chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Quadriplegia
Clinical narrative: Information has been received from a physician who heard from a friend, concerning a 17 year old female who was vaccinated with GARDASIL (lot # not reported). The patient, who had apparently been healthy, became quadriplegic within a month. No further information was available. Upon internal review, the patient's quadriplegia was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Reaction to previous exposure to any vaccine
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant and an other health professional through a Merck pregnancy registry concerning a 16 year old female with depression and a history of "female problems" (unspecified), miscarriage (prior to first GARDASIL( and early spontaneous abortion (WAES #0702USA00083) who on 23-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL. On an unspecified date in 2007, the patient received the second dose of GARDASIL. Concomitant therapy included PAXIL. Subsequently on an unspecified date in 2007, the patient had another miscarriage (date not reported). The reporter stated that she did not think the events were related to GARDASIL. After internal review, spontaneous abortion was considered to be an other important medical event. It was also reported that this patient was vaccinated with the first dose of GARDASIL and experienced adverse events (WAES #0702USA00083). Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope, Visual acuity reduced
Clinical narrative: Dizziness, faintness, blackened vision immediately after second vaccination.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Erythema, Flushing, Headache
Clinical narrative: Fever & chills started 12 hrs after injection.  Temp to 102.5 degrees F.  Taking TYLENOL & ADVIL.  Headache.  Flushed on face.  Arm warm to touch & slightly pinkish.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fever & chills started 12 hrs after injection.  Temp to 102.5 degrees F.  Taking TYLENOL & ADVIL.  Headache.  Flushed on face.  Arm warm to touch & slightly pinkish.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue and muscular pain.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache a.m. after vaccines given.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: 7/7/08: Pt reports sudden onset of rash across abdominal area.  1 cm papulo squamous lesions, red, four total scattered on abdomen.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Full blood count, Laboratory test, Nausea, Pain in extremity
Clinical narrative: Pt states after receiving GARDASIL, has had pains to feet.  Persistent nausea.  Abdominal pains.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen
Clinical narrative: Pt states after receiving GARDASIL, has had pains to feet.  Persistent nausea.  Abdominal pains.
Age: 20.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure, Fall, Heart rate decreased, Loss of consciousness, Oxygen saturation normal
Clinical narrative: Pt given GARDASIL per protocol & when patient went to stand-up; she passed out - she fell into fiance's arms (no injury).  Pt. was lied back onto table - had HR in 40s; B/P 76/48; awoke immediately - alert & oriented.  Rested x20-30 min B/P increased 90/70 HR 80 O2 98%.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection red, swollen, warm to the touch, painful, fatigue, itchy.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Site of injection red, swollen, warm to the touch, painful, fatigue, itchy.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Arthralgia, Blood test, Fatigue, Menorrhagia
Clinical narrative: Excess fatigue.  Heavy periods after absence of period.  Joint pain.  Sensitivity to light (continued 3 mos).
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Ultrasound pelvis
Clinical narrative: Excess fatigue.  Heavy periods after absence of period.  Joint pain.  Sensitivity to light (continued 3 mos).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Felt dizzy & weak 5 minutes after receiving the shot; fingers felt tingly, then stiff; I sat down & felt better after ~20 minutes.  Occurred at the doctor's office.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache
Clinical narrative: Prolonged H/A for 3 days.  H/A did resolve by day #4.
Age: 4.0
Sex: F
Vaccine: DTAP, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given oral ROTATEQ vaccine inadvertently.  Pt's family notified and verbalized child has been fine since vaccinations.  Family notified IPV vaccination still needed to be given and family states will follow up with walk in soon.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given oral ROTATEQ vaccine inadvertently.  Pt's family notified and stated on 7/7/08 no side effects and child has been fine since vaccinations.  Mother notified IPV still needed and verbalized she would follow up.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Abdominal pain, Anorexia, Headache
Clinical narrative: Developed intermittent headaches ( 3/d) daily since receiving vaccines. Headaches unresponsive to OTC meds. Pain is a 6/10, worsening to a 8/10 with exertion. 2 weeks after receiving vaccines developed vaccines developed anorexia and abdominal pain when eating. Symptoms: Headache, general, Abdominal Pain, Anorexia.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein increased, Chest pain, Myocarditis
Clinical narrative: 13 ds post SPV developed Myocarditis.  Symptoms: Chest Pain.  8/8/08 Reviewed medical records which included cardiology consult of 6/9/08. FINAL DX: acute myocarditis Records reveal patient experienced chest pain & SOB 5/17/08.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging abnormal, Troponin I increased
Clinical narrative: 13 ds post SPV developed Myocarditis.  Symptoms: Chest Pain.  8/8/08 Reviewed medical records which included cardiology consult of 6/9/08. FINAL DX: acute myocarditis Records reveal patient experienced chest pain & SOB 5/17/08.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Pt. received ZOSTAVAX vaccine.  7-10 days later developed rash consistent with hives.
