chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concomitant vaccination included MMR (strain not specified), rubella vaccine; manufacturer unspecified given on the same unspecified date as KINRIX; measles and varicella virus vaccine; manufacturer unspecified given on the same unspecified date as KINRIX. On an unspecified date the subject received 1st dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site). A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected. All of the children were within the four to six years age range. She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm. Please see A0780868A, A0780875A, A0780876A, A0780877A, A0780878A and A0780880A for the six additional cases reported by the nurse. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with combined KINRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated MMR II (strain not specified); manufacturer unspecified given on the same unspecified date as KINRIX; VARIVAX virus vaccine; manufacturer unspecified given on the same unspecified date as KINRIX.  On an unspecified date the subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site).  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm.  Please see A0780868A, A0780875A, A0780876A, A0780877A, A0780878A and A0780879A for the six additional cases reported by the nurse.  At the time of reporting the event was resolved.  The healthcare professional considered the event was probably related to vaccination with KINRIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site haematoma
Clinical narrative: This case was reported by a physician and described the occurrence of bruise injection site in a 4-year-old female subject who was vaccinated with combined KINRIX, (GlaxoSmithKline).  The subject had no relevant medical history, and had experienced no adverse events following previous vaccinations.  There were no concomitant medications.  Concurrent vaccination included MMR II (non-gsk) (Merck) given on 9 April 2009 and VARIVAX (non-gsk) (Merck) given on 9 April 2009.  On 9 April 2009 at 15:00 the subject received 2 doses of KINRIX (0.5 ml, unknown route), one in the left leg and one in the right leg (overdose).  The order of the vaccinations was not specified.  On 9 April 2009, immediately after vaccination with KINRIX, the subject experienced bruising at both injection sites.  On 9 April 2009, the events were resolved.
Sex: U
Vaccine: DTAPIPV
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a GSK representative and described the occurrence of arm swollen in a child subject of unspecified gender who was vaccinated with combined KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (details unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swollen.  The subject was sent to an urgent care facility.  At the time of reporting the outcome of the event was unspecified.  There was no further information available.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site vesicles, Skin exfoliation
Clinical narrative: This case was reported by a physician and described the occurrence of injection site blisters in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), VARIVAX. There was no concomitant medications. On 6 May 2009 the subject received KINRIX (0.5 ml, unknown route, left arm) as his 5th dose of Dtap vaccine series and 4th dose of IPV series, and 2nd dose of VARIVAX (details unknown). On 7 May 2009, 1 day after vaccination with KINRIX and VARIVAX, the subject experienced "round circle" injection site blister, peeling of skin around injection site and injection site vesicles. The events were described as having the appearance of a "2nd degree burn". The subject visited the physician for consultation. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (details unknown) At an unspecified time after vaccination with KINRIX, the subject experienced rash, erythema and swelling. At the time of reporting the outcome of the events were unspecified.  There was no further information available at the time of reporting.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site urticaria
Clinical narrative: Urticarial rash at vaccine site and on upper extremity
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Shingle Shot;It was not until 3rd day of the Shot . The area of the vaccination became very hot, ached and red.(Felt inflamed)  Two days later the problem subsided. Two hours after the shot was given I developed hives itching on the other side of my arm. This lasted for a day and a half.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Fatigue, Headache, Hypersomnia, Hypophagia, Pyrexia
Clinical narrative: Fever - 102.7; Headache; Fatigue; Was given tylenol 480 mg every 4-6 hours for 16 hours; slept most of the day; drank liquids but did not eat; no other symptoms; headache only lasted a few hours; fever and fatigue lasted ~16 hours
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Large area of induration at injection site with swelling and pain.
