chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dizziness, Feeling hot, Pallor
Clinical narrative: Pale, felt faint, very warm, chills, symptoms lasting 30 minutes.  Occurred 1/2 hour after injection.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Fall, Mydriasis, Skin warm, Unresponsive to stimuli
Clinical narrative: fell to ground, didn't respond for short time pupils dilated- in Doc Rm felt warm, O2 given
Sex: F
Vaccine: TD
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: pale, fell to knees, felt faint
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Hyperventilation
Clinical narrative: hyperventilated-he stated "he was fine".
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Erythema, Headache, Hypoaesthesia
Clinical narrative: Discoloration to the vagina & rectum, redness around the vagina.  Spreading spot over the body & vagina, rectum.  Uncomfort odor.  A lot of numbs in hands & arm the injection was place in.  Muscle ache, headache, weakness and nausea.  Abdominal pain.  Discomfort during monthly menstruation.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Menstrual discomfort, Myalgia, Nausea, Skin discolouration, Skin odour abnormal
Clinical narrative: Discoloration to the vagina & rectum, redness around the vagina.  Spreading spot over the body & vagina, rectum.  Uncomfort odor.  A lot of numbs in hands & arm the injection was place in.  Muscle ache, headache, weakness and nausea.  Abdominal pain.  Discomfort during monthly menstruation.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male who on approximately 24-NOV-2002 was vaccinated with a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  On approximately 24-NOV-2002 the patient developed a fever of 101 degrees F that lasted for 24 hours.  On approximately 25-NOV-2002, the patient recovered.  The patient subsequently experienced cellulitis, dehydration, diarrhea, gait disturbance, hyponatremia, tachycardia, pyrexia and vaccination complication after vaccination with PNEUMOVAX 23 (MSD WAES 0611USA05643).  No further information is available.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood lead, Erythema, Erythema multiforme, Full blood count, Radioallergosorbent test
Clinical narrative: Confluent red, warm, irregularly shaped areas on all 4 extremities. Initially seen on evening of 5/20/08 as just a few spots. More formed in AM of 5/21/08. More like erythema multiforme on 5/22/08.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Confluent red, warm, irregularly shaped areas on all 4 extremities. Initially seen on evening of 5/20/08 as just a few spots. More formed in AM of 5/21/08. More like erythema multiforme on 5/22/08.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: 2x2 cm at Rt arm, 2x3 cm Lt arm.
Age: 7.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Oedema peripheral
Clinical narrative: Right arm swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Pallor
Clinical narrative: 4/29/08 - Morning following vaccine, red and swollen at injection site. Decreased swelling with ice. 5/6/08 - Rt lateral upper arm with erythema, blanching, below initial injection site with "knot" at presumed site. Not tender. No warmth. Vertical rectangle 3-4in x 2 in.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Foaming at mouth, Hypotonia, Pallor, Vomiting
Clinical narrative: 1-2 min after administration of Varivax/MMR, pt c/o throat feeling funny, went limp/pale and she started vomiting and foaming at the mouth. VS: Sat 95-98%, BP 86/50, Pulse 96 (0.15mg). Given Epipen-O2  06/09/2008 MR received for DOS 5/22&23/2008 including ER record with DX: Anaphylaxis. Within 1-2 minutes of MMR and Varivax pt c/o throat feeling funny, then went limp and pale. Pt began vomiting and foaming at the mouth. Epipen administered and transported to ER. TX with Benadryl and prednisone. No further sx. Seen in F/u the next day with normal exam
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood pressure, Foaming at mouth, Heart rate normal, Hypotonia, Oxygen saturation normal
Clinical narrative: 1-2 min after administration of Varivax/MMR, pt c/o throat feeling funny, went limp/pale and she started vomiting and foaming at the mouth. VS: Sat 95-98%, BP 86/50, Pulse 96 (0.15mg). Given Epipen-O2  06/09/2008 MR received for DOS 5/22&23/2008 including ER record with DX: Anaphylaxis. Within 1-2 minutes of MMR and Varivax pt c/o throat feeling funny, then went limp and pale. Pt began vomiting and foaming at the mouth. Epipen administered and transported to ER. TX with Benadryl and prednisone. No further sx. Seen in F/u the next day with normal exam
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pallor, Throat irritation, Vomiting
Clinical narrative: 1-2 min after administration of Varivax/MMR, pt c/o throat feeling funny, went limp/pale and she started vomiting and foaming at the mouth. VS: Sat 95-98%, BP 86/50, Pulse 96 (0.15mg). Given Epipen-O2  06/09/2008 MR received for DOS 5/22&23/2008 including ER record with DX: Anaphylaxis. Within 1-2 minutes of MMR and Varivax pt c/o throat feeling funny, then went limp and pale. Pt began vomiting and foaming at the mouth. Epipen administered and transported to ER. TX with Benadryl and prednisone. No further sx. Seen in F/u the next day with normal exam
