chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (A) Patient presented to office on the afternoon of 2/09/11 with swelling/erythema & pruritus (nontender). (Patient demonstrated limp only when asked about his thigh). Treatment (1) Hydroxyzine (10mg/5ml) 8 ml PO Q8hrs prn itch (2) BACTRIM suspension 1 1/2 tsp (7.5 ml) PO BID x 7d (B) At follow up visit on 02/10/11, erythema spreading inferiorly & had receded laterally (still pruritic). Patient able to walk/play w/o discomfort. On 2/10/11, patient verbally said that (L) thigh hurt, but demonstrated normal walking, playing, sitting on his knees playing with sides of stroller, etc. Has 2/14/11 appt. scheduled.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: 2/11/11 2.5 x 3 inch area of erythema & swelling & warmth (L) deltoid area patient c/o soreness.
Age: 1.09
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Pt began throwing up bile 7 hours after the vaccination was administered. He was healthy before leading up to shot. Continue to throw up bile for 36 hours following. No temp.
Age: 1.45
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Injection site rash, Rash
Clinical narrative: Rash at injection site.  Rash on bilateral cheeks.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in jaw, Rash, Wheezing
Clinical narrative: After administration OF Tdap & MCV4 c/ of left jaw pain and rash. Also low pitch wheeze
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis
Clinical narrative: Pt reports canker sores on lower lip.  Pharmacist recommended Orabase to protect. Patient said had Blistex at home and would use it. Will return if worsens.
Age: 26.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Erythema, Hypoaesthesia, Local swelling, Musculoskeletal stiffness, Nerve injury
Clinical narrative: 1 AM 2/2/11 - R Thumb red, swollen, numb, hard to move and itchy. 3 PM 2/2/11 - middle fingers R and L hand numb, itchy neck, sl. rash and itchy belly. Took benadryl on own. 2/3/11 AM - R thumb sl. swollen and electricy feeling in hands bilaterally. 2/4/11 tingling starting to subside and MD seen on 2/3 feels not vaccines but a "pulled" nerve Per pt.
Age: 26.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: 1 AM 2/2/11 - R Thumb red, swollen, numb, hard to move and itchy. 3 PM 2/2/11 - middle fingers R and L hand numb, itchy neck, sl. rash and itchy belly. Took benadryl on own. 2/3/11 AM - R thumb sl. swollen and electricy feeling in hands bilaterally. 2/4/11 tingling starting to subside and MD seen on 2/3 feels not vaccines but a "pulled" nerve Per pt.
Age: 0.6
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rotavirus infection in a 7-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On unspecified dates, the subject received 2 doses of ROTARIX (oral) at 2 to 4 months of age. At 7 months of age, the subject experienced rotavirus infection and vaccination failure as confirmed by laboratory testing. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was provided.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Guillain Barre syndrome unknown as this time if will result in permanent disability
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives all over her body and high fevers (over 100) for over three days
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Pruritus, Skin lesion
Clinical narrative: Vesicular rash beginning around 2/10/11 (+) pruritic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Swollen, hard lump at injection site dark pink to red in color, tender-to-touch itchy, dry skin at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, hard lump at injection site dark pink to red in color, tender-to-touch itchy, dry skin at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Formication, Hallucination, Malaise, Screaming
Clinical narrative: Got vaccines 1-27-11. On 2-3-11 had elevated temp; on 2-4-11 woke during the night screaming & hallucinating (seeing & feeling worms & spiders crawling on himself); as of 2-8-11 still said could feel bugs crawling on himself; in general does not feel well & is napping - this is unusual; appt 2-10-11 with PCP; per history mom had hx of drug use; per foster mom following shots 4/2008 pt cried x 3 wks - was not reported by foster parent; saw pcp 2-10-11 & is scheduled for EEG.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pyrexia, Tachycardia, Tremor, Vomiting
Clinical narrative: 12 yo female in ER with sx: shaking, shivering, tachycardia (HR150), vomiting, fever after GARDASIL vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Got TDAP on 1/13/2011 1/16/11 pt noted pain & redness on injection site arm. Pain increased and she present 1/19/11 to clinic. Arm red, warm, tender in band across left deltoid area pt given BACTRIM DS & BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: C-reactive protein normal, CSF protein normal, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre D 2/8. Complaint of walking problem. 1/31 initially thought boney - Reflex ok at that time onset possibly early January. Rx IVIG 2 gm/kg  4 days unit in period. No respiratory involvement.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Lumbar puncture normal, Red blood cell sedimentation rate normal
Clinical narrative: Guillain-Barre D 2/8. Complaint of walking problem. 1/31 initially thought boney - Reflex ok at that time onset possibly early January. Rx IVIG 2 gm/kg  4 days unit in period. No respiratory involvement.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia
Clinical narrative: Weakness.