Age: 1.29
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Coma, Conjunctivitis infective, Eye discharge, Intensive care, Pyrexia
Clinical narrative: Patient had gunk in her eyes real bad the morning of the 10th.  She had a fever of 104.9 when we took her to the emergency room where they gave her Tylenol.  She also tested positive for the rsv virus.  They prescribed ibuprofen and Tylenol.  We tried to control her fever for the next three days and we took her to the family doctor.  Where she was diagnosed with an ear infection and pink eye.  She was prescribed amoxycillin and eye drops.  Two days later she was drastically worse and we took her to the emergency room where they flew her to hospital.  There she was put in the pediatric icu.  She tested positive for the adeno virus.  She was paralyzed and put into a coma.  Two weeks later she was upgraded and released the next day because she was doing good and that she came down with the chicken pox.   Shes currently at home with the chicken pox.  One of the vaccines.  She just got was the varicella.  6/8/09 Received hospital medical records of 5/16-5/29/2009. FINAL DX: respiratory failure secondary to adenovirus; RSV bronchiolitis; secondary bacterial pneumonia. Records reveal patient experienced progressively worsening respiratory distress w/O2 sats 80's.  Seen in outlying ER & transferred to higher level of care.  Temp in ER 104.4.  Tx w/steroids, epi, intubation, PICU, pressor support, TPN,PRBCs.   Developed clot in right femoral secondary to line.  Developed papular rash which became varicella suspected to be from vaccine.  Improved, extubated, diet advanced & tx w/valium/methadone wean. ICD9 Codes:   6/15/09 Received vaccine & PCP medical records of 5/8-5/14/2009. On 5/8 pt noted to have clear nasal discharge, marked speech delay.  Received DTaP, IPV & Varicella, no MMR.  RTC 5/14 w/URI, fever, eye discharge, croupy cough, nasal congestion, decreased appetite, decreased fluid intake x 5 days.  Dx w/RSV bronchiolitis, otitis media & conjunctivitis.  Tx w/antibiotics.    6/29/09 ICD-9 codes received:  4800, 46619   6/17/10 Follow up: She has breathing problems since her hospital stay. She weezes constantly. Has also been treated for asthma.
Age: 1.29
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Varicella
Clinical narrative: Patient had gunk in her eyes real bad the morning of the 10th.  She had a fever of 104.9 when we took her to the emergency room where they gave her Tylenol.  She also tested positive for the rsv virus.  They prescribed ibuprofen and Tylenol.  We tried to control her fever for the next three days and we took her to the family doctor.  Where she was diagnosed with an ear infection and pink eye.  She was prescribed amoxycillin and eye drops.  Two days later she was drastically worse and we took her to the emergency room where they flew her to hospital.  There she was put in the pediatric icu.  She tested positive for the adeno virus.  She was paralyzed and put into a coma.  Two weeks later she was upgraded and released the next day because she was doing good and that she came down with the chicken pox.   Shes currently at home with the chicken pox.  One of the vaccines.  She just got was the varicella.  6/8/09 Received hospital medical records of 5/16-5/29/2009. FINAL DX: respiratory failure secondary to adenovirus; RSV bronchiolitis; secondary bacterial pneumonia. Records reveal patient experienced progressively worsening respiratory distress w/O2 sats 80's.  Seen in outlying ER & transferred to higher level of care.  Temp in ER 104.4.  Tx w/steroids, epi, intubation, PICU, pressor support, TPN,PRBCs.   Developed clot in right femoral secondary to line.  Developed papular rash which became varicella suspected to be from vaccine.  Improved, extubated, diet advanced & tx w/valium/methadone wean. ICD9 Codes:   6/15/09 Received vaccine & PCP medical records of 5/8-5/14/2009. On 5/8 pt noted to have clear nasal discharge, marked speech delay.  Received DTaP, IPV & Varicella, no MMR.  RTC 5/14 w/URI, fever, eye discharge, croupy cough, nasal congestion, decreased appetite, decreased fluid intake x 5 days.  Dx w/RSV bronchiolitis, otitis media & conjunctivitis.  Tx w/antibiotics.    6/29/09 ICD-9 codes received:  4800, 46619   6/17/10 Follow up: She has breathing problems since her hospital stay. She weezes constantly. Has also been treated for asthma.