chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Lethargy, Mental disorder, Mitochondrial enzyme deficiency, Nervous system disorder, Otitis media
Clinical narrative: This case was received on 26 May 2008 via a search of the scientific literature.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A 19-month-old female patient received the following vaccines: IPV, DTaP, HIB, MMR, and varicella (date of vaccination, manufacturers, route, and site of administration not reported).  Medical history included frequent episodes of fever and otitis media, with bilateral polyethylene tube placement.  At the time of vaccination, the patient was reportedly interactive, playful, and communicative.  Two days after vaccination, she became lethargic, irritable, and febrile.  Ten days after vaccination, she developed a "rash consistent with vaccine-induced varicella".  Months later, she developed neurologic and psychological developmental delays and was diagnosed with encephalopathy caused by a mitochondrial enzyme deficit. Her signs included problems with language, communication, and behavior, noted to be features of autism spectrum disorder.  Outcome was not reported.  No additional information was provided.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Speech disorder developmental
Clinical narrative: This case was received on 26 May 2008 via a search of the scientific literature.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A 19-month-old female patient received the following vaccines: IPV, DTaP, HIB, MMR, and varicella (date of vaccination, manufacturers, route, and site of administration not reported).  Medical history included frequent episodes of fever and otitis media, with bilateral polyethylene tube placement.  At the time of vaccination, the patient was reportedly interactive, playful, and communicative.  Two days after vaccination, she became lethargic, irritable, and febrile.  Ten days after vaccination, she developed a "rash consistent with vaccine-induced varicella".  Months later, she developed neurologic and psychological developmental delays and was diagnosed with encephalopathy caused by a mitochondrial enzyme deficit. Her signs included problems with language, communication, and behavior, noted to be features of autism spectrum disorder.  Outcome was not reported.  No additional information was provided.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 5-month o-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccinator included inactivated poliomyelitis virus vaccine ;manufacturer unspecified given on 14 January 2008; live attenuated human rotavirus vaccine ;manufacturer unspecified given on 14 January 2008; pneumococcal vaccine, unspecified ;manufacturer unspecified given on 14 January 2008. Concurrent medications included COMVAX. On 14 January 2008 the subject received primary course of INFANRIX (unknown). On 15 January 2008, 1 day after vaccination with INFANRIX, the subject experienced rash. The rash had appeared intermittently since receiving INFANRIX. The reporting physician did not have the subject chart and some of the information was unknown. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with INFANRIX.  Follow-up information received on 12 May 2008 indicated that the rash experienced by the subject was mostly non-urticarial, but was somewhat urticarial at times.  The rash, according to follow-up, began the same day of administration of INFANRIX, 14 January 2008.  It was an irregular rash over the body.  The event resolved 8 days later on 21 January 2008.  All vaccines given on 14 January 2008 were indicated as suspect.  A skin test was negative.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Rash, Skin test negative, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 5-month o-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccinator included inactivated poliomyelitis virus vaccine ;manufacturer unspecified given on 14 January 2008; live attenuated human rotavirus vaccine ;manufacturer unspecified given on 14 January 2008; pneumococcal vaccine, unspecified ;manufacturer unspecified given on 14 January 2008. Concurrent medications included COMVAX. On 14 January 2008 the subject received primary course of INFANRIX (unknown). On 15 January 2008, 1 day after vaccination with INFANRIX, the subject experienced rash. The rash had appeared intermittently since receiving INFANRIX. The reporting physician did not have the subject chart and some of the information was unknown. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with INFANRIX.  Follow-up information received on 12 May 2008 indicated that the rash experienced by the subject was mostly non-urticarial, but was somewhat urticarial at times.  The rash, according to follow-up, began the same day of administration of INFANRIX, 14 January 2008.  It was an irregular rash over the body.  The event resolved 8 days later on 21 January 2008.  All vaccines given on 14 January 2008 were indicated as suspect.  A skin test was negative.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 5-month o-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccinator included inactivated poliomyelitis virus vaccine ;manufacturer unspecified given on 14 January 2008; live attenuated human rotavirus vaccine ;manufacturer unspecified given on 14 January 2008; pneumococcal vaccine, unspecified ;manufacturer unspecified given on 14 January 2008. Concurrent medications included COMVAX. On 14 January 2008 the subject received primary course of INFANRIX (unknown). On 15 January 2008, 1 day after vaccination with INFANRIX, the subject experienced rash. The rash had appeared intermittently since receiving INFANRIX. The reporting physician did not have the subject chart and some of the information was unknown. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with INFANRIX.  Follow-up information received on 12 May 2008 indicated that the rash experienced by the subject was mostly non-urticarial, but was somewhat urticarial at times.  The rash, according to follow-up, began the same day of administration of INFANRIX, 14 January 2008.  It was an irregular rash over the body.  The event resolved 8 days later on 21 January 2008.  All vaccines given on 14 January 2008 were indicated as suspect.  