chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dry skin, Dysstasia, Erythema, Fall
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hypersomnia, Hypoaesthesia, Impaired driving ability
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Joint injury, Joint swelling, Limb injury, Local swelling, Muscular weakness
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia, Sensation of heaviness
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Ophthalmological examination normal
Clinical narrative: No known drug reaction at time of administration. Administered in am 3/28/2014. Onset of inconsolable crying that night 3/28/2014. Seen in clinic 3/29/2014, normal exam negative fluorescein exam. Crying did not resolve until 3/29 PM.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Feeling achy, tired and woke up next morning with redness and swelling at injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Adenovirus test positive, Febrile convulsion
Clinical narrative: Presented to hospital with febrile seizure. Also noted to be adenovirus positive during admission. Occurred approximately 10days after MMR vaccine was administered as outpatient.
Age: 1.11
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Cyanosis, Lethargy, Vaccination complication, Vomiting
Clinical narrative: Received vaccinations at 11 AM on 02/27/2014. Received call from daycare to mom at 2 pm that child was lethargic, had blue lips and vomited. Saw doctor at 2:30 pm, physician felt it was reaction to DTaP. Instructed to NOT receive any more of this series. Entered in NDIIS as medical exemption.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Emergency room. Guillain Barré syndrome.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever >102-104F, vomiting, diarrhea.  Acetaminophen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Knot at site of injection, warm to touch and very itchy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Vaccination failure
Clinical narrative: Pt. was given Zoster vaccine on 7/2013 - she developed Ocular herpes zoster on 1/27/14 - she saw eye Dr and family practice numerous times. She required multiple medications to treat this. Pt. wanted someone to know there was a vaccine failure.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Spoke with patient's Father. He says that his daughter developed a mild rash on her chest late yesterday afternoon after she had received the HPV vaccine. He states that she has no other symptoms. She still had the rash this morning and her school nurse gave her BENADRYL.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye movement disorder, Pyrexia, Tremor
Clinical narrative: Per parent history, pt developed a tactile fever the evening after booster shots were given. Did not check temperature. Pt had a 2-3 minute episode of eyes rolling back in her head and trembling. Parents did not seek medical attention until next AM when they brought child to Peds visit.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Oedema mouth
Clinical narrative: Inside of mouth swollen, feeling sensitivity from jaw to left eyelid.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema mouth, Sensory disturbance
Clinical narrative: Inside of mouth swollen, feeling sensitivity from jaw to left eyelid.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edema and erythema to (R) post upper arm, warm to touch, grimaces and guards to touch. Instructed warm compresses. TYLENOL/MOTRIN for pain. FU on Monday. 3/24 - Dad states pt "fine". No fever, no edema or erythema.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Hyperaesthesia, Swelling
Clinical narrative: Redness, a little swelling, sensitive to touch; BACTRIM, BACTROBAN prescribed, warm compresses - improved with treatment 2 days after it was started.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: "Pimple-like" rash on chest, arms, back. No fever. No aches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Rash macular
Clinical narrative: Approx 5 minutes after receiving Varicella and KINRIX in left arm pt developed blotchy rash to left arm. Unclear if it was itchy, patient was crying. Given BENADRYL PO with full resolution of rash.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out and fell after receiving Meningitis, GARDASIL and Hepatitis vaccines. Patient broke two teeth during her fall.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Told by 3rd party that client stated above is in hospital for Idiopathic Thrombocytopenia Purpura. Consult with Immunization Division to verify need for VAERS report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Headache, Local swelling, Pruritus, Pyrexia
Clinical narrative: 24 hours later swollen, itchy arm. 48 hours after shot - fever, headache. 5 days post - upper resp infection/bronchitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: 24 hours later swollen, itchy arm. 48 hours after shot - fever, headache. 5 days post - upper resp infection/bronchitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swollen, red and itching.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Restlessness
Clinical narrative: Unconsolability x 3 days, high-pitched shrieking cry; restlessness.
Age: 18.0
Sex: F
Vaccine: DTAP, HPV4, MMR
Symptoms: Convulsion, Posture abnormal
Clinical narrative: Slumping over and a small seizure.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin exfoliation
Clinical narrative: Per Patient, developed redness of the face and neck, c/o itching. Seen by MD on 3/10, prescribed methylprednisolone 4mg X 6 days. Seen again by MD on 3/31 prescribed mometasone furoate cream and instructed to take Benadryl prn. Facial skin is now peeling.
