chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Somnolence
Clinical narrative: 5/13/07 Woke up with body ache and joint pain shoulders, ribs, hips and back and forearm pain significant lethargy, sleepiness, difficulty staying audile except for attempts to keep warm or cool off due to chills and excessive heart episodes. No temperature taking Tylenol for bodyaches - x 2 days, better 3rd day but weak.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria, Vomiting
Clinical narrative: Information has been received concerning a 2-month-old male with atopic dermatitis who on 20-JUL-2006, at 1430, was vaccinated PO with the first dose of Rotateq (Lot #653915/0389F). Concomitant vaccinations administered on that same day included the first dose in the left leg of DTaP (Lot# C2406AA), the first dose in the left leg of IPOL (Lot #Y1068), the first dose in the right leg of ActHib (Lot #UE878AA) and the first dose in the right leg of Prevnar (Lot #B08658C). There was no illness at the time of vaccination. It was reported that on approximately 20-JUL-2006, the patient developed hives and vomited once at home which lasted for approximately one hour. At the time of this report, the patient was noted to be recovered. The reporter considered hives and vomiting to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Erythema, Pruritus generalised, Throat irritation, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no known allergies or pertinent medical history who on 25-APR-2007 was vaccinated with a dose of ProQuad (lot # 657265/0293U). Concomitant therapy included a dose of Dtp (manufacturer unknown) and poliovirus vaccine (manufacturer unknown). On 25-APR-2007, immediately after the injection, the patient developed hives and became short of breath. The patient was treated with BENADRYL and epinephrine injections and was hospitalized overnight. The patient was referred to and ear, nose and throat specialist to determine if an underlying allergy was the reason for the reaction, no underlying cause was found. There was no product quality complaint involved. No further information was available. The patient's experiences were considered serious for hospitalization, life threatening and other important medical events. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no known allergies or pertinent medical history who on 25-APR-2007 was vaccinated with a dose of ProQuad (lot # 657265/0293U). Concomitant therapy included a dose of Dtp (manufacturer unknown) and poliovirus vaccine (manufacturer unknown). On 25-APR-2007, immediately after the injection, the patient developed hives and became short of breath. The patient was treated with BENADRYL and epinephrine injections and was hospitalized overnight. The patient was referred to and ear, nose and throat specialist to determine if an underlying allergy was the reason for the reaction, no underlying cause was found. There was no product quality complaint involved. No further information was available. The patient's experiences were considered serious for hospitalization, life threatening and other important medical events. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0704USA06507. The initial reporter to this manufacturer was a physician. "Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant therapy included Menactra. Subsequently on an unspecified date, the patient "passed out" 15 minutes after receiving Gardasil. The patient was sent to the hospital but the length of stay was unknown. Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested."
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Blister, Cellulitis, Incisional drainage, Rash, Staphylococcal infection
Clinical narrative: proquad and prevnar vaccine administered on 04/05/2007, developed cellulitis abcess.  He had vesicular lesions at injection site.  07/02/2007 MR received which included an Operative Report of 4/24/2007 for an I&D of a right lateral thigh abscess and an admission note of 5/23/2007 for cellulitis/buttocks abscess.    Child initially presented with a vesicular rash on the right buttocks which progressed despite tx with abx and Acyclovir.  Admitted 4/23/07 for tx which required I&D.  The episode resolved however the child presented on 5/22/07 with a 3 day hx of fever and a pustular red lesion which was spreading.  DX: Cellulitis/ buttocks abscess.
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Varicella
Clinical narrative: proquad and prevnar vaccine administered on 04/05/2007, developed cellulitis abcess.  He had vesicular lesions at injection site.  07/02/2007 MR received which included an Operative Report of 4/24/2007 for an I&D of a right lateral thigh abscess and an admission note of 5/23/2007 for cellulitis/buttocks abscess.    Child initially presented with a vesicular rash on the right buttocks which progressed despite tx with abx and Acyclovir.  Admitted 4/23/07 for tx which required I&D.  The episode resolved however the child presented on 5/22/07 with a 3 day hx of fever and a pustular red lesion which was spreading.  DX: Cellulitis/ buttocks abscess.
