chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: patient received 12 mo vaccinations on 7/20/2009, at site of vaccine patient with 4 cm area of erythema, induration, pain, and warmth on right upper arm from day after shots to 7/29/09 when seen at providers once again. diagnosed with cellulitis and put on augmentin 125/5 1 tsp po bid X 14 days.
Age: 26.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Pt was given the following injections: Adacel (Tdap), Gardasil (HPV), and Hep B.  She c/o's feeling suddenly light-headed/dizzy/nauseated.  She was assisted onto the exam table to lie down until sx's subsided
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation, Injection site swelling, Injection site vesicles
Clinical narrative: RIGHT ARM HAS A 13CM RED IRRIATION & SWOLLEN. 4CM HAS WATER BUBBLES & DRAINAGE CLEAR. CENTER OF BUMP MEASURES 1CM PURPLE & RED. PT'S MOTHER WAS TOLD TO GIVE PT MOTRIN AND TRIAMCINOLONE ACETONIDE CREAM TO APPLIED ON INFECTED AREA.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PT'S MOTHER STATED THAT ABOUT 24HRS AFTER ADMINISTRATION OF VACCINE, SHE NOTICED REDNESS AND SWELLING AT VACCINATION SITE.  VACCINE (VARIVAX) ADMINISTERED 7/30/09 AT ABOUT 1030HRS.  PT C/O SORENESS AND ITCHING AT SITE.  NURSE ASSESSED ABOUT 35MM INDURATION, REDNESS AND MINIMAL WARMTH AT VACCINE INJECTION SITE. PT DENIES ANY OTHER SX'S AND NO OTHER SX'S ASSESSED BY NURSE AT TIME PT REPORTED ADVERSE EVENT TO ADMINISTRATION FACILITY (FAMILY MEDICINE DEPT).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: PT'S MOTHER STATED THAT ABOUT 24HRS AFTER ADMINISTRATION OF VACCINE, SHE NOTICED REDNESS AND SWELLING AT VACCINATION SITE.  VACCINE (VARIVAX) ADMINISTERED 7/30/09 AT ABOUT 1030HRS.  PT C/O SORENESS AND ITCHING AT SITE.  NURSE ASSESSED ABOUT 35MM INDURATION, REDNESS AND MINIMAL WARMTH AT VACCINE INJECTION SITE. PT DENIES ANY OTHER SX'S AND NO OTHER SX'S ASSESSED BY NURSE AT TIME PT REPORTED ADVERSE EVENT TO ADMINISTRATION FACILITY (FAMILY MEDICINE DEPT).
Age: 34.0
Sex: F
Vaccine: DTP
Symptoms: Vital capacity abnormal, Vomiting
Clinical narrative: Severe emesis (x7)  24 - 30 hours following  DPT.   Unclear if could have been unrelated event such as gastroenteritis.  Partner not ill.  Patient fully recovered.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Delirium, Pyrexia
Clinical narrative: Approx 1 day after vaccines given, pt's mother reported high fever and talking to herself as if delirious for approx 5 hours.  Called on call physician, but did not seek medical attention.  Fever lasted 48 hours then resolved. No other symptoms.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test normal, Convulsion, Electroencephalogram normal, Endotracheal intubation
Clinical narrative: 4 month old male had had upper extremity movements 2-3 wks prior. He received vaccines 7-21-09 in AM. He had a generalized seizure 16-20 hrs after vaccine administration. He needed intubation after administration of anticonvulsants.  8/17/09 Hospital records received DOS 7/22/09 to 7/23/09. Assessment: Seizure disorder. Patient presents with seizure activity lasting 40 minutes. Started on left arm, progressed to left leg, continuing to generalized seizure. Post admission left sided focal seizure of 5 minutes duration.  ICD-9 Codes: 780.39 Other Convulsions, 345.10 Gen Convul Epilepsy w/o Mention Intract Epilepsy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Vaccines given at 2:40 pm. 2 hives right ant thigh at 2:44 pm - Gave 3/4 tsp. BENADRYL. Hives resolved - never reoccurred.
Age: 25.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Cellulitis, Erythema, Palpitations, Skin warm, Swelling
Clinical narrative: Pt came to clinic 2 days after receiving MMR, area with erythema, swelling, warmth, and tender to palpation. Pt diagnosed with cellulitis, treated with AUGMENTIN 875 mg/125 mg BID x ten days.
