chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abdominal pain, Anaphylactic reaction, Chest pain, Eye oedema, Nausea
Clinical narrative: (Before vaccines given, patient had left eye with itching/redness). Patient here for 5 year old check up and received the four vaccines listed below. Within 5 minutes, patient complained of nausea/vomiting, chest pain, and abdominal pain. Patient encouraged to lay down and sip on juice and rest. Patient still in exam 20 minutes later when Dad came out and told nurse patient's left eye was swollen. Examined by doctor, VS taken. Benadryl 12.5mg PO given at 4 PM and 0.13 mg Epi SQ left arm at 4:10 PM. Left eye with decreased edema and patient perky 5 minutes after Epi. RA SATS 98-100%. Discharge summary states anaphylaxis.  Medical records state hives. msv
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: (Before vaccines given, patient had left eye with itching/redness). Patient here for 5 year old check up and received the four vaccines listed below. Within 5 minutes, patient complained of nausea/vomiting, chest pain, and abdominal pain. Patient encouraged to lay down and sip on juice and rest. Patient still in exam 20 minutes later when Dad came out and told nurse patient's left eye was swollen. Examined by doctor, VS taken. Benadryl 12.5mg PO given at 4 PM and 0.13 mg Epi SQ left arm at 4:10 PM. Left eye with decreased edema and patient perky 5 minutes after Epi. RA SATS 98-100%. Discharge summary states anaphylaxis.  Medical records state hives. msv
Age: 1.28
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Immediately after injection of Varivax, pt's leg became erythematous and swollen without induration but with an area looking like a small wheal "2" posterior inferior to injection site. Ice was applied for 30 min. and 2-3 ml Benadryl was given. After 30 min., leg still swollen and red but wheal had resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: L thigh is red, warm to touch with induration 7 1/2" X 5".
Age: 63.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Blister, Injection site erythema, Injection site mass
Clinical narrative: Developed induration and erythema 7 days after Tdap (Adacel). Started as 4 vesicles and then induration of arm. And received IPV and typhoid Vi polysaccharide in same arm.
Age: 1.02
Sex: F
Vaccine: HBHEPB, HEPA, IPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Local rash at injection site and 104 fever X 4 days, in left thigh. No treatment required.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Back pain, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: 5/16/05, Pt received Yellow Fever. Pt called 5/23/06 and stated that 20-30 min. after shot, she developed L lower back pain and then headache on R side of base. Headache gone after 30 min. Back pain lasted 4 days. Now has fever, muscle aches, fatigue /// ///.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Encephalitis, Laboratory test abnormal
Clinical narrative: Info has been received from a health professional concerning a 7 year old male with no reported relevant history who on 12/23/05 was vaccinated with 1 dose of varicella virus vaccine live. One month after vaccination, in January 2006, the pt presented with encephalitis and was hospitalized. It was noted that he did not refer previous medical history of immunodeficiency. A serology was performed and it did not show seroconversion against mumps, measles, rubella, and varicella. The pt is not yet recovered. Follow-up info has been received on 6/5/06. It was reported that a PCR determination was performed on a sample of CSF to detect the varicella virus. Result was negative. Serology was negative also. The pt's outcome was not reported.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Choking, Flushing, Medication error, Tongue discolouration
Clinical narrative: Info has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 6/2/06 was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot #653661/0146F). Concomitant therapy included generic acetaminophen about one hour before vaccination. Half way through the dose, on 6/2/06, the pt began to choke. He immediately developed a thick white coating on his tongue that came off in hard plaques. The pt became red in the face. The reporter tried to scrape the plaques off his tongue while they waited for the ambulance to transport the child to the ER. It was noted that the baby had been nursing on and off throughout the visit. At the time of the report, the pt had not recovered. A product quality complaint was involved (not further specified). Follow-up info from a health professional indicated that the pt was reported to have actually been given "Indermal", instead of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The follow-up info indicated that a quality complaint was not involved. The reporter felt that the pt's reaction was an Other Important Medical Event, as he was transported to the ER. Additional info has been requested.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm swollen, red.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria after Adacel and Menactra (36 hrs. post/vax). I treated with Prednisone and Zyrtec and urticaria resolved.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Urinary tract infection
Clinical narrative: Was transported by ambulance to ER following seizure at work at 23:00, 6/1/06. No previous history of seizures. Final diagnosis was new onset seizure and urinary tract infection.  Cipro 500m g 1 every 12 hrs to be taken for 3 days.FU with PCP within 1 wk.  Final diagnosis was new onset seizure and urinary tract infection.   Cipro 500m g 1 every 12 hrs to be taken for 3 days. FU with PCP within 1 wk.  10/11/06-records received from neurologist for DOS 9/18/06-patient has been seizure free since last visit on 6/19/06. Takes Topamax 100mg twice a day. Repeat EEG normal, MRI scan of brain was unrevealing. Patient with what I believe to be idiopathic generalized tonic clonic seizures well controlled on Topamax. Follow-up in 6 months. On 6/19/06 lost consciousness began to shake all over bit her tongue, foamed at mouth, eyes rolled back, also urinated. Seen in ER, exam essentially normal. CT scan normal. Had UTI, began antibiotic.  No HX of seizures.  Neuro exam normal.