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Abscess, Abscess drainage, Antimicrobial susceptibility test resistant, Cellulitis, Injection site vesicles
Clinical narrative: proquad and prevnar vaccine administered on 04/05/2007, developed cellulitis abcess.  He had vesicular lesions at injection site.  07/02/2007 MR received which included an Operative Report of 4/24/2007 for an I&D of a right lateral thigh abscess and an admission note of 5/23/2007 for cellulitis/buttocks abscess.    Child initially presented with a vesicular rash on the right buttocks which progressed despite tx with abx and Acyclovir.  Admitted 4/23/07 for tx which required I&D.  The episode resolved however the child presented on 5/22/07 with a 3 day hx of fever and a pustular red lesion which was spreading.  DX: Cellulitis/ buttocks abscess.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Asthenia, Diarrhoea, Injection site swelling, Metabolic disorder, Pallor
Clinical narrative: Information has been received from a physician concerning a 47 month old female with no known allergies or pertinent medical history who on 10-MAY-2007 was vaccinated with a dose of ProQuad (lot # 657297/0429U). Concomitant therapy included a dose of DTP (manufacturer unknown) and a dose of poliovirus vaccine (manufacturer unknown). Subsequently, in the evening, following vaccination, the patient developed a fever, vomiting, a rash, and injection site pain. The patient presented to the emergency room and was treated for dehydration with intravenous fluid replacement. No lab studies were performed. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be life threatening. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Pyrexia, Trismus, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning a 47 month old female with no known allergies or pertinent medical history who on 10-MAY-2007 was vaccinated with a dose of ProQuad (lot # 657297/0429U). Concomitant therapy included a dose of DTP (manufacturer unknown) and a dose of poliovirus vaccine (manufacturer unknown). Subsequently, in the evening, following vaccination, the patient developed a fever, vomiting, a rash, and injection site pain. The patient presented to the emergency room and was treated for dehydration with intravenous fluid replacement. No lab studies were performed. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be life threatening. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Dehydration, Fluid replacement, Injection site pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 47 month old female with no known allergies or pertinent medical history who on 10-MAY-2007 was vaccinated with a dose of ProQuad (lot # 657297/0429U). Concomitant therapy included a dose of DTP (manufacturer unknown) and a dose of poliovirus vaccine (manufacturer unknown). Subsequently, in the evening, following vaccination, the patient developed a fever, vomiting, a rash, and injection site pain. The patient presented to the emergency room and was treated for dehydration with intravenous fluid replacement. No lab studies were performed. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be life threatening. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTP, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 47 month old female with no known allergies or pertinent medical history who on 10-MAY-2007 was vaccinated with a dose of ProQuad (lot # 657297/0429U). Concomitant therapy included a dose of DTP (manufacturer unknown) and a dose of poliovirus vaccine (manufacturer unknown). Subsequently, in the evening, following vaccination, the patient developed a fever, vomiting, a rash, and injection site pain. The patient presented to the emergency room and was treated for dehydration with intravenous fluid replacement. No lab studies were performed. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be life threatening. A lot check has been requested. Additional information has been requested. This is one of several reports from the same source.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema, Intussusception, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a physician concerning a 14-week-old female with a history of GERD and no drug reactions/allergies who on 04-APR-2007 was vaccinated PO with a dose of Rotateq. Concomitant therapy included nizatidine (AXID). On 15-MAY-2007 the patient experienced intussusception and was hospitalized for surgical correction. At the time of the report, the patient remained hospitalized. The outcome was unknown. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 14-week-old female with a history of GERD and no drug reactions/allergies who on 04-APR-2007 was vaccinated PO with a dose of Rotateq. Concomitant therapy included nizatidine (AXID). On 15-MAY-2007 the patient experienced intussusception and was hospitalized for surgical correction. At the time of the report, the patient remained hospitalized. The outcome was unknown. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blister, Hypoaesthesia, Pain in extremity, Rash, Skin discolouration
Clinical narrative: Left deltoid blister after 24-48 hr of shot  which turned dark black 3-4 minutes slightly different site laterally of shot - when bandaid was pulled off. Also c/o left arm pain- numbness weakness slight after shot 24-48 which subsided when came to here on 5/22/07. Also history of reddish rash around vaccine site date not witnessed on 5/22/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Irritability and excessive crying x 24 hours. Tx with Tylenol Q 4 hrs x 24 hours and Benadryl BID x 2 doses
Age: 19.0
Sex: M
Vaccine: MMRV
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Pt came for MMR vaccine given MMR with Varicella
Age: 4.0
Sex: F
Vaccine: DTP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Over upper injection site and lower injection site is a 11 cm wide x 8cm high erythematous flare. Complaints of tenderness with palpation over injection site
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Cardiac electrophysiologic study, Full blood count, Jaundice, Ocular icterus, Tenderness
Clinical narrative: Yellowed Eyes, Arm Tenderness, Mild Jaundice
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Urine analysis, Visual evoked potentials
Clinical narrative: Yellowed Eyes, Arm Tenderness, Mild Jaundice
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Initial report received on 10 May 2007 from a health care professional. A 15-year-old female patient, with no known past medical history, had received a left deltoid, intramuscular injection of Menactra, lot number U2228AA; and a right deltoid, intramuscular injection of Gardasil, lot number 0389U; on 07 May 2007. On the same day following vaccination, the patient "passed out" and fell to the floor. She was unresponsive for approximately 40 seconds. The patient did not experience any respiratory distress, and the event fully resolved without medical intervention.
Sex: U
Vaccine: FLUX
Symptoms: Cutaneous vasculitis, Leukocytoclastic vasculitis, Renal disorder, Urine analysis abnormal
Clinical narrative: Initial information received on 10 May 2007 as a result of a literature abstract that was acquired secondary to the report from a patient's parent (separately reported case). Per the citation, "We describe four cases of leucocytoclastic vasculitis following influenza vaccination. The four patients, who were all elderly, presented with cutaneous vasculitis but all had abnormal urinalysis suggestive of associated renal involvement." Additional information was not reported. The reporter in this case is the same as for case 2007-01692.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Barium double contrast, Inappropriate schedule of drug administration, Intussusception, Surgery
Clinical narrative: Intussusception requiring surgical reduction  6/25/07 Received hospital outpatient clinic med recs which reveal patient seen at another hospital.  Letter faxed to correct hospital to request med recs.  Patient seen in ER on 5/11 for persistent vomiting, dehydration & heme + stool.  US revealed +IS.  Air enema reduction was not successful & taken to OR.  D/C to home on 5/12/07.  Developed candida diaper rash s/p surgery.  7/3/07 Received hospital medical records which reveal patient experienced vomiting & constipation & recent URI.  Admitted 5/10-5/12/07.  Surg consult done s/p unsuccessful enema reduction.  Taken to OR for +IS which spontaneously reduced, appendectomy done.  Did well post operatively & d/c to home FINAL DX: Intussusception.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Barium double contrast, Intussusception, Surgery, Ultrasound abdomen