A skin test was negative.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 25 week old male who on 30-JAN-2008 and 26-MAR-2008 was vaccinated PO with his first and second doses of ROTATEQ (lot# 657517/0877U, 659851/1840U).  On 19-MAY-2008 the patient experienced intussusception which required surgery.  The patient was hospitalized (length of stay unknown).  There was no product quality complaint.  No further information was provided.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 25 week old male who on 30-JAN-2008 and 26-MAR-2008 was vaccinated PO with his first and second doses of ROTATEQ (lot# 657517/0877U, 659851/1840U).  On 19-MAY-2008 the patient experienced intussusception which required surgery.  The patient was hospitalized (length of stay unknown).  There was no product quality complaint.  No further information was provided.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Flushing, Lip swelling, Rash generalised
Clinical narrative: Initial report received 04 Jun 2008 from a health care professional on a online VAERS form, VAERS electronic ID# E-22694.  A 14-year-old male patient, who had no concurrent illnesses, but who was taking PROZAC and FOCALIN XR, had received a first intramuscular right arm injection of MENACTRA (Lot # U2551AA), and a second subcutaneous left arm injection of VARIVAX (Manufacturer Merck, Lot # 1790U), on 30 May 2008 at 10:15 a.m.  Forty-five minutes post-vaccination, around 11:00 a.m., the patient started getting flushed and his lips were swollen, and he had a "rash" all over.  The patient was treated with Decadron 10 mg and Benadryl 50 mg (routes not provided).  After approximately one hour, the patient started to "feel better" and his rash went away after two hours.  At the time of this report, the patient had recovered.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Pupils unequal
Clinical narrative: Information has been received from a health professional concerning a 22 year old female patient with a history of dysmenorrhoea and metrorrhagia who on approximately 19-MAY-2008, past week or two, was vaccinated IM with a 0.5ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and MICROGESTIN FE. On approximately 21-MAY-2008, 2 days after the vaccination, the patient experienced unequal pupils. She saw a chiropracter. The next day she had total blindness for 30 seconds and darkness and tunneling of vision. The patient was taken to the emergency room the weekend of 30-MAY-2008 to 01-JUN-2008. The following day she had a headache with fatigue. The patient's mother questions whether this was a seizure from GARDASIL. On 02-JUN-2008, the patient saw an opthamologist. At the time of this report, the patient's outcome was unknown. Upon internal review, total blindness and seizure were considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Convulsion, Fatigue, Headache, Pupils unequal
Clinical narrative: Information has been received from a health professional concerning a 22 year old female patient with a history of dysmenorrhoea and metrorrhagia who on approximately 19-MAY-2008, past week or two, was vaccinated IM with a 0.5ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and MICROGESTIN FE. On approximately 21-MAY-2008, 2 days after the vaccination, the patient experienced unequal pupils. She saw a chiropracter. The next day she had total blindness for 30 seconds and darkness and tunneling of vision. The patient was taken to the emergency room the weekend of 30-MAY-2008 to 01-JUN-2008. The following day she had a headache with fatigue. The patient's mother questions whether this was a seizure from GARDASIL. On 02-JUN-2008, the patient saw an opthamologist. At the time of this report, the patient's outcome was unknown. Upon internal review, total blindness and seizure were considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Tunnel vision
Clinical narrative: Information has been received from a health professional concerning a 22 year old female patient with a history of dysmenorrhoea and metrorrhagia who on approximately 19-MAY-2008, past week or two, was vaccinated IM with a 0.5ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and MICROGESTIN FE. On approximately 21-MAY-2008, 2 days after the vaccination, the patient experienced unequal pupils. She saw a chiropracter. The next day she had total blindness for 30 seconds and darkness and tunneling of vision. The patient was taken to the emergency room the weekend of 30-MAY-2008 to 01-JUN-2008. The following day she had a headache with fatigue. The patient's mother questions whether this was a seizure from GARDASIL. On 02-JUN-2008, the patient saw an opthamologist. At the time of this report, the patient's outcome was unknown. Upon internal review, total blindness and seizure were considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness transient, Headache, Nuclear magnetic resonance imaging, Pupils unequal, Vision blurred
Clinical narrative: Information has been received from a health professional concerning a 22 year old female patient with a history of dysmenorrhoea and metrorrhagia who on approximately 19-MAY-2008, past week or two, was vaccinated IM with a 0.5ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and MICROGESTIN FE. On approximately 21-MAY-2008, 2 days after the vaccination, the patient experienced unequal pupils. She saw a chiropracter. The next day she had total blindness for 30 seconds and darkness and tunneling of vision. The patient was taken to the emergency room the weekend of 30-MAY-2008 to 01-JUN-2008. The following day she had a headache with fatigue. The patient's mother questions whether this was a seizure from GARDASIL. On 02-JUN-2008, the patient saw an opthamologist. At the time of this report, the patient's outcome was unknown. Upon internal review, total blindness and seizure were considered to be an other important medical event. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Nervousness, Pyrexia, Rash macular
Clinical narrative: Pt. showed me L upper arm on 11-18-07, Sunday.  L upper arm had splotchy red area about the size of a nickel scattered over upper portion of arm.  States she went to ER the night she got the shots with fever and shaking.  Temp. was 100.2.  No fever on 11-18-07.