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 17-FEB-2009, a 2 month old female with no medical history and no preexisting illnesses was vaccinated with a first dose of ROTATEQ (lot# 662738/1358X) by mouth. Concomitant vaccination included a first dose of PREVNAR (LOT#C87310) IM into her right leg, a first dose of ACTHIB (lot# UF575AA) IM into her right leg and a first dose of PEDIARIX (lot#AC21B201AA) IM into her left leg. On 12-APR-2009 the patient experienced intussusception and was hospitalized. Intussusception required ER visit. The patient was administered an air enema. Intussusception was considered to be life threatening. A lot check has been requested. The original reporting source was not provided. The VAERS ID # is 344361. A standard lot check investigation was performed. All in-process quality checks for the lot number in question (Lot # 662738/1358X) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. No further information is available.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site vesicles, Skin lesion
Clinical narrative: Patient was vaccinated with Smallpox on his left arm on 20 May 2009.  Pt's Smallpox blister 'popped' in his sleep the night of 30 May.  He noted that it leaked through the bandage, his T-shirt, and down his arm upon awakening.  The following day, 31 May, he noted a small lesion below his right nare.  He covered the lesion and sought his unit corpsman.  Then brought him to sick call on 1 June, where he was evaluated.  The lesion was a pustular Smallpox lesion and did not extend into the pt's nose.  The lesion was covered after bacitracin was applied.  Pt placed until lesion scabs over with daily site checks.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patients arm swelled up to the wrist and is hot to the touch.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: Feverish, body aches - Patients relates having fever with pertussis as a child.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient in for immunizations on 5/28/2009. Child received DTAP, HPAC, IPV & MMR. Mother telephoned this morning & stated that child began to break out in hives yesterday afternoon-mother stated that the health department was closed-she called the hospital & was instructed to give patient BENEDRYL. Mother stated that patient had no wheezing or problems breathing. Mother stated that patient went to sleep & woke up this morning with hives on her back. Advised mother to give BENEDRYL as directed & to try to manage itching-mother stated child had no respiratory problems this morning. Telephoned healthcare professional, immunization program coordinator & informed of the above. healthcare professional stated that child may have reacted to a component in the vaccine, healthcare professional stated that she will send a list of all components in the immunizations that child received yesterday-advised that mother take the list of components to primary MD & let MD decide if patient should receive additional immunizations. Telephoned mother back & informed of the above. Mother verbalized understanding & stated she will come by clinic to pick up the list. Advised to monitor child for respiratory problems & continue with BENEDRYL & continue with BENEDRYL & comfort measures.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Convulsion, Urinary tract infection, Vaccination complication
Clinical narrative: Mother called, client had high temperature 103.9. Went into convulsions. Sent to ER, diagnosed with UTI. Took her to pediatrician, stated no diagnostic results showed child had UTI. It was probably caused from pertussis vaccine.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Diarrhoea, Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Fast heart rate, fever, vomiting, diarrhea.
Age: 1.1
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Injection site papule, Lip swelling, Oral herpes, Oropharyngeal blistering
Clinical narrative: Vaccinated 4/29/09. Mother noticed small "pimple like" lesion at site of VARIVAX injection (Left thigh) on 5/1/09. Small cold sore like blister on mouth appeared 5/4/09. Blister/cold sore got worse, swollen. On 5/7/09 the lip was swollen "as big as his nose" temp 104.1 axillary went to ER. Diagnosed cold sore. Patient doing fine 5/19/09.
