chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood alcohol normal, Blood thyroid stimulating hormone normal, Chest X-ray normal, Delirium, Drug screen negative
Clinical narrative: Developed paranoia, delirium, hallucinations lasting 2 days after immunizations.  10/22/2007 MR received for DOS 9/12/2007for D/C Dx of Psychosis NOS, R/O pharmacologic precipitant.  Pt presented to ER with the sensation of wetness on her chest.  Pt was refered to Psychiatry for further eval as pt was having hallucinations. Pt reported not feeling well for several days prior to admission.  The night following her Hep A&B vax pt could not sleep and began hearing things, became SOB, and c/o numbness in her arm and worsening irritability.  Pt was having delusional beliefs. Admitted with dx Acute Psychosis, anxiety, HTN, cervical dystonia. Pt had a consult whose impression was that physical sx are part of the psychiatric symptom complex, maybe tactile hallucinations.  Possible paranoid delusions, consider bi-polar disorder.  Non-specific ECG abnormalities. Pt was recommended to remain in hospital for a full workup including an MRI, however pt signed out AMA
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Electrocardiogram normal, Full blood count normal, Hallucination, Metabolic function test normal, Paranoia
Clinical narrative: Developed paranoia, delirium, hallucinations lasting 2 days after immunizations.  10/22/2007 MR received for DOS 9/12/2007for D/C Dx of Psychosis NOS, R/O pharmacologic precipitant.  Pt presented to ER with the sensation of wetness on her chest.  Pt was refered to Psychiatry for further eval as pt was having hallucinations. Pt reported not feeling well for several days prior to admission.  The night following her Hep A&B vax pt could not sleep and began hearing things, became SOB, and c/o numbness in her arm and worsening irritability.  Pt was having delusional beliefs. Admitted with dx Acute Psychosis, anxiety, HTN, cervical dystonia. Pt had a consult whose impression was that physical sx are part of the psychiatric symptom complex, maybe tactile hallucinations.  Possible paranoid delusions, consider bi-polar disorder.  Non-specific ECG abnormalities. Pt was recommended to remain in hospital for a full workup including an MRI, however pt signed out AMA
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated. 10/02/2007 MR received for DOS 9/20-22/2007 for DX:  Positive Immunization Reaction.  Child presented to ER with increased fever and weakness.  Parents noted fever the night before admission and txd with Motrin.  During the night they heard the pt cry out and dad noted the child had pale lips and her body was limp. (+) foaming at the mouth and with decreased responsiveness to parents lasting ~ 15 minutes.  PE (+) for T'=39.8'. L TM dull. otherwise WNL.  Txd with abx and D/C home.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: Enlarged lymph node x2 - (R) clavicle.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Oxygen saturation, Syncope vasovagal
Clinical narrative: No SOB, no chest pain - brief episode several minutes after IM injection given. Pt was responsive, observed for 15" then discharged with parents. Possible Dx vasovagal reaction by overseeing MD.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure normal, Dyskinesia, Oxygen saturation normal, Syncope vasovagal
Clinical narrative: No SOB, no chest pain - brief episode several minutes after IM injection given. Pt was responsive, observed for 15" then discharged with parents. Possible Dx vasovagal reaction by overseeing MD.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Diarrhoea, Malaise, Pallor
Clinical narrative: General malaise, diarrhea, elevated temp 99.8, pallor. Started S/S early am of 7/18. Ibuprofen 600mg given at approx 1300. S/S resolved at 1600.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left upper arm with 15cm x 20cm erythema hard to palpation over shot site 4cm x 2cm non-tender.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Inappropriate schedule of drug administration, Pain, Paraesthesia
Clinical narrative: Description of symptoms after receiving Shingles vaccine: Low grade fever, Burning and tingling in different areas of body, skin super sensitive to touch, to clothing, to anything, painful to take a shower or to pull down pants to go to bathroom, pain/ sensitivity that started in inside of arms and moved to palms of hands, upper body breast area, mid-section, and finally left my body, no energy, life was an effort, some headaches. Given on 8-16-07 symptoms began about 2 weeks later and lasted until 9-18-07. Since then she has been symptom free.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Description of symptoms after receiving Shingles vaccine: Low grade fever, Burning and tingling in different areas of body, skin super sensitive to touch, to clothing, to anything, painful to take a shower or to pull down pants to go to bathroom, pain/ sensitivity that started in inside of arms and moved to palms of hands, upper body breast area, mid-section, and finally left my body, no energy, life was an effort, some headaches. Given on 8-16-07 symptoms began about 2 weeks later and lasted until 9-18-07. Since then she has been symptom free.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Chest discomfort, Dehydration, Dizziness, Dyspnoea