Age: 1.1
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Rash started 6/10/06, with low-grade fever 100.7 (+) maculopapular lesions over face, hip area, thighs, scalp some with crusted over areas per MDA. (+) pruritus. Rx: Benadryl 12.5/5ml 2ml po q 8 hrs, Tylenol 160/5ml 4 tsp po q 6 hrs for fever.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Immediately following administration, pt complained of local itching.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Medication error
Clinical narrative: No adverse reaction. Reporting 2 Hep-B's given at same time. Haemophilus not given. No reaction.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Swelling face, Urticaria, Wheezing
Clinical narrative: Anaphylaxis after Hep A vaccine. Four hrs after received the vaccine child began wheezing, swollen lips and developed generalized urticaria. Received epinephrine and Benadryl in the ER (wheezing had subsided before ER visit). Mother states urticaria resolved within 2-3 ds and received Benadryl during that time.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Febrile-(104F) three days.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella vaccine breakthrough. Developed rash on torso 6/8/06. No fever. Diagnosed in our office on 6/10/06 with vaccine modified varicella by another MD. Had over 150 lesions.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hrs, pt developed local redness/warmth/ pain. (Involved 3" X 3" area of skin). Pt has improved.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Body temperature increased, Rash
Clinical narrative: Increase temperature, rash.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever increased to 101.8, rash.
Age: 1.04
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Infection
Clinical narrative: Vesicular rash with scabs. Pt seen in ER. Caladryl lotion.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Marked erythema surrounding injection site. Fever, chills, nausea and vomiting on day 7-8, after vaccine. Also areas of possibly dissemination on upper and lower extremities. Levaquin 750mg daily X 5 days empirically.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: R arm localized redness, swelling, tenderness. Persistent > 3 days. Fever X 2 days, now resolved. Also bruise (over on arm appears due to restraint during vaccination).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Lg. amt. of swelling around injection site. Knee cap swollen and swelling increased over course if X 2 d and increased up leg to hip and down to knee. Tx: Zyrtec 1 1/2 tsp BID X 4 days, after which child returned to normal. Methotrexate given same R arm.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen and red R thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swollen, red, warm and itchy R arm.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Both thighs tender, swollen and hard.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: After receiving varicella vaccine-obtained the chickenpox virus.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Office visit after injection on 5-4-06. Left upper arm red from shoulder to elbow with mild swelling and tenderness. Redness had extended 8cm medially from shoulder to anterior chest, now improved. 3cm of redness beyond most medial marking on chest wall but within border, redness improved. Did give Benadryl 1tsp every 4 hours overnight on 5-3-06.
