chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Adverse event
Clinical narrative: Initial report received from a PharmD on 03 December 2010.  An 11-year-old male patient whose medical history was unknown, was hospitalized with Acute Disseminated  Encephalomyelitis 1 day after receiving a dose of MENACTRA (lot number unknown), DTAP (DTAP, also may have been TDAP but DTAP is recorded in the record, and trade name unknown), and VARICELLA vaccines on 16 November 2010.  The manufacturer name, lot number, route and site of administration was "unknown" for the DTAP and VARICELLA vaccines.  On 17 November 2010 the patient had symptoms and was hospitalized "20 days".  Recovery status was not reported.  No other medically relevant information was received.  Documents held by sender:  None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Initial report received from a health care professional on 19 October 2010.  A 27-year-old female patient, with a history of allergies (not specified), received on 14 October 2010 a left deltoid intramuscular injection of ADACEL, sanofi pasteur Inc. lot number U3082AA and sanofi pasteur Ltd. lot number C3314.  She had no illness at the time of vaccination, had no adverse event following prior vaccinations and had no other vaccinations within 4 weeks prior to the ADACEL.  The patient's concomitant medications included SINGULAR, ALLEGRA, AVIANE and vitamin C.  On 15 October 2010 the patient developed a large local reaction at the left deltoid which included redness, pain, and swelling comparable to the size of a tennis ball.  She also complained of joint pain and swelling as well as generalized body aches and pains.  The patient was seen in the doctor's office and reported some improvement.  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 December 2010.  Based on this new information, it was determined that the event met seriousness criteria.  The patient had no known drug allergies, and no relevant medical history other than seasonal allergies.  Treatment included KENALOG 40mg intramuscularly, prednisone taper 10mg ("4, 3, 2, 1 x 2 days"), and KEFLEX 500 mg QID x 7 days.  The patient had not returned to the office, and the reporter was unable to provide an updated outcome.  No additional information was available at this time.  Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pain
Clinical narrative: Initial report received from a health care professional on 19 October 2010.  A 27-year-old female patient, with a history of allergies (not specified), received on 14 October 2010 a left deltoid intramuscular injection of ADACEL, sanofi pasteur Inc. lot number U3082AA and sanofi pasteur Ltd. lot number C3314.  She had no illness at the time of vaccination, had no adverse event following prior vaccinations and had no other vaccinations within 4 weeks prior to the ADACEL.  The patient's concomitant medications included SINGULAR, ALLEGRA, AVIANE and vitamin C.  On 15 October 2010 the patient developed a large local reaction at the left deltoid which included redness, pain, and swelling comparable to the size of a tennis ball.  She also complained of joint pain and swelling as well as generalized body aches and pains.  The patient was seen in the doctor's office and reported some improvement.  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 December 2010.  Based on this new information, it was determined that the event met seriousness criteria.  The patient had no known drug allergies, and no relevant medical history other than seasonal allergies.  Treatment included KENALOG 40mg intramuscularly, prednisone taper 10mg ("4, 3, 2, 1 x 2 days"), and KEFLEX 500 mg QID x 7 days.  The patient had not returned to the office, and the reporter was unable to provide an updated outcome.  No additional information was available at this time.  Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody increased, Blood test normal, Chest X-ray normal, Electrocardiogram normal, Flushing
Clinical narrative: One week of flushing and heart racing; followed by one week of extreme muscle stiffness on left side; followed by stroke-like symptoms and 3 weeks (and continuing) of numbness on the left side only.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Palpitations
Clinical narrative: One week of flushing and heart racing; followed by one week of extreme muscle stiffness on left side; followed by stroke-like symptoms and 3 weeks (and continuing) of numbness on the left side only.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness, warmth and swelling of right thigh
