chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood glucose normal, Confusional state, Convulsion, Cyanosis, Dizziness
Clinical narrative: My daughter reported severe pain (for someone who has a very high tolerance for pain) as soon as immunization was administered. She then felt dizziness/light-headed, stepping down from the examining table. While exiting the clinic through the triage area, her lips turned pale, then her face. My daughter then sat down on a chair while I went to get help; a nurse came. Patient (my daughter) had her eyes closed and almost slid from chair, she briefly open her eyes and sat up on chair again, closing her eyes. Nurse asked her to open her eyes, she responded "I can't." Patient lost consciousness and slid from chair. I tried to get closer to catch her when she suddenly began to have some jerking movements, like a seizure. I ran  to the hallway, screaming for more help, and immediately returned to my daughter whom I found on the floor, still having some jerking movements. After a few seconds she stopped moving, as if she went to sleep. Nurse checked her vital signs and blood sugar level. Patient woke up, confused, wondering what she was doing on the floor and where one of her shoes was (she had kicked it off while having jerking movements). A doctor then asked her name and date of birth; she responded appropriately. She was given a pillow for the head, and a popsicle to eat, then was moved to a seated position (on the floor still). Another doctor gave her a vegetable sandwich, she ate it, reported feeling better, waited a few minutes sitting down and slowly stood up and left in stable condition, but still hurting from immunization. No complains up until today, except for pain on upper right arm where vaccine was administered.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Loss of consciousness, Pain, Pain in extremity, Pallor
Clinical narrative: My daughter reported severe pain (for someone who has a very high tolerance for pain) as soon as immunization was administered. She then felt dizziness/light-headed, stepping down from the examining table. While exiting the clinic through the triage area, her lips turned pale, then her face. My daughter then sat down on a chair while I went to get help; a nurse came. Patient (my daughter) had her eyes closed and almost slid from chair, she briefly open her eyes and sat up on chair again, closing her eyes. Nurse asked her to open her eyes, she responded "I can't." Patient lost consciousness and slid from chair. I tried to get closer to catch her when she suddenly began to have some jerking movements, like a seizure. I ran  to the hallway, screaming for more help, and immediately returned to my daughter whom I found on the floor, still having some jerking movements. After a few seconds she stopped moving, as if she went to sleep. Nurse checked her vital signs and blood sugar level. Patient woke up, confused, wondering what she was doing on the floor and where one of her shoes was (she had kicked it off while having jerking movements). A doctor then asked her name and date of birth; she responded appropriately. She was given a pillow for the head, and a popsicle to eat, then was moved to a seated position (on the floor still). Another doctor gave her a vegetable sandwich, she ate it, reported feeling better, waited a few minutes sitting down and slowly stood up and left in stable condition, but still hurting from immunization. No complains up until today, except for pain on upper right arm where vaccine was administered.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Shortness of breathe, anxiety, throat tightening, chest tightening.  Came back to clinic 7/31/07 with these complaints.  Was given prednisone rx for 20mg po bid for 5 days, benadryl 25 mg q4-6h and albuterol
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Arm red and swollen, indurated, nonerythematous, slightly swollen area, left lower deltoid area, 6cmx6cm.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Tachycardia, Urticaria
Clinical narrative: 3 hours after she received a adult Hepatitis B shot she broke out in hives, was dizzy and had tachycardia (however patient did not take her pulse). The usual screening quesitons had been answered including the one about yeast. She indicated that she felt fine and had no allergies. After getting the shot she eat at a restaurant and had catfish, oysters and potatoes. She took 25 mg of Benadryl and it went away. Today, which is the day after, she is fine.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Had vaccination at 2 pm - went home and went to sleep - woke up about 6 pm - severe trouble breathing and heart racing - called Help Line - they said heart rate was elevated - call 911 - transported by ambulance to Hospital - used oxygen and IV fluid in ambulance - did EKG/ECG at hospital - Doctor said patient had "sinus arythmia"? Follow up with Dr. next week.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Wrong drug administered
