chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Drug screen negative, Muscle twitching, Myoclonus, Pyrexia
Clinical narrative: 3hrs after vaccine administered, mother reports fever of 99.5, then began having myoclonic jerks of arms, legs and head. No decrease in level of arousal, no hx of seizure. Pt was admitted and twitching resolved after 24hrs.  6/8/09 Hospital records received DOS 5/14/09.FINAL DIAGNOSIS: New Onset Seizure. Post vaccination presented with twitching, fever, tachycardia, seizures. Transferred to another facility. 6/22/09 Hospital records received DOS 5/15/09 to 5/16/09. Assessment: Acute otitis media, suspected seizures, dehydration. Transferred from another facility, presents with tremor activity.  6/24/09-ICD-9 codes received-382.9 otitis media.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Asthenia, Bacterial culture negative, Blood electrolytes normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Borrelia burgdorferi serology, CSF glucose normal, CSF protein increased, CSF white blood cell count increased, Chills
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Computerised tomogram abnormal, Condition aggravated, Cytomegalovirus test negative, Epstein-Barr virus test negative, Eyelid ptosis
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Facial palsy, Fungus culture, Haemorrhage intracranial, Headache, Herpes simplex serology negative
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Liver function test normal, Muscular weakness, Nervous system disorder, Polymerase chain reaction, Pyrexia
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Red blood cells CSF positive, Syphilis test, Unresponsive to stimuli, Varicella zoster serology negative, West Nile virus test negative
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: White blood cell count normal, Yellow fever vaccine-associated neurotropic disease
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Acid fast stain negative, Asthenia, Bacterial culture negative, Blood electrolytes normal, Blood immunoglobulin G normal
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Blood immunoglobulin M, Borrelia burgdorferi serology, CSF glucose normal, CSF protein increased, CSF test abnormal
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: CSF white blood cell count increased, Chills, Cytomegalovirus test negative, Epstein-Barr virus test negative, Eyelid ptosis
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: Red blood cells CSF positive, Syphilis test negative, Unresponsive to stimuli, Varicella zoster serology negative, West Nile virus test negative
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 68.0
Sex: M
Vaccine: HEP, TYP, YF, YF
Symptoms: White blood cell count normal
Clinical narrative: 68yo M h/o BPH, intra-cranial hemorrhage 10yrs ago admitted on 5/25 with a 1 wk h/o HA, fevers, rigors and progressively worsened weakness, with focal neurological deficits (left upper extremity weakness, ptosis, facial droop) and inability to follow commands. Admission head CT c/w small R. frontal ICH, stable. He is on broad spectrum ABx including Vancomycin/Ceftazidime/FLAGYL/Ampicillin/Acyclovir with persistent fevers and unchanged neurological deficits or mental status. Of note, patient reports receiving yellow fever vaccination about 10d prior to admission. On labs, WBC 9.2 on admission, LFTs, electrolytes WNL, CSF (5/26) (on antibiotics): glu 72, prot 77, 40,000 RBCs, 61 WBCs with neutrophilic predominance; baterial/fungal/AFB cx's NGTD; WNV IgG/IgM neg; HSV/VZV/CMV/EBV/enterovirus PCR not detected; VDRL, Lyme pending, Arbovirus - IgG/IgM pending, PCR pending; serum arbovirus (yellow fever) IgG/IgM/PCR - pending. We are suspicious for yellow fever vaccine associated neurotropic disease.  6/8/09 medical records received DOS 5/7/09 - 5/29/09. FINAL DIAGNOSIS: None Provided. Patient was administered Yellow Fever vaccine. Subsequently clinic was notified by a university hospital that patient was admitted to the neurologic ICU. Follow up received on 7/21/2010: patient recovered.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Congenital anomaly, Laboratory test normal, Ultrasound scan abnormal
Clinical narrative: Baby born without legs on 2/23/09.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Arthralgia, Body temperature increased, Headache, Hypoaesthesia, Musculoskeletal discomfort
Clinical narrative: Temp. 100.5 degrees F, achy joints/neck, HA eyes sensitive to light, numbness in feet/hands. 5/21/09. 5/27/2009 Follow up with parent. Parent stated child was taken to ER and was observed for several hours. States no lab work was done. No follow up has been done and child no longer has any symptoms as stated. 5/20/09.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Photophobia
Clinical narrative: Temp. 100.5 degrees F, achy joints/neck, HA eyes sensitive to light, numbness in feet/hands. 5/21/09. 5/27/2009 Follow up with parent. Parent stated child was taken to ER and was observed for several hours. States no lab work was done. No follow up has been done and child no longer has any symptoms as stated. 5/20/09.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Received KINREX + MMR on R deltoid on 5/29/2009 - came into office 06/02/09 necessary with cellulitis + reddened @ site.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cold sweat, Fall, Hearing impaired, Muscle rigidity
Clinical narrative: Approx 5 minutes after injection Pt became rigid all over, very stiff, and fell down to table. After several minutes then began to arise but was very groggy, clammy, pale and c/o ringing ears and could not hear. BP decrease 80/50.Watched and monitored over 30 minutes which at which time was lunching and felt better and released to home with mother. 12:45PM called Pt to check on her and mom states was doing very well.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Somnolence, Tinnitus
Clinical narrative: Approx 5 minutes after injection Pt became rigid all over, very stiff, and fell down to table. After several minutes then began to arise but was very groggy, clammy, pale and c/o ringing ears and could not hear. BP decrease 80/50.Watched and monitored over 30 minutes which at which time was lunching and felt better and released to home with mother. 12:45PM called Pt to check on her and mom states was doing very well.
