chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Myalgia, Rash
Clinical narrative: Within 12-15 hours of vaccinations with (1) Hep B, (2) DTaP, (3) IPV, and (4) Pneumovax patient had slight rash of race (while later resolved) and aching in both calf muscles of lower legs and didn't want to to go school. Some improved on 8/26/07.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Overdose
Clinical narrative: Inadvertantly gave 2 doses of Pediarix vaccine. 1 dose in each thigh-called GSK (Mfg) and CDC, no life threatening reactions-increase risk for localized react.
Age: 1.9
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: (L) thigh erythema, warmth c/o cellulitis
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Had developed 4 welts on (L) shoulder area; appeared as if hit by tree branch. 3 welts at 7 x 1cm long and one 4 x 25cm. Welts were red, raised and warm to touch. Welts were not located by inj. site but more anterior.
Age: 25.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Thrombotic thrombocytopenic purpura
Clinical narrative: Pt reported to clinic with swelling of injection site, warmth and erythema with minor TTP. LROM of shoulder, no SOB, no CP, no MS changes.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Dizziness, Dyskinesia, Eye movement disorder, Incontinence
Clinical narrative: was given MMR 0.5 ml SQ in right upper arm. Afterward, RN explained the possibility of running a low grade temp from the live virus vaccine. Then employee said she felt light-headed. RN grabbed employee's left arm as she dropped to the floor. Employee's pupils were fully dilated and her head bent and left leg jerked up and down. All this lasted approx. 30 seconds. She was incontinent. Eyes were fixed looking straight ahead midline.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: C-reactive protein increased, Unevaluable event, White blood cell count decreased
Clinical narrative: Notice that he had 2" x 1 3/4" then went up to 4"x4" Rt thigh. 7/8/07 Put on antibiotic BID x 10 days. Topical cream and Epsom salts.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 6"x6" area of swelling and induration - central on site of varicella injection - tx - Aleve, Benadryl, Prednisone 60mg x 2 days.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Malaise, Pyrexia, Vision blurred
Clinical narrative: 3 hrs after dosing chills, malaise, fever, next AM: Fever 102.3. Blurred vision-unable to drive. Sxs x 3-4 days. Resolved. Never presented to MD (Not reportable but significant)
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Varivax #2 given 9-4-07 (L) arm SC. 9-6-07 Mother called stated son has huge red area - hot to touch on (L) arm. 9-6-07 - Presented to office with above red area at injection site about 4" in diameter. Advised Benadryl and ice.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Herpes zoster 9-6-07
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Developed welt (R) triceps 1 day after Varivax administered. Treated w/Benadryl, ice
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, PPV
Symptoms: Herpes zoster, Rash
Clinical narrative: Time of shots none noted. 9-10-07 to MD - diagnosis of shingles. Rash started 9-6-07.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Broke out in rash with itching on chest and arms 30 minutes after Hep B injection.  Patient was observed at clinic 15 minutes after injection without any signs/symptoms of adverse reaction. Returned to work and developed symptoms there.  Returned to Clinic and examined by dr.- received SoluMedrol 125 mg IM and give Rx PO Benadryl.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site cellulitis, White blood cell count normal
Clinical narrative: CELLULITIS AT INJECTION SITE 2 DAYS POST INJECTIONS
Age: 18.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised
Clinical narrative: Patient accompanied by his father @ 2:30pm to HD and complained rashes all over his body and face starting 09-10-07.He had one day fever the following day. The client is alert and oriented to person, time and place.He also c/o itches to his body.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram normal, Confusional state, Fall, Full blood count normal, Head injury
Clinical narrative: Shortly after receiving vaccines, patient walked out to front desk of office. While standing at front desk, patient fell to floor, hitting head on counter & floor. Witnesses noted brief (10-15 seconds) of tonic/clonic activity of right arm & leg. Patient became responsive but was confused for 10-15 minutes afterward.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Metabolic function test normal, Tonic clonic movements
Clinical narrative: Shortly after receiving vaccines, patient walked out to front desk of office. While standing at front desk, patient fell to floor, hitting head on counter & floor. Witnesses noted brief (10-15 seconds) of tonic/clonic activity of right arm & leg. Patient became responsive but was confused for 10-15 minutes afterward.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: CSF protein increased, CSF white blood cell count increased, Facial palsy, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Heart rate increased, Muscle spasms, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Sensory loss
