chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphocyte percentage, Monocyte percentage increased, Myalgia, Neutrophil percentage, Platelet count normal
Clinical narrative: The day after vaccine he developed fever 100.3, fatigue, severe headache, myalgias. He returned to office the next day (7/31/11), still ill. No local reaction noted. He was sent to ER for labs, possible meningitis evaluation. Labs-WBC 12.3, otherwise CBC normal. Felt to have viral syndrome vs febrile vaccine reaction. As of 8/5/11 patient now feels better, recovered.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Viral infection, White blood cell count increased
Clinical narrative: The day after vaccine he developed fever 100.3, fatigue, severe headache, myalgias. He returned to office the next day (7/31/11), still ill. No local reaction noted. He was sent to ER for labs, possible meningitis evaluation. Labs-WBC 12.3, otherwise CBC normal. Felt to have viral syndrome vs febrile vaccine reaction. As of 8/5/11 patient now feels better, recovered.
Age: 1.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 103 degrees
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: high fever 5 days, red itchy bumps on chest July-bumps spread all over body, itchy red patches August- most of bumps gone, still itchy
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: high fever 5 days, red itchy bumps on chest July-bumps spread all over body, itchy red patches August- most of bumps gone, still itchy
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS, SWELLING AT INJECTION SITE
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Papule
Clinical narrative: Mom states that she noticed a rash around injection site and a couple "papules" on the body.
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Tdap - from state stock/ Meningococcal - from private stock:  Nausea, Headache, sore throat, dizziness, shortness of breath, chest tightness, then developed fever and chills the next day. She reported it on 8/2/11.  I told her to go to PCP or ER.  She said it was getting better so she did not go. Called back on 8/3/11 and said she was "fine now."
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Tdap - from state stock/ Meningococcal - from private stock:  Nausea, Headache, sore throat, dizziness, shortness of breath, chest tightness, then developed fever and chills the next day. She reported it on 8/2/11.  I told her to go to PCP or ER.  She said it was getting better so she did not go. Called back on 8/3/11 and said she was "fine now."
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Papule
Clinical narrative: Mom states that pt started with a rash around the injection site on 8/3/11 and has some papules on body since (maybe 10)
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient received Varivax vaccine in right arm SC on 08/04/11.  Mother noticed 08/05/11 approx 3:00 that area was red and hard.  Patient evaluated in office 08/05/11.  Treatment course recommended ice and Benadryl.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient administered vaccinations while unknowingly pregnant (last menstrual period was 27 June 11); reporting solely due to exposure while pregnant
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: The index finger of the arm where injection given was red, swollen and itchy the next morning after vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Large lump and bright red skin rash at injunction site apprixmately 2" inches out from site in all directions. Subsiding by 8/05 PM.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria Rash and Hives
Age: 1.08
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Dyspnoea, Erythema, Gaze palsy, Immediate post-injection reaction
Clinical narrative: Pt was administered Hib and PCV vaccines in thigh. Pt way crying following administration of first vaccine (Hib). Immediately after the second vaccine (PCV) was administered (while I, the administrator of the vaccine was applying a bandage), the patient stopped crying and the parents became alarmed and stated that patient was not breathing. The patient's face appeared dusky and red. The patient's eyes then rolled up and the patient arched her back. I was unable to determine if the patient had, indeed, stopped breathing as the patient's father picked up the infant and began blowing on her face. Within seconds, the patient began crying again. The entire episode lasted less than 1 minute. The patient was examined following the incident and, while clearly frightened, appeared stable.