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration, Asthenia, Blood pressure increased, CSF culture negative, Computerised tomogram normal
Clinical narrative: 12/2 > ER at 12:19 PM with weakness difficulty walking, left & was back at 4:49 PM with worsening symptoms. Inability to walk without help, weakness all extremities, tingling hands, elevated BP 228/88. 12/4 unable to roll or move in bed by self, can raise arms slightly, 12/5 unable to swallow, aspirating, 12/7 able to move arms to head and raise knees off bed. Started Plasmaphoresis started 12/3 ended 12/9. Nasal tube placed for feedings and meds. CT & MRI of brain both negative. Spinal fluid negative culture.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Gait disturbance, Gastrointestinal tube insertion, Mobility decreased, Muscular weakness
Clinical narrative: 12/2 > ER at 12:19 PM with weakness difficulty walking, left & was back at 4:49 PM with worsening symptoms. Inability to walk without help, weakness all extremities, tingling hands, elevated BP 228/88. 12/4 unable to roll or move in bed by self, can raise arms slightly, 12/5 unable to swallow, aspirating, 12/7 able to move arms to head and raise knees off bed. Started Plasmaphoresis started 12/3 ended 12/9. Nasal tube placed for feedings and meds. CT & MRI of brain both negative. Spinal fluid negative culture.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, Plasmapheresis
Clinical narrative: 12/2 > ER at 12:19 PM with weakness difficulty walking, left & was back at 4:49 PM with worsening symptoms. Inability to walk without help, weakness all extremities, tingling hands, elevated BP 228/88. 12/4 unable to roll or move in bed by self, can raise arms slightly, 12/5 unable to swallow, aspirating, 12/7 able to move arms to head and raise knees off bed. Started Plasmaphoresis started 12/3 ended 12/9. Nasal tube placed for feedings and meds. CT & MRI of brain both negative. Spinal fluid negative culture.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Gaze palsy, Grand mal convulsion, Loss of consciousness, Respiratory arrest
Clinical narrative: Grand-mal seizure, fell off bed, eyes rolled back in her head, stopped breathing, loss of consciousness.
Age: 5.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Blood culture negative, Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site oedema
Clinical narrative: Beginning in the evening of 12/1/10 the patient developed edema/erythema and pain to the left upper extremity and ACF which progressed and prompted visit to the emergency department on PM OF 12/3/2010. Patient presented with decreased range of motion secondary to edema and pain of left upper extremity. Negative for DVT, diagnosed with cellulitis origin unknown: either from vaccine or iv infusion site reaction where blood was transfused.
Age: 5.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site pain, Vaccination site cellulitis
Clinical narrative: Beginning in the evening of 12/1/10 the patient developed edema/erythema and pain to the left upper extremity and ACF which progressed and prompted visit to the emergency department on PM OF 12/3/2010. Patient presented with decreased range of motion secondary to edema and pain of left upper extremity. Negative for DVT, diagnosed with cellulitis origin unknown: either from vaccine or iv infusion site reaction where blood was transfused.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Cold sweat, Dyspnoea, Paraesthesia
Clinical narrative: chest pains, breathing, ache in joints, cold sweat, itching, rash on legs and tingling in feet,
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: chest pains, breathing, ache in joints, cold sweat, itching, rash on legs and tingling in feet,
Age: 0.63
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Generalized urticaria.  2ml of Benadryl and 3 ml of Pedia pred given.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Pyrexia
Clinical narrative: My daughter began feeling dizzy immediately after flu mist vaccination was administered.  Within 10 minutes, she had a severe headache. Within 15 minutes, she had a slight fever, which escalated to 102.9 within 1 hour.  She was treated with ibuprofen and aceteminophen (alternately) to bring her fever down and lessen her headache pain.  We returned to the doctor's office where they took her temperature and blood pressure and gave her a dose of ibuprofen. They told us that the onset of her symptoms and the administration of the flu vaccine was "coincidental".