Age: 25.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Tenderness
Clinical narrative: Pt came to clinic 2 days after receiving MMR, area with erythema, swelling, warmth, and tender to palpation. Pt diagnosed with cellulitis, treated with AUGMENTIN 875 mg/125 mg BID x ten days.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Red Itching
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: - L.O.C for 2 sec. - Paleness in face  * Treatment -> lay down with elevated legs
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Malaise, Vomiting
Clinical narrative: Severe headaches evening of vaccine, emesis (4) next day, fatigue + malaise, normal exam.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Developed golf ball size swelling at site, tenderness X8 days. Evaluated 7/31/09 unremarkable, no pain, no redness, no swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines given 29JUL2009. Mom reported swelling/redness at bilateral deltoid areas AM of 31JUL09. Rt deltoid area worse. Pt. evaluated by Dr. and prescribed MOTRIN, TYLENOL and BENADRYL.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Full blood count, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: She received her vaccines 1 week ago, 7/22. Has been seen now 3 times for sx's fatigue, fever,  nausea, headaches, swollen glands, body aches and pain at the injection sites. F/u test, strep screen performed on 7/24 were negative. Labs were drawn and CBC, CMP were essentially normal and mono screen negative. Mom is concerned, convinced that all of her daughter's sx's were caused by the vaccines, despite our discussing the possibility of her having a possible viral infection. Also, pt and family had just returned from 4 weeks abroad, returning late on 7/20 and pt. was jet-lagged. Pt, was feeling better over the past few days, then nausea, headache and fatigue began again last night and this morning. Mom brings pt in for another evaluation and discussion of the vaccines. Would like this to be reported as a Vaccine Adverse Reaction. Also, is concerned because pt is scheduled to go to camp this weekend leaving on Sunday, 8/2.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Pain, Pyrexia
Clinical narrative: She received her vaccines 1 week ago, 7/22. Has been seen now 3 times for sx's fatigue, fever,  nausea, headaches, swollen glands, body aches and pain at the injection sites. F/u test, strep screen performed on 7/24 were negative. Labs were drawn and CBC, CMP were essentially normal and mono screen negative. Mom is concerned, convinced that all of her daughter's sx's were caused by the vaccines, despite our discussing the possibility of her having a possible viral infection. Also, pt and family had just returned from 4 weeks abroad, returning late on 7/20 and pt. was jet-lagged. Pt, was feeling better over the past few days, then nausea, headache and fatigue began again last night and this morning. Mom brings pt in for another evaluation and discussion of the vaccines. Would like this to be reported as a Vaccine Adverse Reaction. Also, is concerned because pt is scheduled to go to camp this weekend leaving on Sunday, 8/2.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Streptococcal identification test negative
Clinical narrative: She received her vaccines 1 week ago, 7/22. Has been seen now 3 times for sx's fatigue, fever,  nausea, headaches, swollen glands, body aches and pain at the injection sites. F/u test, strep screen performed on 7/24 were negative. Labs were drawn and CBC, CMP were essentially normal and mono screen negative. Mom is concerned, convinced that all of her daughter's sx's were caused by the vaccines, despite our discussing the possibility of her having a possible viral infection. Also, pt and family had just returned from 4 weeks abroad, returning late on 7/20 and pt. was jet-lagged. Pt, was feeling better over the past few days, then nausea, headache and fatigue began again last night and this morning. Mom brings pt in for another evaluation and discussion of the vaccines. Would like this to be reported as a Vaccine Adverse Reaction. Also, is concerned because pt is scheduled to go to camp this weekend leaving on Sunday, 8/2.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received shot on Wed 7/29/9. On Thurs. called to say redness, swelling & itching at injection site. Counseled on proper procedure (BENADRYL/TYLENOL). Pt did not take any meds. Called again 8-1-9 called MD (doctor) told her to do BENADRYL.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7-28-09 Vaccine admin after approp. screening. 7-29-09 Pt. arm sore. Red & warm to touch. Minimal swelling. 7-30-09 Called HD. Arms swelling. Encouraged to consult fam. dr. 7-31-09 After Dr visit, came to HD. Swelling (R) MMR measures 50mm x 100mm. (L) varicella measures 30mm x 40mm. Dr states use BENADRYL. Script to cont. vaccine admin on schedule.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and headache.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt. here today for TBST reading C0838. Nurse noted that pt's (L) deltoid area 2 1/4" x 2 1/2" slightly firm swelling reddened  areas with injection site noted in between area. No drainage nor blisters noted at site, slightly warm to touch. Pt stated she developed headaches 1 hour after receiving shot on 7/28/09 #7 on 1-10 pain scale - took med. for it today pain at #3 on 1-10 pain scale. Denies fever. Pulses (L) arm/wrist present & strong on palpation. Inst pt to call PCP.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented to clinic 2 days after injection. Site red, swollen and hot. Pt was diagnosed with cellulitis and given KEFLEX 500mg QID x ten days.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness
Clinical narrative: Dizziness starting - few hours after vaccination. Persisted for 2 wks. Evaluated by EMT.
