chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: No reaction on previous exposure to drug, Pyrexia, Vomiting
Clinical narrative: Sometime around Noon, I started to experience a headache, stomach cramping, and light nausea, but ignored it because it wasn't that bad and I thought I might just be hungry. By 3pm my intestines began gurgling and by 5pm I had diarrhea (lasting 18 hours).  By midnight I was doubled up in cramps. At about 2am on 12/03/2009, I had experienced diarrhea, nausea, vomiting, and dizziness so bad I could hardly function. I also started running a 100.8 fever. At 5am I called my HMO's 24/7 Nurse Helpline. I was told that it's not flu, but likely a (very rare) adverse reaction to the shot itself. She pointed me to the CDC website and said to report my symptoms and if it gets any worse or if I have additional symptoms as listed on the site as "severe," to call my doctor or head to the hospital. (FYI, I've never had adverse reactions to any of the flu shots before, but she said they could start at any time in any given person of the population.) She said I could take OTC meds if I wanted to, but I decided to monitor my symptoms while letting it ride out its course.  At approximately 24 hours after the shot was administered my symptoms improved and as of 2pm today I have been able to keep down food and liquids and all symptoms (except for the dizziness) have subsided.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1), HEPA, HPV4
Symptoms: Dizziness, Hypoacusis
Clinical narrative: Client felt light-headed and had to be helped to the ground.  She described not being able to hear very well and a faint feeling.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, CSF culture negative, Electroencephalogram abnormal, Grand mal convulsion, Lumbar puncture normal
Clinical narrative: 60 second generalized tonic-clonic seizure followed by a second one 6 hours later; MRI negative; EEG markedly abnormal with frequent burst suppression activity; LP normal.  No active infectious or neurological etiology found.  Treating with antiepileptic and seeing slow recovery of mental status. 12/10 12/23 12/24 1/5/09:  Hospital records received for dates of service 11/13/09 to 12/19/09:  Dx:  Encephalopathy, seizures, spinal lesion.    Hospitalized after onset of tonic clonic seizures with bilateral upper and lower extremity shaking lasting 30 to 60 seconds with no respiratory compromise and urinary incontinence,  unusual fatigue, fever,  headache,  sleeping more than normal.  Hx. of enuresis worsened with admission,  taking Dilantin and Trileptal.  EEG abnormal but without epileptiform discharges.  Also poor memory, poor appetite, ten pound weight loss over past month,  nystagmus on lateral gaze both right and left, ataxic gait and slow, slurred speech. Intensive care unit admission after seizure with prolonged apnea. PICC Line placed.  Treated with IVIG with marked improvement, though she did have a reaction to the IVIG with fevers, abdominal pain and a few days of low blood pressure.   Discharged on antiepileptics.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: 60 second generalized tonic-clonic seizure followed by a second one 6 hours later; MRI negative; EEG markedly abnormal with frequent burst suppression activity; LP normal.  No active infectious or neurological etiology found.  Treating with antiepileptic and seeing slow recovery of mental status. 12/10 12/23 12/24 1/5/09:  Hospital records received for dates of service 11/13/09 to 12/19/09:  Dx:  Encephalopathy, seizures, spinal lesion.    Hospitalized after onset of tonic clonic seizures with bilateral upper and lower extremity shaking lasting 30 to 60 seconds with no respiratory compromise and urinary incontinence,  unusual fatigue, fever,  headache,  sleeping more than normal.  Hx. of enuresis worsened with admission,  taking Dilantin and Trileptal.  EEG abnormal but without epileptiform discharges.  Also poor memory, poor appetite, ten pound weight loss over past month,  nystagmus on lateral gaze both right and left, ataxic gait and slow, slurred speech. Intensive care unit admission after seizure with prolonged apnea. PICC Line placed.  Treated with IVIG with marked improvement, though she did have a reaction to the IVIG with fevers, abdominal pain and a few days of low blood pressure.   Discharged on antiepileptics.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Nausea, Pain, Photophobia
Clinical narrative: Headache with onset of about 30 minutes after vaccine administration.  Moderate pain not relieved by Aleve.  Headache progressed to more severe pain with nausea and sensitivity to light.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Persistent headache, more painful than other headaches I've experience (which are not that many). I could feel it as soon as I woke up, and I feel it still (~6:00 PM). It's always there, but the pain is augmented when I am moving around or walking.
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck and arm. Neck stiff as a rock!! It went away though after one day.
Age: 16.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Eye swelling, Fatigue, Lip swelling, Throat tightness
Clinical narrative: Lack of energy, tired, swollen lips,tight throat, eyes puffy. Given Benadyrl 25mg at 3:10 PM, noticed improvement at about 3:20 PM. Called Pediatrician.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Woke up with a sore arm and then began vomiting
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal discomfort, Back pain, Diarrhoea, Fatigue, Flatulence
Clinical narrative: Rash, upset stomach (gassy and diaherria), headache, back ache,tired, very irratiable at school and the teacher complained.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Irritability, Rash
Clinical narrative: Rash, upset stomach (gassy and diaherria), headache, back ache,tired, very irratiable at school and the teacher complained.
Age: 45.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Computerised tomogram normal
Clinical narrative: Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
Age: 45.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
Age: 45.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Blood product transfusion, CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count negative
Clinical narrative: Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
Age: 45.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Computerised tomogram normal, Guillain-Barre syndrome, Headache, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
Age: 45.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Paraesthesia
Clinical narrative: Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Pruritus
Clinical narrative: Within 1 hour pt had joint pain and itching.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Began as soreness, small pink patch, warm to touch. Progressed to larger, but lighter colored pink patch, itchiness, and continued soreness and warmth to touch.
Age: 5.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain, Adverse reaction, Diarrhoea, Flushing, Headache
Clinical narrative: Received Nasal spray at elementary school in AM. Around 7 PM, complained of severe abdominal pain followed by vomiting. Duration lasted from 2 minutes to 7 minutes. Some relief after vomiting. Continued every 45 minutes to 1 hour for 12 hours. Relieved with Phenergan suppository until it wore off and then abdominal pain and vomiting reoccurred. Accompanied with fever, flushed face, headache, and red, glassy eyes. Small amount diarrhea.
Age: 5.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Lacrimation increased, Ocular hyperaemia, Pyrexia, Staring, Vomiting
Clinical narrative: Received Nasal spray at elementary school in AM. Around 7 PM, complained of severe abdominal pain followed by vomiting. Duration lasted from 2 minutes to 7 minutes. Some relief after vomiting. Continued every 45 minutes to 1 hour for 12 hours. Relieved with Phenergan suppository until it wore off and then abdominal pain and vomiting reoccurred. Accompanied with fever, flushed face, headache, and red, glassy eyes. Small amount diarrhea.
Age: 33.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: swelling in fingers and some spots on hand and leg that look like mosquito bites
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Dizziness, Dysphagia, Dyspnoea, Heart rate increased
Clinical narrative: Dizzy, throat felt like it was closing, could not swallow, heart was hard and fast. Sick to stomach nasal congestion,S.O.B.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Palpitations, Throat tightness
Clinical narrative: Dizzy, throat felt like it was closing, could not swallow, heart was hard and fast. Sick to stomach nasal congestion,S.O.B.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, FLU(H1N1), FLU3, HIBV, PNC
Symptoms: Injection site rash, Oedema mouth, Pyrexia
Clinical narrative: mom reported high fever that evening and a rash about 1 inch from injection sites on left thigh the following day on 12/1/09. Treated with Benadryl, but had swelling on the mouth on 12/2/09
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient developed a 3 - 4 inch red, hard, hot raised area around the injection site. She is applying ice and taking Benadryl. She is contacting her physician to see if further treatment is needed.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Anxiety, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: Extreme pressure in stomach/abdomen. Hard/labored breathing. Diarrhea and nausea and vomiting. Panic and anxiety.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Panic disorder, Vomiting
Clinical narrative: Extreme pressure in stomach/abdomen. Hard/labored breathing. Diarrhea and nausea and vomiting. Panic and anxiety.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Discomfort, Drug hypersensitivity, Erythema, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a 26-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy. On 21 October 2009 at approximately 16:00 the subject received unspecified dose of FLULAVAL (.5 cc, unknown, unknown arm). On 21 October 2009, 20 minutes after vaccination with FLULAVAL, the subject experienced itching, burning (nos), discomfort and erythema. The subject experienced itching, burning, redness and discomfort of the arms, chest and neck within 20 minutes of receiving FLULAVAL, subject took 50 mg of BENADRYL by mouth. She returned to yhe physician's office and was administered 8/10th of a cc of adrenaline. The subject was treated with BENADRYL and adrenaline. On 21 October 2009, the itching, burning, redness and discomfort of the arms, chest and neck were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow up information was received on 23 November 2009 via the reporting healthcare professional. The healthcare professional reported that the subject received a dose of FLULAVAL in her left arm. The subject was diagnosed with a drug hypersensitivity. The healthcare professional considered the itching, burning (nos), discomfort, erythema and drug hypersensitivity were clinically significant (or requiring intervention). On 21 October 2009, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.  12/10/2009 records from MD for 10/21/2009, patient with c/o's severe itching and burning on arms chest and neck, given benadryl and then adrenaline when sx did not subside,  given Rx for epi pens
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Alopecia, Anxiety, Candidiasis, Cystitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Disturbance in attention, Dyspepsia, Fatigue, Fungal infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gastric disorder, Headache, Laboratory test abnormal, Memory impairment, Menstruation irregular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Premenstrual syndrome, Systemic candida, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Abdominal pain lower, Abdominal pain upper, Alopecia, Anxiety
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bowel movement irregularity, Candidiasis, Cervical dysplasia, Colitis, Constipation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cystitis, Depression, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspepsia, Dysplastic naevus syndrome, Dysuria, Fatigue, Feeling abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fungal infection, Gastric disorder, Gastrooesophageal reflux disease, Headache, Irritable bowel syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint injury, Laboratory test abnormal, Melanocytic naevus, Memory impairment, Menstruation irregular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Micturition urgency, Mucous stools, Myalgia, Oropharyngeal pain, Pelvic pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pollakiuria, Premenstrual syndrome, Sinusitis, Tenderness, Urinary tract infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with metrorrhagia and a history of septal rhinoplasty with tonsillectomy was vaccinated with a second dose of GARDASIL (lot# 653978/0955F) IM in the left arm on 10-OCT-2006. Concomitant therapy included ORTHO TRI-CYCLEN. Symptoms began with hair loss two months after first shot, from 01-DEC-2006, progressed to stomach problems, indigestion, bloating, menstrual irregularities. PMS symptoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. She was treated for systemic candidias. PCP medical records received assessment: cystitis, irritable bowel syndrome alternating type and GERD. Patient presented with urinary urgency, dysuria and frequency, hypogastric tenderness, nevus on shoulder, dysplastic nevus, multiple benign nevi, sinus infection, stomach ache, constipation, feeling run down, sore throat, UTI, diarrhea, ankle injury, bloating, dizziness, "spacy", hair loss, mucous in stool, pelvic pain, LGSIL, abnormal bowel movement pattern and inflammation of colon. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356950. No further information is available. A standard lot check investigation has been finalized. 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 Agency and was released.
Age: 69.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Lumbar puncture, Muscular weakness
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention (CDC) under VAERS ID number 361028 and 33126. A 69-year-old male patient with no known illness at the time of vaccination, had received a first dose intramuscular injection of H1N1 2009 MONOVALENT Vaccine - Preservative, lot number UP001AA on 14 October 2009 at 3:15 pm, and the following morning on 15 October 2009 at 9:00 am (onset also reported as unknown), the patient developed weakness in his arms and legs leading to hospitalization (date of hospitalization not reported). The patient had a LP (lumbar puncture) performed (results not reported) and he was being treated for possible Guillain-Barre Syndrome. The patient's recovery status was not reported and no additional information was provided at the time of the report. Documents held by sender: None
Age: 69.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention (CDC) under VAERS ID number 361028 and 33126. A 69-year-old male patient with no known illness at the time of vaccination, had received a first dose intramuscular injection of H1N1 2009 MONOVALENT Vaccine - Preservative, lot number UP001AA on 14 October 2009 at 3:15 pm, and the following morning on 15 October 2009 at 9:00 am (onset also reported as unknown), the patient developed weakness in his arms and legs leading to hospitalization (date of hospitalization not reported). The patient had a LP (lumbar puncture) performed (results not reported) and he was being treated for possible Guillain-Barre Syndrome. The patient's recovery status was not reported and no additional information was provided at the time of the report. Documents held by sender: None
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Apraxia, Blood urea abnormal, Brain scan normal, CSF culture negative, CSF test normal
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention under VAERS ID numbers 362988 and 468758. A 44 year old female patient with a history of SVT and asthma, had received a first dose intramuscular right arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative,  lot number UP009AA on 23 October 2009 at 7:45 am. and 15 minutes later, the patient "didn't feel well". An unspecified amount of time later, she subsequently developed facial drooping, facial numbness, bilateral LE numbness and tingling and Guillain-Barre. The patient had previously received a seasonal influenza vaccine (manufacturer, lot number, route and site not reported) on 15 September 2009. On 23 October 2009, 15 minutes after she had received the vaccine, the patient began not feeling well. The patient presented to the employee health office on 26 October 2009 and stated that on Saturday (date not reported), she attended a children's party and was told by a physician friend that she had facial drooping and Guillain-Barre, and that she should go home and rest. That patient states that "today" (date not reported) she has bilateral facial numbness. The patient was evaluated again on 27 October 2009 complaining of bilateral LE numbness and tingling. She was referred to a neurologist (date and results of consultation not reported).