Age: 1.08
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Opisthotonus, Skin discolouration
Clinical narrative: Pt was administered Hib and PCV vaccines in thigh. Pt way crying following administration of first vaccine (Hib). Immediately after the second vaccine (PCV) was administered (while I, the administrator of the vaccine was applying a bandage), the patient stopped crying and the parents became alarmed and stated that patient was not breathing. The patient's face appeared dusky and red. The patient's eyes then rolled up and the patient arched her back. I was unable to determine if the patient had, indeed, stopped breathing as the patient's father picked up the infant and began blowing on her face. Within seconds, the patient began crying again. The entire episode lasted less than 1 minute. The patient was examined following the incident and, while clearly frightened, appeared stable.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Bacterial test, Cellulitis
Clinical narrative: cellulitis
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling of left deltoid aprox. 60cm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: large 10x6 red warm hard area on right shoulder
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient stated that she received the Zostavax vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot of pain. Patient was referred to her primary health care provider for suspected shingles. Patient came back to the pharmacy a couple of hours later with a prescription for Valacyclovir. She had been diagnosed with Shingles by her primary physician.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Patient stated that she received the Zostavax vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot of pain. Patient was referred to her primary health care provider for suspected shingles. Patient came back to the pharmacy a couple of hours later with a prescription for Valacyclovir. She had been diagnosed with Shingles by her primary physician.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site erythema, Injection site vesicles, Pain
Clinical narrative: Patient stated that she received the Zostavax vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot of pain. Patient was referred to her primary health care provider for suspected shingles. Patient came back to the pharmacy a couple of hours later with a prescription for Valacyclovir. She had been diagnosed with Shingles by her primary physician.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient stated that she received the Zostavax vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot of pain. Patient was referred to her primary health care provider for suspected shingles. Patient came back to the pharmacy a couple of hours later with a prescription for Valacyclovir. She had been diagnosed with Shingles by her primary physician.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Malaise, temp of 100.7 through the night of 08/03/2011. Nodules appearing that were hard to touch and hot below injection site on 08/04/2011. Called triage nurse 9:30 PM for Dr. office. She said give Tylenol and cool compress. We did that, next morning several more hot nodules appeared. Went to the Doctor's Office 08/05/2011, the pediatric side was closed, the walk in clinic was open and called Dr. She called in an antibiotic, suggested Zyrtec in case of allergic reaction. I outlined the nodular swelled area on his leg to monitor further spread. Directed by dr to keep eye on it, continue cool compresses and if still not looking right on Monday to bring him in.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Malaise
Clinical narrative: Malaise, temp of 100.7 through the night of 08/03/2011. Nodules appearing that were hard to touch and hot below injection site on 08/04/2011. Called triage nurse 9:30 PM for Dr. office. She said give Tylenol and cool compress. We did that, next morning several more hot nodules appeared. Went to the Doctor's Office 08/05/2011, the pediatric side was closed, the walk in clinic was open and called Dr. She called in an antibiotic, suggested Zyrtec in case of allergic reaction. I outlined the nodular swelled area on his leg to monitor further spread. Directed by dr to keep eye on it, continue cool compresses and if still not looking right on Monday to bring him in.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 2 urticarial like lesions on either side of the mouth (like clown makeup). Child is otherwise fine.
Age: 19.0
Sex: M
Vaccine: HEPAB
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient received TWINRIX vaccine w/o incident. After walking away from immediate shot area, patient lost consciousness and fell.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area on (R) delt. area.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: Patient became faint & pale approx 10 min. after the GARDASIL was administered. Pt. was sitting up & was positioned laying down with pillow elevating her legs. V.S.: SPO2 92 P - 76 B/P 110/50. 9:55 vital sign: P - 74, SPO2 - 98 BP 100/60 alert & responsive & talking.
Age: 34.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: (L)-arm, first 2 month, very sore. As of 8/5/2011, soreness is less, but still exists. Pt feels he cannot lift his arm at shoulder all the way up to ear. Pain & reaction staying local to the pectoral muscle only.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mom noted on 6/22 both arms (deltoid area) are swollen, red and warm to touch. Left more than the right. Fever for 24 hrs only after injection; MD described, (L) arm has erythema, raised, indurated and warm to touch 3 1/4 inch x 3 1/2 inch; Cephalexin 250 mg/ml - 6.5 ml TID x 10 days.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: Redness & swelling to left arm. Rash x 3 days. No SOB. No Distress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Mild local reaction to (L) upper thigh. No tx except for cold compress.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Rash erythematous, Rash pruritic
Clinical narrative: Pt states raised red rash w/ itching for several weeks. Today SC site appears black & blue bruised.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted about 5 minutes after vaccine administration. Paramedics were called and she responded quickly and did not need Epinephrine or any further treatment.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Paresthesias of left arm occurring within 3 to 4 hours of injection. She didn't necessarily describe it as pain, just sort of a tingling or numbness.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was injected w/ ADACEL when she was requesting TB testing. Pt.'s mom said pt received all her shots already but didn't clarify which & when pt was fine physically when they left the pharmacy.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Med/tx BENADRYL 12.5mg/5ml 5ml PO Q6 hours x 24 hours - f/u 8/6/11. (mild rash at site of injection local erythema/warmth no induration).
