chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Skin lesion
Clinical narrative: Patient had normal pelvic exam (per Dr Ob/Gyn) in July 08 and was started on GARDASIL vaccine. About 3 weeks after 1st shot, she developed lesions on her perineum. She denied new sexual partner or any known exposure to HPV/genital warts. 7-10-08 <- Presented to Gyn clinic with 6 genital warts 2-4mm in size on right upper labia majora. Triacetic Acid applied. Aldora Topical 3-4 days after (TCA) burning - resolves. Above treatment started 9-10-08.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.  Treated with Keflex.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Gardasil and Menactra given 9/10/08 - On 9/11/08 patient reports headache and vomiting.
Age: 38.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL
Symptoms: Arthralgia, Chest pain, Dyspnoea, Myalgia, Visual disturbance
Clinical narrative: Muscle aches, chest pain, SOB, visual disturbances, arthralgias. Treated with fluids, OTC NSAID's
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Confusional state, Myalgia, Pyrexia
Clinical narrative: Myalgias, confusion, high fever.  Tx: Acetaminophen, Ketavolac.
Age: 20.0
Sex: M
Vaccine: HEPA, SMALL
Symptoms: Asthenia, Cellulitis, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Cellulitis, fever, headache, weakness, sore throat; TX: acetaminophen, ibuprofen, azithromycin
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash, probable erythema multiforme from Smallpox reaction.  10/27/08 ER record dated 9/5/08 received with DX:  Rash, probable Erythema Muliforme small pox vaccination reaction. Pt presented with 2 day hx of rash.  Red, raised multi-shaped rash noted on torso, extremities and addomen. Tx with steroids and d/c on Medrol dosepak.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of entire left upper leg -> hip knee. Positive erythema. No increased warmth.
Age: 36.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, edema, and warm skin b/L arms at injection sites.  Left arm > right arm.  Patient instructed to take Tylenol and apply warm compress.  Also, go to ER if s/s worsen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, indurated, pain at site of injection.  No treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left arm 2cm x 3 cm, warm, reddened, indurated area.  RXN noted 8/1/08.  Resolved 8/4/08.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Skin lesion
Clinical narrative: 5 x 10cm erythematous lesion at injection site on post. right arm. (+) warm to touch with reported; itchiness. Onset 24 hours after injection; No reaction to varicella vac 31
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash macular, Skin warm
Clinical narrative: On 8/31, started with macular rash and temp 101.  Seen on 9/5/08 - Has 8-10 macular/pyretic lesions on arms and legs.  Exam otherwise negative.  On 9/11, has only 2 lesions remaining.  No fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L deltoid about 8 cm red swollen area over the injection site which was tender
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient developed itching in left arm soon after he had the IPOL and MMR.  Later that day he developed a rash and welts on entire left upper arm.  On 9/12/08, he was seen in the office for swelling, redness, warmth and itching entire left upper arm.  It is all local, no difficulty breathing.  Will re-evaluate 9/15/08.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed itching in left arm soon after he had the IPOL and MMR.  Later that day he developed a rash and welts on entire left upper arm.  On 9/12/08, he was seen in the office for swelling, redness, warmth and itching entire left upper arm.  It is all local, no difficulty breathing.  Will re-evaluate 9/15/08.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling of left upper arm - fever - 100deg - redness 5.0 x 9.00cm; Tx with ice/Tylenol or ibuprofen
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 2 3/4in x 3in rash in left leg
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Urticaria
Clinical narrative: 11 month old received 1st set of vaccines 9/3/2008. Dtap-HIB-IPV, Prevnar, Act HIB.; Child developed hives on back of neck and legs. No fever. Child was irritable. Approximately 24 hours later. Hives continue to come and go. Appt with Dr today. 9/8/08
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14 year old female with no pertinent medical history or allergies who on 23-JUL-2008 was vaccinated intramuscularly with 0.5ml Hp, rll , 6, 16, 18, VLP vaccine (yeast) (lot#660620/051X).Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and diphtheria toxoid (+) pertussis acelluar vaccine (unspecified) (+) tetanus toxoid. On 23-JUL-2008, 5 minutes after vaccination, the patient walked out the office's door, passed out. Fell backwards and hit her head. The patient was revived and taken into the office, where she almost passed out again. The patient had headache and studies were performed. After resting for 45-minutes, the patient recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Albumin CSF decreased, Blood product transfusion, CSF culture negative, CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Pt received influenza vaccine at PCP office. 