A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example

Table 3

Example of table with most frequent coreported adverse events for the category medication errors with harm.

MedDRA® PT	Total
Injection site pain	264
Injection site erythema	233
Pain in extremity	170
Pyrexia	154
Pain	151
Injection site swelling	148
Headache	124
Chills	101
Erythema	101
Herpes zoster	101
Fatigue	99
Influenza-like illness	76
Rash	67
Injection site warmth	62
Myalgia	60
Arthralgia	57
Pruritus	57
Nausea	53
Malaise	48
Peripheral swelling	46
Vaccination failure	42
Swelling	41
Injected limb mobility decreased	33
Injection site pruritus	24
Neuralgia	24
Injection site rash	23
Urticaria	23
Extensive swelling of vaccinated limb	22
Paresthesia	22
Insomnia	20
Overdose	20
Asthenia	18
Dizziness	17
Feeling hot	17
Injection site reaction	17
Skin warm	17
Blister	15
Contusion	15
Diarrhea	15
Injection site bruising	15
Injection site induration	15
Rash vesicular	15
Feeling abnormal	14
Injection site hemorrhage	14
Hypoesthesia	13
Neck pain	13
Back pain	12
Rash erythematous	12
Somnolence	12
Hyperhidrosis	11
Local reaction	11
Condition aggravated	10
Illness	10
Injection site cellulitis	10
Injection site discomfort	10
Tenderness	10
Vomiting	10

MedDRA®, medical dictionary for regulatory activities; PT, preferred term.