chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Mild varicella rash started 1/27/2009.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 79 year old white female patient who on 05-DEC-2007 at 13:45 pm was vaccinated into the right arm with the first dose of ZOSTAVAX. On 07-OCT-2008 the physician noted shingles rash on left buttocks. The patient was treated with VALTREX thrice daily dosage. The patient recovered on 28-OCT-2008. Shingles rash was considered to be other important medical event. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a physician concerning a 65 year old male who on 05-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #661577/1161X). On 05-NOV-2008 the patient experienced tenderness, swelling and pain at the injection site. The pain became severe and stemmed from the shoulder up through the neck. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Follow-up information received from the physician indicated that the patient with asthma, hypolipidaemia, gout, diabetes mellitus and allergies to erythromycin and niacin received a dose of PNEUMOVAX 23 (Lot #661577/1161X) IM into the left arm on 06-NOV-2008 (previously reported by the physician as 05-NOV-2008). Concomitant therapy included influenza virus vaccine (unspecified) IM into the right arm on 06-NOV-2008. The patient experienced pain at injection site on 16-NOV-2008, 10 days after the vaccination. The patient also had difficulty ROM (range of motion). On 14-JAN-2009, one magnetic resonance imaging (MRI) of the left shoulder was performed. The changes on MRI suggested degenerative changes. The patient had an orthopedic evaluation after the MRI. The reporter considered tenderness, swelling and pain at the injection site, pain severe and stemmed from the shoulder up through the neck, difficulty ROM to be other important medical events. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 65 year old male who on 05-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #661577/1161X). On 05-NOV-2008 the patient experienced tenderness, swelling and pain at the injection site. The pain became severe and stemmed from the shoulder up through the neck. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Follow-up information received from the physician indicated that the patient with asthma, hypolipidaemia, gout, diabetes mellitus and allergies to erythromycin and niacin received a dose of PNEUMOVAX 23 (Lot #661577/1161X) IM into the left arm on 06-NOV-2008 (previously reported by the physician as 05-NOV-2008). Concomitant therapy included influenza virus vaccine (unspecified) IM into the right arm on 06-NOV-2008. The patient experienced pain at injection site on 16-NOV-2008, 10 days after the vaccination. The patient also had difficulty ROM (range of motion). On 14-JAN-2009, one magnetic resonance imaging (MRI) of the left shoulder was performed. The changes on MRI suggested degenerative changes. The patient had an orthopedic evaluation after the MRI. The reporter considered tenderness, swelling and pain at the injection site, pain severe and stemmed from the shoulder up through the neck, difficulty ROM to be other important medical events. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 49 year old male with asthma and allergic rhinitis who on 06-NOV-2008 was vaccinated with PNEUMOVAX 23 (lot number 661577/1161X) intramuscularly in the right arm. On 06-NOV-2008 the patient developed tenderness, swelling and pain at the injection site after receiving the dose of PNEUMOVAX 23. The pain became severe and stemmed from the shoulder up through the neck. The patient recovered after stopping therapy. Follow up information was received from the physician. The physician stated that on 06-NOV-2008 post vaccination the patient developed erythema, warmth and pain at the injection site. On 08-NOV-2008 the pain stemmed from shoulder through the neck. The patient was treated with MEDROL and VICODIN. On 14-NOV-2008 the patient's symptoms and signs resolved. There were no additional diagnostic tests. The physician felt the patient's injection site pain, erythema, warmth, and pain from shoulder through the neck were other important medical events. Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Information has been received from a physician concerning a 49 year old male with asthma and allergic rhinitis who on 06-NOV-2008 was vaccinated with PNEUMOVAX 23 (lot number 661577/1161X) intramuscularly in the right arm. On 06-NOV-2008 the patient developed tenderness, swelling and pain at the injection site after receiving the dose of PNEUMOVAX 23. The pain became severe and stemmed from the shoulder up through the neck. The patient recovered after stopping therapy. Follow up information was received from the physician. The physician stated that on 06-NOV-2008 post vaccination the patient developed erythema, warmth and pain at the injection site. On 08-NOV-2008 the pain stemmed from shoulder through the neck. The patient was treated with MEDROL and VICODIN. On 14-NOV-2008 the patient's symptoms and signs resolved. There were no additional diagnostic tests. The physician felt the patient's injection site pain, erythema, warmth, and pain from shoulder through the neck were other important medical events. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Blood pressure decreased, Rash
Clinical narrative: Information has been received from a pharmacist concerning a hospitalized patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23, lot # was not specified. The pharmacist stated that the patient's blood pressure dropped, developed a rash and fluids were ordered after receiving the vaccine. The patient was already in the hospital because of a different issue when this occurred and their discharge was delayed. Patient's outcome is unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive
Clinical narrative: Information has been received through the Merck Pregnancy Registry from a healthcare worker concerning a female (age not reported) who on 02-JUL-2007 was vaccinated with a dose of GARDASIL (lot 657737/0522U).  On 15-APR-2008 the patient was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot 657737/0522U).  Concomitant therapy included CLARITIN 10 mg PO q am.  At the time of the second vaccination the patient was pregnant.  The pregnancy was confirmed via a "pregnancy bloodwork."  No adverse events were reported.  The LMP was reported to be on 08-APR-2008.  Follow up information indicated that on 12-JAN-2009 the 18 year old female patient delivered a baby by cesarean section (no details provided).  The baby's weight was 8 pounds and 2 ounces with normal neonatal course.  It was 39 weeks from last menstrual period.  There were no past medical history and concurrent medical conditions.  Upon internal review, the patient's delivery via cesarean section was considered an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female patient who was mentally handicapped who in 2007 was vaccinated with all 3 doses of GARDASIL (Lot numbers not provided). The patient's mother told the physician that in late 2008, the patient was diagnosed with an abnormal PAP and possible cervical cancer related to HPV. As of 22-JAN-2009 the outcome of the patient is not recovered. Upon internal review, possible cervical cancer was considered to be an Other Important Medical Event. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Alanine aminotransferase increased, Anion gap normal, Arthralgia, Aspartate aminotransferase increased, Blood albumin decreased
Clinical narrative: Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium decreased, Blood chloride decreased, Blood creatinine normal
Clinical narrative: Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blood glucose abnormal, Blood potassium decreased, Blood sodium decreased, Blood urea normal, Carbon dioxide normal
Clinical narrative: Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Lethargy, Myalgia, Myoglobin blood increased, Protein total decreased, Rhabdomyolysis
Clinical narrative: Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Blindness transient, Dizziness, Eyelid disorder, Muscle contractions involuntary, Nausea
Clinical narrative: In AM: Post vaccination: dizzy, dimming vision, nausea. Recovered in clinic: In P.M: Client experienced loss of vision, loss of muscle control, swelling to the face, inability to blink. Taken to ER. Kept over night.  2/2/09 Received hospital medical records of 1/22-1/23/09. FINAL DX: painless vision loss, resolved Records reveal patient experienced dizziness, nausea, vomiting, numbness, tingling, facial swelling, transient loss of vision, passed out.  Held in ER overnight for observation.  Ophtho consult done, was WNL & suggested vasovagal reaction to vaccine.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling face, Visual impairment
Clinical narrative: In AM: Post vaccination: dizzy, dimming vision, nausea. Recovered in clinic: In P.M: Client experienced loss of vision, loss of muscle control, swelling to the face, inability to blink. Taken to ER. Kept over night.  2/2/09 Received hospital medical records of 1/22-1/23/09. FINAL DX: painless vision loss, resolved Records reveal patient experienced dizziness, nausea, vomiting, numbness, tingling, facial swelling, transient loss of vision, passed out.  Held in ER overnight for observation.  Ophtho consult done, was WNL & suggested vasovagal reaction to vaccine.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Pharyngeal oedema
Clinical narrative: 58 yo M with ESRD on HD, HTN, and DM presents to ER from HD center via ambulance after receiving PNEUMOVAX and developing sudden SOB. Pt states he was feeling fine and he received the shot and about an hour after being vaccinated began feeling swelling in his throat and tightness in his chest. Pt received 0.5 of 1-1000 epi, 125mg SOLUMEDROL, 50 mg BENADRYL at HD center. Pt states he is now feeling better but still c/o SOB, throat fullness, and difficulty swallowing. Pt states he has never had symptoms like this before. Symptoms: Anaphylaxis. Treatment Drugs Used: 1 EPINEPHRINE, 2 METHYLPREDNISOLONE, 3 DIPHENHYDRAMINE.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt had vaccination 1/20/09, and 1/22/2009 c/o painful knot, erythema 2 1/4 in on Right Deltoid.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Crying, Eye swelling, Screaming, Swelling face
Clinical narrative: Parents state that infant cried screaming episodes for 3 hours per episode, for 24 -36 hours after receiving immunizations. Increased T. Eyes and face "puffy".
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 24 hours after the injection patient noticed a red wheal approximately 1" in diameter. It was itching and burning. The rash increased in size to 3 1/2-2 3/4 inches in diameter. 72 hours after injection the rash was 1"x 2". Patient put 1 application of NEOSPORIN on rash.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Received FLUZONE 1/15/09.  1 week later noted pain in both forearms & later both legs.   1/22/09 Mainly myalgias.  Still being evaluaated.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin warm, Urticaria
Clinical narrative: Five days after administration, a 2 inch strip of hot, painful whelps developed on middle of the torso, on the left side. The next dayit spread to the front and back. Patient was seen by the MD ten days after the vaccination date and diagnosed with "typical" shingles. He was prescribed Valtrex, prednisone, and oxycodone.