Age: 51.0
Sex: F
Vaccine: TYP
Symptoms: Condition aggravated, Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Took 1st Typhoid cap appropriately --> 6 hrs. later had dizziness, light-headed followed by nausea and vomiting assoc. with movement. Hx of 2 episodes vertigo in the past. This episode passed and cleared at 24 degrees - Pt. Dc'd oral Typhoid and was switched to injectable.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling pruritus in place of injection.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 12-14 hours after vaccines administered (102 degrees F).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Full blood count normal, Metabolic function test normal, Pallor, Pyrexia
Clinical narrative: 5/27/09 about 12:00 patient became weak, pale, collapsed to floor, febrile, tachycardia. Patient seen in ER, monitored, labs (CBC, BASIC chemistry and U/A) obtained. Monitored for 2 hours and 20 minutes . TYLENOL given.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope, Tachycardia, Urine analysis normal
Clinical narrative: 5/27/09 about 12:00 patient became weak, pale, collapsed to floor, febrile, tachycardia. Patient seen in ER, monitored, labs (CBC, BASIC chemistry and U/A) obtained. Monitored for 2 hours and 20 minutes . TYLENOL given.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and area of redness over the skin at the site of injection 7 1/2 x 4 cm. No further reported problems as of 5/26/09.
Age: 70.0
Sex: M
Vaccine: DTOX, FLUX, TTOX
Symptoms: Urticaria
Clinical narrative: 11:30 AM severe hives.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient complain of muscle pain in left deltoid muscle. Pain persists one month after injection.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotavirus is not to be started after 12 wks of age this pt. is 6 mons old.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. It was reported that "3 weeks after getting the second dose of GARDASIL" the patient experienced a seizure. The outcome of the patient was unknown. Upon internal review seizure was determined to be other important medical event. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism spectrum disorder, Childhood disintegrative disorder, Decreased appetite, Self injurious behaviour
Clinical narrative: Information has been received via a literature article regarding a case in litigation concerning a male who in November 2004, was vaccinated with a dose of MMRII (dose, route and lot number not reported).  The family asserted the patient experienced childhood disintegrative disorder, which is on the "spectrum" of autism disorders.  During the week of his vaccination, in November 2004, the patient experienced abrupt loss of speech skills.  In approximately February 2005, the patient began injuring himself prompting his mother to buy a helmet for him in March.  He also experienced a gradual decline in appetite.  Upon internal review, childhood disintegrative disorder, which is on the "spectrum" of autism disorders was determined to be an other important medical event.  No further information is available.
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient returned to clinic on 5-13-09. Lft arm injection site with 4-5 cm area of swelling. Area red and non tender to touch. Patient reports itching to area. Denies any other discomfort. Patient to take Benadryl for itching and see personal MD if condition worsens.
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Abnormal behaviour, Developmental delay, Encephalopathy, Fine motor delay, Selective mutism
Clinical narrative: Information has been received from a case in litigation from a lawyer concerning a patient who on 19-SEP-2003 was vaccinated with a dose of Hep B (manufacturer unknown) (dose, route and lot number not reported). Concomitant therapy included DTaP (manufacturer unknown). It was reported that the patient sustained the first "symptom of manifestation" of an encephalopathy within the time frame set forth. It was reported that the petitioners also alleged that the patient suffered a chronic encephalopathy with injuries "including, but not limited to, global developmental delays, behavioral disorders, social anxiety disorder, selective mutism and motor delay". Upon internal review encephalopathy was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Social phobia
Clinical narrative: Information has been received from a case in litigation from a lawyer concerning a patient who on 19-SEP-2003 was vaccinated with a dose of Hep B (manufacturer unknown) (dose, route and lot number not reported). Concomitant therapy included DTaP (manufacturer unknown). It was reported that the patient sustained the first "symptom of manifestation" of an encephalopathy within the time frame set forth. It was reported that the petitioners also alleged that the patient suffered a chronic encephalopathy with injuries "including, but not limited to, global developmental delays, behavioral disorders, social anxiety disorder, selective mutism and motor delay". Upon internal review encephalopathy was determined to be an other important medical event. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Abdominal pain lower, Dizziness, Muscle spasms, Oropharyngeal pain