1 hour after vaccination, (B) LE weakness developed and progressively worsened on 9/11/08. On 9/12/08, the pt was seen at a clinic and referred to the ER for further eval. Pt came in to ER on 9/14/08 w/ continued (B) LE weakness. Neurological evaluation revealed probable Guillain-Barre syndrome w/ IVIG treatment.9/22/08-records received for DOS-9/14-9/18/08-DC DX: Lower extremity weakness, presumably, possibly Guillain-Barre syndrome status post IVIG treatment. CSF showed cyoalbuminologic dissociation. Strength improved discharged to home. Presented to ED with C/O weakness that began 4 days prior. Abrupt onset and constant, right and left leg and foot weakness. Weakness began same day as receipt of flu shot. Upper respiratory infection one month prior that lasted 2-3 weeks. Difficulty walking.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Pt received influenza vaccine at PCP office. 1 hour after vaccination, (B) LE weakness developed and progressively worsened on 9/11/08. On 9/12/08, the pt was seen at a clinic and referred to the ER for further eval. Pt came in to ER on 9/14/08 w/ continued (B) LE weakness. Neurological evaluation revealed probable Guillain-Barre syndrome w/ IVIG treatment.9/22/08-records received for DOS-9/14-9/18/08-DC DX: Lower extremity weakness, presumably, possibly Guillain-Barre syndrome status post IVIG treatment. CSF showed cyoalbuminologic dissociation. Strength improved discharged to home. Presented to ED with C/O weakness that began 4 days prior. Abrupt onset and constant, right and left leg and foot weakness. Weakness began same day as receipt of flu shot. Upper respiratory infection one month prior that lasted 2-3 weeks. Difficulty walking.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Prolonged pain at site of injection, limited range of motion about shoulder for > 2 weeks
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Dizziness, Electrocardiogram ambulatory
Clinical narrative: See attached (pg 2) Consult re: reaction to GARDASIL; 1st GARDASIL given 7/24/08. Saw PCP - Dr around 8-1-08 for physical. At that time patient complained of sore throat and ringing in the ears. Started Z-Pack 8.4.08 x 5days; Saw Dr on 8/28/08 for "red bumps" on left side of body; was put on Medrol dose pack x 5days. Complained of heart palpitations, dizziness; 9/4/08 - Saw Dr. complained itchy blotches on body. Put on Ativan; Saw Dr 9/11/08 for blood work. ER 9/12/08, Fri evening dinner at dinner patient, felt dizzy warm lethargic, fainted and convulsions; had once; CT scan, MRI; Prone to fainting; Started Holter monitor 9/16/08 by Dr x 24 hours; now; Meds: Yaz, Ativan 0.5mg PRN, Xyzal -> Allergies. Blood work -> Allergy to Shellfish
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling hot, Lethargy, Nuclear magnetic resonance imaging, Palpitations, Pharyngolaryngeal pain
Clinical narrative: See attached (pg 2) Consult re: reaction to GARDASIL; 1st GARDASIL given 7/24/08. Saw PCP - Dr around 8-1-08 for physical. At that time patient complained of sore throat and ringing in the ears. Started Z-Pack 8.4.08 x 5days; Saw Dr on 8/28/08 for "red bumps" on left side of body; was put on Medrol dose pack x 5days. Complained of heart palpitations, dizziness; 9/4/08 - Saw Dr. complained itchy blotches on body. Put on Ativan; Saw Dr 9/11/08 for blood work. ER 9/12/08, Fri evening dinner at dinner patient, felt dizzy warm lethargic, fainted and convulsions; had once; CT scan, MRI; Prone to fainting; Started Holter monitor 9/16/08 by Dr x 24 hours; now; Meds: Yaz, Ativan 0.5mg PRN, Xyzal -> Allergies. Blood work -> Allergy to Shellfish
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Rash erythematous, Rash macular, Syncope, Tinnitus
Clinical narrative: See attached (pg 2) Consult re: reaction to GARDASIL; 1st GARDASIL given 7/24/08. Saw PCP - Dr around 8-1-08 for physical. At that time patient complained of sore throat and ringing in the ears. Started Z-Pack 8.4.08 x 5days; Saw Dr on 8/28/08 for "red bumps" on left side of body; was put on Medrol dose pack x 5days. Complained of heart palpitations, dizziness; 9/4/08 - Saw Dr. complained itchy blotches on body. Put on Ativan; Saw Dr 9/11/08 for blood work. ER 9/12/08, Fri evening dinner at dinner patient, felt dizzy warm lethargic, fainted and convulsions; had once; CT scan, MRI; Prone to fainting; Started Holter monitor 9/16/08 by Dr x 24 hours; now; Meds: Yaz, Ativan 0.5mg PRN, Xyzal -> Allergies. Blood work -> Allergy to Shellfish
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: General symptom, Rash
Clinical narrative: See attached (pg 2) Consult re: reaction to GARDASIL; 1st GARDASIL given 7/24/08. Saw PCP - Dr around 8-1-08 for physical. At that time patient complained of sore throat and ringing in the ears. Started Z-Pack 8.4.08 x 5days; Saw Dr on 8/28/08 for "red bumps" on left side of body; was put on Medrol dose pack x 5days. Complained of heart palpitations, dizziness; 9/4/08 - Saw Dr. complained itchy blotches on body. Put on Ativan; Saw Dr 9/11/08 for blood work. ER 9/12/08, Fri evening dinner at dinner patient, felt dizzy warm lethargic, fainted and convulsions; had once; CT scan, MRI; Prone to fainting; Started Holter monitor 9/16/08 by Dr x 24 hours; now; Meds: Yaz, Ativan 0.5mg PRN, Xyzal -> Allergies. Blood work -> Allergy to Shellfish
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Local reaction that was red then turned purple right in center of local reaction, tender several days; observed per provider 8/28/08 nickel size purple area - it faded to red at present.