Age: 43.0
Sex: M
Vaccine: RUB, TDAP
Symptoms: Arthralgia, Injection site rash, Pain, Pyrexia
Clinical narrative: 100 - 102 degree F  fever, body aches, joint pain:  Rash at injection site.  Symptoms began to subside after 36-48 hours.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Fall, Head injury, Nausea, Scan brain
Clinical narrative: Pt was injected with 2nd GARDASIL inj. About 30 seconds later pt fainted fell head first off of bed. Pt hit right forehead on floor and ice was applied. Pt became nausea and vomited. Pt was sent to Hospital for evaluation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Urine analysis, Vomiting
Clinical narrative: Pt was injected with 2nd GARDASIL inj. About 30 seconds later pt fainted fell head first off of bed. Pt hit right forehead on floor and ice was applied. Pt became nausea and vomited. Pt was sent to Hospital for evaluation.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Rash- 20-30 papules on trunk and groin - No vesicles - very itchy
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site urticaria
Clinical narrative: 9 cm X 5cm red whelp to (R) deltoid, not tender to touch, cellulitis. Treatment - BACTRIM DS
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Mom stated pt came home form Daycare on Thursday 5-28-09 and c/o pain in (L) arm, Mom also stated it was itchy.  Area was reddened, itchy and slightly warm to touch.  Mom stated he had been itching affected area.  Advised Benadryl and Ibuprofen.  In to be seen if sx worsened- Spoke to mom on 6-1-09- area better- no further redness or pain.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Erythema, Injection site haematoma, Injection site swelling, Irritability
Clinical narrative: About 6 hrs after receiving vaccines became irritable, crying & inconsolable for 1 1/2 hrs.  Left leg had nickle sized bruise at injection site.  Left thigh looked swollen.  Both feet + left leg were pink.  No fever.  Resolved in 24 hrs except for bruise.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, heat, bruising after 3 days. Pt was Pt used cold packs and warm packs
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) arm SQ site redness, heat. Pt saw physician who prescribed "Steroid Inj and BENADRYL OD
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria on arms / legs about 1 hour after receiving,MENACTRA, HPV #1, HEP A #1, on 5/27/09 no other complaint.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Pericarditis
Clinical narrative: Information has been received from a physician concerning a female with unspecified reported drug reactions/allergies with Behcet's Syndrome and a history of colitis, who in late April 2009 (approximately 30-APR-2009), was vaccinated with ZOSTAVAX (Oka/Merck) (route and lot number unspecified). The physician stated, the patient developed "pericarditis CHF", 2 weeks post vaccination of ZOSTAVAX (Oka/Merck) and she was hospitalized (hospital demographics and dates unspecified). The patient sought medical attention with her physician. The outcome of the patient was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Chest X-ray, Condition aggravated, Echocardiogram, Laboratory test
Clinical narrative: Information has been received from a physician concerning a female with unspecified reported drug reactions/allergies with Behcet's Syndrome and a history of colitis, who in late April 2009 (approximately 30-APR-2009), was vaccinated with ZOSTAVAX (Oka/Merck) (route and lot number unspecified). The physician stated, the patient developed "pericarditis CHF", 2 weeks post vaccination of ZOSTAVAX (Oka/Merck) and she was hospitalized (hospital demographics and dates unspecified). The patient sought medical attention with her physician. The outcome of the patient was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pericarditis, Pleural effusion
Clinical narrative: Information has been received from a physician concerning a female with unspecified reported drug reactions/allergies with Behcet's Syndrome and a history of colitis, who in late April 2009 (approximately 30-APR-2009), was vaccinated with ZOSTAVAX (Oka/Merck) (route and lot number unspecified). The physician stated, the patient developed "pericarditis CHF", 2 weeks post vaccination of ZOSTAVAX (Oka/Merck) and she was hospitalized (hospital demographics and dates unspecified). The patient sought medical attention with her physician. The outcome of the patient was unknown. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: It was reported in a news magazine article that a male who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed autism. The patient's mother blamed her son's autism on MMR II. The patient's mother reported that they were curing her son's autism "with diet and chelation, a process that chemically binds heavy compounds in the body so they can be excreted". Upon internal review, autism was considered to be other important medical event. No further information is available.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Gait disturbance, Muscular weakness