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large erythematous area on (L) thigh at site of DTaP vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Crying, Full blood count normal, Grunting, Lethargy, Pyrexia
Clinical narrative: Very sudden onset of fever, grunting, crying, lethargy, went to ER. Child f/u in ofc - doing well, no fever, stable.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Urine analysis normal
Clinical narrative: Very sudden onset of fever, grunting, crying, lethargy, went to ER. Child f/u in ofc - doing well, no fever, stable.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Tender erythematous lesion posterior Rt upper arm. Deeply erythematous central area 4x5cm; Outer fainter erythema 7x10cm. No fluctuance noted.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Local reaction
Clinical narrative: On 5/13/2008, pt was administered #4 Anthrax by LPN. Pt reported to immunization clinic on 5/15/08 at 1115 with a large local reaction tot he Anthrax injection (LA). Administered 25mg of oral Benadryl, applied ice pack for 30 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mother returned to clinic with child on 5/20/08 to report bumps and fever.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure, Body temperature, Dizziness, Feeling hot, Heart rate
Clinical narrative: Approximately 10 minutes after administration of injection, pt felt extremely hot and some lightheadedness and nausea. VS 158/89 pulse 95 temp 98.1 F.  Pt sat down and was given some water. Pt recovered from all symptoms in under 15 mins. Area surrounding IM site remains warm to touch, no hardening, no hives.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Injection site warmth, Nausea
Clinical narrative: Approximately 10 minutes after administration of injection, pt felt extremely hot and some lightheadedness and nausea. VS 158/89 pulse 95 temp 98.1 F.  Pt sat down and was given some water. Pt recovered from all symptoms in under 15 mins. Area surrounding IM site remains warm to touch, no hardening, no hives.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Crying, Diet refusal, Irritability, Lymphadenopathy, Malaise
Clinical narrative: 6 days after vaccinations, the patient developed a tiny red pinpoint dot type of rash on her belly and back that progressed up to the face.  She developed a fever of 101F and acted sick.  Mom described daughter as fussy, crying, and not eating.  By day 10 after vaccination, the rash started resolving.  Pt was seen by her medical provider who noted a swollen left groin lymph. node
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: 6 days after vaccinations, the patient developed a tiny red pinpoint dot type of rash on her belly and back that progressed up to the face.  She developed a fever of 101F and acted sick.  Mom described daughter as fussy, crying, and not eating.  By day 10 after vaccination, the rash started resolving.  Pt was seen by her medical provider who noted a swollen left groin lymph. node
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Exposure to communicable disease, No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: 46 y o female who received a Varicella # 1 on 3/07 and Varicella # 2 on 3/3/08. 11 days after vaccination she noted a burning and tingling sensation along the breasts, underarms, and across the back for 3 days. The sensation progressed to include the back of her head and then her eyelid a few days later.  She denies a visible rash or itch just the sensation. She was referred to her primary care physician who did not treat the symptoms.  The reason this patient requested vaccination in because there had been multiple cases of chickenpox in the daughter's pre-school. However the daughter has been immunized and did not have any side effects or rash.    Patient had not had any side effects from varicella #1 in 3/2007.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Rash developed, some that were vesicular in nature, within a few days of vaccine.  When I saw the patient, no vesicles were present, just small papules.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Developed itchy rash and minimal fever.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Conversion disorder, Crying, Head banging, Headache, Hypersomnia
Clinical narrative: She got the first rash nine days after the shot.  This rash was little pin prick size bumps.  Twelve days after the shot she became extremely irritable and at times hysterical.  She complained the following day of a headache and she was sleeping longer for naps and at night.  On day 13 she developed another type of rash that looked about the size of mosquito bites (they were not bites) on her legs.  Her terrible humor continued and she at times would hit her head against the floor.  On day fourteen she had an appointment with her gastro doctor and he was concerned and wanted to make sure we had called our pediatrician as she had fallen asleep in my arms at 10:30 in the morning and had been quite unconsolable prior to falling asleep, which was not her typical behavior at the gastro doctor.  By the afternoon of the 14th day she began to improve and continued over the next three days to have marked improvement until she was back to herself.  The only treatment she received was tylonal.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Irritability