Sex: F
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Hypotonia, Listless, Pallor
Clinical narrative: This Case was reported by the mother of a consumer via another manufacturer and described the occurrence of listlessness in an infant female subject who was vaccinated with (Diphtheria and tetanus and acellular pertussis, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, 21 years ago, the subject received unspecified dose of Diphtheria tetanus acellular pertussis (unknown) . At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced listlessness, pallor, limpness, refusal to nurse and whimpering. At time of reporting the outcome of the events was not specified.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling abnormal, Injection site swelling, Speech disorder
Clinical narrative: This case was reported by a physician and described the occurrence of swelling in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), for prophylaxis. On an unspecified date, the subject received 3rd dose of INFANRIX (.5 ml, unknown, right upper thigh) and the same day began to experience swelling. The swelling resolved a couple of days later. The physician considered this swelling event probably related to vaccination with INFANRIX. It was also reported that with previous DTAP vaccinations, the subject experienced swelling, feeling out of sorts and mumbling. The reporter did not know if the previous DTAP were GSK vaccines. At the time of reporting, the outcomes of the events were unspecified.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling abnormal, Speech disorder, Swelling
Clinical narrative: This case was reported by a physician (an allergist and not the physician responsible for vaccination) and described the occurrence of swelling in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 3rd dose of INFANRIX at 0.5 ml in the right hip. An unspecified amount of time later, on the same day that the 3rd dose of INFANRIX was administered, the subject developed swelling. The event resolved within a couple of days. In the reporter's opinion, the events were probably related to treatment with INFANRIX. The physician also stated that according to the subject's mother, the subject experienced swelling, was out of sorts and mumbling following previous DTAP (manufacturer unknown) vaccinations. The outcome of these events was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, via an other manufacturer, and described the occurrence of rash in a subject of unknown gender who received DTAP (unknown manufacturer) injection for prophylaxis. On an unknown date in childhood, the subject received DTAP (single dose). AT an unknown time following administration of DTAP, the subject experienced a severe rash. At the time of reporting, the outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of loss of making eye contact in a 4 year old male subject who received DTAP (unknown manufacturer) injection for prophylaxis. On 28 March 2005, the subject received DTAP (single dose). On 14 April 2005, following administration of DTAP, the subject experienced loss of eye contact and began to dress himself backwards. At the time of reporting, the outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with DTAP (manufacturer unspecified) for prophylaxis. On 5 March 2008 the subject received 4th dose of DTAP in the left thigh. At an unspecified time after vaccination with DTAP, the subject experienced swelling injection site and injection site redness, local reactions. At the time of reporting the outcome of the events was unspecified.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash, redness around injection area. BENADRYL 25-50mg q 6 hrs. Prednisone 20 mg, III day 1, II days 2-5, I days 6-10
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Reddened anterior thigh at site of injection on R thigh.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Decreased appetite, Erythema multiforme, Pyrexia, Urine analysis normal
Clinical narrative: Fever; target-lesions (erythema multiforme); decreased appetite w/in 24 hours of administration of vaccines.
