chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Mother came in with documentation stating took to ER on 12-2-07.  Bottom of child's feet itched & spots but the spots came & went.  No allergies to eggs.  No problems with previous immunizations.  Immunizations done on 11-29-07.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Crying, Irritability
Clinical narrative: 09-20-06 Immunization with Prevnar, Pediarix, Ped VAX.  09-21-06 Developed elevated temperature 101.9.  Severe irritability, uncontrolled crying for 24 hours.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None - Given Hep A 2nd dose, 3 months apart from 1st dose.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash, Rash generalised, Swelling
Clinical narrative: Rash started around injection site of Pediarix then rash and swelling spread over most of body resulting in trip to hospital - still on oral prednisone at follow-up appointment with MD on 12/10/07.  01/25/2008 MR received for 2 ER visits 12/7/2007 and 12/8/2007 with D/C DX: Allergic Reaction  Systemic-probably reaction to immunizations and Rash likely 2' to medication reaction.  PE (+) for red, macular papular rash  to legs, torso, and arms, otherwise WNL except infant fussy. D/C on benadryl and prednisolone.  Returned to ER next day with worsening sx including puffiness of the cheeks and eyelids and reduced appetite. D/C to f/u with PCP.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Swelling
Clinical narrative: Rash started around injection site of Pediarix then rash and swelling spread over most of body resulting in trip to hospital - still on oral prednisone at follow-up appointment with MD on 12/10/07.  01/25/2008 MR received for 2 ER visits 12/7/2007 and 12/8/2007 with D/C DX: Allergic Reaction  Systemic-probably reaction to immunizations and Rash likely 2' to medication reaction.  PE (+) for red, macular papular rash  to legs, torso, and arms, otherwise WNL except infant fussy. D/C on benadryl and prednisolone.  Returned to ER next day with worsening sx including puffiness of the cheeks and eyelids and reduced appetite. D/C to f/u with PCP.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Immunology test, Injection site nodule, Vaccine positive rechallenge
Clinical narrative: Has developed sterile granulomas at injection sites, multiple times after receiving 2 sets vaccines 8/6/06 and 9/7/07.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Mom reports to PHN 12/18/07 that first 9/17/07 IMM given and returning home baby had redness, swelling from thigh to knee, knot at injection sites.  Duration about 36 hrs.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: 12/17/07 Began approx between 8-8:30pm, very fussy, moping around.  Fever began at 9pm.  Temp remains low grade 100 degrees throughout.  Patient still running low grade fever, fussiness at times.
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV, PNC
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Full blood count, Laboratory test normal
Clinical narrative: Seizure like event.  A series of quick myoclonic jerks=extension of neck, stiffening of arms & legs about 8 times in sequence over 1-2 minutes.  Repeated again 8 times at home, to ED, 8 more times in ED then no more.  No post vital lethargy, no mental status changes, no fever.  (Suspected DTaP reaction).
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV, PNC
Symptoms: Musculoskeletal stiffness, Myoclonus
Clinical narrative: Seizure like event.  A series of quick myoclonic jerks=extension of neck, stiffening of arms & legs about 8 times in sequence over 1-2 minutes.  Repeated again 8 times at home, to ED, 8 more times in ED then no more.  No post vital lethargy, no mental status changes, no fever.  (Suspected DTaP reaction).
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Pain in extremity
Clinical narrative: Pain left deltoid radiating to clavicle and fingers.  Later developed chest pains/mid-epigastria pain.  Persistent feeling of dizziness, leg aches 1 month later.  TC to PCP.  Lot numbers obtained and updated in database.  Child Dxd with "teen fibromyalgia" per office note of 12/27/2007.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event occurred.  Influenza vaccine given at 4 months of age.