Clinical narrative: She got the first rash nine days after the shot.  This rash was little pin prick size bumps.  Twelve days after the shot she became extremely irritable and at times hysterical.  She complained the following day of a headache and she was sleeping longer for naps and at night.  On day 13 she developed another type of rash that looked about the size of mosquito bites (they were not bites) on her legs.  Her terrible humor continued and she at times would hit her head against the floor.  On day fourteen she had an appointment with her gastro doctor and he was concerned and wanted to make sure we had called our pediatrician as she had fallen asleep in my arms at 10:30 in the morning and had been quite unconsolable prior to falling asleep, which was not her typical behavior at the gastro doctor.  By the afternoon of the 14th day she began to improve and continued over the next three days to have marked improvement until she was back to herself.  The only treatment she received was tylonal.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: NO ADVERSE EFFECTS.  EMPLOYEE TOOK VACCINE ON 05-16-2008 AND FOUND OUT ON 05-20-2008 THAT SHE WAS PREGNANT
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: INFANT RECEIVED THE 2 MONTH IMMUNIZATIONS ON 5-22-08 AT APPROX. 1OAM. MOM CALLED AT 4PM STATING INFANT HAS CRIED NON-STOP FOR THE PAST 3-4 HOURS. INFANT NOT CRYING WHILE NURSE ON THE PHONE. ADVICE GIVEN FOR IMMUNIZATION REACTION AND ADVISED TO GO TO ED IF WORSENS.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Deafness unilateral
Clinical narrative: Healthy Patient received Tdap on 5/20/08, 12 hours after receiving the vaccine she developed hearing loss in the same side ear.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Deafness unilateral, Ear discomfort, Injection site pain
Clinical narrative: Healthy Patient received Tdap on 5/20/08, 12 hours after receiving the vaccine she developed hearing loss in the same side ear.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site extravasation, Pain, Pruritus
Clinical narrative: PT WAS TAKEN TO THE ER BY MOTHER WHO OBSERVED A RED RAISED AREA TO RIGHT THIGH AND COMPLAINING OF PAINON THE EVENING FOLLOWING VACCINATION. PT TOOK 1ST INJECTION FINE.DURING ADMINISTRATION OF 2ND VACCINE PT PULLED ON SYRINGE, CAUSING IT TO EXIT THE SKIN. THE INJECTION WAS ATTEMPTED A SECOND TIME WITH OUT INCIDENT.  PT TOLERATED 3RD INJECTION WITHOUT ANY PROBLEM. I ASKED MOTHER TO BRING PT TO OFFICE TODAY TO LOOK AT AREA. AREA MEASURES APPROX. 6CM X 6CM RED AND RAISED. AREA IS WARM TO THE TOUCH. PT DOES NOT COMPLAIN OF PAIN WITH PALPATION. DOES STATE AREA ITCHES. STARTED ON KEFLEX AND PEDIAPRED BY ER ON 5/22/08. AREA WAS FIRST OBSERVED BY FATHER ON 5/22/08 WHEN PUTTING CHILD TO BED.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Malaise, Pallor, Syncope
Clinical narrative: Pt. was given Menactra vaccine, when she went to leave the room she fainted (which is not uncommon with teenagers, she had not eaten anything and it was about 10:30)  We laid her down and gave her some crackers and drink.  Her color did not come back and she did not feel well.  Dr. checked her blood pressure and it was 80/40.  It was 110/70 before the vaccine was given.  We monitored the patient for about two hours at the office her BP finally got back to 110/60 at 12:45 and she felt some better, her color had come back. We let her go home.  Our concern was not that she fainted but that her BP dropped so low and it took us a while to get her back to an acceptable reading.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure, Dizziness, Heart rate normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Right after shot patient feeling faint, intructed head to knee position while seated in chair in exam room. Water given. 5 minutes ambulated to traement room when she stated began to "black out". LOC approxiamtely 5 seconds. Diaphoretic .With assiatance from my coworker aided student to the floor. Lying down elevated legs with pillows. Dr. was made aware. P: 60R: 18 cool cloth to forehead.Within 5 minutes:  color back to face feeling better. 10 minutes later sitting up , gatorade given and crackers. Amulated without difficulty to infirmary to lie down in bed. P: 60 B/P 100/70 R: 18 Additional 40 minutes rested in infirmary feeling better Before discharge: P: 72 R 18 B/P 100/70 Stable, Alert and oriented.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Respiratory rate
Clinical narrative: Right after shot patient feeling faint, intructed head to knee position while seated in chair in exam room. Water given. 5 minutes ambulated to traement room when she stated began to "black out". LOC approxiamtely 5 seconds. Diaphoretic .With assiatance from my coworker aided student to the floor. Lying down elevated legs with pillows. Dr. was made aware. P: 60R: 18 cool cloth to forehead.Within 5 minutes:  color back to face feeling better. 10 minutes later sitting up , gatorade given and crackers. Amulated without difficulty to infirmary to lie down in bed. P: 60 B/P 100/70 R: 18 Additional 40 minutes rested in infirmary feeling better Before discharge: P: 72 R 18 B/P 100/70 Stable, Alert and oriented.
