chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Mood swings, Myalgia, Pancreatitis, Paraesthesia, Photophobia
Clinical narrative: extreme fatigue, migraines, nose bleeds, muscle & joint pain, sensitivity to light, mood swings, irritable, brain fog, dizzy spells, trembles, numbness, back pain, pins & needles, memory fog, skin rashes, pancreatitis, stomach ulcers, shortness of breath
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Tremor, Ultrasound scan
Clinical narrative: extreme fatigue, migraines, nose bleeds, muscle & joint pain, sensitivity to light, mood swings, irritable, brain fog, dizzy spells, trembles, numbness, back pain, pins & needles, memory fog, skin rashes, pancreatitis, stomach ulcers, shortness of breath
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The site where the vaccine was adminstered, which is the left shoulder, has been extremely sore and I am unable to lift my arm up over my head, nearly four weeks after the vaccination.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: diffuse itching began less tan 12 hours after first hepatitis B vaccine; no hives/blisters; mother treated today for poison ivy exposure
Age: 4.0
Sex: F
Vaccine: DTAP, UNK
Clinical narrative: rash left deltoid from Prevnar administered on 05/13/2009. left deltoid 5x4 erythemetous lesion, not indurated, nontender. ice and 12.5mg benadryl twice a day as needed.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Rash macular
Clinical narrative: rash at site of vaccine(prevnar) left deltoid 7x7 indurated erythemetous tender macualar eruption Ice, benadryl and motrin
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Blood pressure decreased, Dizziness, Fall
Clinical narrative: Pt became weak and dizzy while walking outside to car.  Pt had syncopal episode and fell on sidewalk outside clinic.  Her sister reports seeing her strike her head on their vehicle.  Pt c/o her back hurting. Pt declined exam of back.  No nausea.  No LOC.  Pt A & Ox3.  Pallor.  Diaphoretic.  Pulse 72  BP  80/36  Head:  NT/AC without abrasions or bleeding.  Heart:  RRR.  Lungs:  CTA  Neuro:  CNs II-XII grossly intact.   Cold wash rag applied.  Cold water given for hydration.  Pt transferred to vehicle and legs placed above level of heart.  BP increased to 84/46.  Pt states she began feeling better.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Pt became weak and dizzy while walking outside to car.  Pt had syncopal episode and fell on sidewalk outside clinic.  Her sister reports seeing her strike her head on their vehicle.  Pt c/o her back hurting. Pt declined exam of back.  No nausea.  No LOC.  Pt A & Ox3.  Pallor.  Diaphoretic.  Pulse 72  BP  80/36  Head:  NT/AC without abrasions or bleeding.  Heart:  RRR.  Lungs:  CTA  Neuro:  CNs II-XII grossly intact.   Cold wash rag applied.  Cold water given for hydration.  Pt transferred to vehicle and legs placed above level of heart.  BP increased to 84/46.  Pt states she began feeling better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: Client received Zostavax in am on 05/14/2009.  The visit was uneventful.  On 05/15/2009 she came back to the HD stating her r. lower arm was sore.  She had a reddened area approx.2 inches in diameter, warm to touch and slightly swollen.  PHN told her to use ice on area 3-4 times/ day; use Ibuprofen 1 every 4-6 hours and take Benadryl 1 @ hs.  Do this until 05/18/2009.  If it hasn't improved by then, call her Dr.  If it worsens, call her Dr. or go to ER.  PHN called her back on 05/18/2009.  She said area has improved immensely.  Recommend she continue treatment until the small reddened area (now size of a dime) disappears.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Headache, Influenza serology negative, Pain, Pyrexia
Clinical narrative: Fever (101.9), achiness, headache, throwing up the morning after the shots, feeling week
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Streptococcal identification test negative, Vomiting
Clinical narrative: Fever (101.9), achiness, headache, throwing up the morning after the shots, feeling week
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: RAISED INDURATED AND ERYTHEMATOUS. AREA 5CM BY 10CM STARTING AT INJECTION SITE AND EXTENDING DISALY
Age: 12.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Injection site erythema, Injection site infection, Irritability
Clinical narrative: THE VACCINE WAS INJECTED ON HER UPPER LEFT LEG. THE AREA WHERE SHE HAD THE VACCINE GOT INFECTED. IT WAS PURPLE AND RED AROUND IT. THE RED PART WAS ABOUT 1 INCH BIG. SHE ALSO GOT RED BUMPS ON HER BACK, FACE, STOMACH (LEFT RIB AREA), AND RIGHT UPPER LEG.THE RED BUMPS WERE YELLOW FROM THE MIDDLE AND A LITTLE BIT OF CLEAR LIQUID. ONE OF THE BUMPS ON HER BACK ALSO GOT INFECTED. THE DOCTOR GAVE HER SULFAMETHOXAZOLE-TMP TO TREAT INFECTION. SHE NEEDS TO TAKE THIS MEDICATION FOR 10 DAYS. TODAY IS HER 3ERD DAY TAKING IT AND HER INFECTION LOOKS A LOT BETTER. BESIDES THE RED BUMPS SHE WAS VERY IRRITABLE. BUT HAD NO FEVER OR LOSS OF APETITE.