Age: 1.31
Sex: F
Vaccine: DTAP, HEP, HIBV, VARCEL
Symptoms: Blister
Clinical narrative: Multiple scattered vesicles varying sizes, some crusted with yellow along trunk, hands, face and scalp.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash generalised, Varicella
Clinical narrative: Parent called to report chicken pox rash that started on 9-8-08. Started on hands and in mouth. Later in the day rash was all over her body, some with blisters; low grade fever, itching. Full body coverage - breakthrough
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTAP IN ERROR SHOULD HAVE HAD tdap
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: dtap given tdap should have been given
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: DTAP GIVEN tdap should have been
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site mass, Urticaria
Clinical narrative: Developed lump at injection site with a redness at site the size of a silver dollar - lasted two weeks. Developed hives on the bottom of the right food on the instep. (injection was in left arm)Hives still present. Formed a blister which broke open.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient  developed swelling, redness and warmth at injection site 24 hours after administration
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Vomiting
Clinical narrative: Chest pain and tightness, Shortness of breath, vomiting.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cyst, Injection site induration, Pyrexia, Rash, Swelling
Clinical narrative: swelling, fever, a cyst like knot formed where the injection was given.  Rash
Age: 4.0
Sex: M
Vaccine: FLUN3, IPV, MMR
Symptoms: Abdominal pain upper, Blood pressure normal, Crying, Heart rate increased, Nausea
Clinical narrative: child recieved flumist intranasally, followed by ipv (im) in left arm and mmr (sq) in right arm. Child seemed fine, dressed and ran out into waiting room to get stickers. bent over to look at stickers,clutched abdomen and began crying loudly complaining of stomachache. mom took him back into exam room where he continued crying and gripping his chest/abdomen.  i was called into room about 5 minutes after symptoms began. he was nauseous and in obvious significant pain, crying and holding mid epigastric area.  bp 110/64 (baseline for him) pulse ox 99% and heart rate 108.  He had two emeses, non-bilious,no blood. No diarrhea. afebrile. lungs clear. no hives. given zyrtec 15 mg and orapred 22mg with some coaxing. symptoms resoved in about 45 minutes and child was back to baseline in about an hour after symptoms began.  He has no known food or medication allergies.  he had mmr and ipv without adverse events in the past.  On october 27, 2006 he was seen in the office with painless swelling and erythema distal to injection site after recieving the aventis influenza vaccine lot #u2212aa  on 10/25/06.  this was deemed to be a local reaction to the vaccine.
