chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Shot Received 3:15pm, 5:00 PM noticed hives on midline of back and armpit area. Took 2 Benadryl. Itching subsided went to bed at 7:00pm. No hives in am. Have had flu shots before without incident.
Age: 1.78
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure approximately 8 hours following administration of Flu vaccine. Highest fever 103 F. 12/29/06-records requested and received DX: Febrile seizure. FMH: febrile seizures on both sides of family. Temp in ER 103.1.  URI.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Dermatitis, Injection site reaction, Mouth ulceration, Rash maculo-papular
Clinical narrative: Within 15-20 minutes of immunization 3-4 cm of maculo-papular pink, non tender dermatitis at vaccination site on both left and right thighs. Without any systemic symptoms. Rash disappeared within 5 hours with no generalized symptoms.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella occurred on 12/20/2006
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Tension
Clinical narrative: Tense, swelling, erythema at and around vaccine site.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hypoxia
Clinical narrative: Oxygen saturation dropped from 98% to 68% within 1 hour of administration of vaccine and 90% 14 hours later. In previously stable baby.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Night sweats, Thyroid disorder, Tremor
Clinical narrative: Pain joint, nights sweats, shaking, Thyroid problems.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left arm swelling and red from shoulder to elbow. Pain from shot lasted about 2 days. Dr visit 12/08/06 gave 2 tab each day for 2 days Prednisone 10 mg. Got much better after taking for 2 days + 5 Clarinex 1 a day.
Age: 1.02
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Local reactions right thigh marked induration erythema and swelling 4 inches X 5 inches and DTP given right thigh, painful. Left thigh Prevnar given erythema, induration 2 X 3 inches.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot
Clinical narrative: Erythema of arm with warmth 1 week after immunization - ? cellulitis.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash papular
Clinical narrative: Scattered red papules - rash noted 12/22/2006 no treatment.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable crying, onset: 15 minutes after vaccines, duration: 3 hours, description: no fever, no/mild injection site reaction. Shrill-high-pitched loud screaming cry non-stop despite rocking, walking, feeding, verbal comforting, etc.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Patient came into office today with sores all over that doctor felt was chicken pox.
Age: 1.34
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site reaction
Clinical narrative: Quarter- size red macules at site of injection - left thigh. Slowly lumping as of 12/10/06 - redness decrease.
Age: 75.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot
Clinical narrative: Erythema, warmth distal to injection on right upper arm.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hypoxia
Clinical narrative: Oxygen saturation dropped from 96% to 90% within 2 hours after administration O2 saturation returning to 97% then 10 hours after injection O2 saturation to 90% for 3 hours.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site induration, Irritability
Clinical narrative: 12-20-06 approximately 10 am received Pediarix, Prevnar, Hib. 2 hours later extreme irritability, redness and induration in both thighs, no response to bath/Tylenol 80 mg PO at 2 pm; refusing PO. 6:30 pm gave 120 mg Tylenol - seemed to settle. Slept all night. Normal demeanor noted 12/21/06.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: 8.11.06 given Pediarix, Prevnar, Hib developed febrile seizures, seen at the ER. 12.4.06 given DTAP, HIB, IPV, Prevnar developed rash 1 day after vaccination.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Pain, Skin ulcer
Clinical narrative: Skin lesion, edema of arm, generalized aches and pains.
Age: 0.73
Sex: M
Vaccine: HEP
Symptoms: Dyskinesia, Tremor
Clinical narrative: Involuntary head shaking side to side occuring throughout the day and night; each episode lasting 5-10 seconds.  Started the morning after vaccine was given.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dysphagia, Heart rate increased, Vomiting
Clinical narrative: difficulty swallowing rapid heart rate vomiting low blood pressure?