Clinical narrative: Dizzy head spinning, stomach sore, throat hurt for short time. Patient presents to clinic 4/24/09 at 8:50am, report "stomach still hurts" to lower abdomen with lesser pain to mid upper abdomen. Hurts more with palpitation. feels like cramps.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Dizzy head spinning, stomach sore, throat hurt for short time. Patient presents to clinic 4/24/09 at 8:50am, report "stomach still hurts" to lower abdomen with lesser pain to mid upper abdomen. Hurts more with palpitation. feels like cramps.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Mom stated redness and swelling began around 1500 on 5/20. She applied cool compress around 1700 applied ice pack, at 2000 applied lotion "aloe vera" and went to bed with ice pack- woke up at 0630 blister noticed, swelling and redness increased. Returned to clinic, referred to PCP- prescribed- Hydroxyzine 10 mg/5ml, Clindamycin 75mg/5ml oral solution. PCP appt @ 1620.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: C-reactive protein, Full blood count, Injection site erythema, Injection site vesicles, Red blood cell sedimentation rate
Clinical narrative: Mom stated redness and swelling began around 1500 on 5/20. She applied cool compress around 1700 applied ice pack, at 2000 applied lotion "aloe vera" and went to bed with ice pack- woke up at 0630 blister noticed, swelling and redness increased. Returned to clinic, referred to PCP- prescribed- Hydroxyzine 10 mg/5ml, Clindamycin 75mg/5ml oral solution. PCP appt @ 1620.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Cellulitis 4 x 2 1/2 cm indurated, increased warmth. Fever 39 degrees C. Prescribed Keflex.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Cellulitis 4 x 2 1/2 cm indurated, increased warmth. Fever 39 degrees C. Prescribed Keflex.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, heat, and rash at injection site.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt came into office and never was immunized. She was going to camp and needed imms. Dr. Asked nurses to work on seeing what imms could be given due to ins. Dr. Put a box around DTap and checked off TDAP And put the order in the door with a flag up. Dr. didnt inform us (the Medical assistants) of what the nurses were doing. The Tdap was given by mistake when the pt should have got TD. Pt had no reaction to the immunization. Was explained to the mother. Problem was the lack of communication between the doctor, nurses, and medical assistants.No treatment was necessary.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: Wrong drug administered
Clinical narrative: N/A, Pt was administered the DTaP vaccine instead of the Tdap vaccine. There has been no known or reported adverse reaction to the patient. In the future we will look at the MICR more closely and at the CDC vaccine recommendations more closely, and the immunization packaging more closely before administering immunizations in the future.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Barium enema abnormal, Haematochezia, Intussusception, Surgery
Clinical narrative: 4 days after dose of Rota vaccine given patient developed intussuception requiring surgery for repair.  6/2/09 ER records received DOS 4/3/09. FINAL DIAGNOSIS: Acute Intussusception. Post vaccination vomiting, decreased po intake. Abdominal pain. Mild coryza. Blood in stool. Loose stools. Transfer to surgery.  6/10/09 Hospital records / DC summary received DOS 4/3/09 to 4/5/09. FINAL DIAGNOSIS: Insussusception. Post vaccination patient presented to ED - fussy, unwilling to take liquid by mouth, vomiting, bloody stool. Found to have intussusception irreducible by barium enema. Taken to OR for successful reduction of intussusception and appendectomy.
Age: 10.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: N/A, the patient was given the MCV vaccine early. The recommended age to administer is between ages 11-12, it is approved for ages 2-55. He was administered this vaccine at the age of 10. There are no reported or documented adverse events associated with the administration of this vaccine. From now on we will look more closely at the MCIR record, the CDC guidelines, and the actual vaccine packaging to ensure safe and appropriate administration of our immunization.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Crying, Fall, Head injury, Nervousness, Pain in extremity
Clinical narrative: I assessed a 12 year old female who was alert and oriented but appeared nervous, comfort measures were taken.  I proceded to administer the vaccines.  I asked the child if she was okay, she replied that she was alright, but her left arm was in pain. The child left the room as I began to provide vaccines for the third child in the family.  She was out in the hallway near the exam room.  We heard a loud thump,the father abruptly left the room and was beside his child.  She was awake and cyring and responded with a nonverbal manner by nodding her head to the questions being asked of her.  Dr. came and asses the child.  After the assessment, Dr. recommended that the child be taken to the emergency room; for she had sustained a lump on her back of her head.  911 was called.  Shortly after the call was placed the paramedic arrived and took the child.