Age: 78.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Nerve conduction studies abnormal
Clinical narrative: Painful paresthesia down both legs and weakness. 6/30/2008 MR received from Neurologist for DOS 4/3/2008. Seen with c/o onset of heavy aching pain in lower back area which radiates down the lateral aspect of the legs. Sleep disturbed 2' to pain. Also with one week hx of facial drooping of the R eyelid and R corner of mouth. Recent problems with constipation and dribbling of urine. PE (+) for R sided ptosis, weak eye closure and drooping of R side of lips. Muscle weakness of L hip flexors and extensors. Sensation intact. DTRs absent at knees and ankles and 1+ in the bilateral triceps. Gait high stepping.
Age: 78.0
Sex: M
Vaccine: YF
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Painful paresthesia down both legs and weakness. 6/30/2008 MR received from Neurologist for DOS 4/3/2008. Seen with c/o onset of heavy aching pain in lower back area which radiates down the lateral aspect of the legs. Sleep disturbed 2' to pain. Also with one week hx of facial drooping of the R eyelid and R corner of mouth. Recent problems with constipation and dribbling of urine. PE (+) for R sided ptosis, weak eye closure and drooping of R side of lips. Muscle weakness of L hip flexors and extensors. Sensation intact. DTRs absent at knees and ankles and 1+ in the bilateral triceps. Gait high stepping.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Disorientation, Food allergy, Pharyngolaryngeal pain, Rash
Clinical narrative: Pt received VARIVAX & eyes on 5-29-08 4pm 10:45 pm-worsening rash, cough, sore throat, some disorientation. Mom took into steaming shower, gave diphenhydramine with good effect; F/u here 5-30-08- Sx's have resolved.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal malposition
Clinical narrative: Information has been received from a physician and a 20 year old female consumer through a Merck pregnancy registry with no allergies and a history of 1 pregnancy and 1 live birth who on 30-APR-2007 was vaccinated with the first dose of GARDASIL (lot #0210U), 0.5 ml.  Concomitant therapy included ALDARA.  In approximately April 2007, it was determined that the patient was pregnant.  The date of last menstrual period was 10-APR-2007 and estimated delivery date was reported as 15-JAN-2008.  It was reported that the patient has had no ill effects.  On 15-JAN-2008, the patient reported that she delivered a healthy baby girl weighing 7 lbs. 13 oz. via primary cesarean due to fetal malposition (baby was transverse).  At the time of reporting, it was noted that mother and baby are both well, "without any problems."  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Full blood count, Liver function test, Reticulocyte count
Clinical narrative: Information has been received from a nurse practitioner concerning her 27 year old daughter with haemolytic anaemia (requiring blood transfusions every 10 to 12 weeks) and drug hypersensitivity to codeine and a history of splenectomy at 18 months of age and cholecystectomy (December 2007) who on 17-APR-2007, 02-JUN-2007 and October 2007 was vaccinated IM with a first, second and third 0.5 ml dose of GARDASIL. Concomitant therapy included YASMIN, folic acid, PAXIL and vitamins (unspecified). In August 2007, the patient required blood transfusions every 2-3 weeks until March 2008. Since March 2008, the patient has required blood transfusions every 5 to 6 weeks. Laboratory diagnostic studies include a complete blood cell count, liver function tests and reticulocyte count. At the time of this report, the patient had not recovered. Frequent blood transfusions was reported as an other important medical event. Additional information has been requested. 6/20/08-records received-10/05/07-declined tranfusion. LFTs normal. 10/5/07-Feeling sick. Scheduled for cholecystectomy for problems with gall stones and abdominal pain.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Genital haemorrhage, Intra-uterine death, Muscle spasms, Pregnancy test positive
Clinical narrative: Information has been received from the pregnancy registry for GARDASIL from a nurse concerning a 21 year old female with no known pertinent medical history, or drug reactions/allergies who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659657/1487U), 0.5ml, IM to the left deltoid. Concomitant therapy included FEMCON FE and prenatal vitamins (unspecified). On 18-APR-2008 the patient had a positive home pregnancy test. Her last menstrual period was 11-MAR-2008. She was seen for her first prenatal examination on 20-MAY-2008. The patient developed cramping and vaginal spotting on 28-MAY-2008 and was diagnosed by ultrasound on 30-MAY-2008 with fetal demise of twins. The patient was scheduled to have dilation and curettage and evacuation procedure. No other symptoms or treatment were reported. Upon internal review fetal demise of the twins was considered to be an other important medical event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Uterine dilation and curettage