Age: 1.3
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Pt. was given pediatric influenza vaccine -sanofi- lot UT3574CA at approx. noon on 11-24-10. Pt. was admitted with diagnosis of febrile seizure on evening of 11-24-10. Pt. was given antipyretics and observed overnight and discharged the following day with not apparent continuing sequella. I am submitting this report as a result of a media report that I read regarding Ped. Influenza vaccine and what may be an apparent increased incidence of seizure. I followed up with mother today 1-25-2011 and child has had no further problems or seizure activity and is not currently receiving any medication.
Age: 34.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site streaking, Periorbital haematoma
Clinical narrative: Red banding around (L) arm near injection site approx 1-2 cm on 2-14-11. On 2-15-11 red band faded but brighter red band spread almost to elbow (total of 4cm redness) on 2-17-11 left eye dark like black eye look. No treatment.
Age: 16.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: This is a girl - no prior immunizations - noted fever on 2/6/11 - 11 days after shots. Then developed rash on face & neck the next day. Lasted 2 days, then resolved. No further symptoms. Advised poss. reaction from MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eyelid oedema, Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: On 4/13/05 the child received MMR#2 (right thigh), IPV#4 (left thigh) and DTAP#5 (left thigh). The mother states that the child immediately started scratching his head and face. About 5 minutes later she noted red, raised bumps about the size of mosquito bites all over his body (she does not recall if the lesions were on the soles of feet or palms of the hands). The child was given BENADRYL and released after about 40 minutes. The mother states that the child never had SOB, wheezing, difficulty swallowing, abdominal pain or diarrhea. She does not recall if the child's lips were swollen, but she states that his eyelids were puffy. The pt did not receive any additional doses of BENADRYL or any other meds. The next morning (16 hrs after onset) the rash was gone, but mom noted thigh swelling, erythema and induration (left worse than right). The pt was seen on 4/15/05 for the thigh swelling, erythema and induration. The child was treated with TYLENOL with resolution of sx in about 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Radioallergosorbent test negative, Rash erythematous, Rash generalised
Clinical narrative: On 4/13/05 the child received MMR#2 (right thigh), IPV#4 (left thigh) and DTAP#5 (left thigh). The mother states that the child immediately started scratching his head and face. About 5 minutes later she noted red, raised bumps about the size of mosquito bites all over his body (she does not recall if the lesions were on the soles of feet or palms of the hands). The child was given BENADRYL and released after about 40 minutes. The mother states that the child never had SOB, wheezing, difficulty swallowing, abdominal pain or diarrhea. She does not recall if the child's lips were swollen, but she states that his eyelids were puffy. The pt did not receive any additional doses of BENADRYL or any other meds. The next morning (16 hrs after onset) the rash was gone, but mom noted thigh swelling, erythema and induration (left worse than right). The pt was seen on 4/15/05 for the thigh swelling, erythema and induration. The child was treated with TYLENOL with resolution of sx in about 7 days.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Induration, Influenza, Rash, Skin disorder
Clinical narrative: Rash w/patch centrally red base with varying degree of induration & pre-vesicular changes.
