascia or muscle) that is assessed by a health care provider. (BCCD: Vaccine 25 (2007) 5839-5857)
• Rash: A morphologically described change in the appearance of the skin or mucosa at or near vaccination site that consists of one or more clearly identified primary lesion(s) (macule, papule, vesicle, nodule, bulla, cyst, plaque, pustule), and/or secondary skin change(s) (scaling, atrophy, ulcer, fissure, excoriation). (BCCD: Vaccine 25 (2007) 5697-5706)
• Largest diameter of vaccination site reaction: Indicate the diameter (in centimetres) of the largest injection site reaction that is present.
• Site(s) of reaction: Site(s) of the local reaction being reported if known. (Left arm: LA, Right arm: RA, Arm: Arm, Left leg: LL, Right leg: RL, Leg: Leg, Left gluteal: LG, Right gluteal: RG, Gluteal: Glut, Mouth: Mo, Nose: Nose, Multiple sites: MS, if Other: please specify.
• Palpable fluctuance: Wavelike motion on palpation due to presence of liquid content.
• Fluid collection shown by imaging technique: An imaging device is used in the detection of fluid collection (e.g., ultrasound, Magnetic Resonance Imaging (MRI) and/or X-ray).
• Spontaneous drainage: Draining of fluid from a site without intervention. When available, describe drainage material (purulent or non-purulent, bloody, etc) and provide all Gram stain/culture results.
• Surgical drainage: Withdrawal of fluids from the site through needle aspiration or incision which could be complete or partial. When available, describe drainage material (purulent or non-purulent, bloody, etc) and provide all Gram stain/culture results. (BCCD: Vaccine 25 (2007) 5821-5838)
• Microbial results: Tests that are carried out to identify organisms that can cause disease or infection.
• Lymphangitic streaking: Red streaks below the skin's surface that follows the path of lymph draining from the site of infection via lymphatic vessels to regional lymph nodes.
• Regional Lymphadenopathy: Abnormal enlargement of the lymph nodes closest to the vaccination site (e.g., inguinal adenopathy when associated with an IM vaccination in the thigh, axillary adenopathy associated with an IM vaccination in the deltoid, etc.).

Section 9B) Allergic and Allergic-like events

Choose one of the following events below:

• “Anaphylaxis” An acute hypersensitivity reaction with multi-organ-system involvement that can present as, or rapidly progress to, a severe life-threatening reaction. Check all applicable signs/symptoms referable to skin/mucosal, cardio-vascular, respiratory and/or gastrointestinal systems that were observed during the course of the event and use section 10 for additional details. Provide specific measurements, where available, for pulse, respiratory rate and blood pressure and indicate for each if before or after treatment with epinephrine if given. (BCCD: Vaccine 25 (2007) 5675-5684)
• “Oculo-Respiratory Syndrome (ORS)” The presence of “bilateral red eyes” plus ≥1 respiratory symptom (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that starts within 24 hrs of vaccination, with or without facial oedema.
• “Other allergic event” An event considered by reporter to be allergic in nature but not anaphylaxis, or ORS. Check all symptoms/signs in section 9B that were present and use section 10 for any additional details.

For a chosen event, describe the signs and symptoms by checking all that apply from the list below. Provide all additional details in section 10.

Skin/Mucosal

Choose all that apply from the list provided below, and indicate the site of reaction:

Urticaria (‘hives’): Localized redness of superficial layers of skin that is itchy, raised, sharply demarcated and transient (that is skin changes at any location are usually present for less than 12 hours). Specify site of reaction. (BCCD: Vaccine 28 (2010) 4487-4498)

Erythema: Abnormal redness of the skin without any raised skin lesions. Specify site of reaction. (BCCD: Vaccine 28 (2010) 4487-4498)

Pruritus: An unpleasant cutaneous sensation that provokes a desire to rub and/or scratch to obtain relief. Specify site of reaction.

Prickle sensation: Tingling or smarting (stinging) sensation. Specify site of reaction.

