chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 5 month old female who on 16-NOV-2007 and in approximately January 2008, was vaccinated PO with her first and second 2.0 ml doses of ROTATEQ.  Concomitant vaccinations administered in approximately January 2008, with the second dose included a dose of PEDIARIX, a dose of PEDVAXHIB and a dose of PREVNAR.  On 24-JAN-2008 the patient experienced intussusception and was hospitalized.  A barium enema was administered as an intervention and subsequently the patient underwent a "surgical correction."  After the event on that same day, the physician decided to discontinue therapy with ROTATEQ.  The outcome was unknown at the time of this report.  It was noted that the patient had no adverse event with the first dose of ROTATEQ.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Benign intracranial hypertension, Blindness, Diagnostic procedure, Headache, Lumbar puncture
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter with no medical history or concomitant therapies who in July 2007, was vaccinated with her first dose of Gardasil.  In September 2007, the patient was vaccinated with her second dose of Gardasil.  After the second dose, the patient fainted and also had a headache.  She then developed a pseudo cerebral tumor which started to cause blindness.  She had a spinal tap and also had the fluid drained to relieve the pressure she was having.  No further information was provided.  Subsequently, the patient recovered from fainting, her headache, the pseudo cerebral tumor and blindness.  The blindness was considered to be an other important medical event.  Additional information has been requested.  02/29/2008 MR received from neurologist for OV 1/17/2008 with Dx:  Pseudotumor cerebri.  Pt presented with some loss of vision in the L eye and headache x 2 weeks with papilledema noted on fundoscopic exam.  PE WNL except papilledema.  3/27/2008 Additional records received from opthomology consults 1/18/08 and 1/30/08 and f/u neurology 2/28/08. Seen by ophth 1/18/08 with visual field changes with h/a. PE (+) for optic nerve edema. DX: Pseudotumor cerebri.  Mild blepharitis, mild refractive error L eye. Ophth consult 1/30/08 with report of improved visual acuity and no h/a. Edema still present on optic nerve exam, improved from last visit.  Neuro f/u with improvement noted in visual field and h/a.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter with no medical history or concomitant therapies who in July 2007, was vaccinated with her first dose of Gardasil.  In September 2007, the patient was vaccinated with her second dose of Gardasil.  After the second dose, the patient fainted and also had a headache.  She then developed a pseudo cerebral tumor which started to cause blindness.  She had a spinal tap and also had the fluid drained to relieve the pressure she was having.  No further information was provided.  Subsequently, the patient recovered from fainting, her headache, the pseudo cerebral tumor and blindness.  The blindness was considered to be an other important medical event.  Additional information has been requested.  02/29/2008 MR received from neurologist for OV 1/17/2008 with Dx:  Pseudotumor cerebri.  Pt presented with some loss of vision in the L eye and headache x 2 weeks with papilledema noted on fundoscopic exam.  PE WNL except papilledema.  3/27/2008 Additional records received from opthomology consults 1/18/08 and 1/30/08 and f/u neurology 2/28/08. Seen by ophth 1/18/08 with visual field changes with h/a. PE (+) for optic nerve edema. DX: Pseudotumor cerebri.  Mild blepharitis, mild refractive error L eye. Ophth consult 1/30/08 with report of improved visual acuity and no h/a. Edema still present on optic nerve exam, improved from last visit.  Neuro f/u with improvement noted in visual field and h/a.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a physician, regarding a 25 year old caucasian female patient, and editor, with no known drug allergies, who on 07-DEC-2007 at 4:30 pm, was vaccinated IM in the left deltoid, with the second dose, 0.5 ml, of Gardasil (lot #655322/1211U).  There were no side effects associated with the first dose of Gardasil (date not specified).  There was no illness at the time of vaccination.  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On approximately 27-DEC-2008, the patient called the physician's office and stated that post vaccination, her left arm had been sore, but it had gotten better (duration not specified).  She added though, that on approximately 20-DEC-2007, her arm had become sore again.  The patient also reported weakness in her arm.  There was no redness or fever.  Treatment with MOTRIN was recommended by the physician.  On 10-JAN-2008, the patient called the physician back with complaints of continued pain in her arm, described as pain when she lifted her arm over her head and when she lay on her side on the arm.  At the time of this report, the symptoms continued, but had lessened.  The physician considered arm sore again with weakness to be persistent or significantly disabling or incapacitating.