Age: 0.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Swelling, redness & lump at site of injection x7d.  Now 2 weeks later still sm lump about 0.8 and sm dimple on skin.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Oral herpes
Clinical narrative: Within 12-14 hours after Zostavax, the next morning woke up with a cold sore blister.  Went away in 48 hours.  Usually his cold sore blisters last 4-5 days.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Mouth ulceration, Sneezing
Clinical narrative: Back ache, sore on mouth, sneezing, crusted blood in nasal passages.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Neck pain, Pain in extremity
Clinical narrative: Soreness in arm after vaccine administered; soreness spread across chest at approx 2000. Awakened at 2200 with heavy/crushing midsternal chest pain with radiation to neck & both arms.  Relieved after approx 30-40 mins (took Tyl).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Skin nodule
Clinical narrative: 10/4/07 - had [[name]] red 1/8" bump with fluid in it on right elbow and about 6 other bumps scattered on torso.  Remained 5 days.  One on elbow was scratched open, others intact.  12/4/07 - several similar bumps noted on torso and hips 3-4 inches apart, run along each side of torso.  One on left hip, raised and red 1/2" in diameter with [[name]] white tip and one on left hip was oozing slightly.  Itch slightly and hurt a little.  Most irritating.  Will consider calling doctor to observe.  PHN recommended having doctor observe and document.  Have doctor assess further.  12-5-07 - Red bumps present.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Wound drainage
Clinical narrative: 10/4/07 - had [[name]] red 1/8" bump with fluid in it on right elbow and about 6 other bumps scattered on torso.  Remained 5 days.  One on elbow was scratched open, others intact.  12/4/07 - several similar bumps noted on torso and hips 3-4 inches apart, run along each side of torso.  One on left hip, raised and red 1/2" in diameter with [[name]] white tip and one on left hip was oozing slightly.  Itch slightly and hurt a little.  Most irritating.  Will consider calling doctor to observe.  PHN recommended having doctor observe and document.  Have doctor assess further.  12-5-07 - Red bumps present.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 2 hrs after flu shot hives, no respiratory Sx, no Hx egg allergy; Benadryl.
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: Given Pediatrix, DTaP-HepB-IVP combined, when she should have received DTaP alone.  No excessive symptoms noted by mom.  I will not give DTaP at this time, but will give routine 5 yo vacc.  Mom aware.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Neck pain, Pain in extremity, Pruritus, Tremor
Clinical narrative: 1-2 hours after getting Pneumovax pt. experienced soreness up & down arm & neck, began to itch.  Pt woke at 4AM w/ fever symptoms (chilled & shakes) but no temp taken.  Upon recommendation of RPH applied ice & resolving after 3 days later.  Now itches like healing sore up and down arm.  Hurts to scratch but no loss of functionability.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Pharyngolaryngeal pain, Vaccine positive rechallenge
Clinical narrative: Patient stating sore throat with cold symptoms at night after #2 and #3 Gardasil vaccinations.  #2 given 7-26-07 and #3 given 12-03-07.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site swelling
Clinical narrative: 4"x4 1/2" Child has red, swollen right anterior thigh, no fever, is playful and happy; since 10:00 this morning, no shortness of breath.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Severe swelling of L arm from shoulder to wrist + erythema & decreased ROM.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received Tdap at age 9.  Unable to contact parents to determine patient status post vaccine as phone numbers disconnected.  Letter sent via certified mail requesting parents contact office 10-22-07.  As of 12-17-07, no response.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Developed varicella after 2 doses of vaccine - failed protection.  1st varivax given 3-30-04 Merck 0884N and 2nd varivax given 5-29-07 Merck 1391F.