Age: 3.0
Sex: F
Vaccine: HEPA, VARZOS, VARZOS
Symptoms: Cold sweat, Inappropriate schedule of drug administration, Rash
Clinical narrative: Rash, Clammy
Age: 3.0
Sex: F
Vaccine: HEPA, VARZOS, VARZOS
Symptoms: Body temperature increased, Cold sweat, Pyrexia, Rash, Wrong drug administered
Clinical narrative: Rash, Clammy
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Both hands swollen and itchy and knee started 7/10/08. Patient has history of severe; Reaction to onions - she was treated for allergic reaction one week prior
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Abdominal pain, Dizziness, Lacrimation increased, Nausea, Pharyngolaryngeal pain
Clinical narrative: About 10 minutes after the vaccinations "patient" complained of abdominal pain and nausea. 50mg of Benadryl po given. Vomited x2 complained of sore throat, itchy feet, watering eyes. Epinephrine 0.3 mg given. Complained of dizziness. 911 called. Patient was stable. EMT took to hospital ER. Mother took her to "another" ER also.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: About 10 minutes after the vaccinations "patient" complained of abdominal pain and nausea. 50mg of Benadryl po given. Vomited x2 complained of sore throat, itchy feet, watering eyes. Epinephrine 0.3 mg given. Complained of dizziness. 911 called. Patient was stable. EMT took to hospital ER. Mother took her to "another" ER also.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Pt rec'd GARDASIL (initial injection) by nurse on 5/15/08 -> Pt called office following day approx 3 pm reported she developed rash on chest, arm, neck - 4 hrs after injections denied any other potential contact. Pt has some eczema (works around chemicals at beauty salon).
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hypersensitivity, Pruritus, Pyrexia, Swelling
Clinical narrative: Severe reaction, swelling, fever, itching.  Treated at medical center.  Doctor treated with cortisone and Benadryl and cold pack.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope vasovagal
Clinical narrative: Vasovagal reaction, near syncopal episode
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Full blood count, Platelet count decreased, Pyrexia, Rash generalised, Urine analysis
Clinical narrative: FEVER ONSET 6-12-08; HOSPITALIZED FROM 6-15 THRU 6-16 RASH ONSET 6-13-08 UNTIL PRESENT TO GENERALIZED BODY 7/24/08-records received for DOS 6/16/08-presented to ED with C/O fever since 6/13/08- temp in ED 102.1 (T).  PE normal. DX: Acute pyrexia. Pancytopenia. Discharged home.
Age: 1.17
Sex: F
Vaccine: HEP, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: MOTHER CALLED 6/24/08 TO REPORT CHILD HAS A "RASH ON HER STOMACH, BACK AND NECK". RAN FEVER ON 6/20/08 THEN RASH DEVELOPED 6/23/08 ON NECK & SPREAD TO BACK & STOMACH THIS MORNING AND ALMOST RESOLVED BY 3?30 PM 6/24/08 & NO FEVER SINCE 6/21/08.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Vomiting
Clinical narrative: THROWING UP, DIZZY HEADACHE, RAPID HEART BEAT, DIFFICULTY BREATHING
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: 10 Y O MALE W/4 CM X 5 CM CELLULITIS @ INJECTION SITE N 20 HR P INJECTION. TREATED W KEFLEX 500 MG QID X 5 D.