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Blood pressure, CSF protein increased, CSF white blood cell count increased, Facial palsy, Gait disturbance
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Guillain-Barre syndrome, Heart rate increased, Lumbar puncture, Muscle spasms, Myalgia
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Hypotonia, Pallor, Peripheral coldness
Clinical narrative: 3-4 hours after shots face was very pale and baby was limp, the mother thought the hands were cold.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash papular, Rash pruritic
Clinical narrative: Developed a post vaccination rash, seen on 9/21/06 and 9/22/06.  Self resolved in a couple of weeks. Rash not present on visit on 10/13/06. New unilateral trunk rash on right with varicella-like erythematous papules today, starting 9/11/07. No vesicles yet but looks like classic mild shingles to me. rash is very itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Herpes zoster, Rash, Scab, Tenderness
Clinical narrative: SHINGLE OUTBREAK ABOVE 8-29-07 - OVER LEFT EYE -RED, ITCHY, RAISED , SCABBY AFTER 2 DAYS AFTER RASH APPEARED, TENDER TO TOUCH.  WENT TO MD ON 8-31-07 PRESCRIBED - VALTREX 1MG TIDX7D. ACYCLOVIR 800 MG 5 TIMES A DAYSX 7 DAYS
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: patient fainted after vaccination and bump his head.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Erythema, Induration, Oedema peripheral
Clinical narrative: Erythema, induration and swelling of L deltoid  with few weeping vesicles
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: 1 hour after vaccine administration patient had generalized seizure tonic-clonic for 1 minute that self-resolved.  She has no history of seizures and a normal neurodevelopmental history.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Livedo reticularis, Oedema peripheral
Clinical narrative: Immunizations administered between 10 and 11 am on 9/12/07.  Grandmother reports hands and arms became blue and mottled around noon.  Caretaker also noted swelling of right lower extremity.  Thye transported infant to local hospital and was seen in the ER.  Infant was given Benadryl IM
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC, DTAP, IPV, PNC
Symptoms: Anaphylactic reaction, Inappropriate schedule of drug administration
Clinical narrative: This case was received from another manufacturer under the reference number WAES 0708USA01648 on 05 September 2007. The following is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 year old male patient was vaccinated on 17-APR-2007 with Gardasil in the right leg. Concomitant suspect therapy included the fourth dose of Daptacel (lot #C2605AA), in the left leg, the third dose of IPOL (lot #20547) in the left leg and the first dose of Prevnar (lot #BO68699F) in the right leg." On 17-APR-2007, the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. Subsequently, the patient recovered from anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. The listing indicated that one or more of the events were considered to be immediately life-threatening." "Follow-up information has been received from the FDA on 27-AUG-2007. On 17-JUL-2007, ER medical records were received from the hospital which revealed that the patient was seen on 19-APR-2007 after being see by their PCP for vaccination that same day. The patient developed facial swelling, rash and periorbital edema. The patient was treated at the PCPs office and then transported to the ER by EMS. The edema improved by arrival in the ER per the patient's parents but still noted to be significant by ER. The patient was treated with additional steroids and antihistamines and observed in the ER. The patient's status improved and he was discharged to home. The final diagnosis reported was acute allergic reaction." "No further information is available."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC, DTAP, IPV, PNC
Symptoms: Anaphylactic reaction, Drug administered at inappropriate site, Hypersensitivity, Periorbital oedema, Rash
Clinical narrative: This case was received from another manufacturer under the reference number WAES 0708USA01648 on 05 September 2007. The following is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 year old male patient was vaccinated on 17-APR-2007 with Gardasil in the right leg. Concomitant suspect therapy included the fourth dose of Daptacel (lot #C2605AA), in the left leg, the third dose of IPOL (lot #20547) in the left leg and the first dose of Prevnar (lot #BO68699F) in the right leg." On 17-APR-2007, the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. Subsequently, the patient recovered from anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. The listing indicated that one or more of the events were considered to be immediately life-threatening." "Follow-up information has been received from the FDA on 27-AUG-2007. On 17-JUL-2007, ER medical records were received from the hospital which revealed that the patient was seen on 19-APR-2007 after being see by their PCP for vaccination that same day. The patient developed facial swelling, rash and periorbital edema. The patient was treated at the PCPs office and then transported to the ER by EMS. The edema improved by arrival in the ER per the patient's parents but still noted to be significant by ER. The patient was treated with additional steroids and antihistamines and observed in the ER. The patient's status improved and he was discharged to home. The final diagnosis reported was acute allergic reaction." "No further information is available."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC, DTAP, IPV, PNC