Clinical narrative: 9-6-07 came to clinic for physical - received Tdap, Menactra, and Varicella #2. Symptoms started 9-7-07 - dots around site - changing to rash on second day around site - raised - swollen, turned into 2 long areas - from shoulder to elbow - swollen - warm - red- used hydrocortisone to site - she also c/o SOB, tightness of chest, weak and dizzy. Rash spread to check - chest - legs - size of one-two quarts. Still itches. Pt has hx of STV - in hospital at 3 yrs of age. Returned to clinic 9-19-07 - weak - dizzy - not reported until 9-19-07 visit.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site rash, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: 9-6-07 came to clinic for physical - received Tdap, Menactra, and Varicella #2. Symptoms started 9-7-07 - dots around site - changing to rash on second day around site - raised - swollen, turned into 2 long areas - from shoulder to elbow - swollen - warm - red- used hydrocortisone to site - she also c/o SOB, tightness of chest, weak and dizzy. Rash spread to check - chest - legs - size of one-two quarts. Still itches. Pt has hx of STV - in hospital at 3 yrs of age. Returned to clinic 9-19-07 - weak - dizzy - not reported until 9-19-07 visit.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash, Skin warm, Supraventricular tachycardia
Clinical narrative: 9-6-07 came to clinic for physical - received Tdap, Menactra, and Varicella #2. Symptoms started 9-7-07 - dots around site - changing to rash on second day around site - raised - swollen, turned into 2 long areas - from shoulder to elbow - swollen - warm - red- used hydrocortisone to site - she also c/o SOB, tightness of chest, weak and dizzy. Rash spread to check - chest - legs - size of one-two quarts. Still itches. Pt has hx of STV - in hospital at 3 yrs of age. Returned to clinic 9-19-07 - weak - dizzy - not reported until 9-19-07 visit.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Received vaccine 9-13-07 - received call from mother stating fever night of 9-13-07 and day 9-14-07. "Hot" large swollen red area on arm where shot was given and c/o pain at site. Red area reported size of palm of mom's hand - told to put ice pack on site - if not improved - go to after hours clinic. Was seen in clinic on 9-14-07 - doctor report state "hive like reaction 3 inch x 3 inch - non-tender - raised - given script for Benadryl.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Received vaccine 9-13-07 - received call from mother stating fever night of 9-13-07 and day 9-14-07. "Hot" large swollen red area on arm where shot was given and c/o pain at site. Red area reported size of palm of mom's hand - told to put ice pack on site - if not improved - go to after hours clinic. Was seen in clinic on 9-14-07 - doctor report state "hive like reaction 3 inch x 3 inch - non-tender - raised - given script for Benadryl.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Large local reaction - redness, warmth, swelling of entire right upper arm, fever. Treatment: Benadryl, Augmentin.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Received Tdap on 9/19/07. Had already received on 11/1/05 but overlooked on faxed immunization records.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Zostavax on Wed - Thurs welt on leg (LT) hot dog size - Fri tennis ball welt - recommended doc call, Benadryl, ice.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Pallor, Peripheral coldness, Syncope
Clinical narrative: AFTER RECEIVING HER IMMUNIZATIONS THE PT FELT SICK, SHE WAS SITTING IN THE EXAM ROOM WITH HER HEAD IN HER HANDS LEANING FORWARD BETWEEN HER KNEES. THE NURSE SAT HER UP AND SHE WAS PALE AND EXTREMITIES COOL.  THE NURSE WAS UNABLE TO FEEL A RADIAL PULSE, BUT DID GET AN APICAL PULSE.  DR. WAS SUMMONED AND HE WAS ABLE TO FEEL A RADIAL PULSE. THEY BEGAN TO LOWER HER TO THE FLOOR AND SHE LIFTED HER HEAD AND SMILED.  HER COLOR WAS PINK, SKIN WARM.  SHE WAS ALERT AND ORIENTED.  MOM WAS SUMMONED FROM THE WAITING ROOM, AND SHE STATES THAT THE SAME THING HAPPENS TO HER WITH ANY NEEDLE.  PT REMAINED IN THE EXAM ROOM FOR 30 MIN.  BP WERE TAKEN AND THEY WERE AS FOLLOWS.  90/60 LEFT ARM SITTING- 10 MIN POST SYNCOPE,  AND 98/68 LEFT ARM SITTING- 40 MIN POST SYNCOPE.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: SHORTLY AFTER RECEIVING THE HPV IMMUNIZATION FOLLOWED ALMOST IMMEDIATELY BY THE MENINGOCOCCAL IMMUNIZATION, THE PATIENT BECAME LIGHTHEADED, DIZZY AND SLID OFF THE EXAM TABLE TO THE FLOOR. SHE AROUSED WITHIN ONE MINUTE.  SHE WAS DIAPHORETIC, FELT NAUSEATED AND CLAMMY.  VITAL SIGNS AT THAT TIME WERE PULSE: 88  BP: 110/64.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: I have been notified from our Family Practice Center that one of the refrigerators which stores vaccines in the office was found to be at an incorrect temperature.  Unfortunately we are talking about a time frame of three years and five months.  As a result, three of my children need to be revaccinated.  My biggest concern is for my 23 month old daughter in which I'm being told that she needs to be revaccinated for ALL of her shots.  She is a tiny girl and barely weighs 20 pounds.  It is quite possible that the vaccinations she received in the past were okay.  Is it really safe for her to double up on everything?  Are there risk factors involved?  I am contacting other health officials to get some advice as well, but would greatly appreciate some input from you.  If this is something you feel is safe, do you have documented research to support that?  Thank you very much for your time.  I received some information from the CDC and they encouraged me to write my concerns to you.  Please know that I have confirmed with my doctor that ALL of my daughters vaccines MAY have been affected in which they are encouraging me to have her revaccinated on the following (DTaP #1, DTap #2, DTap#3, DTap #4, Hep A # 1, HIB #1, HIB #2, HIB #3, IPV #1, IPV #2, IPV #3, MMR #1, PCV #1, PCV #2, PCV #3, PCV #4, and Varicella).  Some of the information I filled out on the rest of this form is pretty much N/A as my question/concern is within this information.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient received Adult Hepatitis A vaccine instead of Pediatric dose.  No known adverse reaction