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Per phone call from an area urgent care, the patient developed a cellulitis at site of injection - lt deltoid. Patient had follow-up visit at clinic on 12/6, WBC normal and injection site was noted to be slightly tender to touch at center and a flat red rash area around site. Per patient on phone call 12/28/06 she said arm was no longer swollen or red but was still somewhat tender at site. I told the patient I would submit this vaers report.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count increased
Clinical narrative: Per phone call from an area urgent care, the patient developed a cellulitis at site of injection - lt deltoid. Patient had follow-up visit at clinic on 12/6, WBC normal and injection site was noted to be slightly tender to touch at center and a flat red rash area around site. Per patient on phone call 12/28/06 she said arm was no longer swollen or red but was still somewhat tender at site. I told the patient I would submit this vaers report.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: Patient fainted after receiving her second dose of Gardisil Vaccine. Patient c/o headache and pain in back of her head. Returned to office 12/28/06 for exam. Still c/o head pain. To call office prn with followup.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Heart rate increased, Throat tightness
Clinical narrative: Pt's Symptoms were hoarsness, difficulty breathing, rapid heart beat, and throat was closing up.  The treatment by the PCP was an Epinephrine injection and pt. was given a Benadryl 50mg- 1 po q4-6 hrs Rx.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: 6.5 X 9 CM OVAL INFERIORLY SLIGHTLY INDURATED AND INFERIORLY ERYTHEMATOUS WITH RESOLVING ERYTHEMA AT THE UPPER PORTION INDURATION OF THE SOFT TISSUE OF THE RT ARM,MILDLY TENDER, WARM TO TOUCH  DIPHENHYDRAMINE 25 MG Q 6H FOR 5-7 D, ICING.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Loss of consciousness, Vaccine positive rechallenge
Clinical narrative: I passed out on street about 20 minutes after receiving the flu shot, was taken to the emergency room and spent 2 days in the hospital where they tried to determine cause of faint.  I had severe bruises on my face. 1/18/07 Received medical records from hospital which reveal patient admitted 10/30-11/1/06 after being found on the street by passerby with ecchymoes & abrasions to face & knees after leaving flu clinic.  Taken by EMS to hospital.  Regained consciousness while in ambulance w/o memory of the event. FINAL DX: Syncope.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headaches and headpains started 36 hours after the shot and lasted over 3 weeks
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site induration, Paraesthesia, Swelling
Clinical narrative: Marked local swelling, erythema, subsequent vesicles per patient with paresthesias down arm. At 1 month follow up; persistent induration of approximately 3 cm.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Coma
Clinical narrative: Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead.  5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.
Age: 9.0
Sex: M
Vaccine: YF
Symptoms: Chest pain, Heart rate increased
Clinical narrative: Patient went home, slept from 6-10pm. Awoke complaining "heart hurts". Mother took pulse and thought it was fast. Not aware of any temperature. Took child to Emergency Room. No treatment given. Child fine today per mother.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Abortion, Unintended pregnancy
Clinical narrative: This female subject was enrolled in the prophylactic double blind study. On 28 October 2004, 2 December 2004 and 25 April 2005, the subject received the 1st, 2nd and 3rd dose of HPV IM deltoid or Havrix 720 EU, IM deltoid. This subject received Havrix (lot DVHA817B9). The subject's past medical history included no previous pregnancy. The subject and her partner had no abnormal medical and family history. The subject used no contraception method. Her last menstrual period occurred in June 2006. The subject was exposed to the vaccine before conception. The estimated delivery date was in March 2007. On 09 Sept 2006, 17 months after the 3rd dose of blinded vaccine, this 18 year old subject developed an abortion spontaneous complete. No dilation and curettage was needed. Outcome was unknown at time of reporting. Investigator causality was unknown at the time of reporting.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood sodium increased, Dehydration, Diarrhoea, Hyperthermia, Viral infection
Clinical narrative: Rotavirus Diarrhea, admitted overnight at hospital for dehydration and hyperthermia, Cousin did have diarrhea.  2/12/07 Received medical records from hospital which reveal patient experienced multiple episodes of nonbloody vomiting & diarrhea since 12/25 w/decreased oral intake.  He had lost 2 lbs.  On exam, patient was tachycardic & very tired appearing w/sunken eyes & dry mucous membranes. Tx w/IV hydration w/improvement & admitted overnight for continued hydration & monitoring.   FINAL DX: hypernatremic dehydration likely due to viral gastroenteritis.
Age: 23.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient in for travel appointment, given appropriate immunization for area traveling into. Tdap given after 15 minutes. Patient noted "itchy" around injection site, progressed with swelling to area and redness from 25 cent size to covering all of deltoid area. Benadryl 50 mg IM given and ice pack to area.
Age: 12.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Cold sweat, Hyperhidrosis, Syncope
Clinical narrative: Syncope, diaphoretic, cool clammy skin. No respiratory distress was observed. Vital signs monitored HR 85, BP 100/60 (left arm )104/60 (right arm), RR 18. Episode lasted 1-2 minutes.