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: CELLULITIS TO LT. DELTOID REGION.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Viral infection
Clinical narrative: I received 2 of the 3 Gardisil shots. One on 10/16/07 and one on 2/2/08. In April 2008 I had a virus that lasted for 4 weeks and was treated with antibiotics. On May 24th my left side went completely numb and I was diagnosed with Multiple Sclerosis on 5/25/09 and hospitalized for 5 days. I had another flare on 6/23/08 where i was hospitalized for 3 days. 3/4/09-records received for DOS 5/23/-5/27/08-DC DX:New diagnosis of multiple sclerosis.Cephalgia exacerbated by lumbar puncture., .  Presented to ED with C/O 2 day history of neck pain, numbness and tingling in left upper and lower extremity.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, MMR
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient recieved vaccines on 1/16/09 on both upper outer thighs.  On 1/17/09, patient's father phoned doctor on call, stating right thigh was swollen.  That night, parents took patient to ER where she was diagnosed with cellulitis and given a prescription of Keflex.  The next day, on 1/18/09 the swelling and redness had spread but the patient remained afebrile.  She was admitted to the hospital that night of 1/18 and placed on IV ceftriaxone BID, IV clindamycin q 6hrs, and IV benedryl BID.  By 1/19/09, the cellulits had improved.  The site is described as an approximately 1 inch band of redness extending around the right thigh with an irregular border.  There is central clearing at the injection site.  The patient is without pain and fever.  On 1/20/09, the site is described to be without swelling.  There is minimal bluish discoloration of the upper outer thigh where previously it was dark and purple.  Erythema of the right inner thigh was completely resolved.  The patient was in good spirits and eating lunch on the day of discharge, 1/20/09.  Patient was sent home on septra BID for 7 days and claritin qd for 2 days. 2/11/09-records received for DOS 1/18-1/20/09- DC DX:Right leg cellulitis versus allergic reaction to immunizations. Presented with swelling of right upper thigh, erythema, pain and induration. Treated with IVAB.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient experienced swollen, red, hot upper arm at side of injection, patient took benadryl to relieve the symptoms; symptoms were dissipating after a couple of days
Age: 0.33
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Irritability, Somnolence
Clinical narrative: 24 hours after 1st PCV, baby's thigh feels hard and small red area around injection site. Baby extremely irritable and drowsy 24 hours after as well.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Varicella rash; about 2 dozen lesions
Age: 24.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Chills, Cough, Malaise, Pain, Pyrexia
Clinical narrative: Chills, fevers of up to 103.2, body aches, malaise, cough,small pustules on skin
Age: 24.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Rash pustular
Clinical narrative: Chills, fevers of up to 103.2, body aches, malaise, cough,small pustules on skin
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: 20-25 ERYTHEMATOUS LESIONS WITH VESICLES IN DIFFERENT STAGES. 2-3 LESIONS NEW TODAY. ERUPTIONS BEGAN ABOUT 72 HOURS AGO.
Age: 1.08
Sex: M
Vaccine: HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: FOURTH IPV GIVEN AT 12 MONTHS
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Area of swelling 10.5 cm x 9.5 cm, firm, and warm to touch with pain.
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Patient developed a rash 7-10 days later.  Rash has been diagnosed as pityriasis rosea.  The dermatologist informed me that PR may be associated with vaccination.  Rash may last until mid February.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Mom to clinic with 5 yo with concerns about swelling/redness to R thigh.  Received vacc 3d in bil thighs and mom states R thigh had lump next d. with fever but told possible rx monitor.  Following d. child complaining of worsening pain and redness and swelling.  Today redness is bigger with swelling and hardness and hot to touch.  No fever today.  Assessment: R thigh cellulitis post vaccination administratioN.  Rocephin 1000 mg given today advised return in 24 hrs for re-eval.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Mom to clinic with 5 yo with concerns about swelling/redness to R thigh.  Received vacc 3d in bil thighs and mom states R thigh had lump next d. with fever but told possible rx monitor.  Following d. child complaining of worsening pain and redness and swelling.  Today redness is bigger with swelling and hardness and hot to touch.  No fever today.  Assessment: R thigh cellulitis post vaccination administratioN.  Rocephin 1000 mg given today advised return in 24 hrs for re-eval.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle injury, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome, X-ray