Symptoms: Swelling face, Wrong drug administered
Clinical narrative: This case was received from another manufacturer under the reference number WAES 0708USA01648 on 05 September 2007. The following is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 year old male patient was vaccinated on 17-APR-2007 with Gardasil in the right leg. Concomitant suspect therapy included the fourth dose of Daptacel (lot #C2605AA), in the left leg, the third dose of IPOL (lot #20547) in the left leg and the first dose of Prevnar (lot #BO68699F) in the right leg." On 17-APR-2007, the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. Subsequently, the patient recovered from anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face. The listing indicated that one or more of the events were considered to be immediately life-threatening." "Follow-up information has been received from the FDA on 27-AUG-2007. On 17-JUL-2007, ER medical records were received from the hospital which revealed that the patient was seen on 19-APR-2007 after being see by their PCP for vaccination that same day. The patient developed facial swelling, rash and periorbital edema. The patient was treated at the PCPs office and then transported to the ER by EMS. The edema improved by arrival in the ER per the patient's parents but still noted to be significant by ER. The patient was treated with additional steroids and antihistamines and observed in the ER. The patient's status improved and he was discharged to home. The final diagnosis reported was acute allergic reaction." "No further information is available."
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diplopia, VIth nerve paralysis, Vision blurred
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 77 year old female with no known allergies who on 08-JUN-2007 at 14:15 was vaccinated SC with a first dose of Zostavax (Oka/Merck) (lot #657676/0619U). There was no illness at the time of vaccination. At 08:00 on 11-JUN-2007 the patient awoke with double vision. It was also reported that the patient experienced nerve pain around the eye after vaccination. Medical attention was sought. The patient was diagnosed with 6th nerve palsy of the right eye. It was noted that the patient required frequent appointments and monitoring. At the time of the report the patient's outcome was unknown but it was noted that the patient was unable to drive and needed to use a patch for distance tasks and activities. A product quality complaint was not involved. Additional information has been requested. The reporter considered the patient's 6th nerve palsy to be incapacitating. This is one of several reports from the same source.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diplopia, Eye pain, Impaired driving ability, Neuralgia, VIth nerve paralysis
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 77 year old female with no known allergies who on 08-JUN-2007 at 14:15 was vaccinated SC with a first dose of Zostavax (Oka/Merck) (lot #657676/0619U). There was no illness at the time of vaccination. At 08:00 on 11-JUN-2007 the patient awoke with double vision. It was also reported that the patient experienced nerve pain around the eye after vaccination. Medical attention was sought. The patient was diagnosed with 6th nerve palsy of the right eye. It was noted that the patient required frequent appointments and monitoring. At the time of the report the patient's outcome was unknown but it was noted that the patient was unable to drive and needed to use a patch for distance tasks and activities. A product quality complaint was not involved. Additional information has been requested. The reporter considered the patient's 6th nerve palsy to be incapacitating. This is one of several reports from the same source.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Enema administration, Full blood count, Haematochezia, Haemoglobin normal
Clinical narrative: Information has been received from an agency (VAERS# 288297) concerning a 20 week old male, with no medical history, who on 27-JUL-2007 was vaccinated with a second dose of Rotateq (Lot# 657360/0508U). Concomitant vaccines included a second dose of Pediarix (Lot# AC21B115AA), a second dose of PedvaxHib (MSD) (Lot# 655393/1247F) and a second dose of Prevnar (Lot# B086908). On 09-AUG-2007 the patient had crying and bloody stool as noted by the patient's parent. The patient was brought to the emergency department, and was diagnosed with intussusception. The patient was hospitalized. The patient's intussusception was reduced with an air enema. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Platelet count normal, White blood cell count increased