Age: 1.33
Sex: F
Vaccine: DTAPH, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Onset of rash and fever 9-10 days after MMR vaccine was given. Rash is blanching flat erythematous maculopapular in nature. No pruritus. Rash located on face/chest/neck/ears/trunk. Child nontoxic, all these findings from 2/7/05 exam. Patient's mother is 1 month pregnant but is Rubella immune.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Headache, Vomiting, Chills occurred about 30 minutes after vaccine.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Clinical Varicella.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Balance disorder, Difficulty in walking, Dysphagia, Dyspnoea
Clinical narrative: tingling feet and fingers,weakness of arms and legs,difficulty swallowing,back pain, staggering, lumpy feel in throat, no reflexes arms and legs,difficulty walking and maintaining balance,back pain,motor cooridination,difficulty breathing. 2/13/07 Received medical records from hospital which reveal patient experienced progressive weakness & paresthesias of LEs with tingling & numbness for approx 4 days.  Admitted to hospital 12/9-12/14/.  Admit exam revealed areflexia & difficulty standing from squat.  Tx w/IVIG w/some improvement.  D/C to rehab hospital.  FINAL DX: most likely Guillain Barre Syndrome.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Hyporeflexia, Muscular weakness, Paraesthesia, Throat tightness
Clinical narrative: tingling feet and fingers,weakness of arms and legs,difficulty swallowing,back pain, staggering, lumpy feel in throat, no reflexes arms and legs,difficulty walking and maintaining balance,back pain,motor cooridination,difficulty breathing. 2/13/07 Received medical records from hospital which reveal patient experienced progressive weakness & paresthesias of LEs with tingling & numbness for approx 4 days.  Admitted to hospital 12/9-12/14/.  Admit exam revealed areflexia & difficulty standing from squat.  Tx w/IVIG w/some improvement.  D/C to rehab hospital.  FINAL DX: most likely Guillain Barre Syndrome.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Cyanosis
Clinical narrative: This case was reported by a physician who described the occurrence of generalized seizure in a 4 month old subject who was vaccinated with Pediarix for prophylaxis. Medical history included a port wine stain in the face. The physician reported that there was a concern with sturge Weber syndrome, but all test have proven negative. On 06 January 2006 at 1:50pm, the subject received the 2nd dose of Pediarix (lot number AC21B047AA). On 06 January 2006, the subject also received injections of Hib vaccine (unknown manufacturer) and Prevnar. On 11 January 2006, five days after vaccination with Pediarix, the subject experienced a generalized seizure characterized as bicycling feet, windmill arms, purple reddish face, spitting and gasping. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention) (OMIC). The physician reported that nuclear magnetic resonance (MRI) and electroencephalogram (EEG) were both normal. The events resolved and the subject was released from the hospital on an unspecified date on or before 17 January 2006. The physician considered the events to possibly be related to vaccination with Pediarix.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Dyspnoea, Movement disorder
Clinical narrative: This case was reported by a physician who described the occurrence of generalized seizure in a 4 month old subject who was vaccinated with Pediarix for prophylaxis. Medical history included a port wine stain in the face. The physician reported that there was a concern with sturge Weber syndrome, but all test have proven negative. On 06 January 2006 at 1:50pm, the subject received the 2nd dose of Pediarix (lot number AC21B047AA). On 06 January 2006, the subject also received injections of Hib vaccine (unknown manufacturer) and Prevnar. On 11 January 2006, five days after vaccination with Pediarix, the subject experienced a generalized seizure characterized as bicycling feet, windmill arms, purple reddish face, spitting and gasping. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention) (OMIC). The physician reported that nuclear magnetic resonance (MRI) and electroencephalogram (EEG) were both normal. The events resolved and the subject was released from the hospital on an unspecified date on or before 17 January 2006. The physician considered the events to possibly be related to vaccination with Pediarix.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Convulsion, Dyspnoea, Erythema, Skin discolouration
Clinical narrative: This case was reported by a physician who described the occurrence of generalized seizure in a 4 month old subject who was vaccinated with Pediarix for prophylaxis. Medical history included a port wine stain in the face. The physician reported that there was a concern with sturge Weber syndrome, but all test have proven negative. On 06 January 2006 at 1:50pm, the subject received the 2nd dose of Pediarix (lot number AC21B047AA). On 06 January 2006, the subject also received injections of Hib vaccine (unknown manufacturer) and Prevnar. On 11 January 2006, five days after vaccination with Pediarix, the subject experienced a generalized seizure characterized as bicycling feet, windmill arms, purple reddish face, spitting and gasping. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention) (OMIC). The physician reported that nuclear magnetic resonance (MRI) and electroencephalogram (EEG) were both normal. The events resolved and the subject was released from the hospital on an unspecified date on or before 17 January 2006. The physician considered the events to possibly be related to vaccination with Pediarix.
Age: 1.43
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 17 month old female subject who was vaccinated with Pediarix for prophylaxis. The subject had no food or drug allergies. There were no concurrent medications. The subject had not experienced any adverse events following previous vaccinations. On 07 March 2006 at 11:00 am, the subject received 2nd dose of Pediarix in the left thigh (lot number not provided). On 08 March 2006, 1 day after vaccination with Pediarix, the subject experienced hives and itching. The physician considered the events to jeopardize the subject or require clinical intervention. The events resolved on 09 March 2006. The Pediarix immunisation series was discontinued. The physician reported that the intention was to skin test the subject to the product and components to see if there were separate reactions. The subject was reported to have no known medical history or concurrent illness, however, the physician could not rule out that the events may have been associated with medical history or concurrent illness oar an other unknown condition. The physician considered the events were possibly related to Pediarix.