Age: 25.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Activities of daily living impaired, Dysphonia, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: Four days after vaccine pt noticed a rash on her upper left arm. Itchy,red, painful to touch. "Looks like a bee sting." Getting flu-like symptoms. Hoarse voice, tired, sneezing, sleeping a lot.  So tired while driving and had to pull off the road to take a nap. Hive measures 38mm
Age: 25.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Pain, Pruritus, Rash erythematous, Sneezing, Urticaria
Clinical narrative: Four days after vaccine pt noticed a rash on her upper left arm. Itchy,red, painful to touch. "Looks like a bee sting." Getting flu-like symptoms. Hoarse voice, tired, sneezing, sleeping a lot.  So tired while driving and had to pull off the road to take a nap. Hive measures 38mm
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Body temperature, Heart rate, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Approximately 10 minutes after giving shot patient fainted in waiting area at front desk. NP was first to aid student. No apparent injury noted. LOC 3-5 seconds. Responsive. Pale and diaphorectic but alert. P:96 4:30 taken via wheelchair to infirmary. B/P: 100/76 P: 96. Dr. aware. Given water and gatorade and crackers. Lying in bed elevated legs. Cool compress to forehead. 4:45pm B/P96/78P:96 Dangled legs at bedside before ambulating. Color back to faceand no reports of dizziness. Stable and A&Ox3 before discharge.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Approximately 10 minutes after giving shot patient fainted in waiting area at front desk. NP was first to aid student. No apparent injury noted. LOC 3-5 seconds. Responsive. Pale and diaphorectic but alert. P:96 4:30 taken via wheelchair to infirmary. B/P: 100/76 P: 96. Dr. aware. Given water and gatorade and crackers. Lying in bed elevated legs. Cool compress to forehead. 4:45pm B/P96/78P:96 Dangled legs at bedside before ambulating. Color back to faceand no reports of dizziness. Stable and A&Ox3 before discharge.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Erythemia, induration and swelling of right thigh on the evening of May 19th.  On May 21 patient was brought to office and an approx. 6 inch round erythematous, indurated area was noted over the anterior aspect of the right thigh at the immunization site.  Mom was instructed to use cool compresses, benadryl and Tylenol prn.  Over 24 hours the area was noted to have significant improvement.  Area did remain slightly itchy.  No fever, shortness of breath or rash was noted.  This is the first noted reaction of any kind related to Vaccinations for this patient.  Patient does have an allergy to Amoxicillin.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pneumococcal vaccine given left deltoid --> site swollen and red. next day more swollen and red.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Patient has had chronic deltoid pain since 1/10/08.  There is pain to palpation, and weakness in the arm.  MRI normal. 6/3/08- records received-C/O arm pain 4/14/08-arm swollen, arm weakness, discomfort with moving. Injection site tender, pain is aching. C/O getting sick constantly since 3/08, aches and chills, fevers up to 101, nasal congestion, cough. PE: pain on palpation of arm. Assessment:neuritis.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had a reaction to Neomycin containing vaccine.  Was given Varicella on 5/13/2008 and on 5/22/08 had a swollen thigh where only that vaccine had been given.  35 x 40 mm patch of erythema, papules, shallow induration of area. also very itchy.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Radial nerve palsy
Clinical narrative: Left arm had a radial nerve palsy after receiving 2 vaccines in it.  HPV and MCV4 given in the left arm.  6/24/08 Reviewed PCP medical records & vax records of 5/21-6/10/08. FINAL DX: left arm neuropathy Records reveal patient w/concerns about weight, thyroid check up, acid reflux & occasional nosebleeds on day of vax.  Day after vax, had left finger tingling, numbness, unable to move left arm well & had fatigue.  RTC on 5/30 w/left arm redness, forearm & finger numbness, no pain in deltoid but had pain w/movement of arm from shoulder.  Decreased left biceps & triceps strength, absent left arm reflexes, decreased sensation.  Referred to peds neuro.  RTC 6/10 with same symptoms.  Had been seen by consultant & was to start accupuncture.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blood electrolytes normal, Scan brain
Clinical narrative: Generalized seizure x 2 approximately 54 hours after vaccine administration.  6/10/08 Reviewed hospital medical recods of 5/4-5/5/2008. FINAL DX: seizures Records reveal patient experienced low grade fever, had vomited several times since vaccinations & was constipated.  On day of admit, patient had fallen over & lay on floor w/clenched fists, staring, decreased respirations & unresponsive for approx 1 min.  Had vomited several times day before.  Had witnessed gen tonic-clonic seizures x 2 w/n 1 hour for approx 1 min each & postictal while in ER.  Tx w/meds & admitted overnight for observation.  LP done.  No further seizure activity & d/c to home w/diastat for further neuro w/u including EEG.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Syncope