Age: 1.25
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient received MMR and Varicella vaccine's on May 21, 2009 from Merck and Co. Came into office today with rash on face and chest patient has no fever at this time. Parent's informed to call and inform us of any other signs and symptoms and to take to ER if necissary.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: severe swelling in lympyh node on side of chest.  Site swollen, warm to the touch.  Lasted approx. 5 days. Doctors perplexed at the location of the swollen node(s) since they bypassed others before settling a distance away for the shot site, but on the same side of the body as injection site.    Problem appeared within 48 hours
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Angiogram, Antinuclear antibody positive, Apraxia, Blood alkaline phosphatase increased, Blood bilirubin normal
Clinical narrative: Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Diplopia, Eyelid ptosis, IIIrd nerve paralysis, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Pupil fixed, Pupillary disorder, Strabismus, Thyroid function test normal
Clinical narrative: Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, FLUN3
Symptoms: Blindness, Eye disorder, IIIrd nerve paralysis, Mydriasis, Wrong technique in drug usage process
Clinical narrative: Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.
Age: 9.0
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Blood glucose increased, Full blood count, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Child woke up the night of vaccination (5/26)with pain. The next morning the mother noticed a red, round, hard area approximately 4-5 inches.  The child's blood glucose was 400, which mom said was unusual.  The redness and swelling continued and the mother took the child to Dr. on 5/28 who diagnosed the child with a localized vaccine reaction and possible cellulitis and placed her on an oral antibiotic (Keflex). Dr instructed the mother to call him in 24 hours to report her condition.  On 5/28 evening, the child went to the ER with increased arm edema, redness and the area was warm to the touch. She received one dose of IV Clindamycin in the ER and was sent home.  On Friday, 5/29, the child saw Dr. again with increased swelling and redness and blood glucose elevation. Dr. spoke with the child's endocrinologist who recommended the child be hospitalized and placed on IV antibiotics. Blood glucose levels continued to be elevated so the child was transferred to Hospital on 6/1.  7/7/09 Hospital records received DOS 6/1/09 to 6/2/09. Assessment: Local reaction to Pneumovax. Patient presented with erythema and area of firmness on upper extremity (deltoid) injection site. Skin is dry and sensitive. 9/28/09 ICD9 codes received for date of service 6/1/09 to 6/2/09 DX: Serum reaction, diabetes type I, asthma, unspecified procedure with abnormal reaction/late complication. ICD9 codes: 999.5, 250.01, 493.90, E879.0
Age: 9.0
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Urine ketone body present, White blood cell count increased
Clinical narrative: Child woke up the night of vaccination (5/26)with pain. The next morning the mother noticed a red, round, hard area approximately 4-5 inches.  The child's blood glucose was 400, which mom said was unusual.  The redness and swelling continued and the mother took the child to Dr. on 5/28 who diagnosed the child with a localized vaccine reaction and possible cellulitis and placed her on an oral antibiotic (Keflex). Dr instructed the mother to call him in 24 hours to report her condition.  On 5/28 evening, the child went to the ER with increased arm edema, redness and the area was warm to the touch. She received one dose of IV Clindamycin in the ER and was sent home.  On Friday, 5/29, the child saw Dr. again with increased swelling and redness and blood glucose elevation. Dr. spoke with the child's endocrinologist who recommended the child be hospitalized and placed on IV antibiotics. Blood glucose levels continued to be elevated so the child was transferred to Hospital on 6/1.  7/7/09 Hospital records received DOS 6/1/09 to 6/2/09. Assessment: Local reaction to Pneumovax. Patient presented with erythema and area of firmness on upper extremity (deltoid) injection site. Skin is dry and sensitive. 9/28/09 ICD9 codes received for date of service 6/1/09 to 6/2/09 DX: Serum reaction, diabetes type I, asthma, unspecified procedure with abnormal reaction/late complication. ICD9 codes: 999.5, 250.01, 493.90, E879.0
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Biopsy skin abnormal, Cellulitis, Cellulitis staphylococcal, Culture positive, Eschar