Age: 18.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: unknown if any increased symptoms
Sex: F
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: Pt arrived to FHP requesting a PPD only. The test was administered in the left forearm (0.1 ml). Pt states: After recieving the PPD vaccine (Mantoux, Tubersol, Lot: C2807AA, NDC 49281-752-22) I left the clinic. About five minutes, my 4 fingers and thumb started to tingle and go numb. They were stiff, but I could still move and wiggle them. I could move them but they were stiff. So I came back to the clinic to get it looked at. Pts' immunization record indicate that she received 2 previous ppd test (2006 & 2007) with no adverse effects.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Dizziness, Headache, Lethargy, Musculoskeletal stiffness
Clinical narrative: C/O HA, NECK STIFFNESS, T-99 DEGREES FAHRENHEIT, LIGHT HEADINESS, LETHARGIC WITHIN 24 HOURS OF RECEIVING VACCINES.  NO VISION PROBLEMS. NO REDNESS OR SWELLING AT INJECTION SITE.  MOTRIN GIVEN.  ADVISED IF HA WORSE OR TEMP GREATER THAN 101.5 THEN GO TO ER.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Crying, Cyanosis, Loss of consciousness, Oxygen supplementation, Respiratory arrest
Clinical narrative: In mother's lap immediately following vaccination, child went limp, unresponsive, stopped breathing and became cyanotic around mouth.  RN picked up child, placed her in position for CPR and gently shook her while calling for help.  Child started weak cry after 15 seconds.  Oxygen at 4 liters/min administered.  Continued to improve until alert, playful, and vital sounds stable and consistent. Phoned primary md, examined by VCHD md before discharged home.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: In mother's lap immediately following vaccination, child went limp, unresponsive, stopped breathing and became cyanotic around mouth.  RN picked up child, placed her in position for CPR and gently shook her while calling for help.  Child started weak cry after 15 seconds.  Oxygen at 4 liters/min administered.  Continued to improve until alert, playful, and vital sounds stable and consistent. Phoned primary md, examined by VCHD md before discharged home.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Eyelid disorder, Facial palsy, Speech disorder
Clinical narrative: Client noticed difficulty talking on 071208.  She also had difficulty closing her eye and she could not smile.  She then went to the med center where they diagnosed her with Bells Palsy and started her on Prednisone and Valtrex.  8/5/08 Reviewed ER medical records of 7/12/2008. FINAL DX: Bell's palsy Records reveal patient experienced abrupt onset left facial droop, unable to close left eye, mouth stiffness x 1 day. Tx w/antiviral & steroids.  D/C to home w/PCP f/u.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Drooling, Ear pain, Facial palsy
Clinical narrative: Client noticed difficulty talking on 071208.  She also had difficulty closing her eye and she could not smile.  She then went to the med center where they diagnosed her with Bells Palsy and started her on Prednisone and Valtrex.  8/5/08 Reviewed ER medical records of 7/12/2008. FINAL DX: Bell's palsy Records reveal patient experienced abrupt onset left facial droop, unable to close left eye, mouth stiffness x 1 day. Tx w/antiviral & steroids.  D/C to home w/PCP f/u.
Age: 1.83
Sex: M
Vaccine: RV5, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: no adverse events, child too old for rotavirus
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Blood calcium increased, Blood magnesium increased, Calcium ionised normal, Computerised tomogram normal, Electroencephalogram normal
Clinical narrative: On 3-28-2008 patient received Dtap, Hib, Prevnar (PCV7) and Rotateq. Mom called office on 4-1-2008, stated on 3-30-2008 and 3-31-2008 noticed he had a spasm -neck, arms,  legs got stiff all of a sudden, for few seconds, no fever, suggested appointment. Patient seen 4-2-2008 by Dr. Doctor ordered labs (CBC w/dif, Mg, ionized Ca and CMP) and EEG (awake and asleep, if possible, within 1 week).  Also diagnosed oral fungal infection, nystatin suspension ordered and topical yogart to mouth.  On 4-2-2008 EEG set up for 4-8-08. Mom called on 4-7-08 requesting referral to Pediatric Neurology. Dr reviewed labs and agreed to refer to Peds Neurology, labs slightly increase Mg, Calcium, slightly increased eosinophils. Dr request patient be rechecked tonight at office ASAP or ER if mom thought patient having repeated seizures. Also request repeat electrolytes. Patient seen 4-7-2008 by Dr. Dr diagnosed Status Epileptic, requested Vaers be done and admitted to Medical Center. 8/6/08-records received for DOS 4/7-4/8/08-DC DX: Motor overflow/benign infantile spasms. Presented with spasms of upper extremities over past 8 days.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Eosinophil count increased, Musculoskeletal stiffness, Oral fungal infection, Status epilepticus
Clinical narrative: On 3-28-2008 patient received Dtap, Hib, Prevnar (PCV7) and Rotateq. Mom called office on 4-1-2008, stated on 3-30-2008 and 3-31-2008 noticed he had a spasm -neck, arms,  legs got stiff all of a sudden, for few seconds, no fever, suggested appointment. Patient seen 4-2-2008 by Dr. Doctor ordered labs (CBC w/dif, Mg, ionized Ca and CMP) and EEG (awake and asleep, if possible, within 1 week).  Also diagnosed oral fungal infection, nystatin suspension ordered and topical yogart to mouth.  On 4-2-2008 EEG set up for 4-8-08. Mom called on 4-7-08 requesting referral to Pediatric Neurology. Dr reviewed labs and agreed to refer to Peds Neurology, labs slightly increase Mg, Calcium, slightly increased eosinophils. Dr request patient be rechecked tonight at office ASAP or ER if mom thought patient having repeated seizures. Also request repeat electrolytes. Patient seen 4-7-2008 by Dr. Dr diagnosed Status Epileptic, requested Vaers be done and admitted to Medical Center. 8/6/08-records received for DOS 4/7-4/8/08-DC DX: Motor overflow/benign infantile spasms. Presented with spasms of upper extremities over past 8 days.