Clinical narrative: THE FLU SHOT WAS GIVEN DIRECTLY IN TO MY LEFT SHOULDER, UP VERY HIGH, AND BEHIND. I NOW HAVE A TEAR ON MY SUPRASPINATUS AND INFRASPINATUS MUSCLES, AND A PERFORATION ON MY ROTATOR CUFF TENDON. I FELT EXTREME PAIN WITHIN AN HOUR OF RECEIVING THIS IMMUNIZATION. I AM NOW IN PHYSICAL THERAPY, AND I AM GOING TO HAVE SURGERY TO REPAIR IT. I AM SURPRISED AT THE NUMBER OF PEOPLE WITH SHOULDER INJURIES FROM IMMUNIZATIONS. BETTER TRAINING NEEDS TO BE AVAILABLE TO ALL HEALTH CARE PERSONNEL ADMINISTERING THESE IMMUNIZATIONS. THEY ARE CAUSING MORE HARM, THEN GOOD.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Acoustic stimulation tests, Aphasia, Attention deficit/hyperactivity disorder, Autism spectrum disorder
Clinical narrative: My son was on target with speech and gross motor skills approaching his first birthday. He said about 10 words, knew the signs for cup, food, mom and dad. Loved being held and rocked to sleep.  We took him to the doctor for a checkup for an ear infection a slight cold. They told us he needed shots, I asked them if we could reschedule the vaccinations, and they told me that it would be fine to give them to him.  Approximately 7 days following his June vaccinations in 2007, he changed completely. He no longer made eye contact with anyone, went back to babbling like an infant again and seemed to lose his motor skills. He became very clumsy. Not thinking that there would be a tie to the shots, we took him to his old pediatricians office, and they thought nothing of it.  So we figured that we just needed to do more work with him. In November of 2007, when things did not get any better we found a new pediatrician. He recommended speech therapy, behavior therapy and a hearing test. By the time we got all of the tests done, he had a 12-18 month speech delay, behavior problems, ADHD and PDD.  2/18/09 MR received from PCP. First seen a 16 months for asthma.  Spleen noted to be enlarged.  Probable Immune D/O.  18 month WCC WNL. Developmental Assess WNL. Speech Delay noted at 2 yr exam. Developmental Assess with <20 words. No Autism signs. loss of coordination, became sick all the time, loss of speech.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Blood test, Clumsiness, Coordination abnormal, Decreased eye contact, Diagnostic procedure
Clinical narrative: My son was on target with speech and gross motor skills approaching his first birthday. He said about 10 words, knew the signs for cup, food, mom and dad. Loved being held and rocked to sleep.  We took him to the doctor for a checkup for an ear infection a slight cold. They told us he needed shots, I asked them if we could reschedule the vaccinations, and they told me that it would be fine to give them to him.  Approximately 7 days following his June vaccinations in 2007, he changed completely. He no longer made eye contact with anyone, went back to babbling like an infant again and seemed to lose his motor skills. He became very clumsy. Not thinking that there would be a tie to the shots, we took him to his old pediatricians office, and they thought nothing of it.  So we figured that we just needed to do more work with him. In November of 2007, when things did not get any better we found a new pediatrician. He recommended speech therapy, behavior therapy and a hearing test. By the time we got all of the tests done, he had a 12-18 month speech delay, behavior problems, ADHD and PDD.  2/18/09 MR received from PCP. First seen a 16 months for asthma.  Spleen noted to be enlarged.  Probable Immune D/O.  18 month WCC WNL. Developmental Assess WNL. Speech Delay noted at 2 yr exam. Developmental Assess with <20 words. No Autism signs. loss of coordination, became sick all the time, loss of speech.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Malaise, Motor dysfunction, Speech disorder, Speech disorder developmental, Urine analysis
Clinical narrative: My son was on target with speech and gross motor skills approaching his first birthday. He said about 10 words, knew the signs for cup, food, mom and dad. Loved being held and rocked to sleep.  We took him to the doctor for a checkup for an ear infection a slight cold. They told us he needed shots, I asked them if we could reschedule the vaccinations, and they told me that it would be fine to give them to him.  Approximately 7 days following his June vaccinations in 2007, he changed completely. He no longer made eye contact with anyone, went back to babbling like an infant again and seemed to lose his motor skills. He became very clumsy. Not thinking that there would be a tie to the shots, we took him to his old pediatricians office, and they thought nothing of it.  So we figured that we just needed to do more work with him. In November of 2007, when things did not get any better we found a new pediatrician. He recommended speech therapy, behavior therapy and a hearing test. By the time we got all of the tests done, he had a 12-18 month speech delay, behavior problems, ADHD and PDD.  2/18/09 MR received from PCP. First seen a 16 months for asthma.  Spleen noted to be enlarged.  Probable Immune D/O.  18 month WCC WNL. Developmental Assess WNL. Speech Delay noted at 2 yr exam. Developmental Assess with <20 words. No Autism signs. loss of coordination, became sick all the time, loss of speech.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site haematoma, Injection site pain
Clinical narrative: 1. Bruising x 3 weeks. 2. Local pain where shot or injection was given.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Vaginal infection, Vomiting
Clinical narrative: Pt describes temp 102.2 F orally several hours after injection. Also complained of nausea and vomiting but was also taking Flagyl  for Vaginitis.