Age: 21.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hot, indurated area at site of immunization
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chills, Influenza like illness, Nausea, Pyrexia
Clinical narrative: flulike aches and chills, fever, nausea, weight loss
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Weight decreased
Clinical narrative: flulike aches and chills, fever, nausea, weight loss
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test normal, Decreased appetite, Dizziness, Lethargy
Clinical narrative: Severe dizziness, weakness, lethargy and loss of appetite.  Dizziness continued for two days.  26 hours after injection, one welt appeared 2 inches below injection site.  Within minutes, several welts began to appear.  Arm began to throb and became hot to the touch.  Visited Urgent Care, was told the welts were "droplets of medicine under the skin." By the next morning, welts had formed into four large bands around arm, and arm was swollen, hot, and hurt from shoulder to elbow.  Visited ER, blood work-up was done, no infection found, doctor concluded the welts were just a bad reaction to the vaccine itself.  Patient is still dizzy and weak more than two days after the injection.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Severe dizziness, weakness, lethargy and loss of appetite.  Dizziness continued for two days.  26 hours after injection, one welt appeared 2 inches below injection site.  Within minutes, several welts began to appear.  Arm began to throb and became hot to the touch.  Visited Urgent Care, was told the welts were "droplets of medicine under the skin." By the next morning, welts had formed into four large bands around arm, and arm was swollen, hot, and hurt from shoulder to elbow.  Visited ER, blood work-up was done, no infection found, doctor concluded the welts were just a bad reaction to the vaccine itself.  Patient is still dizzy and weak more than two days after the injection.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Severe dizziness, weakness, lethargy and loss of appetite.  Dizziness continued for two days.  26 hours after injection, one welt appeared 2 inches below injection site.  Within minutes, several welts began to appear.  Arm began to throb and became hot to the touch.  Visited Urgent Care, was told the welts were "droplets of medicine under the skin." By the next morning, welts had formed into four large bands around arm, and arm was swollen, hot, and hurt from shoulder to elbow.  Visited ER, blood work-up was done, no infection found, doctor concluded the welts were just a bad reaction to the vaccine itself.  Patient is still dizzy and weak more than two days after the injection.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Increased redness/warmth/swelling/itching at site of injections and swelling in axilla of injection arm.  When patient seen in office injection site swollen 7x9cm, warm to touch, and axilla swollen.  Patient stated increased itching still.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Development of painful erythema from skin overlying deltoid medially and down ventromedial surface of upper arm to the elbow over 24-36 hours.
Age: 1.11
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash maculo-papular
Clinical narrative: Mild fever 2/11, 2/12 & 2/13 max 100 rash maculopapular on trunk on 2/14, no itch, erythema (+).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever to 103 degrees F x 3 days swelling, redness, pain over injection site (of TDAP). Tx: ice, BENADRYL.
Age: 1.36
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Irritability
Clinical narrative: Temp of 105.5 about 6 hrs after vaccination. Defervesced with TYLENOL & MOTRIN after 14 hours. Inconsolable cry with elevated temp. fussy but improved with normal temp. At time of report afebrile but fussy still.
Age: 1.76
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Had TDAP on 02/14/11. Pt's father states on 2/15 the site became red and swollen site became more red and swollen and hard on 2/16 and 2/17. Dr. recommended warm compresses, antibiotic, TYLENOL & Ibuprofen for treatment. If isn't improving after 2-3 doses of antibiotic to come back for further treatment.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eye swelling, Myalgia, Ocular hyperaemia, Pruritus generalised
Clinical narrative: Muscles started to ache - then eyes started to burn they were red and slightly swollen - then that evening I itched all over severe. By the next morning I was still ache and eyes extremely red and slightly swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema peripheral
Clinical narrative: Within 12 hours Lt arm edema, erythema and pain to elbow.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Hypoaesthesia, Injection site pustule, Joint swelling, Pruritus, Rash erythematous
Clinical narrative: Pt. developed itchy red bumps left hand, left wrist swelling & itching Lt. arm - numbness left forearm - scattered pustules left deltoid area & left hand.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: Pt. developed itchy red bumps left hand, left wrist swelling & itching Lt. arm - numbness left forearm - scattered pustules left deltoid area & left hand.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Patient signed for TDAP - RN gave adult Hepatitis B instead of TDAP.
Age: 0.9
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Chest X-ray, Cough, Foreign travel, Pneumonia, Pyrexia
Clinical narrative: Fever, slight runny nose, cough while in foreign country. Diagnosed with pneumonia and treated w/antibiotics in foreign country.