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: 3 DAY LOW FEVER 11/30/10 TO 12/3/10 3 DAYS SEVERE ITCHING ON THE OUTSIDE OF THE THIGHS, AND OUTSIDE OF THE ARMS FROM 12/5/10 TO 12/7/10. NOW FROM 12/8/10 HIVES ON THE RIGHT UPPER THIGH.  I WILL TRY BENADRYL.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I felt the injection was given too high in my deltoid. I felt a burning sensation and then the administrator pull back on the syringe and then continued to inject. It felt like it was a much longer process then previously experienced with flu shots. I have had terrible pain in my right shoulder and upper arm since the vaccine, with very limited mobility.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, VIIth nerve paralysis
Clinical narrative: Bell's Palsy; generalized weakness- diagnosed as Guillain Barre' syndrome by MD
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10.1 cm hot, red area anterior left thigh, non tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, pain at injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red raised, erythemous rash around injection site
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, CSF culture negative, Chest X-ray normal, Clumsiness, Culture positive
Clinical narrative: Hosp from 1/13/10 to 2/19/10.  Per HPI - URI around 1/1/10 with no fever or chills.  Denies travel exposure.  On 1/11/10, noted bilateral finger tingling with right hand clumsiness and worsening bilateral hand numbness.  At admission, notes bilaeral foot numbness to mid-calf and worse R arm weakness.  Admit for 5 days of plasmapheresis.  Pt did not report any dyspnea, dysphagia, slurred speech, vision changes, diplolpia, bowel/bladder incontinence, back/neck pain, headache, recent trauma.  Per MR - MD conclude demyelinating dz like GBS vs cord compression.  GBS Surveillance neuro consult conclude not GBS or GBS variant since discrepency of reflexes.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Demyelination, Gram stain, Gram stain negative, Hypoaesthesia, Muscular weakness
Clinical narrative: Hosp from 1/13/10 to 2/19/10.  Per HPI - URI around 1/1/10 with no fever or chills.  Denies travel exposure.  On 1/11/10, noted bilateral finger tingling with right hand clumsiness and worsening bilateral hand numbness.  At admission, notes bilaeral foot numbness to mid-calf and worse R arm weakness.  Admit for 5 days of plasmapheresis.  Pt did not report any dyspnea, dysphagia, slurred speech, vision changes, diplolpia, bowel/bladder incontinence, back/neck pain, headache, recent trauma.  Per MR - MD conclude demyelinating dz like GBS vs cord compression.  GBS Surveillance neuro consult conclude not GBS or GBS variant since discrepency of reflexes.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, Plasmapheresis, Spinal cord compression, Upper respiratory tract infection
Clinical narrative: Hosp from 1/13/10 to 2/19/10.  Per HPI - URI around 1/1/10 with no fever or chills.  Denies travel exposure.  On 1/11/10, noted bilateral finger tingling with right hand clumsiness and worsening bilateral hand numbness.  At admission, notes bilaeral foot numbness to mid-calf and worse R arm weakness.  Admit for 5 days of plasmapheresis.  Pt did not report any dyspnea, dysphagia, slurred speech, vision changes, diplolpia, bowel/bladder incontinence, back/neck pain, headache, recent trauma.  Per MR - MD conclude demyelinating dz like GBS vs cord compression.  GBS Surveillance neuro consult conclude not GBS or GBS variant since discrepency of reflexes.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site nodule, Injection site pain
Clinical narrative: Severe bruising and pain at sight of injection.  Bruise is about 2" diameter. Patient states got antibiotics and cream to treat it. Patient thinks vaccine was expired or immunizer gave shot wrong...
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Pyrexia, Rash papular, Skin lesion
Clinical narrative: Fever, red papular rash, coalescing lesion head to toe. Was currently on amoxicillin.
Age: 19.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Eye pain, Headache, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Patient woke up and had a headache on 12/1, and described his eyes as sore, but not photo sensitive.  He then broke out in a rash he described as fluid filled pox on face, then back, and rest of body, which were very itchy.  Fever over 100 degrees began the next day on 12/2.  The pox rash has now scabbed over.  Mother is a nurse and felt outbreak resembled a case of chicken pox.