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound abdomen abnormal, Urinary tract infection, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old female who has had "multiple sexual partners and engages in high risk behavior".  Her first pregnancy resulted in a spontaneous abortion in March 2006.  On 06-FEB-2007, the patient had pelvic inflammatory disease from which she recovered.  On 28-FEB-2007, the patient had an ultrasound which revealed a complex ovarian cyst.  Also on 28-FEB-2007, urine and ultrasound tests confirmed that the patient was not pregnant.  She was referred to a gynecologist for evaluation of her ovarian cyst.  On 12-MAR-2007, the patient was vaccinated with the first dose of GARDASIL (lot #653736/0014U), 0.5 ml.  On 30-MAR-2007, the patient presented to the gynecologist for evaluation of her existing ovarian cyst.  It was determined via ultrasound that the patient was 6 weeks and 4 days pregnant.  Her last menstrual period (LMP) was estimated to be late January/early February (estimated delivery date 08-NOV-2007).  In the end of April 2007, the patient had a spontaneous abortion followed by a dilation & curettage (D & C).  Subsequently (date unknown), the patient was diagnosed at the ER with a urinary tract infection (UTI) status post spontaneous abortion and D & C.  On 08-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (lot #657005/0314U).  She was fully recovered from the spontaneous abortion at that time.  On 07-SEP-2007, the patient was vaccinated with the third dose of GARDASIL (lot #657872/0515U).  Subsequently, the patient recovered from the UTI.  In the follow-up phone call of 07-FEB-2008, the PA reported that she did not consider the spontaneous abortion or UTI as disabling or life threatening.  She was unsure if the patient had been hospitalized at all.  Upon internal review, spontaneous abortion was considered to be an other important medical event.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine dilation and curettage
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old female who has had "multiple sexual partners and engages in high risk behavior".  Her first pregnancy resulted in a spontaneous abortion in March 2006.  On 06-FEB-2007, the patient had pelvic inflammatory disease from which she recovered.  On 28-FEB-2007, the patient had an ultrasound which revealed a complex ovarian cyst.  Also on 28-FEB-2007, urine and ultrasound tests confirmed that the patient was not pregnant.  She was referred to a gynecologist for evaluation of her ovarian cyst.  On 12-MAR-2007, the patient was vaccinated with the first dose of GARDASIL (lot #653736/0014U), 0.5 ml.  On 30-MAR-2007, the patient presented to the gynecologist for evaluation of her existing ovarian cyst.  It was determined via ultrasound that the patient was 6 weeks and 4 days pregnant.  Her last menstrual period (LMP) was estimated to be late January/early February (estimated delivery date 08-NOV-2007).  In the end of April 2007, the patient had a spontaneous abortion followed by a dilation & curettage (D & C).  Subsequently (date unknown), the patient was diagnosed at the ER with a urinary tract infection (UTI) status post spontaneous abortion and D & C.  On 08-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (lot #657005/0314U).  She was fully recovered from the spontaneous abortion at that time.  On 07-SEP-2007, the patient was vaccinated with the third dose of GARDASIL (lot #657872/0515U).  Subsequently, the patient recovered from the UTI.  In the follow-up phone call of 07-FEB-2008, the PA reported that she did not consider the spontaneous abortion or UTI as disabling or life threatening.  She was unsure if the patient had been hospitalized at all.  Upon internal review, spontaneous abortion was considered to be an other important medical event.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ovarian enlargement, Pain
Clinical narrative: Information has been received for the Merck Pregnancy Registry for Gardasil from an 18 year old female with no pertinent medical history or drug reactions/allergies who on 31-JAN-2008 was vaccinated with a first dose of Gardasil injection.  There was no concomitant medication.  On 03-FEB-2008 or 04-FEB-2008 (3 to 4 days) after receiving the first dose of Gardasil the patient miscarried.  The patient was approximately 2 weeks pregnant.  The patient was unaware she was pregnant until she miscarried.  The physician stated to the patient that her left ovary was swollen.  The patient was in alot of pain.  The patient was scheduled for a CT scan next week.  At the time of reporting the patient has not recovered.  On approximately 20-JAN-2008 was the patient's date of last menstrual period.  The patient's estimated date of delivery was 26-OCT-2008.  No additional information was provided.  Upon internal review miscarriage was considered to be an other medical event.  Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Laboratory test