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Employee c/o headache, nausea, vomiting, fever, rash on arms, neck, chest, abdomen and pain and swelling at injection site.
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Vomiting
Clinical narrative: Employee c/o headache, nausea, vomiting, fever, rash on arms, neck, chest, abdomen and pain and swelling at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Very stiff neck muscles, onset 24 hours later. No other physical events to potentially cause this no fever or constipation symptoms. Rx: muscle relaxants.  No fever or constitutional symptoms.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Blood test abnormal, Mobility decreased, Screaming
Clinical narrative: 1-16-09 vaccine given. 1-22-09 at 6pm began vomiting. At 9:40pm c/o knees "killing me". Mom carried to bed 1-23-09 and 1-24-09, child home playing table games and watching TV, not running around, more sedentary. 1-25-09, 6:30 am patient lying on floor in bedroom screaming " I can't walk". Taken to ER lab work drawn and MOTRIN given. Discharged at 11am walking and ok.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 1-16-09 vaccine given. 1-22-09 at 6pm began vomiting. At 9:40pm c/o knees "killing me". Mom carried to bed 1-23-09 and 1-24-09, child home playing table games and watching TV, not running around, more sedentary. 1-25-09, 6:30 am patient lying on floor in bedroom screaming " I can't walk". Taken to ER lab work drawn and MOTRIN given. Discharged at 11am walking and ok.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid localized reaction with redness, swelling and itching.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Skin warm
Clinical narrative: Patient c/o right upper arm swelling, localized to immunization site. Hot, painful. Patient seen in clinic, states it feels much better, swelling decreased from last night. Now slightly red and raised.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Hyperaemia, Injection site oedema, Oral disorder
Clinical narrative: Erythema, Hyperemia and edema at injection site R thigh and oral lesion measuring 10x7cm
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Triaged by Dr via telephone and advised to go to emergency room. Patient was triaged by Dr.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness with the left shoulder/arm where shot was given.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was diagnosed with shingles.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: 35 y/o male SM referred to hospital from ED for f/u evaluation of chest pain S/P primary SPV and AVA #2 1/31/2008.  Symptoms:  Dyspnea, Diaphoresis, Nausea w/o vomiting, Paresthesia, Muscle Pain, Chest Pain, sub-sternal.  2/20/2008 MR received dated 2/7/08 to 6/2008 with DX:  Atypical Chest Pain s/p Smallpox vaccine. Pt presented to ER with 3 day hx of intermittant squeezing chest pain and pressure. Cardiac w/u and enzymes (-) so d/c for outpt f/u. Still having some CP 2/15/08. Tx with Motrin with gradual reduct of sx.  Returned 4/10/08 with c/o 1 wk hx of CP, cough, nausea and SOB when reclining. Also fatigue and swelling of hands and feet. Dx:  Atypical chest Pain. CP determined to be non-cardiac. Assess:  Anxiety.  Joint Pain localized in shoulder.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Paraesthesia
Clinical narrative: 35 y/o male SM referred to hospital from ED for f/u evaluation of chest pain S/P primary SPV and AVA #2 1/31/2008.  Symptoms:  Dyspnea, Diaphoresis, Nausea w/o vomiting, Paresthesia, Muscle Pain, Chest Pain, sub-sternal.  2/20/2008 MR received dated 2/7/08 to 6/2008 with DX:  Atypical Chest Pain s/p Smallpox vaccine. Pt presented to ER with 3 day hx of intermittant squeezing chest pain and pressure. Cardiac w/u and enzymes (-) so d/c for outpt f/u. Still having some CP 2/15/08. Tx with Motrin with gradual reduct of sx.  Returned 4/10/08 with c/o 1 wk hx of CP, cough, nausea and SOB when reclining. Also fatigue and swelling of hands and feet. Dx:  Atypical chest Pain. CP determined to be non-cardiac. Assess:  Anxiety.  Joint Pain localized in shoulder.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: 27 y/o AD male referred to facility through call center for hospitalization secondary to acute myopericarditis S/P primary SPV and AVA #6 on 02/01/08. Flu-like symptoms > 96 hours-start:01/08/2008-myalgia, HA, chills, sweating, nausea. Chest Pain Start: 02/11/2008-constant pain 6/10 middle of chest worsening on deep inspiration, no diaphoresis, no nausea, no radiation to left arm.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myalgia, Myopericarditis, Nausea
Clinical narrative: 27 y/o AD male referred to facility through call center for hospitalization secondary to acute myopericarditis S/P primary SPV and AVA #6 on 02/01/08. Flu-like symptoms > 96 hours-start:01/08/2008-myalgia, HA, chills, sweating, nausea. Chest Pain Start: 02/11/2008-constant pain 6/10 middle of chest worsening on deep inspiration, no diaphoresis, no nausea, no radiation to left arm.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Areflexia, Dizziness, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome
Clinical narrative: One week after immunizations, developed leg and arm weakness. Cramping in her legs, severe fatigue, odd sensations in legs, feet and toes. Morning lightheadedness areflexic. Diagnosed by neurologist 11/26- EMR studies post vaccination acute inflammatory demyelinating polyneuropathy (GUILLAIN BARRE syndrome) Seen by rheumatologist and pediatrician.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Laboratory test, Lumbar puncture, Muscle spasms, Muscular weakness, Neurological examination
Clinical narrative: One week after immunizations, developed leg and arm weakness. Cramping in her legs, severe fatigue, odd sensations in legs, feet and toes. Morning lightheadedness areflexic. Diagnosed by neurologist 11/26- EMR studies post vaccination acute inflammatory demyelinating polyneuropathy (GUILLAIN BARRE syndrome) Seen by rheumatologist and pediatrician.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Paraesthesia
Clinical narrative: One week after immunizations, developed leg and arm weakness. Cramping in her legs, severe fatigue, odd sensations in legs, feet and toes. Morning lightheadedness areflexic. Diagnosed by neurologist 11/26- EMR studies post vaccination acute inflammatory demyelinating polyneuropathy (GUILLAIN BARRE syndrome) Seen by rheumatologist and pediatrician.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza serology positive
Clinical narrative: Initial report received on 21 January 2009 from a health care professional. A 2-year-old child, who has past medical history of respiratory syncytial virus (RSV), had received on an unknown day in October 2008 a dose of FLUZONE SV 2008-2009 (lot number unknown, route and site of administration not provided). At the time of the vaccination, the patient was taking Synergis. Approximately three months post vaccination in January 2009; the patient was hospitalized and diagnosed per a flu test with influenza B. It was unknown what type of flu test was administered, or if a sub-strain had been identified. It was reported the patient had received two previous doses of flu vaccine in 2007. The recovery status of the patient was not provided. Documents held by sender: None
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Movement disorder
Clinical narrative: Initial report received on 15 January 2009 from a physician. A 7-month-old female patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received on 18 December 2008 a third intramuscular right thigh injection of ACTHIB (lot number UF520AA), a intramuscular left thigh injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B198BA), and a intramuscular right thigh injection of PREVNAR (manufacturer Wyeth, lot number D126884). The patient had not received any other vaccinations within four weeks of 18 December 2008. Five days after receiving the above vaccines, the patient began having symptoms in her sleep that included gasping and body movements the parents could not describe. The frequency of these symptoms have increased, and currently the patient is hospitalized for workup. The admission date to the hospital was not provided. It was unknown what relevant diagnostic tests or laboratory data have been performed. It was not reported whether the patient has received any treatments for the serious adverse events. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram, Obstruction
Clinical narrative: Initial report received on 15 January 2009 from a physician. A 7-month-old female patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received on 18 December 2008 a third intramuscular right thigh injection of ACTHIB (lot number UF520AA), a intramuscular left thigh injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B198BA), and a intramuscular right thigh injection of PREVNAR (manufacturer Wyeth, lot number D126884). The patient had not received any other vaccinations within four weeks of 18 December 2008. Five days after receiving the above vaccines, the patient began having symptoms in her sleep that included gasping and body movements the parents could not describe. The frequency of these symptoms have increased, and currently the patient is hospitalized for workup. The admission date to the hospital was not provided. It was unknown what relevant diagnostic tests or laboratory data have been performed. It was not reported whether the patient has received any treatments for the serious adverse events. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: HEPA, MEN, MMRV, PNC
Symptoms: Anion gap, Apnoea, Blood culture negative, Blood electrolytes normal, Body temperature increased