Clinical narrative: Information has been received from an agency (VAERS# 288297) concerning a 20 week old male, with no medical history, who on 27-JUL-2007 was vaccinated with a second dose of Rotateq (Lot# 657360/0508U). Concomitant vaccines included a second dose of Pediarix (Lot# AC21B115AA), a second dose of PedvaxHib (MSD) (Lot# 655393/1247F) and a second dose of Prevnar (Lot# B086908). On 09-AUG-2007 the patient had crying and bloody stool as noted by the patient's parent. The patient was brought to the emergency department, and was diagnosed with intussusception. The patient was hospitalized. The patient's intussusception was reduced with an air enema. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Enema administration, Haematochezia, Haemoglobin normal, Intussusception
Clinical narrative: Information has been received from an agency (VAERS# 288297) concerning a 20 week old male, with no medical history, who on 27-JUL-2007 was vaccinated with a second dose of Rotateq (Lot# 657360/0508U). Concomitant vaccines included a second dose of Pediarix (Lot# AC21B115AA), a second dose of PedvaxHib (MSD) (Lot# 655393/1247F) and a second dose of Prevnar (Lot# B086908). On 09-AUG-2007 the patient had crying and bloody stool as noted by the patient's parent. The patient was brought to the emergency department, and was diagnosed with intussusception. The patient was hospitalized. The patient's intussusception was reduced with an air enema. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test normal, Platelet count normal, Ultrasound abdomen abnormal, White blood cell count increased, X-ray abnormal
Clinical narrative: Information has been received from an agency (VAERS# 288297) concerning a 20 week old male, with no medical history, who on 27-JUL-2007 was vaccinated with a second dose of Rotateq (Lot# 657360/0508U). Concomitant vaccines included a second dose of Pediarix (Lot# AC21B115AA), a second dose of PedvaxHib (MSD) (Lot# 655393/1247F) and a second dose of Prevnar (Lot# B086908). On 09-AUG-2007 the patient had crying and bloody stool as noted by the patient's parent. The patient was brought to the emergency department, and was diagnosed with intussusception. The patient was hospitalized. The patient's intussusception was reduced with an air enema. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: X-ray gastrointestinal tract abnormal
Clinical narrative: Information has been received from an agency (VAERS# 288297) concerning a 20 week old male, with no medical history, who on 27-JUL-2007 was vaccinated with a second dose of Rotateq (Lot# 657360/0508U). Concomitant vaccines included a second dose of Pediarix (Lot# AC21B115AA), a second dose of PedvaxHib (MSD) (Lot# 655393/1247F) and a second dose of Prevnar (Lot# B086908). On 09-AUG-2007 the patient had crying and bloody stool as noted by the patient's parent. The patient was brought to the emergency department, and was diagnosed with intussusception. The patient was hospitalized. The patient's intussusception was reduced with an air enema. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. Lot checks were requested. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, 6VAX-F
Symptoms: Autopsy, Death
Clinical narrative: Initial report received on 10 September 2007 from a health care professional. A four-month-old infant with no concurrent illnesses, no known allergies, and who had no pre-existing medical history, had received a second intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2 (reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar (manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not experienced any adverse events following prior vaccinations. Later that evening the patient was "found expired." Reportedly, an autopsy will be completed.  3/19/08 Reviewed autopsy report which states COD as complications of congenital pulmonary malformation.  3/19/08 Autopsy states pathologic diagnoses as: I. Congenital Pulmonary malformation with     A. Microscopic characteristics most c/w congenital cystic adenomatoid malformation, Type I     B. lymphocytic & macrophage peri-bronchial inflammation, mod to marked     C. Intraalveolar hemorrhage, marked     D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o microscopic abnormality of adrenal glands.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, 6VAX-F
Symptoms: Cardiac arrest, Pupil fixed, Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: Initial report received on 10 September 2007 from a health care professional. A four-month-old infant with no concurrent illnesses, no known allergies, and who had no pre-existing medical history, had received a second intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2 (reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar (manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not experienced any adverse events following prior vaccinations. Later that evening the patient was "found expired." Reportedly, an autopsy will be completed.  3/19/08 Reviewed autopsy report which states COD as complications of congenital pulmonary malformation.  3/19/08 Autopsy states pathologic diagnoses as: I. Congenital Pulmonary malformation with     A. Microscopic characteristics most c/w congenital cystic adenomatoid malformation, Type I     B. lymphocytic & macrophage peri-bronchial inflammation, mod to marked     C. Intraalveolar hemorrhage, marked     D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o microscopic abnormality of adrenal glands.