Clinical narrative: Intussusception requiring surgical reduction  6/25/07 Received hospital outpatient clinic med recs which reveal patient seen at another hospital.  Letter faxed to correct hospital to request med recs.  Patient seen in ER on 5/11 for persistent vomiting, dehydration & heme + stool.  US revealed +IS.  Air enema reduction was not successful & taken to OR.  D/C to home on 5/12/07.  Developed candida diaper rash s/p surgery.  7/3/07 Received hospital medical records which reveal patient experienced vomiting & constipation & recent URI.  Admitted 5/10-5/12/07.  Surg consult done s/p unsuccessful enema reduction.  Taken to OR for +IS which spontaneously reduced, appendectomy done.  Did well post operatively & d/c to home FINAL DX: Intussusception.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Coordination abnormal, Guillain-Barre syndrome, Nuclear magnetic resonance imaging normal, Visual field defect
Clinical narrative: Fisher variant of Guillian Barre with ataxia, L6th, L5th, accommodation, also R tract lesion with L periph visual loss L>R eye.  6/12/07 Received hospital records from provider which included consults, ER records, labs & x-ray reports as well as provider notes & vax record.  Returned to office on10/13 w/complaints of right ear pain & tx w/drops but worsened & was placed on antibiotics 10/16/06.  Seen 10/23 for med adjustments.  Returned on 12/13/06 for left eye visual field deficit for approx 4-5 mos & for last 6 weeks numbness on left cheek.  Returned to office 12/19/06 w/worsened vision loss left eye, vision loss comes/goes & occasionally was blinded in left eye. Trigeminal nerve weakness noted.  Referred to neuro opthamologist who dx w/fisher variant of GBS.  Vision improved.  On 4/11/07 returned to office stating had lost vision completely for 90 min approx 1 mo earlier & had been having a lot of double vision & seeing spots.  Opth thought ocular migraine (hx ocular migraine).  Neuro consult indicates that patient experienced flu-like symptoms for about 3 weeks s/p flu shot & prior to developing vision problems.  Continued w/ gait & balance disturbance, fatigue,  & resolving droopy left eyelid.  Neuro could not provide dx other than possibly early MS.  Patient seen in ER on 12/18/06 for severe HA, pressure behind left eye & tingling on left side of face. FINAL DX: Fisher variant of Guillian Barre syndrome.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Receive vaccine 5/2/07 L deltoid. No initial reaction (no fever, pain, swelling at site). On 5/9/07 noticed painful swelling L deltoid with redness, increased to maximum size evening 5/9/07. Pt seen on 5/10/07 and had 2 1/2 cm subcutaneous erythematous area of induration - mobile, mildly tender on left deltoid (pt said smaller then previous night). On phone following 5/12/07 pt said swelling almost gone (only small bump - nontender).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site nodule, Injection site rash, Injection site urticaria
Clinical narrative: Developed firm nodule under injections site and an urticarial rash, spreading approx 7 cm distal to puncture site.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pain, Nausea
Clinical narrative: Vaccination given 05/07/07. Patient reports dizziness and nausea starting 5/09/07 et continues. 5/14/07 redness et hardness noted at injection site. Injection site s/s worsened 5/15/07. On 5/16/07 site less red with 1.2 cm hardened area noted with slight tenderness.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Tdap and Varicella immunization Rxn to L arm size 7x7x7
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Band neutrophil count increased, Fatigue, Full blood count, Laboratory test normal
