chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Muscle swelling, Oedema peripheral, Pain, Pruritus
Clinical narrative: Hives, swollen arm, itching, burning and stinging, swollen muscle
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, swollen arm, itching, burning and stinging, swollen muscle
Age: 1.05
Sex: M
Vaccine: HEP, UNK
Symptoms: Rash generalised
Clinical narrative: Rashn all over.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthropod bite, Inappropriate schedule of drug administration, Skin lesion
Clinical narrative: Patient came in to office today with bug bites fluid filled lesion scattered on arms/ trunk.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: Small elevated erythematous lesions in group in site of injection and pain the palpation left forearm.
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient was healthy without symptoms received Tdap booster on 10/3/07 and no problem. Patient called office 10/4/07 c/o nausea, muscle aches, chills and fever. No SOB, no rash. Seen on 10/5/07 and patient stable. No local site reaction. Can't r/o viral influenza coincidental but does feel all potential vaccine interactions.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Unevaluable event
Clinical narrative: See attached
Age: 3.0
Sex: F
Vaccine: DT, IPV
Symptoms: Unevaluable event
Clinical narrative: See attached from mother
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5, RV5, UNK
Symptoms: Abdominal X-ray, Intussusception, Urinary system X-ray
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 01-OCT-2007 was vaccinated p.o. with a 2 mL dose of Rotateq. Concomitant therapy included "routine 6-months vaccinations". On approximately 04-OCT-2007 the patient experienced profuse vomiting and was hospitalized. Diagnostic studies performed included an ultrasound which indicated that the infant had intussusception. Dates the infant was hospitalized and the vaccine lot number were not reported. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5, RV5, UNK
Symptoms: Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approximately 01-OCT-2007 was vaccinated p.o. with a 2 mL dose of Rotateq. Concomitant therapy included "routine 6-months vaccinations". On approximately 04-OCT-2007 the patient experienced profuse vomiting and was hospitalized. Diagnostic studies performed included an ultrasound which indicated that the infant had intussusception. Dates the infant was hospitalized and the vaccine lot number were not reported. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Blood test, Body temperature increased, Chills, Injection site erythema, Injection site pain
Clinical narrative: rash on right arm from elbow to shoulder. 103.7 fever. given Levaquin 750MG Tablets for 10 days.   I still have a runny nose,but no fever
Age: 73.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Insomnia
Clinical narrative: rash on right arm from elbow to shoulder. 103.7 fever. given Levaquin 750MG Tablets for 10 days.   I still have a runny nose,but no fever
Age: 73.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: rash on right arm from elbow to shoulder. 103.7 fever. given Levaquin 750MG Tablets for 10 days.   I still have a runny nose,but no fever
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Body temperature increased, Dizziness, Dysphonia, Injection site erythema
Clinical narrative: Pt. developed low grade temp, achy all over, wheezing flare up. Pt. saw primary care to treat symptoms not Dr.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Injection site swelling, Pain, Pharyngolaryngeal pain
Clinical narrative: Pt. developed low grade temp, achy all over, wheezing flare up. Pt. saw primary care to treat symptoms not Dr.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Body temperature decreased, Pain, Wheezing
Clinical narrative: Pt. developed low grade temp, achy all over, wheezing flare up. Pt. saw primary care to treat symptoms not Dr.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea
Clinical narrative: NAUSEA,   MUSCLE ACHE (BOTH STARTED APPROXIMATELY 30 HOURS AFTER SHOT GIVEN)
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypoventilation, Intensive care, Lethargy, Petechiae, Rash
Clinical narrative: Pt came in to receive 2 month f/u vaccines. At 1416 on 26 Oct 07, patient received Rotavirus orally (lot# 0875U Exp: 06 Oct 2008), Pedarix (Lot# AC21B114BB Exp: 26 Sep 09), HIB (Lot#: UF065AB Exp: 24 Nov 08), Prevnar (Lot#: 87014SE, Exp: May 09). Few minutes later at around 1425 after receiving those vaccines, patient developed shallow breathing, became lethargic, developed mild rash (mild petechiae) on trunks and arms (thoracic area). Pt was admitted to ICU for continuous assessment, observation and supportive care.  At 1530: VSS (POX 100%, HR 140, RR 40, Temp (axillary) 98.4. No medication required.  Pt stayed over night and discharged the next morning recovered. 12/14/07-records received for DOS 10/26-10/27/07-DC DX: ALTE.  Candidiasis oral thrush. Signs of respiratory distress, became letheragic and breathing shallow 2 mintues after leaving clinic. PE: Slight pallor, behaving lethargically and slight shallow breathing. Physical stimulation required. Rash developed throughout trunk of body. Normal exam, rash resolved.