Age: 73.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: RUE erythema, edema, warmth.  Using Tylenol & cool compresses with good results - decreased sxs over weekend.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Lethargy
Clinical narrative: Fever 102 11/29/97 - fussy & lethargic.  Rt thigh red & swollen & warm to touch at injection site.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 102 11/29/97 - fussy & lethargic.  Rt thigh red & swollen & warm to touch at injection site.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: High fever, break out all over.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Clinical narrative: Child received dose of recalled Hep Hib. 1/16/08-the parents called on 12/14/07 after learning about the HIB recall and stated that the child has not "seemed right since she got the shot."  The provider stated there was no specific complaint  and the child was healthy when he examined her after that.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Blood culture negative, Nerve injury, Nuclear magnetic resonance imaging brain normal, Spinal X-ray normal
Clinical narrative: Nerves to both eyes affected - right eye has a 6 nerve palsy.  Left eye has a 3rd nerve palsy.  Occurred 3 months after last administered vaccine.  No treatment available to date.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Rash erythematous
Clinical narrative: Large erythematous, painful, swelling from shoulder into right forearm and beyond elbow.  Clearing slowly on antibiotic and prednosone.  Brachial Neuritis 12/6/07.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal discomfort, Chest pain, Dyspepsia, Erythema, Nausea
Clinical narrative: 1 hour after vaccination of Anthrax with presented burning chest/abdomen with nausea, skin red, warm, shaking.  "Severe" epigastric pain which changed to burning in abdomen.  Transported via ambulance to hospital.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Skin warm, Tremor
Clinical narrative: 1 hour after vaccination of Anthrax with presented burning chest/abdomen with nausea, skin red, warm, shaking.  "Severe" epigastric pain which changed to burning in abdomen.  Transported via ambulance to hospital.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Chills, Erythema, Haematemesis, Pruritus
Clinical narrative: 1 hour after vaccination of Anthrax with presented burning chest/abdomen with nausea, skin red, warm, shaking.  "Severe" epigastric pain which changed to burning in abdomen.  Transported via ambulance to hospital.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Skin burning sensation
Clinical narrative: 1 hour after vaccination of Anthrax with presented burning chest/abdomen with nausea, skin red, warm, shaking.  "Severe" epigastric pain which changed to burning in abdomen.  Transported via ambulance to hospital.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: L upper arm with redness and mild inflammation half dollar size.  Pt with fever last night.  Treatment with Benadryl 50mg TID and warm compresses.  Follow up tomorrow.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Streptococcal identification test negative, Urticaria
Clinical narrative: Urticaria developed on upper legs and spread through body.  Treatment is cetirizino and diphenhydramine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Medication error
Clinical narrative: None - discovered patient given outdated IPV vaccine.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Appendicitis, Computerised tomogram abnormal, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a sulfonamide allergy (BACTRIM), who in January 2007, was vaccinated with the first dose of Gardasil, and on 02-MAR-2007 with the second dose of Gardasil (lot # not reported). "Within a couple of minutes" after the second vaccination, she experienced pain. The pain resolved within hours. On 26-SEP-2007, her daughter was vaccinated with the third dose of Gardasil (lot # not reported). About 6 hours later, she experienced stomach pain and could not sleep. At approximately 3:00 a.m. (27-SEP-2007), she visited the student health center, and was sent to the emergency room. A magnetic resonance imaging (MRI) and a computed tomography (CT) were performed, and she was diagnosed with appendicitis. That night, 27-SEP-2007, emergency surgery was performed, and she remained hospitalized for 2 nights. On 25-OCT-2007, her daughter returned to the surgeon, and "was cleared." Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep disorder, Surgery
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a sulfonamide allergy (BACTRIM), who in January 2007, was vaccinated with the first dose of Gardasil, and on 02-MAR-2007 with the second dose of Gardasil (lot # not reported). "Within a couple of minutes" after the second vaccination, she experienced pain. The pain resolved within hours. On 26-SEP-2007, her daughter was vaccinated with the third dose of Gardasil (lot # not reported). About 6 hours later, she experienced stomach pain and could not sleep. At approximately 3:00 a.m. (27-SEP-2007), she visited the student health center, and was sent to the emergency room. A magnetic resonance imaging (MRI) and a computed tomography (CT) were performed, and she was diagnosed with appendicitis. That night, 27-SEP-2007, emergency surgery was performed, and she remained hospitalized for 2 nights. On 25-OCT-2007, her daughter returned to the surgeon, and "was cleared." Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain
Clinical narrative: Information has been received from a registered nurse concerning her daughter in her early twenties, who was diagnosed with Guillain-Barre syndrome at the age of 7. On 20-JUN-2007 the patient had her first dose of Gardasil (Lot #657868/0523U) intramuscularly, and on 06-OCT-2007 was vaccinated with her second dose of Gardasil (Lot #658560/1062U). Concomitant therapy included meningococcal vaccine (unspecified) which was also received on 06-OCT-2007. Shortly after her second dose of Gardasil her daughter displayed signs of Guillain-Barre syndrome, specifically "back pain". The patient's second dose of Gardasil was administered 4 months after her first dose. No further information was provided. Upon medical review Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.  12/28/07 Follow up initiated at request of CDC.  T/C to provider who stated patient did not have final dx of GBS.  Had history of GBS at 8 yrs old.  Was not hospitalized in 2007.  12/28/07 Received vax record & office record.  Gardasil #1 given 6/20/07 lot 0523U.  Menactra given 6/20/07 lot# U2231AA.  Gardasil #2 given 10/6/07 lot # 1062U.  Office vs of 10/6 was for shot only, no med record.  Next visit 10/19/07 w/neck, shoulder & back pain, since 10/6/07. Exam revealed sniffles & post nasal drip.  Week before, patient reported dysphagia which had resolved.  Dx w/viral illness & reflux.  Tx w/benadryl & prilosec.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Formication, Laboratory test, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: Information has been received from a pediatrician concerning a 17 year old female who on 22-MAR-2007 was vaccinated with a first dose of Gardasil co administered with therapy included MENACTRA on a different arm. On 27-MAR-2007 the patient complained of pain in the thigh and a "creepy, crawly, tingling feeling". She went to the local emergency room (ER). She was admitted to the hospital on 29-MAR-2007. According to the pediatrician all diagnostics came back clear (not further specified). She underwent an ultrasound (results not reported). The patient was seen by a neurologist who hinted a touch of Guillain-Barre. All conditions resolved by early May. The patient did not continue with the series of Gardasil. The pediatrician considered Guillain-Barre to be disabling. Additional information has been requested. 7/3/08-records received- DC summary is not included in a short stay DOS 3/29-3/30/07.Principal diagnosis of this admission: Guillain-Barre syndrome. Presented with C/O dysesthesias and weakness. One 3/19/07 onset of sore throat,  Received vaccinations on that date. Continued to C/O upper respiratory infection symptoms with sinus type headace. Developed discomfort in legs and burning, aching sensation. Tired and generally weak.  PE:diffuse motor weakenss in arms and legs. Deep tendon reflexes brisk. Suggests peripheral neuropathy.  10/10/08-reviewed by CDC CISA staff who determined that this is NOT GBS
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient who was vaccinated with a dose of Gardasil. Concomitant therapy included varicella virus vaccine live. Concomitant therapy included MENACTRA and BOOSTRIX. The physician reported that the patient developed nausea, vomiting and severe headache. She was taken to the emergency room (ER) and admitted in the adult "hospital where she was given intravenous (IV) fluids and meperidine hydrochloride ("DEMEROL")". Later she was transferred to another hospital where she was given IV fluids again and "TRUODOL". She was admitted overnight. No further information was provided. The patient was released the next day and was recovered. The reporter indicated that the patient getting intravenous (IV) fluids was to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on approximately 19-Nov-2007 was vaccinated with the second dose of Gardasil.  On 20-Nov-2007, within 24 hours of receiving the vaccine, the patient experienced dizziness.  The patient was subsequently admitted to the hospital, however the length of stay was unknown.  The reporting physician that had heard of this event is not this patient's physician.  At the time of this report, the outcome of the event was unknown.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Activities of daily living impaired, Back pain, Borrelia burgdorferi serology, Chest pain, Full blood count
Clinical narrative: Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient's myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Musculoskeletal pain, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient's myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Back pain, Borrelia burgdorferi serology negative, Full blood count normal, Insomnia, Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient's myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Painful respiration, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Vaccine positive rechallenge, X-ray normal