Age: 68.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal discomfort, Cold sweat, Dizziness, Heart rate normal, Nasopharyngitis
Clinical narrative: 1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Age: 68.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiratory rate increased
Clinical narrative: 1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Age: 68.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Blood pressure decreased, Cold sweat, Dizziness, Feeling abnormal
Clinical narrative: 1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Age: 68.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Feeling cold, Hyperhidrosis, Nausea, Presyncope, Pulse pressure decreased
Clinical narrative: 1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Age: 68.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiratory distress
Clinical narrative: 1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Age: 1.5
Sex: M
Vaccine: HEPA, PNC
Symptoms: Allergy test, Crying, Eczema, Irritability, Pruritus
Clinical narrative: Crankiness at 10:30. Fell asleep, woke approx 3am screaming and crying, face looked like a balloon, very irritable, screamed at the touch of the shot site, warm feeling but no fever. Gave MOTRIN at 4. He calmed down and fell asleep at 6:30am. Eczema flare up & itching.
Age: 1.5
Sex: M
Vaccine: HEPA, PNC
Symptoms: Screaming, Skin warm, Swelling face
Clinical narrative: Crankiness at 10:30. Fell asleep, woke approx 3am screaming and crying, face looked like a balloon, very irritable, screamed at the touch of the shot site, warm feeling but no fever. Gave MOTRIN at 4. He calmed down and fell asleep at 6:30am. Eczema flare up & itching.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received VZV and Hep A immunizations on 07/29/09. Mom called to office on 07/31/09 stating had swelling at injection site. Pt brought into office and assessed. Red, raised, swollen oval area. 5 1/2 cm x 6 cm noted on (R) upper arm area of VZV injection. Cool compresses, MOTRIN, triamcinolone.
Sex: U
Vaccine: DTAPIPV
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of adverse reaction 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 (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced adverse reaction.  At the time of reporting the outcome of the event was unspecified.   The healthcare professional reported that a subject had an adverse reaction to KINRIX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II vaccine (non-gsk); Merck; unknown given on 1 July 2009; VARIVAX (non-gsk); Merck; unknown given on 1 July 2009.  On 1 July 2009 the subject received 1st dose of KINRIX (.5 unknown, unknown, left arm).  On 3 July 2009, 2 days after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the event was resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II vaccine (non-gsk); Merck; unknown given on 1 July 2009; VARIVAX (non-gsk); Merck; unknown given on 1 July 2009.  On 1 July 2009 the subject received 1st dose of KINRIX (.5 unknown, unknown, left arm).  On 3 July 2009, 2 days after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the event was resolved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 9 June 2009; VARIVAX (non-gsk); Merck; unknown given on 9 June 2009.  On 9 June 2009 the subject received 1st dose of KINRIX (.5 ml, unknown).  On 11 June 2009, at an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  The subject experienced an injection site reaction from shoulder to biceps.  At the time of reporting the event was resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 21 May 2009; VARIVAX (non-gsk); Merck; unknown given on 21 May 2009.  On 21 May 2009 the subject received 1st dose of KINRIX (.5 ml, unknown).  On 23 May 2009, 2 days after vaccination with KINRIX, the subject experienced injection site reaction.  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 reaction
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site reaction 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 (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative was told that the physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796722A, A0796723A, and A0796724A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via sales representatives and described the occurrence of injection site reaction 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 (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative was told that he physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796720A, A0796723A, and A0796724A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site reaction 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 (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the events was unspecified.  The sales representative was told that the physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796720A, A0796722A, and A0796724A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site reaction 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 (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the tie of reporting the outcome of the event was unspecified.  The sales representative was told that the physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796720A, A0796722A, and A0796723A.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Local reaction, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There was no relevant medical history.  The subject had not experienced adverse events following previous vaccinations.  Concurrent vaccination included MMR II vaccine (non-gsk) (Merck; right arm) given on 20 July 2009; VARIVAX (non-gsk) (Merck; right arm) given on 20 July 2009.  