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 20 year old female with an ovarian cyst of left ovary (28-NOV-2006) who on 05-JAN-2007 was vaccinated in the right upper arm with a first dose of Gardasil (lot 653736/0868F). Concomitant therapy included ethinyl estradiol/norethidrone (NECON 1/35). On the day the patient was vaccinated with Gardasil she was being seen at the clinic for follow up for a cyst of her left ovary. At that time, the patient though she was beginning her period cycle. The patient also had a prescription for birth control, but it was found out that she stopped taking them on an unspecified date. The patient called the clinic on 16-JAN-2007 stating that she performed a urine home pregnancy test which was positive. On 17-JAN-2006, she was seen at the clinic. An ultrasound was performed and results revealed patient was 6 weeks, 1 day intrauterine pregnancy. The patient told the resident physician that this was an unplanned and undesired pregnancy, and she would be terminating the pregnancy. On 12-FEB-2007, at 8 weeks gestation, the patient terminated the pregnancy. The patient continued with the Gardasil series having received 3 doses. Upon internal review, the patient's induced abortion was considered an other important medical event. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no known medical history or drug allergies who on 18-APR-2007 was vaccinated intramuscularly with a dose of Gardasil (Lot # 656371/0181U) while pregnant. Concomitant vaccinations included Menactra and DTaP. The patient's last menstrual period was "6 weeks ago" and her estimated date of delivery is 12-DEC-2007. No symptoms had been reported. No laboratory diagnostic tests were performed. Subsequently, on an unspecified date, the patient had an abortion. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a history of seizures after unspecified vaccines (believed to be associated with pain of vaccination) who on 22-OCT-2007 was vaccinated intramuscularly with a 0.5 second dose of Gardasil. Concomitant vaccinations at the same visit included influenza virus vaccine (unspecified (unspecified) and Vaqta (MSD). On 22-OCT-2007 the patient had a "small seizure." The patient was kept at the doctors office for 30 minutes. On 22-OCT-2007, the patient recovered and was sent home. Upon internal review, "small seizure" was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Full blood count, Pregnancy test positive
Clinical narrative: Information has been received via the Merck Pregnancy registry, from a registered nurse, concerning a female patient (age not specified) who on 05-JUL-2007 was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included ethinyl estradiol/noregestimate (ORTHO TRI-CYCLEN LO). On an unknown date, the patient became pregnant (gestation details not provided), and on 23-OCT-2007 she had miscarriage. She was treated in the physician's office (details not provided). At the time of this report, the patient was recovering from the miscarriage. Upon internal review, the event of miscarriage was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell scan
Clinical narrative: Information has been received via the Merck Pregnancy registry, from a registered nurse, concerning a female patient (age not specified) who on 05-JUL-2007 was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included ethinyl estradiol/noregestimate (ORTHO TRI-CYCLEN LO). On an unknown date, the patient became pregnant (gestation details not provided), and on 23-OCT-2007 she had miscarriage. She was treated in the physician's office (details not provided). At the time of this report, the patient was recovering from the miscarriage. Upon internal review, the event of miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Body temperature increased, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 10 year old male child with sickle cell anaemia, no known drug allergies, and no history of a reaction on previous exposure to Pneumovax 23 (2 prior doses, dates unknown), who on 22-OCT-2007 was vaccinated IM with a third dose, 0.5 ml, of Pneumovax 23 (lot #657529/0993U). Concomitant therapy included folic acid, hydroxyurea and influenza virus vaccine (date and manufacturer unspecified). On 22-OCT-2007, following the vaccination, the child experienced pain at the injection site, and his mother gave him ibuprofen (MOTRIN) as treatment. On 23-OCT-2007, when the child returned from school, his temperature and reached 102 degrees F, and he had pain and swelling of right arm from the elbow to the shoulder. The pain worsened with movement. The child was taken to an emergency room, and was admitted to the hospital. Treatment included morphine and intravenous antibiotics, including ceftriaxone (ROCEPHIN) and cefotaxime (CLAFORAN). At the time of this report, the child was still hospitalized, and had not recovered. The reporting pharmacist considered the events to be serious as an other important medical event. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 10 year old male child with sickle cell anaemia, no known drug allergies, and no history of a reaction on previous exposure to Pneumovax 23 (2 prior doses, dates unknown), who on 22-OCT-2007 was vaccinated IM with a third dose, 0.5 ml, of Pneumovax 23 (lot #657529/0993U). Concomitant therapy included folic acid, hydroxyurea and influenza virus vaccine (date and manufacturer unspecified). On 22-OCT-2007, following the vaccination, the child experienced pain at the injection site, and his mother gave him ibuprofen (MOTRIN) as treatment. On 23-OCT-2007, when the child returned from school, his temperature and reached 102 degrees F, and he had pain and swelling of right arm from the elbow to the shoulder. The pain worsened with movement. The child was taken to an emergency room, and was admitted to the hospital. Treatment included morphine and intravenous antibiotics, including ceftriaxone (ROCEPHIN) and cefotaxime (CLAFORAN). At the time of this report, the child was still hospitalized, and had not recovered. The reporting pharmacist considered the events to be serious as an other important medical event. Additional information has been requested.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Deafness neurosensory
Clinical narrative: Information has been received for a case in litigation from information obtained from a published article regarding a male child (age at AE onset unknown) with autosomal recessive nonsyndromic deafness, who, on an unspecified date was vaccinated with a dose of PEDVAXHIB. Concomitant suspect therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Subsequently, the patient experienced bilateral sensorineural hearing loss. At the time of the report, it was noted that the patient was currently 10 years old but the patient was "so young at the time" of the event and the patient's outcome was unknown. Upon internal review, bilateral sensorineural hearing loss was considered an other important medical event. Additional information is not expected. A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Deafness neurosensory
Clinical narrative: Information has been received for a case in litigation from information obtained from a published article concerning a female patient with autosomal recessive nonsyndromic deafness who was vaccinated with PEDVAX HIB. Concomitant vaccination included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Subsequently the patient experienced bilateral sensorineural hearing loss. At the time of the report, the patient was 12 years old and her outcome was unknown. Upon internal review bilateral sensorineural hearing loss was considered an other important medical event. No further information is available. A copy of the published literature article is attached as further documentation of the patient's experience.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on 06-OCT-2007 was vaccinated p.o. with a dose ("1 tube") of Rotateq. On 07-OCT-2007 the patient experienced bloody stools and was hospitalized due to intussusception on the same day. The patient's diagnosis was considered to be immediately life threatening. The intussusception was corrected with surgery. No other information was available. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested. 9/27/07- Seen on 10/5/07-visit after hospitalization for gastroenteritis. 1/29/08-records received for DOS 10/7-10/9/07-DC DX: Intussusception status post reduction with exploratory laparotomy, manual reduction and incidental appendectomy. C/O nausea, vomiting and bloody stools times 1 day.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 17 October 2007. A 60-year-old female with a history of asthma and allergies to Biaxin and Keflex had received a left deltoid intramuscular injection of Fluzone (lot number U2463AA). On 16 October 2007 and immediately after vaccination, she experienced paresthesia in her left cheek and lip. The patient also experienced soreness at the injection site on the left deltoid on an unspecified date. The patient had received three previous doses of Fluzone. At the time of the report, the patient had not recovered. No additional information was provided. The reporter of this case is the same as for case 2007-03521, which involves a nodule at test site of left forearm following receipt of Tubersol, lot number C2461AA.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Joint stiffness, Pain in extremity
Clinical narrative: rt leg pain, rt knee stiffnes and gait disturbance that waxes and wanes and then resolves.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: No adverse reaction
Clinical narrative: none
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site nodule, Injection site pain, Injection site warmth, Lethargy
Clinical narrative: Day 1: feverish at injection site Day 2: soreness/knot at injection site Day 3: body aches, chills Day 4: fever, severe chills, nasal congestion Day 5: low grade fever, lethargic (report made on day 5)
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Day 1: feverish at injection site Day 2: soreness/knot at injection site Day 3: body aches, chills Day 4: fever, severe chills, nasal congestion Day 5: low grade fever, lethargic (report made on day 5)
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site swelling, Musculoskeletal pain
Clinical narrative: Afew days after receiving shot shoulder starting hurting a little bit.swelling at stick site.By Friday severe pain in should. Sunday morning went to urgent care.