Age: 16.0
Sex: M
Vaccine: MNQ, PPV, VARCEL
Symptoms: Blood immunoglobulin G increased, Rash, Secondary transmission, Varicella
Clinical narrative: Rash started 4/15/09, chicken pox.  Elevated IGG 1550 on 4/16/09.  Transmitted to 9 mon old sib who also tested IGG positive.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: syncope after vaccines
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Left Deltoid raised, reddened, approx 4 1/4 in x 3 1/2 in area painful and warm to touch. Left arm Posterior subqutaneous area has reddened area approx 1 1/2 in x 1 1/2 in. Tylenol 325mg and ice applied.
Age: 69.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: pt. received in clinic Td and Pneumovax injection.  Pt states that evening she was ambulanced to ER with severe body aches, chills, and diaphoresis.  Pt states she was informed it was an allergic reaction to the vaccinations she was given.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Dry skin, Rash erythematous, Rash generalised
Clinical narrative: fine red rash all over body, no urticaria, feels sandpapery
Age: 11.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Throat irritation, Urticaria
Clinical narrative: fine red rash all over body, no urticaria, feels sandpapery
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Catatonia, Communication disorder, Convulsion, Dyspnoea, Fatigue
Clinical narrative: Shortly after her first shot patient started having episods of what we thought were panic attacks. She had a hard time breathing, her heart would race and she could not catch her breath. After the second shot this so called panic attacks seemed to get worse and she was having them more freqently. She was tired all the time and a bit withdrawn. She had her third shot on June 9th of 2008 and on June 12th I saw one of these episods for the first time. I was stunned. This was no panic attack. She knows it going to happen she get a real intense pain on the top right side of her head. Usually within 30 to 60 seconds of the pain she becomes completly catatonic like. She is unable to comunicate at all. Then she goes into seizure like activity. But, during these seizures she goes into a breathing pattern, she will seizure like activity for about 45 seconds and then she will stop breathing for anywhere from 30 to 40 seconds and this will continue for anywhere from 2 mins to 50 mins. This has been going on for almost a year. She will have these episodes anywhere from 2 to 4 a week.  6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Assessment: Paroxysmal disturbance, etiology indeterminate. Patient presents with stereotypical episodes consisting of sharp stabbing incapacitating discomfort in right parietal or temporal area. Hyperventilation, irregular breathing, unresponsive, dissociated, amnestic. Gardasil Dose #1 (0211U) LA 8/13/07 Gardasil Dose #2 (1266O) RA 1/21/08
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Palpitations, Respiratory arrest, Social avoidant behaviour, Vaccine positive rechallenge
Clinical narrative: Shortly after her first shot patient started having episods of what we thought were panic attacks. She had a hard time breathing, her heart would race and she could not catch her breath. After the second shot this so called panic attacks seemed to get worse and she was having them more freqently. She was tired all the time and a bit withdrawn. She had her third shot on June 9th of 2008 and on June 12th I saw one of these episods for the first time. I was stunned. This was no panic attack. She knows it going to happen she get a real intense pain on the top right side of her head. Usually within 30 to 60 seconds of the pain she becomes completly catatonic like. She is unable to comunicate at all. Then she goes into seizure like activity. But, during these seizures she goes into a breathing pattern, she will seizure like activity for about 45 seconds and then she will stop breathing for anywhere from 30 to 40 seconds and this will continue for anywhere from 2 mins to 50 mins. This has been going on for almost a year. She will have these episodes anywhere from 2 to 4 a week.  6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Assessment: Paroxysmal disturbance, etiology indeterminate. Patient presents with stereotypical episodes consisting of sharp stabbing incapacitating discomfort in right parietal or temporal area. Hyperventilation, irregular breathing, unresponsive, dissociated, amnestic. Gardasil Dose #1 (0211U) LA 8/13/07 Gardasil Dose #2 (1266O) RA 1/21/08
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Dizziness, Malaise, Nausea, Streptococcal identification test negative