Age: 1.14
Sex: F
Vaccine: MEA
Symptoms: Eye movement disorder, Staring
Clinical narrative: Measles given 3/24/06, 7 days later, pt was noted by parents and family friends that pt was staring off and eyes went back in head often X 1 wk, then resolved.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Gastrointestinal necrosis, Haematochezia, Intussusception, Irritability
Clinical narrative: 2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Lethargy
Clinical narrative: 2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: 2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Agitation, Crying, Haematochezia, Intussusception
Clinical narrative: 2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Pain
Clinical narrative: 2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: PT REC'D SHOTS ON 6/8/06 AND WE REC'D CALL ON 6/9/06 FROM MOM THAT SHE WAS AT CLINIC BECAUSE INJECTION SITE TO LEFT THIGH WAS SWOLLEN AND PAINFUL.  MOM STATED THAT THIGH HAD FIST SIZE KNOT IN IT.  PT WAS PLACE ON ANTIBIOTIC BY THE MD AT THAT CLINIC.  MOM CALLED ON MONDAY TO LET US KNOW THAT LEG WAS MUCH BETTER.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: PT REC'D 2 MONTH SHOTS.  REC'D PEDIARIX TO RIGHT THIGH AND AREA IMMEDIATELY BECAME VERY RED WITH RED CIRCLE APPROXIMATELY 5 INCHES IN CIRCUM.  MOM WAS ADVISED TO APPLY COOL COMPRESSES TO AREA AND MEDICATE WITH TYLENOL EVERY 4 HOURS AS NEEDED FOR PAIN.   MA CALLED MOM LATER THAT EVENING TO CHECK ON PT AROUND 7:18PM AT WHICH TIME MOM REPORTED SITE REACTION HAD IMPROVED.  NO FURTHER CALLS REC'D REGARDING THIS AS OF TIME OF THIS REPORT.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Hives all over body after Menomune injection that lasted intermittently over 2 days.  No respiratory distress or localized reaction.  Saw primary care manager 2 days after hives appeared and sxs resolved.  No ER visit.
Age: 0.34
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: T,SCREAMING X 4 HOURS-TWELVE HOURS AFTER IMMUNIZATION.  NO REDNESS, NO TENDERNESS, NO SWELLING.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother of child reported a red, warm to the touch, area the size of an apple at the injection site.  Child did not have a fever. Today mom reports that there is a bruise at the injection site, red edematous area is gone.  Mom was told by M.D. to treat with Motrin, Benadryl and ice.
Age: 1.62
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Injection site swelling
Clinical narrative: Swollen area ( 7 cm x 5  cm) on left anterior thigh.  This occurred within 24 hours after the injection.
Age: 5.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Livedo reticularis
Clinical narrative: DTaP administered in r leg on 6-8-2006.  Father brought child into clinic on 6-15-2006 with redness measuring 6 inches x 3 inches with mottling appearance and very hot to touch. Area was firm to touch.  Child did not complain of any pain or fever.  Able to walk on it with no problems.  Child started on Keflex per doctor by phone conversation with myself.  Child then seen in clinic on 6-16-2006 with much improvement of site.  There did appear to be an area at injection site that looked as if the child had scratched that area.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Malaise, Pain, Rash macular
Clinical narrative: Onset of severe pain in Rt deltoid shortly after receiving immunization, noted malaise the next day and  and development of a macular, red, confluent rash at injection site, over lower abdomen and mid back approx 2 days later. RASH STILL PRESENT AS OF THIS REPORT.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 18  X  23 cm redness and swelling left deltoid.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pharyngolaryngeal pain, Rhinorrhoea, Syncope
Clinical narrative: Sore throat, runny nose 6/15; syncope 6/15/06.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Started 12 hours after the injection. Sudden swelling and redness a site with pain increasing to surrounding areas with severe itching. Also fevers to 102.
Age: 46.0
Sex: F
Vaccine: MMR, TD
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Febrile illness for > 10 days, fatigue and headaches. Ibuprofen, rest. No treatment.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable high pitched crying over the weekend.