Age: 74.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: no adverse event. Tdap vaccine given to an individual greater than 64 years of age.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 days after receiving vaccine my arm is red, swelled and sore at site of the injection.  Also feel weak and tired.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: Started to feel sick a few hours after the shot was administered.  Turned into fever, felt like my head was going to explode, face felt like it was on fire, but hands and feet where frozen, body aches, stiff neck, labored breathing, hands itching. No treatment sought, suffered through, felt better next day.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Pruritus, Pyrexia, Skin warm
Clinical narrative: Started to feel sick a few hours after the shot was administered.  Turned into fever, felt like my head was going to explode, face felt like it was on fire, but hands and feet where frozen, body aches, stiff neck, labored breathing, hands itching. No treatment sought, suffered through, felt better next day.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Areflexia, Blood mercury, Blood test, Childhood disintegrative disorder, Developmental delay
Clinical narrative: Four days following vaccination patient displayed a regression in fine motor skills.  He lost his ability to reach for and bat at objects, as well as his ability to grasp.  The loss of these abilities coincided with the onset of neurologically self-stimmulating behaviors.  These behaviors, coupled with the regression in fine motor skills, caused measurable developmental delay in a previously healthy child.  Despite the fact that patient had shown typical, appropriate development up until this point, he was not sitting at six months of age, and was still not using his arms or hands.  He began receiving physical therapy and occupational therapy through early intervention services and was referred to a neurologist for suspicion of seizures. 12/10/07-records received for DOS 6/06-8/14/07-developmental delay, questionable seizures. Shaking head from side to side. Unsuccessful attempts at MRI.  12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leukodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted to palliative care at our local hospital. He has 2 additional VAERS reports-ID# 295018, filed by myself, and VAERS ID# 284671-1, filed by his pediatrcian.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyskinesia, Electroencephalogram normal, Hypertonia, Muscle spasticity, Nervous system disorder
Clinical narrative: Four days following vaccination patient displayed a regression in fine motor skills.  He lost his ability to reach for and bat at objects, as well as his ability to grasp.  The loss of these abilities coincided with the onset of neurologically self-stimmulating behaviors.  These behaviors, coupled with the regression in fine motor skills, caused measurable developmental delay in a previously healthy child.  Despite the fact that patient had shown typical, appropriate development up until this point, he was not sitting at six months of age, and was still not using his arms or hands.  He began receiving physical therapy and occupational therapy through early intervention services and was referred to a neurologist for suspicion of seizures. 12/10/07-records received for DOS 6/06-8/14/07-developmental delay, questionable seizures. Shaking head from side to side. Unsuccessful attempts at MRI.  12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leukodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted to palliative care at our local hospital. He has 2 additional VAERS reports-ID# 295018, filed by myself, and VAERS ID# 284671-1, filed by his pediatrcian.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Nervous system disorder, Psychomotor skills impaired, Regressive behaviour
Clinical narrative: Four days following vaccination patient displayed a regression in fine motor skills.  He lost his ability to reach for and bat at objects, as well as his ability to grasp.  The loss of these abilities coincided with the onset of neurologically self-stimmulating behaviors.  These behaviors, coupled with the regression in fine motor skills, caused measurable developmental delay in a previously healthy child.  Despite the fact that patient had shown typical, appropriate development up until this point, he was not sitting at six months of age, and was still not using his arms or hands.  He began receiving physical therapy and occupational therapy through early intervention services and was referred to a neurologist for suspicion of seizures. 12/10/07-records received for DOS 6/06-8/14/07-developmental delay, questionable seizures. Shaking head from side to side. Unsuccessful attempts at MRI.  12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leukodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted to palliative care at our local hospital. He has 2 additional VAERS reports-ID# 295018, filed by myself, and VAERS ID# 284671-1, filed by his pediatrcian.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Received pneumococcal and flu injections ins (left) arm on 10/26/07, Friday.  Saturday morning - was sore, site was puffy, "swollen red". Body was achy, chills/warm, fever? - temp not taken".  By Sunday was feeling better.  Reaction site measure on Monday at doctor's office as 16.5 cm across by 8 cm downward - about the size of a hand print. On 10/31/07 - Wednesday, having started Keflex treatment on Monday, everything is fine, site reduced to about 2 in circle of a sore, reddened lump.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Pt received varicella vaccine from our office on 10/20/2007.  Pt diagnosed with chickenpox by Reading Hospital ER physician in October 2007.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Abnormal behaviour, Amino acid level normal, Childhood disintegrative disorder, Developmental delay, Dyskinesia