Clinical narrative: Information has been received from a physician concerning either 15 or 16 years old male patient who on an unspecified date was vaccinated with a dose of VAQTA (Lot # not reported). On an unspecified date the patient had progressive weakness, some muscle weakness and difficulty walking over couple days and had to be admitted to the emergency room and the hospital. The outcome was not reported. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Torsade de pointes
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not provided). The physician reported that  the patient experienced long QT interval and torsade de pointes after getting the vaccine. At the time of reporting the outcome of the event was unknown. The patient sought medical attention. Upon internal review torsade the pointes was considered to be an other important medical event. This is an amended report. The adverse event Torsade de Pointes was added in the AE info screen as other important medical event. No further information is available.
Age: 23.0
Sex: M
Vaccine: HEPAB, MMR, TDAP
Symptoms: Body temperature increased, Chills, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: 5/24/09 experienced swelling in the lymph node of the left armpit.  5/25/09 chills, generalized malaise, Temp 99.8  5/26/09 Malaise continued, fever at night 100.2  5/27/09 fever gone, feeling better, able to do ADLs without any problems.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5cm erythema and induration at arm injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Entire (R) thigh red/warm swollen with itching within 24 hours of vaccines given.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Posturing, Syncope
Clinical narrative: Patient given dose #2 of GARDASIL, seems to tolerate well. No c/o offered - fainted upon preparing to leave facility, hitting back of head hard on door frame - Loss of consciousness for approx. 1min; with posturing of head and arms, possible seizure no obvious head wound or bleeding. Patient transported to local hospital for evaluation. Had further episode of posturing after regaining consciousness.  7/13/09 Hospital ER records received DOS 5/13/09. Assessment: Vasovagal syncope. Patient present at ER after having a syncopal episode in a clinic waiting room after receiving shot of "Depo". Parents report patient was shaking and "posturing" - flexed arms and wrists. Dizziness. Mild headache.   6/19/09 ICD-9 codes received. 780.2 784.0
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Swelling and erythema at Lt site of immunization 10 days after immunization. No signs of injection - No treatment given - Local reaction presumed to be due to VARIVAX vaccine
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Purpura
Clinical narrative: (L) thigh with erythema and purpura skin in large circular area 8cm - no adjacent to but not symptom surrounding needle insertion site from vaccination. No no tracking, no proximal adenopathy (upper spongitis)
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 34.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Arthralgia, Chest discomfort, Hyperaesthesia, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Left arm - substantial swelling of injection arm from shoulder to elbow, skin sensitivity, stiffness - joint pain (ankles, knees, elbows, wrists, neck) - fever over 100 degrees for four days straight - tight chest (not asthma)
Age: 34.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Pyrexia
Clinical narrative: Left arm - substantial swelling of injection arm from shoulder to elbow, skin sensitivity, stiffness - joint pain (ankles, knees, elbows, wrists, neck) - fever over 100 degrees for four days straight - tight chest (not asthma)
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema multiforme, Laboratory test normal, Rash
Clinical narrative: Erythema Multiforme rash started on 5-22-09 started in groin area spread allover started on BENADRYL change to ZYRTEC on 5-26-09 PRELONE  started on 5-24-09 by ER
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling of R deltoid area. Erythema and induration surrounding injection site.