Age: 12.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dizziness, Fall
Clinical narrative: Patient fell forward about 5 minutes after receiveing vaccines.  Patient went down on the floor (fell dizzy).  Patient continued to be checked for an hour; recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Aprox. 8 hours after receiving vaccine, mother noticed redness, itching and swelling at the injection site.  Pt was brought to clinic the next morning.  Both thigh and arm sites had aprox 3" - 3 1/2" dia. of swelling and redness.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Injection site erythema
Clinical narrative: Patient develope swelling under both eyes (and redness around the injection site) about 10-15 minutes after varicella vaccine administered.  No respiratory distress.  Benadryl prescribed (with provision for follow-up in 1-2 days).  Patient treated in the clinic before going home (no separate emergency room visit needed),  Patient had varicella vaccine before with no incident.  Also, had same periorbital swelling on 6/26/05
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Adacel instead of Boostrix. Age was miscalculated. No adverse reaction. Explained to guardian after call made to immunization board.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed a raised hyperemic non pruritic rash at lateral aspect  of site of injection. Ice was applied afterward 32 days before rash appeared. He had no improvement after 3 days.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Crying
Clinical narrative: INCONSOLIBLE CRYING FOR 2 HRS. AFTER ADMINISTRATION OF VACCINE. TREATMENT TYLENOL 60MG SUPP. AND BENADRYL ELIX, 1/4 TSP. POREACTION SUBSIDED.
Age: 30.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Discomfort, Disorientation, Disturbance in attention, Headache, Injection site erythema
Clinical narrative: Pt TDY in route. Received Meningococcal (MCV4) on Thursday, 5 Jun 08, in the left arm. On Friday morning around 0830, pt developed a fever approx 101-102 and headache, stiff neck, disoriented, could not concentrate. This continued through out the night. Fever broke the next morning. Pt states that he took regular Tylenol for the discomfort. Left arm shot site was red, hard, swollen. Lymph nodes were swollen under both arms.
Age: 30.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Injection site induration, Injection site swelling, Lymphadenopathy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt TDY in route. Received Meningococcal (MCV4) on Thursday, 5 Jun 08, in the left arm. On Friday morning around 0830, pt developed a fever approx 101-102 and headache, stiff neck, disoriented, could not concentrate. This continued through out the night. Fever broke the next morning. Pt states that he took regular Tylenol for the discomfort. Left arm shot site was red, hard, swollen. Lymph nodes were swollen under both arms.
Age: 0.92
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: no adverse events, child too old for Rotavirus
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Gait disturbance, Mass, Oedema peripheral, Pain in extremity
Clinical narrative: MOTHER OF PATIENT CALLED ON 6/27/08 TO REPORT THAT PATIENT'S RIGHT LEG WAS SWOLLEN FROM THE TOP TO DOWN PAST THE KNEE, IS PAINFUL AND HAS DIFFICULTY WALKING. STATES SHE HAS APPLIED COLD COMPRESS. I INSTRUCTED HER TO TAKE HIM TO THE DOCTORS. LATER THAT DAY I RECEIVED A CALL FROM HIS DOCTORS OFFICE REQUESTING THE LOT # AND SITE OF THE INJECTION. MADE TELEPHONE CALLS TO THE HOME 6/30/08 AND 7/2/08 NO ANSWER, LEFT MESSAGES. TELEPHONED 7/14/08 AND SPOKE WITH MOTHER AND SHE REPORTS WAS INSTRUCTED TO GIVE HIM BENADRYL BY THE DOCTOR.STATES THAT HIS LEG IS MUCH BETTER, ONLY HAS A SMALL BUMP.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: near syncopal event 30 minutes after vaccination.  Improved with rest and oral hydration
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Unusal muscle soreness-- going into his neck and shoulder
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, Dizziness, Dyskinesia, Heart rate normal, Pallor
Clinical narrative: syncopal episode began with client answer to nurse that he had fainted at one time in his life after he broke his finger and that he felt "fainty now" Nurse sat back down in chair by patient, and mother of client moved to his other side. As client was sitting in chair he slumped down and nurse grabbed hold of upperbody and asked mother to get onto floor so she could hold her sons head in her lap as the nurse laid the child on the floor. As the child's head was laid in mothers lap; the client's arms and legs began to flail in slow movement x 5 seconds. As this movement subsided the young man awakened, frightened calling for his mother. Both nurse and mother were able to calm the client.At this point he was able to lye quietly and nurse elevated the lower extremeties on a chair. Nurse and mom continued to speak with the young man-Nurse questioning previous episode of fainting-Nurse observed that the client was pale, with a strong, slow, and regular pulse approximately 60 bpm. After 5-7 mins. client was slowly sat up and was placed in a chair for approx. 