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Dyspnoea, Flushing, Rash generalised
Clinical narrative: Dizziness, clamminess, flushing, rashes all over body, SOB w/c subsided immediately when pt was asked to sit down. Rashes slowly went away 15-30 min after giving 50mg liquid BENADRYL (gen).
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: (R) deltoid red, warm, and discomfort voiced per patient. No treatment needed at this time. - Suspected reaction.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: At 9:24AM MCV4 0.5 ml was given IM in Rt. deltoid. At 9:25AM a PPD 0.1 ml was placed intradermally into Rt. forearm. Almost immediately client c/o nausea; face became very pale; had client lie down and deep breathe. BP 100/60 P-64 R-20. Reclined for 15 minutes; ice pack to forehead. At 9:42AM color returned to cheeks. She stated she felt much better. BP-106/60 P-68 R-20.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Patient's birthday was wrong in chart so she was given Hep A peds instead of adult dosing.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given second Hep A too soon. There was not 6 months between 1st & 2nd dose.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) upper arm redness/swelling.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with a history of fainting when blood had been taken, who on 28-OCT-2010 was vaccinated with a dose of GARDASIL (Lot # unknown). Concomitant therapy included a dose of HepB (Lot # unknown), HepA (Lot# unknown) a dose of BOOSTRIX and MENACTRA. On 28-OCT-2010, the patient fainted after being vaccinated with a dose of GARDASIL. The patient received other shots listed before GARDASIL was given. At the time of the report the patient's outcome was recovering. The patient sought unspecified medical attention. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Blister, Drug eruption, Fatigue, Headache
Clinical narrative: Rash that looks like poison ivy. Extremely painful and itchy that spread to multiple spots on my body. New blister like spots appear each day and have since 8/1/11. The first spot appeared on my neck 2 hours after the injection of Gardasil. I also have been fatigued, with a headache and stomach upset for days. I went to the hospital and they diagnosed it as a drug rash from the Gardasil. Because of taking the Gardasil, I am unable to treat the rash with steroids, so I am left in agonizing pain. Take this vaccine off the market!!
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: Rash that looks like poison ivy. Extremely painful and itchy that spread to multiple spots on my body. New blister like spots appear each day and have since 8/1/11. The first spot appeared on my neck 2 hours after the injection of Gardasil. I also have been fatigued, with a headache and stomach upset for days. I went to the hospital and they diagnosed it as a drug rash from the Gardasil. Because of taking the Gardasil, I am unable to treat the rash with steroids, so I am left in agonizing pain. Take this vaccine off the market!!
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Chills, fever 101. Muscle aches, difficulty moving arm. Temp 99.8 this morning with Tylenol.
Age: 1.38
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Shot site became really red with huge line going across his leg. Slight fever, leg is hot, sore to touch, and very swollen. Seems to be in a lot of pain.
Age: 1.38
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: Shot site became really red with huge line going across his leg. Slight fever, leg is hot, sore to touch, and very swollen. Seems to be in a lot of pain.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: High fever, irritable
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Insomnia, Irritability, Rash
Clinical narrative: In first couple of days after MMR shots (also got HEP A, Pevnar 13, and Varivax) she was irritable and cried more often when trying to sleep, but seemed to improve after first couple days. Then woke up around 5 AM (usually sleeps until around 7 AM) crying on July 19, 2011 and rubbing her head. Over the course of the next few hours she continued to rub her head, often violently and a rash began to appear on her forehead, behind her ears, neck, stomach and around her back. Did not appear on legs or arms as far as we could tell. The rash then lasted a few days (possibly up to about a week), although faded after first couple days, especially fading where it had been worst on her head and neck. After the first two days she stopped rubbing her head, however, although it interfered with her sleep most significantly the night of July 19, 2011-July 20, 2011. We did not give her any treatment other than liquid Benadryl as instructed by her doctor for the first day or two for the rubbing the head, which the doctor was not sure was related, although the doctor thought the rash seemed to be an MMR reaction rash.
Age: 18.0
Sex: F
Vaccine: HPV2, MEN, TDAP
Symptoms: Blood test normal, Headache, Pyrexia
Clinical narrative: Started with headaches 9 days after Cervarix vaccine. Began to run fever in the evening on 8/3/2011 for 3 days. Doctor did a full blood work and everything came back negative.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Rash erythematous, Rash pruritic
Clinical narrative: Large, red swollen mass on arm, itching red bumps on mass, shot given 8/2, she came in 8/4 to report .