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received the vaccine at approximately 1500.  At 1620, she returned to report a large area of redness and warmth at the site of the injection.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: seen in E.R. with difficulty breathing swelling at the site.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Pain in extremity, Paraesthesia
Clinical narrative: Patient complained of very sore left arm, extreme weakness, dizziness, difficulty breathing and generalized tingling.  Arm soreness developed a few hours after vaccination.  Other symptoms began 12 hours later.  Required no treatment.  Contacted 9/20/2007 and said was much improved.  Contacted  9/21/2007 and stated felt "great"
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Body temperature fluctuation, Feeling hot
Clinical narrative: Mother states when child woke this AM she felt very hot.  Digital thermometer used with temperature 101.5 AX. Gave Tylenol. Temperature @ 1:00p.m. 99.9 Ax.  Temp @ 3:00p.m. 99 Ax.  Denies baby crying, states child is alert and smiling.
Sex: M
Vaccine: HEP
Symptoms: Bacterial culture, Blood culture negative, CSF culture negative, Convulsion, Encephalopathy
Clinical narrative: Infant readmitted with fever and seizures at around 10 days of life.  Sibling with viral illness.  Sepsis workup negative; MRI shows multifocal encephalopathy consistent with viral process, likely not related to vaccine (but reported due to old DTP/encephalopathy concerns)Outcome uncertain, viral cultures pending and unclear if permanent disability will be present.  11/01/2007 MR received for hospital DOS beginning 9/13/2007.  12/18/2007 D/C Summary received for DOS 9/13-26/2007 with D/C Dx: Febrile Illness.  Suspected neonatal sepsis/meningitis.  Seizures.  Encephalitis.  Poor feeding. One week old infant developed fever and rash and was taken to ER and admitted.  In hospital pt developed seizure activity. Pt had some jerking movements c/w tonic-clonic activity. This resolved with meds. Neuro consult with hypotonia noted on PE. Developmental eval with impression: Encephalitis and seizure hx. Clinical picture c/w a viral encephalitis.  D/Cd with some diminished tone to be f/u as an outpt Follow up: May be too early to tell if he will have developmental delays. Currently within normal limits for milestones. 1/12/2010 Mild hypotomia and mild gross motor delay.
Sex: M
Vaccine: HEP
Symptoms: Febrile infection, Gross motor delay, Nuclear magnetic resonance imaging abnormal, Pyrexia, Virus culture negative
Clinical narrative: Infant readmitted with fever and seizures at around 10 days of life.  Sibling with viral illness.  Sepsis workup negative; MRI shows multifocal encephalopathy consistent with viral process, likely not related to vaccine (but reported due to old DTP/encephalopathy concerns)Outcome uncertain, viral cultures pending and unclear if permanent disability will be present.  11/01/2007 MR received for hospital DOS beginning 9/13/2007.  12/18/2007 D/C Summary received for DOS 9/13-26/2007 with D/C Dx: Febrile Illness.  Suspected neonatal sepsis/meningitis.  Seizures.  Encephalitis.  Poor feeding. One week old infant developed fever and rash and was taken to ER and admitted.  In hospital pt developed seizure activity. Pt had some jerking movements c/w tonic-clonic activity. This resolved with meds. Neuro consult with hypotonia noted on PE. Developmental eval with impression: Encephalitis and seizure hx. Clinical picture c/w a viral encephalitis.  D/Cd with some diminished tone to be f/u as an outpt Follow up: May be too early to tell if he will have developmental delays. Currently within normal limits for milestones. 1/12/2010 Mild hypotomia and mild gross motor delay.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Irritability, Laboratory test, Pyrexia, Vomiting
Clinical narrative: fever, fussiness, vomitting starting 7 days after Rotavirus vaccine.  Had partial sepsis workup done.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hot flush, Rash
Clinical narrative: Patient reported onset of cold chills and hot flashes intermittently and rash to left arm that migrated to legs on 9/18/2007. Reports that had been vaccinated with Td on 4/21/2007 at local emergency room but failed to disclose that information until after Tdap was administered.  Was seen by primary care provider on 9/19/2007 and symptoms resolved spontaneously on same day. Took Ibuprofen 200mg once daily for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nausea, Post herpetic neuralgia, Pruritus, Skin burning sensation
Clinical narrative: I was the administrator, have given two different patients in the last couple of months the shingles vaccination. On 8/25/07 I developed intense itching and burning of skin on abdomen, left side and on 8/27/07 was diagnosed with shingles. Concern that administrator may have gotten shingles from administrating "aerosol method" tx by LMD with acyclovir, and lyrica; still have post herpatic nerve pain, nausea