Clinical narrative: Pt walked to front making next appointment. The next thing the pt fainted. Pt got up rested a few minutes and was fine. Pt walked to front of the office and fell down.  We helped her up a made her rest we gave her water/pop and crakers.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Drug exposure during pregnancy, Full blood count, Pregnancy test positive
Clinical narrative: As I was injecting the 3rd vaccine ordered for this patient-the patient's mother asked me if we did a pregnancy test on patient. I told her no and asked if a pregnancy test was needed. Mother stated yes. I then asked pt if she was sexually active and she said no. I notified doctor immediately and she ordered a urine pregnancy test. The result of the pregnancy test was positive. I notified doctor immediately. The vaccines that the patient received were Varivax, Gardasil and Menactra. Doctor ordered a referral to OB/GYN. I called doctor's office to get patient an appointment as soon as possible. The receptionist informed the doctor of the situation and he stated patient needed checked in mid-June 08 due to the fact patient states is about 10 days late for menstrual cycle. The receptionist informed med that this patient also had a history of miscarriage in 2007. I informed doctor of this. Patient has an appointment with doctor June 18, 2008. Referral for the appointment was given to Mother and I stressed importance of keeping the appointment as scheduled. Mother verbalized understanding.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: 4cm x 2cm erythematous area on R deltoid.  Treated with BENADRYL & cool compress.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Fatigue, Induration, Nodule, Pain
Clinical narrative: Donor has red raised area w/ hard nodule, warm to tough, soreness upon touch.  Donor states she felt tired for 2 days after shot.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Skin warm, Swelling
Clinical narrative: Donor has red raised area w/ hard nodule, warm to tough, soreness upon touch.  Donor states she felt tired for 2 days after shot.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Emotional distress, Injection site erythema, Injection site haemorrhage
Clinical narrative: Lt. thigh skin: 8 cm. area of slight erythema and almost appears ecchymotic.  Evening of 5-22-08 - patient was "not consolable".
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Leg swollen, red and warm to the touch a few hours after injection.  (The whole thigh).  Temperature 99-100.9, mild induration - mild erythema.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Upper L arm with 12x12 cm area induration, warm, erythema.  Tx: clindamycin.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Communication disorder, Irritability, Nausea, Pyrexia, Social avoidant behaviour
Clinical narrative: 1st 24 hrs post injection; fever, nausea, vomiting with extreme irritability.  Symptoms persist for 72 hrs, then return idiopathically >/~ 4 mos.  Speech regression & withdrawal with minimal to no verbal communication.  Speaking prior to event.  Dates on this form are correct & this supercedes the prior report.  My info is now correct.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Speech disorder, Vomiting
Clinical narrative: 1st 24 hrs post injection; fever, nausea, vomiting with extreme irritability.  Symptoms persist for 72 hrs, then return idiopathically >/~ 4 mos.  Speech regression & withdrawal with minimal to no verbal communication.  Speaking prior to event.  Dates on this form are correct & this supercedes the prior report.  My info is now correct.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Rt delt- MMR #2 & polio Rt delt #4.  5x3" induration & redness over rt deltoid.  No tenderness.  Shoulder movt nl.  BENADRYL 1 tsp Q 6, MOTRIN 2 tsp Q 8.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Pain in jaw
Clinical narrative: Headache while taking pills on Friday 5/16/08 lower jaw pain both sides to ear.
Age: 1.7
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: En el muslo D. parte superior presenta edema, eritema, caliente al tacto, area endureicta.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Reddened area right arm.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Feeling hot, Induration, Pain, Swelling
Clinical narrative: Increasing pain, swelling, induration, warm to touch.  4 cm x 6 cm firm area showing cellulitis.  Treatment Cefril.
Age: 4.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt. is a 4 year old male. Source of patient information was mother. Patient accompanied by mother. Feeling fine. Normal appetite. Skin symptoms; No fever. No head symptoms. No swollen glands in the neck. No eye symptoms. No ear symptoms, no nasal discharge, no nasal passage blockage, and no sore throat. No dyspnea, no cough, and no wheezing. No nausea, no vomiting, and no diarrhea. No oliguria. Received immunization 2 days ago and now right arm swollen red and hot to the touch. Received Hep A injection in right arm. Fluid intake is normal.