Clinical narrative: She has had dizziness, nausea and vomiting on and off since HPV was given 3/16/09, associated with body malaise.  There was no reported fever.  she had visited the ER 2x and had received IV hydration in 1 occasion.  7/3/09 ER records received DOS 5/15/09. Assessment: Gastritis - acute, no bleeding. Patient presents with vomiting, abdominal pain, dizziness, tired, lethargic, dizziness, facial pain. Dehydration. Posterior pharynx injected. Returned 5/28/08 with c/o sore throat, cough and fever.  DX:  Tonsillitis. T=102'F. Throat injected with exudate with swelling of R tonsil. D/C on amoxicillin.    7/8/09 PCP recs received. Pt in for OV 3/16/08 with cough, congestion, fever and sore throat. Dx with viral throat infection.  HPV#1 given. On 4/6/08 parent reported that pt had experienced dizziness, nausea and vomiting since receiving the HPV vax.  Been 2 ER twice. In for OV with c/o congestion, scratchy throat. itchy nose x 2 days.  nasal turbinates and mucosa boggy with mucoid nasal drip. DX:  Allergic rhinitis.  Acute URI.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: She has had dizziness, nausea and vomiting on and off since HPV was given 3/16/09, associated with body malaise.  There was no reported fever.  she had visited the ER 2x and had received IV hydration in 1 occasion.  7/3/09 ER records received DOS 5/15/09. Assessment: Gastritis - acute, no bleeding. Patient presents with vomiting, abdominal pain, dizziness, tired, lethargic, dizziness, facial pain. Dehydration. Posterior pharynx injected. Returned 5/28/08 with c/o sore throat, cough and fever.  DX:  Tonsillitis. T=102'F. Throat injected with exudate with swelling of R tonsil. D/C on amoxicillin.    7/8/09 PCP recs received. Pt in for OV 3/16/08 with cough, congestion, fever and sore throat. Dx with viral throat infection.  HPV#1 given. On 4/6/08 parent reported that pt had experienced dizziness, nausea and vomiting since receiving the HPV vax.  Been 2 ER twice. In for OV with c/o congestion, scratchy throat. itchy nose x 2 days.  nasal turbinates and mucosa boggy with mucoid nasal drip. DX:  Allergic rhinitis.  Acute URI.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site swelling, Malaise, Nausea, Pruritus generalised
Clinical narrative: With the first booster injection given (April 8, 2009 I think) I experienced left arm itchiness with small bumps 1 week post the injection. The injection site swelled up as well. The itchiness disappeared after the bumps healed and was only where the bumps were. Which took about one week to heal. The Second injection given on May 14 2009  I experienced light headiness within minutes of the injection, Also I was extremely sick the following days after the injection with all over itchiness (whole body) light headiness, nausea, extreme dizziness..The symptoms caused me to go to the Doctor which they gave me 50 mg IM of Benadryl and Loratadine 10mg tablets. They did not treat me for the dizziness. The Next day I went to the ER (May 16, 2009)due to the dizziness and nausea They told me to stop the Loratadine and perscribed me Mecclazine Tablets for the dizziness and nausea which helped with that on Monday the 18th of May I yet again had a whole body itchiness reaction I went back to the first Doctor who told me to take the Loratadine 10mg tabs once a day for about a week he gave me another 50mg IM dosage of benadryl I have a follow up Appt on the 26th of May. He also told me to take an Aveno oat bath.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Similar reaction on previous exposure to drug
Clinical narrative: With the first booster injection given (April 8, 2009 I think) I experienced left arm itchiness with small bumps 1 week post the injection. The injection site swelled up as well. The itchiness disappeared after the bumps healed and was only where the bumps were. Which took about one week to heal. The Second injection given on May 14 2009  I experienced light headiness within minutes of the injection, Also I was extremely sick the following days after the injection with all over itchiness (whole body) light headiness, nausea, extreme dizziness..The symptoms caused me to go to the Doctor which they gave me 50 mg IM of Benadryl and Loratadine 10mg tablets. They did not treat me for the dizziness. The Next day I went to the ER (May 16, 2009)due to the dizziness and nausea They told me to stop the Loratadine and perscribed me Mecclazine Tablets for the dizziness and nausea which helped with that on Monday the 18th of May I yet again had a whole body itchiness reaction I went back to the first Doctor who told me to take the Loratadine 10mg tabs once a day for about a week he gave me another 50mg IM dosage of benadryl I have a follow up Appt on the 26th of May. He also told me to take an Aveno oat bath.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Myalgia, Pain in extremity
Clinical narrative: Large lump at injection site.  Sore arm.  Achey muscles.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blepharospasm, Decreased appetite, Irritability, Pyrexia, Unresponsive to stimuli
Clinical narrative: Eyes twitching, unresponsive. Fussiness, fever, decreased appetite.  6/3/09 Hospital records received DOS 5/15/09 to 5/16/09. FINAL DIAGNOSIS: Inconsolability after immunizations. Post vaccination developed fever then becoming fussy, irritable. Eyes twitch. Eating and drinking poorly. Inconsolable. Screams.  ICD-9 Codes: 78091 Fussy infant (baby) 7852 Undiagnosed cardiac murmurs. PMH:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left deltoid swollen with redness and pain.