Age: 0.9
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rhinorrhoea
Clinical narrative: Fever, slight runny nose, cough while in foreign country. Diagnosed with pneumonia and treated w/antibiotics in foreign country.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Barium double contrast, Colectomy, Colostomy, Dehydration, Explorative laparotomy
Clinical narrative: 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 month old female patient on 02-MAR-2010 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccination included a second IM dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (lot # C3532AA) in her left leg, a second IM dose of PREVNAR (lot# C13802) in her left leg, a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown). On 05-MAR-2010 the patient developed intussusception with vomiting. A diagnosis of intussusception with perforation of ascending colon with necrosis of distal ileum was made. On 08-MAR-2010 an ultrasound revealed intussusception and the patient underwent surgery for intussusception with bowel rupture and resection. The patient underwent exploratory laparotomy with reduction of intussusception and right hemicolectomy with distal ileal to transverse colostomy. Records revealed that during a visit out of state, the patient experienced cold with signs and symptoms for three days, vomiting for one day, some of it mixed with bile, decreased urine output for one day, fever for 1 day, guaiac (+) positive stool and lethargy. The patient had several bouts of bilious emesis in the ER (Emergency Room). She was admitted with dehydration, emesis and oral intolerance. Medical records with laboratory results: Ultrasound of abdomen revealed intussusception at hepatic flexure. Air contrast enema was performed three times which was unsuccessful and the bowel remained perforated. It was also reported that on 25-NOV-2009 the patient presented with acute URI (upper respiratory infection) which was treated symptomatically and improved to just sniffles on 30-NOV-2009 when vaccinated. The listing indicated that one or more of the events were considered to be life-threatening. The original reporting source was not provided. The VAERS ID number: 382236-1. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Food intolerance, Gastrointestinal necrosis, Haematochezia, Intestinal perforation, Intestinal resection
Clinical narrative: 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 month old female patient on 02-MAR-2010 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccination included a second IM dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (lot # C3532AA) in her left leg, a second IM dose of PREVNAR (lot# C13802) in her left leg, a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown). On 05-MAR-2010 the patient developed intussusception with vomiting. A diagnosis of intussusception with perforation of ascending colon with necrosis of distal ileum was made. On 08-MAR-2010 an ultrasound revealed intussusception and the patient underwent surgery for intussusception with bowel rupture and resection. The patient underwent exploratory laparotomy with reduction of intussusception and right hemicolectomy with distal ileal to transverse colostomy. Records revealed that during a visit out of state, the patient experienced cold with signs and symptoms for three days, vomiting for one day, some of it mixed with bile, decreased urine output for one day, fever for 1 day, guaiac (+) positive stool and lethargy. The patient had several bouts of bilious emesis in the ER (Emergency Room). She was admitted with dehydration, emesis and oral intolerance. Medical records with laboratory results: Ultrasound of abdomen revealed intussusception at hepatic flexure. Air contrast enema was performed three times which was unsuccessful and the bowel remained perforated. It was also reported that on 25-NOV-2009 the patient presented with acute URI (upper respiratory infection) which was treated symptomatically and improved to just sniffles on 30-NOV-2009 when vaccinated. The listing indicated that one or more of the events were considered to be life-threatening. The original reporting source was not provided. The VAERS ID number: 382236-1. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Large intestine perforation, Lethargy, Nasopharyngitis, Occult blood positive
Clinical narrative: 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 month old female patient on 02-MAR-2010 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccination included a second IM dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (lot # C3532AA) in her left leg, a second IM dose of PREVNAR (lot# C13802) in her left leg, a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown). On 05-MAR-2010 the patient developed intussusception with vomiting. A diagnosis of intussusception with perforation of ascending colon with necrosis of distal ileum was made. On 08-MAR-2010 an ultrasound revealed intussusception and the patient underwent surgery for intussusception with bowel rupture and resection. The patient underwent exploratory laparotomy with reduction of intussusception and right hemicolectomy with distal ileal to transverse colostomy. Records revealed that during a visit out of state, the patient experienced cold with signs and symptoms for three days, vomiting for one day, some of it mixed with bile, decreased urine output for one day, fever for 1 day, guaiac (+) positive stool and lethargy. The patient had several bouts of bilious emesis in the ER (Emergency Room). She was admitted with dehydration, emesis and oral intolerance. Medical records with laboratory results: Ultrasound of abdomen revealed intussusception at hepatic flexure. Air contrast enema was performed three times which was unsuccessful and the bowel remained perforated. It was also reported that on 25-NOV-2009 the patient presented with acute URI (upper respiratory infection) which was treated symptomatically and improved to just sniffles on 30-NOV-2009 when vaccinated. The listing indicated that one or more of the events were considered to be life-threatening. The original reporting source was not provided. The VAERS ID number: 382236-1. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Rhinorrhoea, Surgery, Ultrasound abdomen abnormal, Upper respiratory tract infection