Clinical narrative: Two days after receiving vaccinations patient began flapping his hands, a neurologically self- stimmulating behavior, and stopped babbling entirely.  Up until this point, patient was above-average language abilities.  He became listless, and also stopped napping.  Nine days after the immunizations he lost his ability to roll from front to back and back to front.  Patient had been able to roll since three months of age.  We sought medical evaluation from Dr. and received a diagnosis of encephalopathy.  At this point Dr. expressed concern about the possibility of regressive autism, but patient's social interaction was relatively good.  Patient underwent a cranial MRI, as well as extensive metabolic and genetic testing.  All were normal.  Patient did regain his ability to roll after over two months of immobility, but still suffers from marked developmental delays. 12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leudodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted into palliative care at our local childern's hosptial. He has additional VAERS reports - ID# 295015, filed by myself, and VAERS ID 284671-1, filed by his peditrician.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Encephalopathy, Gene mutation identification test, Hypertonia, Listless, Nervous system disorder
Clinical narrative: Two days after receiving vaccinations patient began flapping his hands, a neurologically self- stimmulating behavior, and stopped babbling entirely.  Up until this point, patient was above-average language abilities.  He became listless, and also stopped napping.  Nine days after the immunizations he lost his ability to roll from front to back and back to front.  Patient had been able to roll since three months of age.  We sought medical evaluation from Dr. and received a diagnosis of encephalopathy.  At this point Dr. expressed concern about the possibility of regressive autism, but patient's social interaction was relatively good.  Patient underwent a cranial MRI, as well as extensive metabolic and genetic testing.  All were normal.  Patient did regain his ability to roll after over two months of immobility, but still suffers from marked developmental delays. 12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leudodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted into palliative care at our local childern's hosptial. He has additional VAERS reports - ID# 295015, filed by myself, and VAERS ID 284671-1, filed by his peditrician.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Nuclear magnetic resonance imaging normal, Sleep disorder, Urine analysis normal
Clinical narrative: Two days after receiving vaccinations patient began flapping his hands, a neurologically self- stimmulating behavior, and stopped babbling entirely.  Up until this point, patient was above-average language abilities.  He became listless, and also stopped napping.  Nine days after the immunizations he lost his ability to roll from front to back and back to front.  Patient had been able to roll since three months of age.  We sought medical evaluation from Dr. and received a diagnosis of encephalopathy.  At this point Dr. expressed concern about the possibility of regressive autism, but patient's social interaction was relatively good.  Patient underwent a cranial MRI, as well as extensive metabolic and genetic testing.  All were normal.  Patient did regain his ability to roll after over two months of immobility, but still suffers from marked developmental delays. 12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leudodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted into palliative care at our local childern's hosptial. He has additional VAERS reports - ID# 295015, filed by myself, and VAERS ID 284671-1, filed by his peditrician.
Age: 31.0
Sex: F
Vaccine: IPV, TDAP, TYP
Symptoms: Dizziness, Erythema, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Left arm w/swelling and redness - approx 5 1/2" x 3 1/2", additional sx's include: N, lightheadedness, area warm to touch, pt states "just don't feel good"; Denies any respiratory difficulty, fever, numbness or tingling at site.  Pt seen at urgent care facility 2 days after vaccine 10/28/07. TX - ABX (Cephalexin 500mg PO qid x7 d) along w/Benadryl for itching at site.  Pt advised to f/u w/urgent care facility after ABX complete.  HD received TC from pt 10/30. Pt states redness has decreased, however, swelling remains at site.  Advised pt to f/u w/HD if any additional changes.