Clinical narrative: Pt was here for a well-child check-up.  Immunizations were given at the end of the visit.  I inadvertantly used regular diluent from our supply instead of the diluent supplied with the ActHib vaccine.  I've been informed by a supervisor that it's probably OK but the provider will have the choice whether to revaccinate or not.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Blood creatine phosphokinase normal, Electromyogram abnormal, Muscle twitching, Nuclear magnetic resonance imaging abnormal
Clinical narrative: muscle twitching (fasciculations) all over body 3 days after receiving the tetanus-diphtheria vaccine
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Electrocardiogram abnormal, Fatigue
Clinical narrative: DIFFICULTY BREATHING, NAUSEA,VERY RAPID HEART BEATS(157BPM) DIZZYNESS,FATIGUE, HEADACHE AND STOMACH ACHE.   TOOK HER TO EMERGENCY ROOM THEY GAVE HER AN IV AND SENT US HOME BECAUSE HER EKG WAS FINE EXCEPT FOR HER RAPID HEARTBEAT.  THE NEXT NIGHT I HAD TO TAKE HER AGAIN FOR THE SAME SYMPTOMS, HER HEARTBEAT WAS 128BPM THEY SENT US HOME AGAIN.  SHE DIDNT FEEL BETTER UNTIL TODAY 08/08/07.  SHE STILL DOESNT FEEL 100% BACK TO NORMAL.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Tachycardia
Clinical narrative: DIFFICULTY BREATHING, NAUSEA,VERY RAPID HEART BEATS(157BPM) DIZZYNESS,FATIGUE, HEADACHE AND STOMACH ACHE.   TOOK HER TO EMERGENCY ROOM THEY GAVE HER AN IV AND SENT US HOME BECAUSE HER EKG WAS FINE EXCEPT FOR HER RAPID HEARTBEAT.  THE NEXT NIGHT I HAD TO TAKE HER AGAIN FOR THE SAME SYMPTOMS, HER HEARTBEAT WAS 128BPM THEY SENT US HOME AGAIN.  SHE DIDNT FEEL BETTER UNTIL TODAY 08/08/07.  SHE STILL DOESNT FEEL 100% BACK TO NORMAL.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT Initial report received on 25 July 2007 from a health care professional. A 13-year-old female patient, who had a history of a prior evaluation for multiple sclerosis, had received an intramuscular, left deltoid injection of Adacel, lot number C2720AA; a first dose, intramuscular, right deltoid injection of Menactra, lot number U2069AA; a first dose, subcutaneous, left arm injection of Varivax, manufacturer  Merck, lot number 0598U; and a first dose, intramuscular, right deltoid injection of Havrix, manufacturer GSK, lot number AHAZB162CB; on 16 July 2007. Three days later, the patient experienced "left sided numbness and tingling from head to toe along lateral aspect of the upper and lower extremities." The patient was examined in an emergency room and was scheduled for a neurological evaluation. The patient had a history of headaches and had been evaluated for multiple sclerosis "six to twelve months ago." Test results were negative, and the patient was supposed to have a repeat MRI "six months ago, but never did." Recovery status was unknown. 1/10/08-records received for DOS 7/21-7/24/08-DC DX: left-sided paresthesias/multiple sclerosis flare. Presented with 4 day history of worsening paresthesias on her left side beginning in left hand and progressing into the left leg. Described as tingling and numbness.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Confusional state, Disorientation, Dysarthria, Fatigue
Clinical narrative: Initial report received on 23 July 2007 from the patient's parent. A 16-year-old male patient had received a first dose, intramuscular, left arm infection of Menactra, lot number 41974AB (not valid Sanofi Pasteur lot number specific for Menactra); and a left arm injection of Adacel, lot number U2639AA; on 29 March 2007. Approximately one month post-vaccination, the patient experienced visual distortion. In approximately June 2007, he experienced severe fatigue, unsteady gait, slow and slurred speech, disorientation, confusion, hallucinations, paranoia, increased anxiety, and panic attacks. In addition, he experienced a 22 pound weight loss "since March." The patient was being evaluated and treated by a neurologist. At the time of this report, the patient had not recovered.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gait disturbance, Hallucination, Panic attack, Paranoia, Speech disorder
Clinical narrative: Initial report received on 23 July 2007 from the patient's parent. A 16-year-old male patient had received a first dose, intramuscular, left arm infection of Menactra, lot number 41974AB (not valid Sanofi Pasteur lot number specific for Menactra); and a left arm injection of Adacel, lot number U2639AA; on 29 March 2007. Approximately one month post-vaccination, the patient experienced visual distortion. In approximately June 2007, he experienced severe fatigue, unsteady gait, slow and slurred speech, disorientation, confusion, hallucinations, paranoia, increased anxiety, and panic attacks. In addition, he experienced a 22 pound weight loss "since March." The patient was being evaluated and treated by a neurologist. At the time of this report, the patient had not recovered.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Visual disturbance, Weight decreased