Clinical narrative: Information has been received regarding a case in litigation received from a consumer concerning her an approximate 3-year-old son, with no pertinent medical history or allergies, who in approximately 2006 ("2 years ago") was vaccinated with a dose of MMR II. There was no concomitant medication. Within a month after receiving the vaccine the patient started developing behaviors that were described as "cute". In approximately November 2007 ("three months ago"), the patient was diagnosed with moderate to severe autism. The patient sought unspecified medical attention. On an unspecified date the patient had a "vitamin count check" diagnostic lab performed. At the time of the report the patient's status was not recovered. The patient's mother insists that the diagnosis was due to the MMR II. A product quality complaint was not involved. Upon internal review, autism was determined to be an other important medical event (OME). No further information is available.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Autism
Clinical narrative: Information has been received from a consumer concerning her 2-year-old daughter with no pertinent medical history or allergies who on 28-MAR-2005 and 14-APR-2005 was vaccinated with a first and second dose of MMR II. There was no concomitant medication. On 14-APR-2005 the patient stopped talking and signed for 18 months. She also lost eye contact at that time. The patient was later diagnosed with autism. The patient sought unspecified medical attention. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Upon internal review, autism was determined to be an other medically important event (OME). Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Colitis, Rectal haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning a female with "many health unspecified problems" and a dairy allergy who on 27-NOV-2007 and 25-JAN-2008 was vaccinated PO with her first and second doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine (human-bovine) (lot# 657672/0903U, lot# 657989/1838U). Concomitant drug therapy included lansoprazole (PREVACID), digoxin, acetaminophen (TYLENOL), aspirin and milk of magnesia. In 2007 and in 2008, about 1 week after vaccination, the patient experienced rectal bleeding after the first and second doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was subsequently admitted to a hospital. The patient sought medical attention through a visit with the "gastroenterologist who diagnosed her with colitis." The outcome was unknown at the time of this report. There was no product quality complaint. Additional information has been requested.  03/03/2008 MR received for DOS 11/2-22/2007 as well as F/U GI consult 1/30/08 with DX: Colitis.  Bloody stools began again in December. Seen by GI on 1/30/08 to r/o infection vs dairy-soy allergic colitis vs Hirschsprung's. 3/19/2008 Vax record received and updated.  Pt received 1st dose of DTap, Hib, Prevnar, IPOL, and Rotateq on 11/27/2007.
Age: 50.0
Sex: M
Vaccine: HEPAB, IPV, PPV, TDAP, TYP, YF, HEPAB, IPV, PPV, TDAP, TYP, YF
Symptoms: Pancreatitis
Clinical narrative: Developed Pancreatitis.  3/25/08 Reviewed hospital medical records of 2/12-2/14/2008. FINAL DX: Acute pancreatitis, etiology unclear. Records reveal patient experienced recurrent abdominal pain.  Started 4 days prior & resolved, recurred more severely on day of admission.  Had been on business trip out of country 2 wks prior to pain.  Seem by pcp & had outpatient US of abdomen done which was WNL & labs which revealed amylase of 59.  Sent to ER for admission.  In hospital, pain free & completely asymptomatic after initial pain med.
Age: 50.0
Sex: M
Vaccine: HEPAB, IPV, PPV, TDAP, TYP, YF, HEPAB, IPV, PPV, TDAP, TYP, YF
Symptoms: Pancreatitis, Serology test
Clinical narrative: Developed Pancreatitis.  3/25/08 Reviewed hospital medical records of 2/12-2/14/2008. FINAL DX: Acute pancreatitis, etiology unclear. Records reveal patient experienced recurrent abdominal pain.  Started 4 days prior & resolved, recurred more severely on day of admission.  Had been on business trip out of country 2 wks prior to pain.  Seem by pcp & had outpatient US of abdomen done which was WNL & labs which revealed amylase of 59.  Sent to ER for admission.  In hospital, pain free & completely asymptomatic after initial pain med.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Glomerulonephritis
Clinical narrative: Medical history and concomitant medications were not reported. The patient received FluMist vaccine on 19-Nov-2007. On 23-Nov-2007, four days after receiving FluMist vaccine, the patient developed glomerunephritis. No additional information was reported. The event of glomerulonephritis subsequently resolved on an unreported date. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The sponsor considered the glomerulonephritis an important medical event. The reporting source of this case is spontaneous, thus the reporter's comment is not applicable.
Age: 0.59
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluviron given. Rec for >4yrs. Marked on box not actual vial. No Reaction
Age: 0.88
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25ml Fluvirin given, rec >4 yrs.  No reaction.
Age: 1.01
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given.  Rec for 74 yrs.  No reaction.