5 mins. Client cont. to recover and was slowly stood up and walked a few steps to door wherein the client reported he was getting dizzy. Nurse slid client down the wall to sit on the floor for 5-10 mins. Upon closer questioning nurse deduced client had not had any protein in his diet today and the time was after lunch. Grandfather does have a hx of DM. A protein and carbohydrate bar was given to the client with a glass of water. After food intake client sat on floor 5 minutes and then was helped to a seat in the lobby. Client was observed for another 10 to 15 minutes and then allowed to go home with Mom. RN reinforced with Mom to call agency if anything should come up in the next days to call agency with info.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: syncopal episode began with client answer to nurse that he had fainted at one time in his life after he broke his finger and that he felt "fainty now" Nurse sat back down in chair by patient, and mother of client moved to his other side. As client was sitting in chair he slumped down and nurse grabbed hold of upperbody and asked mother to get onto floor so she could hold her sons head in her lap as the nurse laid the child on the floor. As the child's head was laid in mothers lap; the client's arms and legs began to flail in slow movement x 5 seconds. As this movement subsided the young man awakened, frightened calling for his mother. Both nurse and mother were able to calm the client.At this point he was able to lye quietly and nurse elevated the lower extremeties on a chair. Nurse and mom continued to speak with the young man-Nurse questioning previous episode of fainting-Nurse observed that the client was pale, with a strong, slow, and regular pulse approximately 60 bpm. After 5-7 mins. client was slowly sat up and was placed in a chair for approx. 5 mins. Client cont. to recover and was slowly stood up and walked a few steps to door wherein the client reported he was getting dizzy. Nurse slid client down the wall to sit on the floor for 5-10 mins. Upon closer questioning nurse deduced client had not had any protein in his diet today and the time was after lunch. Grandfather does have a hx of DM. A protein and carbohydrate bar was given to the client with a glass of water. After food intake client sat on floor 5 minutes and then was helped to a seat in the lobby. Client was observed for another 10 to 15 minutes and then allowed to go home with Mom. RN reinforced with Mom to call agency if anything should come up in the next days to call agency with info.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Gingival pain, Periodontitis, Purulent discharge, Stomatitis
Clinical narrative: 12 days after immunization, onset of painful gum lesions with purulent exudate, still present at OV 7/14/08.  Treated with penicillin and Periogard for acute periodontitis.  No previous history of similar symptoms, good dental hygiene.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood pressure normal, Dizziness, Feeling abnormal, Heart rate normal, Impaired driving ability
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of dizziness in a 28-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 30 June 2008 the subject received 1st dose of TWINRIX at 0.5 ml.  On 30 June 2008, less than one day after vaccination with TWINRIX, the subject experienced dizziness, pallor, nausea, lethargy, was foggy minded and had to lie down after receiving TWINRIX.  This was considered to be a systemic reaction.  The subject was given something to drink and had normal vital signs.  He was unable to drive and was advised to visit the emergency room.  The physician considered the events were disabling and clinically significant (or requiring intervention).  At the time of reporting the outcome of the events was unspecified.  The physician considered the events of dizziness, pallor, nausea and foggy minded to be probably related to vaccination with TWINRIX.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Lethargy, Nausea, Pallor, Respiratory rate
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of dizziness in a 28-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 30 June 2008 the subject received 1st dose of TWINRIX at 0.5 ml.  On 30 June 2008, less than one day after vaccination with TWINRIX, the subject experienced dizziness, pallor, nausea, lethargy, was foggy minded and had to lie down after receiving TWINRIX.  This was considered to be a systemic reaction.  The subject was given something to drink and had normal vital signs.  He was unable to drive and was advised to visit the emergency room.  The physician considered the events were disabling and clinically significant (or requiring intervention).  At the time of reporting the outcome of the events was unspecified.  The physician considered the events of dizziness, pallor, nausea and foggy minded to be probably related to vaccination with TWINRIX.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial palsy in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent vaccination included MENACTRA (Sanofi) given on 7 July 2008.  There were no concurrent medications.  On 7 July 2008 the subject received 1st dose of BOOSTRIX at 1.0 ml in the left arm.  On the evening of 8 July 2008, 1 day after vaccination with BOOSTRIX, the subject experienced facial palsy, a systemic reaction.  The healthcare professional considered the events were clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: Information has been received from a gynecologist concerning a female patient (age not reported) with lupus erythematosus who was vaccinated on an unknown date with the first dose of GARDASIL (lot #, route, and injection site not reported).  The outcome was not reported.  On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot #, route, and injection site not reported).  After vaccination, the patient's lupus erythematosus aggravated.  The outcome was not reported.  Upon internal review, the case was considered as medically significant.  Other business partner numbers include E2008-06022.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Clinical narrative: None stated.  8/11/08 Gross autopsy findings:  Visceral congestion.  Diaper rash.  Full report pending. 10/20/2008 Autopsy received. COD-Sudden unexplained death in infancy. Manner of death natural.  Infant found unresponsive with abundant vomitus.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Antinuclear antibody positive, Asthenia, C-reactive protein normal, CSF test normal, Full blood count normal
