chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urinary casts present, Urine analysis, Urine leukocyte esterase, Urine transitional cells present, Urobilinogen urine decreased
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting, White blood cell count, White blood cells urine, White blood cells urine positive, pH urine
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection
Clinical narrative: This case was reported by a vaccine regional medical scientist by a sales representative and described the occurrence of rotavirus infection in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced severe rotavirus infection and was hospitalized. No additional information was provided.
Age: 42.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Arthralgia, Asthenia, Blister, Blood test normal, Dyspnoea
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of blisters on the neck in a 42-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), BOOSTRIX. Concurrent medical conditions included anterior cervical fusion. Concurrent medications included Calcium and Vitamin D. On 18 April 2011 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm and 1st dose of BOOSTRIX. On the morning of 19 April 2011, 1 day after vaccination with BOOSTRIX and TWINRIX, the subject developed a sore on the left arm up to the neck in the form of blisters on her neck (about 5-6 in number). On 21 April 2011, three days after vaccination with BOOSTRIX and TWINRIX, the patient awakened with muscle stiffness in the middle of the night. She was unable to move, had difficulty breathing and multiple symptoms of weakness on both sides. All symptoms were alternating and sporadic. Sharp pains in the wrist and elbow were also reported. The subject was hospitalized on the morning of 21 April 2011 with symptoms improved and with diagnosis of possible shingles (for which she received VALTREX treatment) and possible Guillain Barre Syndrome. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was released the next day with events improved. Blood work was negative and MRI negative status post cervical fusion surgery. Events of blistering, shingles and Guillain Barre Syndrome were reported to be resolved and probably attributable to treatment with TWINRIX and BOOSTRIX. It was reported that the subject experienced symptoms previously to flu vaccine (date was not specified). The symptoms were not known, but the subject did not feel well.
Age: 42.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Movement disorder, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of blisters on the neck in a 42-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), BOOSTRIX. Concurrent medical conditions included anterior cervical fusion. Concurrent medications included Calcium and Vitamin D. On 18 April 2011 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm and 1st dose of BOOSTRIX. On the morning of 19 April 2011, 1 day after vaccination with BOOSTRIX and TWINRIX, the subject developed a sore on the left arm up to the neck in the form of blisters on her neck (about 5-6 in number). On 21 April 2011, three days after vaccination with BOOSTRIX and TWINRIX, the patient awakened with muscle stiffness in the middle of the night. She was unable to move, had difficulty breathing and multiple symptoms of weakness on both sides. All symptoms were alternating and sporadic. Sharp pains in the wrist and elbow were also reported. The subject was hospitalized on the morning of 21 April 2011 with symptoms improved and with diagnosis of possible shingles (for which she received VALTREX treatment) and possible Guillain Barre Syndrome. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was released the next day with events improved. Blood work was negative and MRI negative status post cervical fusion surgery. Events of blistering, shingles and Guillain Barre Syndrome were reported to be resolved and probably attributable to treatment with TWINRIX and BOOSTRIX. It was reported that the subject experienced symptoms previously to flu vaccine (date was not specified). The symptoms were not known, but the subject did not feel well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: polyarthralgias & myalgias starting about 6 hours after receiving Zostavax
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 103.8 that would not come down with medication.  Fever was gone within 24 hours of onset.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Ankylosing spondylitis, Computerised tomogram abnormal, Inflammation, Nuclear magnetic resonance imaging abnormal, Oedema peripheral
Clinical narrative: Right foot pain including swelling and rashes on foot and above right knee.  Treatment included Motrin 800mg.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Rash, Ultrasound scan abnormal, White blood cell scan, X-ray abnormal
Clinical narrative: Right foot pain including swelling and rashes on foot and above right knee.  Treatment included Motrin 800mg.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lymph node palpable, Tenderness
Clinical narrative: Pt developed fatigue and tender L posterior cervical node. Developed a few more small L post cervical nodes over next few days then came to see me 5/09/11. She still c/o fatigue and was concerned about role of HPV vaccine in causing her sxs because she had "read about it online" She stated she didnt want any further doses for now. PE revealed only some shotty L post cervical nodes. Otherwise unremarkable.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: Baby was up screaming at 10:00 PM after going to bed at 7:00 PM, and it was discovered she had a fever of 102.6. Treated with Infant Tylenol, which would reduce the fever slightly for about 3 hours, after which it went up again. Our child was also extremely fussy and irritable. Fever persisted until the afternoon of 05/14/2011, so about 16 hours. She was fussy for about 24 hours after onset of the fever.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Full blood count, Headache, Pyrexia, Stomatitis, White blood cell count decreased
Clinical narrative: Fever up to 103, severe headache, Fever lasted 5 days, headache still persisting at 8 days, sores in mouth developed on 5/12.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Diffuse rash; head to toe
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Full blood count normal, Grand mal convulsion, Urine analysis normal
Clinical narrative: My son had a generalized tonic clonic seizure that lasted 16 minutes and required 2 doses of Valium from the paramedics to stop it.  He was admitted to the hospital overnight for observation.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Full blood count normal, Grand mal convulsion, Urine analysis normal
Clinical narrative: My son had a generalized tonic clonic seizure that lasted 14 minutes and required 2 doses of medication to stop it.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Blood test, Convulsion, Pallor, Staring, Tremor
Clinical narrative: Pt. became pale and then had a seizure. He was staring and tremors in his legs and hands. Seizure symptoms lasted less than 5 min. We took the baby to ER for eval.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Appendicitis, Laboratory test abnormal, Pathology test
Clinical narrative: Appendicitis the next day 5/6/11 after HPV only administered 5/5/11.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal tenderness, Appendicectomy, Appendicitis, Blood glucose normal
Clinical narrative: Appendicitis the next day 5/6/11 after HPV only administered 5/5/11.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Laparoscopic surgery, Lymphocyte percentage decreased, Neutrophil percentage increased, Pathology test
Clinical narrative: Appendicitis the next day 5/6/11 after HPV only administered 5/5/11.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Protein urine present, Psoas sign, Urine ketone body present, Vomiting, White blood cell count
Clinical narrative: Appendicitis the next day 5/6/11 after HPV only administered 5/5/11.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Pt had welt at site of injection with 3 1/2 inches started within 24 hours. Pt took BENADRYL & CLARITIN around 5/13/11 and it started resolving. Still treating as of 5/16/11, not much better.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on face and torso per call on 5/16/11 at 4 pm. Tx with 1/2 tsp BENADRYL q 6hrs PRN until rash is gone.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: 1) Vaccine given at about 10:30AM & she came back at about 1:30pm = RD area some swelling & redness, "feels heavy". No dyspnea or SOB or any other sxs. Advised to put warm compress if any other sxs - go to ER ASAP.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area red and hot to touch. Swelling, area measured about 115cm. width.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Nasopharyngitis, Pain in extremity
Clinical narrative: Left deltoid skin redness and lt. arm pain/cough/cold sx. MOTRIN PRN, KEFLEX x 7 days.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site vesicles
Clinical narrative: Pt presented in office on 05/04/2011 with triangle-shaped blister at injection site. Pt. discharged home with Hydroxyzine HCI: 10 mg/5ml 1.5 mL po.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site urticaria, Pruritus
Clinical narrative: Wheal & flare rxn at injection site & itching chills/possible fever.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Culture urine, Flank pain, Protein urine present
Clinical narrative: Following immunization for puncture wound developed bilateral flank pain without fever, chills, dysuria. Flank pain has steadily worsened over past three days. Arm at injection site asymptomatic.