Age: 1.43
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 17 month old female subject who was vaccinated with Pediarix for prophylaxis. The subject had no food or drug allergies. There were no concurrent medications. The subject had not experienced any adverse events following previous vaccinations. On 07 March 2006 at 11:00 am, the subject received 2nd dose of Pediarix in the left thigh (lot number not provided). On 08 March 2006, 1 day after vaccination with Pediarix, the subject experienced hives and itching. The physician considered the events to jeopardize the subject or require clinical intervention. The events resolved on 09 March 2006. The Pediarix immunisation series was discontinued. The physician reported that the intention was to skin test the subject to the product and components to see if there were separate reactions. The subject was reported to have no known medical history or concurrent illness, however, the physician could not rule out that the events may have been associated with medical history or concurrent illness oar an other unknown condition. The physician considered the events were possibly related to Pediarix.
Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Arthropathy, Myalgia, Myositis, Pain
Clinical narrative: Three days after first hepatitis B shot, experienced stiffness, joint pain, inflammation. Followed by excruciating abrupt, relentless muscle contractions in extremities. Had to carry right arm with left arm; unable to move shoulder or arm without intense unbearable pain (10/10). Extreme aching, muscle atrophy, wasting, weakness.   Cannot position arm comfortably and relentless pain prevents sleep for three and-a-half consecutive months. Sleep still difficult six months later. Radiating pain extending to wrists. Pain expanding across top of shoulders under shoulder blades, and neck. Total existance is fighting pain and seeking help. Treated for hyper inflammatory autoimmune response to Hep B vaccination. VAERS requests only one date for vaccination. I record both first and second vaccination dates with progressive adverse reactions. Seeing six doctors and physical therapist. Not recovered to date, over six months after first vaccination. Please develop test for people who may have autoimmune response. Feel like someone was hitting me with a hatchet.
Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Hypokinesia, Injection site inflammation, Insomnia, Muscle contractions involuntary
Clinical narrative: Three days after first hepatitis B shot, experienced stiffness, joint pain, inflammation. Followed by excruciating abrupt, relentless muscle contractions in extremities. Had to carry right arm with left arm; unable to move shoulder or arm without intense unbearable pain (10/10). Extreme aching, muscle atrophy, wasting, weakness.   Cannot position arm comfortably and relentless pain prevents sleep for three and-a-half consecutive months. Sleep still difficult six months later. Radiating pain extending to wrists. Pain expanding across top of shoulders under shoulder blades, and neck. Total existance is fighting pain and seeking help. Treated for hyper inflammatory autoimmune response to Hep B vaccination. VAERS requests only one date for vaccination. I record both first and second vaccination dates with progressive adverse reactions. Seeing six doctors and physical therapist. Not recovered to date, over six months after first vaccination. Please develop test for people who may have autoimmune response. Feel like someone was hitting me with a hatchet.
Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Musculoskeletal stiffness, Pain, Shoulder pain
Clinical narrative: Three days after first hepatitis B shot, experienced stiffness, joint pain, inflammation. Followed by excruciating abrupt, relentless muscle contractions in extremities. Had to carry right arm with left arm; unable to move shoulder or arm without intense unbearable pain (10/10). Extreme aching, muscle atrophy, wasting, weakness.   Cannot position arm comfortably and relentless pain prevents sleep for three and-a-half consecutive months. Sleep still difficult six months later. Radiating pain extending to wrists. Pain expanding across top of shoulders under shoulder blades, and neck. Total existance is fighting pain and seeking help. Treated for hyper inflammatory autoimmune response to Hep B vaccination. VAERS requests only one date for vaccination. I record both first and second vaccination dates with progressive adverse reactions. Seeing six doctors and physical therapist. Not recovered to date, over six months after first vaccination. Please develop test for people who may have autoimmune response. Feel like someone was hitting me with a hatchet.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00076. An 11 week old male patient, with past history of mild atopic dermatitis, had received a first dose , intramuscular, left thigh injection of Daptacel, lot number C249DAA9 (not a valid lot number), a first dose, intramuscular, right thigh injection of IPOL, lot number 2040 (not valid lot number), a first dose, reported intramuscular, left thigh injection of Rotateq, lot number 655296/0979F, a first dose, intramuscular, left thigh injection of Comvax, lot number 654802/0681F, a first dose, intramuscular, right thigh injection of Prevnar, lot number B08666H, on 03 November 2006. The patient had no illness at the time of vaccination. Twenty two days post vaccination, the patient developed persistent crying. The next day, he had a diaper of blood. Unspecified medical attention was sought. The patient was diagnosed with intussusception and hospitalized. A partial small bowel resection was performed emergently. At the time of the report to this manufacturer the patient was still hospitalized. It was noted that the reporter was unable to assess if the patients adverse event resulted in permanent disability. Persistent crying and intussusception were considered to be immediately life threatening. Outcome was unknown.