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, Intensive care, Oxygen saturation decreased, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased oxygen saturation in a neonate male subject who was inadvertently vaccinated with FLUARIX (GlaxoSmithKline). There were no concomitant medications or relevant medical history. On 6 April 2009 the subject accidentally received a dose of FLUARIX (0.5 ml, unknown site) instead of ENGERIX B; wrong vaccine administered and maladministration (asymptomatic/child too young). On 7 April 2009, 1 day after vaccination with FLUARIX, the subject experienced decreased oxygen saturation. The subject was transferred to the Neonatal Intensive Care Unit, prolonging hospitalization. He was discharged on an unspecified date. On 8 April 2009, the events were resolved. The reporting pharmacist considered the maladministration occurred due to the ENGERIX B and FLUARIX syringes resemblance and small print. The pharmacist also stated that FLUARIX had been stocked in the ENGERIX B holder in the refrigerator in labor and delivery. The pharmacist intended to complete a "report".
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Fever 103-104 X 2 days
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site swollen/red 2 days after vaccine administered (left thigh).
Age: 23.0
Sex: U
Vaccine: ANTH, FLU3
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin positive, Chlamydia identification test positive, Drug exposure during pregnancy
Clinical narrative: Pt had AVA and Influenza shot on 4/14/09 and SPV 4/16/09.  She returned to the Imm Clinic on 4/23/09 for evaluation of SPV (major take); pt requested a pg test which was positive (LMP 3/16/09).  Pt indicated that she was not pg on the SPV questionnaire.  Symptoms:  Amenorrhea.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Nausea, Vertigo
Clinical narrative: In evening of day of shots - She developed chills vertigo, nausea (still able to drink.) confined to bed - missed school next day. Mom states " this sensitive to shots"
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: DTap #5 given in R thigh- 48 hours later, thigh with edema + splotchy erythema.  R thigh 33 cm diameter, L thigh 29 cm.  At 72 hours, rash worsened then Sxs largely noticed by 96 hours.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: HEPATITIS B #2 (accelerated schedule) given 4/15/09 - later on 4/14/09 pt called with "arm burning".  No other symptoms advised ADVIL/cold compress.  On 4/28/09 pt.  notified me that on 4/15/09 he came down with severe H/A.  Fever, aches & extreme fatigue.  PCP diagnosed "para-flu" & he was to stay home & Tx symptoms. 4/28/09 Gave HB #3 (accelerated schedule). 4/29/09 Pt. called feeling very tired, achy. "Not as sick as before". Denies H/A, fever, N/V/D. Taking OTC ADVIL to Tx symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: L deltoid inflammation 3 cm Rx for Benadryl given.
Age: 0.4
Sex: M
Vaccine: DTAP, PNC, RV5
Symptoms: Rash, Rash papular
Clinical narrative: Fine rash systemically see clinical data report.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood culture, Cellulitis, Full blood count, Injection site erythema, Injection site induration
Clinical narrative: Redness, swelling-hard and warm to touch . Left upper thigh 8"x5" (redness). Seen at hospital. DX: cellulitis. RX: BACTRIM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, White blood cell count increased
Clinical narrative: Redness, swelling-hard and warm to touch . Left upper thigh 8"x5" (redness). Seen at hospital. DX: cellulitis. RX: BACTRIM.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Local reaction
Clinical narrative: Erythematous, swollen, large local reaction greater then 30cm 1 week after vaccine for DTAP.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives
Age: 2.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh red, indurated 1 1/2 - 2" area
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting, which began a couple of hours after receiving vaccine.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Site on upper right arm appeared red, swollen and hard with a measurement of 60mm induration. Patient denied any itching or difficulty breathing.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Induration, Somnolence
Clinical narrative: Pt's aunt called back 2 days after ER visit to notify us that patient was very weak + had drowsiness, a "knot on the left arm". The was patient last dose of HPV that she received in Texas.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hepatic enzyme increased, Hepatitis B surface antigen positive, Hyperbilirubinaemia
Clinical narrative: This case was reported in a literature article and described the occurrence of hepatitis B antigenemia in a 111-day-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject was born at 25 and 4/7 weeks gestational age to a 31-year-old female via emergent C-section as a result of placental abruption. Maternal history was significant for ARNOLD-CHIARI malformation and preeclampsia. Prenatal testing revealed negative results including human immunodeficiency virus and rapid plasma regain. She was also rubella immune and her Group B Streptococcus status was unknown. After birth, the neonate required chest compressions, was intubated and received bovine lung surfactant in the delivery room. APGAR scores were 1 and 3 at 1 and 5 minutes respectively. The baby was admitted to the neonatal intensive care unit, where he stayed for the first 117 days of life. His hospital course was complicated by illness of prematury and multiple blood transfusions. On day of life 108, the subject received unspecified dose of PEDIARIX (unknown route of administration, lot number not provided). The