Age: 22.0
Sex: M
Vaccine: JEV
Symptoms: Balance disorder, Convulsion, Pallor
Clinical narrative: Within 5 min of receiving JE vaccination, client had a seizure lasting  1-2 min.  Alert & oriented after, though very pale and unsteady.  BP 122/80 No sob, N; V, DIAPHORESIS.  Had not eaten since 10am so given cheese & H20 Neuro check - WNL observed for 1 1/2 hrs and released to home F/up call to parent on 6/5 10 AM - No further seizure activity
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pruritus
Clinical narrative: c/o itchiness on neck, arms, legs, about 10 minutes after shots were given, no difficulty breathing, nor swallowing, no rash noted. BENADRYL 25 mg given with itchiness.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Injection site swelling, Joint swelling, Joint warmth
Clinical narrative: Right knee swollen warm to touch.  Swelling from knee to hip
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746427A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746427A, A0746428A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a 4 year old female. Topical reaction was documented with the onset of events provided as 04 September 2008. The events resolved on an unspecified date in September 2008. In the reporter's opinion, the events were possibly related to treatment with INFANRIX. This was the subject's 5th dose of INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747167A, A0747168A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a one year old male. The events began on 21 August 2008 and resolved on an unspecified date in August 2008. In the reporter's opinion, the events were possibly related to treatment with INFANRIX. This was the subject's 4th vaccination with INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747164A, A0747168A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a one year old male. The events began on 14 August 2008 and resolved on an unspecified date in September 2008. In the reporter's opinion, events of injection site that was hot to the touch, and swelling at the injection site were possibly related to treatment with INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747164A, A0747167A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX, GlaxoSmithKline. On an unspecified date, the subjects received either their 4th or their 5th dose of INFANRIX (.5ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (lot# AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the event was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a 4 year old male. The events began on 20 August 2008 and resolved on an unspecified date in August 2008. In the reporter's opinion, the events of injection site that was hot to the touch, and swelling at the injection site were possibly related to treatment with INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747164A, A0747167A, A0747168A and AC752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of erythema in a 5-year-old male subject who was vaccinated with INFANRIX, GlaxoSmithKline. Concurrent vaccination included MMR vaccine, Merck and VARIVAX Merck both given on 15 September 2008. Concurrent medications included Allegra. On 15 September 2008 the subject received 5th dose of INFANRIX at 0.5ml in the left thigh. On 16 September 2008, 1 day after vaccination with INFANRIX, the subject experienced erythema, induration, itching and local reaction at injection site. The subject's itching was treated with Westcort cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 14 October 2008, via nurse, who reported the subject received INFANRIX by intramuscular injection. The subject has a concurrent medical condition of allergic rhinitis.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen thigh (injection site) in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccinations given on 22 August 2008 included the 2nd dose of MMR II (Merck). On 22 August 2008, the subject received 5th dose of INFANRIX (.5 ml, unknown, left thigh). At an unspecified time after vaccination with INFANRIX, the subject experienced a swollen thigh (injection site) and injection site redness. The reporting nurse stated that the subject came back into the physician's office five days after receiving the INFANRIX vaccination with entire thigh swelling and redness. A product complaint was lodged for this report, as the nurse inquired if GSK had changed the formulation or if there were "hot" lots with the company's DTaP vaccines. At the time of reporting, the thigh swelling was resolved, but the outcome of the erythema was unspecified. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 21October 2008 indicated that all of the events resolved and were considered by the reporter to be possibly related to treatment with INFANRIX. It was also reported that INFANRIX was administered intramuscularly and that the previous four doses of DTaP were all Aventis vaccines. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse event were recorded."
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Product quality issue
Clinical narrative: This case was reported by a physician, via another health care provider, and described the occurrence of injection site hot to touch in a 3 year old female who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date, the subject received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subject experienced injection site that was hot to the touch, swelling at the injection site and local reaction. The onset date of events was reported as 29 August 2008 with resolution on an unspecified date in August 2008. In the reporter's opinion, the events were possibly related to treatment with INFANRIX. The physician's office reported this case in follow-up in conjunction with four additional child subjects that experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these four reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. Linked case numbers include: A0747164A, A0747167A, A0747468A and A0747169A.