Clinical narrative: Left Shoulder soft tissue infection with tender indurated area central eschar surrounding cellulitis. Treateed with  Zithromax and Bactrim.Cultured area with 4+ Staph aureus.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Induration, Soft tissue infection, Tenderness
Clinical narrative: Left Shoulder soft tissue infection with tender indurated area central eschar surrounding cellulitis. Treateed with  Zithromax and Bactrim.Cultured area with 4+ Staph aureus.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling, Tenderness at surrounding injection site (Left Deltoid)
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Became ill Saturday 05/30/2009 with headache, stomachache.  Also injection site of menactra (r arm) red and swollen approx. 1cm.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Day following administration of vaccine the patient developed stomache ache, fever, and headache.  Highest fever was 101.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given on 5/26/09. Day after arm hurt, administration site, red, swollen,firm to touch and warm. Worsened on Thursday. Saw Employee Health Nurse Practitioner on Friday 5/29/09. Instructed to apply cool moist compresses over weekend. Present to Employee Health today left arm less sore, less redness, swelling and decreased tissue involvement. No drainage noted. Evaluated by EHS NP again
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reacted post vaccine 2 days ago, no fever, no previous vaccine reaction.  Recieved DTaP IM and VZV SQ but reaction started around DTaP area, painful to touch and itchy.  NAD SKIN R arm with erythema and swelling extends over 4 in x 3 in in area, warm to touch and tender, can mover arm all over, R arm circ=7 1/2 in, L arm is unaffected and circ=6 1/2 in.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Reacted post vaccine 2 days ago, no fever, no previous vaccine reaction.  Recieved DTaP IM and VZV SQ but reaction started around DTaP area, painful to touch and itchy.  NAD SKIN R arm with erythema and swelling extends over 4 in x 3 in in area, warm to touch and tender, can mover arm all over, R arm circ=7 1/2 in, L arm is unaffected and circ=6 1/2 in.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Grand mal convulsion
Clinical narrative: Tonic Clonic Seizure acttivity lasting 2 minutes.  6/29/09 Hospital records received DOS 5/19/09 to 5/21/09. Assessment: Acute onset seizure secondary to vaccination.  Patient presented with body shaking, eyes rolled up, struggling to breath, stopped breathing. Crying, fussy.  7/21/09 ICD-9 Codes: 780.39
Age: 11.0
Sex: U
Vaccine: TDAP, TYP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash to face torso arms and legs onset 05-29-09. Pt. c/o itching. Parent is giving Benadryl. Possible Fifth Disease
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Blood glucose increased, Body temperature increased, Confusional state, Crying
Clinical narrative: After the vaccine was administered, the patient complained of pain in the right arm, started crying, became diaphoretic, ashen, and lost consciousness for about 15 seconds. Sequential vital signs:  T98.6, BP 79/46, HR79, RR20; BP 68/33, HR 59, RR 24 (after regaining consciousness.  15 minutes later: BP 72/41, HR 85, RR 20.  Last set: BP 88/40, HR 72, RR 20.  After regaining consciousness, patient was weak, confused, and continued to be diaphoretic.  Blood glucose was 97. He could not describe how he was feeling to his father.  The patient sneezed two times, which he had not done before the shot.  He became more alert and oriented and was able to stand and walk, denying dizziness, shortness of breath or pain.  I contacted Emergency Room to advise that patient was enroute, driven by his father.  My manager of operations was notified of event.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Injection site pain, Loss of consciousness, Pallor, Sneezing
Clinical narrative: After the vaccine was administered, the patient complained of pain in the right arm, started crying, became diaphoretic, ashen, and lost consciousness for about 15 seconds. Sequential vital signs:  T98.6, BP 79/46, HR79, RR20; BP 68/33, HR 59, RR 24 (after regaining consciousness.  15 minutes later: BP 72/41, HR 85, RR 20.  Last set: BP 88/40, HR 72, RR 20.  After regaining consciousness, patient was weak, confused, and continued to be diaphoretic.  Blood glucose was 97. He could not describe how he was feeling to his father.  The patient sneezed two times, which he had not done before the shot.  He became more alert and oriented and was able to stand and walk, denying dizziness, shortness of breath or pain.  I contacted Emergency Room to advise that patient was enroute, driven by his father.  My manager of operations was notified of event.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash on face, exerting, trunk, back starting on 29 May 2009.
