chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Initial report received 14 August 2007 from a health care professional. A 31-year-old female patient had received a prophylactic injection of Fluzone on 26 December 2006 during her second trimester of pregnancy. The patient's date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2007. Exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold "in office". During her third trimester, beginning on 12 February 2007, she experienced a cough which lasted seven days, ending on 18 February 2007. Then, beginning 08 March 2007, she experienced a temperature of 100 degrees Fahrenheit, and "bronchitis/cold" symptoms. Her temperature returned to normal the following day but her bronchitis/cold symptoms persisted until 04 May 2007. She had been prescribed "antibiotics NCS" from 01 April 2007 until 30 April 2007 and Z-PAKs from 15 April 2007 to 04 May 2007. An ultrasound performed 02 May 2007 revealed "low amniotic fluid" and a non-stress test performed on 08 May 2007 had normal results. The patient had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. The baby had cyanosis at birth which resolved within 2 hours. Shortly after birth the baby started having difficulties breathing and was diagnosed with pulmonary hypertension and intubated for 24 hours and the pulmonary hypertension resolved. Oxygen was administered another 24 hours and on 20 May 2007, the baby was breathing normally. The baby had been prescribed antibiotics for one week and all laboratory results were normal, negative for infection. The baby had been monitored for five additional days and had been released on 26 May 2007. This case was originally reported as non-serious, however, it was upgraded to serious by manufacturer. This case is linked to the baby's case 2007-02795 (pulmonary hypertension, jaundice).
Sex: M
Vaccine: FLU3
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Laboratory test normal
Clinical narrative: Initial report received 14 August 2007 from a health care professional. A male newborn baby had received a prophylactic dose of Fluzone transplacentally through maternal exposure during his second trimester of pregnancy on 26 December 2006. The baby was born and presented with jaundice at birth which resolved within 2-3 days requiring no treatment. The baby had cyanosis at birth which resolved within 2 hours after birth. Shortly after birth, the baby started having difficulties breathing, he was diagnosis with pulmonary hypertension and intubated for 24 hours. Baby was admitted to the NICU for four days for pulmonary hypertension. The pulmonary hypertension resolved within 24 hours; however resolved within 24 hours; however the baby was breathing normally and no longer required supplemental oxygen. He was given prophylactic antibiotics for one week and all laboratory results were normal, he was not positive for any infection. The baby was monitored for five additional days and released from the hospital on 26 May 2007. Per the reporter, the baby's mother "had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. Her date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2006". Maternal exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold "in office". During her third trimester, from 08 March 2007 until 04 May 2007, she experienced "bronchitis/cold" symptoms which had been treated with antibiotics from 01 April 2007 to 04 May 2007. An ultrasound had been performed on 02 May 2007 which revealed "low amniotic fluid". This case is linked to the mother's case 2007-02829 (Oligohydramnios).
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope after immunization administration.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Oxygen saturation normal, Pallor, Syncope, Vomiting
Clinical narrative: 10 min after shots patient had a short 15 sec seizure and fainting episode. 30 min later looked pale and vomited x two. Sent to ER - did fine overnight.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash generalised
Clinical narrative: Immediate redness and swelling at site. Rash over entire body 8/22.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Dysphonia, Pharyngolaryngeal pain, Throat tightness, Urticaria
Clinical narrative: Immediate redness and swelling at site. Rash over entire body 8/22.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Anxiety, Arthralgia, Fatigue, Nausea, Pain
Clinical narrative: Fatigue, body aches, joint pain, nausea, anxiety. 9/10/07-records received for DOS 8/16-8/17/07-C/O episodes of nausea, diaphoresis and bodyaches since last night. C/O pain at injection sites. Last night developed acute episode of fever and chills, body aches and lethargy.Assessment: allergic reaction although clinically stable questionable psychosomatic rule out anxiety attack.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Streptococcal identification test
Clinical narrative: Fatigue, body aches, joint pain, nausea, anxiety. 9/10/07-records received for DOS 8/16-8/17/07-C/O episodes of nausea, diaphoresis and bodyaches since last night. C/O pain at injection sites. Last night developed acute episode of fever and chills, body aches and lethargy.Assessment: allergic reaction although clinically stable questionable psychosomatic rule out anxiety attack.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Per mom's report, within 24 hours at back of right arm, presumed site of varicella, became red and hard. States site is not painful and is approximately 8-10 cm round.