Clinical narrative: Received HPV #2 at 1315 on 3/09/07. Did become faint immed after but ok after rest and P liquids. Came to clinic on 3/11/07 eve and reports multiple symptoms: fatigue, fever, aches, stomach pain and nausea; returned again on 3/12/07. She believes these s/s were due to HPV vacc. TX: CL's and rest. Refused RX. Labs WNL with Bands Sl increased.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: Received HPV #2 at 1315 on 3/09/07. Did become faint immed after but ok after rest and P liquids. Came to clinic on 3/11/07 eve and reports multiple symptoms: fatigue, fever, aches, stomach pain and nausea; returned again on 3/12/07. She believes these s/s were due to HPV vacc. TX: CL's and rest. Refused RX. Labs WNL with Bands Sl increased.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: Received HPV #2 at 1315 on 3/09/07. Did become faint immed after but ok after rest and P liquids. Came to clinic on 3/11/07 eve and reports multiple symptoms: fatigue, fever, aches, stomach pain and nausea; returned again on 3/12/07. She believes these s/s were due to HPV vacc. TX: CL's and rest. Refused RX. Labs WNL with Bands Sl increased.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was brought into have a well child and immunizations completed. In the process of drawing up immunizations other nurse offered to help. When I informed her that I needed the PCV serum the PPV was brought out and drawn up. Instead of double checking the serum the immunizations were administered.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Patient was brought in to have a well child immunizations completed. In the process of drawing up the immunizations. Offered to help. When I informed that I needed PCV serum the PPV was brought out and drawn up instead if checking these in the immunizations were administered.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Hard red lump within 24 hours.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with an infected toe and a OMNICEF /allergy who on 07-MAY-2007was vaccinated SC with a 0.5 ml dose of ProQuad (lot # 657183/0299U). Concomitant therapy included an unspecified antibiotic for a toe infection. On 08-MAY-2007 the patient experienced swelling, redness and warmth at the injection site. Unspecified medical attention was sought in the emergency room on an unspecified date. There were no lab tests performed. The patient was then seen in the office on 10-MAY-2007 and it was noted that the swelling, redness and warmth was getting less. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be other important medical events because the patient was taken to the emergency room. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal movements decreased, Inappropriate schedule of drug administration, Intra-uterine death
Clinical narrative: Information has been received from a physician through a manufacturer pregnancy registry concerning a 32 year old female with a history of 5 pregnancies and 4 live births (one fetal loss at 16-20 weeks) who on 13-FEB-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F). Concomitant medication was not reported. On 13-NOV-2006, an ultrasound was performed results reported were fetal leiometry which corresponds the size and dates. On 04-DEC-2006, serum alpha-fetoprotein test was performed results were negative. On 13-FEB-2007, after the patient was vaccinated with Gardasil, the physician found out that the patient was pregnant. The physician reported that the pregnancy was normal to date. Follow-up information has been received from a physician. On 13-JAN-2007, an ultrasound performed showed adequate fetal growth since last sonography and fetal anatomy appears to be normal. On 13-APR-2007, an ultrasound performed showed biophysical profile 8/8, AFI 20.5 cm, S/D ratio 2.71, cervical length 4.44cm. On 23-APR-2007, an ultrasound performed showed adequate fetal growth since last ultrasound AFI 12.1 cm. On 24-APR-2007, the patient was diagnosed with intrauterine fetal demise and a female infant was delivered on 26-APR-2007 at 06:40, 3.235 kg. The placenta and cord were sent to pathology with no pathological diagnosis. Autopsy was refused. Clinically fetal death was due to cord accident, long umbilical cord, around body once and legs twice. Upon internal review, intrauterine fetal demise and umbilical cord complication were considered to be other important medical events. Additional ifnormation is not expected.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, Ultrasound scan abnormal, Ultrasound scan normal, Umbilical cord abnormality