Clinical narrative: Information has been received from an investigator concerning a 12 month old female with nasal congestion and a history of a recent cold and methicillin-resistant staphylococcal aureus infection/abscess x 2 (July 2008 and November 2008) who entered a study. It was reported that the patient does not have a history of seizure, febrile or otherwise. On 10-DEC-2008 the patient was vaccinated S.Q. with a 0.5 ml dose of PROQUAD (Merck) administered in the left arm. Concomitant vaccinations included four 0.50 I.M. doses of MCV4 administered in the right thigh on 06-FEB-2008, 07-APR-2008, 17-JUN-2008 (lot # V59P14) and 10-DEC-2008. Three 0.50 I.M. doses of PEDIARIX administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # A021B097AB) and 17-JUN-2008 (lot # A021B097AB). One 0.50 I.M. dose of HAVRIX administered in the left thigh on 10-DEC-2008. Three 0.50 I.M. doses of ACTHIB administered in the left thigh on 06-FEB-2008 (lot # UF214AA), 07-APR-2008 and 17-JUN-2008. Four 0.50 I.M doses of PREVNAR administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # B54013K), 17-JUN-2008 (lot # C63111) and 10-DEC-2008. Three oral 2.00 doses of ROTATEQ on 06-FEB-2008, 07-APR-2008 (659915/0015X) and 17-JUN-2008 (lot # 657513/1052U). Other concomitant therapy included hydrocortisone, SULFATRIM, CLEOCIN, HIBICLENS, mupirocin acetaminophen and heparin. On 18-DEC-2008, the patient experienced an apnea episode and was hospitalized at 18:00. It was noted that the patient was taken to the emergency room and eventually admitted to the hospital overnight following an apnea spell at home during a feeding. It was reported that the patient went limp. The patient's aunt gave rescue breaths until the ambulance arrived. After 2 minutes the patient got better and came around and was then acting normally. Once the ambulance arrived, oxygen was given. In the emergency room, the patient had a fever and the doctor could not rule out febrile seizure vs. apparent life-threatening event (ALTE). It was noted that the patient eventually recovered and had no futher distress. Discharge diagnoses apnea or apneic event. The reporting investigator felt that apnea was possibly related to study therapy. The patient's vaccination history included a 0.50 I.M. dose of ENGERIX-B administered in the right thigh on 05-DEC-2007. Additional information is not expected. All available medical records will be provided upon request.
Age: 1.0
Sex: F
Vaccine: HEPA, MEN, MMRV, PNC
Symptoms: Electrocardiogram normal, Full blood count normal, Heart rate increased, Hypotonia, Influenza serology negative
Clinical narrative: Information has been received from an investigator concerning a 12 month old female with nasal congestion and a history of a recent cold and methicillin-resistant staphylococcal aureus infection/abscess x 2 (July 2008 and November 2008) who entered a study. It was reported that the patient does not have a history of seizure, febrile or otherwise. On 10-DEC-2008 the patient was vaccinated S.Q. with a 0.5 ml dose of PROQUAD (Merck) administered in the left arm. Concomitant vaccinations included four 0.50 I.M. doses of MCV4 administered in the right thigh on 06-FEB-2008, 07-APR-2008, 17-JUN-2008 (lot # V59P14) and 10-DEC-2008. Three 0.50 I.M. doses of PEDIARIX administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # A021B097AB) and 17-JUN-2008 (lot # A021B097AB). One 0.50 I.M. dose of HAVRIX administered in the left thigh on 10-DEC-2008. Three 0.50 I.M. doses of ACTHIB administered in the left thigh on 06-FEB-2008 (lot # UF214AA), 07-APR-2008 and 17-JUN-2008. Four 0.50 I.M doses of PREVNAR administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # B54013K), 17-JUN-2008 (lot # C63111) and 10-DEC-2008. Three oral 2.00 doses of ROTATEQ on 06-FEB-2008, 07-APR-2008 (659915/0015X) and 17-JUN-2008 (lot # 657513/1052U). Other concomitant therapy included hydrocortisone, SULFATRIM, CLEOCIN, HIBICLENS, mupirocin acetaminophen and heparin. On 18-DEC-2008, the patient experienced an apnea episode and was hospitalized at 18:00. It was noted that the patient was taken to the emergency room and eventually admitted to the hospital overnight following an apnea spell at home during a feeding. It was reported that the patient went limp. The patient's aunt gave rescue breaths until the ambulance arrived. After 2 minutes the patient got better and came around and was then acting normally. Once the ambulance arrived, oxygen was given. In the emergency room, the patient had a fever and the doctor could not rule out febrile seizure vs. apparent life-threatening event (ALTE). It was noted that the patient eventually recovered and had no futher distress. Discharge diagnoses apnea or apneic event. The reporting investigator felt that apnea was possibly related to study therapy. The patient's vaccination history included a 0.50 I.M. dose of ENGERIX-B administered in the right thigh on 05-DEC-2007. Additional information is not expected. All available medical records will be provided upon request.