Clinical narrative: Initial report received on 23 July 2007 from the patient's parent. A 16-year-old male patient had received a first dose, intramuscular, left arm infection of Menactra, lot number 41974AB (not valid Sanofi Pasteur lot number specific for Menactra); and a left arm injection of Adacel, lot number U2639AA; on 29 March 2007. Approximately one month post-vaccination, the patient experienced visual distortion. In approximately June 2007, he experienced severe fatigue, unsteady gait, slow and slurred speech, disorientation, confusion, hallucinations, paranoia, increased anxiety, and panic attacks. In addition, he experienced a 22 pound weight loss "since March." The patient was being evaluated and treated by a neurologist. At the time of this report, the patient had not recovered.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 74 year old caucasian male with no medical history or allergies who on 07-JUN-2007, was vaccinated in the right arm with a 0.65 ml dose of Zostavax. There was no illness at the time of vaccination. On 11-JUN-2007 the patient developed Bells palsy. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who stated that on 19-JUN-2007 (previously reported as 11-JUN-2007) patient developed Bells palsy. No diagnostic laboratory tests were undertaken. At the time of report, the patient was improving. The physician considered patient's experience of Bells palsy to be an other important medical event. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature increased, Full blood count, Headache, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 25-JUL-2007 was vaccinated with Varivax. On 27-JUL-2007, the patient was brought to the emergency room with a fever of 101-102 degrees fahrenheit associated with a headache and pain in both legs below the knees. A complete blood count was done. At the time of this report, the patient was not recovered. No product quality complaint was involved. No further information was available. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Arthralgia, Body temperature increased
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 25-JUL-2007 was vaccinated with Varivax. On 27-JUL-2007, the patient was brought to the emergency room with a fever of 101-102 degrees fahrenheit associated with a headache and pain in both legs below the knees. A complete blood count was done. At the time of this report, the patient was not recovered. No product quality complaint was involved. No further information was available. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Autism, Encephalitis, Gastrointestinal disorder
Clinical narrative: Information has been received from GlaxoSmithKline (Other Company manufacturer # A0665589A) from a consumer concerning her 0-9 year old son who on an unspecified date was vaccinated with PedvaxHIB. Concomitant vaccination included the first dose of Pediarix on an unspecified date, the second dose on 03-JUN-2004 (Lot # 21899C9), and the third dose on 23-JAN-2004 (Lot # 21899A9). The patient's mother reported that after receiving almost all of his childhood vaccines, the subject developed gut issues and was reacting to wheat containing products. The subject additionally developed encephalitis (date not reported). A physician or health care professional has not verified this report. Upon internal review autism and encephalitis were determined to be other important medical events. At the time of reporting autism was unresolved and the outcome of the other events was not known. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Pyrexia, Rash, Roseola, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a infant female patient with no allergies who was vaccinated with a first dose of MMR II. The patient at experienced high fever, vomiting and rash and was hospitalized. At the time of this report, the patient was 20 years of age and had never received the second dose of vaccine. Unspecified medical attention was sought. At the time of report the patient was recovered. Additional information has been received from the registered nurse who stated that the there was no reaction to the vaccine and "was wrong". The patient's mother stated that the patient developed roseola the day after vaccination and the physician also diagnosed it as roseola. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Immunoglobulins, Platelet count decreased