Age: 0.9
Sex: F
Vaccine: UNK
Symptoms: No adverse reaction
Clinical narrative: 0.25ml Fluviron given Rec for >4 yrs no reaction
Age: 0.77
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluvirin given, rec >4 yrs, no reaction.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluviron given Rec >4 yrs no reaction
Age: 1.21
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluvirin given, >4yrs rec, no reaction.
Age: 0.8
Sex: F
Vaccine: UNK
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given.  Rec 74 years.  No reaction.
Age: 0.56
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluviron given > 4 yrs Rec no reaction
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25ml Fluviron given Rec >4yrs; No reaction
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given.  Rec 74 yrs.  No reaction.
Age: 0.81
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluvirin given, rec >4 yrs, no reaction.
Age: 0.7
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluviron given Rec >4 yrs no reaction
Age: 0.7
Sex: M
Vaccine: UNK
Symptoms: No adverse reaction
Clinical narrative: 0.25ml fluviron given.  Rec 74 yrs.  No reaction.
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given.  Rec 74 yrs.  No reaction.
Age: 1.57
Sex: M
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: 0.25ml Fluviron give. Rec >4yrs. Box marked but not actual vial. Pt had no Reaction.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluvirin given to pt, rec >4 yrs.  Box marked but not an actual vial.  Pt had no reaction.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.5 ml Fluviron given to pt Rec for >4 yrs. Box marked but not actual vial. Pt had no reaction
Age: 1.74
Sex: F
Vaccine: UNK
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given to patient.  Rec for 74 yrs.  Box marked but not on actual vial.  Patient had no reaction.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, HEP, PNC
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluvirin given, rec for >4 yrs.  Box marked but not on actual vial.  Pt had no reaction.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluviron given. Rec for > 4 yrs. Box marked but not on actual vial. Pt had no reaction.
Age: 0.56
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25ml Fluvirin given.  Rec for >4yrs.  Box marked but not on actual vial.  Pt had no reaction.
Age: 1.3
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given to patient.  Vaccine meant for 74 yrs.  Marked on box but not actual vial.  No reaction.
Age: 0.83
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: 0.25 ml Fluviron given. Vaccine meant > 4 yrs. Marked on box but not marked on actual vial. Pt had no reaction.
Age: 1.92
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient 0.25ml Fluviron vaccine meant for >4yrs. Box marked but not actual vial. Patient had no Reaction
Age: 1.31
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient given 0.25 ml fluviron vaccine for >4 yrs.  Marked on box.  Not marked on actual vial.  Patient had no reaction.
Age: 1.02
Sex: M
Vaccine: DTAP, HEP, PNC
Symptoms: Wrong drug administered
Clinical narrative: 0.25ml Fluviron given. Rec for >4yrs. marked on box, not on actual vial. Patient had no Reaction.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.5ml fluviron was given to patient.  Vaccine for 44 yrs and older.  Warning on box but not on actual vial.  Patient had no reaction.
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 0.25 ml fluviron given.  Vaccine meant for 44 yrs and older.  Warning on box but not on actual vial.  Patient had no reaction.
Age: 60.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Received vaccine on 1/21/08.  Noticed quarter-size red area on 1/25/08 am at site of injection.  Saw M.D. afternoon of 1/25/08.  Red area was then 50-cent size and hard.  Took Benadryl five days every 6 hrs.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Bone pain, Pain of skin, Pruritus, Rash, Skin discolouration
Clinical narrative: Rashes, itch, skin pain, bones pain, small dark poits dath come and go away for times.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pain when lifting arm almost at shoulder level (left arm). I thought the symptom might just go away on its own. Pain is near site where shot was given.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash generalised, Rash papular
Clinical narrative: Patient presented to office today with complaint of rash all over body, papular, fine erythema. Was last in office 1/28/08; Received 1 yr vaccines at that time. Rash started yesterday 2/6/08
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 8x6 cm erythema, swelling, itching (L) deltoid- Inflammatory response? Allergic? R/O early Infections.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Discomfort, Erythema
Clinical narrative: Called 2-9-08 complaining of slightly red with palpable swelling only (not visible) and discomfort.  Applied ie and took Motrin and found redness - went to ER, treated for cellulitis.  Only little improvement.  ABL 24 hours later.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Body temperature increased, Chills, Lymphadenopathy, Rash
