Common Proparacaine Side Effects


The most commonly reported Proparacaine side effects (click to view or check a box to report):

Visual Acuity Reduced (11)
Eye Pain (8)
Keratitis (7)
Eyelid Oedema (7)
Vision Blurred (5)
Dizziness (5)
Corneal Scar (4)
Corneal Epithelium Defect (4)
Headache (4)
Photophobia (4)
Corneal Neovascularisation (3)
Convulsion (3)
Corneal Opacity (3)
Corneal Infiltrates (3)
Feeling Abnormal (3)
Paraesthesia (3)
Eye Inflammation (3)
Pain (3)
Ocular Hyperaemia (3)
Nausea (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Proparacaine Side Effects Reported to FDA



Proparacaine Side Effect Report#9920187
Grand Mal Convulsion
This is a report of a 28-year-old female patient (weight: NA) from SG, suffering from the following health symptoms/conditions: NA, who was treated with Proparacaine Hcl (dosage: Unk Drp, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Grand Mal Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hcl treatment in female patients, resulting in Grand Mal Convulsion side effect.
Proparacaine Side Effect Report#9883987
Vision Blurred, Glassy Eyes
This report suggests a potential Proparacaine Hydrochloride Vision Blurred side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pupil dilation procedure and used Proparacaine Hydrochloride (dosage: NA) starting
Feb 05, 2014. After starting Proparacaine Hydrochloride the patient began experiencing various side effects, including: Vision Blurred, Glassy EyesAdditional drugs used concurrently:
  • Tropicamide
Although Proparacaine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vision Blurred, may still occur.
Proparacaine Side Effect Report#9648675
Eye Pruritus
This Eye Pruritus problem was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ophthalmological examination. On
Sep 27, 2007 this consumer started treatment with Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% (dosage: 1 Drop In Each Eye; Once). The following drugs were being taken at the same time: NA. When using Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5%, the patient experienced the following unwanted symptoms/side effects: Eye PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Eye Pruritus, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#9648668
Nausea, Syncope, Muscle Spasticity, Asthenia, Photophobia, Hyperacusis, Headache
This Nausea side effect was reported by a consumer or non-health professional from US. A 17-year-old female patient (weight:NA) experienced the following symptoms/conditions: ophthalmological examination.The patient was prescribed Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% (drug dosage: One Drop In Each Eye Once), which was initiated on
Jan 29, 2013. Concurrently used drugs: NA..After starting to take Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% the consumer reported adverse symptoms, such as: Nausea, Syncope, Muscle Spasticity, Asthenia, Photophobia, Hyperacusis, HeadacheThese side effects may potentially be related to Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5%.
Proparacaine Side Effect Report#9648666
Shock, Convulsion, Chills, Syncope, Dysphonia
This is a report of a 14-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypoaesthesia eye,mydriasis, who was treated with Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% (dosage: Ophthalmic; One Time, start time:
Jul 31, 2013), combined with:
  • Tropicamide Ophthalmic Solution Usp 1% (Ophthalmic; One Time)
and developed a serious reaction and side effect(s): Shock, Convulsion, Chills, Syncope, Dysphonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% treatment in male patients, resulting in Shock side effect.
Proparacaine Side Effect Report#9648664
Blood Pressure Increased, Increased Insulin Requirement, Vertigo, Alopecia, Dyspepsia
This report suggests a potential Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% Blood Pressure Increased side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: ophthalmological examination and used Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% (dosage: Drop; Right Eye) starting
Jul 17, 2013. After starting Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% the patient began experiencing various side effects, including: Blood Pressure Increased, Increased Insulin Requirement, Vertigo, Alopecia, DyspepsiaAdditional drugs used concurrently: NA. Although Proparacaine Hydrochloride Ophthalmic Solution Usp 0.5% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Increased, may still occur.
Proparacaine Side Effect Report#9300674
Keratitis
This Keratitis problem was reported by a physician from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypoaesthesia eye. On
Feb 22, 2013 this consumer started treatment with Proparacaine Hydrochloride (dosage: Ou 1 Gtt Eye Drop). The following drugs were being taken at the same time:
  • Paremyd (Ou 1 Gtt 2 Times Eye Drop)
When using Proparacaine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: KeratitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Keratitis, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#9241076
Gait Disturbance, Anxiety, Paraesthesia, Disturbance In Attention, Hypoaesthesia, Fatigue, Feeling Abnormal, Chest Pain, Pain In Extremity
This Gait Disturbance side effect was reported by a consumer or non-health professional from US. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: ophthalmological examination.The patient was prescribed Proparacaine (drug dosage: Poured In Eye Area Liberally - One Time, But Shook All Onto My Face), which was initiated on
Apr 15, 2013. Concurrently used drugs:
  • Phenylephrine
.After starting to take Proparacaine the consumer reported adverse symptoms, such as: Gait Disturbance, Anxiety, Paraesthesia, Disturbance In Attention, Hypoaesthesia, Fatigue, Feeling Abnormal, Chest Pain, Pain In ExtremityThese side effects may potentially be related to Proparacaine.
Proparacaine Side Effect Report#9059637
Nausea, Dizziness, Loss Of Consciousness, Paralysis, Presyncope, Photophobia, Headache