Rash: A morphologically described change in the appearance of the skin or mucosa that occurs in the context of and in conjunction with an emerging allergic event that consists of one or more clearly identified primary lesion(s) (macule, papule, vesicle, nodule, bulla, cyst, plaque, pustule) and/or secondary skin change(s) (scaling, atrophy, ulcer, fissure, excoriation). (BCCD: Vaccine, 25 (2007) 5697-5706)

Angioedema: Areas of deeper swelling of the skin and/or mucosal tissues in either single or multiple sites which may not be well circumscribed and is usually not itchy (Reported symptoms of “swelling of the lip” or “swelling of the tongue or throat” should not be documented as angioedema unless there is visible skin or mucosal swelling. Check all of the locations where angioedema is seen on the AEFI report form and if “other” is checked, provide details. (BCCD: Vaccine 28 (2010) 4487-4498)

Red eyes (bilateral or unilateral): Redness of the white(s) of the eye(s) (sclera). (BCCD: Vaccine 28 (2010) 4487-44498)

Itchy eyes: A sensation that provokes the desire to rub and/or scratch to obtain relief. (BCCD: Vaccine 28 (2010) 4487-4498)

Cardio-Vascular

Choose all that apply from the list provided below:

• Measured hypotension: An abnormally low blood pressure and documented by appropriate measurement. Infants and children: age specific systolic BP of <3-5% percentile or greater than a 30% decrease from that person's baseline; Adults: systolic BP of <90mm Hg or greater than 30% decrease from that person's baseline. (BCCD: Vaccine 28 (2010) 4487-4498)
• Decreased central pulse volume: Absent or decreased pulse in one of the following vessels: carotid, brachial or femoral arteries. (BCCD, Vaccine 28 (2010) 4487-4498)
• Capillary refill time >3 sec: Capillary refill time is the time required for the normal skin colour to reappear after a blanching pressure is applied. It is usually performed by pressing on the nail bed to cause blanching and then counting the time it takes for the blood to return to the tissue, indicated by a pink colour returning to the nail. Normally it is <3 seconds. (BCCD: Vaccine28 (2010) 4487-4498)
• Tachycardia: A heart rate that is abnormally high for age and circumstance (In beats per minute: <1year old: >160; 1 – 2 yrs: >150; 2-5 yrs: >140; 5-12 yrs: >120; >12 yrs: >100) (BCCD: Vaccine 28 (2010) 4487-4498). Citation for norms is Don & Roberton; Physical examination; in Practical Pediatrics 2007; 6th ed.
• Decreased consciousness: Reduced alertness or awareness of the outside world. Indicate duration of the event.
• Loss of consciousness: Total suspension of conscious relationship with the outside world demonstrated by the inability to perceive and to respond to verbal, visual, and painful stimulus. . Indicate duration of the event. (BCCD: Vaccine 28 (2010) 4487-4498)

Respiratory

Choose all that apply by choosing from the list provided below:

• Sneezing: An involuntary (reflex), sudden, violent, and audible expulsion of air through the mouth and nose. (BCCD: Vaccine 28 (2010) 4487-4498).
• Rhinorrhea: Discharge of thin nasal mucus. (BCCD: Vaccine 28 (2010) 4487-4498).
• Hoarse voice: An unnaturally harsh cry of infant or vocalization in a child or adult. (BCCD: Vaccine 28 (2010) 4487-4498).
• Sensation of throat closure: Feeling or perception of throat with sensation of difficulty breathing. (BCCD: Vaccine 28 (2010) 4487-4498)
• Stridor: A harsh and continuous sound made on breathing in. (BCCD: Vaccine 28 (2010) 4487-4498)
• Dry cough: Rapid expulsion of air from the lungs to clear the lung airways and not accompanied by expectoration (a non-productive cough). (BCCD: Vaccine 28 (2010) 4487-4498)
• Tachypnea: Rapid breathing which is abnormally high for age and circumstance rapid breathing which is abnormally high for age and circumstance (<1yr: >60; 1-2 yrs: >40; 2-5 yrs: >35; 5-12 yrs: >30: >12 yrs: >16), (same source as tachycardia). (BCCD: Vaccine 28 (2010) 4487-4498)
• Wheezing: A whistling, squeaking, musical, or puffing sound made by breathing out. (BCCD: Vaccine 28 (2010) 4487-4498)
• Indrawing/retractions: Inward movement of the muscles between the ribs (inter-costal), in the lower part of the neck (supra-clavicular or tracheal tug) or below the chest (sub-costal). The movements are usually a sign of difficulty with breathing. (BCCD: Vaccine 28 (2010) 4487-4498)
• Grunting: A sudden and short noise with each breath when breathing out. (BCCD: Vaccine 28 (2010) 4487-4498)
• Cyanosis: A dark bluish or purplish discolouration of the skin and mucous membrane due to lack of oxygen in the blood. (BCCD: Vaccine 28 (2010) 4487-4498)
• Sore throat: Discomfort or pain in the throat.
• Difficulty swallowing: Sensation or feeling of difficulty in the passage of solids and liquids down to the stomach.
• Difficulty breathing: Sensation or feeling of difficult/uncomfortable breathing or a feeling of not getting enough air.
• Chest tightness: Inability or perception of not being able to move air in or out of the lungs.