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Varicella vaccine 9/17/07 at H.C.  Pt c/o pain in the left upper quadrant of left arm, at the injection site before going to bed.  On 9/18/07 next morning the pt noticed swelling and redness at the injection site.  Pt returned to the clinic at 4:00pm 8/18/07.  The patient's left arm was examined and redness, swelling and warmth were noted at the injection site the area of redness and swelling measured 50mm.  b/p 122/90, P 82, R 20.  No other adverse SxS noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: REceive vaccine on 9-18-2007. Father came in and provided info. Mother gave Tylenol. Child had red and warm area where vaccine was given. Child was given Benadryl with good effect. RN spoke with mom this am, child immediately responded to Benadryl. No redness today or other problems.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Change of bowel habit, Dyspnoea, Nausea
Clinical narrative: 9/21/07 at 0200 - 1535 woke up. Nauseated. "Felt like intestines were on fire" Soft bowel movements x4 (0200-0330. States felt SOB at 0600-1000. Talked to nurse at Dr. no openings w/doctor offered N.P. She declined. States not SOB at this time. Still naueseated. Advised to follow up with Dr. and report to ER if SOB.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash maculo-papular
Clinical narrative: Fever 103, febrile seizure, maculopapular rash
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Rt. ARM IS RED AND TENDER TO TOUCH ON Rt. DELTOID AREA.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Area red and tender (R) deltoid.
Age: 38.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Anorexia, Asthenia, Dizziness, Fatigue, Feeling cold
Clinical narrative: Day 0: Vaccinated Day 1: Woke up with body pain all over; weakness all over; loss of appetite; some fever; cold, inability to think; some dizziness; took 1 advil in the morning which made me feel a little better but after a few hours symptoms got worse and worse; then felt extreme coldness (wore full thermal underwear, fleece, t-shirt & sweatshirt plus needed 2 thick blankets) along with extreme tiredness (slept for ~16 hours starting mid-afternoon with short periods waking up); Day 2: other symptoms from day 1 went away except still had loss of appetite; but new symptom appeared which was unsettling - experienced sudden, sharp pain all over my brain when sneezing or with quicker head movements, it felt like my brain was going to explode; took 1 advil in late afternoon; Day 3: mild pain with quick head movements, headache at temples but otherwise feel pretty much recovered
Age: 38.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Headache, Pain, Pyrexia, Thinking abnormal
Clinical narrative: Day 0: Vaccinated Day 1: Woke up with body pain all over; weakness all over; loss of appetite; some fever; cold, inability to think; some dizziness; took 1 advil in the morning which made me feel a little better but after a few hours symptoms got worse and worse; then felt extreme coldness (wore full thermal underwear, fleece, t-shirt & sweatshirt plus needed 2 thick blankets) along with extreme tiredness (slept for ~16 hours starting mid-afternoon with short periods waking up); Day 2: other symptoms from day 1 went away except still had loss of appetite; but new symptom appeared which was unsettling - experienced sudden, sharp pain all over my brain when sneezing or with quicker head movements, it felt like my brain was going to explode; took 1 advil in late afternoon; Day 3: mild pain with quick head movements, headache at temples but otherwise feel pretty much recovered
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Drug hypersensitivity, Oedema peripheral
Clinical narrative: 9-14-07 Pt's mom called and stated (R) arm and hands were swollen after injection on 9-13-07. Pt received Hep A and Menactra in this (R) deltoid. Mom advised by health department to call physician and come by so nurse to see. Saw PCP - received Benadryl at office, came by HD - nurse stated had some swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Drug hypersensitivity, Hyperaesthesia, Irritability, Oedema peripheral, Skin discolouration
Clinical narrative: Mom states pt got immunizations Monday 9/10/07 and that by Tuesday afternoon (9/11/07) patient was very cranky and "she looked like she had a huge purple bicep on left arm"; Mom gave her Tylenol yesterday (9/11/07) and "arm looks better today", but still a bit swollen and sensitive to touch.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: Zostavax 8/21/07. Hive-like lesions started 9/7 - pt thought initial lesion (8/25) on her stomach was Lymes disease and started herself on Doxycycline 8/25-9/6. Seen 9/9 - doc says hives, pt says was told was a vaccine. When I saw it 9/9 - each lesion had a tiny vesicle and was very itchy.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: 3x4cm red, tender, itchy area around (L) inferior deltoid area. Some warmth, induration. Treated with oral Benadryl and Keflex Rx given in case of no improvement.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Pt phoned to notify nurse that (R) arm reddened, tender, firm to touch starting 9/12 and continuing thru 9/16. Reddened area on back of (R) arm to elbow area.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Erythema multiforme, Full blood count, Pyrexia, Rash, Urticaria