Clinical narrative: Patient had unusual persistence of weakness. Both legs, below knees, numbness, tingling sensations. Underwent extensive tests at hospital- all neg.  9/12/08-records received for DOS 9/20-9/21/07-DC DX: Peripheral neuropathy. Presented to ED with C/O bilateral lower extremity weakness/numbness began 2 days prior. Tingling began next day.PE: decreased sensation, strength 4/4 times four. End point nystagmus L>R.  Follow-up with neurology clinic.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia, Polymerase chain reaction
Clinical narrative: Patient had unusual persistence of weakness. Both legs, below knees, numbness, tingling sensations. Underwent extensive tests at hospital- all neg.  9/12/08-records received for DOS 9/20-9/21/07-DC DX: Peripheral neuropathy. Presented to ED with C/O bilateral lower extremity weakness/numbness began 2 days prior. Tingling began next day.PE: decreased sensation, strength 4/4 times four. End point nystagmus L>R.  Follow-up with neurology clinic.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: CSF test normal, Computerised tomogram normal, Fontanelle bulging, Irritability, Lumbar puncture normal
Clinical narrative: increased intracranial pressure (pseudotumor cerebri) with irritability and bulging fontanelle7/29/08-records received for DOS 7/12-7/15/08-DC DX: fever and bulging fontanelle with irritability. Idiopathic intracranial hypertension secondary to vaccinations.Presented with fever times 3 ago after vaccinations. Irritability and listless, intermittent fever.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Scan brain
Clinical narrative: increased intracranial pressure (pseudotumor cerebri) with irritability and bulging fontanelle7/29/08-records received for DOS 7/12-7/15/08-DC DX: fever and bulging fontanelle with irritability. Idiopathic intracranial hypertension secondary to vaccinations.Presented with fever times 3 ago after vaccinations. Irritability and listless, intermittent fever.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Urticaria
Clinical narrative: per Tmax 102 w/hives (urticaria) on the day of vaccination. Seen at the emergency room hospital. tx with BENADRYL 81 mg
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Received zoster vaccine 7/9/08 SQ LA. States developed redness at site along with induration and pain to light palpitation. Palpation of indurated area measures 5"x5" states ice paks and OTC analgesia minimally helpful
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash
Clinical narrative: 6/17/08 Pt c/o rash- Saturday 6/14/08 am. with itching to chest and over body for about 2 days "annoying" rash, then disappeared. Denies any shortness of breath, no fever or tongue swelling. Took a BENADRYL tablet x 1 dose and nothing else.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Site rash left upper leg with swelling.
Age: 18.0
Sex: M
Vaccine: DTAP, HEP, MNQ
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Administered DTaP instead of Tdap.
Age: 1.77
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Lymphadenopathy, Viral test
Clinical narrative: 7/14/08- Mom called stated baby developed temp 104- swollen glands in neck. 7/12/08 after MMR/Varicella given 7/2/08- denies diff breathing or rash. Seen in ER on 7/12/08 and by physician 7/14/08- Dx Viral- Dr wanted to put on antiviral med. but mom refused. COC called 7/14/08 11:00 AM referred reaction as moderate and less likely to have reaction when has #2 MMR. Dr notifed 7/14/08 of visit Imm. with calling COD. Instr mom continue Tyl. with f/u with Dr.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Swollen (R) arm, fever of 102 deg, nausea, pain in arm x 2 days (could not lift arm) red area, hot to touch, hard
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Swollen (R) arm, fever of 102 deg, nausea, pain in arm x 2 days (could not lift arm) red area, hot to touch, hard
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Fever (102deg), Nausea, Diarrhea, Muscle spasms, Myalgia, Dizziness, Chills, Backache, Headache
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever (102deg), Nausea, Diarrhea, Muscle spasms, Myalgia, Dizziness, Chills, Backache, Headache
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: RUA swelling, redness, hot to touch, painful - unsure if this is reaction to shot or cellulitis.  Placed on cephalexin.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Pharyngolaryngeal pain, Vomiting
Clinical narrative: Developed repeated episodes of vomiting after receiving rabies vaccine and immunoglobulin injection.  Next day no energy, sore throat, no chills, no fever.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Parotid gland enlargement, Pyrexia
Clinical narrative: Parotid swelling - left cheek anterior to pinna.  Displaced pinna up & out.  Fever 101.