Age: 18.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Myalgia
Clinical narrative: Pins and needles in extremeties, muscle weakness and aches.
Age: 18.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Neurological examination, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Pins and needles in extremeties, muscle weakness and aches.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Ear pain, Fall, Seizure like phenomena
Clinical narrative: After administrating Meningococcal vaccine patient fell foward off of examining table onto the floor and appeared to have seizure-like movements for about 3 seconds. Sat on floor for a few minutes and was asked questions as to alertness which she was so was assisted was assisted to couch to lay down and was given some juice. Mother had given her some Tylenol she complained of her right ear hurting. Doctor was notified and examined. After about 30 minutes patient stated that she was feeling better and was able to go home.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Left arm swollen at site "the size of a softball", tense, hot, red, tender. Called PCP Friday evening (3/28) who assessed for anaphylaxis. No respiratory or GI symptoms. 3 small nonpruritic blanching pinpoint erythematous lesions on ipsilateral trunk. Advised likely large local reaction, instructed parents to ice area, give Benadryl and ibuprofen until resolved and follow up if no improvement in 3 days or worsening at any point. Patient came in for reassessment Monday 3/31 and arm was still slightly swollen, hot, and tender but vastly improved as per patient and family.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth, Local reaction, Skin lesion, Skin tightness
Clinical narrative: Left arm swollen at site "the size of a softball", tense, hot, red, tender. Called PCP Friday evening (3/28) who assessed for anaphylaxis. No respiratory or GI symptoms. 3 small nonpruritic blanching pinpoint erythematous lesions on ipsilateral trunk. Advised likely large local reaction, instructed parents to ice area, give Benadryl and ibuprofen until resolved and follow up if no improvement in 3 days or worsening at any point. Patient came in for reassessment Monday 3/31 and arm was still slightly swollen, hot, and tender but vastly improved as per patient and family.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Abdominal discomfort, Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine negative, Ultrasound antenatal screen normal
Clinical narrative: Approximately 26 week gestation pregnant patient was unaware she was pregnant, had a negative urine pregnancy test that day, then was subsequently administered 1 dose of injectable anthrax vaccine and initiated a 7-day, 4-dose course of oral typhoid vaccination.
Age: 1.86
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Patient was calm, sitting in waiting room with his mother when he suddenly began vomiting, roughly 10 minutes after administration of the MMR vaccine. He had several episodes of forceful, nonbloody nonbilious emesis that resolved on its own. He had no difficulty breathing, no rash, and no other symptoms following his emesis.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Fatigue
Clinical narrative: Throughout the day and afternoon patient reports increasing temperature from 99.8F to 101.3F with increasing fatigue and dizziness.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Rash extending from head extending to trunk. Fever of 102.5 which lasted for 3-5 days. Cough.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Injection site pain, Lip swelling, Pruritus, Urticaria
Clinical narrative: First had very sore arm at site for 3days. Since then mostly later into the day and late at night I am breaking out into very itchy hives in the arms, legs, groin area and neck along with lips swelling and becoming numb. I have taken Benadryl for it to help relieve itching. Will be contacting doctor for advice.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Headache, Local swelling, Pain, Pain in extremity
Clinical narrative: Headache, soreness of arm, face flushed, arm swelled, and as evening wore on pain in arm grew greater and greater with every passing hour - could not move arm without experiencing very bad pain that encompassed several days' time.