Age: 10.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Wrong drug administered
Clinical narrative: 2 days after varicella and Menactra developed red, indurated, hot 14cm x 7cm area at area of chicken pox vaccine. Subjective fever reported. Started on Keflex 500mg BID x 10 d.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Pharyngeal oedema, Pruritus, Rash generalised, Swollen tongue
Clinical narrative: Rash, itching, swelling lips and tongue and throat. Helped by Benadryl. Rash was on back, legs and torso lasted few days.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Decreased appetite, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: 6/11/07 Beginning at 8:00-9:00pm, child had watery eyes, crying (parent says she was able to comfort child) and decreased appetite. 6/12/07 Child went to babysitters. Babysitter tells mom he vomited twice during the day. Mom says child had red, puffy eyes when she picked him up at 4:00. Child was somewhat better at 4:30 pm with puffy eyes and a decreased appetite. Tylenol was given for comfort and according to mother on 6/12/07 5:00pm appetite increased and feeling ok.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: 6/11/07 Beginning at 8:00-9:00pm, child had watery eyes, crying (parent says she was able to comfort child) and decreased appetite. 6/12/07 Child went to babysitters. Babysitter tells mom he vomited twice during the day. Mom says child had red, puffy eyes when she picked him up at 4:00. Child was somewhat better at 4:30 pm with puffy eyes and a decreased appetite. Tylenol was given for comfort and according to mother on 6/12/07 5:00pm appetite increased and feeling ok.
Age: 18.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Dizzy, pale for 10-15 min, water and rest.
Age: 16.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: 4:00 PM 06/19/07 HA, dizzy, nauseous, "breathing hard". 5:15 PM 06/19/07 Dizzy, nauseous, "hard to take a breath" 5:30 PM 06/19/07 Dizzy, nauseous, chest tight "hard to take a breath". No treatment at this time other than an Advil for HA. Recommend to see doctor if S/S get worse.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Rash papular, Skin warm
Clinical narrative: Localized rash on right thigh approx 6: x 5". Rash is papular and warm with irregular border.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7 x 5.5cm red swollen, warm area on right upper arm in vaccine site area.
Age: 10.0
Sex: F
Vaccine: IPV, MMRV, TD
Symptoms: Erythema, Pain
Clinical narrative: 4"x4 1/2" local reaction the next day with soreness and erythema. Tx ice packs and Tylenol. Checked with physician for other tx - no further necessary.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Lacrimation increased, Urticaria
Clinical narrative: Pt returned with watery eyes and hives on left cheek. Was given Tap. Only med for the visit she originally presented with.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Reaction occurred 2-3 hours after shots. Right thigh, red, firm, hot - rt leg 1.5 inches larger than left - area of induration 5.5 x 4.5 inches. At least 1.2 of leg or more.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Hot flush, Nausea, Vomiting
Clinical narrative: pt received 1st Gardasil injection and a few hours after injection reported symptoms of nausea, vomiting, hot flashes, abd cramping and diarrhea which subsided after a few hours.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dyskinesia, Immediate post-injection reaction, Pallor, Unresponsive to stimuli
Clinical narrative: At least 3-4 min after administration of Gardasil vaccine. Mom called us into room-pt was jerking and unresponsive to touch or voice-smelling salts were introduced and pt's arms and feet pointed inward and pt soon awoke pt skin was pale and clammy to touch BP-132/79 in R arm Pt advised to stay in office until feeling better.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Local reaction
Clinical narrative: local reaction (R) arm-no medication. Treatment needed
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 2cm x 4cm area that is red and swollen. Parent just noticed today and brought her straight in at 3:30 PM (8/29/07). Pt denied any other symptoms. Vital signs normal. Keflex was given, pt's parent instructed to watch and if gets any worse call Dr. or go to ER.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMRV, PNC
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever on 8.10.07 x 1 day Vomited x 1 8.17.07 Rash started on 8.12.07
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gaze palsy, Tremor, Unresponsive to stimuli