Clinical narrative: Information has been received from a physician through a manufacturer pregnancy registry concerning a 32 year old female with a history of 5 pregnancies and 4 live births (one fetal loss at 16-20 weeks) who on 13-FEB-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F). Concomitant medication was not reported. On 13-NOV-2006, an ultrasound was performed results reported were fetal leiometry which corresponds the size and dates. On 04-DEC-2006, serum alpha-fetoprotein test was performed results were negative. On 13-FEB-2007, after the patient was vaccinated with Gardasil, the physician found out that the patient was pregnant. The physician reported that the pregnancy was normal to date. Follow-up information has been received from a physician. On 13-JAN-2007, an ultrasound performed showed adequate fetal growth since last sonography and fetal anatomy appears to be normal. On 13-APR-2007, an ultrasound performed showed biophysical profile 8/8, AFI 20.5 cm, S/D ratio 2.71, cervical length 4.44cm. On 23-APR-2007, an ultrasound performed showed adequate fetal growth since last ultrasound AFI 12.1 cm. On 24-APR-2007, the patient was diagnosed with intrauterine fetal demise and a female infant was delivered on 26-APR-2007 at 06:40, 3.235 kg. The placenta and cord were sent to pathology with no pathological diagnosis. Autopsy was refused. Clinically fetal death was due to cord accident, long umbilical cord, around body once and legs twice. Upon internal review, intrauterine fetal demise and umbilical cord complication were considered to be other important medical events. Additional ifnormation is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Evans syndrome, Eye disorder, Idiopathic thrombocytopenic purpura, Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or known drug reactions or allergies who on 03-JAN-2007 was vaccinated with Gardasil 0.5 ml injection. In February 2007, the patient experienced heavy menstrual bleeding, nose bleeds and eye problems and was hospitalized for four days (admittance and discharge dates not reported), and while hospitalized was diagnosed with Evans syndrome. The patient needed a blood transfusion. The patient's Evans syndrome persisted. There was no product quality complaint. Additional information has been requested. 06/06/07-records received from facility for DOS 5/7-5/10/07. DC DX: Evan's Syndrome, immune thrombocytopenia and anemia. Prolonged episode of epistaxis. HX: Nosebleeds frequently since age of 3 or 4. In last 4 weeks have increased in frequency 6-7 times per day, harder to stop. Prior to admission nosebleed from 21:30 through 9:30 with nausea and bloody emeses. HX of bruising easily. Menses 3 days longer in duration and heavier with clotting and clumps. Petechia on lower extremities, more tired or fatigued. Feels faints if she stands up too quickly. Black out this morning. Fell.  Follow up visits 5/17/07: Impression Evan's Syndrome, Strong family history of autoimmunity. Abnormal labs including positive ANA, low complement.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Transfusion
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or known drug reactions or allergies who on 03-JAN-2007 was vaccinated with Gardasil 0.5 ml injection. In February 2007, the patient experienced heavy menstrual bleeding, nose bleeds and eye problems and was hospitalized for four days (admittance and discharge dates not reported), and while hospitalized was diagnosed with Evans syndrome. The patient needed a blood transfusion. The patient's Evans syndrome persisted. There was no product quality complaint. Additional information has been requested. 06/06/07-records received from facility for DOS 5/7-5/10/07. DC DX: Evan's Syndrome, immune thrombocytopenia and anemia. Prolonged episode of epistaxis. HX: Nosebleeds frequently since age of 3 or 4. In last 4 weeks have increased in frequency 6-7 times per day, harder to stop. Prior to admission nosebleed from 21:30 through 9:30 with nausea and bloody emeses. HX of bruising easily. Menses 3 days longer in duration and heavier with clotting and clumps. Petechia on lower extremities, more tired or fatigued. Feels faints if she stands up too quickly. Black out this morning. Fell.  Follow up visits 5/17/07: Impression Evan's Syndrome, Strong family history of autoimmunity. Abnormal labs including positive ANA, low complement.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Dermatomal vesicular rash began 4 days after varicella #2 vaccine and with acyclovir with improvement resolved lypopigmented area mandibalardermatone. History eczema.