Age: 4.0
Sex: M
Vaccine: FLUN3, IPV, MMR
Symptoms: Oxygen saturation normal, Pain, Reaction to previous exposure to any vaccine, Vomiting
Clinical narrative: child recieved flumist intranasally, followed by ipv (im) in left arm and mmr (sq) in right arm. Child seemed fine, dressed and ran out into waiting room to get stickers. bent over to look at stickers,clutched abdomen and began crying loudly complaining of stomachache. mom took him back into exam room where he continued crying and gripping his chest/abdomen.  i was called into room about 5 minutes after symptoms began. he was nauseous and in obvious significant pain, crying and holding mid epigastric area.  bp 110/64 (baseline for him) pulse ox 99% and heart rate 108.  He had two emeses, non-bilious,no blood. No diarrhea. afebrile. lungs clear. no hives. given zyrtec 15 mg and orapred 22mg with some coaxing. symptoms resoved in about 45 minutes and child was back to baseline in about an hour after symptoms began.  He has no known food or medication allergies.  he had mmr and ipv without adverse events in the past.  On october 27, 2006 he was seen in the office with painless swelling and erythema distal to injection site after recieving the aventis influenza vaccine lot #u2212aa  on 10/25/06.  this was deemed to be a local reaction to the vaccine.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Abdominal pain upper, Back pain, Dizziness, Pallor
Clinical narrative: pt started to feel faint and light headed. Became pale in face. After 5-10 mins, pt started to have lower back pain then began to wrap around to her stomache area. Also, had stomache cramping. Didn't start to feel better until 30mins post injection reaction time.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Abdominal pain, Back pain, Dizziness, Injection site coldness, Injection site pain
Clinical narrative: pt started to feel faint and light headed. Became pale in face. After 5-10 mins, pt started to have lower back pain then began to wrap around to her stomache area. Also, had stomache cramping. Didn't start to feel better until 30mins post injection reaction time.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Pain in extremity
Clinical narrative: pt started to feel faint and light headed. Became pale in face. After 5-10 mins, pt started to have lower back pain then began to wrap around to her stomache area. Also, had stomache cramping. Didn't start to feel better until 30mins post injection reaction time.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 2 days after vaccine admonistration, patient return with complaints of swelling, and pain on one of the sites where vaccines were given. She had no fevers.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Sudden cardiac death
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, found dead in his room at home on 8/14/08. Cause of death listed as Sudden cardiac death due to cor pulmonale due to COPD due to cigarette smoking. Vaccination took place on 1/28/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.  9/19/08 Case notes received from reporter. Pt had recently been hospitalized for Community Acquired Pneumonia and COPD exacerbation. During admission noted to have signs of CHF. Tx with abx and steroids with return to baseline. Seen 8/6/08 for f/u. PE (+) for 2+ lower extremity edema. Pulse ox 91%. Encouraged to wear O2 supp 24/7. Pt found dead 8/14/08. Nasal cannula off. COD listed by PCP as sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking. 1/23/2009 Death Cert received from ME. COD: sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking.     .
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature, Inappropriate schedule of drug administration
Clinical narrative: Rota given to pt at wrong age (9months). pt was delayed on immunizations, did not recieve 6 month vaccines. temp 97.6. dr notified.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC
Symptoms: Injection site mass
Clinical narrative: has lump to right leg, started one day after vaccine administration. no temp.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Flushing, Pruritus, Tension headache, Urticaria
Clinical narrative: I received Tdap (Tetanus, Diphtheria, & Pertussis)and Pneumococcal vaccinations on Fri., 8/29/08.  On Sat.evening, 8/30/08, I started feeling flushed and a tight feeling in my forehead.  I then started itching all over my torso, arms and neck.  When I checked my body, I had hives-type rash on my chest and back.  I took 2 benadryl tabs to relieve symptoms.  Itching subsided, but rash remained.  A couple hours later it started again; I took 1 benadryl tab which carried me through the night.  The next morning, the itching and tightness in the forehead started again.  I made an urgent care appt. The doctor thought the reaction was from the Tdap vaccine.  He said that benadryl was appropriate course of treatment.  He also gave Rx for Prednisone should I need it within the next few days.  I didn't need it.  All was fine until the following Sat., 9/8/08 when I had the same reaction.  I then took 2 benadryl tabs and no further reaction has occurred since.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Patient received multiple immunizations on 9-17-08 including DTaP, MMR, Varicella, IPV.  The last 2 were given in the left thigh.  Today we received a phone call from the child's mother stating the injection site on the left thigh was red with a raised area in the center.  The area of induration was no larger than the center of the bandaid that covered the site.  She also was reported with of fever of 101.7 F (O).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3"x3.5" redness on right thigh at injuection Site on right anterior thigh.  No painful. Instructed per physician t apply coolpacks to area.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TD, VARCEL
Symptoms: Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: Onset of fever evening of vaccinations, 101 degrees. Fever gone by next morning, responded to Tylenol;  c/o achiness that evening, lasted 3-4 days; poor appetite onset that evening, lasted x 1 week;  has been feeling "tired and draggy" ever since evening of vaccinations.  scheduled to see private provider today. P/C from mtoher who states her son saw provate provider yesterday. Per private provider: it is not abnormal to have aching for 2 weeks after immunizations and feel tired 2-3 weeks after immunizations; patient should have : very good immunity" to the diseases for which he was vaccianted. Mom instructed to call health department should there be any new development.
Age: 66.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: patient was given Pediarix by mistake, should have been given TD
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDDENED AREAS AT 2 VACCINE SITES ON LEFT ARM.  BOTH AREAS RED, HOT TO TOUCH, AND SLIGHTLY PAINFUL TO PATIENT.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PHN gave Prevnar inappropriately regarding age.  No symtoms/rx observed.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called clinic to describe reaction to injection site to back of left arm. Patient describes adverse reaction began 24 hours after injection which included back of arm swelling to a golf ball size, warm to touch, painful; describes site as a "knott".  R arm injction site was also swollen, but to a lesser degree. Patient states she has no fever. She state she is on a 6-day course of Augmentin 800 mg dailey for a throat cyst and started antibiotic on day of injection. Discussed monitoring for a fever, worsening symptoms, continuing antibiotic course to completion and taking tylenol or motrin for pain.  Patient will call if symtpoms do not improve.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Fatigue, Haemoglobin decreased, Hypoaesthesia, Myalgia
Clinical narrative: Generalized muscle and joint ache, fatigue, left arm numbness, no treatment.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Impaired work ability, Lymphadenopathy, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Got the vaccine on Mon sep 15th, These symptoms appeared 24 hours  later:                                           - pain in my left arm (lasted about 12 hours)                                           - mild fever of 101.4 F (lasted about 4 hours, took Acetaminophen and resolved)                                    -severe muscle aches, more pronounced on lower extremities, could not move for about 4 hours, could not go to work)                                            - 2 swollen lymph nodes on left side of neck (still present)                                           - soar throat (more pain when swallowing solids, still present)                                    - no diarrhea, abdominal pain, nausea, loss of apettite, or vomiting
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Got the vaccine on Mon sep 15th, These symptoms appeared 24 hours  later:                                           - pain in my left arm (lasted about 12 hours)                                           - mild fever of 101.4 F (lasted about 4 hours, took Acetaminophen and resolved)                                    -severe muscle aches, more pronounced on lower extremities, could not move for about 4 hours, could not go to work)                                            - 2 swollen lymph nodes on left side of neck (still present)                                           - soar throat (more pain when swallowing solids, still present)                                    - no diarrhea, abdominal pain, nausea, loss of apettite, or vomiting
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Well child visit 8/27/08.  Reported positive pregnancy test via mother 9/8/08.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Asthenia, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Started with HA & chills about 10PM after being out in weather.  Had gotten home about 6PM did homework.  Weak decreased HA at school next day no N/V neck stiff but not on exam.  Arm sore.  Mom p/u from school 10AM slept until came in to be seen 3PM.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Started with HA & chills about 10PM after being out in weather.  Had gotten home about 6PM did homework.  Weak decreased HA at school next day no N/V neck stiff but not on exam.  Arm sore.  Mom p/u from school 10AM slept until came in to be seen 3PM.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Confusional state, Disturbance in attention, Dizziness, Dysphonia
Clinical narrative: Fever 102.2, extreme pain at injection site, wheezing, difficulty breathing, joint pain, severe headache.  Took 600 mg Ibuprophen and 1,000 mg of Tylenol which helped to break temperature and subside other symptoms.  Next morning felt confused/could not concentrate/pay attention, felt lethargic.  Husband took her to ER.  At ER, wait too long, couldn't sit up so went back home.  Took more Tylenol and Advil to fight fever ever since.  She thought she was going to die.  Called doctor upon return from ER but did not know what to do.  Recommended just to fight it, wait until it went away.  The fever won't break.  Hoarseness has worsened as well as joint pain.  Feels dizzy from fever.  Can think more clearly now but can only break fever for about 30 minutes; it goes back to 102.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Headache, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Fever 102.2, extreme pain at injection site, wheezing, difficulty breathing, joint pain, severe headache.  Took 600 mg Ibuprophen and 1,000 mg of Tylenol which helped to break temperature and subside other symptoms.  Next morning felt confused/could not concentrate/pay attention, felt lethargic.  Husband took her to ER.  At ER, wait too long, couldn't sit up so went back home.  Took more Tylenol and Advil to fight fever ever since.  She thought she was going to die.  Called doctor upon return from ER but did not know what to do.  Recommended just to fight it, wait until it went away.  The fever won't break.  Hoarseness has worsened as well as joint pain.  Feels dizzy from fever.  Can think more clearly now but can only break fever for about 30 minutes; it goes back to 102.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Fever 102.2, extreme pain at injection site, wheezing, difficulty breathing, joint pain, severe headache.  