Clinical narrative: Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient's myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Activities of daily living impaired, Back pain, Borrelia burgdorferi serology, Chest pain, Full blood count
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with asthma, and allergies to penicillin and a sulfonamide allergy, who on 09-AUG-2007 was vaccinated intramuscularly in the deltoid with a 0.5cc first dose of GARDASIL (Lot# 658490/0802U). Concomitant therapy included SINGULAIR. Subsequently, the patient experienced shoulder and back pain (previously reported as the patient did not experience any problems) after the first dose. On 11-OCT-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 658560/1062U). Concomitant vaccination and ADACEL. Subsequently, five days after the second vaccination the patient experience shoulder and back pain. The patient rated the pain as 7 out of 10. The patient was not able to sleep. The symptoms increased with range of motion with the back and shoulder. When the patient would take a deep breath her chest hurt. It was reported by the nurse that the patient played soccer but she was unaware of any injuries. On 21-NOV-2007, the patient rated the pain as 6 out of 10. It was reported that the shoulder and back pain was less intense after the first dose than after the second dose. The patient was seen in the office. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Musculoskeletal pain, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with asthma, and allergies to penicillin and a sulfonamide allergy, who on 09-AUG-2007 was vaccinated intramuscularly in the deltoid with a 0.5cc first dose of GARDASIL (Lot# 658490/0802U). Concomitant therapy included SINGULAIR. Subsequently, the patient experienced shoulder and back pain (previously reported as the patient did not experience any problems) after the first dose. On 11-OCT-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 658560/1062U). Concomitant vaccination and ADACEL. Subsequently, five days after the second vaccination the patient experience shoulder and back pain. The patient rated the pain as 7 out of 10. The patient was not able to sleep. The symptoms increased with range of motion with the back and shoulder. When the patient would take a deep breath her chest hurt. It was reported by the nurse that the patient played soccer but she was unaware of any injuries. On 21-NOV-2007, the patient rated the pain as 6 out of 10. It was reported that the shoulder and back pain was less intense after the first dose than after the second dose. The patient was seen in the office. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Back pain, Borrelia burgdorferi serology negative, Full blood count normal, Insomnia, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with asthma, and allergies to penicillin and a sulfonamide allergy, who on 09-AUG-2007 was vaccinated intramuscularly in the deltoid with a 0.5cc first dose of GARDASIL (Lot# 658490/0802U). Concomitant therapy included SINGULAIR. Subsequently, the patient experienced shoulder and back pain (previously reported as the patient did not experience any problems) after the first dose. On 11-OCT-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 658560/1062U). Concomitant vaccination and ADACEL. Subsequently, five days after the second vaccination the patient experience shoulder and back pain. The patient rated the pain as 7 out of 10. The patient was not able to sleep. The symptoms increased with range of motion with the back and shoulder. When the patient would take a deep breath her chest hurt. It was reported by the nurse that the patient played soccer but she was unaware of any injuries. On 21-NOV-2007, the patient rated the pain as 6 out of 10. It was reported that the shoulder and back pain was less intense after the first dose than after the second dose. The patient was seen in the office. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Painful respiration, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Vaccine positive rechallenge, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with asthma, and allergies to penicillin and a sulfonamide allergy, who on 09-AUG-2007 was vaccinated intramuscularly in the deltoid with a 0.5cc first dose of GARDASIL (Lot# 658490/0802U). Concomitant therapy included SINGULAIR. Subsequently, the patient experienced shoulder and back pain (previously reported as the patient did not experience any problems) after the first dose. On 11-OCT-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 658560/1062U). Concomitant vaccination and ADACEL. Subsequently, five days after the second vaccination the patient experience shoulder and back pain. The patient rated the pain as 7 out of 10. The patient was not able to sleep. The symptoms increased with range of motion with the back and shoulder. When the patient would take a deep breath her chest hurt. It was reported by the nurse that the patient played soccer but she was unaware of any injuries. On 21-NOV-2007, the patient rated the pain as 6 out of 10. It was reported that the shoulder and back pain was less intense after the first dose than after the second dose. The patient was seen in the office. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: Information has been received from a certified medical assistant, concerning her 25 year old daughter, with a sulfonamide allergy, who on 30-AUG-2007 was vaccinated IM, with the first dose, 0.5 ml, of HPV vaccine (lot 3658558/1061U), and on 27-NOV-2007, was vaccinated IM, with the second dose, 0.5 ml, of HPV vaccine (lot #659435/1265U).  Concomitant therapy included hormonal contraceptives (unspecified).  In November 2007, following the second vaccination, her daughter developed an itchy rash to her torso and the back of her arm.  Treatment included diphenhydramine (Benadryl) and hydrocortisone cream (manufacturer unspecified).  At the time of this report, the outcome of the event was not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who on an unspecified date was vaccinated with a dose of Gardasil (lot # not reported).  The physician stated that "about" two weeks after the vaccination, the patient "had a lot of soreness in her arm."  At the time of this report, the outcome of the event was unknown.  The patient did not require medical attention for the event.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist, concerning her 20 year old daughter, who in November 2007 ("about 2 weeks ago"), was vaccinated with the first dose of HPV vaccine (lot #not reported).  Concomitant therapy included fexofenadine hydrochloride (Allegra).  In November 2007, following the vaccination (duration onset not reported), her daughter developed a case of mild shingles, and was seen by the college physician.  At the time of this report, the patient was recovering from the event.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a pharmacist, concerning her 20 year old daughter, a student with mild and well-controlled asthma, who in November 2007 ("about 2 weeks ago") , was vaccinated with the first dose of GARDASIL (lot # not reported). There was no illness at the time of vaccination. Concomitant therapy included ALLEGRA. In November 2007, also indicated as "about 3 weeks after administration of vaccine" her daughter, who was otherwise healthly, developed a case of mild shingles and was seen by the college physician. At the time of this report, tthe outcome of the event was unknown. Additional informafon is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on 25-Oct-2007 was vaccinated with the third dose of Gardasil (lot # not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  On 12-Nov-2007, the patient visited her physician with swollen inguinal lymph nodes, and was sent to the emergency room (ER).  The ER sent the patient to surgery, as they considered that she had a hernia, however, it was then confirmed that the patient did not have a hernia but only the swollen inguinal lymph nodes.  It was unclear if the patient had surgery.  At the time of this report, the outcome of the event was unknown.  The physician considered swollen inguinal lymph nodes to be serious as an other important medical event (intervention required).  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of drug hypersensitivity to Cefaclor who on 10-AUG-2007 was vaccinated with her first dose of Gardasil (Lot #658222/0927U).  On 12-Oct-2007 the patient was vaccinated with the second dose of Gardasil (Lot #659435/1265U).  Concomitant therapy included influenza virus vaccine (unspecified) (influenza virus vaccine USP) on 20-Nov-2007 and ethinyl estradiol/norgestimate (Ortho Tri-Cyclen).  On 30-Nov-2007 the patient experienced a rash all over her body.  The patient sought unspecified medical treatment.  No labs or diagnostic studies were performed regarding the rash.  At the time of this report, the patient still had not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid volume decreased, Anaemia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Nausea
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 21 year old hispanic female patient with a history of cervical dysplasia and headaches with no allergies who on 23-Mar-2007, was vaccinated with a first dose of Gardasil (Lot #656049/0187U).  Concomitant therapy included acetaminophen as needed.  The nurse reported that the patient had a blood pregnancy test on 02-Apr-2007 and was confirmed to be pregnant.  Her last menstrual period was 24-Feb-2007 and her estimated due date was 01-Dec-2007.  It was reported that her pregnancy was normal to date.  On 11-May-2007, cetirizine hydrochloride (Zyrtec) 10 mg as needed was prescribed for nausea.  On 05-Jul-2007, the patient had an ultrasound for a fetal survey.  The results of the test were within normal limits; fetal growth was appropriate.  On 30-Aug-2007, iron (unspecified) 65mg daily, was prescribed for anemia.  On 02-Nov-2007, a second ultrasound was performed for a fetal survey and the result of this test was low amniotic fluid or oligohydramnios.  On 12-Nov-2007, a biophysical profile test was performed.  