Age: 19.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Scab
Clinical narrative: Patient woke up and had a headache on 12/1, and described his eyes as sore, but not photo sensitive.  He then broke out in a rash he described as fluid filled pox on face, then back, and rest of body, which were very itchy.  Fever over 100 degrees began the next day on 12/2.  The pox rash has now scabbed over.  Mother is a nurse and felt outbreak resembled a case of chicken pox.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Gait disturbance
Clinical narrative: Pt. is walking but her left leg wont bend. She looks, acts, and now walks like she is handicapped.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Skin lesion, Vaccination site warmth
Clinical narrative: Itching, warmth to the vaccination site, lesions surrounding site.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Injection site pain
Clinical narrative: pain through out injection site and upper back
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: brief fainting spell and jerking movement for 3-5 sec. Treatment: rest for at least 30min apple juice, monitor vitals
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Decreased appetite, Headache, Wheezing
Clinical narrative: Weakness, Headache; wheezing; with loss of appetite over several days through 12/04/2010.  Then began some improvement.  By Tuesday 12/07/2010 she states she felt better in the am but worse as the day progressed.  She called us to report in on Wednesday 12/08/2010 and stated was again feeling better in the am.  Recommended she also notify her personal doctor of her symptoms as well.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Eye swelling, Hypersensitivity
Clinical narrative: Vaccine adm. approximately 11:25 AM. Watch in rx no symptom. 2:30 -2:45 difficulty swallowing, SOB, eyes swollen excreting water, refused EPI-PEN & to call 911. Reported to pharmacy / gave BENADRYL 25mg capsules. Treated at hospital for allergic reaction - 2 hours put on Diphenhydramine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased
Clinical narrative: Vaccine adm. approximately 11:25 AM. Watch in rx no symptom. 2:30 -2:45 difficulty swallowing, SOB, eyes swollen excreting water, refused EPI-PEN & to call 911. Reported to pharmacy / gave BENADRYL 25mg capsules. Treated at hospital for allergic reaction - 2 hours put on Diphenhydramine.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: (L) shoulder extremely painful several hours after flu shot. Pain increased over several weeks. Unable to move arm without severe pain ROM limited. MD placed on modified duty, NSAIDS stretching exercises.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Haemoglobin decreased
Clinical narrative: Headache, fatigue, cough, fever, chills, nausea, vomiting, loss of appetite.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, fatigue, cough, fever, chills, nausea, vomiting, loss of appetite.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Child complained of his left arm being itchy where he received flu shot. Mother noticed arm around site of vaccination was red & swollen & feels "hard". Denies respiratory problems or itching anywhere else on body. Able to move arm without difficulty. Did not give any medication. Refer to PMD for assessment. Recommend ice to site.
Age: 61.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Ct given nasal FLUMIST at mass vaccination clinic. Spoke with ct on 12/09/10, reported no adverse effects.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Culture wound negative, Incisional drainage, Injection site abscess
Clinical narrative: Skin abscess (L) upper arm at site of flu vaccine. Antibiotic did not help. Had to have I+D of abscess by surgeon.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dry mouth, Fatigue, Flushing, Headache
Clinical narrative: Pt. called on 12/9/10 stating she has experienced progressive symptoms of muscle weakness and soreness (back, neck and injection site), fatigue, headaches, dry mouth and flushing since she has received the influenza vaccine 2 months prior. Has not seen physician for symptoms as of 12/9/10.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Neck pain
Clinical narrative: Pt. called on 12/9/10 stating she has experienced progressive symptoms of muscle weakness and soreness (back, neck and injection site), fatigue, headaches, dry mouth and flushing since she has received the influenza vaccine 2 months prior. Has not seen physician for symptoms as of 12/9/10.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: 2 hours after injection developed a headache throbbing posterior. This was followed by persistent headache, nausea and then dizziness. Local ER informed patient this is a side effect. In ER 1 week post injection. No peripheral neuralgia.