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml first dose of Gardasil (date not reported). There was no concomitant medication. Subsequently, the patient "experienced dizziness and fainted" after receiving Gardasil. While in the physician's office it was reported that the patient also experienced "hypotensiveness". The office called 911. The patient went to the hospital and was released after four hours. Subsequently, the patient recovered. The reporting physician considered dizziness, hypotensiveness and fainting to be immediately life-threatening events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Drug administered at inappropriate site, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 0469U) 0.5mL IM in the gluteus. There was no concomitant medication. On 16-AUG-2007 the patient had a short seizure and then fainted shortly after being vaccinated with Gardasil series for approximately 20 seconds. Medical attention was sought. The patient was treated with an ammonia inhalant and oral fluid (Gatorade). On 16-AUG-2007, the patient had fully recovered. Follow-up information was received from the medical assistant. The patient had no injection site reaction. The patient was adopted so a medical history of the patient was not available. Upon internal review, short seizure is considered to be an other medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Fatigue, Mental status changes
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on 16-MAY-2007 was vaccinated with a first dose of Gardasil (lot 657622/0388U). On 16-MAY-2007, the patient was concomitantly vaccinated with hepatitis A vaccine (inactive) (manufacturer unknown). The nurse reported that the patient stated that she received a second dose of Gardasil, but the nurse noted that there was no documentation that the patient received a second dose of Gardasil. On 23-AUG-2007 the patient experienced fatigue, altered mental status and weakness. On 25-AUG-2007, the patient was brought to the emergency room. The patient was hospitalized (details and length of hospitalization not provided). The patient was visited by her physician on 25-AUG-2007, 26-AUG-2007, and 28-AUG-2007. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Familial risk factor, Grand mal convulsion, Immediate post-injection reaction
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 03-AUG-2007 was vaccinated with first dose of Gardasil (lot# 09294). Concomitant therapy included several psychiatric medications [therapy unspecified]. On 03-AUG-2007 within minutes of receiving the vaccine the patient went into grandmal seizure. It was stated that the patient's mother has seizures all the time as well: Medical attention was sought. The patient was referred to a neurologist. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoxia, Oxygen saturation decreased, Oxygen supplementation, Pneumonia primary atypical, Pneumonia viral
Clinical narrative: 9/6/07 Fever 105.1, thick green mucous suctioned from airway. O2 sat at 78-88, Albuterol neb and O2 given. Sent to ED and pt admitted to hospital. Treated with antibiotic for viral vs atypical pneumonia. Discharged from hospital 9-7-07 in stable condition.   11/13/2007 MR received for DOS 9/6/2007. Pt presented to ER with fever (105'F) and hypoxia. O2 sats at nsg facility dropped to 78-88%.  Suctioned for "grren stuff".  O2 sats in ER mid 90's on RA. Txd with abx
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 9/6/07 Fever 105.1, thick green mucous suctioned from airway. O2 sat at 78-88, Albuterol neb and O2 given. Sent to ED and pt admitted to hospital. Treated with antibiotic for viral vs atypical pneumonia. Discharged from hospital 9-7-07 in stable condition.   11/13/2007 MR received for DOS 9/6/2007. Pt presented to ER with fever (105'F) and hypoxia. O2 sats at nsg facility dropped to 78-88%.  Suctioned for "grren stuff".  O2 sats in ER mid 90's on RA. Txd with abx
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Otitis media, Pyrexia, Swelling face
Clinical narrative: Fever, swelling of right cheek, bilateral otitis media.  12/26/2007 MR received for ER visit 9/14/2007 for c/o fever and swelling of R cheek x 2 days. DX: R cheek cellulitis.  L otitis media. L inguinal hernia. On PE R cheek noted to be warm, swollen, and tender. D/C on abx.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Local reaction, Pallor
Clinical narrative: Patient presented 9/11/07 with a local reaction at vaccination site, on left thigh. She had a 3cm x 5cm red, slightly raised area, + blanching, slightly warm to touch, non-tender. Patient was well, in no pain and active. She had no fever.  9/28/07 Reviewed hospital medical records which reveal patient experienced fever with progressively increasing injection site redness, warmth, rash & itching on left leg DTaP site. Failed outpatient treatment w/oral antibiotics.  Admitted 9/14-9/16/2007.  Tx w/IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics FINAL DX: left leg cellulitis s/p immunizations.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Large area of induration, redness and swelling on (R) shoulder at site of shot.