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00076. An 11 week old male patient, with past history of mild atopic dermatitis, had received a first dose , intramuscular, left thigh injection of Daptacel, lot number C249DAA9 (not a valid lot number), a first dose, intramuscular, right thigh injection of IPOL, lot number 2040 (not valid lot number), a first dose, reported intramuscular, left thigh injection of Rotateq, lot number 655296/0979F, a first dose, intramuscular, left thigh injection of Comvax, lot number 654802/0681F, a first dose, intramuscular, right thigh injection of Prevnar, lot number B08666H, on 03 November 2006. The patient had no illness at the time of vaccination. Twenty two days post vaccination, the patient developed persistent crying. The next day, he had a diaper of blood. Unspecified medical attention was sought. The patient was diagnosed with intussusception and hospitalized. A partial small bowel resection was performed emergently. At the time of the report to this manufacturer the patient was still hospitalized. It was noted that the reporter was unable to assess if the patients adverse event resulted in permanent disability. Persistent crying and intussusception were considered to be immediately life threatening. Outcome was unknown.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Agitation, Crying, Haematochezia, Intussusception
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00076. An 11 week old male patient, with past history of mild atopic dermatitis, had received a first dose , intramuscular, left thigh injection of Daptacel, lot number C249DAA9 (not a valid lot number), a first dose, intramuscular, right thigh injection of IPOL, lot number 2040 (not valid lot number), a first dose, reported intramuscular, left thigh injection of Rotateq, lot number 655296/0979F, a first dose, intramuscular, left thigh injection of Comvax, lot number 654802/0681F, a first dose, intramuscular, right thigh injection of Prevnar, lot number B08666H, on 03 November 2006. The patient had no illness at the time of vaccination. Twenty two days post vaccination, the patient developed persistent crying. The next day, he had a diaper of blood. Unspecified medical attention was sought. The patient was diagnosed with intussusception and hospitalized. A partial small bowel resection was performed emergently. At the time of the report to this manufacturer the patient was still hospitalized. It was noted that the reporter was unable to assess if the patients adverse event resulted in permanent disability. Persistent crying and intussusception were considered to be immediately life threatening. Outcome was unknown.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HEP, HIBV, PNC, RV5
Symptoms: Dehydration, Gastroenteritis, Haematochezia, Haemoglobinaemia, Irritability
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00463. The initial reporter to this manufacturer had been a health care professional. A 13 week old male patient, with no significant past medical history, had received an injection of ActHib, lot number unknown, an injection of DTap, manufacturer unknown, lot number unknown, a first dose, oral administration of Rotateq, lot number unknown, an injection of Prevnar, lot number unknown, and an injection of Recombivax HB, lot number unknown, on 11 October 2006. Routes and sites of administration of the vaccine injections were unknown. Twenty days post vaccination, the patient had three episodes of yellow vomiting and was fussy. Thirty seven days post vaccination, the patient was evaluated by a physician for acute persistent vomiting and pallor. The physician indicated that the patient looked sickly. The patient was hospitalized on the same day. Hemoglobin on admission was 34. Abdominal X ray revealed bowl gas, and upper gastrointestinal series was normal. Intentions were to send the patient home as he seemed to be doing fine. However, hemoglobin decreased to 28 post hydration, and the patient began to vomit again. All labs were normal (specific test identified) except for a slightly increased white blood cell count of 16,000. Stool test were negative (specific test not identified), but were guiac positive. The physician indicated that the stools were not grossly bloody. The patient subsequently recovered and was discharged from the hospital with a diagnosis of gastroenteritis and dehydration. The physician had indicated that although he suspected the event to be a case of intussusception, he could not be sure as no formal diagnosis of intussusception was made during the hospitalization as no barium enema was performed. He also noted that the second dose of rotavirus vaccine would not be administered. The patient recovered from the event and was reported to be doing fine.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HEP, HIBV, PNC, RV5
Symptoms: Malaise, Pallor, Vomiting, White blood cell count increased