Age: 51.0
Sex: M
Vaccine: TTOX
Symptoms: Feeling cold, Headache, Pyrexia, Tremor, Wheezing
Clinical narrative: Was injected with Tetanus @ 9:30am about 4:30 pm began shaking and freezing for 2 1/2 hours, then wheezing for 1 1/2 hours then high fever and bad headache.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: 3 inches wide - increased redness (1 inch) in center - per doctor - Keflex 500mg 1 BID x 10
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Nystagmus, Pyrexia, Vertigo
Clinical narrative: Mild vertigo, nausea and fever. Exam: mild mystagmus. Rx: meclyin
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Induration, Musculoskeletal discomfort, Musculoskeletal pain, Oedema peripheral, Skin warm
Clinical narrative: Around 7:00 p.m. on 5/17/07 right arm became swollen, tender, har to touch and warm.  Swollen area is 80 mm x 80 mm.  Also, shoulder pain and discomfort began around 9:00 p.m. on 5/17/07.  Ice pack to affected area.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Around 7:00 p.m. on 5/17/07 right arm became swollen, tender, har to touch and warm.  Swollen area is 80 mm x 80 mm.  Also, shoulder pain and discomfort began around 9:00 p.m. on 5/17/07.  Ice pack to affected area.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Flushing, Urticaria, Wheezing
Clinical narrative: FLUSHING WITH URTICARIA, SHORTNESS OF BREATH WITH WHEEZING WITHIN 30 MINUTES OF VACCINE ADMINISTRATION.  TREATED WITH IV STEROIDS, ANTIHISTAMINES, EPINEPHRINE
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Body temperature increased, Rash, Staphylococcal infection, Vaccination complication
Clinical narrative: Five days after receiving the Chicken Pox Vaccine, my son started breaking out with sores.  They got very large in size and oozed and bled.  He ran a high temperature for four days.  He broke out for eleven days before being put into the hospital by his doctor for staph infection due to reaction to Chicken Pox vaccine.  He was treated with Clendomycin through an IV for three days.  After his release from the hospital he is taking seven days of Cefelexin.  We are also treating the sores with Bactroban.  07/02/2007 MR received for 2 night admission 5/16-18/2007 for a skin infection. Child began to break out in vesicular lesions approx 1 week after Varicella vax. Topical antibiotic tried initially, but lesions continued to spread and fever developed. Admitted with dx of bullous impetigo. PE significant for crusted vesicular lesions and crusty green nasal discharge. Txd with IV and po abx and hydroxyzine. Discharge DX:  MSSA Impetigo.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Death.  6/12/07 Received Autopsy Report which reveal COD as Undetermined.  Found unresponsive face down in bed between parents (anamnestic).  No anomalies, trauma, infectious agents or metabolic anomalies detected.  Toxicology revealed acetaminophen 6.5 mcg/mL; fluconazole + & caffeine. 6/25/07 Received vax record from pcp which confirms RO lot & dose # as reported.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Fatigue, Pyrexia, Rash papular, Skin lesion
Clinical narrative: fatique, loss of appetite, 5-6 paplular lesions, non-umbilicated, 5 of them very small over upper torso and 2 over face
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Condition aggravated, Laboratory test, Muscular weakness, Neurological examination, Pain in extremity
Clinical narrative: Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Balance disorder, C-reactive protein normal, Fatigue, Muscular weakness
Clinical narrative: Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, C-reactive protein normal, Condition aggravated, Fatigue, Guillain-Barre syndrome
Clinical narrative: Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Muscular weakness, Myalgia, Neurological examination normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Age: 1.25
Sex: F
Vaccine: MMRV, PNC, MMRV, PNC
Symptoms: Rash
Clinical narrative: Severe rash 10 days after vaccination of MMRV
Age: 1.25
Sex: F
Vaccine: MMRV, PNC, MMRV, PNC
Symptoms: Measles, Pyrexia
Clinical narrative: Severe rash 10 days after vaccination of MMRV
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Deep vein thrombosis, Dyspnoea, Influenza like illness, Malaise
Clinical narrative: This 43 year old reported receipt of 6 Anthrax vaccinations between 1999 and 2004. He remembers typically experienced adverse events to include malaise, flu-like syndrome and fevers for one week. Onset cough, sob, calf pain, swelling Jan-March 2007 with dx Pulm embolism and DVT: common and superficial veins of leg. 7/13/07-records received-12/06 began to experience right calf pains, 1/07-experienced shortness of breath with wheezing. DX bronchitis.  3/07 right calf pain and calf swollen from knee to foot, US revealed blood clot. DVT. Treated with anticoagulant therapy. Surgery and TPA to remove clot. Right basal segmental pulmonary emboli.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pulmonary embolism, Pyrexia, Swelling