Age: 1.0
Sex: F
Vaccine: HEPA, MEN, MMRV, PNC
Symptoms: Nasal aspiration, Oxygen saturation normal, Pyrexia, Respiratory rate increased, Respiratory syncytial virus test negative
Clinical narrative: Information has been received from an investigator concerning a 12 month old female with nasal congestion and a history of a recent cold and methicillin-resistant staphylococcal aureus infection/abscess x 2 (July 2008 and November 2008) who entered a study. It was reported that the patient does not have a history of seizure, febrile or otherwise. On 10-DEC-2008 the patient was vaccinated S.Q. with a 0.5 ml dose of PROQUAD (Merck) administered in the left arm. Concomitant vaccinations included four 0.50 I.M. doses of MCV4 administered in the right thigh on 06-FEB-2008, 07-APR-2008, 17-JUN-2008 (lot # V59P14) and 10-DEC-2008. Three 0.50 I.M. doses of PEDIARIX administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # A021B097AB) and 17-JUN-2008 (lot # A021B097AB). One 0.50 I.M. dose of HAVRIX administered in the left thigh on 10-DEC-2008. Three 0.50 I.M. doses of ACTHIB administered in the left thigh on 06-FEB-2008 (lot # UF214AA), 07-APR-2008 and 17-JUN-2008. Four 0.50 I.M doses of PREVNAR administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # B54013K), 17-JUN-2008 (lot # C63111) and 10-DEC-2008. Three oral 2.00 doses of ROTATEQ on 06-FEB-2008, 07-APR-2008 (659915/0015X) and 17-JUN-2008 (lot # 657513/1052U). Other concomitant therapy included hydrocortisone, SULFATRIM, CLEOCIN, HIBICLENS, mupirocin acetaminophen and heparin. On 18-DEC-2008, the patient experienced an apnea episode and was hospitalized at 18:00. It was noted that the patient was taken to the emergency room and eventually admitted to the hospital overnight following an apnea spell at home during a feeding. It was reported that the patient went limp. The patient's aunt gave rescue breaths until the ambulance arrived. After 2 minutes the patient got better and came around and was then acting normally. Once the ambulance arrived, oxygen was given. In the emergency room, the patient had a fever and the doctor could not rule out febrile seizure vs. apparent life-threatening event (ALTE). It was noted that the patient eventually recovered and had no futher distress. Discharge diagnoses apnea or apneic event. The reporting investigator felt that apnea was possibly related to study therapy. The patient's vaccination history included a 0.50 I.M. dose of ENGERIX-B administered in the right thigh on 05-DEC-2007. Additional information is not expected. All available medical records will be provided upon request.
Age: 1.0
Sex: F
Vaccine: HEPA, MEN, MMRV, PNC
Symptoms: Urine ketone body present, Virus culture negative
Clinical narrative: Information has been received from an investigator concerning a 12 month old female with nasal congestion and a history of a recent cold and methicillin-resistant staphylococcal aureus infection/abscess x 2 (July 2008 and November 2008) who entered a study. It was reported that the patient does not have a history of seizure, febrile or otherwise. On 10-DEC-2008 the patient was vaccinated S.Q. with a 0.5 ml dose of PROQUAD (Merck) administered in the left arm. Concomitant vaccinations included four 0.50 I.M. doses of MCV4 administered in the right thigh on 06-FEB-2008, 07-APR-2008, 17-JUN-2008 (lot # V59P14) and 10-DEC-2008. Three 0.50 I.M. doses of PEDIARIX administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # A021B097AB) and 17-JUN-2008 (lot # A021B097AB). One 0.50 I.M. dose of HAVRIX administered in the left thigh on 10-DEC-2008. Three 0.50 I.M. doses of ACTHIB administered in the left thigh on 06-FEB-2008 (lot # UF214AA), 07-APR-2008 and 17-JUN-2008. Four 0.50 I.M doses of PREVNAR administered in the left thigh on 06-FEB-2008, 07-APR-2008 (lot # B54013K), 17-JUN-2008 (lot # C63111) and 10-DEC-2008. Three oral 2.00 doses of ROTATEQ on 06-FEB-2008, 07-APR-2008 (659915/0015X) and 17-JUN-2008 (lot # 657513/1052U). Other concomitant therapy included hydrocortisone, SULFATRIM, CLEOCIN, HIBICLENS, mupirocin acetaminophen and heparin. On 18-DEC-2008, the patient experienced an apnea episode and was hospitalized at 18:00. It was noted that the patient was taken to the emergency room and eventually admitted to the hospital overnight following an apnea spell at home during a feeding. It was reported that the patient went limp. The patient's aunt gave rescue breaths until the ambulance arrived. After 2 minutes the patient got better and came around and was then acting normally. Once the ambulance arrived, oxygen was given. In the emergency room, the patient had a fever and the doctor could not rule out febrile seizure vs. apparent life-threatening event (ALTE). It was noted that the patient eventually recovered and had no futher distress. Discharge diagnoses apnea or apneic event. The reporting investigator felt that apnea was possibly related to study therapy. The patient's vaccination history included a 0.50 I.M. dose of ENGERIX-B administered in the right thigh on 05-DEC-2007. Additional information is not expected. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a pharmacist concerning a female who in 2008 was vaccinated with a dose of GARDASIL. The patient experienced seizure after receiving the GARDASIL. At the time of this report the patient had recovered. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested.