chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Convulsion, Dizziness, Heart rate decreased, Muscle twitching
Clinical narrative: Initial report received on 04 Jun 2007 from a physician. A 17-year-old female patient with no medical conditions, no concurrent illnesses, not use of other medications, or known allergies had received a first, intramuscular, deltoid dose of Menactra (lot number unknown), on 04 June 2007. The site of administration was not reported. Within minutes of receiving the vaccination, the patient became dizzy and her blood pressure dropped into the 80s and she was pale. Her pulse was faint and slow. She had a brief twitching of her mouth that "appeared to be a seizure." The patient was placed in a supine position and the episode resolved after approximately 20 minutes with no treatment. The patient was observed for a full hour and experienced no further complaints.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor
Clinical narrative: Initial report received on 04 Jun 2007 from a physician. A 17-year-old female patient with no medical conditions, no concurrent illnesses, not use of other medications, or known allergies had received a first, intramuscular, deltoid dose of Menactra (lot number unknown), on 04 June 2007. The site of administration was not reported. Within minutes of receiving the vaccination, the patient became dizzy and her blood pressure dropped into the 80s and she was pale. Her pulse was faint and slow. She had a brief twitching of her mouth that "appeared to be a seizure." The patient was placed in a supine position and the episode resolved after approximately 20 minutes with no treatment. The patient was observed for a full hour and experienced no further complaints.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a physician concerning a 11 year old female with a history of convulsion disorder who was vaccinated with Gardasil. It was reported that the patient had a seizure after receiving a dose of Gardasil. Unspecified medical attention was sought. It is not known which dose this was in the series. Lot number was not available. No further information was given. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity, Thrombosis
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient's swelling and pain persisted. No further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus the apparent association.  Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was documented
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Body temperature increased, Chest X-ray, Cough, Dizziness
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Full blood count, Laboratory test, Metabolic function test, Nausea
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pharyngolaryngeal pain
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anorexia, Asthenia, Chest X-ray normal, Chills, Dizziness
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Full blood count normal, Headache, Liver function test normal, Nausea
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: 6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Lethargy, Rash papular, Vomiting
Clinical narrative: Initial report received on 11 May 2007 from a health care professional. A 12-year-male patient had received a first dose, left deltoid, intramuscular injection of Menactra, lot number U1908AA, on 09 May 2007. On the evening of the same day, the patient developed lethargy and vomiting. He was examined "in the office" the following day and was complaining of vomiting, temperature of 99.7 degrees Fahrenheit, and a pink papular rash on his face. At the time of this report, recovery status was unknown.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A 39-year-old female patient had received a left arm, subcutaneous (not recommended route of administration for this product) injection of Menactra, lot number 02207AA, on 16 May 2007. The following day, she experienced redness, itching and swelling at the injection site. The event required medical examination, and the patient was treated with Tylenol and hydrocortisone cream. At the time of this report, the patient has not recovered.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, MMRV
Symptoms: Ear infection, Oral mucosal blistering, Pyrexia
Clinical narrative: Onset of fever 6/1/07 and blisters in mouth started 6/3/07. Treated for bilateral ear infection diagnosed 6/3/07 and treated with Amoxicillin and Motrin.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Electroencephalogram normal, Pyrexia, Screaming, Sleep disorder, Tremor
Clinical narrative: Tremors,  head and torso shake uncontrollably for 10-60 seconds,  at least one per week, no treatment yet. Extended sleep disruption, prior to shots, slept at least one 5-7 hour stretch, beginning 2/26/07 no more than 3 hour stretch, no treatment yet. Hives / welts, screaming, 1-1/2 hours, one dose of children's Claritin. Fever, temperature 100 degrees, screaming, 1-1/2 hours, on e dose of children's Tylenol.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Tremors,  head and torso shake uncontrollably for 10-60 seconds,  at least one per week, no treatment yet. Extended sleep disruption, prior to shots, slept at least one 5-7 hour stretch, beginning 2/26/07 no more than 3 hour stretch, no treatment yet. Hives / welts, screaming, 1-1/2 hours, one dose of children's Claritin. Fever, temperature 100 degrees, screaming, 1-1/2 hours, on e dose of children's Tylenol.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site mass, Injection site rash, Rash generalised
Clinical narrative: 5-16-07 Knot growing left area, no fever - given Keflex. 5/23/07 Recheck ov - monitor - papular rash around shot given. 5/29/07 Rash all over body - given Augmentin and referred to surgeon.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left arm, red, hard and swollen. Advised as long as can move arm well, no fever and minimal pain - not to worry by doctor.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right deltoid, red, hot, indurated area no fluctance or real tenderness. Use ice pack per doctor - patient not to receive anymore DT's
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis on left thigh. Warm compression.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling to right upper arm redness.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Oedema peripheral
Clinical narrative: Within 2 hours - right thigh became swollen and
Age: 1.8
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an adult dose of hepatitis A.
Age: 35.0
Sex: F
Vaccine: MMR, TD, UNK
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient stated that after 1 week of vaccines administration, she noticed inflammation of lymph nodes on the neck, arm pit and groin area. Lymph nodes were painful. Doctor recommended fluid therapy and antiinflammatory.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphthous stomatitis, Blister, Herpes zoster, Laboratory test, Lip pain
Clinical narrative: Patient received Zostavax on 30 May.  By the next morning, she reports soreness on her upper lip and "canker like sores" in her mouth.  Two days later (June 2) she woke up to blisters on her face, in the shape of a "C" from her cheekbone down to her chin.  She made a visit to clinic where she was diagnosed with Shingles and was prescribed Valtrex.  On Monday, June 4, she saw her regular physician who confirmed a diagnosis of Shingles.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immunology test normal, Laboratory test, Rash, Stomatitis
Clinical narrative: Patient received Zostavax on 30 May.  By the next morning, she reports soreness on her upper lip and "canker like sores" in her mouth.  Two days later (June 2) she woke up to blisters on her face, in the shape of a "C" from her cheekbone down to her chin.  She made a visit to clinic where she was diagnosed with Shingles and was prescribed Valtrex.  On Monday, June 4, she saw her regular physician who confirmed a diagnosis of Shingles.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling locally at injection site
Age: 44.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blister, Pain, Skin lesion
Clinical narrative: On or about May 16th, noticed a lesion similar to that of the vaccine on the anterior aspect of this R foot. It was a raised, pus filled lesion NOT associated with any trauma to his foot. He then noted he had 3 other similar lesions 2 on his R leg (shin) and one on his R forearm, none of these lesions could be associated with trauma/bug bites etc, however the lesions on his legs were several days old and had been scratched during the work day and were not intact. We really didn't associate the lesions with the vaccine until the lesion on his foot appeared. He is meticulous about his hygiene and especially careful about his feet due to health issues as a child. Once we noticed the lesions we did contact the proper people and an ER doc friend of mine. No fever was associated with this. No malaise, some slight body aches. We did not seek treatment other than to observe and be mindful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: HAD VACCINES ON 5/22/07 DEVELOPED SWELLING, REDNESS AND PAIN IN THE LEFT DELTOID AREA.  WAS SEEN IN THE OFFICE ON 5/29/07 MUCH IMPROVED ALLEGEDLY LASTED 5-6 DAYS.  FINDINGS ON 5/29/07 WERE A BRUISE ON THE LEFT UPPER ARM APPROXIMATELY 2-3 CM, ASSOCIATED ERYTHEMA APPROXIMATELY 8-10 CM. NO PAIN, SWELLING, OR TENDERNESS.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient had a localized swelling and erythema at injection site.  Also two varicella-form pustules distal to site
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Malaise, Muscle twitching, Pallor, Syncope
Clinical narrative: Pt came into clinic with parent for vaccines, Tdap,Hepatitis A,Menactra, gardasil,varivax. After vaccines pt skin tone became white and she said "I don't feel well" then pt had syncopal episode nurse used ammonia inhalant to bring pt around pt legs elevated ice applied to back of neck, pt initialy responded to nurse and parent, then pt had what appeared to be another syncopal episode but pts body began twitching and jerking and then pt lost control of her bladder, another ammonia inhalant was used to bring pt around.  When pt was able she was assisted to exam table and placed in supine position with legs elevated.  After incident nurse questioned parent if pt had history of seizures and parent confirmed previous history although on immunization consent form questionairre parent anwered no to question of history of seizures or neurological problems.  pt given 8 ozs apple juice which she tolerated well and left clinic approximately 30 minutes later with parent.  Parent instructed to follow up with MD.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urinary incontinence
Clinical narrative: Pt came into clinic with parent for vaccines, Tdap,Hepatitis A,Menactra, gardasil,varivax. After vaccines pt skin tone became white and she said "I don't feel well" then pt had syncopal episode nurse used ammonia inhalant to bring pt around pt legs elevated ice applied to back of neck, pt initialy responded to nurse and parent, then pt had what appeared to be another syncopal episode but pts body began twitching and jerking and then pt lost control of her bladder, another ammonia inhalant was used to bring pt around.  When pt was able she was assisted to exam table and placed in supine position with legs elevated.  After incident nurse questioned parent if pt had history of seizures and parent confirmed previous history although on immunization consent form questionairre parent anwered no to question of history of seizures or neurological problems.  pt given 8 ozs apple juice which she tolerated well and left clinic approximately 30 minutes later with parent.  Parent instructed to follow up with MD.
Age: 63.0
Sex: F
Vaccine: HEPAB, TD, YF
Symptoms: Blood test, Ear pain, Eye movement disorder, Hypoaesthesia facial, Hypokinesia
Clinical narrative: On 6/207 pt. state she developed ringing in her L. ear accompanied by pain. It continued for the next two days without relief. On 6/5/07 she contacted her primary MD to ask for pain medication. She states she then developed numbness on the L/ side of her face and had difficulty sipping/drinking liquids(but not difficulty swallowing).  No fever, rashes or swelling was noted by the patient. She saw her primary MD who began tests. Pt. states she had bloodwork and an MRI of her head.  She states now has difficulty with her L. eye closely simultaneously as her R. eye.  She was told to take ibuprofin for pain and states she has relief from the medication.  She was advised to wear a patch on L. eye at night when sleeping as it is not closing completely. She states that the L. side of her face is "twisted" and not symmetrical.   She is under MD care for the above and no diagnosis has been made yet.
Age: 63.0
Sex: F
Vaccine: HEPAB, TD, YF
Symptoms: Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: On 6/207 pt. state she developed ringing in her L. ear accompanied by pain. It continued for the next two days without relief. On 6/5/07 she contacted her primary MD to ask for pain medication. She states she then developed numbness on the L/ side of her face and had difficulty sipping/drinking liquids(but not difficulty swallowing).  No fever, rashes or swelling was noted by the patient. She saw her primary MD who began tests. Pt. states she had bloodwork and an MRI of her head.  She states now has difficulty with her L. eye closely simultaneously as her R. eye.  She was told to take ibuprofin for pain and states she has relief from the medication.  She was advised to wear a patch on L. eye at night when sleeping as it is not closing completely. She states that the L. side of her face is "twisted" and not symmetrical.   She is under MD care for the above and no diagnosis has been made yet.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Incorrect dose administered
Clinical narrative: Patient mistakenly admistered 2 .5cc doses of Anthrax Vaccine (MANUFACTURED BY BIOPORT) in one day.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Swelling and redness at the site noticed 6 days post vaccination.  Warm to the touch.  Redness was traveling down the arm.  Arm still red and swollen 8 days post vaccination.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Aphthous stomatitis, Fatigue, Hypoaesthesia, Pharyngolaryngeal pain, Vaccination complication
Clinical narrative: 1. Aphthous ulcer (tongue blisters) fatigue, sore throat and left arm numb from shoulder to hand lasted 12 hours -"probably related to recent vaccination.  Will treat symptomatically with magic mouthwash" Doctor stated  2. Adverse effect of drug therapy vaccines "Moderate systemic reation to anthrax vaccination. Treat symptomatically with tylenol." Doctor stated.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Pt. states she was dizzy for a short time after recieving vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Pt. C/o fever 2 days after recieving vaccine. (102 degrees).
Age: 65.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient presented to ER 3 days after Tetanus Shot with Right Arm Red and Swollen.  SYmptoms began the day of the shot (5/19/2007
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Throat tightness, Urticaria
Clinical narrative: SPOKE WITH EMPLOYEE 6/13/07 WHO STATES THAT ONE WEEK AFTER RECEIVING MMR BOOSTER ON 10/25/06 DEVELOPED ONSET OF HIVES THAT HAVE BEEN RE-OCCURING SINCE THEN AND NOW HAS ALSO DEVELOPED TIGHNESS IN THROAT WITH HIVES. HAS SEEN HER PRIMARY PHYSICIAN, A DERMATOLOGIST AND AN ALLERGIST WITHOUT DIAGNOSIS OR RESOLUTION OF PROBLEM. SHE FEELS IT IS RELATED TO THE MMR VACCINE. hAS BEEN TREATED UNSUCCESSFULLY WITH ANTIHISTAMINES (ZYRTEC & ALLEGRA) AND PREDNISONE.
Age: 27.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101.6, Injection site red and very swollen. Fever breaks with tylenol but has returned.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Head injury, Pallor, Syncope
Clinical narrative: Patient was given two vaccines(Menactra and HPV) and she looked pale after administered the vaccine, thus this nurse had her rest several minutes on an exam table and then moved her to the hallway (waiting area) into a chair.  This nurse returned to the vaccination room and heard a thump.  Client was found on the floor with an episode of syncope for approximately 15 to 30 seconds and then became responsive to verbal stimuli.  Client made to rest on the floor for a minute before getting up and then she returned to her chair for questioning.  Client hit her head on the floor during her episode of syncope and thus was taken to the Emergency Department on the second floor of this hospital for evaluation where she was released after examination by Dr.  No apparent injury noted.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt given HPV vaccine at 11:35 at 11:40 began to give Hep A vaccine,  at beginning of administration client lost consciencousness. VS were as follows BP 110/70, pulse 74 Resp 20, client awoke independantly.  EMT's had been called and responded by 11:44, benedryl 50mg given per MD order.  Client recovered and she and her mother declined transport to Emergency room.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blood electrolytes normal, Electroencephalogram normal, Full blood count normal, Hypotonia, Hypoventilation
Clinical narrative: patient went limp and was poorly responsive to stimulation. breathing was shallow. EMS was activated and patient was admitted to the hospital.  6/15/07 Received hospital medical records which reveal patient admitted for 23 hour observation from 4/2-4/3/07 after becoming fussy,pale & limp on afternoon of vax.  All studies were WNL & D/C to home on apnea monitor FINAL DX: apparent life threatening event.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: patient went limp and was poorly responsive to stimulation. breathing was shallow. EMS was activated and patient was admitted to the hospital.  6/15/07 Received hospital medical records which reveal patient admitted for 23 hour observation from 4/2-4/3/07 after becoming fussy,pale & limp on afternoon of vax.  All studies were WNL & D/C to home on apnea monitor FINAL DX: apparent life threatening event.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cold compress therapy, Dizziness, Fatigue, Syncope
Clinical narrative: Fainted immediately after vaccine; slow to recover. Was placed in supine position with legs elevated.  Cold compress to face and neck applied.  Became concscious after a few minutes but it took about 50 minutes until she was able to sit up without feeling lightheaded again.  C/o fatigue.  After returning to consciousness, given fluids ie, water, juice and cola.  BP initally 100/60 P 80 but this fell to 80/40 and 60 before recovery.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PT COMES IN TODAY ON 6-13-07 C/O SMALL REACTION NOTED FROM SHOTS RT UPPER ARM RED AND WARM TO TOUCH DOESN'T HURT
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L UPPER BACK SIDE OF ARM WITH RED, RAISED AREA 45 MM X 35 MM NOTED BY GRABMOTHER THE MORNING PAST INJECTION. PATIENT C/O TNEDERNESS @ SITE
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Blood electrolytes, Eosinophil count normal, Liver function test normal, Somnolence, Syphilis test
Clinical narrative: Developed Uticaria rash 5 days after 4th Anthrax shot.  Rash spread to distal forearms, hands, shoulders, face, back, upper chest, knees.  He couldn't work for 3 days because of sleepiness.  Treated with Atarax and prednisone.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Urine analysis, Urticaria, White blood cell count increased
Clinical narrative: Developed Uticaria rash 5 days after 4th Anthrax shot.  Rash spread to distal forearms, hands, shoulders, face, back, upper chest, knees.  He couldn't work for 3 days because of sleepiness.  Treated with Atarax and prednisone.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Convulsion
Clinical narrative: Nonfebrile seizure x 2 minutes. 5 Days after Adacel vaccination.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Unresponsive to stimuli
Clinical narrative: Nonfebrile seizure x 2 minutes. 5 Days after Adacel vaccination.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Nonfebrile seizure x 2 minutes. 5 Days after Adacel vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ, TD, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, sore - mild tender with deep palpation developed around vaccine site 1 week after vaccines watching - if increase red, fever, increase tender. Abx treatment (Crx GIVEN).
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema swelling left lateral arm Arthus-cite reaction
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Body temperature increased, Erythema, Rash, Rash macular
Clinical narrative: Facial red blotchy rash starting evening of 6/5/07. Rash on arms, trunk on 6/6/07 - denies itching. Rash faded slightly on face - persists in arms, trunk, slight rash on legs was given Motrin 2 x 6/5, 1 x 6/6. 6/7/07 Temperature 99.1 with temporal scan.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives-lips, face and itching 6 hours after having Gardasil #2 Patient had eaten sushi with that 6 hr period
Age: 12.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Left arm hot to touch cant tell if red. Patient is dark/fever/ a little sore.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Large cellulitis left thigh extending up into femoral area. Hot, tender, erythemic.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Cold compress therapy
Clinical narrative: Cellulitis (L) arm Tx with Augmentin ES 600/5 mg 2tsp twice a day for 7 days Also Motrin every 6 hr apply cool compress prn will f/u after meds comp
Age: 9.0
Sex: F
Vaccine: IPV, TD
Symptoms: Asthma, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Mother stated child ran fever of 103 deg arm became red and swollen at injection site. Mother states child has asthma because of injections.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Rash papular, Skin lesion
Clinical narrative: Scattered erythema pap vesicles lesions trunk (15), neck (3), edge of scalp (1) upper thighs and arms.
Age: 38.0
Sex: M
Vaccine: UNK, ANTH, MMR, SMALL, TYP, UNK, YF
Symptoms: Unevaluable event
Clinical narrative: Hypertension, polyps, blood stool, hemorrhoids internal, sinus chronic.   8/14/07 Received medical records for 12/2004 through 5/2007 from MC which reveal patient experienced: HTN; mixed conductive & sensorineural hearing loss; tinnitus; bilateral knee pain; back pain; tinea corporis, insomnia; hyperlipidemia; nasal polyps; chronic & allergic rhinitis; colon polyps; & IBS.
Age: 38.0
Sex: M
Vaccine: UNK, ANTH, MMR, SMALL, TYP, UNK, YF
Symptoms: Chronic sinusitis, Haematochezia, Haemorrhoids, Hypertension, Polyp
Clinical narrative: Hypertension, polyps, blood stool, hemorrhoids internal, sinus chronic.   8/14/07 Received medical records for 12/2004 through 5/2007 from MC which reveal patient experienced: HTN; mixed conductive & sensorineural hearing loss; tinnitus; bilateral knee pain; back pain; tinea corporis, insomnia; hyperlipidemia; nasal polyps; chronic & allergic rhinitis; colon polyps; & IBS.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5, DTAP, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Haematochezia, Vomiting
Clinical narrative: This report was received from another manufacturer on 07 June 2007 under the manufacturer number WAES0704USA02470. The following is verbatim: "Information has been received from a physician concerning a 6 month old female (previously reported as male) who on 30-MAR-2007 was vaccinated with a third oral dose of Rotateq, concomitant vaccination included the third doses of Prevnar and dose of Daptacel both in the right thigh. "The week of" 02-APR-2007 the patient developed vomiting, diarrhea and blood in stool and was hospitalized. All tests that were performed "came up negative". A stool culture was done. It was reported that the physician was "unsure of what caused the patient's symptoms". The patient's present status was "fully" recovered. it was reported that the patient was at home. The date of discharge from the hospital was not reported. There was no product quality complaint involved. In follow-up, it was reported that the patient developed blood diarrhea (onset date, outcome, and serious criteria not provided). Additional information has been requested."
Age: 21.0
Sex: F
Vaccine: FLUX, IPV, MNQ, TD, TYP, YF, FLU3, IPV, MNQ, TD, TYP, YF
Symptoms: Dermatomyositis, Electromyogram, Musculoskeletal discomfort
Clinical narrative: Mother reported to me on this day that her daughter developed dermatomyocitis which started with muscle weakness in mid-June 2005.  She has already completed Vaers #280170
Age: 21.0
Sex: F
Vaccine: FLUX, IPV, MNQ, TD, TYP, YF, FLU3, IPV, MNQ, TD, TYP, YF
Symptoms: Dermatomyositis, Muscular weakness
Clinical narrative: Mother reported to me on this day that her daughter developed dermatomyocitis which started with muscle weakness in mid-June 2005.  She has already completed Vaers #280170
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Eye pain, Full blood count, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 16 year old female with diabetes and many other unspecified medical conditions, who on 15-MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007 the patient came back to the office for her second dose but it was not administered because the patient was experiencing headache, eye pain and loss of vision in one eye (it was not known which eye). The patient was hospitalized because of this and has been released. Subsequently, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Optic neuritis, Papilloedema, Positron emission tomogram normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female with diabetes and many other unspecified medical conditions, who on 15-MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007 the patient came back to the office for her second dose but it was not administered because the patient was experiencing headache, eye pain and loss of vision in one eye (it was not known which eye). The patient was hospitalized because of this and has been released. Subsequently, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Blindness unilateral, Eye pain, Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female with diabetes and many other unspecified medical conditions, who on 15-MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007 the patient came back to the office for her second dose but it was not administered because the patient was experiencing headache, eye pain and loss of vision in one eye (it was not known which eye). The patient was hospitalized because of this and has been released. Subsequently, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DPP, HPV4, MNQ
Symptoms: Syncope, Tremor
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2007; 6/20/2007. Initial and follow up information has been received from a physician, a registered nurse  and additional nurse, concerning a 14 year old female student with a history of syncope when receiving treatment for ingrown toenail. (previously reported as no pertinent history) who "last week," on approximately 28-MAY-2007, was vaccinated with Gardasil. Concomitant therapy included "a couple of other vaccines (unspecified)." Subsequently, "last week, on approximately 28-MAY-2007, the patient experienced a seizure in the treatment room. A blood pressure test was performed (results not provided). Subsequently, she recovered on the same day at the office. Unspecified medical attention was sought. Upon internal review, the patient's seizure was considered to be an other important medical event. Follow up information from the nurse indicated that it has not been determined if the patient will receive the second dose of GARDASIL. This report no longer meets the criteria for an expedited report, because it has been determined that the report was not serious. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DPP, HPV4, MNQ
Symptoms: Convulsion, Syncope, Tremor
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2007; 6/20/2007. Initial and follow up information has been received from a physician, a registered nurse  and additional nurse, concerning a 14 year old female student with a history of syncope when receiving treatment for ingrown toenail. (previously reported as no pertinent history) who "last week," on approximately 28-MAY-2007, was vaccinated with Gardasil. Concomitant therapy included "a couple of other vaccines (unspecified)." Subsequently, "last week, on approximately 28-MAY-2007, the patient experienced a seizure in the treatment room. A blood pressure test was performed (results not provided). Subsequently, she recovered on the same day at the office. Unspecified medical attention was sought. Upon internal review, the patient's seizure was considered to be an other important medical event. Follow up information from the nurse indicated that it has not been determined if the patient will receive the second dose of GARDASIL. This report no longer meets the criteria for an expedited report, because it has been determined that the report was not serious. No further information is expected.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Flushing, Hypoventilation, Pyrexia, Tremor
Clinical narrative: shallow breathing shakiness fever 102.8 flushed face given Tylenol v.s. checked
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site pain, Injection site swelling, Oedema, Pyrexia
Clinical narrative: Rt arm sore and swollen, + 2 edema in office, fever (101.3), Tx with Tylenol, rest and increase fluids.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Respiratory distress
Clinical narrative: Information has been received from a physician concerning a 6 year old male with a family history of asthma who on approximately 01-JUN-2007 was vaccinated with a dose of Vaqta. Suspect vaccination on the same day included a dose of Varivax. On approximately 01-JUN-2007, after vaccination the patient experienced dizziness and respiratory distress while leaving the office. The patient returned to the office and was given a breathing treatment and Prednisone. At the time of report, the patient had recovered. A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypoaesthesia, Musculoskeletal pain, Nausea
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female student (128 lb., 62.5 in.) with type I diabetes mellitus who on 17-MAY-2007 in the evening was vaccinated with Gardasil (Lot # 653736/0014U), intramuscular route (left arm). On 18-MAY-2007 in the morning the patient experienced headache, fatigue, shoulder pain and transient numbness on two fingers of her hand on same side as injection. 48 hours after injection of Gardasil, on approximately 19-MAY-2007, the patient experienced nausea and emesis. 24 hours later, on approximately 20-MAY-2007, the patient was treated with Phenergan to "get resolution of symptoms" Subsequently, on 23-MAY-2007 the patient recovered from headache, fatigue, shoulder pain and transient numbness on two fingers of her hand, nausea and emesis. The patient did not have an illness at the time of vaccination. The patient's headache, fatigue, shoulder pain, transient numbness on two fingers of hand, nausea and emesis were considered to be an other important medical event by the reporting nurse. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female student (128 lb., 62.5 in.) with type I diabetes mellitus who on 17-MAY-2007 in the evening was vaccinated with Gardasil (Lot # 653736/0014U), intramuscular route (left arm). On 18-MAY-2007 in the morning the patient experienced headache, fatigue, shoulder pain and transient numbness on two fingers of her hand on same side as injection. 48 hours after injection of Gardasil, on approximately 19-MAY-2007, the patient experienced nausea and emesis. 24 hours later, on approximately 20-MAY-2007, the patient was treated with Phenergan to "get resolution of symptoms" Subsequently, on 23-MAY-2007 the patient recovered from headache, fatigue, shoulder pain and transient numbness on two fingers of her hand, nausea and emesis. The patient did not have an illness at the time of vaccination. The patient's headache, fatigue, shoulder pain, transient numbness on two fingers of hand, nausea and emesis were considered to be an other important medical event by the reporting nurse. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Chest pain, Heart rate irregular, Medical observation, Nausea
Clinical narrative: Information has been received from a nurse concerning a 24 year old female patient who in April 2007, "about two months ago" was vaccinated IM with a first dose of Gardasil. Within about a half an hour, the patient experienced chest pains, nausea, tightening of the throat, and an irregular heartbeat. The nurse reported that the patient has been hospitalized twice for the irregular heartbeat since receiving Gardasil. The nurse also reported that the patient has no prior history of heartbeat irregularities. Laboratory diagnostic studies included blood pressure and monitoring. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness
Clinical narrative: Information has been received from a nurse concerning a 24 year old female patient who in April 2007, "about two months ago" was vaccinated IM with a first dose of Gardasil. Within about a half an hour, the patient experienced chest pains, nausea, tightening of the throat, and an irregular heartbeat. The nurse reported that the patient has been hospitalized twice for the irregular heartbeat since receiving Gardasil. The nurse also reported that the patient has no prior history of heartbeat irregularities. Laboratory diagnostic studies included blood pressure and monitoring. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Blood test, Chest pain, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: Information has been received from an 82 year old female patient with osteoporosis, hypothyroidism and no allergies who on 15-APR-2007 (also reported as 12-APR-2007) was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium and Synthroid. On 17-APR-2007 (also reported as 12-APR-2007), 2 days after vaccination the patient woke up sweating and could hardly stand up. It was reported that the patient started throwing up and was taken to the hospital by ambulance. The patient was admitted to the hospital where they ran "some blood tests" and MRI. It was determined that patient was having an allergic reaction to vaccine. Unspecified medical attention was sought. At the time of report the patient had recovered with 2 days of hospitalization. A product quality complaint was not involved. It was reported that two days after vaccination patient experienced chest pain and nausea. She was admitted to the hospital for 2 days to rule out myocardial infarction. All tests including an MRI, CT scan and EKG were all negative. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Laboratory test, Movement disorder, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from an 82 year old female patient with osteoporosis, hypothyroidism and no allergies who on 15-APR-2007 (also reported as 12-APR-2007) was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium and Synthroid. On 17-APR-2007 (also reported as 12-APR-2007), 2 days after vaccination the patient woke up sweating and could hardly stand up. It was reported that the patient started throwing up and was taken to the hospital by ambulance. The patient was admitted to the hospital where they ran "some blood tests" and MRI. It was determined that patient was having an allergic reaction to vaccine. Unspecified medical attention was sought. At the time of report the patient had recovered with 2 days of hospitalization. A product quality complaint was not involved. It was reported that two days after vaccination patient experienced chest pain and nausea. She was admitted to the hospital for 2 days to rule out myocardial infarction. All tests including an MRI, CT scan and EKG were all negative. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from an 82 year old female patient with osteoporosis, hypothyroidism and no allergies who on 15-APR-2007 (also reported as 12-APR-2007) was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium and Synthroid. On 17-APR-2007 (also reported as 12-APR-2007), 2 days after vaccination the patient woke up sweating and could hardly stand up. It was reported that the patient started throwing up and was taken to the hospital by ambulance. The patient was admitted to the hospital where they ran "some blood tests" and MRI. It was determined that patient was having an allergic reaction to vaccine. Unspecified medical attention was sought. At the time of report the patient had recovered with 2 days of hospitalization. A product quality complaint was not involved. It was reported that two days after vaccination patient experienced chest pain and nausea. She was admitted to the hospital for 2 days to rule out myocardial infarction. All tests including an MRI, CT scan and EKG were all negative. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female patient in her 70's who in 2007 was vaccinated with a 0.65 ml dose of Zostavax. Subsequently "recently" in 2007, the patient developed a zoster-like rash and alot of pain all over. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. The physician considered the patient's experiences to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Confusional state, Dyspnoea, Headache, Neuralgia
Clinical narrative: Information has been received from a physician concerning a male who on 14-MAY-2007 was vaccinated with Zostavax. On 27-MAY-2007 the patient experienced a sharp shooting headache on the right side of his head. The patient went to the hospital where he was evaluated and diagnosed with trigeminal neuralgia. The patient was prescribed Tegretol and discharged from the hospital. A few days later, on approximately 30-MAY-2007, the patient experienced confusion and shortness of breath. The patient went to the emergency  room where it was noted that the patient was too weak to stand on his own. The patient has a prior history of shingles. Unspecified medical attention was sought. There was no product quality complaint. Lot number was not available. Additional information has been requested.