On 25-Nov-2007, the patient delivered a female baby weighing 6 pounds 6 ounces and measuring 19 inches in length.  The patient was reported to be 39 weeks from her last menstrual period.  The infant was reported to be normal with no congenital anomalies or other complications.  At the time of this report, the patient's outcome was unknown.  Additional  information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 21 year old hispanic female patient with a history of cervical dysplasia and headaches with no allergies who on 23-Mar-2007, was vaccinated with a first dose of Gardasil (Lot #656049/0187U).  Concomitant therapy included acetaminophen as needed.  The nurse reported that the patient had a blood pregnancy test on 02-Apr-2007 and was confirmed to be pregnant.  Her last menstrual period was 24-Feb-2007 and her estimated due date was 01-Dec-2007.  It was reported that her pregnancy was normal to date.  On 11-May-2007, cetirizine hydrochloride (Zyrtec) 10 mg as needed was prescribed for nausea.  On 05-Jul-2007, the patient had an ultrasound for a fetal survey.  The results of the test were within normal limits; fetal growth was appropriate.  On 30-Aug-2007, iron (unspecified) 65mg daily, was prescribed for anemia.  On 02-Nov-2007, a second ultrasound was performed for a fetal survey and the result of this test was low amniotic fluid or oligohydramnios.  On 12-Nov-2007, a biophysical profile test was performed.  On 25-Nov-2007, the patient delivered a female baby weighing 6 pounds 6 ounces and measuring 19 inches in length.  The patient was reported to be 39 weeks from her last menstrual period.  The infant was reported to be normal with no congenital anomalies or other complications.  At the time of this report, the patient's outcome was unknown.  Additional  information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cystitis, Drug exposure during pregnancy, Premature baby, Premature labour, Small for dates baby
Clinical narrative: Information has been received via the Merck pregnancy registry, from a physician concerning a 15 year old female patient, who on 13-JUN-2007 was vaccinated with the first dose of Gardasil (Lot #655620/0171U).  There was no concomitant medication.  After receiving the vaccination (date not reported), the patient learned that she was pregnant (date of LMP and estimated date of delivery not reported).  Follow up information received from the physician, via a company representative, indicated that the pregnancy resulted in a premature birth (date and gestational week not provided).  The infant (gender not specified), also was "a low birth weight baby" (weight not specified).  At the time of this report, the outcome and details of premature birth and low birth weight baby were unknown.  No further details were provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Initial and follow-up information has been received via the Merck pregnancy registry, from a physician concerning a 15 year old female patient with an allergy to Penicillin, who on 13-JUN-2007 (also reported as March 2007) was vaccinated with the 0.5mL first dose of GARDASIL (Lot #655620/0171U).  There was no concomitant medication.  After receiving the vaccination (date not reported), the patient learned that she was pregnant (date of LMP and estimated date of delivery not reported) (also reported that the patient became pregnant in January 2007). Follow up information received from the physician, via a company representative, indicated that the pregnancy resulted in a premautre birth (date and gestational week not provided).  The infant (gender not specified), also was "a low birth weight baby" (weight not specified).  At the time of this report, the outcome and details of premature birth and low birth weight baby were unknown.  It was reported that "everything is ok."  The patient was hospitalized when she had the baby for a little over one day.  No further details were provided.  Follow-up information was received on 24-MAR-2008 and on 07-APR-2008 from a physician and a woman from the physician's office.  It was reported that in July or August 2007, the patient was vaccinated intramuscularly with one 0.5 ml dose of GARDASIL (previously reported as 13-JUN-2007).  In October 2007, the patient became pregnant (previously reported as January 2007).  During her pregnancy, the patient had a bladder infection and was restricted to bedrest because of preterm labor.  The outcome of the patient was not reported.  This is a consolidation of two reports.  Additional information has been requsted.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning several females who were vaccinated with 0.5 ml doses of Gardasil.  Subsequently the nurse reported that the needle is "dull after withdrawing the medication from the vial and is causing the patients extreme pain".  The office was replacing the needle on the syringe in order to lessen the pain.  Unspecified medical attention was sought.  At the time of the report the patients' outcomes were unknown.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Erythema, Rash generalised