Gastrointestinal:

Choose all that apply from the list provided below:

• Diarrhea: Loose and/or watery stool which may occur more frequently than usual. Please provide details. (BCCD: Vaccine 28 (2010) 4487-4498)
• Abdominal pain: Sensation of discomfort, distress or agony in the abdominal region. (BCCD: Vaccine 28 (2010) 4487-4498)
• Nausea: An unpleasant sensation vaguely referred to the upper region of the abdomen, and the abdomen, with a tendency to vomit. (BCCD: Vaccine 28 (2010) 4487-4498)
• Vomiting: The reflex act of ejecting the contents of the stomach through the mouth. Provide details. (BCCD: Vaccine 28 (2010) 4487-4498)

Section 9C) Neurologic Events

Indicate, by choosing all that apply from the list provided all neurologic events. Provide all additional details in section 10.

• Meningitis*: Should be diagnosed by a physician. Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results. (BCCD: Vaccine 25 (2007) 5793-5802)
• Encephalopathy/Encephalitis*: Should be diagnosed by a physician. Should be diagnosed by a physician. Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results. (BCCD: Vaccine 25 (2007) 5771-5792)
• Guillain-Barre Syndrome*: Should be diagnosed by a physician. Check all applicable 9c boxes and use section 10 to record all additional pertinent clinical details and test results especially Electromyograph (EMG) and /or Lumbar Puncture (LP). (BCCD: Vaccine 29 (2011) 599-612)
• Bell’s Palsy*: Should be diagnosed by a physician. Provide any pertinent details.
• Other Paralysis*: Should be diagnosed by a physician. Provide all pertinent details.
• Seizure(s): Sudden loss in conjunction with involuntary generalized motor manifestations. (BCCD: Vaccine 22 (2004) 557-562)
• Other Neurologic Diagnosis*: Specify and provide all details.

Indicate all signs, symptoms and test results relating to the reported neurologic event by choosing all that apply from the list below and provide a detailed description in section 10.

• Depressed/altered level of consciousness: Impairment of ability to maintain awareness of self and environment combined with markedly reduced responsiveness to environmental stimuli.
• Lethargy: A general state of sluggishness, listless, or uninterested, with being tired, and having difficulty concentrating and doing simple tasks.
• Personality changes lasting ≥ 24 hours: Change in personal behaviour-response patterns.
• Focal or multifocal neurologic sign(s): Neurological impairment which is caused by a lesion in one particular focus or many foci of the central nervous system.
• Fever (≥ 38.0 °C): Endogenous elevation of at least one body temperature, regardless of measurement device, anatomic site, age or environmental conditions. (BCCD: Vaccine 22 (2004) 551-556)
• CSF (Cerebral Spinal Fluid) abnormality: Alteration in the normal CSF visual appearance, measured hydrostatic pressure, chemistry (protein, sugar) and/or cellular content (white blood cells, red blood cells) as well as Gram stain/routine bacterial culture results or other tests for presence of microbes.
• EEG (Electroencephalography) abnormality: Abnormal EEG as interpreted by a qualified health professional.
• EMG (Electromyography) abnormality: Abnormal skeletal EMG as interpreted by a qualified health professional.
• Neuroimaging abnormality: Abnormal results of any test to detect anomalies or trace pathways of nerve activity in the central nervous system; includes Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scans.
• Brain/spinal cord histopathologic abnormality: Microscopic changes of the diseased brain/spinal cord tissues. Abnormalities seen on routine and/or electron microscopy by qualified health professionals using appropriately prepared (e.g.: using special stains) tissue samples from brain and/or spinal cord.
• Seizure Details: Check all that apply and record additional details in section 10. Indicate if the event was witnessed by a health care professional by choosing yes or no/unknown.
• Witnessed by healthcare professional: A healthcare professional (e.g.: doctor, nurse, etc.) observed the seizure.
• Sudden loss of consciousness: Sudden total unresponsiveness (suspension of conscious relationship with the outside world, inability to perceive and respond). If Yes, indicate duration of the event.
• Generalized: Bilateral, with more than minimal muscle involvement.