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Gave DTAP IPV instead of TDAP.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm was red and swollen.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: Temperature 103 degrees F, erythema.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever within 24 hours. Redness, swelling, warmth at site of vaccine with 48 hours.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Autism spectrum disorder, Muscular weakness, Walking aid user
Clinical narrative: Patient's mother, on Friday May 13, 2011 called Customer Service Department to report that her son developed leg weakness after receiving vaccines in December. Mother states her son could no longer walk independently after the vaccinations in December. Mother states she watched him "for a little while" waiting for improvement and when there was no improvement, she took patient to a specialist (unknown). Mother states she did not report this issue to the pediatrician because she waiting until after the specialist report was completed. Patient has been diagnosed with PDD through the early intervention program. Mother would like to know if other children had similar outcomes after receiving the same vaccinations.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Headache, Injection site pain, Oedema peripheral, Pain
Clinical narrative: Patient received Tdap vaccine at 0830 on 4/25/11 reported onset of body aches by 1000, aches progressed to diffuse joint pain, headache, tremors in hands, swelling in feet, and increase in "hot flashes". Patient reported symptoms on 4/26/11 and said they had resolved.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tremor
Clinical narrative: Patient received Tdap vaccine at 0830 on 4/25/11 reported onset of body aches by 1000, aches progressed to diffuse joint pain, headache, tremors in hands, swelling in feet, and increase in "hot flashes". Patient reported symptoms on 4/26/11 and said they had resolved.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Headache, Hot flush, Oedema peripheral, Pain
Clinical narrative: Patient received Tdap vaccine at 0830 on 4/25/11 reported onset of body aches by 1000, aches progressed to diffuse joint pain, headache, tremors in hands, swelling in feet, and increase in "hot flashes". Patient reported symptoms on 4/26/11 and said they had resolved.
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Culture wound, Exposure to vaccinated person, Viral infection
Clinical narrative: CDC calls Call Center for assistance with an ADSM in a civilian ER with a possible SPV lesion despite not being vaccinated. Possible contact transmission case. SM's unit was vaccinated about 17-20 April 2011 whereas the SM was exempted due to a cut on his face. He recalls playing full contact football with members of his unit several days later and then the onset of a lesion on his left hip. The lesion progressively worsened over next few days resulting in visit to clinic. Placed on antibiotics without improvement. Went to civilian ED where lesion was recognized as possible SPV lesion. CDC called initially and then another agency consulted.
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Orthopoxvirus test positive, Polymerase chain reaction, Skin lesion
Clinical narrative: CDC calls Call Center for assistance with an ADSM in a civilian ER with a possible SPV lesion despite not being vaccinated. Possible contact transmission case. SM's unit was vaccinated about 17-20 April 2011 whereas the SM was exempted due to a cut on his face. He recalls playing full contact football with members of his unit several days later and then the onset of a lesion on his left hip. The lesion progressively worsened over next few days resulting in visit to clinic. Placed on antibiotics without improvement. Went to civilian ED where lesion was recognized as possible SPV lesion. CDC called initially and then another agency consulted.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Encephalopathy
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Fatigue, Feeling abnormal, Flushing, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Hypotension, Influenza like illness, Lymphadenopathy, Malaise, Muscular weakness
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Myalgia, Neuropathy peripheral, Pain, Paraesthesia, Petechiae
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Photophobia, Visual impairment
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Altered state of consciousness, Amnesia, Cognitive disorder, Disorientation, Encephalopathy
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Feeling abnormal, Hypoaesthesia, Incorrect dose administered, Paraesthesia, Visual impairment
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Asthenia, Blood test normal, Cognitive disorder, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 21.0
Sex: M
Vaccine: HEP, HEP, HEPA, HEP, HEPA
Symptoms: Laboratory test normal, Memory impairment
Clinical narrative: This case was reported by a consumer and described the occurrence of cognitive impairment in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included a complete three dose series of hepatitis B vaccine recombinant (manufacturer unspecified) given on unspecified dates. Concurrent vaccination included VAQTA (Merck) given on 13 May 2011. There were no concurrent medications. On afternoon of 13 May 2011 the subject inadvertently received a 4th dose of ENGERIX B in the right arm. This was an extra dose administered. On 14 May 2008, less than one day after vaccination with ENGERIX B, the subject experienced cognitive impairment. Events reported included memory loss, spacey feeling, disorientation, feeling out of it (lack of awareness), numbness, tingling and vision disturbance. The subject was diagnosed with encephalopathy. At the time of reporting cognitive impairment and encephalopathy were unresolved. The outcome of the other specified events was not indicated.
Age: 1.02
Sex: U
Vaccine: MMR, HEPA, MMR, VARCEL
Symptoms: Otitis media, Upper respiratory tract infection
Clinical narrative: (R)OM/URI.
Age: 72.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Respiratory failure
Clinical narrative: Patient was admitted to the hospital on 5/5/11 for weakness and tingling in legs, which has ascended and now involves her arms as well.  MRI rulted out intrinsic cord lesion or cord compression.  Per neurologist, patient is likely experiencing Guillain-Barre Syndrome, possibly a post-immunization response.  Patient has not recent viral illness.  Patient has history of degenerative disk disease and has received epidural in the past.  Patient has received IVIG has treatment (8 doses).
Age: 72.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Patient was admitted to the hospital on 5/5/11 for weakness and tingling in legs, which has ascended and now involves her arms as well.  MRI rulted out intrinsic cord lesion or cord compression.  Per neurologist, patient is likely experiencing Guillain-Barre Syndrome, possibly a post-immunization response.  Patient has not recent viral illness.  Patient has history of degenerative disk disease and has received epidural in the past.  Patient has received IVIG has treatment (8 doses).
Age: 21.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Incorrect route of drug administration, Pain of skin, Skin induration, Skin oedema
Clinical narrative: Td (Tetanus diphtheria) booster dose given intradermally - dispensed & mislabeled as tuberculin (TUBERSOL) by pharmacist. Pt developed painful, indurated, erythematous, edematous skin rx x 3 days.
Age: 21.0
Sex: M
Vaccine: TD
Symptoms: Skin reaction, Wrong drug administered
Clinical narrative: Td (Tetanus diphtheria) booster dose given intradermally - dispensed & mislabeled as tuberculin (TUBERSOL) by pharmacist. Pt developed painful, indurated, erythematous, edematous skin rx x 3 days.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper right arm red, warm and swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Pt received vaccine in am on 5/13. Pt called back that afternoon to report N/V. Pt was also taking MACROBID. PCP spoke to pt & was advised to d/c MACROBID & switch to CIPRO.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Pt received ADACEL 5/11, pt called 5/13 to report body aches, pain at injection site, feverish feeling. Pt spoke to PCP and.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Exposure to vaccinated person, Orthopoxvirus test positive, Polymerase chain reaction, Skin lesion
Clinical narrative: A 25 y/o female nursing student contacted the DOH about a suspicious lesion on her chin. She had contact with her boyfriend, who is a contractor and was vaccinated against smallpox 4/26/11. The patient was with her boyfriend from May 4 through May 9 during which time the vaccinee only wore a band-aid on the site while they slept. She helped him change the bandage on his vaccination site on May 7 (site was red with central depression and purulent drainage). On May 9, the patient developed what she thought was a pimple on her chin. The lesion progressed and she recognized it as not being a pimple, and called the DOH on 5/11. On 5/13/11 she developed 3 additional lesions on her chin. She was treated with VIG on 5/14/11.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Exposure to vaccinated person, Laboratory test abnormal, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission
Clinical narrative: A 25 y/o female nursing student contacted the DOH about a suspicious lesion on her chin. She had contact with her boyfriend, who is a contractor and was vaccinated against smallpox 4/26/11. The patient was with her boyfriend from May 4 through May 9 during which time the vaccinee only wore a band-aid on the site while they slept. She helped him change the bandage on his vaccination site on May 7 (site was red with central depression and purulent drainage). On May 9, the patient developed what she thought was a pimple on her chin. The lesion progressed and she recognized it as not being a pimple, and called the DOH on 5/11. On 5/13/11 she developed 3 additional lesions on her chin. She was treated with VIG on 5/14/11.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Skin lesion
Clinical narrative: A 25 y/o female nursing student contacted the DOH about a suspicious lesion on her chin. She had contact with her boyfriend, who is a contractor and was vaccinated against smallpox 4/26/11. The patient was with her boyfriend from May 4 through May 9 during which time the vaccinee only wore a band-aid on the site while they slept. She helped him change the bandage on his vaccination site on May 7 (site was red with central depression and purulent drainage). On May 9, the patient developed what she thought was a pimple on her chin. The lesion progressed and she recognized it as not being a pimple, and called the DOH on 5/11. On 5/13/11 she developed 3 additional lesions on her chin. She was treated with VIG on 5/14/11.
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to >103 starting 3 days after vaccination without other symptoms or signs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Patient's father reported patient had swelling of left arm localized around injection day after immunization. Swelling progressed to the middle of forearm the next day. Therefore father took patient to ER. Received TYLENOL for fever and supportive care (cold compresses). PE: Left arm: warmth, erythema, swelling of left upper arm extending from shoulder to midline of forearm. No neurovascular compromise. Able to move left arm in all directions without any restrictions.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Chest discomfort, Oropharyngeal pain
Clinical narrative: Pt. rec'd vaccine in our clinic 5/16/11 at 0830 c/o sore throat and tightness of chest in PM hours. Returned to clinic at 830 5/17/11 gave steroid injection and BENADRYL 50 mg.
Age: 34.0
Sex: F
Vaccine: TYP, YF
Symptoms: Unevaluable event
Clinical narrative: Was left message to return to clinic if symptoms persisted or got worse. Pt has not come in nor does she reply to messages left, stressed need to complete VAERS with more details, but she does not comply.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Inj was administered in Left deltoid, then two days post inj. Left arm from shoulder to elbow was red, hot & swollen.
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Initial report received from an incarcerated consumer on 10 May 2011. A patient (age and birth date not provided) received on an unknown date an injection (route and site not reported) of INFLUENZA VACCINE (unspecified), sanofi pasteur lot number not reported. The patient reported that he received FLUZONE 2010-2011 formula bar code #5961. The patient has a history of seizures and has been on DILANTIN 500 milligrams (mg) daily to control his seizures. Since receiving the vaccine, he reported experiencing extremely more amounts of "petty MA seizures". The patient can not "tie it to anything meaning time of day eating, habits events maybe other than causing a bit more stress on my brain". The outcome was reported as not recovered. Documents held by sender: None.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Gianotti-Crosti syndrome, Rash papular, Skin plaque
Clinical narrative: Initial case was retrieved from the scientific literature on 09 May 2011. A 15-month-old male child received on an unknown date an injection (route and site not reported) of DTaP, manufacturer and lot number not reported, and an injection (route and site not reported) of MMR, manufacturer and lot number not reported. "A previously healthy 15-month-old male child presented with a monomorphic papular rash that persisted for 10 days. The rash began two days after vaccination with both MMR and DTaP, first appearing on his thighs and then extending to his arms, legs, and face. It was nonpruritic in nature and not associated with fever, any constitutional symptoms, or recent illness. There was no involvement of mucosal membranes. He was not on any medication, did not have any medical condition, and met all of his developmental milestones. His immunizations were up-to-date and without previous adverse reactions. He had no family history of atopy. On physical examination, there were erythematous papules that were symmetric and measured 1-4 mm in an acral distribution. The papules coalesced to form plaques and were without scale or desquamation. There was notable sparing of his chest, abdomen, back, and buttocks. He was otherwise well and did not have lymphadenopathy or hepatosplenomegaly. A clinical diagnosis of GIANOTTI-CROSTI syndrome was made, and no further workup was pursued. The outcome was not reported. Documents held by sender: None.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 09 May 2011 from the Investigator participating in a post-marketing observational surveillance study. This is one case out of a cumulative total of 19 pertussis cases received during the surveillance period between 01 January 2010 and 09 May 2011. A case of pertussis disease in a 12 month old, male subject (initials not collected) was identified by the Investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL vaccine: dose 3 was received on 02 September 2010, dose 2 was received on 01 June 2010, and dose 1 was received on 30 March 2010 (lot numbers, route and site of administration were not reported). The subject developed cold-like symptoms on 11 February 2011, approximately 162 days after his last dose of PENTACEL. In addition, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR (date not reported). Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 March 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 31 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 78 days. The outcome was not reported. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left outer arm where varicella vaccine administered became red, hot and slightly raised at the injection site with a symetrical diameter of 50 mm.  No treatment at all.  The next day, it increased in size to 100 mm and was now non symmetrical.  The area was approximately 10 degrees hotter than the surrounding tissue.  No treatment given.  The area was slightly tender.  It then became itchy.  It receded and on the fouth day post vaccination was no longer present.  Child not given any medical attention.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV5
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: Upon physical assessment on 4-27-11, the pt had approximately 3" above knee on (R)-leg a 1 1/2" wide and 1 1/4" in length a swollen area with a purple/bruise in the center of the raised area.
Age: 5.0
Sex: M
Vaccine: TYP, YF
Symptoms: Erythema, Full blood count normal, Liver function test normal, Pyrexia, Swelling
Clinical narrative: Redness & swelling noted at 20 hrs after vaccine. Fever started 48 hrs after vaccine administration with worsening of local redness.
Age: 5.0
Sex: M
Vaccine: TYP, YF
Symptoms: Urine analysis normal
Clinical narrative: Redness & swelling noted at 20 hrs after vaccine. Fever started 48 hrs after vaccine administration with worsening of local redness.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion
Clinical narrative: Mom reported an unwitnessed event - similar to a possible seizure 24-30 hours after pt received 3rd dose of PEDIARIX (DTAP, HEP B, IPV) & 3rd dose of PCV-13. ER physician noted that unwitnessed event was determined to a "childhood seizure".
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Papule, Pruritus, Rash, Wheezing
Clinical narrative: Pt noted wheezing - 15 min after MENACTRA & Tdap. Known asthma. Diffuse wheeze on exam & felt itchy & given Epi & albut neb. Sx cleared & remain clear 2 hour after treatment.  Slight rash & fine papules. Allergist felt possible latex rxn.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient was standing against the wall after getting his vaccine and watching his brother get his shots when he just slid down the was on to the floor and was unresponsive to mom and became stiff and ridged on the floor.  The nurse came and he was responsive again.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Member given expired dose of MMR.  No adverse reaction noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh red & swollen, warm to touch (4.5 in x 2.5 in).
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Lethargy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lethargy in a 72-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included lethargy which required previous hospitalization. Concurrent medical conditions included anemia, coronary artery disease, diabetes, dialysis, end stage renal disease, gout, hypertension and liver cirrhosis. The subject had 18 unspecified concomitant medications. No other vaccines were given on 10 May 2011. Initially, the healthcare professional reported that the subject received the second dose of ENGERIX B on 03 May 2011. The healthcare professional later reported that the subject received the second dose of ENGERIX B on 10 May 2011 at 18:08 (40 mcg, unknown, left arm). On 12 May 2011, 2 days after vaccination with ENGERIX B, the subject experienced lethargy. The subject had presented to the dialysis facility experiencing lethargy. The subject was hospitalised and the healthcare professional considered the event was disabling and clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Erythema, Fatigue, Localised oedema, Pain
Clinical narrative: Redness, pain, edema, local area & generalized fatigue & arthralgia.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: 5/14/11 intussusception ileocolic. 5/16/11 recurrent intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PPV
Symptoms: Aphagia, Injection site mass, Injection site pain, Moaning, Movement disorder
Clinical narrative: as described on other page...high fever..unable to move or eat...large painful lump in leg where shot was given..moaning in sleep
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: as described on other page...high fever..unable to move or eat...large painful lump in leg where shot was given..moaning in sleep
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Immune system disorder, Insomnia
Clinical narrative: irregular periods, migraines, lower stomach pains, constant tiredness, dizzy, mood changes, insomnia, nausea, lowered immunity to other illnesses
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Migraine, Mood altered, Nausea
Clinical narrative: irregular periods, migraines, lower stomach pains, constant tiredness, dizzy, mood changes, insomnia, nausea, lowered immunity to other illnesses