Age: 1.4
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Skin warm, Wheezing
Clinical narrative: Patient came in for routine health check and immunization.  Initially questioned mother about child being sick.  (Mother checked yes on questionnaire).  Mother stated child had a cold and was "hoarse", but had no fever.  Shots given about 30 minutes later child started to get warm and began wheezing.  EMS called.  Mother refused transport, but did state she would take child to ER.  Child did calm down and sounded better before she left facility.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Blotchy, red rash on upper R thigh the size of a dollar bill.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site cyst, Injection site discharge
Clinical narrative: Patient developed 1 cm cyst of left thigh at PEDIARIX injection site 1 mo after injection, lesion gradually became more superficial and started discharged milky white fluid on 7/5/08. Now lesion is smaller but dimpling of skin remaining
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood glucose normal, Electrocardiogram normal, Grand mal convulsion, Immediate post-injection reaction, Syncope
Clinical narrative: Child had a syncopal event with brief tonic-clonic seizure immediately after vaccines were given.  Spontaneous recovery.  Normal glucose (122 mg/dl) & normal EKG.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Injection site pruritus, Injection site urticaria
Clinical narrative: Local hive-like reaction at injection site.  Itching at site.  Coughing.  BENADRYL given, 25mg PO.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother called ACHD about 9 A.M.  7/9/08 to say patient ran a fever after receiving imm. on 7/8/08.  Patient began throwing up this morning, he did not have fever today.  No unusual redness or edema noticed at inj. site.  Mother stated that she had given the child MOTRIN on 7/8/08 and had not given him any this a.m.  Mother was advised to call pediatrician at clinic.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Quarter - Sized area of redness/swelling on R-arm at vaccine site; painful, warm to touch 7/3. Mom applied ice as tolerated, gave Advil. As of 7/6, dime-sized (at most) area slightly raised, little redness and still some pain if touched, per mom's report over phone.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Cognitive disorder, Disturbance in attention
Clinical narrative: Reports short term memory loss, inattention and concentration deficits after AVA in 2007.  Symptoms: Cognitive deficiency.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Lymphadenitis, Lymphadenopathy, Pyrexia, Rash, Rash vesicular
Clinical narrative: Pt with rash, fever and swollen glands 21 days after MMR, VARIVAX and DAPTACEL vaccine.  Mother convinced sx related to MMR vaccine.  One wk post vacc. got "chicken pox" rash; & fever; 15 days post vaccine dev. rash; post auricular lymphadenopathy & fever.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Pt noted itchy rash several days after receiving the varicella immunization on L thigh, beginning on L thigh involving large patch surrounding immunization site, and spreading to other parts of the body.  BENADRYL & triamcinolone cream minimally helpful.  Given short course of prednisone.