Age: 1.02
Sex: M
Vaccine: HBHEPB, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local vaccine reaction: Right thigh: 30x18mm area of redness and swelling.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Blood creatine phosphokinase increased, Dizziness, Liver function test abnormal, Vomiting
Clinical narrative: Given DT 6/14/06 for superficial laceration on lower leg. 6/15/06, had acute onset of weakness, dizziness and vomiting. Lab work showed CPK 85 and increased LFT, given 2 liters of fluids with improvement.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Chest pain, Dyspnoea, Petechiae, Pyrexia, Tachycardia
Clinical narrative: One hour prior to receiving this MMR, client received her #2 dose of adult Hep-B vaccine at doctor's office. She denies any reaction to her 1st dose of Hep-B vaccine, which was given one month prior to this 2nd dose. She then came to HD for her 1st dose of MMR vaccine, as doctor's office out of vaccine. Chest pain and SOB evening of 6/11/06. Petechial rash began on both arms 6-12 and has continued to spread quickly to entire body as of report date. Older portions of rash have faded, but seem to have consolidated into clusters. Fever of 102F evening of 6/13/06, 101F on 6/14 and 100F on 6/15. As of this report date, 6/16, her fever has resolved without further episodes. Seen by NP at doctor's office on 6/14/06. At that time she presented with fever, spreading rash and SOB with tachycardia. Was sent to ER for evaluation and treatment, as indicated. Was discharged home after receiving IV ibuprofen. Per pt, no other meds or prescriptions were given. She reports a history of intermittent tachycardia over the past 4 years, and intermittent SOB over the past 20 years. As of today, 6/16/06, pt is fever free, but head to toe rash has not yet resolved.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives on extremities, upper and lower. Began evening after vaccination.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Blister, Rash, Viral infection
Clinical narrative: My son received the Varicella vaccine on June 15 2006. On the morning of June 17, he woke up and had numerous spots all over him. As the day went on, he kept getting more spots and then they turned into blisters in the evening. He now has a full blown case of chicken pox. He has them on his face, arms, legs, bottom, in his ears, and on his chest.
Age: 4.0
Sex: M
Vaccine: MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Initial report received on 07Jun06 from another manf with the report number WAES0604USA01181. The information in this report was originally provided to the other manf by another company report number of HQWYE491023MAR06, who originally received the information from a health care professional. A four year old Hispanic male with a history of febrile seizures had received a fourth IM dose of ActHib, lot number UE036AA (lot number W1479-2); a second SC (also reported as IM) dose of Measles Mumps and Rubella II vaccine, lot number 650099/0582R; a third IM dose of Prevnar, lot B05643F (also reported as B08643F); a a first SC (also reported and IM) dose of Varivax, lot number 651052/0562R on 07MAR06. The lot number provided for ActHib had an expiration date of 18Nov05, indicating that the product was expired when administered. Three days later, on 10Mar06, the pt experienced a febrile seizure and was admitted to the hospital for two days. Per the reporter, it was unk if any diagnostic tests/laboratory data were collected for this event. The pt recovered and was discharged from the hospital. The reporter considered the event of febrile seizure to be immediately life-threatening.
Age: 4.0
Sex: M
Vaccine: MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Medication error
Clinical narrative: Initial report received on 07Jun06 from another manf with the report number WAES0604USA01181. The information in this report was originally provided to the other manf by another company report number of HQWYE491023MAR06, who originally received the information from a health care professional. A four year old Hispanic male with a history of febrile seizures had received a fourth IM dose of ActHib, lot number UE036AA (lot number W1479-2); a second SC (also reported as IM) dose of Measles Mumps and Rubella II vaccine, lot number 650099/0582R; a third IM dose of Prevnar, lot B05643F (also reported as B08643F); a a first SC (also reported and IM) dose of Varivax, lot number 651052/0562R on 07MAR06. The lot number provided for ActHib had an expiration date of 18Nov05, indicating that the product was expired when administered. Three days later, on 10Mar06, the pt experienced a febrile seizure and was admitted to the hospital for two days. Per the reporter, it was unk if any diagnostic tests/laboratory data were collected for this event. The pt recovered and was discharged from the hospital. The reporter considered the event of febrile seizure to be immediately life-threatening.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Coma, Dyskinesia, Loss of consciousness, Screaming
Clinical narrative: Initial report received on 09Jun06 from a health care professional. A 17 year old female, who in the past, had experienced a single syncopal episode that was not related to any vaccination or injection, and for which a specific cause was not determined, had received her first IM dose of Menactra, lot number U2004AA, in the left arm on 09Jun06 at 09:00AM. Two minutes later, the mother ran from her car stating the pt was unconscious. The pt was found to be unresponsive, with a strong pulse and adequate respirations. She remained unresponsive for approximately 1.5 minutes. When the pt aroused, she began screaming and moving her body in an erratic manner. Post episode recovery took approx five minutes. At that time, the pt became verbal and had stopped screaming and moving erratically. The pt was medically evaluated and her blood pressure was reported as 124/72 and a pulse oximetry reading showed 100% oxygen saturation on room air. At the time of this report, the pt had recovered from these events. (OMIC)
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Coma, Crying, Loss of consciousness, Screaming, Syncope