Clinical narrative: Developed rash likely erythema multiforme vs hives plus fever.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Induration, Pain in extremity
Clinical narrative: Pt rec'd Gardasil in (L) upper arm. Observed x 10 min w/o problem. Left office - returned a short while later c/o pain in forearm and (L) hand; pt had a bruise at base of thumb. (L) forearm and hard cool to touch. Injection site ok.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Contusion, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Pt rec'd Gardasil in (L) upper arm. Observed x 10 min w/o problem. Left office - returned a short while later c/o pain in forearm and (L) hand; pt had a bruise at base of thumb. (L) forearm and hard cool to touch. Injection site ok.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever. Time course: (10 days) after vaccine
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Developed chicken pox from the varicella vaccine.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt had fainting spell while standing in hallway approx 5-10 min after receiving vaccine. Unconscious > 1 min. Pt alert and oriented immediately after episode. Pt allowed to sit and sip Coke for 5-10 min after episode then sent home with parents.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug hypersensitivity, Fall, Syncope, Viral upper respiratory tract infection
Clinical narrative: Pt had fainting spell while standing in hallway approx 5-10 min after receiving vaccine. Unconscious > 1 min. Pt alert and oriented immediately after episode. Pt allowed to sit and sip Coke for 5-10 min after episode then sent home with parents.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: (R) deltoid showed large area of well demarcated edema/erythema. No systemic signs/sx. This would have been site of varicella and Hep A.
Age: 1.4
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Body temperature increased, Cardiac disorder, Developmental delay, Febrile convulsion, Gait disturbance
Clinical narrative: Febrile seizure, probable vaccine related. Tonic convulsion by postictal limping. Tylenol and cooling measures done at home, temperatures from 102.6 - 103.9.
Age: 1.4
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Immunisation reaction, Postictal state, Tonic convulsion
Clinical narrative: Febrile seizure, probable vaccine related. Tonic convulsion by postictal limping. Tylenol and cooling measures done at home, temperatures from 102.6 - 103.9.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site papule
Clinical narrative: Area of erythema and edema 8cm x 7.5cm (L) deltoid (site of Proquad). Also 3 small papules at center of swollen area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Redness, edema, tenderness, pruritus at site of injections. Developed one day after injections. + reported fever (by parents) Tm 102.4. Mom using ice packs, Motrin and Benadryl.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Within 1 hour of receiving Hepatitis A vaccine and HPV vaccine, mother reported that patient experiencing nausea, vomiting, and fever.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Decreased appetite, Feeling hot, Lethargy, Pyrexia
Clinical narrative: Decreased appetite and "a little lethargy" afternoon early evening day of vaccines, cried 1030-11 PM. Felt hot T 105. Gave Tylenol, tepid bath, pacifier - then "settled down" and by next AM was "fine" afebrile, no other seizure activity noted.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness, right arm pain after 1 week.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Carbon dioxide abnormal, Diarrhoea, Rotavirus test negative, Vomiting, Vomiting projectile
Clinical narrative: Diarrhea - started Sun 9/16 - 9/18/07 occasional diarrhea 5x day, small spit up then projectile in late PM.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Arthralgias, myalgias, fatigue from 24 hours after vaccination through now. Pt still has symptoms. Last office visit 9/18/07.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Local reaction, Pyrexia, Swelling
Clinical narrative: Local reaction - redness and swelling about 4" diameter and fever 103.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration, redness of both injection sites on left deltoid area.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Cough, Dyspnoea
Clinical narrative: 9/13/07 5:40 PM Patient returned to office a few hours after receiving Menactra. SOB, cough, chest pains. Vaccine was given 11:00 AM. Office visit 5:40 PM. Was given albuterol neb, seemed to improve then given Rx for nebs and prednisone. F/U 9/19/07 Ok, improved.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: Child was screaming non stop. Mom unable to lay child down, give Tylenol and will not give Pertussis next visit.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cough, Wheezing
Clinical narrative: 15 min s/p varicella, DTaP - cough, wheezing. Given 0.01 mg/kg epi SC x 1 - resolved cough, wheeze (within 5 min). Vitals stable.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Allergy to vaccine, Erythema, Pruritus, Skin nodule
Clinical narrative: Sm described area as a "red knot" looks like a pimple and the area is "itchy." Received Gardasil on 9/10/07. Saw provider who stated this was a mild allergy. Benadryl to be taken.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: (R) deltoid about 1 inch of erythema/swelling slight pain. (L) deltoid about 1/2 inch of erythema/swelling and pain.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash generalised