Clinical narrative: After receiving immunizations, stand at check out counter she fell to floor, face up, eyes open and rolled back, unresponsive x 3 seconds to verbal stimulus. Arms shaking. W/in 12 minute, pt able to walk to exam room with assistance. BP 112/68, HR 80. Pt monitored for 1--15 minutes. Rest unremarkable.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Erythema, Rash morbilliform, Rash papular
Clinical narrative: On 8/20/07 received and dose of Gardasil; Pt reports 4-5 hrs later got fine papular eruption not welts; no itch, no prev allergies or hives. Dermatologist examined on 8/23/07 1700 for Morbilliform eruption so far forearms and lower abdomen minimal erythema Dx: Eruption probably due to Gardasil sensitivity
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: On 5-30/07 Gardasil #2 received. ON 5-31-07 grandmother reports "hives all over", states no redness or irritation at injection site. Report took to ER where physician told them unsure if reaction to vaccine or possible other allergic reaction. Received steroid injection, Benadryl PO and steroid dose pack PO "per grandmother". (3rd dose Gardasil held per doctor). Report completed after speaking to pt's grandmother when she called to schedule #3 on 8-31-07.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Blisters on and around injection site.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 7cm x 8cm area of induration. 4cm x 4cm area of erythema.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient's mother called clinic 8/28/07 stating child has rash on him resembling chicken pox. Patient was brought to clinic and assessed by physician. Physician agrees rash looks similar to chicken pox. No treatment was given. Reassurance to patient's family - given.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 1" x 1" warm, reddened area on left thigh in area where Varicella vaccination was received.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives onset 6.3.07. Hives on arms, chest, back, thighs, itchy
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Circular reddened area 1 1/2 in diameter starting 8/25 (the day after the shot). No swelling or induration.
Age: 66.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: 2 days post vaccine developed flat blotchy mild red rash to arms/legs and torso. C/O mild itching with some relief with Benadryl. 8/20 - reported rash resolved.
Age: 1.07
Sex: F
Vaccine: MEA
Symptoms: Blister, Psychomotor skills impaired, Speech disorder developmental
Clinical narrative: 2 days S/P Measles vaccine, pt. with "spacy" behavior, staring off, with developmental regression. Pt had 30 words, then lost them entirely. No speech and poor interaction.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Ear pain, Pyrexia
Clinical narrative: Fever of 101 and ear pain x 2 days
Age: 15.0
Sex: F
Vaccine: HEPA, HPVX, MNQ, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: At injection site there was immediate swelling, redness and skin/muscle was hot to touch.  Patient experienced a fairly intense headache, her entire arm was quite painful and she was not feeling well ingeneral.  This lasted for several days.  PLEASE NOTE:  HEP A IMMUNIZATION WAS ADMINISTERED ON THE SAME DATE AT A DIFFERENT LOCATION (PUBLIC HEALTH CLINIC).
Age: 15.0
Sex: F
Vaccine: HEPA, HPVX, MNQ, VARCEL
Symptoms: Pain in extremity
Clinical narrative: At injection site there was immediate swelling, redness and skin/muscle was hot to touch.  Patient experienced a fairly intense headache, her entire arm was quite painful and she was not feeling well ingeneral.  This lasted for several days.  PLEASE NOTE:  HEP A IMMUNIZATION WAS ADMINISTERED ON THE SAME DATE AT A DIFFERENT LOCATION (PUBLIC HEALTH CLINIC).
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Several days after adminstration, fever broke out 102-103 degrees followed by full blown outbreak of chickenpox.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Coronary artery aneurysm, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Kawasaki disease with probable coronary aneurysms.  9/10/2007 MR received for DOS 5/29-6/02/2007 for admission for DX of Kawasaki's Disease.  Seen in ER at another facility for fever and discharged.  Infant continued with fevers and developed red, cracked lips, red conjunctiva, and a diffuse macular rash. Emesis and diarrhea also present, now resolved.  PE significant for tachycardia, (+) murmur, and erythematous macular rash.  Txd with IVIG, ASA, and propranalol. D/C PE WNL except 1/6 systolic ejection murmur.  9/11/2007 Reviewed ER medical records of 5/21/07 which reveal patient experienced fever, nasal congestion, runny nose.  Patient's 3 siblings have vupper respiratory viral syndromes.  Tx w/IM antibiotics x 1.  Released to home. FINAL DX: Fever. 5/12/10 Follow up: unknown-coronary arter aneurysms have resolved, but longterm effects of this unknown.