Clinical narrative: 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 month old female patient on 02-MAR-2010 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccination included a second IM dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (lot # C3532AA) in her left leg, a second IM dose of PREVNAR (lot# C13802) in her left leg, a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown). On 05-MAR-2010 the patient developed intussusception with vomiting. A diagnosis of intussusception with perforation of ascending colon with necrosis of distal ileum was made. On 08-MAR-2010 an ultrasound revealed intussusception and the patient underwent surgery for intussusception with bowel rupture and resection. The patient underwent exploratory laparotomy with reduction of intussusception and right hemicolectomy with distal ileal to transverse colostomy. Records revealed that during a visit out of state, the patient experienced cold with signs and symptoms for three days, vomiting for one day, some of it mixed with bile, decreased urine output for one day, fever for 1 day, guaiac (+) positive stool and lethargy. The patient had several bouts of bilious emesis in the ER (Emergency Room). She was admitted with dehydration, emesis and oral intolerance. Medical records with laboratory results: Ultrasound of abdomen revealed intussusception at hepatic flexure. Air contrast enema was performed three times which was unsuccessful and the bowel remained perforated. It was also reported that on 25-NOV-2009 the patient presented with acute URI (upper respiratory infection) which was treated symptomatically and improved to just sniffles on 30-NOV-2009 when vaccinated. The listing indicated that one or more of the events were considered to be life-threatening. The original reporting source was not provided. The VAERS ID number: 382236-1. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: 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 month old female patient on 02-MAR-2010 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccination included a second IM dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (lot # C3532AA) in her left leg, a second IM dose of PREVNAR (lot# C13802) in her left leg, a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown). On 05-MAR-2010 the patient developed intussusception with vomiting. A diagnosis of intussusception with perforation of ascending colon with necrosis of distal ileum was made. On 08-MAR-2010 an ultrasound revealed intussusception and the patient underwent surgery for intussusception with bowel rupture and resection. The patient underwent exploratory laparotomy with reduction of intussusception and right hemicolectomy with distal ileal to transverse colostomy. Records revealed that during a visit out of state, the patient experienced cold with signs and symptoms for three days, vomiting for one day, some of it mixed with bile, decreased urine output for one day, fever for 1 day, guaiac (+) positive stool and lethargy. The patient had several bouts of bilious emesis in the ER (Emergency Room). She was admitted with dehydration, emesis and oral intolerance. Medical records with laboratory results: Ultrasound of abdomen revealed intussusception at hepatic flexure. Air contrast enema was performed three times which was unsuccessful and the bowel remained perforated. It was also reported that on 25-NOV-2009 the patient presented with acute URI (upper respiratory infection) which was treated symptomatically and improved to just sniffles on 30-NOV-2009 when vaccinated. The listing indicated that one or more of the events were considered to be life-threatening. The original reporting source was not provided. The VAERS ID number: 382236-1. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Acute disseminated encephalomyelitis, Coma, Confusional state, Death, Lumbar puncture
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Subacute sclerosing panencephalitis
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Acute disseminated encephalomyelitis, Confusional state, Death, Dementia, Headache
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Cognitive disorder, Coma, Death, Hallucination, Lumbar puncture
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Neurological decompensation, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: A serious spontaneous report of acute disseminated encephalomyelitis with symptoms of fever, dementia, confusion, headaches and vomiting has been received from a consumer concerning a seven-year-old female, subsequent to FLUMIST. The patient's medical history included measles that she had as a child and a diagnosis of subacute sclerosing panencephalitis. The patient was adopted. Concomitant medications were not reported. The patient received FLUMIST on 08-Nov-2010. On 13-Nov-2010, five days after receiving FLUMIST, the patient developed symptoms of fever, dementia, confusion, headaches and vomiting. She was admitted to the hospital on 24-Nov-2010 and died on 02-Jan-2011. She was diagnosed with Acute disseminated encephalomyelitis at the time of death. The outcome of the event was fatal. The cause of death was not reported.