Clinical narrative: Initial report received on 09Jun06 from a health care professional. A 17 year old female, who in the past, had experienced a single syncopal episode that was not related to any vaccination or injection, and for which a specific cause was not determined, had received her first IM dose of Menactra, lot number U2004AA, in the left arm on 09Jun06 at 09:00AM. Two minutes later, the mother ran from her car stating the pt was unconscious. The pt was found to be unresponsive, with a strong pulse and adequate respirations. She remained unresponsive for approximately 1.5 minutes. When the pt aroused, she began screaming and moving her body in an erratic manner. Post episode recovery took approx five minutes. At that time, the pt became verbal and had stopped screaming and moving erratically. The pt was medically evaluated and her blood pressure was reported as 124/72 and a pulse oximetry reading showed 100% oxygen saturation on room air. At the time of this report, the pt had recovered from these events. (OMIC)
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Acanthosis, Blister, Cellulitis, Diarrhoea, Eosinophilia
Clinical narrative: From initial information received on 6/5/06 from a literature report, it was reported that a seven year old female patient had received a dose of Diphtheria and Tetanus Toxoids vaccine on an unspecified date. The trade name, product manufacturer, lot number, route and site of administration were not reported. One week post-immunization, the patient presented with an itchy, indurated rash on her right foot. The induration spread centrifugally forming large plaques that subsequently became edematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. She experienced a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. Physical examination revealed a well-appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well-demarcated erythematous plaques were present on her upper extremities. Red-brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medial instep. The remainder of the physical examination was unremarkable. There was a family history of atopy. Her laboratory data were notable for a peripheral eosinophilia (976/mm^3, 16%) with a normal white blood cell count (56.1), negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hemotoxylin and eosin-stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flame figure consistent with Well's syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5mg/Kg and slowly tapered with adjunctive high-potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She has continued to have episodic flares that have responded to symptomatic topical therapy. (OMIC)
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Erythema, Inflammation, Oedema peripheral, Rash papular, Rash pruritic
Clinical narrative: From initial information received on 6/5/06 from a literature report, it was reported that a seven year old female patient had received a dose of Diphtheria and Tetanus Toxoids vaccine on an unspecified date. The trade name, product manufacturer, lot number, route and site of administration were not reported. One week post-immunization, the patient presented with an itchy, indurated rash on her right foot. The induration spread centrifugally forming large plaques that subsequently became edematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. She experienced a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. Physical examination revealed a well-appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well-demarcated erythematous plaques were present on her upper extremities. Red-brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medial instep. The remainder of the physical examination was unremarkable. There was a family history of atopy. Her laboratory data were notable for a peripheral eosinophilia (976/mm^3, 16%) with a normal white blood cell count (56.1), negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hemotoxylin and eosin-stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flame figure consistent with Well's syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5mg/Kg and slowly tapered with adjunctive high-potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She has continued to have episodic flares that have responded to symptomatic topical therapy. (OMIC)
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Rash vesicular, Skin discolouration
Clinical narrative: From initial information received on 6/5/06 from a literature report, it was reported that a seven year old female patient had received a dose of Diphtheria and Tetanus Toxoids vaccine on an unspecified date. The trade name, product manufacturer, lot number, route and site of administration were not reported. One week post-immunization, the patient presented with an itchy, indurated rash on her right foot. The induration spread centrifugally forming large plaques that subsequently became edematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. She experienced a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. Physical examination revealed a well-appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well-demarcated erythematous plaques were present on her upper extremities. Red-brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medial instep. The remainder of the physical examination was unremarkable. There was a family history of atopy. Her laboratory data were notable for a peripheral eosinophilia (976/mm^3, 16%) with a normal white blood cell count (56.1), negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hemotoxylin and eosin-stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flame figure consistent with Well's syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5mg/Kg and slowly tapered with adjunctive high-potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She has continued to have episodic flares that have responded to symptomatic topical therapy. (OMIC)
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Bacterial infection, Blister, Cellulitis, Diarrhoea, Eosinophilia