Age: 25.0
Sex: F
Vaccine: ANTH, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient was given Anthrax, PPD and TDAP without her HCG results. Patient is pregnant.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, headache and lightheadedness sore arm at site of injection.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Grand mal convulsion, Lumbar puncture
Clinical narrative: Immunizations given in AM 8/28/07; around 9PM patient had temp of 103F and 5 minute generalized tonic-clonic seizure; patient brought to ER, seizure stopped before patient arrived in ER.  Septic work-up including spinal tap was done - initial results are all negative.  9/7/07 Reviewed hospital medical records which reveal patient experienced limpness, eyes rolled back in head, vomiting, fever & tonic clonic seizure activity.  Admitted 8/28-8/30/2007.  Afebrile & no further seizure activity in hospital.  D/C to home w/pcp f/u. FINAL DX: Febrile seizure.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: patient developed indurated, sollen, erythemous area at injection site on RLE along with vomiting & 3 day history of fever.  Fever developed approx 3 hours of immunization, vomiting began 24 hours post & erythema developing 48 hours post injection.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Fall
Clinical narrative: patient came in clinic for vaccintion and stated she didn't like needle at all.After recieving MMR and Varicella vaccination she complained of dizziness. At 3:23 patientfloor and legs up position. patient was alert and oriented BP100/80Respiration rate:18.ammonia administered as precaution.patient left clinic at 3:38pm on own ability ambulating and stating she is fine.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Patient has had continued pain at injection site and now is having increasing weakness in right arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Influenza like illness, Pain
Clinical narrative: Dizziness, and body aches (flu like) were experienced.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Significant swelling and errythema just below the injection site, hot and painful to touch.  Redness and induration measured 10 cm X 12.5 cm.  Ran a fever of 102.8.  Local reaction started the afternoon of administration.  Fever started the next morning.  Patient was seen by physician on 8/27/07 and was prescribed p. o. benedryl and antibiotics.  She was seen again by same physician the afternoon of 8/28/07 and was give an injection (probably of Rocephin).  On 8/29/07 the site was no longer red irritated or swollen.  Patient stated the upper arm was itchy today.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pruritus, Pyrexia
Clinical narrative: Significant swelling and errythema just below the injection site, hot and painful to touch.  Redness and induration measured 10 cm X 12.5 cm.  Ran a fever of 102.8.  Local reaction started the afternoon of administration.  Fever started the next morning.  Patient was seen by physician on 8/27/07 and was prescribed p. o. benedryl and antibiotics.  She was seen again by same physician the afternoon of 8/28/07 and was give an injection (probably of Rocephin).  On 8/29/07 the site was no longer red irritated or swollen.  Patient stated the upper arm was itchy today.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site urticaria, Paraesthesia, Pruritus
Clinical narrative: pt presented 6 days post immunization witk localized inflammation (red, round wheal approx 5 to 6 inches in diameter)at or near injection site - pt describes as "itchy and tingling" - pt saw their physician who prescribed antibiotic (unknown) and antihistime
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Ear pain, Headache, Pyrexia, Viral infection
Clinical narrative: 08/29/07 1115 Received phone call from client;s mother who stated "Patient has not been feeling well and we were wondering if it was from the vaccine he was given."  Mother stated patient complained of a headache on Monday and had a slight fever.  She took to the doctor and he stated it was a viral infection.  Mother stated today patient is off balance and complaining of right ear pain.  Encouraged mother to take patient to doctor and explain symptoms and that he received Hepatitis A vaccine on 08/22/07.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Anaphylactic reaction, Chest pain, Cough, Pharyngeal oedema, Pyrexia