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Dizziness, Feeling abnormal, Feeling of body temperature change, Syncope
Clinical narrative: About 2 min after vaccine was administered, patient stood up & then fainted. She regained consciousness about less than 1 min. She complained of feeling dizzy, hot, then cold. She stated her arm felt strange. Her BP dropped to 70-90/40.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis
Clinical narrative: Large cellulitis (L) arm 14cm x 12cm.
Age: 1.78
Sex: M
Vaccine: PNC13
Symptoms: Agitation, Clumsiness, Crying, Dysstasia, Pyrexia
Clinical narrative: 8/5/11 per after shot - low gd temp (fever) "clumsy" - not able to climb stairs - up at noc - very agitated, crying, fever-101.6.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Mass
Clinical narrative: Per nurse, pt. presented with large, swollen red mass, shot given 8/1/11.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site 15 minutes after injection. Symptoms resolved within one hour.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Local swelling, Pruritus, Skin warm
Clinical narrative: Warm to touch, tender, swollen - about 5x3 inches, itches, erythema. Local reaction. No systemic effects reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Warm to touch, tender, swollen - about 5x3 inches, itches, erythema. Local reaction. No systemic effects reported.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with penicillin allergy who was vaccinated intramuscularly with three doses of GARDASIL (lot#s not reported) respectively on 27-MAY-2008, 28-JUL-2008 and 17-JUN-2010. Concomitant therapy included YAZ and ADVIL. The third dose fell out of the recommended interval, but in addition to the misuse, on 17-JUN-2010 the patient experienced pain at the injection site. No medical attention was sought. There were no laboratory diagnostics studies performed. The patient was gone within 2 days, 19-JUN-2010. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEPA, IPV, MMR, TD
Symptoms: Discomfort, Joint range of motion decreased, Myalgia
Clinical narrative: Myalgia in L deltoid, with reduced active ROM. Denies paresthesia. Myalgia and reduced ROM have been slowly improving. Now has almost full active ROM with minimal discomfort.
Age: 1.01
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Injection site rash, Pyrexia, Vaccination site erythema
Clinical narrative: Starting 8/3/2011, started to get erythema around vaccine site left anterior thigh. By 8/5, injection site area broke out into shingles-appearing rash. No other symptoms except for mild fever, child is doing well.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Infantile spitting up, Irritability, Pyloric stenosis, Surgery, Ultrasound abdomen
Clinical narrative: At first baby starts spitting up and fussy; increases to vomiting over next couple of days; took into clinic for check on 7/21/11 - presumed to be expected side effect of vaccines. Then projectile vomiting begins. Mother took back to clinic on 7/22/11 - admitted to hospital for surgery on 7/23/11 for Dx pyloric stenosis. What caused it? Live Rota Vius vaccine??
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: At first baby starts spitting up and fussy; increases to vomiting over next couple of days; took into clinic for check on 7/21/11 - presumed to be expected side effect of vaccines. Then projectile vomiting begins. Mother took back to clinic on 7/22/11 - admitted to hospital for surgery on 7/23/11 for Dx pyloric stenosis. What caused it? Live Rota Vius vaccine??
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Fatigue, Lacrimation increased, Pyrexia, Sluggishness
Clinical narrative: Rapid high fever onset, sluggish, watery eyes, tired, loss of appetite
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blood test, Lumbar puncture, Oedema peripheral, Pyrexia, Swelling face
Clinical narrative: high fever, severe hives from head to toe, swelling of face and all extremities
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Urine analysis, Urticaria
Clinical narrative: high fever, severe hives from head to toe, swelling of face and all extremities
Age: 40.0
Sex: F
Vaccine: YF
Symptoms: Borrelia test, Full blood count, Headache, Influenza like illness, Mononucleosis heterophile test
Clinical narrative: Severe, pounding headache, fever, muscle aches - severe flu-like symptoms. Movement made headache worse, at times orthostatic hypotension. These symptoms have occurred every 2 - 3 years since the inoculation, with no other apparent medical cause.