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00463. The initial reporter to this manufacturer had been a health care professional. A 13 week old male patient, with no significant past medical history, had received an injection of ActHib, lot number unknown, an injection of DTap, manufacturer unknown, lot number unknown, a first dose, oral administration of Rotateq, lot number unknown, an injection of Prevnar, lot number unknown, and an injection of Recombivax HB, lot number unknown, on 11 October 2006. Routes and sites of administration of the vaccine injections were unknown. Twenty days post vaccination, the patient had three episodes of yellow vomiting and was fussy. Thirty seven days post vaccination, the patient was evaluated by a physician for acute persistent vomiting and pallor. The physician indicated that the patient looked sickly. The patient was hospitalized on the same day. Hemoglobin on admission was 34. Abdominal X ray revealed bowl gas, and upper gastrointestinal series was normal. Intentions were to send the patient home as he seemed to be doing fine. However, hemoglobin decreased to 28 post hydration, and the patient began to vomit again. All labs were normal (specific test identified) except for a slightly increased white blood cell count of 16,000. Stool test were negative (specific test not identified), but were guiac positive. The physician indicated that the stools were not grossly bloody. The patient subsequently recovered and was discharged from the hospital with a diagnosis of gastroenteritis and dehydration. The physician had indicated that although he suspected the event to be a case of intussusception, he could not be sure as no formal diagnosis of intussusception was made during the hospitalization as no barium enema was performed. He also noted that the second dose of rotavirus vaccine would not be administered. The patient recovered from the event and was reported to be doing fine.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HEP, HIBV, PNC, RV5
Symptoms: Dehydration, Gastroenteritis, Haemoglobin decreased, Irritability, Malaise
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00463. The initial reporter to this manufacturer had been a health care professional. A 13 week old male patient, with no significant past medical history, had received an injection of ActHib, lot number unknown, an injection of DTap, manufacturer unknown, lot number unknown, a first dose, oral administration of Rotateq, lot number unknown, an injection of Prevnar, lot number unknown, and an injection of Recombivax HB, lot number unknown, on 11 October 2006. Routes and sites of administration of the vaccine injections were unknown. Twenty days post vaccination, the patient had three episodes of yellow vomiting and was fussy. Thirty seven days post vaccination, the patient was evaluated by a physician for acute persistent vomiting and pallor. The physician indicated that the patient looked sickly. The patient was hospitalized on the same day. Hemoglobin on admission was 34. Abdominal X ray revealed bowl gas, and upper gastrointestinal series was normal. Intentions were to send the patient home as he seemed to be doing fine. However, hemoglobin decreased to 28 post hydration, and the patient began to vomit again. All labs were normal (specific test identified) except for a slightly increased white blood cell count of 16,000. Stool test were negative (specific test not identified), but were guiac positive. The physician indicated that the stools were not grossly bloody. The patient subsequently recovered and was discharged from the hospital with a diagnosis of gastroenteritis and dehydration. The physician had indicated that although he suspected the event to be a case of intussusception, he could not be sure as no formal diagnosis of intussusception was made during the hospitalization as no barium enema was performed. He also noted that the second dose of rotavirus vaccine would not be administered. The patient recovered from the event and was reported to be doing fine.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HEP, HIBV, PNC, RV5
Symptoms: Pallor, Vomiting, White blood cell count increased
Clinical narrative: Initial report received on 15 December 2006 from another manufacturer, report number WAES0612USA00463. The initial reporter to this manufacturer had been a health care professional. A 13 week old male patient, with no significant past medical history, had received an injection of ActHib, lot number unknown, an injection of DTap, manufacturer unknown, lot number unknown, a first dose, oral administration of Rotateq, lot number unknown, an injection of Prevnar, lot number unknown, and an injection of Recombivax HB, lot number unknown, on 11 October 2006. Routes and sites of administration of the vaccine injections were unknown. Twenty days post vaccination, the patient had three episodes of yellow vomiting and was fussy. Thirty seven days post vaccination, the patient was evaluated by a physician for acute persistent vomiting and pallor. The physician indicated that the patient looked sickly. The patient was hospitalized on the same day. Hemoglobin on admission was 34. Abdominal X ray revealed bowl gas, and upper gastrointestinal series was normal. Intentions were to send the patient home as he seemed to be doing fine. However, hemoglobin decreased to 28 post hydration, and the patient began to vomit again. All labs were normal (specific test identified) except for a slightly increased white blood cell count of 16,000. Stool test were negative (specific test not identified), but were guiac positive. The physician indicated that the stools were not grossly bloody. The patient subsequently recovered and was discharged from the hospital with a diagnosis of gastroenteritis and dehydration. The physician had indicated that although he suspected the event to be a case of intussusception, he could not be sure as no formal diagnosis of intussusception was made during the hospitalization as no barium enema was performed. He also noted that the second dose of rotavirus vaccine would not be administered. The patient recovered from the event and was reported to be doing fine.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Irritability, Pyrexia, Viral infection, Vomiting