Age: 1.54
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Seizure 11/1/10. Seizure 11/27/10 - Hospitalized 11/26-11/29. Repeat seizure 12/8/10.
Age: 1.54
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Scan brain, Viral test negative
Clinical narrative: Seizure 11/1/10. Seizure 11/27/10 - Hospitalized 11/26-11/29. Repeat seizure 12/8/10.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain, Pruritus, Rash erythematous
Clinical narrative: Pt. describes a "bump" 1/2 inch the next day which caused itching & was raised. A red rash about 2 " also occurred. The area is still sore to touch 2 days later. Pt used 50mg BENADRYL & had no temperature.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Demyelination, Epidural blood patch, Guillain-Barre syndrome
Clinical narrative: 11-15-10 - Urgent care decreased strength hands & feet 11-16-10 ER -> neuro admit to hospital re weakness spreading to lower extremities. 2 wks prior had URIs. Pt stated he had been playing football but head CT was normal. Guillain Barre - 11/24 hospital discharge 11/26 ER - blood patch myelin sheath damage in extremities.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Muscular weakness, Post lumbar puncture syndrome
Clinical narrative: 11-15-10 - Urgent care decreased strength hands & feet 11-16-10 ER -> neuro admit to hospital re weakness spreading to lower extremities. 2 wks prior had URIs. Pt stated he had been playing football but head CT was normal. Guillain Barre - 11/24 hospital discharge 11/26 ER - blood patch myelin sheath damage in extremities.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Swelling
Clinical narrative: Back pain (across upper back) axillary swelling reddened area on breast ipsilateral to injection site.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Gave pt a ADACEL immunization on 12-3-10. On Wed. 12-8-10 pt. came in and complained of fevers, redness, swelling at injection site.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Received vaccines MMR & varicella 11/29-10. At one of sites, (R) leg, swelling, redness. No fever (99 degrees). Acting fine. Using leg. Bright red knot at (R) thigh, injection site, firm, slight tenderness. Normal ROM. Hip, leg, without pain. Not fluctuant, no drainage, nothing expressible.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: (L) arm rash from shoulder area to elbow with soreness.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Face was bright red raised warm rash 6pm took to ER 12/4/10 8pm.
Sex: U
Vaccine: HIBV
Symptoms: Product quality issue, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate preparation of medication in a subject aged between 0 and 4 years old unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline). In August 2010 the subject received the diluent only of the 1st dose of HIBERIX (.5 unknown, unknown, unknown thigh) and experienced inappropriate preparation of medication. A pharmaceutical product complaint was associated with this report. It was reported that one of ten vials contained diluent only (the product contained ten units of diluent, but only nine vials of medicine). Ten doses were administered, but the facility was uncertain which child received the diluent only. According to product complaint investigation results reported by GSK quality assurance on 01 September 2010, the product complaint assessed to be unsubstantiated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Arthralgia, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram ambulatory, Feeling abnormal, Infection, Insomnia, Lyme disease
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Menstruation irregular, Myalgia, Nuclear magnetic resonance imaging, Postural orthostatic tachycardia syndrome, Rheumatoid arthritis
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Single photon emission computerised tomogram, Streptococcal bacteraemia, Tilt table test, Upper respiratory tract infection, Urinary tract infection
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal discomfort, Activities of daily living impaired, Amnesia, Anger, Arthralgia
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature fluctuation, Constipation, Diarrhoea, Disturbance in attention, Dysarthria
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysmenorrhoea, Fatigue, Gastrointestinal disorder, Hyperaesthesia, Initial insomnia
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Insomnia, Joint range of motion decreased, Mass, Menstruation irregular, Mood altered
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myalgia, Night sweats, Pain, Palpitations
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Panic attack, Pharyngitis streptococcal, Postural orthostatic tachycardia syndrome, Rhinorrhoea, Sleep disorder
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.