vaccine was given at the appropriate time when he weighted 2310 grams. On day of life 111, 3 days after vaccination with PEDIARIX, as part of workup for persistently elevated liver function tests and increased direct hyperbilirubinemia, a hepatitis panel was sent. The results were negative for hepatitis B surface antibody, hepatitis B core immunoglobulin IgM, hepatitis A IgM and hepatitis C antibody; however the hepatitis B surface antigen was positive. This case was assessed as medically serious by GSK. Repeat testing in 3 to weeks was recommended by the pediatric infectious disease specialist. The infant was discharged home on day of life 117 to continue ursodiol for cholestiasis. The hepatitis B surface antigen test was repeated 5 weeks after the initial hepatitis panel was done and was negative. The subject did not have the blood work repeated until 5 weeks post vaccination. Therefore it was difficult to determine exactly how long the antigenemia persisted. However, the fact that it was short term supported the diagnosis of antigenemia caused by the PEDIARIX vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain, Swelling
Clinical narrative: Patient came in for Flu vaccine, Right and TDAP, Left. Complaint of pain and swelling next day- c/o very painful. Called PMD today-appointment made for 5/7/09 at 8:30/AM.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Itching at injection site, right arm. Erythema right arm. Taking BENADRYL about every 8 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid 13X14 CM Swollen, Redness, warm to touch. Apply cold compress (ice) every 2 hrs for 15 min. Then warm.
Age: 39.0
Sex: F
Vaccine: DTAP, MEN, TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient should have received a Tdap patient was administered a DTaP. No adverse event reported. Patient notified of mistake. There was not an adverse event this was a misadministration error on 5/11/09 where an adult received a childs dose of DTAP instead of an adult dose of TDAP.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Heart rate increased, Vomiting
Clinical narrative: Client reports that after HPV vaccine given on 2/27/09 she went home, started feeling dizzy, had chest pain, rapid heart rate and vomiting for 3-4 days.  No medical treatment resulted.  Symptoms resolved on her own.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Red swollen lump L thigh.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Oedema peripheral
Clinical narrative: Several vesicles at injection site, followed by patch of erythema & induration expanding to 8 X 10 cm by 5/13/09.  Borders slightly raised, mildly tender.  Right deltoid region mildly swollen.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Varicella
Clinical narrative: Patient received VARIVAX vaccine on 12/19/97 and 6/27/08. Exposed to chicken pox vaccine 2 weeks ago. Developed chicken pox rash on 5/10/09.
Age: 38.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given 5/1/09 pri 5/1 - 5/09 Redness + swelling at site  5/5 - 8/09 no fever/chills. No antibiotics given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 36% After receiving vaccine, mild swelling and tenderness of left upper arm / L axilla.
Age: 21.0
Sex: M
Vaccine: FLUX, HEPAB
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 1.6
Sex: F
Vaccine: DTAP, HEP, HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria, generalized. Benadryl 6.25 BID X 5 days ; weak 2y in
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 25 y/o WM ADSM is referred from a study for evaluation of previous local reaction to AVA #2.  Symptoms:  Edema @ injection site 50-120mm, Pain, Erythema.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: 24 y/o WM ADSM is referred from the HMJF Anthrax research study site for evaluation of local reaction after AVA # 2.  Symptoms:  Edema at injection site 50-120mm, Pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersomnia, Pallor
Clinical narrative: DDX reaction to the pertussis in DTAP #5. Became pale approx 15-30 minutes after imm in peds. Returned to peds at Dr.'s direction. Place on exam table with head of the table raised slightly and head at the foot of the table. BP initially 76/50 and 15 min later 72/50 both recumbent; soon after 2nd BP stood up and BP 78/50; initial pulse 84 and final pulse 72. Pale at first and good color at end. Ultimately able to walk up and down the hall x3: felt fine. Went home and slept the entire afternoon. As of 9 PM up and fine. No vom or loss of consciousness throughout.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: 4-28-2009  1150/AM.- MMR #2 given.  730/PM.  Pt had seizure taken to ER s+s unknown.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Concussion, Cyanosis, Full blood count, Head injury
Clinical narrative: Daughter received first GARDASIL shot in June 2008. She passed out and hit her head getting a concussion -the Dr believed-. She had to stay in bed for over a week. She had severe headaches and neck pain. After the second shot, in September she also went to bed for about a week and a half. She had achiness all over especially in legs and stomach. The doctor ran CBC and xrays but could only find a slightly elevated protein level in the urine at this time. Because of these, she did not receive third vaccine. Over the winter, her toes started turning blue. She is now being tested for lupus. I will know the results in about one week, but if she has it I am sure it is from GARDASIL. This is a very dangerous vaccine and I wish I would have researched it more before forcing my daughter to receive it. I will never forgive myself for making her take this vaccine against her will. I was trying to help her by giving her a guaranteed cancer free future but may have ended up shortening her life or making her have a chronically ill life and she is only 17. I am so furious with the makers of this drug. If she tests positive for lupus, I plan on hiring a lawyer.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Loss of consciousness, Neck pain, Pain, Protein urine present