Clinical narrative: Rash all over body (a light rash); no other symptoms. Could also be from scented lotion - bath - first the rash occurred less than 24 hours after the vaccine.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at vaccine site. Tx with Augmentin and Benadryl.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: 9 x 9 cm injected and indurated area with vesicles at injection site. Area is warm to touch. Keflex 250mg 2tsp BID x 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Bilateral red thighs, induration, warm, very red 24 hours post immunizations. Tx Atarax syrup tsp q 6 hrs prn, Tylenol liquid 1 1/2 tsp q 4-6 hours prn, Prelone tsp bid x 4 days (15mg/5ml)
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth, induration at vaccine site left deltoid.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Decreased appetite, Erythema, Headache, Pain, Pruritus
Clinical narrative: Right arm red, warm, pruritic and painful to touch with raised red area approximately 4 x 5cm with larger area 7 x 8cm not raised but red. Could not go to school. Had decreased appetite and headache. On exam, appeared to feel badly.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin warm
Clinical narrative: Right arm red, warm, pruritic and painful to touch with raised red area approximately 4 x 5cm with larger area 7 x 8cm not raised but red. Could not go to school. Had decreased appetite and headache. On exam, appeared to feel badly.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: 9/10/07 Extreme pain - slight swelling ate site. 9/11/07 Pain, swelling, site very hot. 9/12/07 Pain less but swelling more severe with itchiness. Swollen site about 2 inches.  9/15/07 Itchiness and swelling subsiding.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash break-out
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 4 x 4cm circumferential erythema with swelling, not tender. 1 Day after shot of. No fever, not fluctuant.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cold compress therapy, Erythema, Skin warm, Swelling
Clinical narrative: 10 cm, redness, swelling, warm to touch told patient to take Benadryl Elixir and use cool compresses.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Rash
Clinical narrative: On 9/13/07 patient reported a reaction after receiving the pneumonia shot described that she developed a large hive (note the site of injection on her left arm within 2 hours of receiving the shot reported that she developed one other hive and a slight rash to her left arm. Patient did not seek medical attention.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Abnormal behaviour, Culture throat, Dizziness, Irritability, Pyrexia
Clinical narrative: Onset 9/12 6 days after shots given on 9/7/07 with fevers, irritability, dizziness and behavioral changes of quietness, nonplayful during the day. Fever, irritability and dizziness occurred even through night from 9/12/07 ----> 9/17/07. Two visit during this time were negative for bacterial infection. Fever lasted until 9/19/07.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Streptococcal identification test
Clinical narrative: Onset 9/12 6 days after shots given on 9/7/07 with fevers, irritability, dizziness and behavioral changes of quietness, nonplayful during the day. Fever, irritability and dizziness occurred even through night from 9/12/07 ----> 9/17/07. Two visit during this time were negative for bacterial infection. Fever lasted until 9/19/07.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site vesicles, Skin lesion
Clinical narrative: (R) thigh with erythematous papulovesicular lesion about 9 cm in diameter - small patch of vesicle lesion - reaction encompasses injection of both vaccine.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Large area/ tender area left arm at injection site = 6 x 9 cm.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Pt c/o swollen, hot, red and painful (L) deltoid.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pain, Swelling
Clinical narrative: Varivax to (L) upper arm SC. Blister, pain swelling appeared 9-14-07. Started abx therapy with Keflex 250/5.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Pediarix, HIB, Prevnar were given at a regular 6 months check by visit on 2/20/07. Pt developed a seizure episode that evening. Taken to ER.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: 2 days from Menactra immunization, local swelling at site and on (L) deltoid; + erythema, + warmth (hot), pain at injection site. Skin tight - taunt - resembling cellulitis. Erythema from top deltoid to 1 inch above antecubital region. - abscess, - resp distress. Pt was sent to school.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Full blood count, Hyperaemia
Clinical narrative: (L) arm triangular in shape 3x3.5cm hyperemia surrounded by slight reddish area 12x12cm. No warmth, no pain, no itching, no swelling. Treatment: Zithromax 280mg PO on day 1 and 140 mg po one day for 4 days.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever to 101.4 and irritable x 1 day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left leg
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of redness and swelling of thigh 7" x 4" two days after injection.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Appetite disorder, Irritability, Screaming
Clinical narrative: Fussy, irritable, screaming, no appetite started soon after receiving vaccines at HD today. Signs and symptoms lasted > 2 hours.