Clinical narrative: From initial information received on 6/5/06 from a literature report, it was reported that a seven year old female patient had received a dose of Diphtheria and Tetanus Toxoids vaccine on an unspecified date. The trade name, product manufacturer, lot number, route and site of administration were not reported. One week post-immunization, the patient presented with an itchy, indurated rash on her right foot. The induration spread centrifugally forming large plaques that subsequently became edematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. She experienced a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. Physical examination revealed a well-appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well-demarcated erythematous plaques were present on her upper extremities. Red-brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medial instep. The remainder of the physical examination was unremarkable. There was a family history of atopy. Her laboratory data were notable for a peripheral eosinophilia (976/mm^3, 16%) with a normal white blood cell count (56.1), negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hemotoxylin and eosin-stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flame figure consistent with Well's syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5mg/Kg and slowly tapered with adjunctive high-potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She has continued to have episodic flares that have responded to symptomatic topical therapy. (OMIC)
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Erythema, Oedema, Rash pruritic
Clinical narrative: From initial information received on 6/5/06 from a literature report, it was reported that a seven year old female patient had received a dose of Diphtheria and Tetanus Toxoids vaccine on an unspecified date. The trade name, product manufacturer, lot number, route and site of administration were not reported. One week post-immunization, the patient presented with an itchy, indurated rash on her right foot. The induration spread centrifugally forming large plaques that subsequently became edematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. She experienced a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. Physical examination revealed a well-appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well-demarcated erythematous plaques were present on her upper extremities. Red-brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medial instep. The remainder of the physical examination was unremarkable. There was a family history of atopy. Her laboratory data were notable for a peripheral eosinophilia (976/mm^3, 16%) with a normal white blood cell count (56.1), negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hemotoxylin and eosin-stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flame figure consistent with Well's syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5mg/Kg and slowly tapered with adjunctive high-potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She has continued to have episodic flares that have responded to symptomatic topical therapy. (OMIC)
Age: 0.25
Sex: M
Vaccine: DTP
Symptoms: Agitation, Crying, Injection site atrophy, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 05Jun06, from a literature report entitled "Nicolau's syndrome in a newborn caused by triple DTP (diphtheria tetanus pertussis) vaccination, it was reported that a three month old male pt had received a dose of Diphtheria, Tetanus, and Pertussis vaccine, in the right thigh on an unspecified date. The trade name, product manf, lot number and route of administration were not reported for the vaccine. The pt was referred to the dept of dermatology with a one week history of painful swelling on his right thigh. His mother described immediate redness and swelling at the injection site of the DPT vaccine. Within the following week, redness and swelling had become intense and slight central depression had developed. The baby cried when the affected area was touched. Dermatologic examination revealed a circumscribed, irregular, edematous, red-violet, four cm plaque located on the right thigh. Skin lines were prominent over the plaque. The lesion was tender on light tough as evidenced by the baby's restlessness. A topical steroid cream and EMLA were prescribed. Typical livedoid necrosis was observed within one week and an atrophic scar remained at the site of injection at a two month follow up. The topical steroid cream and EMLA were effective in the alleviation of pain and reduction of erythema and swelling. At the time of this report. The pt had not fully recovered.
Age: 0.25
Sex: M
Vaccine: DTP
Symptoms: Injection site pain, Necrosis, Restlessness, Tenderness
Clinical narrative: From initial information received on 05Jun06, from a literature report entitled "Nicolau's syndrome in a newborn caused by triple DTP (diphtheria tetanus pertussis) vaccination, it was reported that a three month old male pt had received a dose of Diphtheria, Tetanus, and Pertussis vaccine, in the right thigh on an unspecified date. The trade name, product manf, lot number and route of administration were not reported for the vaccine. The pt was referred to the dept of dermatology with a one week history of painful swelling on his right thigh. His mother described immediate redness and swelling at the injection site of the DPT vaccine. Within the following week, redness and swelling had become intense and slight central depression had developed. The baby cried when the affected area was touched. Dermatologic examination revealed a circumscribed, irregular, edematous, red-violet, four cm plaque located on the right thigh. Skin lines were prominent over the plaque. The lesion was tender on light tough as evidenced by the baby's restlessness. A topical steroid cream and EMLA were prescribed. Typical livedoid necrosis was observed within one week and an atrophic scar remained at the site of injection at a two month follow up. The topical steroid cream and EMLA were effective in the alleviation of pain and reduction of erythema and swelling. At the time of this report. The pt had not fully recovered.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Wheal, welt urticaria at injection site (L deltoid only).