Clinical narrative: Patient complained of rash on left shoulder and across left pectoral, swollen lymph nodes, chills.  Patient temp at 99.1 F at 0940 2 Feb 08, all other vital signs normal.  Patient was instructed to continue tylenol and sent home with 48 hours quarters.  Patient returned 4 Feb 08 with BP 138/76, temp 98.6 F, other vital signs normal.  Rash was reduced in size, vaccine site appeared to be healing well.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Non-stop inconsolable crying x 4-5 hrs
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Had adverse reaction to Varivax. Redness/Tender at injection site
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Had adverse reaction to Varivax. Red/tender at injection site
Sex: U
Vaccine: UNK
Symptoms: General symptom
Clinical narrative: Sx onset approximately 30-45 min after giving injection, then returned 5-6 hrs after taking Benadryl - see original note.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Pain
Clinical narrative: Difficulty breathing (shortness of breath), paleness, weakness, fast heart beat, dizziness, blood pressure went up to 150/75 when I'm always normal, soreness.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Pallor
Clinical narrative: Difficulty breathing (shortness of breath), paleness, weakness, fast heart beat, dizziness, blood pressure went up to 150/75 when I'm always normal, soreness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPAB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Injection site reaction, Varicella virus test positive, Virus culture
Clinical narrative: Clinical zoster same arm as vaccine administered. Information has been received from a physician concerning a 15 month old female with no pre-existing allergies, birth defects, or medical conditions, who on 06-NOV-2007 at 12:32 hours, was vaccinated with a first subcutaneous dose in the left deltoid of VARIVAX (lot # 658431/1154U). Concomitant vaccination on 06-NOV-2008 included at 12:32 hours, a first subcutaneous dose in the left deltoid of MMR II (lot #666034/0182U), at 13:30 hours a first intramuscular dose in the right deltoid of HAVRIX (lot # ahavD300aa), and at 12:13 hours, a fourth subcutaneous dose in the right deltoid of PREVNAR (lot # 870141U). There was no reported illness at the time of the vaccination. On 08-FEB-2008, the patient developed zoster in the same arm as her vaccination with VARIVAX. It was indicated that the patient was seen in the physician's office and was being treated with acyclovior. VZV Analysis by PCR was offered but the physician had already sent vesicles for culture. The samples of the lesion was collected on 09-FEB-2008. Samples were obtained from unspecified site as a swab and medin at a local hospital. They were resulted on 20-FEB-2008, by the Center for Disease COntrol and Prevention NAtional VZV Laboratory as POSITIVE, and reported specimen was adquate. It was reported that as of 21-FEB-2008, the patient had recovered. A product quality complaint was not reported. Follow up by the physician provided no additional information. Additional information is not expeceted.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPAB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Clinical zoster same arm as vaccine administered. Information has been received from a physician concerning a 15 month old female with no pre-existing allergies, birth defects, or medical conditions, who on 06-NOV-2007 at 12:32 hours, was vaccinated with a first subcutaneous dose in the left deltoid of VARIVAX (lot # 658431/1154U). Concomitant vaccination on 06-NOV-2008 included at 12:32 hours, a first subcutaneous dose in the left deltoid of MMR II (lot #666034/0182U), at 13:30 hours a first intramuscular dose in the right deltoid of HAVRIX (lot # ahavD300aa), and at 12:13 hours, a fourth subcutaneous dose in the right deltoid of PREVNAR (lot # 870141U). There was no reported illness at the time of the vaccination. On 08-FEB-2008, the patient developed zoster in the same arm as her vaccination with VARIVAX. It was indicated that the patient was seen in the physician's office and was being treated with acyclovior. VZV Analysis by PCR was offered but the physician had already sent vesicles for culture. The samples of the lesion was collected on 09-FEB-2008. Samples were obtained from unspecified site as a swab and medin at a local hospital. They were resulted on 20-FEB-2008, by the Center for Disease COntrol and Prevention NAtional VZV Laboratory as POSITIVE, and reported specimen was adquate. It was reported that as of 21-FEB-2008, the patient had recovered. A product quality complaint was not reported. Follow up by the physician provided no additional information. Additional information is not expeceted.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Pain in extremity, Syncope vasovagal
Clinical narrative: Syncope.  Pt. received vaccinations with TdaP & Influenza.  Shots L arm each separated by ~15 seconds, then received Menactra R arm & no problems, 4th vaccine Gardasil R arm.  Pt had pain with RUSH up arm & within seconds of shot fell off exam table to R side striking R frontal parietal area and few seconds LOC with vagal type appearance.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: Localized urticaria, redness, swelling at site of vaccination (left arm).