Age: 40.0
Sex: F
Vaccine: YF
Symptoms: Myalgia, Orthostatic hypotension, Pain, Pyrexia
Clinical narrative: Severe, pounding headache, fever, muscle aches - severe flu-like symptoms. Movement made headache worse, at times orthostatic hypotension. These symptoms have occurred every 2 - 3 years since the inoculation, with no other apparent medical cause.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at adminstration site that continued for over 24 hours and was hot to the touch and itchy.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Laboratory test normal, Skin warm
Clinical narrative: Rash at injection site. Warm to touch. Rash appeared 2 days after administration.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: 8/7/11 after waking up 6:30 am, welts on chest. At 2:30pm- welts spread all over body. Feels like "fire ants stinging". May or may not due to shots. These symptoms presented on 8/7/11. Shots given 8/3/11.
Age: 14.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Blood test, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, loss of appetite, headache, tiredness, vomit.
Age: 14.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Vomiting
Clinical narrative: Fever, loss of appetite, headache, tiredness, vomit.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Back pain, Bladder catheterisation, Bladder disorder, Burning sensation
Clinical narrative: Information has been received from a physician regarding a 15 year old female who on 26-SEP-2007 was vaccinated with her second dose of GARDASIL for prevention of HPV (human papillomavirus). She was taking no concomitant medications and had no pertinent medical history of drug reactions/allergies. Thirty minutes after the vaccination, the patient experienced a headache and that night went home and slept until the next morning. The patient woke up the next day and went to school. The school nurse called the patient's mother and informed her that the patient felt tingling in both hands. Later that day, the patient was again sent to the nurse's office due to a shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning in her back. The patient was taken to the emergency room by her parents. In the emergency room, the patient collapsed and was not able to walk; she was paralyzed from the waist down. It was reported that the patient was hospitalized for two months. After several months of therapy, the patient was able to walk with the assistance of a walker (by November 2007) but at the time of the report, she remained paralyzed on her left side. The patient also had to have a catheter for four months and at the time of the report had bladder and bowel problems. Many labs were performed (results not provided). Therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Gastrointestinal disorder, Headache, Hemiplegia, Laboratory test
Clinical narrative: Information has been received from a physician regarding a 15 year old female who on 26-SEP-2007 was vaccinated with her second dose of GARDASIL for prevention of HPV (human papillomavirus). She was taking no concomitant medications and had no pertinent medical history of drug reactions/allergies. Thirty minutes after the vaccination, the patient experienced a headache and that night went home and slept until the next morning. The patient woke up the next day and went to school. The school nurse called the patient's mother and informed her that the patient felt tingling in both hands. Later that day, the patient was again sent to the nurse's office due to a shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning in her back. The patient was taken to the emergency room by her parents. In the emergency room, the patient collapsed and was not able to walk; she was paralyzed from the waist down. It was reported that the patient was hospitalized for two months. After several months of therapy, the patient was able to walk with the assistance of a walker (by November 2007) but at the time of the report, she remained paralyzed on her left side. The patient also had to have a catheter for four months and at the time of the report had bladder and bowel problems. Many labs were performed (results not provided). Therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Paralysis, Syncope, Tremor, Walking aid user
Clinical narrative: Information has been received from a physician regarding a 15 year old female who on 26-SEP-2007 was vaccinated with her second dose of GARDASIL for prevention of HPV (human papillomavirus). She was taking no concomitant medications and had no pertinent medical history of drug reactions/allergies. Thirty minutes after the vaccination, the patient experienced a headache and that night went home and slept until the next morning. The patient woke up the next day and went to school. The school nurse called the patient's mother and informed her that the patient felt tingling in both hands. Later that day, the patient was again sent to the nurse's office due to a shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning in her back. The patient was taken to the emergency room by her parents. In the emergency room, the patient collapsed and was not able to walk; she was paralyzed from the waist down. It was reported that the patient was hospitalized for two months. After several months of therapy, the patient was able to walk with the assistance of a walker (by November 2007) but at the time of the report, she remained paralyzed on her left side. The patient also had to have a catheter for four months and at the time of the report had bladder and bowel problems. Many labs were performed (results not provided). Therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood immunoglobulin G increased, Blood immunoglobulin M, Borrelia test negative, Full blood count