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who during the last week of April 2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included tetanus toxoid, tetracycline and hormonal contraceptives (unspecified brand). In June 2007, the patient developed nose bleed and bruising of her body. The patient's platelet count reached 2000 and was hospitalized for ITP (Idiopathic Thrombocytopenic Purpura). The patient was treated with intravenous immunoglobulin and high dose corticosteroids (unspecified). The patient responded to the corticosteroids (unspecified) but became intolerant to the side effects. There have been more than one attempts to taper the patient off the corticosteroid but the platelets decreased each time. As of 26-JUL-2007, the patient's platelet count was 8000. No other details were provided. Physician did not provide specifics on corticosteroid side effects that the patient developed. The patient had not recovered. The events nose bleeds, bruising of patient's body, and Idiopathic Thrombocytopenic Purpura (ITP) were considered to be life-threatening. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. After receiving the vaccine, the patient had a seizure for 5 minutes. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging, Tinnitus, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a female nurse (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil. On 29-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # not reported) IM. On the morning of 11-APR-2007, the patient was non-symptomatic. Later that day, she woke up from a nap and she could hear nothing in her ear, except ringing. The patient sought the medical attention of primary care, ear, nose and throat (ENT) and surgical ENT services. It was determined that the patient had a "92% hearing loss". A magnetic resonance imaging was performed, result not reported. She was treated with antibiotics, steroids, and steroids injected into her ear without any improvement. The diagnosis was sudden, unilateral hearing loss due to a viral attack on the nerve. The surgical ENT had no idea of the etiology except that this was a rare experience. The patient had no idea of the etiology except that this was a rare experience. The patient had 8% word recognition in the left ear with the ability to hear one tonal frequency. It was reported that the permanent hearing loss was disabling. At the time of reporting, the unilateral hearing loss persisted. Additional information has been requested.  8/28/07 Received medical records from reporter which reveal patient received #1 HPV vax 2/1/07, lot # 1427F.  #2 HPV vax 3/28/07 lot# 0314U.  #3 HPV vax 7/19/07, lot# 0524U.  With 3rd HPV, patient reported complete hearing loss of left ear which ENT felt permanent.  10/2/07 Reviewed ENT medical records of 5/1-9/13/2007 which reveal patient experienced sudden hearing loss of left ear on 4/11/2007.  Upon awakening from nap, had tinnitus & hearing loss.  Seen by pcp on 4/13 & referred to another ENT.  Hearing test at that time revealed left hearing loss at all frequencies.  Intratympanic steroid injection series x 3 w/o significant improvement. FINAL DX: viral labyrinthitis left ear; sudden hearing loss, left ear; tinnitus, left ear; abnormal auditory perception.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Infectious mononucleosis
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 17 year old female with pertinent medical history and drug reactions/allergies reported as none who in 2007 was vaccinated with the first dose of Gardasil. The LPN was unable to provide the lot number. Concomitant medication was reported as none. The nurse stated that the patient was close to the time that she should receive the second dose. ON 07-JUL-2007, the patient experienced mononucleosis and was hospitalized. Before the patient was discharged from the hospital she developed shingles. The patient sought unspecified medical attention. On an unspecified date, the patient was discharged from the hospital and she was recovering from the mononucleosis and shingles. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness, Mydriasis
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female, who on 26-JUL-2007 was vaccinated with a first dose of Gardasil. On 26-JUL-2007 the patient passed out. It was reported that her pupils were dilated and she experienced a 10 second seizure. The patient sought unspecified medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her 13 month old female daughter who in approximately 1995 was vaccinated with her first dose of MMR II (manufacturer unknown). In approximately 1995, 6 to 8 weeks after receiving the M-M-R vaccine, the child developed autism. The patient sought unspecified medical attention. At the time of the report, the child was 12 1/2 years old and is still autistic, but the condition had improved as the child got older. The child was recently tested for immunity and the measles immunity was present, but "low". The child's physician would like the child to receive a booster or second dose of measles vaccine. No further information was reported. Upon internal review, autism is considered an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Intensive care, Respiratory distress
Clinical narrative: Hives on arm injection received this developed respiratory distress within 2 hours of injection. ICU at hospital. 8/29/07-records received for DOS 8/7-8/9/07-DC DX:Asthma, unspecified. Nonspecific skin eruption. Adverse effect diptheria vaccine. Adverse effect tetanus vaccine. C/O arm swollen at injection site, rash was itchy, chest tightness and SOB. Perioral paleness. No cough no wheeze.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Cerebellar ataxia, Chest X-ray, Computerised tomogram, Irritability, Pyrexia