Sex: U
Vaccine: VARCEL
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck).  Subsequently the patient developed transverse myelitis.  No further information was provided.  There was no product quality complaint involved.  Additional information was received on 29-OCT-2007.  The reporting physician did not have any further information as the patient belonged to another physician's practice.  Upon internal review the patient's transverse myelitis was determined to be an other important medical event.  No additional information is available.  This is one of several reports from the same source.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a 6-year-old female who on an unspecified date was vaccinated with a 0.5 mL second dose of VARIVAX. Subsequently the patient developed transverse myelitis. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Follow-up information was received on 02-AUG-2007 via a telephone call. The physician reported that the patient's date of birth was 09-NOV-2000 and he did not know the relationship of the transverse myelitis to VARIVAX. Upon internal review the patient's transverse myelitis was determined to be an other important medical event. Additional information is not expected. This is one of several reports from the same source. 6/12/08-records received for DOS 6/14-7/3/07- DC DX: Transverse myelitis. Neuropathic pain. Neurogenic bowel and bladder. Asthma. Mild azotemia. Presented with fever, leg pain, arm pain, abdominal pain began 6/6/07-Previously diagnosed with strep throat. Inability to walk. PE: 2+ deep tendon reflexes symmetric in upper and lower extremities, bilateral clonus. Incontinent of bladder, bladder distention. Developed spasticity in ankles, neuropathic pain. Decreased sensation up to T4. At time of discharge to rehabilitation facility minimal abduction and adduction of both legs.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 11 year old male with a history of 2 liver transplants in his life, who in approximately 2005 "a couple of years ago" was vaccinated with a dose of VARIVAX. On approximately 17-JUL-2007 "a couple of days ago" the patient developed shingles and was hospitalized. At the time of this report the patient was still in the hospital and had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a registered nurse concerning a approximately 4 year old male who was vaccinated with a dose of VARIVAX. Suspect vaccination given that day included a dose of MMR II. The patient had a febrile seizure after being vaccinated. Unspecified medical attention was sought. No product quality complaint was involved. Follow up from the registered nurse indicated there was no additional information available. Upon internal review febrile seizure was determined to be an other Important Medical Event. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 7 year old female who on 07-MAR-1996, at 12 months of age, was vaccinated with a dose of VARIVAX. It was reported on 07-NOV-2002, the patient developed shingles. A dermatologist diagnosed the lesions as shingles and the patient was prescribed acyclovir as treatment. Subsequently, the patient fully recovered from shingles. PCR analysis was refused by the reporter. No product quality complaint was involved. Shingles was considered to be other important medical event by the reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Guillain-Barre syndrome, Laboratory test abnormal, Occupational problem environmental
Clinical narrative: Information has been received from a company representative concerning a male who has been working in the VARIVAX processing unit and has been diagnosed with Guillain Barre Syndrome. The patient has been out of work on disability since January 2007. Unspecified testing was done to diagnose the symptoms of his illness. The patient and his wife believe that the illness is a result of working with VARIVAX product. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Blood pressure immeasurable, Dyspnoea
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8-year-old male who on 02-APR-2007 was vaccinated SC with a second 0.5mL dose of VARIVAX. On 02-APR-2007 the patient experienced an anaphylactic reaction. He had "no blood pressure" and had "difficulty breathing". He as admitted to the hospital for 2 days. He was given large amounts of epinephrine and fluids. The events were considered other important medical events by the reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old white male who on 07-NOV-2000 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) and on 7-AUG-2006 was vaccinated on the left deltoid with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 652666/0248F). It was reported that on 23-JUL-2007, the patient had a exposure to varicella from his brothers and the patient developed 2 varicella lesions on his abdomen. The physician prescribed the patient acyclovir 400 mg Bid for 5 days. At the time of report the patient had recovered. The patient's experience was considered to be an other important medical event by the reporter. This is on of several reports received from the same source. It was reported that the patient's brother, WAES 0709USA03362, experienced a similar adverse event following vaccination with varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male who on 19-MAR-1998 was vaccinated in the left thigh with a first dose of VARIVAX (Oka/Merck) (Lot#625050/1610E).  Illness at the time of vaccination included right otitis media, an upper respiratory tract infection and constipation.  On 23-JUL-2007 the patient developed 1 lesion on the mid right abdomen after varicella exposure to his brother.  Medical attention was sought and the doctor prescribed acyclovir 800mg twice a day for 5 days.  On 30-AUG-2007 the patient recovered.  No further information was provided.  The reporter considered the patient's experience to be an other important medical event since medication was prescribed.  Additional information is not expected.  