This is a report of a 17-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: anaesthesia procedure,ophthalmological examination, who was treated with Proparacaine Hydrochloride (dosage: NA, start time:
Jan 29, 2013), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Dizziness, Loss Of Consciousness, Paralysis, Presyncope, Photophobia, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hydrochloride treatment in female patients, resulting in Nausea side effect.
Proparacaine Side Effect Report#9058377
Eye Disorder, Ocular Hyperaemia, Eyelid Oedema, Eye Discharge, Feeling Abnormal, Insomnia, Hypoaesthesia Eye, Visual Acuity Reduced, Ocular Discomfort
This report suggests a potential Proparacaine Eye Disorder side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Proparacaine (dosage: NA) starting
Sep 21, 2009. After starting Proparacaine the patient began experiencing various side effects, including: Eye Disorder, Ocular Hyperaemia, Eyelid Oedema, Eye Discharge, Feeling Abnormal, Insomnia, Hypoaesthesia Eye, Visual Acuity Reduced, Ocular DiscomfortAdditional drugs used concurrently:
  • Tropicamide
Although Proparacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eye Disorder, may still occur.
Proparacaine Side Effect Report#8887462
Ocular Hyperaemia, Scleral Disorder, Eyelid Oedema, Eye Discharge, Vision Blurred, Abnormal Sensation In Eye, Insomnia, Eye Pain, Headache
This Ocular Hyperaemia problem was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: eye numbness,pupil dilation procedure. On
Sep 21, 2009 this consumer started treatment with Proparacaine (dosage: NA). The following drugs were being taken at the same time:
  • Tropicamide
When using Proparacaine, the patient experienced the following unwanted symptoms/side effects: Ocular Hyperaemia, Scleral Disorder, Eyelid Oedema, Eye Discharge, Vision Blurred, Abnormal Sensation In Eye, Insomnia, Eye Pain, HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ocular Hyperaemia, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#8371874-7
Eye Inflammation, Pain, Visual Acuity Reduced, Eye Pain, Vision Blurred
This Eye Inflammation side effect was reported by a pharmacist from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Proparacaine Hcl (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Velcade
  • Povidone Iodine (5 % In Bss)
  • Ofloxacin (3 % Ophth)
.After starting to take Proparacaine Hcl the consumer reported adverse symptoms, such as: Eye Inflammation, Pain, Visual Acuity Reduced, Eye Pain, Vision BlurredThese side effects may potentially be related to Proparacaine Hcl.
Proparacaine Side Effect Report#8035726-4
Impaired Healing, Corneal Endothelial Cell Loss, Keratitis, Visual Acuity Reduced, Ocular Discomfort, Conjunctival Hyperaemia, Corneal Opacity, Eye Pain
This is a report of a 29-year-old male patient (weight: NA) from Korea, Republic Of, suffering from the following health symptoms/conditions: NA, who was treated with Proparacaine Hcl (dosage: Ophthalmic, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Impaired Healing, Corneal Endothelial Cell Loss, Keratitis, Visual Acuity Reduced, Ocular Discomfort, Conjunctival Hyperaemia, Corneal Opacity, Eye Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hcl treatment in male patients, resulting in Impaired Healing side effect.
Proparacaine Side Effect Report#8034061-8
Corneal Epithelium Defect, Corneal Opacity, Corneal Infiltrates, Visual Acuity Reduced, Eye Pain, Corneal Neovascularisation, Infectious Crystalline Keratopathy, Rash, Corneal Scar
This report suggests a potential Proparacaine Hcl Corneal Epithelium Defect side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Proparacaine Hcl (dosage: (ophthalmic)) starting NS. After starting Proparacaine Hcl the patient began experiencing various side effects, including: Corneal Epithelium Defect, Corneal Opacity, Corneal Infiltrates, Visual Acuity Reduced, Eye Pain, Corneal Neovascularisation, Infectious Crystalline Keratopathy, Rash, Corneal ScarAdditional drugs used concurrently: NA. Although Proparacaine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Corneal Epithelium Defect, may still occur.
Proparacaine Side Effect Report#8001300-9
Punctate Keratitis, Scar, Corneal Epithelium Defect, Sleep Disorder, Ulcerative Keratitis
This Punctate Keratitis problem was reported by a physician from United States. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Proparacaine Hcl (dosage: (1 Gtt 10x/day Ophthalmic)). The following drugs were being taken at the same time: NA. When using Proparacaine Hcl, the patient experienced the following unwanted symptoms/side effects: Punctate Keratitis, Scar, Corneal Epithelium Defect, Sleep Disorder, Ulcerative KeratitisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Punctate Keratitis, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#8000747-4
Keratitis Fungal, Corneal Thinning, Hyperaemia, Corneal Abscess, Photophobia, Eyelid Oedema, Erythema Of Eyelid
This Keratitis Fungal side effect was reported by a physician from United States. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Proparacaine Hydrochloride (drug dosage: (ophthalmic)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Proparacaine Hydrochloride the consumer reported adverse symptoms, such as: Keratitis Fungal, Corneal Thinning, Hyperaemia, Corneal Abscess, Photophobia, Eyelid Oedema, Erythema Of EyelidThese side effects may potentially be related to Proparacaine Hydrochloride.
Proparacaine Side Effect Report#8000634-1
Corneal Neovascularisation, Keratopathy, Corneal Epithelium Defect, Hypopyon, Visual Acuity Reduced, Corneal Infiltrates, Corneal Oedema, Eye Pain
This is a report of a 29-year-old male patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Proparacaine Hcl (dosage: (ophthalmic), start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Corneal Neovascularisation, Keratopathy, Corneal Epithelium Defect, Hypopyon, Visual Acuity Reduced, Corneal Infiltrates, Corneal Oedema, Eye Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hcl treatment in male patients, resulting in Corneal Neovascularisation side effect. The patient was hospitalized.