Clinical narrative: Within 24 hours of imms - fever and fussiness 4 days post imms - shaking of head, arms and legsstarted seen in our office that day - admitted hospital. Hosp diagnosis - acute cerebellar ataxia following imms.  8/10/07 Received vax records from pcp which confirm RO lot & dose as reported.  8/14/07 Received hospital medical records which reveal patient experienced head titibations, irritability, crying inconsolably, shaky movements, fever & URI s/s 4 days s/p vax. Admitted 7/23-7/25/07.  Neuro consult done.  Developed rash in hospital.  Treated w/IV antibiotics FINAL DX: acute cerebellar ataxia, vaccine & viral URI induced, resolving; mildly abnormal renal US; and viral rash.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Tremor, Ultrasound kidney
Clinical narrative: Within 24 hours of imms - fever and fussiness 4 days post imms - shaking of head, arms and legsstarted seen in our office that day - admitted hospital. Hosp diagnosis - acute cerebellar ataxia following imms.  8/10/07 Received vax records from pcp which confirm RO lot & dose as reported.  8/14/07 Received hospital medical records which reveal patient experienced head titibations, irritability, crying inconsolably, shaky movements, fever & URI s/s 4 days s/p vax. Admitted 7/23-7/25/07.  Neuro consult done.  Developed rash in hospital.  Treated w/IV antibiotics FINAL DX: acute cerebellar ataxia, vaccine & viral URI induced, resolving; mildly abnormal renal US; and viral rash.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram abnormal, Facial palsy, Herpes zoster oticus, Neuropathy
Clinical narrative: Patient developed chronic right facial neuropathy from Bell's Palsy and Ramsay Hunt Syndrome on 3/20/07. 10/22/07-records received for DOS 4/2-10/8/07-seen for right sided facial pain, ear pain, neck spasm, throat irritation and facial droop. Symptoms began on 3/20/07-. Pain lancinating shocks over right side of face and scalp tenderness along with few vesicles around right ear preauricularly. Bells's Palsy. Visit on 4/3/07-tongue aphthous like ulcer and continues with facial pain. 4/5/07-Geniculate herpes with cluster of lesions in front of right ear. Difficulty keeping eyes shut. Systemic drug reaction due to carbamazepine. Herpes Zoster and facial nerve palsy. Symptoms continue 4/25/07-trigeminal neuralgia. 10/8/07-visit lid lag status post Bell's palsy with weight and postherpetic neuralgia. Confusion secondary to polypharmacy now improving. Refused influenza vaccine. 1/11/2010 Still has facial weakness and pain.  02/02/2010 Residual eye lid droop, facial droop and pain.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chills, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Red hot swollen area about 8cm in diameter surrounding injection site at shoulder. Pt had fever, chills, night before, T  max 101. Also with pain/mild surrounding left axilla. This began about 48 hours after injection. Has been indurated on day 4. PE is to culture area follow up.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Red hot swollen area about 8cm in diameter surrounding injection site at shoulder. Pt had fever, chills, night before, T  max 101. Also with pain/mild surrounding left axilla. This began about 48 hours after injection. Has been indurated on day 4. PE is to culture area follow up.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Effusion, Injection site swelling, Joint effusion, Oedema peripheral
Clinical narrative: Two vaccines IPV and DTaP given on the left thigh on 7/30/07. 8/1/07 Pt returned to clinic swelling from upper thigh to effusion through knee and below knee. Treatment Benadryl, Ibuprofen, Ice.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cold compress therapy, Injection site cellulitis, Injection site erythema, Injection site nodule, Injection site oedema
Clinical narrative: At injection site (L) deltoid-pt developed a large nodule with increased erythema/edema, increased pain/itching appeared as if cellulitis (maybe it was). Treatment: cold compress, rest, Benadryl 25 mg once po every 4-6 hrs, and EES 500 mg once oral bid x 7 days.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: At injection site (L) deltoid-pt developed a large nodule with increased erythema/edema, increased pain/itching appeared as if cellulitis (maybe it was). Treatment: cold compress, rest, Benadryl 25 mg once po every 4-6 hrs, and EES 500 mg once oral bid x 7 days.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Full blood count normal, Gait disturbance, Laboratory test normal, Myalgia, Pyrexia
Clinical narrative: Patient woke early am, sometime after MN with fever and was unable to walk due to muscle pain. Patient was alert/oriented, but "sleepy acting." Sent to ER, had normal CBC and CMP, was given IV fluids, started on Doxycycline (for possibly tick bite) and sent home.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Somnolence