This is one of several reports from the same source. Follow-uo information from the reporting registered nurse indicated that this patient was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot# 625050/1610E) on 19-MAR-1998 and then the patient's brother was vaccinated (WAES# 0709USA03365). This patient was the first to experience the lesion on the mid right abdomen and then his brother developed 2 lesions on his abdomen and 1 lesion on his upper leg. The reporter stated there was no mention of an exposure to VZV WILD TYPE STRAIN virus in the patient's chart. The patient recovered, it was noted that there were on reoccurrences of the event. Additional information is not expected.  This is one of several reports from the same source.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 09-AUG-2007 was vaccinated subcutaneously in the right thigh with VARIVAX (Oka/Merck) (Lot # 657757/0641U).  Concomitant therapy included Hep A (unspecified).  On 10-AUG-2007 the patient experienced injection site induration.  It was reported that the patient had a "12cm x 13 cm area "erythroneia" center area with firm, tender warm induration" on her right lateral thigh.  The patient was treated with KEFLEX.  The patient outcome was not reported.  The reporter considered injection site induration to be an other important medical event.  Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Hyperpyrexia
Clinical narrative: Information has been received from a health authority (case # 84292) (local case # IT173/08) concerning a 14 month old boy who on 05-NOV-2007 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 654405/0471F) (batch # ND70600) and concomitantly with the first dose of PRIORIX (batch # A69FA949A). Both vaccines were administered via subcutaneous route in an unspecified site of administration. On 12-NOV-2007 he presented with hyperpyrexia and convulsion crisis due to hyperpyrexia. He was admitted to the hospital. The patient completely recovered on 15-NOV-07. Other company number included E2008-04011. The case is closed.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Chest X-ray, Convulsion, Familial risk factor
Clinical narrative: Information has been received from a physician concerning a 12 month old twin male no allergies who on 02-AUG-2007 at approximately 15:00 PM was vaccinated SC on the right arm with a first dose of VARIVAX (lot # 658024/0833U). Concomitant therapy on the same day included a SC dose on the left arm of MMR II (Lot # 655414/1470F) and a fourth dose of PREVNAR (Lot # B58845A) with no previous adverse experiences related to it. There was no illness at the time of vaccination. It was reported that on 10-AUG-2007 the patient experienced a seizure, 15 minutes after his twin brother experienced a seizure. Unspecified medical attention sought. A chest x-ray was done (results not reported). At the time of report the patient had recovered. A product quality complaint was not involved. The patient's twin brother had similar experience after therapy with VARIVAX (WAES # 0708USA05300). Additional information has been received from the physician who stated that the patient had seizure 1 week after vaccination on 10-AUG-2007 at approximately 10:00 AM. The patient had febrile seizure (also reported as seizure) and at the time of report the patient had recovered. Upon internal review seizure was considered to be an other important medical event. No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Chest X-ray, Convulsion, Familial risk factor, Febrile convulsion
Clinical narrative: Information has been received from a physician concerning a 12 month old twin male with pneumonia and no allergies who on 02-AUG-2007 at approximately 15:00 was vaccinated SC on the right arm with a first dose of VARIVAX (lot # 658024/0833U). Concomitant therapy included a first SC dose on left arm of MMR II (Lot # 655414/1470F) and a fourth IM dose on left thigh of PREVNAR with no previous adverse experiences related to it. It was reported that on 10-AUG-2007 the patient experienced seizure. Unspecified medical attention sought. A chest x-ray was done (results not reported). At the time of report the patient had recovered. A product quality complaint was not involved. The patient's twin brother had similar experience after therapy with VARIVAX (WAES # 0709USA00135). Additional information has been received from the physician who stated that the patient had seizure 1 week after vaccination on 10-AUG-2007 at approximately 10:00 AM. The patient had febrile seizure (also reported as seizure), 15 minutes after his twin brother had same experience. At the time of report the patient had recovered. Upon internal review seizure was considered to be an other important medical event. No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Cyanosis, Rash pruritic, Vomiting
Clinical narrative: Information has been received from a health professional concerning an 8 year old male with no medical history or allergies who on an unspecified date was vaccinated with a first dose of VARIVAX. Subsequently the patient experienced an anaphylactic reaction. On 17-AUG-2007, at 8 years of age the patient was vaccinated SC on upper left extremity with a 0.5 ml second dose of VARIVAX (Lot # 658062/0829U). There was no concomitant medication. There was no illness at the time of vaccination. On 17-AUG-2007 the patient had an anaphylactic reaction after vaccination. The patient vomited and his face turned blue. The patient was treated with oxygen, epinephrine and BENADRYL. The patient's body was covered with itchy rash. It was reported that the patient was treated in the office and ambulance was not called. No diagnostic laboratory test was undertaken. At the time of report the patient was recovering. A product quality complaint was not involved. A lot check has been initiated. 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 of the Center for Biologics Evaluation and Research and was released. The patient's experiences were considered to be an other important medical event and life threatening by the reporter. Additional information has been received from the medical assistant who stated that on 17-AUG-2007 the patient developed an itchy rash then the patient's lips turned blue. The patient was given oxygen and epinephrine injection. The patient was put on oxygen for 1 hour. The patient was also given BENADRYL. The patient recovered on the same date.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Malaise, No reaction on previous exposure to drug, Wheezing