Clinical narrative: Daughter received first GARDASIL shot in June 2008. She passed out and hit her head getting a concussion -the Dr believed-. She had to stay in bed for over a week. She had severe headaches and neck pain. After the second shot, in September she also went to bed for about a week and a half. She had achiness all over especially in legs and stomach. The doctor ran CBC and xrays but could only find a slightly elevated protein level in the urine at this time. Because of these, she did not receive third vaccine. Over the winter, her toes started turning blue. She is now being tested for lupus. I will know the results in about one week, but if she has it I am sure it is from GARDASIL. This is a very dangerous vaccine and I wish I would have researched it more before forcing my daughter to receive it. I will never forgive myself for making her take this vaccine against her will. I was trying to help her by giving her a guaranteed cancer free future but may have ended up shortening her life or making her have a chronically ill life and she is only 17. I am so furious with the makers of this drug. If she tests positive for lupus, I plan on hiring a lawyer.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: Daughter received first GARDASIL shot in June 2008. She passed out and hit her head getting a concussion -the Dr believed-. She had to stay in bed for over a week. She had severe headaches and neck pain. After the second shot, in September she also went to bed for about a week and a half. She had achiness all over especially in legs and stomach. The doctor ran CBC and xrays but could only find a slightly elevated protein level in the urine at this time. Because of these, she did not receive third vaccine. Over the winter, her toes started turning blue. She is now being tested for lupus. I will know the results in about one week, but if she has it I am sure it is from GARDASIL. This is a very dangerous vaccine and I wish I would have researched it more before forcing my daughter to receive it. I will never forgive myself for making her take this vaccine against her will. I was trying to help her by giving her a guaranteed cancer free future but may have ended up shortening her life or making her have a chronically ill life and she is only 17. I am so furious with the makers of this drug. If she tests positive for lupus, I plan on hiring a lawyer.
Age: 69.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Rash erythematous, Rash macular, Rash vesicular
Clinical narrative: Pt seen by MD on 3/13/09. Pt c/o rash in dermatome pattern from right lower flank which extends down and wraps around to ant thigh. Sx started 7 days ago. The rash was painful but he does not remember if it was vesicular. He had ZOSTAVAX on 2/20/09. Healing erythematous macular rash 1,1/1,2 distribution, no active lesion. ASSESSMENT-Zoster-like rash possible ADR to ZOSTAVAX, no h/o immune deficiency, no steroids or other meds which would contribute. No HIV risk factors. Plan- Triancinolone cream BID PRN.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, TTOX
Symptoms: Drug exposure during pregnancy, Foetal disorder, Urine human chorionic gonadotropin
Clinical narrative: Information has been received through the Merck pregnancy registry, from a registered nurse concerning an approximately 18 year old female with no medical history of allergies who on 20-JAN-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 656373/0243U). Concomitant therapy included ADACEL and Tetanus Toxoid. Subsequently, it was reported that the patient is pregnant. The patient sought unspecified medical attention. Diagnostic laboratory testing included a urine pregnancy test. The due date was reported as 27-SEP-2008. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Follow up information was received from the initial reporter. She stated the patient transferred from their care due to preterm labor symptoms in July 2008. The patient had no further problems with preterm labor symptoms or any other concerns for the remainder of her pregnancy. She had an uncompleted vaginal birth on 25-SEP-2008 (reported as "25-SEP-2009") at 40 weeks gestation; there were no complications at the birth either. The baby had mild physiologic jaundice after delivery, which did not require treatment or an extended stay, and he was discharged home with his mother. The baby had met all of his developmental milestones and was healthy and well. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL, concerning a 22 year old female who on 22-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #658560/1062U).  There was no concomitant medication.  On an unspecified date, the patient found out she was pregnant (LMP = 28-JAN-2008).  The patient sought unspecified medical attention via an office visit.  No adverse experience was related to this event.  No further information is available.  Follow up information has been received from a registered nurse on 02-APR-2009.  It was reported that the patient delivered a normal baby girl on 23-OCT-2008 at 38.2 weeks gestation.  The baby was 5 pounds and 14 ounces.  She was 19 inches long.  Prenatal care included pregnancy induced hypertension, which did not resolve after delivery.  The patient's last visit to the office was on 05-MAR-2009, and she was started on hydrochlorothiazide at that time.  She also received her third dose of GARDASIL on 05-MAR-2009.