Clinical narrative: Patient woke early am, sometime after MN with fever and was unable to walk due to muscle pain. Patient was alert/oriented, but "sleepy acting." Sent to ER, had normal CBC and CMP, was given IV fluids, started on Doxycycline (for possibly tick bite) and sent home.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope, Tremor
Clinical narrative: Fainted with "shaking" "seizure" activity 2 hrs after injection
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 8-6-07 Patient phones to report pain to the injection site shortly after receiving vaccine and continues to have the pain. Also reports a raised red rash developed to the injection site area approximately 2 weeks ago. Will check with MD before she receives last vaccination.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Localized reaction at Varivax site. "Egg sized" area of redness - itchy. Resolved with Benadryl.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizzy spells numerous times a day for 3-7 days.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Full blood count normal, Nausea, Paraesthesia, Pregnancy test negative
Clinical narrative: Dizziness and nausea x 1-2 hours. vomiting, tingling in hands.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Dizziness and nausea x 1-2 hours. vomiting, tingling in hands.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Severe swelling in left upper arm
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Eye rolling, Immediate post-injection reaction, Syncope
Clinical narrative: Child was given Vaqta, then Gardasil vaccine.  She immediately felt faint-slumped over (was helped to lay down on exam table) and "eyes rolled back". Child became responsive quickly
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Pain in extremity
Clinical narrative: Pt called in c/o arm throbbing and area firm to touch
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Angioedema, Swelling face, Urticaria
Clinical narrative: Hives and possibly angioedema localized only on left side of face on 8-1-07. (Less than 24 hours after shot)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dad called reported that pt's RA was red and swollen-warm to touch-no pain, no itching. area 10 cm x 8 cm
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Culture, Herpes zoster
Clinical narrative: Shingles to dermatomes L2, L3 to left leg beginning 3 days after administration of Gardasil (L leg), Menactra (R leg)
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Had Menactra 3 days prior. Hives, dyspnea, ER visit for treatment. Possibly related to vaccine?
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urticaria
Clinical narrative: Had Menactra 3 days prior. Hives, dyspnea, ER visit for treatment. Possibly related to vaccine?
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Rash macular, Wrong drug administered
Clinical narrative: Developed fever 101.1 and then fine macular rash on extremities. Fever lasted 24 hours, rash faded same interval. No other sequelae. Treated with Tylenol and Claritin
Age: 14.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt left arm - subcutaneous area began swelling after the injection and continued to increase in diameter over past 2-3 days. No 15cmx15cm slightly raised, warm and tender
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Hallucination, Pain in extremity, Pyrexia
Clinical narrative: From mom: patient had a fever (101F). Complained of sore are; Had hallucinated the night of the vaccine. According to patient "now acting OK, took the dog out" data from 7/28/07.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Local swelling, Vaccine positive rechallenge
Clinical narrative: Given Tdap in left buttocks LUOQ and next day developed lump at injection site but then noticed swelling left groin 7/30/07
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis one week after receiving vaccination (localized to injection site)
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Rash
Clinical narrative: Pt. noticed she began to be flushed around her chest, neck and upper arms bilaterally about 45 min. after vaccine given. Fine red rash noted on both arms. Benadryl 25mg given PO. No respiratory distress.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Heart rate increased, Hyperventilation, Panic reaction, Swollen tongue
Clinical narrative: Pt went to bed at 2 AM, woke up at 4 AM, SOB, felt like tongue was swollen, heart rate increased, felt panicky, hyperventilating, looked for bag to breathe into. Watched TV until calm; episode occurred over about 30 mins
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Cough, Retching, Salivary hypersecretion, Sneezing, Stomach discomfort
Clinical narrative: Upset stomach, lots of coughing, gagging, sneezing, increased throat secretions. Mom remembers a similar experience at 4 month vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Vaccine positive rechallenge
Clinical narrative: Upset stomach, lots of coughing, gagging, sneezing, increased throat secretions. Mom remembers a similar experience at 4 month vaccines.