Age: 1.76
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt. received immunizations on 02/14/2011 parents noticed swelling and hardness on the DTAP injection site on 02/16/2011. Injection site was hard, red, and swollen.
Age: 19.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dehydration, Flavivirus test positive, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu-like sx - seen here 3/8/10 - 3/12/10 resp. sx, myalgia - dehydration, nausea.
Age: 19.0
Sex: F
Vaccine: TYP, YF
Symptoms: Polymerase chain reaction, Respiratory disorder, Yellow fever
Clinical narrative: Flu-like sx - seen here 3/8/10 - 3/12/10 resp. sx, myalgia - dehydration, nausea.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Lip swelling, Musculoskeletal stiffness, Rash generalised
Clinical narrative: Rash over entire body lasting 4 days lower (L) side lip swollen stiff neck.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Computerised tomogram normal, Full blood count, Injection site erythema, Injection site reaction
Clinical narrative: Significant UE arthralgia, red, tender blotchy local reaction (L) deltoid.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Significant UE arthralgia, red, tender blotchy local reaction (L) deltoid.
Age: 0.76
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Laboratory test, Pyrexia
Clinical narrative: Hep B #3 given 2/2/11 at 10:30 AM high fever (104 degrees) at 3pm approximately 4 hours later leading to a brief generalized seizure. Brought to ER did well. No URI sx, other cause. On 2/3/11 developed full URI sx.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Mobility decreased, Pain
Clinical narrative: Rec'd PPSV23 at 3pm 2/8/11. At dinner itchy. At bedtime sore, difficult to lift, redness from site to elbow, sore to touch. No fever. Took ADVIL 2/9/11 am. 2/9 eve symptoms no better - went to ER. Dx cellulitis. Rx'd w/IV antibx, given po antibx to take at home 2/14/11 - slowly improving.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Rec'd PPSV23 at 3pm 2/8/11. At dinner itchy. At bedtime sore, difficult to lift, redness from site to elbow, sore to touch. No fever. Took ADVIL 2/9/11 am. 2/9 eve symptoms no better - went to ER. Dx cellulitis. Rx'd w/IV antibx, given po antibx to take at home 2/14/11 - slowly improving.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 1 1/2 to 2 inch-diameter warm, firm red area at injection site. Pt also c/o increased discomfort for 3 days post-injection.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Client felt her throat begin to close up.  She took two 25mg Benadryl and 10mg of prednisone that happened to be on hand.  Problem resolved and patient did not seek medical attention.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site irritation
Clinical narrative: redness & irriatation at vaccination site
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: large area of redness, slightly warm to touch, slightly firm underneath at area of vaccination
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Chest X-ray normal, Pyrexia, Urine analysis normal
Clinical narrative: Baby was noted to have temperature in the AM after vaccination.  Temp at that time was around 103.  Temp spiked to 105F on Wednesday, 2/16/11 and baby was seen in ER.  CXR and urinalyisis were negative.  Mom is alternating acetaminophen and ibuprofen every 3 hours and reports that fever remains at 103 or above at 9AM on 2/18/11.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Death
Clinical narrative: Patient deceased within 30 days of vaccine administration.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity
Clinical narrative: Patient describes pain and swelling of left arm and also left ear hearing loss
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vaccination site pain
Clinical narrative: Pain at site of vaccination 10/10 Rx Naproxen 500 mg and TYLENOL #3.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Extreme swelling, pain, redness & hardness of arm injected lasting for 3 days. Swelling, redness, hardness eventually dissipated. Pain spread to upper shoulder, armpit and neck. Still experiencing pain 3 weeks later which limits arm movement despite pain killers & allergy meds.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Extreme swelling, pain, redness & hardness of arm injected lasting for 3 days. Swelling, redness, hardness eventually dissipated. Pain spread to upper shoulder, armpit and neck. Still experiencing pain 3 weeks later which limits arm movement despite pain killers & allergy meds.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Cough, Depressed level of consciousness, Pallor, Vomiting
Clinical narrative: Within 1-2 mins of administrating vaccine, child began to cough with small amt of vomit. Paleness & weakness noted. Began to regain color & alertness within 5- 7 mins. No SOB, wheezing or unconsciousness. Monitored in office & referred to private physician.