Age: 33.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Pruritus, Skin discolouration
Clinical narrative: Reports soreness at site of Tdap (L) deltoid within 1-2 days post administration. Reports itching on (L) arm w/discoloration approx. 10-14 days post injection. Continues on day of reporting. Applied warm compresses for soreness.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Both my wife and myself had severe reaction to Pneumonia shot soreness, red swelling approx. 2x 4 on underarm where shot was given. Wife had chills was at a point she just shook for about 2 hours. Both our upper arms looked like it was blown up like a balloon and hurt like hell.  Shot was given under the tender part of the arm which I had never seen before. After three days my are is still somewhat sore but wife still in some pain and still red and sore.  I would expect that I would have some kind of reaction  because of my allergic history but  with my wife getting same reaction I find it very strange and wonder if dosage was faulty.  I am 74 years of age and my wife is 65 and we have never had a reaction like this on other shot.  I called the store and asked if anyone else had a reaction to the shot and they said they had no complaints............I find that hard to believe and would appreciate if you would look into the situation. Thank you.
Age: 1.62
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Recieved DtaP and IPV on 2/8/08.  Wkoe up 2/9/08 with red, swollen left arm.  Seen in our office and diagnosed with vaccine local reaction vs. cellulitis.  Treated wih Augmentin.
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Gait disturbance, Injection site pain, Injection site swelling, Neutrophil percentage increased
Clinical narrative: Severe Pain and swelling at the site of injection. Developed fever up to 103 F. Limping with pain. Thigh X-ray within normal limits. Symptoms lasted for 4 days and treated with Ice pack, Ibuprofen and Keflex for presumed cellulitis.
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased, X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: Severe Pain and swelling at the site of injection. Developed fever up to 103 F. Limping with pain. Thigh X-ray within normal limits. Symptoms lasted for 4 days and treated with Ice pack, Ibuprofen and Keflex for presumed cellulitis.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Cellulitis, Injection site mass
Clinical narrative: Recieved Prevnar #4, Hep A #1, and Varivax on 1/29/08.  Had lump on arm for 1 week.  Seen in our office on 2/7/08 and diagnosed with right arm cellulitis s/p Varivax vaccine.  Treated with Augmentin.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Nausea
Clinical narrative: 2 minutes after receiving the Gardasil vaccine patient had vagal episode and hit left frontal area of head on cement floor.  Resulted in 20 second tonic seizure.  After seizure patient remained dizzy and nauseated.  Taken to ER for cervical spine films and head CT - both negative.  Patient discharged from ER with Zofran and Motrin.  Almost 24 hours later patient still dizzy and nauseated.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Scan brain, Spinal X-ray normal, Syncope vasovagal, Tonic convulsion
Clinical narrative: 2 minutes after receiving the Gardasil vaccine patient had vagal episode and hit left frontal area of head on cement floor.  Resulted in 20 second tonic seizure.  After seizure patient remained dizzy and nauseated.  Taken to ER for cervical spine films and head CT - both negative.  Patient discharged from ER with Zofran and Motrin.  Almost 24 hours later patient still dizzy and nauseated.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Patient was given the Menactra Vaccine on 11/6/07.  The patient was then given the Menactra vaccine agian on 2/14/08.  The patient did complain of any side effects.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Face oedema, Oedema peripheral, Pruritus generalised
Clinical narrative: 24 hours after receiving her first dose of Gardasil, the patient developed edema in her face, hands and feet, which lasted until 2-14-08.  She also had generalized itching from the neck down, which lasted for 24 hours.  She reported these side effects to her physician on 2-14-08.