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL from a health care worker concerning a her 15 year old daughter with hip dysplasia and two hip surgeries who on 25-OCT-2007 was vaccinated with a first dose of GARDASIL (Lot # 648563/1063U) 0/5ml, intramuscularly.  On 07-FEB-2008 she received second dose of GARDASIL (Lot # 655327/1287U) 0.5ml, intramuscularly.  There was no Concomitant therapy.  Patient had a baby on 17-MAR-2008.  Mother and baby were doing well and due to be discharged home on 19-MAR-2009.  There were no Laboratory Diagnostics Studies performed.  The patient was seen by the physician.  Follow up information has been received from a physician concerning a 15 year old pregnant female who on 25-OCT-2007 was vaccinated with GARDASIL.  Concomitant therapy included vitamins (unspecified) and NAPROSYN for pain in the III trimester.  There were no complications or infections during the pregnancy.  Subsequently, on 17-MAR-2009 the patient delivered a normal, healthy male baby weighting 3448 grams.  APGAR score was 8/9.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 10 years old female patient who on 06-MAR-2008, was vaccinated with the third doe of GARDASIL vaccine (lot no. 659653/1448U) (route not reported). The nurse reported that on the same date of vaccination the patient had a routine physical exam and a PAP smear was done, results of the PAP smear showed atypical squamous changes (ASCUS) and Human papilloma virus was detected. The patient was treated with vaginal antibiotics (unspecified). It was reported that in September 2008 another PAP smear was done which showed ASCUS however the Human papilloma virus was not detected. In March 2009 a PAP smear was done and it came back negative. The nurse did not have information on the first two doses of GARDASIL vaccine as they were not administered at this doctor's office. The registered nurse considered the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vision blurred
Clinical narrative: Information has been received from a physician's nurse concerning a female who in 01 July 2008, was vaccinated with GARDASIL vaccine (Lot# and dose sequence number not reported), 0.5ml, IM. Subsequently, the patient experienced intermittent headaches and blurred vision for 2 weeks. The patient did not seek medical attention. At the time of reporting, the patient had recovered from intermittent headaches and blurred vision. The patient decided not to complete the series after she experienced the adverse events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Headache, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a registered nurse and a 26 year old female with no pertinent medical history and no history of known drug reactions/allergies who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (therapy site unknown, lot # not reported).  On 17-OCT-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 mL IM (therapy site unknown;  lot # not reported).  On 17-FEB-2009 the patient received the third dose of GARDASIL 0.5 ml IM (therapy site unknown) (Lot# 661044/0548X).  There was no concomitant medication.  On 01-APR-2009, a nurse reported that after the third dose, the patient developed varicose vein on her legs, headaches, chest pain and shortness of breath.  The patient was seen by her primary care physician.  The nurse reported the patient was recovering.  On 02-APR-2009, the patient reported that "a few days before receiving the third dose:, she started to experience leg pain, chest pain, headaches.  After receiving the third dose, the patient still had the same symptoms.  The patient reported she had a Magnetic resonance imaging (MRI) done and had seen a knee doctor, a spine doctor and her primary care physician.  The doctors were still unsure what was causing her symptoms and she will soon find out the results of the MRI.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Varicose vein
Clinical narrative: Information has been received from a registered nurse and a 26 year old female with no pertinent medical history and no history of known drug reactions/allergies who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (therapy site unknown, lot # not reported).  On 17-OCT-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 mL IM (therapy site unknown;  lot # not reported).  On 17-FEB-2009 the patient received the third dose of GARDASIL 0.5 ml IM (therapy site unknown) (Lot# 661044/0548X).  There was no concomitant medication.  On 01-APR-2009, a nurse reported that after the third dose, the patient developed varicose vein on her legs, headaches, chest pain and shortness of breath.  The patient was seen by her primary care physician.  The nurse reported the patient was recovering.  On 02-APR-2009, the patient reported that "a few days before receiving the third dose:, she started to experience leg pain, chest pain, headaches.  After receiving the third dose, the patient still had the same symptoms.  The patient reported she had a Magnetic resonance imaging (MRI) done and had seen a knee doctor, a spine doctor and her primary care physician.  The doctors were still unsure what was causing her symptoms and she will soon find out the results of the MRI.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 20 year old female patient with no relative medical history, drug reactions or allergies who was vaccinated with third doses of GARDASIL (lot number 661044/0648X), site and route not reported).  Concomitant therapy included OCELLA.  She didn't know the dates of the vaccination, but she finished the series about one month ago, in approx March 2009.  After the second dose, she developed joint pain at the wrists and ankles and this got worse after the third dose.  