Sex: F
Vaccine: HPV4
Symptoms: Disability
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 213 female patients of unknown age. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). On an unknown date, the reporter stated that the patients who took GARDASIL suffered permanent disability. At the time of the report outcome of permanent disability was unknown. The reporter considered the events as permanent disability. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Medication error
Clinical narrative: Information has been received from a physician, author of the abstract title as stated above. Patients with inflammatory bowel disease (IBD) often receive immunosuppressive therapy (eg, thiopurines, methotrexate, tumor necrosis factor inhibitors) for prolonged periods of time. Although such medications maintain remission and improve quality of life, they put patients at risk for infection. Therefore, it is important to implement preventative care, including immunizations to minimize the risk of vaccine-preventable infections. In general, inactivated vaccines are considered to be safe in patients with IBD receiving immunosuppressive therapies. Two recent studies of the influenza vaccine demonstrated that the immune response in patients with IBD overall is good but that there may be a reduction in serologic response in patients receiving tumor necrosis factor inhibitors. However, there is a paucity of data regarding the immune response to the varicella vaccine in patients with IBD. Studies in other immunocompromised papulations (eg, oncology, chronic renal failure, human immunodeficency virus (HIV), transplant) show that varicella vaccine is generally well tolerated and immunogenic. We present a series of children with IBD receiving immunosuppressive therapy who were injected with varicella vaccine (manufacturer unknown), tolerated it without adverse events, and developed antibodies to the varicella virus. A 15 year old male was diagnosed at age 9 years in 2002 as having Crohn ileitis. He was given 6-MP shortly after diagnosis. Five years later, the family inquired about the varicella vaccine, given the patient's chronic immunosuppressed state. He was vaccinated with the primary varicella (manufacturer unknown) dose at age 6 years in approximately 1999. A baseline varicella titer was not drawn. After a discussion of risks versus benefits, the family decided to immunize the patient with varicella (manufacturer unknown) booster to prevent him from developing wild-type varicella in the setting of immunosuppression in approximately 2007 at 14 year old. He was receiving 6-MP (1.5 mg-kg-1-day-1, mesalamine, and ciprofloxacin at the time of vaccination. He tolerated the varicella booster without clinical manifestations of varicella. The follow-up titer was 0.90 IV (equivocal immunity) (A value of <0.89 IV indicates negative immunity) when patient was 15 years old in approximately 2008. The outcome of the event was unknown. A  copy of the published article as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown ages and genders. Pertinent medical history and drug reactions/allergies were not reported. On 24-MAR-2014, the patients received improperly stored, GARDASIL (lot # J006850, expiration date 31-MAR-2016) 0.5 ml, intramuscular; exposed to 31F for 84 hours. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 24-MAR-2014, the patient was administered a properly stored dose of ROTATEQ (dose and route not provided) (lot #H017672, expired on 19-MAR-2014). No adverse events were reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling from mid-upper thigh down to knee, red painful hot to touch. Pt is unable to walk on foot. 4/1/2014 1:39 PM > spoke with mom, his leg is better, no fever, walking, BENADRYL is helping. Yesterday he was fine. Then gave him BENADRYL and TYLENOL, now better. Continue BENADRYL and TYLENOL. To be seen if it does not improve, please cx today appt and fill out VAERS.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, stomach ache, fever, vomiting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Redness, swelling, itching (entire back arm) started next day. Pt took APAP and BENADRYL - swelling slowly subsiding - seeing Dr. on 4/1.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 13-FEB-2014, the patient was vaccinated with second dose of PROQUAD (Merck) subcutaneous, Lot #J009886; Expiration date: 15-FEB-2015 (dose, strength and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse originally called on 13-DEC-2013 requesting stability information for PROQUAD (Merck) that was improperly stored. During the call she was told that based on company stability data PROQUAD (Merck) would had to be used within 1 month or by 13-JAN-2014. Nurse reported that improperly stored PROQUAD (Merck) was administered to patient on 13-FEB-2014. No adverse effect were reported. This is one of 3 reports concerning same reporter (MARRS #1403USA007675 and 1403USA012820). Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-FEB-2014, the patient was vaccinated with second dose of PROQUAD (Merck) subcutaneous, Lot #J009886; Expiration date: 15-FEB-2015 (dose, strength and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse originally called on 13-DEC-2013 requesting stability information for PROQUAD (Merck) that was improperly stored. During the call she was told that based on company stability data PROQUAD (Merck) would had to be used within 1 month or by 13-JAN-2014. Nurse reported that improperly stored PROQUAD (Merck) was administered to patient on 20-FEB-2014. No adverse effect were reported. This is one of 3 reports concerning same reporter (MARRS #1403USA012819 and 1403USA012820). Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with first dose of PROQUAD (Merck) subcutaneous, Lot #J009886; Expiration date: 15-FEB-2015 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse originally called on 13-DEC-2013 requesting stability information for PROQUAD (Merck) that was improperly stored. During the call she was told that based on company stability data PROQUAD (Merck) would had to be used within 1 month by 13-JAN-2014. Nurse reported that improperly stored PROQUAD (Merck) was administered to patient on 12-FEB-2014. No adverse effect were reported. This is one of 3 reports concerning same reporter (MARRS #1403USA007675 and 1403USA012819). Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Tenderness
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 36 year old female patient with asthma and allergy to albuterol. On 05-MAR-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscular in left deltoid (lot# J014399, exp date 20-NOV-2014). Concomitant therapies included SYMBICORT. The healthcare worker stated client was vaccinated with PNEUMOVAX 23 on 05-MAR-2014 and the next day came into the office with an adverse event. Client's left arm was very tender, she had redness in the area, body aches and chills. The client had taken over the counter MOTRIN 600 mg. No lab diagnostics studies were performed. The patient sought medical attention by coming into office. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered GARDASIL (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered PROQUAD (Merck) (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered VARIVAX (Merck) (dose, route, lot number and expiration date were not reported) and TD had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered M-M-R II (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered VARIVAX (Merck) (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered ROTATEQ (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered PEDVAXHIB (dose, route, lot number and expiration date were not reported) and Td that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Fatigue, Pain in extremity, Pyrexia, Somnolence, Unresponsive to stimuli
Clinical narrative: 03/28/14 Client in for 5 year vaccines. Became upset and combative after MMRV vaccine given. Attempted to give KINRIX in same arm but child pulled away so full dose wasn't given. Drew up another full dose to give in same arm, different site. Mother unable to restrain child so another nurse in to help with process. KINRIX given in LD and then Hep A given in RD all the while child screaming and resisting restraint. Right after Hep A given child eyes closed and body became flaccid. Child had good color and strong pulse but not responsive to verbal stimuli. Mother with child on her lap layed in supine/reverse Trendelenburg position. Cool cloth placed on child's head and neck. Child did not respond for at least one minute. Maintained appropriate color and adequate pulse. Once child responded, he was somewhat sleepy but answering questions appropriately. Gave juice box and snack and had mother and child lay for 15 min. Child able to walk out. Encouraged mother to keep watchful eye on child after leaving office. Take to ED if needed. 04/01/14 Call to mother to f/u. Mother reports child had fever the next day and sore arms. Was also fatigued. 2 days post-vaccination to current: no issues.
Age: 1.0
Sex: U
Vaccine: HEPA, MMRV, PPV
Symptoms: Body temperature increased, Erythema, Rash
Clinical narrative: Exanthema developed on 12th day and developed into intense erythema on face and upper arms with increased temperature over 3 day period DECADRON IM x 1 BENADRYL PO x 2 days.
Age: 34.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity
Clinical narrative: Patient developed a persistent sore arm after the vaccination that has not subsided since the vaccination - patient has managed pain with TYLENOL.
Age: 34.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient developed a persistent sore arm after the vaccination that has not subsided since the vaccination - patient has managed pain with TYLENOL.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mouth ulceration
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 years old male patient. The patient's medical history and concurrent conditions were not reported. The patient had no known allergies. On 17-JUL-2013, the patient received the first dose of GARDASIL (dose and rout not provided). On an unspecified date the patient experienced mouth sores in and around the mouth. The nurse referred to the sores as "canker sores". On 02-OCT-2013, the patient then received the second dose of GARDASIL (lot # J007354) (dose and rout not provided). On an unspecified date the patient experienced mouth sores in and around the mouth again, but with much greater severity. On an unspecified date the patient fully recovered from the events. The relationship between events mouth sores and GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aphthous stomatitis, Stomatitis