Age: 1.02
Sex: M
Vaccine: PNC
Symptoms: Cough, Decreased appetite, Dyspnoea, Influenza serology negative, Pyrexia
Clinical narrative: Onset of fever approximately 24 hours after receiving vaccination. Fever range from 101-103 degrees Fahrenheit.  Decreased appetite, coughing, labored breathing.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Body temperature increased, Gaze palsy, Unresponsive to stimuli
Clinical narrative: Patient's temperature was 103 degrees.  Patient became unresponsive and his eyes rolled back.  Mom called our office and then 911.  Patient transferred to local hospital and discharged home.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt seen in clinic 2/11/08 w/c/o large erythema, swollen, painful L upper arm. No rash or sob. pt assessed by RN and initially, then scheduled with physician and treated with IV Rocephin 2 grams on 2/11/08 and 2/12/08. On 2/13/08, Cephalexin 500mg tid x10 days prescribed.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Acoustic stimulation tests, Sudden infant death syndrome
Clinical narrative: NO ADVERSE REACTIONS AT TIME OF VACCINATION. CHILD WAS EXAMINED BY PHYSICIAN AND DEEMED HEALTHY. CHILD WENT HOME ALERT AND SHOWING NO NEGATIVE SYMPTOMS BUT WE WERE ADVISED BY CORONER'S OFFICE ON FEBRUARY 14, 2008 THAT BABY DIED. CORONER'S OFFICE DOES NOT KNOW CAUSE OF DEATH -- POSSIBLE SIDS.    2/19/08 Reviewed provisional autopsy which states COD as SIDS.  Patient co-sleeping w/parents & unresponsive when parent awoke.  Both parents smoke in home.  Mother w/gestational diabetes.  Home unkept & narcotics found in home.  3/13/08 Reviewed autopsy report which is unchanged from prelim autopsy.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to arthropod bite, Allergy to vaccine, Burning sensation, Drug hypersensitivity, Erythema
Clinical narrative: Patient received her third Gardasil vaccine 2 months too soon. She has had frequent breakouts of a hive type rash, which required three hospitalizations resulting in IV medication. She was prescribed cortisone and Benadryl. I recently found out the vaccine contains a sulfur ingredient, which my daughter is allergic and which she stated upon doctor visit when history was obtained. Patient still experiences breakouts as recently as two weeks ago. Follow-up Information 04-Sep-2008: I am writing to update my daughter's symptoms. She has continuous hive/type rash breakouts on her face and left arm. Her face will be red and swollen and her lips get puffy. In January 2008, she went to the emergency room and, as several times before, she was given IV medication and Benadryl. In July 2008, she was at the emergency room twice in three days became of insect bites that were swollen and red and also spread to the size of a small plate on her leg. The doctor and a couple of his colleagues had never seen anything like it. He outlined the bite to make sure it didn't spread. Each time, my daughter had been outside no longer than ten minutes and was the only one to have such a reaction. In August 2008, she returned to the emergency room with swollen, red palms of her hands and soles of her feet, which were very painful with a burning sensation. Seven doctors examined my daughter and were baffled. They decided to test her for everything possible. The test results were negative and the symptoms lasted for three to four days. Also, my daughter was given antibiotics to treat the insect bites and the hands/feet episode. I am very concerned that the Gardasil vaccine may have changed my daughter's metabolism especially since she is allergic to sulfur drugs, and the vaccine has a sulfur ingredient, and the vaccine was improperly administered by being given to my daughter two months too soon (the third injection). Please feel free to contact me at any time. I appreciate your attention to this matter.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Laboratory test normal, Lip swelling, Oedema peripheral, Palmar erythema
Clinical narrative: Patient received her third Gardasil vaccine 2 months too soon. She has had frequent breakouts of a hive type rash, which required three hospitalizations resulting in IV medication. She was prescribed cortisone and Benadryl. I recently found out the vaccine contains a sulfur ingredient, which my daughter is allergic and which she stated upon doctor visit when history was obtained. Patient still experiences breakouts as recently as two weeks ago. Follow-up Information 04-Sep-2008: I am writing to update my daughter's symptoms. She has continuous hive/type rash breakouts on her face and left arm. Her face will be red and swollen and her lips get puffy. In January 2008, she went to the emergency room and, as several times before, she was given IV medication and Benadryl. In July 2008, she was at the emergency room twice in three days became of insect bites that were swollen and red and also spread to the size of a small plate on her leg. The doctor and a couple of his colleagues had never seen anything like it. He outlined the bite to make sure it didn't spread. Each time, my daughter had been outside no longer than ten minutes and was the only one to have such a reaction. In August 2008, she returned to the emergency room with swollen, red palms of her hands and soles of her feet, which were very painful with a burning sensation. Seven doctors examined my daughter and were baffled. They decided to test her for everything possible. The test results were negative and the symptoms lasted for three to four days. Also, my daughter was given antibiotics to treat the insect bites and the hands/feet episode. I am very concerned that the Gardasil vaccine may have changed my daughter's metabolism especially since she is allergic to sulfur drugs, and the vaccine has a sulfur ingredient, and the vaccine was improperly administered by being given to my daughter two months too soon (the third injection). Please feel free to contact me at any time. I appreciate your attention to this matter.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling face