Clinical narrative: Information has been received from a physician concerning a 9 year old male allergic to ibuprofen who at "one year of age", in approximately 1999, was vaccinated with a first dose of VARIVAX and did not have any symptoms. On 14-AUG-2007, 8 years between doses, the patient was vaccinated with a second subcutaneous dose of VARIVAX (Lot # 657796/0842U). There was no concomitant medication. Shortly after vaccination, the child had an anaphylactic reaction. The patient was treated with epinephrine and BENADRYL and was sent to the emergency room. At the time of the report, the patient was recovering. No product quality complaint was involved. The event of anaphylactic reaction was considered to be an other important medical event and life threatening by the investigator. Additional information has been requested. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from a healthcare professional who reported that the patient, with no prior history of medical conditions, or allergies (previously reported as allergy to ibuprofen), developed anaphylaxis, with wheezing and "feeling unwell". The patient was not experiencing any illness at the time of vaccination. There were no lab diagnostic studies performed. The patient recovered on an undisclosed date. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: DNA antibody positive, Rash, Varicella
Clinical narrative: Information has been received from a pharmacist concerning a 4-year-old female with acute lymphoblastic leukaemia (diagnosed in November 2005) and was possibly on chemotherapy who was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX "some time prior to November 2005". On 20-JUL-2007 the patient experienced varicella, a rash on her left foot and was hospitalized. It was reported that the patient was recently exposed to her sister who recently had the wild type disease. Medical attention was sought and isolates from the rash = DNA positive and the pharmacist is requesting A VZV analysis b conducted. It was reported that the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Urticaria
Clinical narrative: Information has been received from a physician concerning a male between the ages of 4 & 5 who in approximately OCT-2007 (month and half ago) was vaccinated subcutaneous with a second 0.5 ml dose of VARIVAX (Oka/Merck). In approximately OCT-2007 (after receiving his second dose) the patient developed urticaria followed by lesions and was admitted to the hospital. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: Information was received from a healthcare professional via GSK, concerning a male child, with no history of anaphylaxis, who on an unreported date(s) in 2007 was vaccinated with VARIVAX and HAVRIX. Immediately following the vaccination with VARIVAX and HAVRIX (lot # B206BA) the subject experienced an anaphylactic reaction. Adrenaline (Epinephrine) was administered and "the child was not admitted". At the time of reporting the outcome of the event was unspecified. The reporter was questioning the incidence of adverse reactions with this particular lot number of HAVRIX (lot # B206BA), or when given in combination with VARIVAX. The event of anaphylactic reaction was considered as a other medically important event (OME) by the reporter. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11 year old male who on 27-MAY-1997 and 09-OCT-2007 was vaccinated SC with a first and second (lot number: 658375/1118U) dose of VARIVAX. Subsequently, the patient developed a severe case of chicken pox and was hospitalized. The case of chicken pox was considered to be disabling. No additional information. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first dose of VARIVAX (Oka/Merck). Concomitant therapy included MMR II. "Two weeks after receiving the vaccinations the patient was admitted to the hospital and was diagnosed with ITP". The physician reported that at the hospital the patient was given IV treatments. No further adverse event information. It was noted that the adverse event was considered to be life threatening. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Herpes zoster, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female who with no pre-existing allergies, birth defects or medical conditions who on 29-NOV-2001 was vaccinated in the left leg with her first dose of VARIVAX (lot # 636565/0922K). There were no illnesses at the time of vaccination. On 17-OCT-2007 the patient developed multiple vesicular lesions on arms, legs, face, neck and back, as well as a fever and no appetite. On 01-NOV-2007 varicella titer was ordered and the results were not back at the time of reporting. The patient was treated with ZOVIRAX 600 mg PO every 6 hours for five days. On an unspecified date the patient recovered from all adverse events. Multiple vesicular lesions on arms, legs, face, neck and back, as well as a fever and no appetite was considered to be an other important medical. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a patient who were vaccinated with a dose of VARIVAX (Oka/Merck) and developed hives. No other information was available. It was noted that the above information was on a fax that the office received from the another hospital. This patient was not a patient from this office. Unspecified medical attention was sought. There was no product quality complaint. This event was considered an other medical event by the reporter. This is one report of several from the same source. Additional information has been requested.