Clinical narrative: Initial report received on 15 December 2006 from an other manufacturer, report number WAES0612USA00126, who received the original report from a physician. A 23 week old male patient had received on 16 June 2006 a dose of ActHib, a dose of Dtap, manufacturer unknown, a dose of Recombivax HB, and a first 2.0 ml oral dose of Rotateq, lot number 653661/0146F. The trade name, manufacturer name, lot number, route and site of administration were not reported for the Dtap, and the lot numbers routes and sites of administration were not reported for the ActHib and Recombivax HB. Twenty eight days later, on 14 July 2006 the patient was vaccinated with a second, 0.2ml, oral dose of Rotateq, lot number not reported. On an unspecified day in July 2006, the patient was noted to have fallen out of a shopping cart. On 02 August 2006, the patient developed a fever and was taken to the emergency room, and X ray and labs (not further specified) were normal. No formal diagnosis was made and the patient was simply thought to have a virus. On 17 August 2006, the patient was vaccainted with another dose of ActHib, another dose of Dtap, a dose of IPOL, a dose of Prevnar and a third, 2.0 ml oral dose of Rotateq. The manufacturer names, lot numbers, routes and sites of administration were not reported. Forty two days later, on 28 September 2006, the patient developed vomiting and irritability. The patient was subsequently hospitalized due to persistent vomiting. While hospitalized intussusception was diagnosed and reduced via Barium enema. The patient recovered within 24 hours and was discharged to home. Per the other manufacturer, at the time of the report, the patient was noted to be doing fine by the physician. The physician indicated that he could provide additional information, including medical records if it became available. Per the other manufacturer, no product quality complaint was involved. No other information was provided. Additional information has been requested.  1/25/07 Received medical records from hospital which reveal patient admitted 9/29-10/1/06 for 3 days of intermittent vomiting which was non bloody & non bilious.  No fever & no diarrhea.  Surgery consult done.  Reduced with air enema, but concern remained for only partial reduction & so had NGT placed to suction & remained in hosp for continued observaion.. FINAL DX: Intussusception.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Fall, Intussusception, Irritability, Pyrexia, Viral infection
Clinical narrative: Initial report received on 15 December 2006 from an other manufacturer, report number WAES0612USA00126, who received the original report from a physician. A 23 week old male patient had received on 16 June 2006 a dose of ActHib, a dose of Dtap, manufacturer unknown, a dose of Recombivax HB, and a first 2.0 ml oral dose of Rotateq, lot number 653661/0146F. The trade name, manufacturer name, lot number, route and site of administration were not reported for the Dtap, and the lot numbers routes and sites of administration were not reported for the ActHib and Recombivax HB. Twenty eight days later, on 14 July 2006 the patient was vaccinated with a second, 0.2ml, oral dose of Rotateq, lot number not reported. On an unspecified day in July 2006, the patient was noted to have fallen out of a shopping cart. On 02 August 2006, the patient developed a fever and was taken to the emergency room, and X ray and labs (not further specified) were normal. No formal diagnosis was made and the patient was simply thought to have a virus. On 17 August 2006, the patient was vaccainted with another dose of ActHib, another dose of Dtap, a dose of IPOL, a dose of Prevnar and a third, 2.0 ml oral dose of Rotateq. The manufacturer names, lot numbers, routes and sites of administration were not reported. Forty two days later, on 28 September 2006, the patient developed vomiting and irritability. The patient was subsequently hospitalized due to persistent vomiting. While hospitalized intussusception was diagnosed and reduced via Barium enema. The patient recovered within 24 hours and was discharged to home. Per the other manufacturer, at the time of the report, the patient was noted to be doing fine by the physician. The physician indicated that he could provide additional information, including medical records if it became available. Per the other manufacturer, no product quality complaint was involved. No other information was provided. Additional information has been requested.  1/25/07 Received medical records from hospital which reveal patient admitted 9/29-10/1/06 for 3 days of intermittent vomiting which was non bloody & non bilious.  No fever & no diarrhea.  Surgery consult done.  Reduced with air enema, but concern remained for only partial reduction & so had NGT placed to suction & remained in hosp for continued observaion.. FINAL DX: Intussusception.