Proparacaine Side Effect Report#7995769-3
Keratitis Fungal, Corneal Neovascularisation, Erythema, Eyelid Oedema, Swelling Face, Staphylococcus Test Positive, Corneal Scar, Corneal Oedema, Hypersensitivity
This report suggests a potential Proparacaine Hcl Keratitis Fungal side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: corneal abrasion and used Proparacaine Hcl (dosage: Ophthalmic) starting NS. After starting Proparacaine Hcl the patient began experiencing various side effects, including: Keratitis Fungal, Corneal Neovascularisation, Erythema, Eyelid Oedema, Swelling Face, Staphylococcus Test Positive, Corneal Scar, Corneal Oedema, HypersensitivityAdditional drugs used concurrently: NA.The patient was hospitalized. Although Proparacaine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Keratitis Fungal, may still occur.
Proparacaine Side Effect Report#7995766-8
Pain, Keratitis, Conjunctival Oedema, Dermatitis Contact, Periorbital Oedema, Eye Pain, Corneal Epithelium Defect, Corneal Infiltrates
This Pain problem was reported by a physician from United States. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Proparacaine Hcl (dosage: Ophthalmic). The following drugs were being taken at the same time: NA. When using Proparacaine Hcl, the patient experienced the following unwanted symptoms/side effects: Pain, Keratitis, Conjunctival Oedema, Dermatitis Contact, Periorbital Oedema, Eye Pain, Corneal Epithelium Defect, Corneal InfiltratesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#7982181-6
Hyperhidrosis, Presyncope, Dizziness, Asthenia, Bradycardia
This Hyperhidrosis side effect was reported by a pharmacist from United States. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: intraocular pressure test.The patient was prescribed Proparacaine Hcl (drug dosage: 1 Drops Once Eye), which was initiated on
Sep 01, 2011. Concurrently used drugs: NA..After starting to take Proparacaine Hcl the consumer reported adverse symptoms, such as: Hyperhidrosis, Presyncope, Dizziness, Asthenia, BradycardiaThese side effects may potentially be related to Proparacaine Hcl. The patient was hospitalized.
Proparacaine Side Effect Report#7814850-2
Eye Inflammation, Product Quality Issue, Vision Blurred, Eye Pain
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Proparacaine Hcl (dosage: NA, start time:
Aug 12, 2011), combined with:
  • Povidone Iodine
  • Avastin (Dose 0.15 Ml. Injection)
  • Droxaine
  • Ofloxacin
and developed a serious reaction and side effect(s): Eye Inflammation, Product Quality Issue, Vision Blurred, Eye Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hcl treatment in male patients, resulting in Eye Inflammation side effect.
Proparacaine Side Effect Report#7769315-3
Eye Pain, Product Quality Issue, Vision Blurred, Pain, Visual Acuity Reduced, Eye Inflammation
This report suggests a potential Proparacaine Hcl Eye Pain side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Proparacaine Hcl (dosage: NA) starting
Aug 12, 2011. After starting Proparacaine Hcl the patient began experiencing various side effects, including: Eye Pain, Product Quality Issue, Vision Blurred, Pain, Visual Acuity Reduced, Eye InflammationAdditional drugs used concurrently:
  • Ofloxacin (3 % Ophth)
  • Povidone Iodine (5 % In Bss)
  • Avastin (Frequency: 1 Of 3 Inj)
  • Avastin (Dose: Reported As 3.75 Mg (0.15 Ml))
Although Proparacaine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eye Pain, may still occur.
Proparacaine Side Effect Report#7658143-5
Macular Oedema, Ocular Hypertension, Disease Recurrence, Post Procedural Complication, Visual Acuity Reduced
This Macular Oedema problem was reported by a health professional from Taiwan, Province Of China. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anaesthesia. On NS this consumer started treatment with Proparacaine Hcl (dosage: 0.5 Pt;1x;oph). The following drugs were being taken at the same time:
  • Povidone Iodine (5 Pt;1x;top)
  • Triamcinolone Acetonide (4 Mg;1x;io)
  • Tobramycin (;oph)
When using Proparacaine Hcl, the patient experienced the following unwanted symptoms/side effects: Macular Oedema, Ocular Hypertension, Disease Recurrence, Post Procedural Complication, Visual Acuity ReducedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Macular Oedema, may become evident only after a product is in use by the general population.
Proparacaine Side Effect Report#7658121-6
Visual Acuity Reduced, Macular Oedema, Disease Recurrence, Cataract, Post Procedural Complication, Ocular Hypertension
This Visual Acuity Reduced side effect was reported by a health professional from Taiwan, Province Of China. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: anaesthesia,surgery,macular oedema.The patient was prescribed Proparacaine Hydrochloride (drug dosage: 0.5 Pt;1x;oph), which was initiated on NS. Concurrently used drugs:
  • Tobramycin (;oph)
  • Triamcinolone Acetonide (4 Mg;1x;io)
  • Povidone Iodine (5 Pt;1x;top)
.After starting to take Proparacaine Hydrochloride the consumer reported adverse symptoms, such as: Visual Acuity Reduced, Macular Oedema, Disease Recurrence, Cataract, Post Procedural Complication, Ocular HypertensionThese side effects may potentially be related to Proparacaine Hydrochloride.
Proparacaine Side Effect Report#7655915-8
Toxic Anterior Segment Syndrome
This is a report of a 69-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: anaesthesia, who was treated with Proparacaine Hcl (dosage: 1 Drop, start time:
Jul 13, 2011), combined with:
  • Lidocaine (1-10ml)
and developed a serious reaction and side effect(s): Toxic Anterior Segment Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Proparacaine Hcl treatment in female patients, resulting in Toxic Anterior Segment Syndrome side effect.