Age: 34.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Agitation, Anger, Anorexia, Anxiety, Arthralgia
Clinical narrative: Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
Age: 34.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Back pain, Blood urine present, Constipation, Cyst, Depression
Clinical narrative: Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
Age: 34.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Headache, Hypersensitivity, Hypoaesthesia, Influenza like illness, Insomnia
Clinical narrative: Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
Age: 34.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Irritability, Menstrual disorder, Nasopharyngitis, Nervousness, Pain in extremity
Clinical narrative: Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
Age: 34.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Paraesthesia, Sinusitis, Sleep disorder
Clinical narrative: Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea
Clinical narrative: 20 min. following inj. pt felt shortness of breath with chest tightness. At 3:00 PM, pt sought ER care for continued chest tightness. Breathing at that was good.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Cold compress therapy, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Developed sore edematous left axilla and left clavicular areas. Clavicle area has notable redness. Taking ibuprofen and ice packs periodically for pain control x 1 day.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left leg red swollen area size 2 inches diameter, warm to touch, no itching. Right leg 3 inch diameter swollen, warm, tender to touch, itching. Recommended Tylenol, Benadryl and ice packs.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: 6/27/07 Adacel given IM. 6/28 Chills, fever 101 x 24x36 hours.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Child started a 104.3 T about 24 hours after receiving vaccines. Marked irritability noted by mother but no other symptoms. Fever lasted about 6 days - would reduce but not to normal after ibuprofen. Evaluated by MD - no additional findings - MD attributed to "shots" per mom. See attached notes for details - Rx: Ibuprofen as needed. Referred to PMD for future shots.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling, Wrong drug administered
Clinical narrative: Area red, swollen
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold compress therapy, Erythema, Skin warm
Clinical narrative: 3x5 raised, red, warm area right posterior arm ice pack at home, Ibuprofen, Benadryl
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: No s/y occurred, the MMR was given IM instead of sub-q in (R) deltoid.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling started yesterday, increase today 8-8-07. Red swelling approx 3.75" x 4" slightly warm, no fever, no pain, no itching. Advised start Benadryl two times every 4-6 hours today. Call if increase swelling or pain
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Electrocardiogram normal, Headache, Metabolic function test normal, Pain
Clinical narrative: 24 hrs after vaccine-severe aching x 24-36 hrs 36hr after vaccine-slept for 2 days RTC, then continued increased sleepiness until sx'g gone at 1 wk. (+) mental confusion, HA
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: 24 hrs after vaccine-severe aching x 24-36 hrs 36hr after vaccine-slept for 2 days RTC, then continued increased sleepiness until sx'g gone at 1 wk. (+) mental confusion, HA
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration
Clinical narrative: Local area of induration and erythema measuring 15 x 10 cm.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Hep B was given by mistake
Age: 1.3
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site streaking
Clinical narrative: Pt received immunizations on 7-25-07: DTaP, MMR II, Varicella on 7-27-07 developed edema and redness/red streaking to entire leg where vaccine admin. Pt seen at ER on 7-27-07 and Dx'd with reaction to DTaP per mom.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Prevnar injection given R upper thigh on 8/6/07. Mother noticed swelling on 8/6/07. Brought to clinic 8/8/07 with redness, warm to touch and swelling.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 4" x 2" area redness-surrounded by Lt pink 1 cm border. Swollen-tender. no itchy better with Benadryl