Clinical narrative: Anaphylaxis, throat swelling causing coughing, wheezing, chest pain, mucous drainage within 10 minutes of the shots given.  Patient recieved Epi jr., albuterol through a spacer and two tablets of benadryl. Then she had xeponex through a nebulizer. She stabilzed. Enroute to ER to be observed, Anaphlaxis occured again, with body hives, wheezing, coughing and she also had a high fever. She recieved another breathing treatment with ALbuterol and an Epi Jr once again. Oxygen was then given and she was admitted to ER. She was then give IV steroids and Motrin for fever. She was evaluated 6 hours and released. She is still running high fever and is on antihistimines.  8/31/07 Received vax record from pcp which corrected vax info.  VAERS database updated w/same.  10/26/07 Received hospital medical records which reveal patient experienced coughing, vomited, wheezing , & increased phlegm.  Seen in ER 8/27/07 from pcp office.  Had already received repeat epi pen prior to arrival along with orapred, nebs, O2 & benadryl.  Tx w/additional IV steroids & benadryl.  Improved & d/c to home from ER. FINAL DX: acute allergic reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: Anaphylaxis, throat swelling causing coughing, wheezing, chest pain, mucous drainage within 10 minutes of the shots given.  Patient recieved Epi jr., albuterol through a spacer and two tablets of benadryl. Then she had xeponex through a nebulizer. She stabilzed. Enroute to ER to be observed, Anaphlaxis occured again, with body hives, wheezing, coughing and she also had a high fever. She recieved another breathing treatment with ALbuterol and an Epi Jr once again. Oxygen was then given and she was admitted to ER. She was then give IV steroids and Motrin for fever. She was evaluated 6 hours and released. She is still running high fever and is on antihistimines.  8/31/07 Received vax record from pcp which corrected vax info.  VAERS database updated w/same.  10/26/07 Received hospital medical records which reveal patient experienced coughing, vomited, wheezing , & increased phlegm.  Seen in ER 8/27/07 from pcp office.  Had already received repeat epi pen prior to arrival along with orapred, nebs, O2 & benadryl.  Tx w/additional IV steroids & benadryl.  Improved & d/c to home from ER. FINAL DX: acute allergic reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling abnormal, Pyrexia, Rash erythematous
Clinical narrative: Patient returned to clinic on 8/28/2007 with a red rash to face, torso and arms.  Pts mother states the rash was worse and child ran a fever and felt bad for a few days.
Age: 28.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Confusional state, HLA marker study, Headache, Hypoaesthesia
Clinical narrative: arthritis, neurological symptoms-tingling, numbness, brain fog, muscle twithces, muscle pain, headaches, difficulty finding words, increased floaters in eyes
Age: 28.0
Sex: F
Vaccine: LYME
Symptoms: Immunology test, Immunology test normal, Lyme disease, Muscle twitching, Myalgia
Clinical narrative: arthritis, neurological symptoms-tingling, numbness, brain fog, muscle twithces, muscle pain, headaches, difficulty finding words, increased floaters in eyes
Age: 28.0
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia, Polymerase chain reaction, Speech disorder, Vitreous floaters
Clinical narrative: arthritis, neurological symptoms-tingling, numbness, brain fog, muscle twithces, muscle pain, headaches, difficulty finding words, increased floaters in eyes
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site nodule, Injection site swelling, Lethargy, Lumbar puncture, Moaning
Clinical narrative: During well visit at 2 months, patient was given shots HIB and Prevnar.  He has a bump and slight swelling on the leg that was injected with the Prevnar shot.  Less than 24 hours later I noticed that he was moaning and he felt warm.  The doctor said that he might get a slight fever, so I wasn't too alarmed, but that night his fever reached 103 degrees and he didn't sleep much, just seemed to be lethargic.  He couldn't focus on anything and the moaning got worse.  He developed a rash on his chest and didn't want to eat much.  In the morning I called the doctor to take him and she heard him moaning on the phone and wanted me to take him to the emergency room.  I took him and he was given many tests to diagnose his condition including a Spinal tap, strep culture, lab work, urinanalysis, chest X-Ray, and fluids through an IV.  