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 years old male patient. The patient's medical history and concurrent conditions were not reported. The patient had no known allergies. On 17-JUL-2013, the patient received the first dose of GARDASIL (dose and rout not provided). On an unspecified date the patient experienced mouth sores in and around the mouth. The nurse referred to the sores as "canker sores". On 02-OCT-2013, the patient then received the second dose of GARDASIL (lot # J007354) (dose and rout not provided). On an unspecified date the patient experienced mouth sores in and around the mouth again, but with much greater severity. On an unspecified date the patient fully recovered from the events. The relationship between events mouth sores and GARDASIL was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a other health professional refers to a 61 years old male patient. The patient's medical history included shingles 25 years ago. No known drug allergy was reported. On 27-MAR-2014, the patient was vaccinated with ZOSTAVAX, lot # J13134, 0.5 ml (dose), in the right upper arm, route of administration (unknown). Concurrent medications were reported as none. On 27-MAR-2014, the patient developed red raised itchy and papular rash, one hour post vaccination. Distribution of lesions were around random left right abdomen, right hip and leg. Total number of lesions was 15. Body temperature on 27-MAR-2014 was 98 degree (unit not provided). VZVIP (Varicella Zoster Virus Identification Program) samples from papule and scab were obtained on 28-MAR-2014. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present. Patient did not have recent Chickenpox or shingles VZV (Varicella Zoster Virus) exposure. The outcome of events was unknown. Causality was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Papule, Rash erythematous, Rash papular, Rash pruritic, Scab
Clinical narrative: This spontaneous report as received from a other health professional refers to a 61 years old male patient. The patient's medical history included shingles 25 years ago. No known drug allergy was reported. On 27-MAR-2014, the patient was vaccinated with ZOSTAVAX, lot # J13134, 0.5 ml (dose), in the right upper arm, route of administration (unknown). Concurrent medications were reported as none. On 27-MAR-2014, the patient developed red raised itchy and papular rash, one hour post vaccination. Distribution of lesions were around random left right abdomen, right hip and leg. Total number of lesions was 15. Body temperature on 27-MAR-2014 was 98 degree (unit not provided). VZVIP (Varicella Zoster Virus Identification Program) samples from papule and scab were obtained on 28-MAR-2014. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present. Patient did not have recent Chickenpox or shingles VZV (Varicella Zoster Virus) exposure. The outcome of events was unknown. Causality was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Varicella virus test
Clinical narrative: This spontaneous report as received from a other health professional refers to a 61 years old male patient. The patient's medical history included shingles 25 years ago. No known drug allergy was reported. On 27-MAR-2014, the patient was vaccinated with ZOSTAVAX, lot # J13134, 0.5 ml (dose), in the right upper arm, route of administration (unknown). Concurrent medications were reported as none. On 27-MAR-2014, the patient developed red raised itchy and papular rash, one hour post vaccination. Distribution of lesions were around random left right abdomen, right hip and leg. Total number of lesions was 15. Body temperature on 27-MAR-2014 was 98 degree (unit not provided). VZVIP (Varicella Zoster Virus Identification Program) samples from papule and scab were obtained on 28-MAR-2014. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present. Patient did not have recent Chickenpox or shingles VZV (Varicella Zoster Virus) exposure. The outcome of events was unknown. Causality was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Rash generalised
Clinical narrative: Got shot 11 AM March 29, 2014. Woke up March 30th noticed a few hive bumps as the day went on more started BENADRYL in afternoon. Monday March 31st went to doctor he prescribed Prednisone for 12 days, BENADRYL 2 tabs 3 x's a day hives were all over body..eyelids swollen almost shut, both ears so swollen couldn't move lobe.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear swelling, Eyelid oedema, Urticaria
Clinical narrative: Got shot 11 AM March 29, 2014. Woke up March 30th noticed a few hive bumps as the day went on more started BENADRYL in afternoon. Monday March 31st went to doctor he prescribed Prednisone for 12 days, BENADRYL 2 tabs 3 x's a day hives were all over body..eyelids swollen almost shut, both ears so swollen couldn't move lobe.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Mobility decreased, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 65 year old male registered nurse refers to himself. There was no Pertinent Medical History and no Drug Reactions/Allergies. On 25-MAR-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # not provided), subcutaneous in the arm. There was no concomitant medication. The nurse reported that on 25-MAR-2014, 4 hours after being administered PNEUMOVAX 23, his entire arm, where he had the injection administered, developed edema. The patient was unable to bend his arm or even touch his face with that arm that had edema. There was no laboratory studies performed. Patient did not seek medical attention. The patient was treated with BENADRYL. The outcome of events was reported as not recovered/not resolved. The events were considered to be disability by the reporter. This is one of the several reports received from the same source (linked MARS # 1404USA000194). Additional information has been requested.