The pain affected all of her joints and muscles after the third dose.  She was seen on 24-MAR-2009 by the doctor and was prescribed NAPROXEN but it didn't help.  She saw the physician again on 30-MAR-2009 for the condition described above.  The events persisted at this report time.  Follow-up information was received from a registered nurse who reported that the patient was seen by the physician on 08-APR-2009 and still had "aches" and the doctor referred patient to a rheumatologist.  It was confirmed that the patient was not hospitalized.   Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Dizziness, Hypersensitivity, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 18-MAR-2009 was vaccinated intramuscularly with a first dose of GARDASIL (lot #661044/0548X) 0.5 mL. The patient experienced "dizziness, syncope, blurred vision, nausea and vomiting" after being given GARDASIL. The patient brought to the ER but was not admitted. She was diagnosed with "an allergic reaction, dehydration, probably due to the vomiting". On unspecified date, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 18-MAR-2009 was vaccinated intramuscularly with a first dose of GARDASIL (lot #661044/0548X) 0.5 mL. The patient experienced "dizziness, syncope, blurred vision, nausea and vomiting" after being given GARDASIL. The patient brought to the ER but was not admitted. She was diagnosed with "an allergic reaction, dehydration, probably due to the vomiting". On unspecified date, the patient recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: Information has been received from a 28 year old female patient with irregular heartbeat and no allergies who in June 2007, was vaccinated with the first dose of GARDASIL. In September 2007 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In October 2007, the patient developed two ovarian cysts, vaginal discharge and vaginal bleeding after receiving GARDASIL. The patient's two ovarian cysts and vaginal discharge and vaginal bleeding persisted. She has not yet received the third dose. The patient sought unspecified medical attention and saw a physician. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information hs been received from a physician concerning a 15 year old female who was vaccinated with GARDASIL. The patient developed genital warts after completing the GARDASIL series. The outcome of the patient was unknown. The patient sought unspecified medical attention and was seen by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a either 15 or 16 year old female who was vaccinated with a dose of GARDASIL (lot number not available) on an unspecified date. Immediately following injection, the patient experienced faint. Subsequently, the patient recovered on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with sore throat on 23-FEB-2009 who was vaccinated with her first dose of GARDASIL (lot #661766/0652X) after the strep throat test on 23-FEB-2009. She performed a strep throat test but it came back negative and she did not have fever before vaccination. Subsequently, soon after receiving GARDASIL, the patient experienced fever, nausea, and had swelling, a rash and a knot at the injection site. In the second week of March 2009, the patient's father called the office and stated that the patient still had swelling and knot at the injection site. At the time of reporting, the nurse did not know if the patient had fully recovered and was not sure if the patient would receive the second dose of GARDASIL. The patient called the physician for medical attention. Additional information has requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with sore throat on 23-FEB-2009 who was vaccinated with her first dose of GARDASIL (lot #661766/0652X) after the strep throat test on 23-FEB-2009. She performed a strep throat test but it came back negative and she did not have fever before vaccination. Subsequently, soon after receiving GARDASIL, the patient experienced fever, nausea, and had swelling, a rash and a knot at the injection site. In the second week of March 2009, the patient's father called the office and stated that the patient still had swelling and knot at the injection site. At the time of reporting, the nurse did not know if the patient had fully recovered and was not sure if the patient would receive the second dose of GARDASIL. The patient called the physician for medical attention. Additional information has requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Feeling abnormal, Gait disturbance, Injection site pruritus, Joint stiffness
Clinical narrative: Information has been received from a 30 year old female patient with papilloma viral infection, who on 24-JAN-2009 was vaccinated with a 0.5 mL dose of GARDASIL. There was no concomitant medication. On approximately 24-JAN-2009 the patient experienced tightness in her fingers and itching at the injection site. Sometimes it was hard for her to breath. It was difficult for the patient to walk and her body was feeling different. No laboratories studies performed. The patient sought unspecified medical attention. The patient has not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Pallor
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with a penicillin allergy who on 02-APR-2009 was vaccinated with GARDASIL, lot number 661846/1312X. Concomitant therapy included XANAX, LAMICTAL and GEODON. On 01-APR-2009, the nurse reported the patient's blood pressure dropped and her color became pale after a dose of GARDASIL was given. The patient complained of "feeling faint but did not actually faint". The patient sought medical attention she spoke with the nurse. The patient was recovered on 2-APR-2009. No further information was reported. Additional information has been requested.