• Tonic: Sustained increase in muscle contraction lasting a few seconds to minutes.
• Clonic: Sudden, brief (<100 milliseconds) involuntary contractions of the same muscle groups, regularly repetitive at a frequency of about 2 to 3 contractions/second.
• Tonic-clonic: A sequence consisting of a tonic followed by a clonic phase.
• Atonic: Sudden loss of tone in postural muscles often pre-ceded by, a myoclonic jerk and precipitated by hyperventilation (in the absence of Hypotonic-Hyporesponsive Episode or syncope, or myoclonic jerks).
• Absence: The occurrence of an abrupt, transient loss of impairment of consciousness (which may not be remembered), sometimes with light twitching, fluttering eyelids, etc.
• Myoclonic: Involuntary shock-like contractions, irregular in rhythm and amplitude, followed by relaxation, of a muscle or a group of muscles.

• Partial: Seizure that originates from a localized area of the cerebral cortex and involves neurologic symptoms specific to the affected area of the brain.
• Previous history of seizures: Individuals who have had seizures at anytime prior to this vaccination.

• Febrile: With fever of ≥ 38.0οC.
• Afebrile: Without fever.
• Unknown type: It is unknown if the seizure was febrile or afebrile. Provide all known details.

Section 9D) Other Events

For a selected event, describe the signs and symptoms by checking all that apply. Provide all additional details in section 10.

• Hypotonic-Hyporesponsive Episode (age<2 years): Sudden onset, in a child aged less than two years, of two to three of: limpness, change in skin colour (pallor or cyanosis) and/or reduced responsiveness. Check each appropriate box in section 9d and use section 10 to indicate if muscle tone, responsiveness or skin colour is known to be normal. Do not use the HHE checkbox if the patient is two (2) years of age or older; instead please check "Other severe or unusual events not listed above" and describe the episode. (BCCD: Vaccine 22 (2004) 563-568)
• Choose all that apply to the reported AEFI from the list provided below:

• Limpness: Lacking firmness and strength, no muscle tone.
• Pallor: Unnatural lack of colour in the skin (abnormal loss of colour from normal skin).
• Cyanosis: A dark bluish or purplish discolouration of the skin and mucous membrane due to lack of oxygen of the blood. (BCCD: Vaccine 28(2010) 4487-4498)
• Decreased responsiveness: Change in usual responsiveness to sensory stimuli.
• Unresponsiveness: Lack of responsiveness to sensory stimuli.

• Persistent crying: Crying which is continuous unaltered and lasts for 3 or more hours. (BCCD: vaccine 28 (2010) 4487-4489)
• Intussusception*: Should be diagnosed by a physician. The prolapse of one part of the intestine into the lumen of an immediately adjacent part causing partial or complete intestinal obstruction. Use section 10 to provide all pertinent details. (BCCD: Vaccine 22 (2004) 569-574).
• Arthritis: Inflammation of the joint(s) which is usually accompanied by pain Indicate the presence, if applicable, of joint redness, warmth or swelling as well as synovial fluid inflammatory changes and use section 10 to provide additional details.

• Joint redness: Redness of the skin at the joint(s).
• Joint warm to touch: Sensation of increase in temperature, above body temperature, at the joint(s) to touch.
• Joint swelling: An abnormal increase in the size of the joint(s).
• Inflammatory synovial fluid: Laboratory synovial or joint fluid analysis indicative of inflammatory response.