Clinical narrative: Information has been received from the pregnancy registry for GARDASIL from a nurse concerning a 21 year old female with no known pertinent medical history, or drug reactions/allergies who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659657/1487U), 0.5ml, IM to the left deltoid. Concomitant therapy included FEMCON FE and prenatal vitamins (unspecified). On 18-APR-2008 the patient had a positive home pregnancy test. Her last menstrual period was 11-MAR-2008. She was seen for her first prenatal examination on 20-MAY-2008. The patient developed cramping and vaginal spotting on 28-MAY-2008 and was diagnosed by ultrasound on 30-MAY-2008 with fetal demise of twins. The patient was scheduled to have dilation and curettage and evacuation procedure. No other symptoms or treatment were reported. Upon internal review fetal demise of the twins was considered to be an other important medical event. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea, Urticaria, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 16 month female with no drug allergies and a history of respiratory syncytial virus infection who on 22-MAY-2008 was vaccinated SC with her first 0.5 ml dose of MMR II (lot# 658582/0043X). There was no concomitant medication. On that same day 15 minutes after administration, the patient experienced wheezing, hives and rhinorrhea. The patient sought medical attention at the office. No labs or diagnostic studies were performed. The patient was given epinephrine, BENADRYL and PRELONE. The symptoms were reduced with treatment and the reactions cleared and the patient recovered by the next day. There was no product quality complaint. The registered nurse considered wheezing, hives and rhinorrhea to be other important medical events. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site erythema, Injection site streaking, Lymphadenopathy
Clinical narrative: Started having L axillary adenopathy, L deltoid erythema/streaking adjacent to scab vaccine/inoculation site which appears okay.  Adenopathy reaction to vaccine that is typical; questionable cellulitis secondarily & will prescribe short course of KEFLEX 500 QID x7 day; take ibuprofen or Q6 hours PRN; f/u with provider next week; NKDA.
Age: 48.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Headache, Malaise, Myalgia, Rash papular, Streptococcal identification test negative
Clinical narrative: 2 days after Smallpox vaccination developed headache, myalgias malaise. That night I developed a fine papular rash covering my whole body except my head, soles of feet, palms of hands. Treatment: NSAIDS, antihistamines
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site vesicles, Injection site warmth
Clinical narrative: Shot given 6/5/08 by the evening area was the size of a golf ball.  By morning it grew larger, hot to touch, itchy.  By the evening of 6/6/08, it had blistered and burst with serious fluids.  Today, 6/7/08, she has a 4x4 cm wheal in the center of a 18x20cm.  Localized raised red area on back of left arm.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Vomiting 5-31-08.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pharyngeal erythema, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Rash on torso, fever, headache; supportive care; strep screen done due to sore throat and red throat
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Streptococcal identification test
Clinical narrative: Rash on torso, fever, headache; supportive care; strep screen done due to sore throat and red throat
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia, Rash maculo-papular, Urticaria
Clinical narrative: 2 cm hives on torso, front of chest and back. Father is a physician-described hives as macular papular. Father gave BENADRYL 25 mg. Capsule at 4 pm, at 10 pm 12 1/2 mg chewable and RANITIDINE to cover antihistamine receptors. Today hives gone-fever, 100
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure, Dizziness, Heart rate, Pallor
Clinical narrative: Vaccine adm 1838 after approx 2 minutes, pt feel week, pale and dizzy c/o fainting like sensation, pt alert and oriented x3.  Ammonia inhalers given, PCP informed, pt placed in examination table for recovery.  BP 90/58, SPO2 98-99 at room air pulse 66 bpm.  Pt recovered and d/c home in good condition.  12 minutes - total - recovery time.
Age: 17.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Reporting second dose of MENACTRA, no increased reaction - 1st dose 8/15/05.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Lacrimation increased, Urticaria
Clinical narrative: Was playing golf after received VARIVAX- at 11:45 am-started breaking out in hives -> face-was getting worse- eyes. Watery etc- Did not eat anything new- Severe allergy to bee stings, peanuts and eggs gave 50 mg BENADRYL @ 4:11 pm. Carries Epi Pen
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 5-30-08 at 230 lower L VL 32 mm x 40 mm area red, swollen, & hot to touch.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Blood glucose normal, Chest X-ray abnormal, Clonus, Convulsion, Crying
Clinical narrative: Heard strange cry. Mother found child around 11:00pm, 5-26-08 having seizure, eyes rolled back, clonic, generalized (E.R. Report). Parents called 911. Lasted 1-2 minutes; Fever 102 - later increased to 104. Glucose 90 is field. Chest XRay and urinalysis in ER; Bilateral patchy appeared normal in ER. Infiltrate on XRay. UA - Normal - Diagnosed Febrile seizure.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Culture negative, Febrile convulsion, Gaze palsy, Lung infiltration, Pyrexia
Clinical narrative: Heard strange cry. Mother found child around 11:00pm, 5-26-08 having seizure, eyes rolled back, clonic, generalized (E.R. Report). Parents called 911. Lasted 1-2 minutes; Fever 102 - later increased to 104. Glucose 90 is field. Chest XRay and urinalysis in ER; Bilateral patchy appeared normal in ER. Infiltrate on XRay. UA - Normal - Diagnosed Febrile seizure.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Urine analysis normal
Clinical narrative: Heard strange cry. Mother found child around 11:00pm, 5-26-08 having seizure, eyes rolled back, clonic, generalized (E.R. Report). Parents called 911. Lasted 1-2 minutes; Fever 102 - later increased to 104. Glucose 90 is field. Chest XRay and urinalysis in ER; Bilateral patchy appeared normal in ER. Infiltrate on XRay. UA - Normal - Diagnosed Febrile seizure.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration/redness on left thigh.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Electroencephalogram normal, Nervousness, Stridor
Clinical narrative: History of noisy breathing (stridor) and difficulty breathing 5-6 hrs after receiving DTaP.  Also hx of shaking episode at same time.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Client states injection site sore from time of injection to onset sx. c/o redness, discoloration (yellow) at injection site on 6th day (June 2nd) Redness spread to bicep area almost to elbow. Area became swollen and itching on 6/2. Client seen at clinic by PA-C. Received 5 day course of prednisone and 5 day course of AUGMENTIN. Clinical Dx-Delayed urticarial reaction to tdap.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Client states injection site sore from time of injection to onset sx. c/o redness, discoloration (yellow) at injection site on 6th day (June 2nd) Redness spread to bicep area almost to elbow. Area became swollen and itching on 6/2. Client seen at clinic by PA-C. Received 5 day course of prednisone and 5 day course of AUGMENTIN. Clinical Dx-Delayed urticarial reaction to tdap.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Head injury, Syncope, Tooth fracture
Clinical narrative: Pt. fainted after receiving vaccines she hit head on counter and chipped her tooth.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Eye pain, Screaming, Skin laceration, Swelling
Clinical narrative: Pt. fainted after receiving vaccines she hit head on counter and chipped her tooth.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope, Tooth injury
Clinical narrative: Pt. fainted after receiving vaccines she hit head on counter and chipped her tooth.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Full blood count normal, Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: Pt seen in ER for f/u on 5/13 after receiving pneumococcal vaccine in clinic on 5/12. He reported feeling general malaise, was febrile and had erythema and irritation at injection site. Pt began w/u to r/o cellulitis as cause of reaction, but left before full eval was completed. At f/u visit with MD on 5/15, fever had abated, however, injection site on right upper arm biceps region was still warm red and indurated, no adenopathy and CBC within NL. Pt was given antibiotics for treatment of presumptive cellulitis at injection site vs. injection site reaction from pneumococcal vaccine. Over several weeks, the injection site irritation has resolved with no further sequelae.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Pt seen in ER for f/u on 5/13 after receiving pneumococcal vaccine in clinic on 5/12. He reported feeling general malaise, was febrile and had erythema and irritation at injection site. Pt began w/u to r/o cellulitis as cause of reaction, but left before full eval was completed. At f/u visit with MD on 5/15, fever had abated, however, injection site on right upper arm biceps region was still warm red and indurated, no adenopathy and CBC within NL. Pt was given antibiotics for treatment of presumptive cellulitis at injection site vs. injection site reaction from pneumococcal vaccine. Over several weeks, the injection site irritation has resolved with no further sequelae.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Wrong drug administered
Clinical narrative: Small raised area
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Alopecia, Chest discomfort, Diarrhoea, Vomiting
Clinical narrative: After receiving the GARDASIL vaccine, pt is losing lots of hair. It has been a year and she is still losing hair. She has diarrhea often and vomits weekly. She has also been experiencing lower right ab pain. She has also been hurting in her chest right side.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma exercise induced, Trichorrhexis
Clinical narrative: Patient was given the GARDASIL vaccine and now her hair is breaking off.  She has always had very healthy hair.  She has also developed asthma induced by exercise.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: None - patient given adult dose of Hep A rather than pediatric/adolescent dose.