Clinical narrative: Information has been received from a nurse practitioner, concerning a 20 year old female patient, with no pertinent medical history reported and allergy to pollen and mold, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #: 665768/1354Y, Exp: JUN-2012) (Dose and route not reported). Concomitant therapy included unspecified hormonal contraceptives for menstrual cycle control. Nurse practitioner reported that on approximately 03-JUN-2011, about a week ago, the patient was seen in the office with low grade fever, deep muscle aches, headaches and herpetic-like ulceration on her labia. ADVIL, TYLENOL, and prednisone were given as treatment for the events. A complete blood count (CBC) was performed and revealed a low white cell count. Lyme disease, sedimentation rate, and Herpes simplex titer tests were performed (Results not provided). Patient sought medical attention through office visit. Follow-up information has been received from the nurse practitioner who reported that no other vaccines were administered concomitantly to the patient with the GARDASIL, the adverse events onset date was approximately 31-MAY-2011. On 06-JUN-2011 a blood work was drawn resulting in the low white count of 3.2. Nurse reported that some swelling of lymph nodes was noted. A titrating dose of oral prednisone was given for the event. On 13-JUN-2011, patient was seen again and all symptoms were better, except for some neck stiffness. FLEXERIL, for bedtime use, was given for the event. Nurse reported that the GARDASIL series would not continue at consumer's request. Follow up information has been received from a nurse practitioner who reported that on 27-MAY-2011 a 20 year old white patient received a dose of GARDASIL intramuscularly in the left deltoid. On 01-JUN-2011, approximately 3 days after the vaccine was administered, the patient developed headache, neck stiffness, muscle aches, fatigue, a small vulvar ulcer and mucositis. The patient was treated with prednisone 30 mg x 2 days, 20 mg x 2 days and 10 mg x 2 days and a muscle relaxer [type not legible] at bedtime. On 06-JUN-2011 laboratory tests were performed which included: WBC: 3.2 x10^3/ uL (low); MCH: 25.8 pg (low); MCHC 31.3 g/dl (low); RDW 15.4% (high); monocytes: 16% (high); absolute Neutrophils 1.5 x 10^3/uL (low); sedimentation rate Westergren: 22 mm/hr (normal); Lyme IgG/IgM Ab index: <0.91 (negative); lyme disease Ab, Quant IgM index: <0.91 (negative); HSV 1 IgM antibodies and HSV 2 IgM antibodies titer: <1:10 (normal); HSV1 IgG, type specific index: 1.72 (positive; antibodies detected) and HSV 2 IgG, type specific index: <0.91 (negative). It was reported that the event resulted in persistent or significant disability/incapacity. At the time of reporting, the patient had recovered. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Genital ulceration, Headache, Myalgia, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a nurse practitioner, concerning a 20 year old female patient, with no pertinent medical history reported and allergy to pollen and mold, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #: 665768/1354Y, Exp: JUN-2012) (Dose and route not reported). Concomitant therapy included unspecified hormonal contraceptives for menstrual cycle control. Nurse practitioner reported that on approximately 03-JUN-2011, about a week ago, the patient was seen in the office with low grade fever, deep muscle aches, headaches and herpetic-like ulceration on her labia. ADVIL, TYLENOL, and prednisone were given as treatment for the events. A complete blood count (CBC) was performed and revealed a low white cell count. Lyme disease, sedimentation rate, and Herpes simplex titer tests were performed (Results not provided). Patient sought medical attention through office visit. Follow-up information has been received from the nurse practitioner who reported that no other vaccines were administered concomitantly to the patient with the GARDASIL, the adverse events onset date was approximately 31-MAY-2011. On 06-JUN-2011 a blood work was drawn resulting in the low white count of 3.2. Nurse reported that some swelling of lymph nodes was noted. A titrating dose of oral prednisone was given for the event. On 13-JUN-2011, patient was seen again and all symptoms were better, except for some neck