Patient was admitted to the pediatric ward for 3 days.  His fever would come down with Motrin, but then would go back up again when the medicine would wear off.  His fever finally stayed down and we were released after 3 days.  He had the fever for 5 days though.  The rash went away and he returned to normal.  Patient was completely healthy before the immunizations were administered.  8/31/07 Received vax record which included lot #s.  VAERS database updated w/same./ss 9/11/07 Reviewed hospital medical records which reveal patient experienced fever, cough, moaning, constipation & rash x 2 days.  Admitted 8/2-8/5/07.  Full septic w/u was WNL.  Treated w/antibiotics. FINAL DX: Fever, resolved; viral syndrome.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Oral intake reduced, Pyrexia, Rash, Skin warm, Sleep disorder
Clinical narrative: During well visit at 2 months, patient was given shots HIB and Prevnar.  He has a bump and slight swelling on the leg that was injected with the Prevnar shot.  Less than 24 hours later I noticed that he was moaning and he felt warm.  The doctor said that he might get a slight fever, so I wasn't too alarmed, but that night his fever reached 103 degrees and he didn't sleep much, just seemed to be lethargic.  He couldn't focus on anything and the moaning got worse.  He developed a rash on his chest and didn't want to eat much.  In the morning I called the doctor to take him and she heard him moaning on the phone and wanted me to take him to the emergency room.  I took him and he was given many tests to diagnose his condition including a Spinal tap, strep culture, lab work, urinanalysis, chest X-Ray, and fluids through an IV.  Patient was admitted to the pediatric ward for 3 days.  His fever would come down with Motrin, but then would go back up again when the medicine would wear off.  His fever finally stayed down and we were released after 3 days.  He had the fever for 5 days though.  The rash went away and he returned to normal.  Patient was completely healthy before the immunizations were administered.  8/31/07 Received vax record which included lot #s.  VAERS database updated w/same./ss 9/11/07 Reviewed hospital medical records which reveal patient experienced fever, cough, moaning, constipation & rash x 2 days.  Admitted 8/2-8/5/07.  Full septic w/u was WNL.  Treated w/antibiotics. FINAL DX: Fever, resolved; viral syndrome.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Streptococcal identification test
Clinical narrative: During well visit at 2 months, patient was given shots HIB and Prevnar.  He has a bump and slight swelling on the leg that was injected with the Prevnar shot.  Less than 24 hours later I noticed that he was moaning and he felt warm.  The doctor said that he might get a slight fever, so I wasn't too alarmed, but that night his fever reached 103 degrees and he didn't sleep much, just seemed to be lethargic.  He couldn't focus on anything and the moaning got worse.  He developed a rash on his chest and didn't want to eat much.  In the morning I called the doctor to take him and she heard him moaning on the phone and wanted me to take him to the emergency room.  I took him and he was given many tests to diagnose his condition including a Spinal tap, strep culture, lab work, urinanalysis, chest X-Ray, and fluids through an IV.  Patient was admitted to the pediatric ward for 3 days.  His fever would come down with Motrin, but then would go back up again when the medicine would wear off.  His fever finally stayed down and we were released after 3 days.  He had the fever for 5 days though.  The rash went away and he returned to normal.  Patient was completely healthy before the immunizations were administered.  8/31/07 Received vax record which included lot #s.  VAERS database updated w/same./ss 9/11/07 Reviewed hospital medical records which reveal patient experienced fever, cough, moaning, constipation & rash x 2 days.  Admitted 8/2-8/5/07.  Full septic w/u was WNL.  Treated w/antibiotics. FINAL DX: Fever, resolved; viral syndrome.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Neuralgia, Nuclear magnetic resonance imaging brain normal, Pain, Pain in jaw
Clinical narrative: This patient developed neuralgias with lancinating pain in the left deltoid starting ~8/11/07 and lancinating pains in left jaw, left temple, left forehead starting ~8/18/07.  This continues to cause her pain.