Age: 38.0
Sex: F
Vaccine: DT, VARCEL
Symptoms: Excoriation, Rash papular, Rash pruritic
Clinical narrative: Itchy rash, excoriated papules on scalp, neck, trunk, extremities.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives pm 7/8/08 arms, leg.  Seen in office 7/9/08 late AM - Dx urticaria no facial swelling; BENADRYL 3/4 tsp given at 12:45/pm.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: The pt., a medical student, received a pneumococcal vaccine instead of a meningococcal vaccine.  There was no adverse reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Urticaria
Clinical narrative: Immediately after administering the MMR, notice redness.  Within 10-15 min. the redness was 40mm with a 2mm wheal.  Clt. reported pain at site but denied all other s/s such as SOB, itching etc.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea
Clinical narrative: On 7-20-08 the day DTaP # 4 given, Grandmother, reports client had asthma and she watched client often. Client went to bed at 8 or 9 pm. Client slept with grandmother. Grandmother reports "in middle of night" she noticed client had shallow respirations while client slept. Reported that she patted him and talked to him as she usually does as he often had "bad dreams." Reports client eventually "calmed down" and resps returned to normal. Reports did not seek medical tx. Reports made PCP aware of routine visit for next week.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2 1/2 inch x 2 inch red edematous area Lt arm at site of Varicella vaccine given on 7-8-08
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Rash, Swelling, Tenderness
Clinical narrative: R Leg reaction started day of injection. Persists at 48 hrs. Swelling, tenderness and red. Red rash around injection site. Swelling involved Ant. thigh
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site swelling, Pain, Tenderness
Clinical narrative: 7-2-08 swollen area at injection site, tender to touch, hurt to move his arm up and down, mom described the area to office staff on 7-3-08 as half size of tennis ball and the lump/swollen area was hard to touch. 7-3-08 seen in office Dx cellulitis upper arm: ordered KEFLEX for 10 days.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Heart rate increased, Rash erythematous
Clinical narrative: Pt broke out in rash-red raised erythema- Hx of PDA on LASIX- HR increased to >200-sent to ERD-same evening-vaccine
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Antimicrobial susceptibility test, Blood culture positive, Brain death, CSF culture positive, Culture urine positive
Clinical narrative: Information has been received from a physician concerning a 13 month old previously healthy female with no reported past medical history (PMH: ex-full term infant; no history of splenic disorder, immune dysfunction, no history of daycare, and no past history of antibiotic therapy) who was vaccinated with MMR II (Lot # 657630/1483U) 0.5 ml SQ on a "Monday," 05-May-2008 during a well child visit. Concomitant therapy included PREVNAR, which was also given on 05-May-2008 during a well child visit. It was reported that on 10-May-2008, "Saturday evening" the patient developed a fever. On "Sunday," 11-May-2008, six days after receiving MMR II, the patient continued with fever and lethargy, and by that evening it was noted that she had a "collapse" episode. 911 was called and CPR was performed. The patient was admitted to the pediatric intensive care unit of a hospital with a diagnosis of pneumococcal meningitis. A CSF sample showed pneumococcus serotype 29 (a non-PREVNAR pneumococcal sero-type). The patient was stabilized and treatment was started. Hours later the patient was determined to be "brain dead." The patient died on 12-May-2008, the day after being admitted to the hospital. The cause of death was meningitis pneumococcal. No product quality complaint. The event was considered to be life-threatening and disabling. A lot check has been requested. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Death, Intensive care, Pneumococcal bacteraemia, Respiratory failure, Septic shock
Clinical narrative: Information has been received from a physician concerning a 13 month old previously healthy female with no reported past medical history (PMH: ex-full term infant; no history of splenic disorder, immune dysfunction, no history of daycare, and no past history of antibiotic therapy) who was vaccinated with MMR II (Lot # 657630/1483U) 0.5 ml SQ on a "Monday," 05-May-2008 during a well child visit. Concomitant therapy included PREVNAR, which was also given on 05-May-2008 during a well child visit. It was reported that on 10-May-2008, "Saturday evening" the patient developed a fever. On "Sunday," 11-May-2008, six days after receiving MMR II, the patient continued with fever and lethargy, and by that evening it was noted that she had a "collapse" episode. 911 was called and CPR was performed. The patient was admitted to the pediatric intensive care unit of a hospital with a diagnosis of pneumococcal meningitis. A CSF sample showed pneumococcus serotype 29 (a non-PREVNAR pneumococcal sero-type). The patient was stabilized and treatment was started. Hours later the patient was determined to be "brain dead." The patient died on 12-May-2008, the day after being admitted to the hospital. The cause of death was meningitis pneumococcal. No product quality complaint. The event was considered to be life-threatening and disabling. A lot check has been requested. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 13 month old previously healthy female with no reported past medical history (PMH: ex-full term infant; no history of splenic disorder, immune dysfunction, no history of daycare, and no past history of antibiotic therapy) who was vaccinated with MMR II (Lot # 657630/1483U) 0.5 ml SQ on a "Monday," 05-May-2008 during a well child visit. Concomitant therapy included PREVNAR, which was also given on 05-May-2008 during a well child visit. It was reported that on 10-May-2008, "Saturday evening" the patient developed a fever. On "Sunday," 11-May-2008, six days after receiving MMR II, the patient continued with fever and lethargy, and by that evening it was noted that she had a "collapse" episode. 911 was called and CPR was performed. The patient was admitted to the pediatric intensive care unit of a hospital with a diagnosis of pneumococcal meningitis. A CSF sample showed pneumococcus serotype 29 (a non-PREVNAR pneumococcal sero-type). The patient was stabilized and treatment was started. Hours later the patient was determined to be "brain dead." The patient died on 12-May-2008, the day after being admitted to the hospital. The cause of death was meningitis pneumococcal. No product quality complaint. The event was considered to be life-threatening and disabling. A lot check has been requested. Additional information has been requested.