stiffness. FLEXERIL, for bedtime use, was given for the event. Nurse reported that the GARDASIL series would not continue at consumer's request. Follow up information has been received from a nurse practitioner who reported that on 27-MAY-2011 a 20 year old white patient received a dose of GARDASIL intramuscularly in the left deltoid. On 01-JUN-2011, approximately 3 days after the vaccine was administered, the patient developed headache, neck stiffness, muscle aches, fatigue, a small vulvar ulcer and mucositis. The patient was treated with prednisone 30 mg x 2 days, 20 mg x 2 days and 10 mg x 2 days and a muscle relaxer [type not legible] at bedtime. On 06-JUN-2011 laboratory tests were performed which included: WBC: 3.2 x10^3/ uL (low); MCH: 25.8 pg (low); MCHC 31.3 g/dl (low); RDW 15.4% (high); monocytes: 16% (high); absolute Neutrophils 1.5 x 10^3/uL (low); sedimentation rate Westergren: 22 mm/hr (normal); Lyme IgG/IgM Ab index: <0.91 (negative); lyme disease Ab, Quant IgM index: <0.91 (negative); HSV 1 IgM antibodies and HSV 2 IgM antibodies titer: <1:10 (normal); HSV1 IgG, type specific index: 1.72 (positive; antibodies detected) and HSV 2 IgG, type specific index: <0.91 (negative). It was reported that the event resulted in persistent or significant disability/incapacity. At the time of reporting, the patient had recovered. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count
Clinical narrative: Information has been received from a nurse practitioner, concerning a 20 year old female patient, with no pertinent medical history reported and allergy to pollen and mold, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #: 665768/1354Y, Exp: JUN-2012) (Dose and route not reported). Concomitant therapy included unspecified hormonal contraceptives for menstrual cycle control. Nurse practitioner reported that on approximately 03-JUN-2011, about a week ago, the patient was seen in the office with low grade fever, deep muscle aches, headaches and herpetic-like ulceration on her labia. ADVIL, TYLENOL, and prednisone were given as treatment for the events. A complete blood count (CBC) was performed and revealed a low white cell count. Lyme disease, sedimentation rate, and Herpes simplex titer tests were performed (Results not provided). Patient sought medical attention through office visit. Follow-up information has been received from the nurse practitioner who reported that no other vaccines were administered concomitantly to the patient with the GARDASIL, the adverse events onset date was approximately 31-MAY-2011. On 06-JUN-2011 a blood work was drawn resulting in the low white count of 3.2. Nurse reported that some swelling of lymph nodes was noted. A titrating dose of oral prednisone was given for the event. On 13-JUN-2011, patient was seen again and all symptoms were better, except for some neck stiffness. FLEXERIL, for bedtime use, was given for the event. Nurse reported that the GARDASIL series would not continue at consumer's request. Follow up information has been received from a nurse practitioner who reported that on 27-MAY-2011 a 20 year old white patient received a dose of GARDASIL intramuscularly in the left deltoid. On 01-JUN-2011, approximately 3 days after the vaccine was administered, the patient developed headache, neck stiffness, muscle aches, fatigue, a small vulvar ulcer and mucositis. The patient was treated with prednisone 30 mg x 2 days, 20 mg x 2 days and 10 mg x 2 days and a muscle relaxer [type not legible] at bedtime. On 06-JUN-2011 laboratory tests were performed which included: WBC: 3.2 x10^3/ uL (low); MCH: 25.8 pg (low); MCHC 31.3 g/dl (low); RDW 15.4% (high); monocytes: 16% (high); absolute Neutrophils 1.5 x 10^3/uL (low); sedimentation rate Westergren: 22 mm/hr (normal); Lyme IgG/IgM Ab index: <0.91 (negative); lyme disease Ab, Quant IgM index: <0.91 (negative); HSV 1 IgM antibodies and HSV 2 IgM antibodies titer: <1:10 (normal); HSV1 IgG, type specific index: 1.72 (positive; antibodies detected) and HSV 2 IgG, type specific index: <0.91 (negative). It was reported that the event resulted in persistent or significant disability/incapacity. At the time of reporting, the patient had recovered. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Borrelia test, Disability, Fatigue, Genital herpes, Headache