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: A male, child (age, date of birth not reported) experienced soreness and bruising at the right and left, gluteal injection sites after he received dose 5 of Daptacel (lot number C2626AA, route of administration not reported) in the left gluteus and dose 4 of IPOL (lot number Z0548-2, route of administration not reported) in the right gluteus on 07 May 2007. The patient also received dose 2 of ProQuad (MMR and Varicella, lot number 1484F, route of administration not reported) in the right gluteus. The parent treated the patient with Tylenol. At the time of the report, the patient was resolving. This case has the same reporter as case 2007-1630.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: A 2 month old, female patient had inconsolable crying for 4-5 hours, after she received Daptacel (lot number C2605AA, route of administration not reported) in the gluteus (side not reported), IPOL (lot number Z0548-2, route of administration not reported) in the gluteus (side not reported), and ActHIB (lot number UE975AA, route of administration not reported) in the gluteus (side not reported). She also received PCV7 (lot number B36258C) in the gluteus (side not reported) and Rotavirus (lot number 0023U/908VR) in the gluteus (side not reported). The parent treated with patient with Tylenol and the patient recovered. This case has the same reporter as case 2007-01629.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Initial report received on 06/Sep/2006 from a health care provider. A 5-year-old female patient, with no pre-existing medical history, had received an intramuscular, right thigh fourth dose injection of IPOL, lot number Y0991-2, an intramuscular, left thigh, fifth dose injection of Daptacel, lot number C2627AA, and a subcutaneous, left thigh injection of MMR, lot number 0615F; on 25/Aug-2006. The next day, the patient developed a large local reaction of redness, swelling and itching from the front of the right thigh to her knee. She was evaluated by a physician and treated with Benadryl and Augmentin. No diagnostic testing was performed, and the patient recovered from the event. Follow-up information received on 10 October 2006 from a health care provider. The adverse reaction involved the entire R upper thigh. Additional medically relevant information was not provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Initial report received from a health care professional on 23 January 2007. A 2 month old, male patient developed left foot swelling, the evening after he received Daptacel (lot number C2630AA) intramuscularly in the left thigh and IPV (lot number Y1031-2) subcutaneously in the left thigh on 17 January 2007. On the same day, he also received Comvax (lot number 0010F) intramuscularly in the right thigh and Prevnar (lot number B086760B) intramuscularly in the right thigh. The left foot swelled almost double and turned purple in color. By the next morning, it was 50% reduced. It resolved totally. The patient did not have any illness at the time of vaccination and did not have any medical history. Follow-up information received on 09 February 2007. No treatment was given to the patient for the swelling of his left foot. His mother was instructed to check the ankle for any strings or fibers from the sock and to make sure that nothing was obstructing the blood flow. The mother was also instructed to keep the foot elevated or at heart level. The patient's status was totally resolved within 24 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Crying
Clinical narrative: Crying
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Irritability, Pallor
Clinical narrative: Initial report received from a parent of a patient on 07 March 2007. An 11 week old, male patient was irritable slightly, a few hours after he received Daptacel (lot number unknown, route of administration not reported) in the right thigh; Act-HIB (lot number unknown, route and site of administration not reported); IPOL (lot number unknown, route and site of administration not reported) and Rotateq (lot number unknown, route and site of administration not reported) on 06 March 2006 at 3PM. At approximately 8PM, he appeared pale in colour for 10 minutes, then his colour was pink. She denied difficulty breathing, illness at the time of vaccination or other medications. It was reported that the patient recovered. Follow-up information received on 08 June 2007 from a health care professional. The date of vaccination was amended to 06 March 2007 (previously reported as 2006). Vaccines administered on that date included Daptacel, lot number C2569AA, ActHIB, lot number UE929AA (lot number Z0579-2), administered in the right thigh; IPOL, lot number Z0547-2, administered in the left thigh; and Rotateq, lot number 1232F, administered orally. The adverse event onset date was also amended to 06 March 2007 (previously reported as 2006).