Age: 12.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Body temperature increased, Culture wound negative, Hypersensitivity, Incisional drainage, Injection site erythema
Clinical narrative: 12 year old male "allergic reaction to varicella vacc."; 6/8 seen in ER at hospital; Temperature 99.9 - Induration 3cm left tricep-surrounded by 10cm erythema I+D -> serosanguineous fluid -> rare gram pos/epith cells/Rbc. No growth
Age: 12.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Injection site induration
Clinical narrative: 12 year old male "allergic reaction to varicella vacc."; 6/8 seen in ER at hospital; Temperature 99.9 - Induration 3cm left tricep-surrounded by 10cm erythema I+D -> serosanguineous fluid -> rare gram pos/epith cells/Rbc. No growth
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 40 mm soft indefined lump at (L) deltoid-tender only today pressure- (not red) - bad redness and DTaP given-swelling has remained.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Culture throat negative, Pyrexia
Clinical narrative: Fever - tactile 5/27/08 to 5/29/08
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity
Clinical narrative: Narrative: 48 y/o male with h/o of alcohol dependence, htn, obesity, and h/o DVT (RLE) come to SARTP program for alcohol dependence. Patient given pneumococcal injection on 5/2/08 (4pm)- on 5/3/09 (12am), patient complains of soreness & painful L upper arm. Redness was noted  & warm to touch. Patient given on dose of hydroxyzine 50mg. Redness continues (5/4/08@5pm), acetaminophen and hydrocortisone 2.5% cream ordered. Symptoms: 1. Other 2. redness, soreness, and burning of area
Age: 0.8
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Medication error
Clinical narrative: Medication error.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Varicella site 5/29 immediately after injection site got swollen, hard & red.  Gave BENADRYL.  Then got white around site (per mom).  5/24 redness spreading.  5/25 redness.  5/26 a red raised & "fired red" had knot.  10x8 cm swollen area.  Seen in ER.  Given KEFLEX.  5/27 seen in clinic swelling decreased.  MMR & VAR site after injection swollen & red.  Seen in ER for varicella site reaction.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Fifteen minutes after injection, site was red and 5cm around in diameter.  On 6/6/08 pt. returned to office & site was 10cm in diameter, red & warm to touch.  Dr. prescribed BENADRYL & prednisone dosepak.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 15 cm diameter erythematous, edematous and painful patch - Allegra suspension, 1tsp. bid ordered. Mom called 6/9 to report area is almost totally back to normal. Child has no fever and is fine.
Age: 38.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Client came in to clinic for vaccines and blood work and to see the doctor.  When asked if he had any chronic medical problems, client said no.  Nurse went over vaccines (Tdap and MMR).  After vaccine administration, as blood was about to be drawn, client disclosed that he is a patient at a local HIV clinic.  Nurse unsure of HIV status.  Client signed medical release form.  Letter sent to client's doctor at HIV clinic informing doctor of vaccines administered.    No adverse events.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Gastrointestinal disorder, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: My daughter has been having seizures since she had her second Gardasil vaccination.  She also had intestinal problems for approximately four weeks immediately after vaccination.  She continues to have seizures.  6/16/2008 MR received for 2 ER visits 3/31 and 4/10 2008 with DX: Dystonic Reaction, Anxiety (3/31) and Seizure, Costochondritis (4/10). Initially presented with uncontrollable shaking and stiffness episodes several times/hr. Some diarrhea/ vomiting recently. MD observed tonic-clonic motions of the neck muscle. Pt remained awake. Seen again 4/10 with c/o of seizure with sharp chest pain.  Tremors noted of the upper body. Recently started on Topamax for Seizure    7/15/2008 MR received for DOS 5/14-19/2008 with D/C DX: Non-epileptic seizures. Pt presented with ~6 week hx of episodes of unresponsiveness, jaw tremors with arm flexing which began 6 weeks after 2nd Gardasil vax. Pt has no recollection of events. Episodes down from 15-25/day to 1-2/day after starting Topamax and Keppra. Pt c/o post-ictal h/a and confusion. Pt had multiple events without EEG changes during hospitalization. Weaned from Keppra and Topamax and d/c.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Scan brain
Clinical narrative: My daughter has been having seizures since she had her second Gardasil vaccination.  She also had intestinal problems for approximately four weeks immediately after vaccination.  She continues to have seizures.  6/16/2008 MR received for 2 ER visits 3/31 and 4/10 2008 with DX: Dystonic Reaction, Anxiety (3/31) and Seizure, Costochondritis (4/10). Initially presented with uncontrollable shaking and stiffness episodes several times/hr. Some diarrhea/ vomiting recently. MD observed tonic-clonic motions of the neck muscle. Pt remained awake. Seen again 4/10 with c/o of seizure with sharp chest pain.  Tremors noted of the upper body. Recently started on Topamax for Seizure    7/15/2008 MR received for DOS 5/14-19/2008 with D/C DX: Non-epileptic seizures. Pt presented with ~6 week hx of episodes of unresponsiveness, jaw tremors with arm flexing which began 6 weeks after 2nd Gardasil vax. Pt has no recollection of events. Episodes down from 15-25/day to 1-2/day after starting Topamax and Keppra. Pt c/o post-ictal h/a and confusion. Pt had multiple events without EEG changes during hospitalization. Weaned from Keppra and Topamax and d/c.