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Computerised tomogram, Facial palsy, Gait disturbance, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention under VAERS ID numbers 362988 and 468758. A 44 year old female patient with a history of SVT and asthma, had received a first dose intramuscular right arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative,  lot number UP009AA on 23 October 2009 at 7:45 am. and 15 minutes later, the patient "didn't feel well". An unspecified amount of time later, she subsequently developed facial drooping, facial numbness, bilateral LE numbness and tingling and Guillain-Barre. The patient had previously received a seasonal influenza vaccine (manufacturer, lot number, route and site not reported) on 15 September 2009. On 23 October 2009, 15 minutes after she had received the vaccine, the patient began not feeling well. The patient presented to the employee health office on 26 October 2009 and stated that on Saturday (date not reported), she attended a children's party and was told by a physician friend that she had facial drooping and Guillain-Barre, and that she should go home and rest. That patient states that "today" (date not reported) she has bilateral facial numbness. The patient was evaluated again on 27 October 2009 complaining of bilateral LE numbness and tingling. She was referred to a neurologist (date and results of consultation not reported).
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Intervertebral disc protrusion, Malaise, Medical observation, Muscular weakness, Nervous system disorder
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention under VAERS ID numbers 362988 and 468758. A 44 year old female patient with a history of SVT and asthma, had received a first dose intramuscular right arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative,  lot number UP009AA on 23 October 2009 at 7:45 am. and 15 minutes later, the patient "didn't feel well". An unspecified amount of time later, she subsequently developed facial drooping, facial numbness, bilateral LE numbness and tingling and Guillain-Barre. The patient had previously received a seasonal influenza vaccine (manufacturer, lot number, route and site not reported) on 15 September 2009. On 23 October 2009, 15 minutes after she had received the vaccine, the patient began not feeling well. The patient presented to the employee health office on 26 October 2009 and stated that on Saturday (date not reported), she attended a children's party and was told by a physician friend that she had facial drooping and Guillain-Barre, and that she should go home and rest. That patient states that "today" (date not reported) she has bilateral facial numbness. The patient was evaluated again on 27 October 2009 complaining of bilateral LE numbness and tingling. She was referred to a neurologist (date and results of consultation not reported).
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention under VAERS ID numbers 362988 and 468758. A 44 year old female patient with a history of SVT and asthma, had received a first dose intramuscular right arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative,  lot number UP009AA on 23 October 2009 at 7:45 am. and 15 minutes later, the patient "didn't feel well". An unspecified amount of time later, she subsequently developed facial drooping, facial numbness, bilateral LE numbness and tingling and Guillain-Barre. The patient had previously received a seasonal influenza vaccine (manufacturer, lot number, route and site not reported) on 15 September 2009. On 23 October 2009, 15 minutes after she had received the vaccine, the patient began not feeling well. The patient presented to the employee health office on 26 October 2009 and stated that on Saturday (date not reported), she attended a children's party and was told by a physician friend that she had facial drooping and Guillain-Barre, and that she should go home and rest. That patient states that "today" (date not reported) she has bilateral facial numbness. The patient was evaluated again on 27 October 2009 complaining of bilateral LE numbness and tingling. She was referred to a neurologist (date and results of consultation not reported).
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthma, Computerised tomogram, Facial palsy, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial report received 13 November 2009 from the Centers for Disease Control and Prevention under VAERS ID numbers 362988 and 468758. A 44 year old female patient with a history of SVT and asthma, had received a first dose intramuscular right arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative,  lot number UP009AA on 23 October 2009 at 7:45 am. and 15 minutes later, the patient "didn't feel well". An unspecified amount of time later, she subsequently developed facial drooping, facial numbness, bilateral LE numbness and tingling and Guillain-Barre. The patient had previously received a seasonal influenza vaccine (manufacturer, lot number, route and site not reported) on 15 September 2009. On 23 October 2009, 15 minutes after she had received the vaccine, the patient began not feeling well. The patient presented to the employee health office on 26 October 2009 and stated that on Saturday (date not reported), she attended a children's party and was told by a physician friend that she had facial drooping and Guillain-Barre, and that she should go home and rest. That patient states that "today" (date not reported) she has bilateral facial numbness. The patient was evaluated again on 27 October 2009 complaining of bilateral LE numbness and tingling. She was referred to a neurologist (date and results of consultation not reported).