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Body temperature increased, Hypoaesthesia, Rash
Clinical narrative: Patient received 1/2 dose Td due to local reaction in 1996. She experienced elevated temperature (100) numbness all over, worse in legs, rash evening of vaccine; presented to ER 6-10-06. No treatment; symptoms resolved.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Description: Large area of redness with blisters, swelling and itchy of upper arm 2 days after receiving yellow fever vaccine. Denies fever, SOB, chest or joint pains, headache, nausea or vomiting. Reports slight amount of swelling evening of the injection that progressed the following day to include advance of the redness and swelling from triceps area to just below his elbow with blister formation along the outer aspect of his arm. Also had 3 blisters along inner aspect of the arm with redness extending upward to @ 4 inches below left axilla.
Age: 0.45
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Convulsion, Fatigue, Pyrexia
Clinical narrative: This subject was a 5 month old male, who experienced seizure-like activity, while enrolled in a study. The subject received three doses of study vaccines (Daptacel, IPOL and ActHIB); last doses prior to the event were administered on 11May06. The subject also received his third doses of Prevnar and Recombivax, the same day. The subject experienced seizure-like activity, 2 days post immunization, described as shaking episode upon waking up, which lasted up to a minute, was not accompanied by fever and was followed by fatigue. There were 3 or 4 such episodes. Per the mother, the subject was evaluated by a pediatrician and reportedly there were no concerns. No further details were provided about diagnostics and treatment. A neurological appointment was scheduled to take place approx 1.5 months after the event. A follow up conversation with the parent revealed that the subject had not had such instances for a week prior to the contact. The event was ongoing. The event of seizure-like activity was reported by the investigator as related to the study vaccine (Daptacel) and unrelated to ActHIB, IPOL, Prevnar and Recombivax. (OMIC)
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Rash macular
Clinical narrative: Developed enlarging red, macules up to approx. 7mm on face, trunk and extremities, 6 days after vaccination. No pruritic and no fever. Otherwise, normal.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site oedema, Rash maculo-papular
Clinical narrative: Fine maculopapular rash L zygoma, forehead and chin. Developed into fine vesicles. Eye not involved. TX with Atarax, 1 dose 60mg prednisone po for mild edema. Localized erythema. Resolved with 96.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Pain in jaw
Clinical narrative: 4 hours after vaccine, felt like jaw locking. Jaw painful, hurt to move and couldn't open mouth much for 48 hours. Rapidly, the pain stopped 72 hours after vaccine and jaw felt fine. Prior tetanus vac. more than 10 years before.
Age: 33.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Hot to touch, reddening (about size of softball(, hard, very painful. No treatment.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives to chest and upper back.
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Diarrhoea, Flatulence, Irritability
Clinical narrative: Vaccine given 5/30/06. Diarrhea started 2-3 days later. Fussy, gassy. Seen 6/13/06. Still with loose stool, green. c/s sent.
Age: 1.05
Sex: M
Vaccine: HBHEPB, MER, PNC
Symptoms: Pyrexia
Clinical narrative: High fever, 24 hours after vaccines given. Motrin q 4-6 hrs, as needed for fever.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Abdominal pain, Acne, Amblyopia, Amnesia, Arthralgia
Clinical narrative: Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Asthenia, Back pain, Blister, Bone disorder, Cognitive disorder
Clinical narrative: Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Depression, Difficulty in walking, Disturbance in attention, Gastrooesophageal reflux disease, Headache
Clinical narrative: Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Infection, Memory impairment, Muscle spasms, Myalgia, Neck pain
Clinical narrative: Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Pain, Rash, Shoulder pain, Weight increased
Clinical narrative: Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MER
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R arm redness and swelling after DPT injection on 6/2/06.