• Parotitis: Swelling with pain and/or tenderness of parotid gland(s). (Previous Cdn def'n – CCDR 1995; 21-13: page F-8)
• Rash: A skin or mucosal change (either new or an exacerbation of a previous condition) following immunization that consists of clearly identified primary lesion(s) (bulla, cyst, macule, nodule, papuple plaque, pustule, vesicle, wheal), and/or secondary skin change(s) (scaling, atrophy, excoriation, fissure ulcer). When possible provide a written description of the rash, using the terminology provided. (BCCD: Vaccine, 25 (2007) 5697-5706)

• Generalized rash: Systemic eruption in 2 or more parts of the body.
• Localized at non-vaccination site: Eruption localized at another part of the body, away from the vaccination site.

• Thrombocytopenia*: Should be diagnosed by a physician. Platelets count of less than 150 X 109/liter; accompanied by petechial rash or other clinical signs and/or symptoms of spontaneous bleeding (epistaxis, hematoma, hematemasis, hematochezia, hematuria, hemoptysis, petechia, purpura, ecchymiosis). Indicate the lowest platelet count on the AEFI form and provide any additional pertinent details, including the clinical evidence for spontaneous bleeding.
• Anaesthesia: The loss of normal feeling or sensation.
• Paraesthesia: Abnormal physical sensation such as tingling, burning, prickling, formication, etc.

• For Anaesthesia/Paraesthesia, describe the symptoms by checking all that apply, indicate the site of reaction.
• Numbness: Loss of sensation often accompanies by tingling. Indicate site of reaction.
• Tingling: Sensation commonly described as "pins and needles". Indicate site of reaction.
• Burning: Sensation of stinging or heat not necessarily accompanied by redness, or physical signs of skin irritation. Indicate site of reaction.
• Formication: Sensation of insects crawling over or within the skin. Indicate site of reaction.
• Other, Specify: Specify in section 10.

• Fever (≥ 38.0°C): Endogenous elevation of at least one body temperature, regardless of measurement device, anatomic site, age or environmental conditions. (BCCD: Vaccine 22 (2004) 551-556)
• Serious adverse event: Is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalisation or results in prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a medically important event or reaction.
• Unexpected adverse event: Is an event that has either not been identified previously or one that has been identified previously but is, at current, being reported at an increased frequency.
• For additional information regarding unexpected events, please refer to the ICH Harmonised Tripartite Guideline (E2D 2003).

Section 10.
Supplementary Information

Section 10 should be used to capture information that is pertinent to the AEFI but that has not been fully captured elsewhere or that needs further explanation. Document all known details of any investigations or treatments for the recorded AEFI. Indicate the section of the AEFI report that the information applies to, if applicable, when recording information in section 10.

Section 11.
Recommendations for Further Immunization

This section is to be completed by the health professional. In some P/Ts, only the MOH or MD can provide recommendations for future immunizations. In others, RNs have been trained to provide the recommendations as well.

Indicate, by choosing all that apply in section 11, your recommendations for the patient with regard to future vaccinations and specify additional information when requested. A comments section has been added for your convenience; however, should you require additional space for your recommendation(s), please capture this information in section 10.

Complete the reporter information section in full providing your full name and professional status (MOH/MHO: Medical Officer of Health/Medical Health Officer; MD: Medical Doctor; RN: Registered Nurse). If your professional status is not listed, describe under other. In addition, indicate a phone number where you can be reached and sign and date the AEFI form in the space provided.

Section 12.
Follow up Information for a Subsequent Dose of Same Vaccine(s)

Note: The information in this section is not collected by all provinces/territories.

Complete section 12 when an individual who has previously experienced an AEFI following administration of a vaccine receives a subsequent dose of the same vaccine.

Choose one of the responses as described below to describe the outcome following the administration of the subsequent dose of vaccine and provide all pertinent details in section 10.

• Vaccine administered without AEFI: A subsequent dose of vaccine was administered without the occurrence of any AEFI.
• Vaccine administered with recurrence of AEFI: A subsequent dose of vaccine was administered and followed by the occurrence of the same adverse event that was previously experienced by the patient. Please fill out a new AEFI form for the subsequent AEFI.
• Vaccine administered, other AEFI observed: A subsequent dose of vaccine was administered and followed by the occurrence of a different adverse event than was previously experienced by the patient. Please fill out a new AEFI form for the subsequent AEFI.
• Vaccine administered without information on AEFI: A subsequent dose of vaccine was administered and it is unknown if it was followed by the occurrence of any AEFI.
• Vaccine not administered: A subsequent dose of the vaccine was not administered.