Age: 31.0
Sex: F
Vaccine: IPV, TDAP, TYP
Symptoms: Nasopharyngitis, Nausea, Oedema peripheral, Skin warm, Swelling
Clinical narrative: Left arm w/swelling and redness - approx 5 1/2" x 3 1/2", additional sx's include: N, lightheadedness, area warm to touch, pt states "just don't feel good"; Denies any respiratory difficulty, fever, numbness or tingling at site.  Pt seen at urgent care facility 2 days after vaccine 10/28/07. TX - ABX (Cephalexin 500mg PO qid x7 d) along w/Benadryl for itching at site.  Pt advised to f/u w/urgent care facility after ABX complete.  HD received TC from pt 10/30. Pt states redness has decreased, however, swelling remains at site.  Advised pt to f/u w/HD if any additional changes.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: Received flu vaccine at 0200, 10/18/07. By 1530, 10/18/07, lips became tingly and numb. Top lip became swollen. Took a Benadryl and by 10/19/07, symptoms had subsided.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of cellulitic type skin reaction in an adult (50 plus years of age) male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified) given on 9 October 2007. Concurrent medications were not specified. On 9 October 2007 the subject received unspecified dose of Fluarix in an unknown arm. Within a few days of vaccination with Fluarix, the subject experienced a cellulitic type skin reaction, fever to 102 degrees and body pain. The subject received antibiotics in the emergency room and missed work due to the events. This case was assessed as medically serious by GSK. At the time of working the events were resolved.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a child male subject who was vaccinated with (Havrix, GlaxoSmithKline), (Varivax) for prophylaxis. In 2007 the subject received unspecified dose of Havrix (unknown) and unspecified dose of Varivax (unknown). Immediately following vaccination with Havrix and Varivax, the subject experienced an anaphylactic reaction. Adrenaline (Epinephrine) was administered, and the child was not admitted. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The reporter was questioning the incidence of adverse reactions with this particular lot number of Havrix, or when given in combination with Varivax.
Sex: M
Vaccine: HEP
Symptoms: Death, Eye disorder, Herpes simplex serology positive, Herpes virus infection, Stomach discomfort
Clinical narrative: A small sore appeared on baby's left eye. When he was in for circumcision 11-21-05 doctor mentioned it looked like herpes but did nothing. On 11-25 he began to get upset tummy and on 11-26 Mom took him to emergency for test. On Tuesday 11-29-05 doctor called parents and told them to take him to hospital for treatment with IV Acyclovir. Contracted strep in hospital and died.  5/29 Autopsy states COD as ischemic hemorrhagic colitis of small bowel; peritoneal surfaces demonstrate focal adhesions; neonatal herpes (c/s +). 12/14/07 Reviewed hospital medical records which reveal patient seen in ER on 11/26/2005 after experienced small spot on lateral edge of left eye x 3 days.  Area had opened up & then crusted over, eyes reddened & became slightly swollen.  Viral c/s obtained & tx w/Bactroban & was to be seen by pcp next day.  Both hospital records for admission of 11/29/2005 included.  Eye lesion had cleared but then developed blistering lesions on outside of left eye & base of penis.  PCP wanted patient transferred to higher level of care but family declined.  After culture (+) for herpes, returned to hospital & agreed to transfer to higher level of care.  Admitted 11/29-12/4/2007.  Tx w/IV antivirals & peds optho consult done.  Optho dx: herpetic keratitis & herpetic dermatitis of eyelid.  Condition deteriorated, intubated & admitted to PICU.  Taken to OR 12/4/05 secondary to abdominal distention due to sepsis.  Penrose drain inserted & drained approx 200 cc of clear straw colored fluid.  Cultures sent.  Continued to deteriorate & developed bloody drainage from abdominal drain.  Taken back to OR for exp lap & found total intestinal ischemia from ligament of Treitz to descending left colon.  Suspected a vascular insult due to underlying disease process.