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The appearance of Proparacaine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Proparacaine Side Effects for Women?

Women Side Effects Reports
Visual Acuity Reduced 7
Eyelid Oedema 5
Corneal Scar 4
Dizziness 4
Headache 4
Keratitis 4
Photophobia 4
Eye Pain 3
Feeling Abnormal 3
Paraesthesia 3

What are common Proparacaine Side Effects for Men?

Men Side Effects Reports
Eye Pain 5
Visual Acuity Reduced 4
Eye Inflammation 3
Keratitis 3
Vision Blurred 3
Corneal Epithelium Defect 2
Eye Irritation 2
Eyelid Oedema 2
Pain 2
Product Quality Issue 2

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  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Proparacaine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Proparacaine Safety Alerts, Active Ingredients, Usage Information

    NDC 16590-195
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Proparacaine Hydrochloride
    Name Proparacaine Hydrochloride
    Dosage Form SOLUTION
    Route OPHTHALMIC
    On market since 20000605
    Labeler STAT Rx USA LLC
    Active Ingredient(s) PROPARACAINE HYDROCHLORIDE
    Strength(s) 5
    Unit(s) mg/mL
    Pharma Class Local Anesthesia [PE],Local Anesthetic [EPC]

    More About Proparacaine

    Side Effects reported to FDA: 45

    Proparacaine safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 5

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