Clinical narrative: Information has been received from a nurse practitioner, concerning a 20 year old female patient, with no pertinent medical history reported and allergy to pollen and mold, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #: 665768/1354Y, Exp: JUN-2012) (Dose and route not reported). Concomitant therapy included unspecified hormonal contraceptives for menstrual cycle control. Nurse practitioner reported that on approximately 03-JUN-2011, about a week ago, the patient was seen in the office with low grade fever, deep muscle aches, headaches and herpetic-like ulceration on her labia. ADVIL, TYLENOL, and prednisone were given as treatment for the events. A complete blood count (CBC) was performed and revealed a low white cell count. Lyme disease, sedimentation rate, and Herpes simplex titer tests were performed (Results not provided). Patient sought medical attention through office visit. Follow-up information has been received from the nurse practitioner who reported that no other vaccines were administered concomitantly to the patient with the GARDASIL, the adverse events onset date was approximately 31-MAY-2011. On 06-JUN-2011 a blood work was drawn resulting in the low white count of 3.2. Nurse reported that some swelling of lymph nodes was noted. A titrating dose of oral prednisone was given for the event. On 13-JUN-2011, patient was seen again and all symptoms were better, except for some neck stiffness. FLEXERIL, for bedtime use, was given for the event. Nurse reported that the GARDASIL series would not continue at consumer's request. Follow up information has been received from a nurse practitioner who reported that on 27-MAY-2011 a 20 year old white patient received a dose of GARDASIL intramuscularly in the left deltoid. On 01-JUN-2011, approximately 3 days after the vaccine was administered, the patient developed headache, neck stiffness, muscle aches, fatigue, a small vulvar ulcer and mucositis. The patient was treated with prednisone 30 mg x 2 days, 20 mg x 2 days and 10 mg x 2 days and a muscle relaxer [type not legible] at bedtime. On 06-JUN-2011 laboratory tests were performed which included: WBC: 3.2 x10^3/ uL (low); MCH: 25.8 pg (low); MCHC 31.3 g/dl (low); RDW 15.4% (high); monocytes: 16% (high); absolute Neutrophils 1.5 x 10^3/uL (low); sedimentation rate Westergren: 22 mm/hr (normal); Lyme IgG/IgM Ab index: <0.91 (negative); lyme disease Ab, Quant IgM index: <0.91 (negative); HSV 1 IgM antibodies and HSV 2 IgM antibodies titer: <1:10 (normal); HSV1 IgG, type specific index: 1.72 (positive; antibodies detected) and HSV 2 IgG, type specific index: <0.91 (negative). It was reported that the event resulted in persistent or significant disability/incapacity. At the time of reporting, the patient had recovered. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes simplex serology, Herpes simplex serology positive, Lymphadenopathy, Mean cell haemoglobin, Mean cell haemoglobin concentration decreased
Clinical narrative: Information has been received from a nurse practitioner, concerning a 20 year old female patient, with no pertinent medical history reported and allergy to pollen and mold, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #: 665768/1354Y, Exp: JUN-2012) (Dose and route not reported). Concomitant therapy included unspecified hormonal contraceptives for menstrual cycle control. Nurse practitioner reported that on approximately 03-JUN-2011, about a week ago, the patient was seen in the office with low grade fever, deep muscle aches, headaches and herpetic-like ulceration on her labia. ADVIL, TYLENOL, and prednisone were given as treatment for the events. A complete blood count (CBC) was performed and revealed a low white cell count. Lyme disease, sedimentation rate, and Herpes simplex titer tests were performed (Results not provided). Patient sought medical attention through office visit. Follow-up information has been received from the nurse practitioner who reported that no other vaccines were administered concomitantly to the patient with the GARDASIL, the adverse events onset date was approximately 31-MAY-2011. On 06-JUN-2011 a blood work was drawn resulting in the low white count of 3.2. Nurse reported that some swelling of lymph nodes was noted. A titrating dose of oral prednisone was given for the event. On 13-JUN-2011, patient was seen again and all symptoms were better, except for some neck stiffness. FLEXERIL, for bedtime use, was given for the event. Nurse reported that the GARDASIL series would not continue at consumer's request. Follow up information has been received from a nurse practitioner who reported that on 27-MAY-2011 a 20 year old white patient received a dose of GARDASIL intramuscularly in the left deltoid. On 01-JUN-2011, approximately 3 days after the vaccine was administered, the patient developed headache, neck stiffness, muscle aches, fatigue, a small vulvar ulcer and mucositis. The patient was treated with prednisone 30 mg x 2 days, 20 mg x 2 days and 10 mg x 2 days and a muscle relaxer [type not legible] at bedtime. On 06-JUN-2011 laboratory tests were performed which included: WBC: 3.2 x10^3/ uL (low); MCH: 25.8 pg (low); MCHC 31.3 g/dl (low); RDW 15.4% (high); monocytes: 16% (high); absolute Neutrophils 1.5 x 10^3/uL (low); sedimentation rate Westergren: 22 mm/hr (normal); Lyme IgG/IgM Ab index: <0.91 (negative); lyme disease Ab, Quant IgM index: <0.91 (negative); HSV 1 IgM antibodies and HSV 2 IgM antibodies titer: <1:10 (normal); HSV1 IgG, type specific index: 1.72 (positive; antibodies detected) and HSV 2 IgG, type specific index: <0.91 (negative). It was reported that the event resulted in persistent or significant disability/incapacity. At the time of reporting, the patient had recovered. No further information is expected.