Clinical narrative: Patient received her third Gardasil vaccine 2 months too soon. She has had frequent breakouts of a hive type rash, which required three hospitalizations resulting in IV medication. She was prescribed cortisone and Benadryl. I recently found out the vaccine contains a sulfur ingredient, which my daughter is allergic and which she stated upon doctor visit when history was obtained. Patient still experiences breakouts as recently as two weeks ago. Follow-up Information 04-Sep-2008: I am writing to update my daughter's symptoms. She has continuous hive/type rash breakouts on her face and left arm. Her face will be red and swollen and her lips get puffy. In January 2008, she went to the emergency room and, as several times before, she was given IV medication and Benadryl. In July 2008, she was at the emergency room twice in three days became of insect bites that were swollen and red and also spread to the size of a small plate on her leg. The doctor and a couple of his colleagues had never seen anything like it. He outlined the bite to make sure it didn't spread. Each time, my daughter had been outside no longer than ten minutes and was the only one to have such a reaction. In August 2008, she returned to the emergency room with swollen, red palms of her hands and soles of her feet, which were very painful with a burning sensation. Seven doctors examined my daughter and were baffled. They decided to test her for everything possible. The test results were negative and the symptoms lasted for three to four days. Also, my daughter was given antibiotics to treat the insect bites and the hands/feet episode. I am very concerned that the Gardasil vaccine may have changed my daughter's metabolism especially since she is allergic to sulfur drugs, and the vaccine has a sulfur ingredient, and the vaccine was improperly administered by being given to my daughter two months too soon (the third injection). Please feel free to contact me at any time. I appreciate your attention to this matter.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Pt received Twinrix vaccine.  2 hours after the vaccination, she developed Hives on neck, arms, trunk of body.  Nasal congestion also occurred.  She took Zyrtec at that time, and 4 hours later the symptoms were gone.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Abscess, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: PRESENTED TO OUR OFFICE 02/13/2008 COMPLAINING OF REDNESS, SWELLING AND PALPABLE LUMP THAT WAS WARM TO TOUCH IN THE AREA WHERE VARIVAX WAS ADMINISTERED 02/04/2008. DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Arthralgia, Headache
Clinical narrative: Patient complains of headaches and joint pain that started 1 day after vaccination. Patient states pain has been a constant 4 out of 10 on a pain scale of 0-10. Patient has experienced headaches and joint pain over a month to date.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Antinuclear antibody negative, Arthralgia, Diarrhoea, Erythema, Headache
Clinical narrative: Patient complains of headaches and joint pain that started 1 day after vaccination. Patient states pain has been a constant 4 out of 10 on a pain scale of 0-10. Patient has experienced headaches and joint pain over a month to date.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Hepatitis viral test, Metabolic function test, Metabolic function test normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Patient complains of headaches and joint pain that started 1 day after vaccination. Patient states pain has been a constant 4 out of 10 on a pain scale of 0-10. Patient has experienced headaches and joint pain over a month to date.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Rheumatoid factor negative, Skin warm, Swelling, Urine analysis normal, Vaccine positive rechallenge
Clinical narrative: Patient complains of headaches and joint pain that started 1 day after vaccination. Patient states pain has been a constant 4 out of 10 on a pain scale of 0-10. Patient has experienced headaches and joint pain over a month to date.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Abscess, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: PRESENTED COMPLAINING OF SWELLING, WARMTH AND RED LUMP ON LEFT THIGH AT SITE WHERE HE RECEIVED A VARIVAX.  DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Abscess sterile, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PRESENTED COMPLAINING OF SWELLING, WARMTH AND RED LUMP ON LEFT THIGH AT SITE WHERE HE RECEIVED A VARIVAX.  DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.
Age: 14.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was ordered for TdaP, but nurse inadvertently administered DTaP.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site vesicles, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Full case of Varicella per parents reliable history with healed crusted lesions over entire body on exam 13d after administration, lesions particularly centered at administration site.  Purely subjectively but clinic seems to have a recently increased incidence of (usually local) side effects from Varivax of same lot number (though several lots currently in use in clinic) supplied by state.  I am physician MD, partner of administering physician, who saw patient in follow-up.
Age: 1.01
Sex: M
Vaccine: FLU3, PNC, VARCEL
Symptoms: Abscess, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PRESENTED TO OFFICE 11/12/2007 COMPLAINING OF REDNESS, HEAT AND SWELLING OF RIGHT THIGH AT SITE OF PREVIOUS VACCINE.  DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Blood immunoglobulin M, CSF lymphocyte count increased, CSF protein increased, Constipation, Encephalitis
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.