Age: 15.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Injection site rash, Loss of consciousness, Syncope
Clinical narrative: Black out, fainting spell after vaccination of HPV. Rash around the inj site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection sites. Topical Calamine, oral Benadryl PRN.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot, painful at site of injection on Rt hip. Started Keflex 500mg and Benadryl
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: Localized induration and itching at site of injection ---> left arm approximately cm area.
Age: 27.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Asthenia, Headache
Clinical narrative: She reported a headache that lasted for 2 weeks with weakness for 1 week. Relieved with Motrin but came back.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient was seen as new obstetrical patient on 9/13/07 USN done 9/7/07 intrauterine preg at 19 + 4 weeks gestation. Patient received vaccines on August 10, 2007 at 15 + 4 week gestation. Patient currently under 0B care with doctor. Follow-up Information 14-Sep-2007: Pt pregnant, unknown risk to unborn fetus.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: Immediately after receiving 1st Gardasil vaccine, student had "seizure-like"  movements for approximately 15-20 seconds then passed out. Per student, no history of seizures no activity even no ppeng with other vaccines. Does "feel faint" when has blood drawn.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Complex partial seizures, Computerised tomogram normal, Drooling, Dysarthria, Electroencephalogram abnormal
Clinical narrative: Child seen at ER with drooling, slurred speech, lethargy diagnosed with probable partial complex seizure. No fever. On review child may have had two milder episodes over last 6 months also consistent with seizure - so unclear if vaccines have any association.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Lethargy
Clinical narrative: Child seen at ER with drooling, slurred speech, lethargy diagnosed with probable partial complex seizure. No fever. On review child may have had two milder episodes over last 6 months also consistent with seizure - so unclear if vaccines have any association.
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Injection site reaction, Local reaction, Rash maculo-papular
Clinical narrative: Local reaction at injection site and diffuse macular papular rash develop approximately 48 hours after injection was on 2 antibiotics so with if rash Dpt.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Feeling hot, Loss of consciousness, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Client states everything getter dark, head went back, pale. hot, unconscious not responding to verbal stimuli, body got stiff, took V/S, layed on floor, gave Sprite, 911 called parents/client refused to go to ER.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site urticaria, Nausea, Pallor
Clinical narrative: Given vaccine mid afternoon, 2 hours later - hives at site of injection, 4 hours later dizzy. Next day - very pale, nausea, dizziness, headache lasted 48 hours.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain, Erythema, Full blood count normal, Nausea, Pain
Clinical narrative: Area erythematous with swelling, c/o nausea, wheezing, abdominal pain, fever. Area erythematous by swelling growing larger, painful, itchy. 9/10/07 Pt in for reeval today f/u CBC normal. Swelling has enlarged. CHN provided w/Merck NSC #1 encouraged MD to call and also review package insert - reaction should not preclude f/up dose.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Pruritus, Pyrexia, Swelling, Wheezing
Clinical narrative: Area erythematous with swelling, c/o nausea, wheezing, abdominal pain, fever. Area erythematous by swelling growing larger, painful, itchy. 9/10/07 Pt in for reeval today f/u CBC normal. Swelling has enlarged. CHN provided w/Merck NSC #1 encouraged MD to call and also review package insert - reaction should not preclude f/up dose.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: I don't know whether this is coincidence or an adverse event secondary to vaccination. On July 24, 07 I received an injection of Shingles vaccine. On the morning of July 27 or 28 I had premonitory pain around my right lower rib cage. The morning of July 31st I had a rash typical of shingles in the same distribution on the right.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyspnoea, Pain, Paraesthesia
Clinical narrative: Severe body pain, paresthesia, dyspnea
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever after shots - continue Tylenol PRN, RTC if s/s continue.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Gait disturbance, Heart rate increased, Nausea
Clinical narrative: MCV4 given approximately 1417 on 9-6-07. According to mom about 1-2 hours after IZ given patient had dizziness, nausea, difficulty walking and increase HR.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Blood pressure increased, Cyanosis, Fatigue, Headache, Influenza like illness
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Laboratory test, Oxygen saturation normal, Pain, Somnolence
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Anorexia, Blood pressure, Cyanosis, Fatigue, Headache
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Heart rate, Muscular weakness, Myalgia, Oxygen saturation, Pain
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Pain in extremity, Paraesthesia, Rhinorrhoea, Skin discolouration, Tenderness
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.