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a "3rd dose" of Gardasil (lot # not reported) two weeks after the second dose was administered.  The patient's status was not reported.  There was no product quality complaint involved.  Follow-up information was received.  The patient had received a first dose of Gardasil on 01-Aug-2007 IM in the left arm at 9:00AM.  On 01-Aug-2007, at 9:30 AM the patient broke out in a rash all over the body, a temperature was developed and redness around the injection site.  Medical attention was sought.  The patient came back 2 days later.  There was no temperature and the patient still had a rash.  On an unspecified date the patient recovered.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Skin burning sensation, Urticaria
Clinical narrative: Information has been received from a health care professional concerning a female who on 10-Jul-2007 (previously reported as approximately August 2007) was vaccinated with the first dose of Gardasil (lot #658100/0525U).  There was no concomitant medication.  The patient experienced headache and flu-like symptoms 15 to 30 minutes after vaccination.  Subsequently, the patient recovered the day after vaccination.  The patient sought unspecified medical attention by calling the physician's office.  Additional information has been requested.  Follow up information was received on 14-Nov-2007 which stated that the patient had hives from head to toe and felt like her skin was on fire after receiving the second dose in July 2007.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Incorrect route of drug administration, Injection site reaction, Pain, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 females (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with Gardasil (lot # unknown).  There was no concomitant medication.  The nurse reported that 4 patients received Gardasil due to a nursing error.  Each patient received 0.25 mL dose of Gardasil given subcutaneously near the wrist on 17-Oct-2007.  The person who administered the doses split a 0.5 mL dose of Gardasil equally among the 4 patients.  They were supposed to receive a tuberculin test.  The day after administration, each patient developed an injection site reaction right above the wrist.  The injection site was red, hard to the touch and painful.  One of these patients was seen by the nurse and the other 3 patients called her office.  Medical attention was sought.  At the time of reporting the patient had not recovered.  Follow-up information was received.  A 25 year old white female patient who on 17-Oct-2007 was vaccinated with Gardasil (lot #658282/1263U).  On 18-Oct-2007 the patient was given a 1/4 dose of Gardasil by mistake.  The patient was to receive a tuberculin test instead.  On an unspecified date one week later the patient recovered.  Follow-up information was received from a licensed practical nurse.  The LPN reported that one vial of purified protein derivative (PPD) was delivered to one office one day.  On the following day one vial of Gardasil was delivered to the same office.  The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from the Gardasil vial instead of the prescribed PPD vial.  The LPN stated that the error was not due to Product Confusion.  As a result of this error, the Gardasil vaccination would only be administered at another office and not in the current office to assure that this error would not occur again.  The patient that received Gardasil was treated with cold/warm compresses and recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Information has been received from a registered nurse concerning about 12 female patients between 11-15 years old with no pertinent medical history and no drug reactions/allergies who were vaccinated with 0.5 ml of Gardasil (657736/0389U).  There was no concomitant medication.  The nurse stated that she noticed a trend with Gardasil (657736/0389U) in about 12 patients who complained of the arm numbness within seconds after receiving Gardasil.  No lab diagnostic studies were performed.  The patients were observed after the injection and all recovered before leaving the office.  No other symptoms were reported.  Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report.  Additional information will be provided if available.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with the first two doses of Gardasil. There was no concomitant medication. Subsequently the patient has not menstruated for 3 months. Physician decided to stop the third dose. Patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a female registered nurse concerning a 25 year old female patient with no known allergies and no reported medical history who on 22-OCT-2007 was vaccinated with Gardasil (Lot #658560/1062U) 0.5 ml intramuscularly in the right deltoid. There was no concomitant medication. On 22-OCT-2007, the same day after receiving the first injection, the patient developed nausea, vomiting and fever, on 23-OCT-2007 the patient notified the physician via telephone after the adverse symptoms were resolved. No treatment was rendered and no other information is available. Additional information has been requested.