Age: 1.6
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered "DTaP4" and "Hepatitis B4", medical assistant gave Pediarix and Hepatitis B vaccine.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Patient was given extra dose of Hib - Health Professional; told doctor patient was complete; doctor insisted that another HIB was to be given.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Urticaria
Clinical narrative: LOCALIZED SKIN ERYTHEMA, AND HIVES ON LEFT UPPER ARM OVER DELTOID EXTENDING TO ALMOST CLAVICULAR LINE AND AXILA AREA.  ONSET V+7 (ONE WEEK POST TYPHOID VACCINATION)
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Fatigue, Gaze palsy, Hyperhidrosis
Clinical narrative: Pt. was noted to be holding breath during vaccination, and within 15-30 seconds after administration of vaccine, pt fell backwards from sitting postion. She was not verbally responsive, and was pale. Pt was laid in a supine postion and then had stiffening of the upper body with a few jerking movements of the upper extremities. Briefly her eyes rolled backwards. This lasted for approximately 5 sec, upon witch the patient came to, was alert, responsive, sat up briefly and stated she felt dizzy, sweaty, and tired. There was no loss of bowel/bladder control. Her exam and vital signs were normal. She was observed for approximately 20 min. without further problem and discharged form the office. It was noted by her mother afterwards that she had nothing to eat or drink today, and has had past pre-syncopal episode, as have multiple siblings associated with blood/blood draw, prolonged standing, and stress.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Pt. was noted to be holding breath during vaccination, and within 15-30 seconds after administration of vaccine, pt fell backwards from sitting postion. She was not verbally responsive, and was pale. Pt was laid in a supine postion and then had stiffening of the upper body with a few jerking movements of the upper extremities. Briefly her eyes rolled backwards. This lasted for approximately 5 sec, upon witch the patient came to, was alert, responsive, sat up briefly and stated she felt dizzy, sweaty, and tired. There was no loss of bowel/bladder control. Her exam and vital signs were normal. She was observed for approximately 20 min. without further problem and discharged form the office. It was noted by her mother afterwards that she had nothing to eat or drink today, and has had past pre-syncopal episode, as have multiple siblings associated with blood/blood draw, prolonged standing, and stress.
Age: 31.0
Sex: M
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Chest pain, Chills, Computerised tomogram, Headache, Lumbar puncture
Clinical narrative: Sudden onset of fever (~102), chills, nausea, body aches, head aches, chest pain.  10/09/2007 MR received for DOS 9/20-24/2007 with D/C Dx of Immunization Reaction, Post LP headache. Pt presented to ER with H/A, diffuse arthralgias, CP, SOB, shaking chills and fever which began within 15 minutes after receiving TDaP vax.  Had similar rxn after Typhoid vax in the past.  PE significant for being ill appearing, shaking chills, tachycardia, pain with ROM, myalgias.  Admitted with assessment: adverse reaction to TDaP immunization.  Clinical presentation of aseptic meningitis. Had episodes of jerky movements and one episode of urianry incontinance. (+) nausea and photophobia. Some numbness from the waist down. Pt received blood patch for post LP H/A. Symptoms resolving by hospital day 4.
Age: 31.0
Sex: M
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Sudden onset of fever (~102), chills, nausea, body aches, head aches, chest pain.  10/09/2007 MR received for DOS 9/20-24/2007 with D/C Dx of Immunization Reaction, Post LP headache. Pt presented to ER with H/A, diffuse arthralgias, CP, SOB, shaking chills and fever which began within 15 minutes after receiving TDaP vax.  Had similar rxn after Typhoid vax in the past.  PE significant for being ill appearing, shaking chills, tachycardia, pain with ROM, myalgias.  Admitted with assessment: adverse reaction to TDaP immunization.  Clinical presentation of aseptic meningitis. Had episodes of jerky movements and one episode of urianry incontinance. (+) nausea and photophobia. Some numbness from the waist down. Pt received blood patch for post LP H/A. Symptoms resolving by hospital day 4.