Took 600 mg Ibuprophen and 1,000 mg of Tylenol which helped to break temperature and subside other symptoms.  Next morning felt confused/could not concentrate/pay attention, felt lethargic.  Husband took her to ER.  At ER, wait too long, couldn't sit up so went back home.  Took more Tylenol and Advil to fight fever ever since.  She thought she was going to die.  Called doctor upon return from ER but did not know what to do.  Recommended just to fight it, wait until it went away.  The fever won't break.  Hoarseness has worsened as well as joint pain.  Feels dizzy from fever.  Can think more clearly now but can only break fever for about 30 minutes; it goes back to 102.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Sent from PCP: NWMP per father to obtain vaccines.  Vaccines and VIS reviewed with father.  No prior history of vaccine complications or illness.  Vaccines provided - 10:15am.  Received phone call from father of child at 10:56am.  Noticing patient "breaking out in welts".  Denies any difficulties in breathing.  Instructed to contact PCP.  Father states went to PCP office and was informed to bring back to clinic where vaccines were received.  Father states is now at pharmacy and will be giving Benadryl.  Instructed to go to local ER (closer).  Parents notified and cell phone number for father provided.  Doctor called, instructed to go to local ER.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Hives within 24 hours of vaccine, localized injection/redness at site where vaccine given.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 4 Hours after shot, with fevers, sweating, nausea with no vomiting.  Pain from shoulder to elbow.  Lasted 4 hours. Not pregnant.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Emotional distress
Clinical narrative: Inconsolable, crying for about 3 hours after vaccination
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient had a 3-4 centimeter welt at the injection site.  Patient was given the CDC phone number and informed that this reaction is normal.  MD requested vaccine before telling family.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Truncal hives developed approximately 24 hours after administration of vaccine.  No other systemic symptoms.  Treated with 60 mg ZANTAC orally, some resolution in ~1 hour, placed on oral PEDIAPRED x3 days.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt has 1 1/2" x 1" raised erythmic area to L arm.  Warm to touch.  Burning sensation.  Denies itching or elevated temp.  No temp. today.  Denies nausea vomiting or diarrhea.  9-18-09 at 12:00.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain
Clinical narrative: Varivax given 08.16.08. Awoke 9-17-08 with sore hard, red area. Painful. Throughout day - redness increased to 70mm with 60mm induration.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Lip swelling, Pyrexia
Clinical narrative: Fever 104, difficulty breathing, swelling in lips.  1 cc dexamethasone given IM.
Age: 16.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on 07-JUL-2008 was vaccinated with the first dose of HPV rtl, 6,11,16,18, VLP vaccine (yeast) (lot#660393/0067X). Concomitant therapy included diphtheria toxoid (+) pertussis cellular vaccine (unspecified) (+) tetanus toxoid and Meninggococcal ACYW Conjugation vaccine (Dip toxoid) (Menactra). On 07-JUL-2008 the patient fainted post vaccination and her arms got stiff as well. Subsequently, the patient recovered the same day. Medical attention was sought from physician. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope  Information has been received from a nurse concerning 5-10 female patients who were vaccinated with a dose of HPV rll 6 11 16 18 VLP vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patients fainted. Some fainted after the first dose, other after the second and third dose of vaccine. Several times the patient had left the office but fainted in the elevator. Subsequently, the patients all recovered from the events. Attempts are being made to obtain additional identifying information to distinguish the individual patience mentioned in this reports. Additional information will be provided if available. This is in follow-up to report (s) previously submitted on 8/14/2008. Follow-up information was received from the registered nurse which reported that she did not have specific patient information but stated that most of the faining occuured in girls who received more than one immunization (unspecified vaccine) at the time of the GARDASIL administration. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Dizziness, Inappropriate schedule of drug administration, Migraine, Nausea
Clinical narrative: Information has been received from a 31 year old female with no known drug allergies and no pertinent medical history, Who on 05-May-2008 was vaccinated with the first dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast) (lot#  number not provided, 0.5ml. Concomitant therapy included Sumatriptan (IMITREX) and topiramate (Topamax). On approximately 13-MAY-2008, a week after receiving her first dose. The patient experienced memory loss, dizziness, nausea and migraines. After receiving her second dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast) (lot# number not reported) on approximately 08-JUL-2008, all of the symptoms worsened. Every time she ate she felt as if she had to vomit. She had to sit in the dark because of her migraines. The patient sought medical attention. No lab diagnostic studies were preformed. As of the 15-Jul-2008 report date, the patient had not recovered. She is not expected to receive the third dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast)