Sex: M
Vaccine: HEP
Symptoms: Streptococcal infection
Clinical narrative: A small sore appeared on baby's left eye. When he was in for circumcision 11-21-05 doctor mentioned it looked like herpes but did nothing. On 11-25 he began to get upset tummy and on 11-26 Mom took him to emergency for test. On Tuesday 11-29-05 doctor called parents and told them to take him to hospital for treatment with IV Acyclovir. Contracted strep in hospital and died.  5/29 Autopsy states COD as ischemic hemorrhagic colitis of small bowel; peritoneal surfaces demonstrate focal adhesions; neonatal herpes (c/s +). 12/14/07 Reviewed hospital medical records which reveal patient seen in ER on 11/26/2005 after experienced small spot on lateral edge of left eye x 3 days.  Area had opened up & then crusted over, eyes reddened & became slightly swollen.  Viral c/s obtained & tx w/Bactroban & was to be seen by pcp next day.  Both hospital records for admission of 11/29/2005 included.  Eye lesion had cleared but then developed blistering lesions on outside of left eye & base of penis.  PCP wanted patient transferred to higher level of care but family declined.  After culture (+) for herpes, returned to hospital & agreed to transfer to higher level of care.  Admitted 11/29-12/4/2007.  Tx w/IV antivirals & peds optho consult done.  Optho dx: herpetic keratitis & herpetic dermatitis of eyelid.  Condition deteriorated, intubated & admitted to PICU.  Taken to OR 12/4/05 secondary to abdominal distention due to sepsis.  Penrose drain inserted & drained approx 200 cc of clear straw colored fluid.  Cultures sent.  Continued to deteriorate & developed bloody drainage from abdominal drain.  Taken back to OR for exp lap & found total intestinal ischemia from ligament of Treitz to descending left colon.  Suspected a vascular insult due to underlying disease process.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Blood culture negative, CSF cell count normal, CSF culture negative, CSF test normal, Computerised tomogram normal
Clinical narrative: The evening of imm's - irritability, crying, increasing to unconsolable screaming for over 12 hours starting the next morning, seizure like activity x 1 - shaking, eye rolling, drooling approximately 19 hours after imm's. No fever. Hospitalized x 2 days for w/u of seizures in infant. 11/7/07-records received for DOS 10/23-10/25/07- DC DX: Possible seizures, developmental delay, infection ruled out. Day prior to admission she was noted by PCP to be mildly developmentally delayed in her gross motor functions. Not sitting up, rolling front to back only. Later same day became irritable, fussy and next afternoon whole body shaking and her eyes rolled up. Parents are poor historians as they are both diagnosed with MR and are delayed.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Convulsion, Crying, Culture urine negative, Drooling, Electrocardiogram normal
Clinical narrative: The evening of imm's - irritability, crying, increasing to unconsolable screaming for over 12 hours starting the next morning, seizure like activity x 1 - shaking, eye rolling, drooling approximately 19 hours after imm's. No fever. Hospitalized x 2 days for w/u of seizures in infant. 11/7/07-records received for DOS 10/23-10/25/07- DC DX: Possible seizures, developmental delay, infection ruled out. Day prior to admission she was noted by PCP to be mildly developmentally delayed in her gross motor functions. Not sitting up, rolling front to back only. Later same day became irritable, fussy and next afternoon whole body shaking and her eyes rolled up. Parents are poor historians as they are both diagnosed with MR and are delayed.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Electroencephalogram normal, Gaze palsy, Irritability, Screaming, Tremor
Clinical narrative: The evening of imm's - irritability, crying, increasing to unconsolable screaming for over 12 hours starting the next morning, seizure like activity x 1 - shaking, eye rolling, drooling approximately 19 hours after imm's. No fever. Hospitalized x 2 days for w/u of seizures in infant. 11/7/07-records received for DOS 10/23-10/25/07- DC DX: Possible seizures, developmental delay, infection ruled out. Day prior to admission she was noted by PCP to be mildly developmentally delayed in her gross motor functions. Not sitting up, rolling front to back only. Later same day became irritable, fussy and next afternoon whole body shaking and her eyes rolled up. Parents are poor historians as they are both diagnosed with MR and are delayed.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypokinesia, Myalgia, Tendonitis
Clinical narrative: I was given the flu vaccine in my shoulder area. Ever since, I have this horrible pain down my arm to my elbow. The pain is now in my shoulder area, upper back, and outer shoulder. I can't raise my arm above my head - it hurts too much. It also hurts at night. In all the years I've received the flu vaccine. I have never had this kind of persistent pain in the shoulder area. Usually, it is in my arm muscle and last only a couple of days. I think the nurse did not administer it correctly. The shot was given in the upper shoulder area. I think it may be tendonitis. I'm not sure if it is an administration error or a bad lot of vaccine that I was give. I hope the pain goes away. It has been going on now for 2 weeks and has become worse. I can hear my shoulder joint pop as well when moving it. I didn't have any issues with this shoulder prior to the vaccine. Per 60 day follow up: Still have arm pain & muscle pain. Arm is painful & can't lift things over my head. This has been going on for 4 months now. Is this happening to others? The Dr. office should be made aware that this problem is still going on. When will it go away. 1/15/2010 Arm pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Pain, Pyrexia