Age: 10.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling over injection site - X 2 days - cool compresses.
Age: 5.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site x 2 days. Treatment cool compresses.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Immediately following injection patient had syncopal episode for 15 seconds. She had Flailing of arms/ Legs when she was unconscious, as nurse was exposing pt to smelling salt pt upper.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pain, Pruritus, Pyrexia, Rash papular
Clinical narrative: Feverish on 5/29/09, raised, itchy, painful x 2d seen in the office 5/29/09: T: 98.2. Exam: dry papules upper forearms, back, trunk, scattered = 6 = blisters at base. Imp: Varicella Keratosis Pilanis. 6/1/09: No new lesions, activity level WNL, papules decreased in size. Pt was seen in own office on 5/29/09 but symptoms rash started 2 days prior (5/29/09) her appt time on 5/29/09 was 16:05
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling, Varicella
Clinical narrative: Feverish on 5/29/09, raised, itchy, painful x 2d seen in the office 5/29/09: T: 98.2. Exam: dry papules upper forearms, back, trunk, scattered = 6 = blisters at base. Imp: Varicella Keratosis Pilanis. 6/1/09: No new lesions, activity level WNL, papules decreased in size. Pt was seen in own office on 5/29/09 but symptoms rash started 2 days prior (5/29/09) her appt time on 5/29/09 was 16:05
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema at site of injection up to 15 cm. Peak with underlying induration almost entire extent of quad. (right).
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dyspnoea, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: SM reports receipt of third AVA vaccine on 5/2/2009 (AVA #1 8/2/05, #2 8/17/05).  He reported no problems for 2 days.  5/4-7/2009 he c/o:  1) a round raised pimple like bump -rash over injection site that gradually progressed down and around his upper left arm, 2) his left shoulder forearm to elbow region redness, tenderness, and 3)pain with movement of left shoulder/elbow.  He described anterior and lateral areas of forearm as mostly affected.  This area does itched profusely.  He also admits to mild SOB sensation with exertion starting 5/6/09 with no ha, cp, n/v or GI discomfort, fevers, tinnitus, etc.  He sought medical care 5/7/09 and placed on ALBUTEROL for wheezing, given steroid titrating dose pack and TYLENOL.  (allergy to ASA-anaphylactic like).  He advised hypdrocortisone cream to site was ineffective.  AVA vaccine AE discussed with SM.  His reactions sounds like a robust take and we reviewed what this means.  He will f/u with PCP on monday (may be put on AB if s/s persist to r/o cellulitis).  He agreed to keep in touch with VHC.  VAERS will be filed and evaluation for exemption to AVA vaccine initiated.  Symptoms:  Edema @ injection site >120mm not beyond elbow, Erythema, Lesions, papule, Pain, Joint Pain, multiple joints.