Age: 47.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Extreme pain in right leg (from thigh to foot) within 6 hours of shots leading to inability to walk without pain and dragging leg for the last 4 days.  I had treatment yesterday afternoon with my doctor, Dr and feel some relief today.  Am having another treatment Wednesday.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Erroneously given third Varicella vaccine.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Anorexia, Inappropriate schedule of drug administration, Pain, Pyrexia
Clinical narrative: Within a few hours of immunization, the patient developed 105.8 fever with Children's Tylenol already administered.  Additional doses were given to get fever down which only lasted for 2-3 hours for 6 days straight.  Child was taken to Urgent care on 04-25-08 and parents were instructed to continue fever reducing treatment.  Fever broke after 6 days.  Baby was in pain and had no appetite along with very high fever.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Scar
Clinical narrative: Within 14 days of immuization (03/31/08) a severe and very painfull rash appeared on upper right knee/thigh area spreading to inside of thigh and back of thigh area.  Another severe and painfull rash appeared on the right upper buttock a day latter. Same day I was seen by PCP and diagnosised with a full-blown case of shingles. I was given Rx for Acyclovir Tab 800 mgm to be taken 4 times daily of which I had to refill for additional treatment because the shingles were not gone in 7days but were in 14 days.  I was also given Rx/PROPO-N/APAP TAB 100/650 for the pain that helped make the pain bearable.  At the end of 16 days the rash was completely gone but there are scars where the rash/blisters were.
Age: 1.0
Sex: M
Vaccine: MEA
Symptoms: Asthenia, Blood culture, Dermatitis diaper, Discomfort, Full blood count normal
Clinical narrative: On June 5, 2008, dense rash from mid-abdomenal area to upper left side of the chest - diagonally with the abdomenal area covered wider and narrowing as the rash went up over the heart area.  This rash was not bumpy (i.e., appeared to be under the skin resembling popped cappillaries).  Saw Dr. at the clinic.  Did a CBC - normal, said come back if rash spreads.  June 7, 2008, bumpy rash on buttox and lower back.  Saw Dr. at clinic's Pediatri Urgent Care.  Attributed to diaper rash and advised to return/call if child gets fever.  June 8, 2008, fever all day, Tylenol did not help, fluctuated between 100 and 102.7 degrees.  Called pediatric advice nurse - told us this type of reaction occurs in 1 in 10 children and is normal; also said to go to Dr. if fever goes to 105 degrees or fever persists over 3 days.  June 9, 2008, fever persisted to above 103 (child woke up at 2 am and cried for half an hour). Went back to facility and saw Dr. again.  Strap - negative.  Also ordered another CBC and blood culture test.  Continued Tylenol with again only temporary fever relief.  June 10, 2008, child again woke up with 101 degree fever at 5 am.  Gave another 120 ml Tylenol suppository and called Dr, left message with conserns.  Waiting for call back.  OTHER OBSERVATIONS:  Child normally very active, does not like to be held or picked up, sleeps through the night without waking up, not cranky at all, normal appetite, and normal two-three times of sleep during the day about 1-1.5 hrs each.  After the immunization shot, woke up every night beginning June 3, 2008.  Beginning June 7, 2008, very weak, always wanted to be held and slept during the day three to four times for extended periods of time.  Head weak, grabbing our hands and bringing our hands to his head to hold his head up, head always slouching to a side; extremely cranky, unable to find a comfortable position to be held, lie, sit.  This extreme weakness and crankiness subsided a little on morning of June 9, but returned in late afternoon and evening.  This report is being submitted on June 10 at approximately 10:15 am, child is currently napping.