Clinical narrative: This 43 year old reported receipt of 6 Anthrax vaccinations between 1999 and 2004. He remembers typically experienced adverse events to include malaise, flu-like syndrome and fevers for one week. Onset cough, sob, calf pain, swelling Jan-March 2007 with dx Pulm embolism and DVT: common and superficial veins of leg. 7/13/07-records received-12/06 began to experience right calf pains, 1/07-experienced shortness of breath with wheezing. DX bronchitis.  3/07 right calf pain and calf swollen from knee to foot, US revealed blood clot. DVT. Treated with anticoagulant therapy. Surgery and TPA to remove clot. Right basal segmental pulmonary emboli.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Hypokinesia, Musculoskeletal stiffness, Neck pain, Paraesthesia
Clinical narrative: ANTHRAX VACCINE, SC 11/28/2003, 12/18/2003, 01/28/2004, & 06/21/2004  Received first 11/28/2003 at sea with second and third AVA while in on land, prep for deployment w/o remembered adverse events. Received fourth AVA vaccine 6/2004 off coast. Wk as chief master of arms on ship....no uncommon adverse events remembered. She began to experience neck pain April/May 2004 running on ship. she awoke with a stiff neck thinking she slept wrong, saw medical and given Naprosyn. Upon return from deployment in 7/04 moving to new house, work, etc thought joint pain (legs, arm, lower back) attributed to activity. took Motrin for discomfort w/some relief. Describes discomfort as a dull constant ache to joints themselves. Scale 2-3/10 and pain resolved, movement made better.  Pain worse upon awakening and initial movements. October 2005 reached up while shopping raised hand overhead and felt sharp stabbing pain in lower back, thought was going to pass out, was assisted to floor by bystander, drank some water then able to drive home...c/o severe pain across upper back in neck, c/o radiating pain with tingling to right arm, unable to use arm due to pain but could move fingers and grip.  Came to ER in 10/2005 where MRI diagnosed cervical herniated disc x 3.
Age: 16.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Oedema peripheral, Sickle cell anaemia, Skin warm
Clinical narrative: Pt's arms were mildly edematous and warm to touch.  There was a slight redness to the site of the injections.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Skin warm, Tenderness
Clinical narrative: Two hours after receiving Pneumovax, patient noticed pain around injection site.  Pain gradually increased.  24 hrs later, she had 10x20 cm area of warmth, redness and tenderness. She could not abduct or posteriorly rotate shoulder due to 7/10 pain.  C/o myalgias, no fever, no respiratory symptoms.  Patient prescribed Allegra 180 mg po daily and ibuprofen for pain and inflammation; to apply ice pack and return if symptoms continued or worsened; to seek emergency medical assistance if any sign of systemic or respiratory symptoms.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Vaccine received 5/21/07 in the morning.  Patient called clinic 5/23/07 am to report arm that was vaccinated had reddness extending to anticubital area.  "Hot" yesterday, "warm" today.  Taking Tylenol.  Pain level 4.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local swelling, Tenderness
Clinical narrative: Localized swelling, induration & tenderness of LUE. Currently hospitalized, outcome not known at this time
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Within 24 hours of receiving Menactra, developed fever to 102.6 max, headache, myalgia and malaise which responded fairly well to ibuprofen until complete resolution of symptoms within 24 hours from onset.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: IMMUNIZATIONS RECEIVED ON 5/21/2007, ON 5/22/2007 IN THE AFTERNOON CHILD HAD A FEVER, THE MOTHER GAVE HIM TYLENOL AT 1:30PM. HE TOOK A NAP IN THE LATE AFTERNOON, SHORTLY AFTER HE WOKE UP AT 7:00 PM, HE STARTED HAVING A SEIZURE, THE PARENTS CALLED 911 AND HE WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR A FEBRILE CONVULSION. HE WAS NOT HOSPITALIZED, AND DID NOT HAVE ANY MORE CONVULSIONS.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy, Surgery
Clinical narrative: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C) performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events" (date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine dilation and curettage
Clinical narrative: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C) performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events" (date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.