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 15 December 2006 from an other manufacturer, report number WAES0612USA00126, who received the original report from a physician. A 23 week old male patient had received on 16 June 2006 a dose of ActHib, a dose of Dtap, manufacturer unknown, a dose of Recombivax HB, and a first 2.0 ml oral dose of Rotateq, lot number 653661/0146F. The trade name, manufacturer name, lot number, route and site of administration were not reported for the Dtap, and the lot numbers routes and sites of administration were not reported for the ActHib and Recombivax HB. Twenty eight days later, on 14 July 2006 the patient was vaccinated with a second, 0.2ml, oral dose of Rotateq, lot number not reported. On an unspecified day in July 2006, the patient was noted to have fallen out of a shopping cart. On 02 August 2006, the patient developed a fever and was taken to the emergency room, and X ray and labs (not further specified) were normal. No formal diagnosis was made and the patient was simply thought to have a virus. On 17 August 2006, the patient was vaccainted with another dose of ActHib, another dose of Dtap, a dose of IPOL, a dose of Prevnar and a third, 2.0 ml oral dose of Rotateq. The manufacturer names, lot numbers, routes and sites of administration were not reported. Forty two days later, on 28 September 2006, the patient developed vomiting and irritability. The patient was subsequently hospitalized due to persistent vomiting. While hospitalized intussusception was diagnosed and reduced via Barium enema. The patient recovered within 24 hours and was discharged to home. Per the other manufacturer, at the time of the report, the patient was noted to be doing fine by the physician. The physician indicated that he could provide additional information, including medical records if it became available. Per the other manufacturer, no product quality complaint was involved. No other information was provided. Additional information has been requested.  1/25/07 Received medical records from hospital which reveal patient admitted 9/29-10/1/06 for 3 days of intermittent vomiting which was non bloody & non bilious.  No fever & no diarrhea.  Surgery consult done.  Reduced with air enema, but concern remained for only partial reduction & so had NGT placed to suction & remained in hosp for continued observaion.. FINAL DX: Intussusception.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Viral infection, Vomiting
Clinical narrative: Information has been received concerning a female, with no previous illness, who on 27 Nov 2006 was vaccinated with an oral 2 ml first dose of rotavirus vaccine (lot # 655863/1034F). Concomitant vaccines administered on the same day included Dtap, a dose of IPOL, a dose of Hib vaccine (manufacturer unknown) and a dose Of Prevnar. On 29 Nov 2006, two days after vaccination with Rotavirus vaccine the patient began vomiting. An ultrasound on 01 Dec 2006 showed signs of obstruction and missing abdomen. The patient was hospitalized. Surgery on 01 Dec 2006 revealed intussusception with gangrenous ascending and transverse colon. After colectomy of involved segment the patient was reassessed and the patient was doing well. The patient's experience was considered to be an other important medical event by the reporter (OMIC). A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: Information has been received concerning a female, with no previous illness, who on 27 Nov 2006 was vaccinated with an oral 2 ml first dose of rotavirus vaccine (lot # 655863/1034F). Concomitant vaccines administered on the same day included Dtap, a dose of IPOL, a dose of Hib vaccine (manufacturer unknown) and a dose Of Prevnar. On 29 Nov 2006, two days after vaccination with Rotavirus vaccine the patient began vomiting. An ultrasound on 01 Dec 2006 showed signs of obstruction and missing abdomen. The patient was hospitalized. Surgery on 01 Dec 2006 revealed intussusception with gangrenous ascending and transverse colon. After colectomy of involved segment the patient was reassessed and the patient was doing well. The patient's experience was considered to be an other important medical event by the reporter (OMIC). A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 1.54
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 19 December 2006 from a health care provider. An 18 month old male patient, with no past medical history and no illness at the time of vaccination, had received a first dose, 25ml, injection of Fluzone SV 2006-2007, lot number U2245AA, on 14 December 2006. Two hours later, the patient developed a temperature of 103 degrees farenheit and had a seizure. At the time of the seizure, the patient had been napping. The patient did not have any other symptoms prior to the seizure. He was evaluated in an emergency room and observed for several hours. The patient was sent home and had no further symptoms. Other medications at the time of vaccination included Zyrtec at bedtime. The patient recovered from the event.
Age: 1.54
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 19 December 2006 from a health care provider. An 18 month old male patient, with no past medical history and no illness at the time of vaccination, had received a first dose, 25ml, injection of Fluzone SV 2006-2007, lot number U2245AA, on 14 December 2006. Two hours later, the patient developed a temperature of 103 degrees farenheit and had a seizure. At the time of the seizure, the patient had been napping. The patient did not have any other symptoms prior to the seizure. He was evaluated in an emergency room and observed for several hours. The patient was sent home and had no further symptoms. Other medications at the time of vaccination included Zyrtec at bedtime. The patient recovered from the event.
Age: 1.86
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, PNC
Symptoms: Cellulitis, Cough, Erythema, Feeling hot, Irritability
Clinical narrative: R THIGH CELLULITIS, URI. COUGH, CONGESTED, FUSSY. R THIGH WARM, RED. TEMP 101(R). TREATED WITH MOTRIN.