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a 31 year old female with no known drug allergies and no pertinent medical history, Who on 05-May-2008 was vaccinated with the first dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast) (lot#  number not provided, 0.5ml. Concomitant therapy included Sumatriptan (IMITREX) and topiramate (Topamax). On approximately 13-MAY-2008, a week after receiving her first dose. The patient experienced memory loss, dizziness, nausea and migraines. After receiving her second dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast) (lot# number not reported) on approximately 08-JUL-2008, all of the symptoms worsened. Every time she ate she felt as if she had to vomit. She had to sit in the dark because of her migraines. The patient sought medical attention. No lab diagnostic studies were preformed. As of the 15-Jul-2008 report date, the patient had not recovered. She is not expected to receive the third dose of HPV rll, 6, 11, 16, 18, VLP vaccine (yeast)
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (Lot#658556/10600) 0.5ml, intramusclar administration. The patient developed hives and joint pain 8-10 hours post vaccination with GARDASIL. The patient sought medical attention and was treated with diphenhydramine hydrochloride (Benadryl) and Corticosteroids.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Lymphadenitis, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who in July 2007, was vaccinated with the first dose of GARDASIL on 09-JUL-2008, the patient was vaccinated with the second dose of GARDASIL it was reported that 24 hours later the patient developed sharp abnormal pain and had a fever of 102.5 on 11-JUL-2008 the patient went to see her physician and she was sent to the Emergency Room. It was reported that the patient was diagnosed of "mesentery "adentite" and was prescribed with a pain medication, and was told that it should be resolved after a week. At the time of this report the patient recovered from a fever of 102.5. But the patient's abdominal pain persisted.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Malaise, Oedema peripheral, Skin warm
Clinical narrative: Mom noticed she was hot and feverish early this morning bout 2:00 AM, and has vomited twice and has general malaise.  Her left arm is swollen and red.  She has been given TYLENOL for fever which helps but patient says she still do not feel well.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Mom noticed she was hot and feverish early this morning bout 2:00 AM, and has vomited twice and has general malaise.  Her left arm is swollen and red.  She has been given TYLENOL for fever which helps but patient says she still do not feel well.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Mom noticed she was hot and feverish early this morning bout 2:00 AM, and has vomited twice and has general malaise.  Her left arm is swollen and red.  She has been given TYLENOL for fever which helps but patient says she still do not feel well.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Body temperature, Loss of consciousness, Oxygen supplementation, Syncope, Urinary incontinence
Clinical narrative: Symptoms = Fainting, urination, short of breath. Signs = None; Time cause= 4:15 pm 30 minutes after doses given. Please see attached !!; On Tuesday August 26, 2008 we had a 18 year-old female patient who came in with mother for vaccines, that were in need promptly requested by school. Patient information, Vaccine Questioner, and VFC application were given to the patient due to the fact that it was the patients first time at the facility. After the patient had concluded inputting here information she was registered in LINK. Patient at the moment was due for a total of 4 vaccines which are as follows: Varicella, HPV, Meningococcal, and Hepatitis A. The patients mother was then informed that the subsequent vaccines mentioned were due along with HPV, but that GARDASIL was not needed by School system. After the mom was informed about GARDASIL and what it prevents, mother agreed to render that vaccine along with the other three. The patient was then taken to the triage room and vitaled. The temperature recorded at the time was 97.9 Oral-temperature. Routing slip from LINK was then given to P.A.C to approve all vaccines that were in need. After approval all four vaccines were administered. Patient was advised by Medical Assistant to have a seat in the waiting room, while vaccine card was being printed. While the patient was seated at the waiting area she collapse while being seated. The patient was unconscious and ammonia was passed by nasal area. The patient gained conscience, but immediately went unconscious again. While patient collapsed again she urinated at the same time. Ammonia was passed for the second time and gained permanently. Oxygen tank was then put on the patient to help the oxygen flow. Paramedics were called and arrived 5 minutes later at the scene. Paramedics vitaled the patient and recommended for her to go with them. patient was adamant and denied the advice and she signed the AMA for the paramedics. The patient left 5 minutes after the paramedics were gone. Patient was called the following day of the incident and mother stated daughter was fine and no problem were noticeable.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Dyspnoea, Loss of consciousness, Oxygen supplementation, Syncope, Urinary incontinence