Age: 31.0
Sex: M
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Chest pain, Dyspnoea, Malaise, Pyrexia
Clinical narrative: Sudden onset of fever (~102), chills, nausea, body aches, head aches, chest pain.  10/09/2007 MR received for DOS 9/20-24/2007 with D/C Dx of Immunization Reaction, Post LP headache. Pt presented to ER with H/A, diffuse arthralgias, CP, SOB, shaking chills and fever which began within 15 minutes after receiving TDaP vax.  Had similar rxn after Typhoid vax in the past.  PE significant for being ill appearing, shaking chills, tachycardia, pain with ROM, myalgias.  Admitted with assessment: adverse reaction to TDaP immunization.  Clinical presentation of aseptic meningitis. Had episodes of jerky movements and one episode of urianry incontinance. (+) nausea and photophobia. Some numbness from the waist down. Pt received blood patch for post LP H/A. Symptoms resolving by hospital day 4.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Breath holding, Erythema, Hypotonia, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: A few hours after receiving an injection of Diphtheria, Tetanus, Acellular Pertussis Vaccine (DtaP, Infanrix), the patient experienced an episode where she was screaming and frightened for about 3 minutes and became very red in the face. She let out a long yell, then suddenly stopped screaming and her body went totally limp. She could be aroused by verbal and physical intervention. After a few seconds, she would go back to being limp, then aroused. This cycle happened 3-5 times over a 10-30 second time span, screaming intermittently while awake. After the episodes concluded, the patient appeared to be spaced out for approximately 1 hour. The mother stated that the patient appeared pale at the time of the event and did not appear to stop breathing. The episode was diagnosed as either a breath-holding spell or a hypotensive hyporesponsive episode (HHE) secondary to pertussis vaccine.  10/02/2007 MR received for DOS 7/10-11/2007 with DX:  Breath-holding spell vs hypotonic-hyporesponsive episode.  Infant was admitted with cheif complaint of ALTE.  On the day of vax child went limp following a screaming fit. Child appeared pale.   Arousable with stimulation, but went limp 3-5 times with screaming in between.  Mom states child appeared to be "spaced out" afterwards.  PE significant for hypotonia and absent reflexes bilaterally.  Erythematous lesion R cheek.  No further episodes of cyanosis, limpness or pallor.  D/C home.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Screaming
Clinical narrative: A few hours after receiving an injection of Diphtheria, Tetanus, Acellular Pertussis Vaccine (DtaP, Infanrix), the patient experienced an episode where she was screaming and frightened for about 3 minutes and became very red in the face. She let out a long yell, then suddenly stopped screaming and her body went totally limp. She could be aroused by verbal and physical intervention. After a few seconds, she would go back to being limp, then aroused. This cycle happened 3-5 times over a 10-30 second time span, screaming intermittently while awake. After the episodes concluded, the patient appeared to be spaced out for approximately 1 hour. The mother stated that the patient appeared pale at the time of the event and did not appear to stop breathing. The episode was diagnosed as either a breath-holding spell or a hypotensive hyporesponsive episode (HHE) secondary to pertussis vaccine.  10/02/2007 MR received for DOS 7/10-11/2007 with DX:  Breath-holding spell vs hypotonic-hyporesponsive episode.  Infant was admitted with cheif complaint of ALTE.  On the day of vax child went limp following a screaming fit. Child appeared pale.   Arousable with stimulation, but went limp 3-5 times with screaming in between.  Mom states child appeared to be "spaced out" afterwards.  PE significant for hypotonia and absent reflexes bilaterally.  Erythematous lesion R cheek.  No further episodes of cyanosis, limpness or pallor.  D/C home.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Head aches, muscle and joint aches
Age: 1.33
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 2 hours after the flu vaccine was administered my son began getting hives. The hives were all over his body-red, raised,itchy whelps. The hives went away when Aveeno ant-itch cream was administered but new hives cont. to pop-up in different places. The peditrician's office was contacted, they did not associate the hives with the vaccine and told me to give him children's liquid Benadryl. The hives improved with Benadryl but have cont. to reoccur for over 1 week. My son is to see his Pediatrican again in 2 days.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Surgery, X-ray
Clinical narrative: Information has been received from the FDA (VAERS # 288035) through the CDC concerning a 4 month old female with no history or pre-existing conditions, who on 09-JUL-2007 was vaccinated with her second dose of Rotateq (Lot# 655153/0847F). Concomitant vaccinations administered on that same day included the second dose of Prevnar (Lot# B47300A), the second dose of ActHIB (lot# UF051AA) and the second dose of Pediarix (Lot# AC21B092AA). There was no other concomitant drug therapy. On 13-JUL-2007, the patient experienced intussusception and was hospitalized. Lab diagnostic studies included an x-ray and a barium enema. The patient underwent surgery. On 14-AUG-2007, the patient recovered. Intussusception was also considered to be immediately life-threatening by the reporter. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologics Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain Barre Syndrome
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Paraesthesia, Unevaluable event
Clinical narrative: Guillain Barre Syndrome
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Back pain, Computerised tomogram normal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulins
Clinical narrative: Guillain Barre Syndrome
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Guillain Barre Syndrome
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Amputation, Clostridium difficile sepsis, Culture positive, Gastroenteritis
Clinical narrative: Initial report received on 12 September 2007 from a health care professional. A 19-year-old female patient, with no history of trauma to her right arm, had received a first dose, left deltoid injection of Menactra, lot number unknown, on 29 August 2007. Eight days post-vaccination, the patient developed fever and arm pain. The following day, she was hospitalized and diagnosed with necrotizing fasciitis of the right upper extremity. The patient subsequently underwent an amputation of the right upper extremity and right scapula. It was noted, "organism clostridium/septica." The infectious disease specialist was questioning a gastrointestinal source. At the time of this report, the subject had not recovered.