Clinical narrative: I received the pneumonia vaccination on 10-29-07.When I arrived home a short time later my body began to ache all over, I developed a fever that increased from 99.1 to 101.7 over the next several hours. I was so weak that I had to lay down. I stayed in bed until 10-31. The soreness around the injection area was much more severe than stated for the "after effects", it is now 2 days later and my arm is still extremely sore.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient developed diarhea following rotovirus vaccine that has persisted for 2 weeks. No other symptoms present.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Culture wound, Erythema, Injection site erythema, Injection site nodule
Clinical narrative: Pt was seen 06 days after vaccination as per protocols. Pt had normal reaction at this time. Pt came back in at 14 day mark and presented with erythema, pruritis, and satelite lesions. Skin was warm, with eryhtma spreading from vaccine site to axillary area with noted adenoapthy. Pt was afebrile. Nodule at vaccination site is 3 cm, raised, and ulcerated 1 mm at the center, Site is concurrent with that of a major reaction to the smallpox vaccine. Pt dx with cellultis and given 150 mg Clydamycin, take two tabs po qid times 10 days. SIQ for 24 hours. Pt came back on day two and three with marked improvement of the site. Site is healing as per smallpox immunization standards.  A culture has been taken, awaiting results.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site ulcer, Lymphadenopathy, Pruritus, Skin lesion, Skin warm
Clinical narrative: Pt was seen 06 days after vaccination as per protocols. Pt had normal reaction at this time. Pt came back in at 14 day mark and presented with erythema, pruritis, and satelite lesions. Skin was warm, with eryhtma spreading from vaccine site to axillary area with noted adenoapthy. Pt was afebrile. Nodule at vaccination site is 3 cm, raised, and ulcerated 1 mm at the center, Site is concurrent with that of a major reaction to the smallpox vaccine. Pt dx with cellultis and given 150 mg Clydamycin, take two tabs po qid times 10 days. SIQ for 24 hours. Pt came back on day two and three with marked improvement of the site. Site is healing as per smallpox immunization standards.  A culture has been taken, awaiting results.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea
Clinical narrative: Patient complained of minor shortness of breath, no wheezing or tightness noted.  Patient states he "felt like he had been running for a while" after receiving influenza, live, intranasal vaccination.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Anorexia, Asthenia, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: Received shot at 3:10 PM on Monday Oct 29th woke up during the night with very bad headache, took Tyneol.  In the morning every muscle ached, felt week and short of breath.  Slept most of the day.Kept breaking out with sweats and then chills, no appitite no energy to get sometime to eat.  Felt so bad I wish I would die.  Today is day 2 and I am able to get up and move around some as soon as I move I break out in a sweat.  I am hoping that this is the end
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Myalgia
Clinical narrative: Received shot at 3:10 PM on Monday Oct 29th woke up during the night with very bad headache, took Tyneol.  In the morning every muscle ached, felt week and short of breath.  Slept most of the day.Kept breaking out with sweats and then chills, no appitite no energy to get sometime to eat.  Felt so bad I wish I would die.  Today is day 2 and I am able to get up and move around some as soon as I move I break out in a sweat.  I am hoping that this is the end
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: RIGHT ARM INJECTION SITE WARM TO TOUCH AND SWOLLEN
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Swelling
Clinical narrative: Pt. states approximately 5 hrs. after receiving MMR yesterday she noticed that her gums were sensitive.  When she awakened the next AM her upper lip was noticeably swollen "and tight".  Her gums were also swollen.  She was able to eat breakfast and drink fluids without difficulty.  Denies that she had any difficulty swallowing or breathing at any time.  When seen in clinic at 3:01 pm she reported that her lips were "normal", her gums were still "slightly swollen" (not noticeable on PE) and she had detected a bump behind one of her front teeth  (again not noticeable on PE).  She also denies any other s/s of an allergic reaction, ie tight chest, wheezing, hives, etc.  The only medicine she's taken is Tylenol.  After consult with Dr, pt. advised to return to clinic if symptoms increased or changed.  Advised how to contact the universities after hour nurses for health advice.