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Hyperventilation, Hypoaesthesia, Hypotonia
Clinical narrative: Here for physical exam 8/6/07. Rec'd shot Hep A - got into car became dizzy, lightheaded, sweating - not feeling well, pale. Returned to office; appeared to look like fainting spell. Dr/CRNP saw pt. He went limp in waiting room - legs buckled under him. Did not pass out completely - laid pt on floor with legs up; came to. Brought pt into room to observe. Checked B/P and blood sugar - all within normal limits. After all done, started hyperventilating.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Malaise, Pallor
Clinical narrative: Here for physical exam 8/6/07. Rec'd shot Hep A - got into car became dizzy, lightheaded, sweating - not feeling well, pale. Returned to office; appeared to look like fainting spell. Dr/CRNP saw pt. He went limp in waiting room - legs buckled under him. Did not pass out completely - laid pt on floor with legs up; came to. Brought pt into room to observe. Checked B/P and blood sugar - all within normal limits. After all done, started hyperventilating.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Pt received Vvax #1 on 7/24/06 Dx with chicken pox on 8-6-07 at Dr. office 1st pox noted by parent on 8/4/07 Received Rx Acyclovir 200/5 4ml po QID x 5 days
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Hypersensitivity, Injection site cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old male with high cholesterol, asthma, chronic rhinitis and hypertension who on 19-DEC-2006, was vaccinated SC with a second 0.5 ml dose of Pneumovax 23 (lot# 655499/0988F). Concomitant therapy included ADVAIR, BENICAR, COMBIVENT, NEXIUM, montelukast sodium, cough, cold and flu therapies (unspecified) and an unspecified cholesterol medication. The next day, the patient's arm was very red and swollen and his temperature was 102F. He was seen in Urgent Care and was diagnosed with cellulitis at the injection site and allergic reaction. The patient was treated with doxycycline and prednisone. At the time of this report, the patient's outcome was unknown. It was noted that the patient received his first dose in May 2004. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old male with high cholesterol, asthma, chronic rhinitis and hypertension who on 19-DEC-2006, was vaccinated SC with a second 0.5 ml dose of Pneumovax 23 (lot# 655499/0988F). Concomitant therapy included ADVAIR, BENICAR, COMBIVENT, NEXIUM, montelukast sodium, cough, cold and flu therapies (unspecified) and an unspecified cholesterol medication. The next day, the patient's arm was very red and swollen and his temperature was 102F. He was seen in Urgent Care and was diagnosed with cellulitis at the injection site and allergic reaction. The patient was treated with doxycycline and prednisone. At the time of this report, the patient's outcome was unknown. It was noted that the patient received his first dose in May 2004. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Muscle twitching, Oedema peripheral, Pain in extremity
Clinical narrative: Pt received a tetanus, diphtheria vaccine shot 8-24-2006. After the shot, I had soreness, pain, swelling, muscle breaking down in my arms. I still have serious problems my fingers lock down, my breathing is not good. Bacterial infection
Age: 74.0
Sex: U
Vaccine: TD, TD
Symptoms: Arthritis, Bacterial infection, Breath sounds abnormal, Muscle atrophy, Pain
Clinical narrative: Pt received a tetanus, diphtheria vaccine shot 8-24-2006. After the shot, I had soreness, pain, swelling, muscle breaking down in my arms. I still have serious problems my fingers lock down, my breathing is not good. Bacterial infection
Age: 74.0
Sex: U
Vaccine: TD, TD
Symptoms: Swelling
Clinical narrative: Pt received a tetanus, diphtheria vaccine shot 8-24-2006. After the shot, I had soreness, pain, swelling, muscle breaking down in my arms. I still have serious problems my fingers lock down, my breathing is not good. Bacterial infection
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Condition aggravated, Laboratory test, Muscular weakness, Neurological examination, Pain in extremity
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. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U) and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This report was filed with the FDA. The VAERS number is 279407.