Age: 1.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Couple of bumps on neck the same day as vaccine was given 2/9/11 - Following day temp 99.4 - red bumps with itching noted in day care given BENADRYL - worsened and seen in office - treated with PRELONE & BENADRYL 2/11/11 - urticaria - face trunk & extremities.
Age: 0.9
Sex: M
Vaccine: HEP, PNC13
Symptoms: Feeling abnormal, Pallor, Respiratory disorder, Tachypnoea
Clinical narrative: Mother reports that approximately 36 hours after the vaccine, patient had an abnormal respiratory pattern (parting respirations & periods of tachypnea), was very pale, & "seemed dazed". No frank lovert seizure activity. Patient was back to normal the next morning.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cyanosis, Pain, Skin discolouration, X-ray normal
Clinical narrative: After receiving flu vaccine, pt. had a black & blue painful area on her arm that was present for 2 months. It did go away for a few weeks but is now back & has been for about 2-3 weeks. She states that it is very painful, & she doesn't know what else could be causing it.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: 1st dose of HPV was given & pat. was told he needs to remain seated for 10 min. He did not follow command & started walking. MA asked him to sit, he cont. & felt dizzy & fell onto the back of his head (fainted). EMR was called & pat. was taken to ER.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Injection site pain, Ultrasound scan normal, Weight bearing difficulty
Clinical narrative: Refusal to bear wt on (L) leg & tenderness to touch at injection site within 12 hrs of flu vaccine being given in (L) leg. MOTRIN helped some.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Woke up 1/8/11 c/o R > L leg pain. Had trouble sitting up & walking. MOTRIN helped some. 1/9/11 - a little better & less pain. 1/10/11 - better.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Rash, Tenderness
Clinical narrative: Local skin reaction. Erythema, tenderness, & raised in the deltoid area.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Severe pain radiating into shoulder & neck. Limited range of motion to arm. Plan: Ice, MOTRIN, Physical therapy off work for 1 week.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Biopsy kidney abnormal, Eye disorder, Eye pain
Clinical narrative: Pt received Influenza vaccination on 9/30/08 (pt unable to remember site). The pt states that at that time her lupus sx were stable (intermittent joint pain; no hx of viral illness or GI sx). She states that about 2 days later she noted a severe right-sided headache (10/10) and severe pain behind her right eye. She states that she was diagnosed with a 6th cranial nerve palsy with inward turning of her right eye. She was evaluated by Ophthalmology and per the pt had a normal brain MRI. Her headache resolved after 2 days (of note her BP med dosage was increased) and her ocular sx resolved after 3 weeks (without tx per the pt). The pt received her next Influenza vaccination on 08/27/09. Again at that time her lupus sx were stable (intermittent joint pain) and she had no sx of a viral illness (ENT or GI). The following day the pt noted arm pain (at the injection site; no erythema, induration or swelling). Within 3 days the pt noted that the joints in her hands were swollen, stiff and painful (5/10). The next day she noted "knots" on her elbows and shoulders which were also painful and stiff. The pt was having difficulty with ADLs. Within the next 2 days she noted bilateral knee and ankle pain, stiffness and joint swelling. She was having difficulty getting out of bed and ambulating. The pt was evaluated by her Rheumatologist approx. 8 weeks after her vaccination. She was started on prednisone with improvement of her pain and decrease in the swelling and stiffness. After 4 weeks the prednisone was discontinued and she was started on PLAQUENIL. The pt states that all of her sx have returned to baseline (intermittent joint pain worse in am and cold weather) except for her right foot and right leg which she states are frequently painful (4/10) and increases to a 9/10 with activity that requires ambulation of longer than 30 minutes.