Previous medications included Allergy medication (Allergy shot) given on 10 July 2009.  On 20 July 2009 the subject received a dose of KINRIX (.5 cc, unknown route, left arm) as the 5th dose in the DTAP series, and 4th in the Polio series.  The lot number was reported as ACZ0B115AA.  On 20 July 2009, less than one day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site redness, and later on an injection site rash.  The healthcare professional reported that the subject experienced a 7 centimeter local reaction at the injection site in his left arm only.  The swelling and redness occurred the same day of vaccination but the rash developed later.  At the time of reporting, the rash had spread to the subject's elbow.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There was no relevant medical history.  The subject had not experienced adverse events following previous vaccinations.  Concurrent vaccination included MMR II vaccine (non-gsk) (Merck; right arm) given on 20 July 2009; VARIVAX (non-gsk) (Merck; right arm) given on 20 July 2009.  Previous medications included Allergy medication (Allergy shot) given on 10 July 2009.  On 20 July 2009 the subject received a dose of KINRIX (.5 cc, unknown route, left arm) as the 5th dose in the DTAP series, and 4th in the Polio series.  The lot number was reported as ACZ0B115AA.  On 20 July 2009, less than one day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site redness, and later on an injection site rash.  The healthcare professional reported that the subject experienced a 7 centimeter local reaction at the injection site in his left arm only.  The swelling and redness occurred the same day of vaccination but the rash developed later.  At the time of reporting, the rash had spread to the subject's elbow.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician, via a GSK representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with (KINRIX, GlaxoSmithKline), varicella virus vaccine (unknown manufacturer). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown arm), unspecified dose of Varicella virus vaccine (unknown route, unknown arm). At an unspecified time after vaccination with KINRIX and Varicella virus vaccine, the subject experienced fever. At the time of reporting the outcome of the event was unspecified. The reporting physician was unsure whether the fever was caused by KINRIX or Varicella virus vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Within 48 hours of receiving vaccine developed low grade fever 100. Cold like symptoms runny, stuffy nose. 72 hrs began dry cough.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: large red mark at injection site
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pt developed large area of firmness, pain and swelling of left arm and shoulder 1 days after receiving vaccines
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Aphasia, Autism, Disturbance in social behaviour, Lethargy, Malaise
Clinical narrative: Within hours, Jonah became lethargic, sickly, pale, fever.  After the fever subsided 4 days later, my son was then displaying autistic symptoms like loss of eye contact, no facial expressions, and loss of language.  He was officially diagnosed with autism in July 2009. 9/11/09 Office note received dated 7/13/08.  Parents report that several days after receiving HAV, MMR and Varicella vax pt developed fever, rash emesis and decreased appetite.  Pt has developed balance problems, frequent falls and difficulty focusing the eyes.  PE WNL except faint pink macules on face and back. Assessment:  Likely viral illness 12/4/09 Medical records received for date 7/13/09 to 10/13/09.  7/13/09 DX:fever, UTI.   10/13/09 DX: burn rt. upper extremity.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Pyrexia
Clinical narrative: Within hours, Jonah became lethargic, sickly, pale, fever.  After the fever subsided 4 days later, my son was then displaying autistic symptoms like loss of eye contact, no facial expressions, and loss of language.  He was officially diagnosed with autism in July 2009. 9/11/09 Office note received dated 7/13/08.  Parents report that several days after receiving HAV, MMR and Varicella vax pt developed fever, rash emesis and decreased appetite.  Pt has developed balance problems, frequent falls and difficulty focusing the eyes.  PE WNL except faint pink macules on face and back. Assessment:  Likely viral illness 12/4/09 Medical records received for date 7/13/09 to 10/13/09.  7/13/09 DX:fever, UTI.   10/13/09 DX: burn rt. upper extremity.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Blood urine absent, Bruxism
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervicitis, Clumsiness, Colonoscopy normal, Confusional state
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Constipation, Diarrhoea, Disturbance in attention, Dizziness, Dysplasia
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ear infection, Ear pain, Fatigue, Full blood count normal, Glomerular filtration rate decreased
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Glucose urine present, Headache, Hyperhidrosis, Influenza, Irritable bowel syndrome
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Kidney infection, Loop electrosurgical excision procedure, Mononucleosis heterophile test negative, Myalgia, Nasopharyngitis
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Nitrite urine present, Pain, Pain in extremity, Palpitations
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain, Pharyngitis, Photophobia, Rash, Red blood cell sedimentation rate normal
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.