chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Localized redness @ injection site- esp with VARICELLA.  0 Rx except for observation for 30 mins Pt. advised to give BENADRYL @ home no sob, wheezing
Age: 1.6
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Hives, redness @ injection site - (immediate) --> Hives developed after 5 mins. on chest - observed pt. for 30 mins. Advised BENADRYL PO @ home - no SOB, wheezing.
Age: 47.0
Sex: F
Vaccine: HEPA, MMR, YF
Symptoms: Pruritus, Rash
Clinical narrative: Complained of itching all over. Rash noted arms, face, inner legs and buttocks. BENADRYL 25mg given PO. DECADRON 4mg with Depomedral 40mg IM. Pruritis improving released to husband. Use BENADRYL PRN. Itching legs, rash continues.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope approximately 5 minutes after receiving vaccinations.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Disturbance in social behaviour, Dyskinesia, Hypersomnia, Loss of consciousness, Muscle twitching
Clinical narrative: After his 2 month shots, my son developed some shrill, high-pitched screaming and alternated between screaming and passing out for about 12 hours.  After the screaming/passing out episodes abated he slept really hard.  For the next two weeks he stopped making eye contact, smiling and cooing/babbling like he'd been doing.  We also observed him twitching/jerking his head in his sleep.  The twitching/jerking lasted for about two weeks as well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: After his 2 month shots, my son developed some shrill, high-pitched screaming and alternated between screaming and passing out for about 12 hours.  After the screaming/passing out episodes abated he slept really hard.  For the next two weeks he stopped making eye contact, smiling and cooing/babbling like he'd been doing.  We also observed him twitching/jerking his head in his sleep.  The twitching/jerking lasted for about two weeks as well.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Chills, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: temp of 100, chills, redness behow injection area, swollen around injection area, hot to the touch, hard, very very painful, sweats, dizzy
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Induration, Infection, Injection site erythema, Injection site swelling, Pain
Clinical narrative: temp of 100, chills, redness behow injection area, swollen around injection area, hot to the touch, hard, very very painful, sweats, dizzy
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Autism spectrum disorder, Convulsion, Discomfort, Disturbance in attention
Clinical narrative: Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Encephalitis, Immediate post-injection reaction, Pyrexia, Rash, Speech disorder developmental
Clinical narrative: Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Autism spectrum disorder, Childhood disintegrative disorder, Convulsion, Discomfort
Clinical narrative: Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Disturbance in attention, Immediate post-injection reaction, Laboratory test, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Rash, Screaming, Social avoidant behaviour, Unresponsive to stimuli
Clinical narrative: Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Decreased appetite, Lethargy, Urine output decreased
Clinical narrative: 24hrs-lethargic, not eating well, not as many wet diapers
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Erythema
Clinical narrative: EXPERIENCED ITCHING ,SHORTNESS OF BREATH, HEAVINESS IN CHEST DIFFICULTY BREATHING,  RASH ,REDDNESS SWELLING ALSO HAD FEVER CHILLS OVERALL WEAKNESS WITH NUMBNESS AND TINGLING IN ARMS AND FACE.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: EXPERIENCED ITCHING ,SHORTNESS OF BREATH, HEAVINESS IN CHEST DIFFICULTY BREATHING,  RASH ,REDDNESS SWELLING ALSO HAD FEVER CHILLS OVERALL WEAKNESS WITH NUMBNESS AND TINGLING IN ARMS AND FACE.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Swelling
Clinical narrative: EXPERIENCED ITCHING ,SHORTNESS OF BREATH, HEAVINESS IN CHEST DIFFICULTY BREATHING,  RASH ,REDDNESS SWELLING ALSO HAD FEVER CHILLS OVERALL WEAKNESS WITH NUMBNESS AND TINGLING IN ARMS AND FACE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Redness occurred at site of administration within hours, spreading over the next day to a total size of approximately 3" by 5", accompanied by itching and tenderness.  No treatment administered.  Reaction was still present but diminished to approximately 1 square inch by 2/16/09.  Patient reported vaccine "burned" on administration.
Age: 0.33
Sex: M
Vaccine: PNC, RV5
Symptoms: Dyskinesia, Tremor
Clinical narrative: After recieving the vaccines at his 4 month appointment, my son demonstrated some jerking/shaking of his head while sleeping.  This lasted for about two weeks.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Erythema, Injection site induration, Injection site warmth, Rash
Clinical narrative: The same day as receiving the combo booster shot, his arm around the site got very warm, Hard to the touch and he aid it hurt.  It was a large red rash which he still has 2 weeks later.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Feeling hot, Hiccups, Nausea, Vomiting
Clinical narrative: Hiccups continuous non stop, nausea vomiting 1 today, 2 times yesterday, normal breathing, c/o warming, no report of rash 140/92, 74, 22R, No wheezing noted 1432 /2/21/09 1501 137/86 - 88- 20R - 98% Advised to go to hospital. Refused Medical Treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: No reaction 5 hours post vaccination.  24 hours post vaccination: 1.5" hard, raised, hot, red area around injection sites on thighs.  36 hours post vaccination:  Areas grown to 2"--all other attributes same.  Low-grade fever throughout episode.
Age: 1.3
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Anorexia, Aphasia, Blood creatinine decreased, Blood heavy metal normal, Decreased appetite
Clinical narrative: Immediately after the proquad and hep A vaccines, his appetite severley decreased. Less than a week later, he had a fever of 102 to 105 for three days, completely lost appetite and lost all speech. Prior to the shot he was speaking a few words. In fact, previously his speech and vocalizations appeared to be a bit advanced for his age. A few weeks later, he started to try and speak again. He had great difficulty saying words previously he had said with ease. He was evalute by the state run program early intervention and recommended for speech therapy.  I was told he had premotor speech problem. He also seem to be having memory problem which I never noticed before.  I was told there was not a diagnotic test for children his age.  Also after a few weeks of his shots his appetite only improved slightly.  Prior to the shots he ate a varied diet and a substantial amount. For a long time after the shot he would only eat certain fruits and meats and not as much.  3/27/09 Received vaccine records & PCP medical records of 11/20/07-11/10/2008. FINAL DX: speech & language regression Records reveal patient experienced good health on 11/20/07.  RTC 11/28 w/fever, dx w/viral illness.  RTC 2/29/08 w/speech loss, had already been evaluated by early intervention, ST & peds neuro.  Had respiratory congestion.  Dx w/serous OM, mild conductive hearing loss.  Parent dizzy & feeling unwell.  Carbon monoxide, sulfure dioxide & nitrogen found in home.  Seen in ER & labs slightly abnormal at that time.  RTC 4/08 Slowly regaining speech, dx w/recurrent serous otitis media.  RTC 9/08 much improved speech, ears clear.
Age: 1.3
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Immediate post-injection reaction, Memory impairment, Pyrexia, Speech disorder
Clinical narrative: Immediately after the proquad and hep A vaccines, his appetite severley decreased. Less than a week later, he had a fever of 102 to 105 for three days, completely lost appetite and lost all speech. Prior to the shot he was speaking a few words. In fact, previously his speech and vocalizations appeared to be a bit advanced for his age. A few weeks later, he started to try and speak again. He had great difficulty saying words previously he had said with ease. He was evalute by the state run program early intervention and recommended for speech therapy.  I was told he had premotor speech problem. He also seem to be having memory problem which I never noticed before.  I was told there was not a diagnotic test for children his age.  Also after a few weeks of his shots his appetite only improved slightly.  Prior to the shots he ate a varied diet and a substantial amount. For a long time after the shot he would only eat certain fruits and meats and not as much.  3/27/09 Received vaccine records & PCP medical records of 11/20/07-11/10/2008. FINAL DX: speech & language regression Records reveal patient experienced good health on 11/20/07.  RTC 11/28 w/fever, dx w/viral illness.  RTC 2/29/08 w/speech loss, had already been evaluated by early intervention, ST & peds neuro.  Had respiratory congestion.  Dx w/serous OM, mild conductive hearing loss.  Parent dizzy & feeling unwell.  Carbon monoxide, sulfure dioxide & nitrogen found in home.  Seen in ER & labs slightly abnormal at that time.  RTC 4/08 Slowly regaining speech, dx w/recurrent serous otitis media.  RTC 9/08 much improved speech, ears clear.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Secondary transmission, Skin lesion
Clinical narrative: Contact tranfer from sharing towels/clothing with roomate vaccinated 27 Jan 2009.  Developed lesions along jawline  17Feb 2009.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: Contact tranfer from sharing towels/clothing with roomate vaccinated 27 Jan 2009.  Developed lesions along jawline  17Feb 2009.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cardiac flutter, Headache, Pain in extremity
Clinical narrative: Temperature of 102.6.  Headache.  Sore arm.  Strange fluttery sensation in chest.  Treatment:  Bedrest.  Aspirin.  Fluids.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Agitation, Anorexia, Chest X-ray, Cyanosis, Dyskinesia
Clinical narrative: loss of muscle control in both arms, restless, high fever - 103.4 - 105.8 at one point, lethargic, lifeless, limp, blue around mouth, fingernails and feet, loss of appetite, fussy, easily agitated, thick green/yellow mucus drainage from nose and in back of throat
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count, Hypotonia, Irritability, Lethargy, Listless
Clinical narrative: loss of muscle control in both arms, restless, high fever - 103.4 - 105.8 at one point, lethargic, lifeless, limp, blue around mouth, fingernails and feet, loss of appetite, fussy, easily agitated, thick green/yellow mucus drainage from nose and in back of throat
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Nail discolouration, Pyrexia, Respiratory syncytial virus test, Restlessness, Rhinorrhoea
Clinical narrative: loss of muscle control in both arms, restless, high fever - 103.4 - 105.8 at one point, lethargic, lifeless, limp, blue around mouth, fingernails and feet, loss of appetite, fussy, easily agitated, thick green/yellow mucus drainage from nose and in back of throat
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin discolouration, Streptococcal identification test
Clinical narrative: loss of muscle control in both arms, restless, high fever - 103.4 - 105.8 at one point, lethargic, lifeless, limp, blue around mouth, fingernails and feet, loss of appetite, fussy, easily agitated, thick green/yellow mucus drainage from nose and in back of throat
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Single patch of shingles in C5 distribution 9 days after administration of Zostavax
Age: 38.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Blood pressure increased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: SWELLING AND PAIN AT INJECTION SITE, FEVER, ELEVATED BLOOD PRESSURE
Age: 38.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Arthralgia, Blood culture, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND PAIN AT INJECTION SITE, FEVER, ELEVATED BLOOD PRESSURE
Age: 38.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Metabolic function test, Pain in extremity, Pyrexia
Clinical narrative: SWELLING AND PAIN AT INJECTION SITE, FEVER, ELEVATED BLOOD PRESSURE
Age: 49.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Blood pressure increased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 49 year old female with hypertension who on 28-OCT-2008 was vaccinated IM with PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). It was reported the patient had received a pneumococcal vaccine in the past (date and manufacturer not specified). Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and lisinopril (manufacturer unspecified). On 29-OCT-2008 the patient experienced arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The patient was treated in an Emergency Room for fever. Complete blood count, complete metabolic profile and blood cultures were performed (results unknown). Her symptoms lasted 5-7 days. Subsequently, the patient recovered from arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The reporter considered swelling and redness at the injection site, arm pain, a fever of 101 degrees F and hip and joint pain to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Arthralgia, Blood culture, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 49 year old female with hypertension who on 28-OCT-2008 was vaccinated IM with PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). It was reported the patient had received a pneumococcal vaccine in the past (date and manufacturer not specified). Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and lisinopril (manufacturer unspecified). On 29-OCT-2008 the patient experienced arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The patient was treated in an Emergency Room for fever. Complete blood count, complete metabolic profile and blood cultures were performed (results unknown). Her symptoms lasted 5-7 days. Subsequently, the patient recovered from arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The reporter considered swelling and redness at the injection site, arm pain, a fever of 101 degrees F and hip and joint pain to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Metabolic function test, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 49 year old female with hypertension who on 28-OCT-2008 was vaccinated IM with PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). It was reported the patient had received a pneumococcal vaccine in the past (date and manufacturer not specified). Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and lisinopril (manufacturer unspecified). On 29-OCT-2008 the patient experienced arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The patient was treated in an Emergency Room for fever. Complete blood count, complete metabolic profile and blood cultures were performed (results unknown). Her symptoms lasted 5-7 days. Subsequently, the patient recovered from arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The reporter considered swelling and redness at the injection site, arm pain, a fever of 101 degrees F and hip and joint pain to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Cough, Deep vein thrombosis, Hypercoagulation, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 20 year old female with respiratory allergies who on 21-FEB-2008, 24-APR-2008 and 16-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (first and second dose lot # unspecified, lot # third dose 660612/0229X). Concomitant therapy included MENACTRA (administered on 21-FEB-2008), ZYRTEC and ALLEGRA. On 04-NOV-2008 the patient went to the physician's office with chest pain and coughing. On 07-NOV-2008 and 14-NOV-2008 the patient came back to the physician's office because the symptoms were still persisting. On 14-NOV-2008 the physician suggested to the patient to go to the hospital. The patient was hospitalized on 15-NOV-2008, a lot of different unspecified tests were done, and the patient was diagnosed with hypercoagulable state and deep venous thrombosis. On an unspecified date the patient was released from the hospital, but the physician did not mention how long the patient was in the hospital for. The physician stated he feels that hypercoaguable state and DVT are life threatening, he was unsure if GARDASIL caused the experience. The patient is still recovering. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Intussusception, Lethargy, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 3 month old female patient who on 04-NOV-2008 was vaccinated with the second dose of ROTATEQ (lot no. 661395/0926X) given by mouth. Concomitant therapy included the second dose of DAPTACEL (lot no. C3176AA) IM into the left leg and the second dose of PREVNAR (lot no. C97882) IM into the right leg. On 16-NOV-2008, the patient experienced intussusception, reduction required surgery. The patient presented with intermittent severe episodes of abdominal pain and lethargy. A barium enema was performed that diagnosed intussusception. Hydrostatic reduction was unsuccessful. Air contrast enema failed to reduce the intussusception. The listing indicated that the events required ER visit, hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed for lot no. 661395/0926X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release met all release specifications. The lot met the requirements of the government and was released. The original reporting source was not provided the VAERS ID # is 334872. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Ultrasound scan abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 3 month old female patient who on 04-NOV-2008 was vaccinated with the second dose of ROTATEQ (lot no. 661395/0926X) given by mouth. Concomitant therapy included the second dose of DAPTACEL (lot no. C3176AA) IM into the left leg and the second dose of PREVNAR (lot no. C97882) IM into the right leg. On 16-NOV-2008, the patient experienced intussusception, reduction required surgery. The patient presented with intermittent severe episodes of abdominal pain and lethargy. A barium enema was performed that diagnosed intussusception. Hydrostatic reduction was unsuccessful. Air contrast enema failed to reduce the intussusception. The listing indicated that the events required ER visit, hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed for lot no. 661395/0926X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release met all release specifications. The lot met the requirements of the government and was released. The original reporting source was not provided the VAERS ID # is 334872. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Rash all over body (bumps).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over body (bumps).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from a health professional concerning a 12 month old female patient who on 21-JAN-2009 at 07:43 was vaccinated with MMR II (lot # 660212/1120X), VARIVAX (lot # 661998/1389X), HAVRIX (lot # AHAVB258AA) in the right thigh, and PREVNAR (lot # D05879). On 22-JAN-2009, 1 day after the vaccinations the patient died (death nos). This report was received from GlaxoSmithKline and was assigned manufacturer report number A0766166A for HAVRIX. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Information has been received from a health professional concerning a 12 month old female patient who on 21-JAN-2009 at 07:43 was vaccinated with MMR II (lot # 660212/1120X), VARIVAX (lot # 661998/1389X), HAVRIX (lot # AHAVB258AA) in the right thigh, and PREVNAR (lot # D05879). On 22-JAN-2009, 1 day after the vaccinations the patient died (death nos). This report was received from GlaxoSmithKline and was assigned manufacturer report number A0766166A for HAVRIX. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Death
Clinical narrative: Information has been received from a health professional concerning a 12 month old female patient who on 21-JAN-2009 at 07:43 was vaccinated with MMR II (lot # 660212/1120X), VARIVAX (lot # 661998/1389X), HAVRIX (lot # AHAVB258AA) in the right thigh, and PREVNAR (lot # D05879). On 22-JAN-2009, 1 day after the vaccinations the patient died (death nos). This report was received from GlaxoSmithKline and was assigned manufacturer report number A0766166A for HAVRIX. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood chloride normal, Blood creatinine increased, Blood potassium normal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Rotavirus infection
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Body temperature
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Dehydration, Enterovirus serology test positive, Fatigue, Gastroenteritis norovirus, Gastrointestinal sounds abnormal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.