Clinical narrative: Symptoms = Fainting, urination, short of breath. Signs = None; Time cause= 4:15 pm 30 minutes after doses given. Please see attached !!; On Tuesday August 26, 2008 we had a 18 year-old female patient who came in with mother for vaccines, that were in need promptly requested by school. Patient information, Vaccine Questioner, and VFC application were given to the patient due to the fact that it was the patients first time at the facility. After the patient had concluded inputting here information she was registered in LINK. Patient at the moment was due for a total of 4 vaccines which are as follows: Varicella, HPV, Meningococcal, and Hepatitis A. The patients mother was then informed that the subsequent vaccines mentioned were due along with HPV, but that GARDASIL was not needed by School system. After the mom was informed about GARDASIL and what it prevents, mother agreed to render that vaccine along with the other three. The patient was then taken to the triage room and vitaled. The temperature recorded at the time was 97.9 Oral-temperature. Routing slip from LINK was then given to P.A.C to approve all vaccines that were in need. After approval all four vaccines were administered. Patient was advised by Medical Assistant to have a seat in the waiting room, while vaccine card was being printed. While the patient was seated at the waiting area she collapse while being seated. The patient was unconscious and ammonia was passed by nasal area. The patient gained conscience, but immediately went unconscious again. While patient collapsed again she urinated at the same time. Ammonia was passed for the second time and gained permanently. Oxygen tank was then put on the patient to help the oxygen flow. Paramedics were called and arrived 5 minutes later at the scene. Paramedics vitaled the patient and recommended for her to go with them. patient was adamant and denied the advice and she signed the AMA for the paramedics. The patient left 5 minutes after the paramedics were gone. Patient was called the following day of the incident and mother stated daughter was fine and no problem were noticeable.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Full blood count normal, Laboratory test normal, Neurological examination normal, Tremor
Clinical narrative: Initial and follow up information has been received from a nurse practitioner in form of medical record, concerning a healthy 21 year old female patient with no previous medical history reported, who on 21-AUG-2008 was vaccinated with the third dose of GARDASIL. On the same date, the patient was vaccinated with a first dose of hepatitis A (unspecified) (manufacturer unknown). Vaccines were administered in preparation of travel abroad. The nurse reported that the patient experienced seizure after receiving her third dose of GARDASIL. Subsequently, the patient experienced lower abdominal pain and seizure described as uncontrollable left sided shaking to left arm face and shoulders. On 23-AUG-2008, the patient started to have the same shakes and was taken to the emergency room but was not admitted. She had no headache, nausea, vomiting, numbness or weakness. While being examined in the emergency room, the patient had the same rhythmic movement of face and arm. Possible extrapyramidal and muscular contraction symptoms were noted by the emergency room. Liver function tests were check and were within normal limits. The patient was prescribed benztropine mesylate (manufacturer unknown), BENADRYL, and dexamethasone (manufacturer unknown). On 28-AUG-2008, the patient was seen in the reporting nurse practitioner's office for follow-up to the emergency room visit. It was noted that the patient had no problems since the emergency room visit. Assessment noted as an allergic reaction, possible reaction to GARDASIL. On an unknown date, the patient recovered. There was no product quality complaint. Upon internal review, the patient's seizure was considered an other important medical event. No additional information is expected. All available medical records will be provided on request.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain lower, Alanine aminotransferase decreased, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood glucose normal
Clinical narrative: Initial and follow up information has been received from a nurse practitioner in form of medical record, concerning a healthy 21 year old female patient with no previous medical history reported, who on 21-AUG-2008 was vaccinated with the third dose of GARDASIL. On the same date, the patient was vaccinated with a first dose of hepatitis A (unspecified) (manufacturer unknown). Vaccines were administered in preparation of travel abroad. The nurse reported that the patient experienced seizure after receiving her third dose of GARDASIL. Subsequently, the patient experienced lower abdominal pain and seizure described as uncontrollable left sided shaking to left arm face and shoulders. On 23-AUG-2008, the patient started to have the same shakes and was taken to the emergency room but was not admitted. She had no headache, nausea, vomiting, numbness or weakness. While being examined in the emergency room, the patient had the same rhythmic movement of face and arm. Possible extrapyramidal and muscular contraction symptoms were noted by the emergency room. Liver function tests were check and were within normal limits. The patient was prescribed benztropine mesylate (manufacturer unknown), BENADRYL, and dexamethasone (manufacturer unknown). On 28-AUG-2008, the patient was seen in the reporting nurse practitioner's office for follow-up to the emergency room visit. It was noted that the patient had no problems since the emergency room visit. Assessment noted as an allergic reaction, possible reaction to GARDASIL. On an unknown date, the patient recovered. There was no product quality complaint. Upon internal review, the patient's seizure was considered an other important medical event. No additional information is expected. All available medical records will be provided on request.