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oedema peripheral
Clinical narrative: A 4 month old male patient received on 19 March 2007 the second dose of Daptacel (lot # C2552AA), intra-muscular into the left thigh, IPOL (lot# Y1031) (corrected), subcutaneous into the left thigh; Comvax (Merck, lot# MSV0O1-F), into the right thigh; Prevnar (Wyeth, lot#086708) into the right thigh. The patient's left foot began to swell. Treatment was not reported. The patient's outcome was not reported. First dose of Daptacel (lot# C2430AA) given on 17 January 2007, intra-muscular, into left thigh and experienced swelling of left foot and ankle only (approximately twice of normal size), lasted approximately 20 hours and resolved. Denied illness at vaccination time. The patient's medical history included gastroesophageal reflux disease (GERD) and possible heart murmur. The patient was taking Prevacid as concomitant medication. The events reported after first vaccination with Daptacel are captured is case 2007-00213. Follow-up information received on 12 April 2007. The patient received IPOL-Lot number Y1032. There was no treatment provided-no apparent distress. The duration of the symptoms was 20-24 hours, it was reported the patient was fine after that.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Initial report received on 20 March 2007, from a healthcare professional. A 5 year old male patient received on 16 March 2007 (at morning time) the fourth dose of Daptacel (lot# C2521AA), intra-muscular, into the left arm; third dose of IPOL (lot# Z0456-2), into the left arm; and a dose of MMR (lot# 1025F-9308), into the right arm. On 17 March 2007 (at morning time), a day post vaccination, the left arm was swollen and painful with a rash. The patient returned into the (doctor's) office, unspecified time after vaccination with "cellulitis". The patient was treated with an unknown injection. The patient's outcome was unknown. The patient had no illness and medical condition at the time of vaccination and was not taking other medications. Follow-up information received on 23 April 2007. The patient had no known allergies, did not have any illness at the time of the vaccinations and did not have any additional vaccines within 4 weeks. It was reported the patient recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Injection site induration, Irritability, Pyrexia
Clinical narrative: Initial report received from a nurse on 02 April 2007. A 2 month old, male patient developed a fever of 100.2 F axillary, was fussy and had redness around the left eye after he received ActHIB (reported lot number UF071AA, corresponding lot number Z1094-2) intramuscularly in the left thigh; IPOL (lot number Z0457) intramuscularly in the right thigh; Tripedia (lot number U1751BA) intramuscularly in the left thigh and Prevnar (lot number B08646A) intramuscularly in the right thigh, on 01 March 2007. He had a temperature of 101.4F axillary at the office. Both of his legs have induration, no warmth, tenderness or erythema. Tylenol was given before the vaccinations, it was also given after - 0.8 ml po every 4 hours. He had no illness at the time of the vaccinations - well child visit. It was reported the patient recovered. Follow-up information received on 19 June 2007 from a health care professional. The case was reviewed, and there was no additional information at this time. Same reporter as cases 2007-01010, 2007-01012, 2007-01013, 2007-01014, 2007-01015.
Age: 1.8
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Initial report received from a health care professional on 10 April 2007. A 21 month old, female patient (with no medical history) developed hives within a week after receiving her fourth dose of Daptacel (lot number C2565AA) intramuscularly in the right thigh and her fourth dose of IPOL (lot number not reported) intramuscularly in the left thigh on 21 March 2007. It was reported the hives started at the injection site and spread all over her body. She was seen at the pediatrician's office on 10 April 2007 and the generalized hives persisted with itching. Hydroxyzine was prescribed. The patient did not have any illness at the time of the vaccinations. At the time of the report, the patient had not recovered. Follow-up information received on 30 April 2007. The patient had no known allergies. She received dose 3 of IPOL (lot number Z0547). As of 1 week ago, she still had a rash.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Full blood count, Haemoglobin normal, Petechiae, Platelet count increased
Clinical narrative: Petechial rash
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Tic
Clinical narrative: Initial report received from a health care professional in the USA in 17 May 2007. A 4 year old male patient (with a history of no known allergies, possible heart murmur and tick bites) developed "ticks and high fever" 9 days after he received IPOL (lot number Y0576-2) subcutaneously in the left deltoid on 03 May 2007. The patient had no illness at the time of vaccination and was on Xantac. As the time of the report, the patient had not recovered. It was reported the family was going to follow up with a pediatric neurologist.
Age: 21.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Blood urine present, Chest X-ray, Dysuria
Clinical narrative: A 21 year-old, male patient with a medical history of no known allergies) developed blood in the urine and burning with urination after he received IPOL (lot number Z0547-2) intramuscularly in the right arm, Typhim VI (lot number Z0443-2) intramuscularly in the left arm, YF-VAX (lot number UE945AA) intramuscularly in the left arm, TD vaccine (Massachuttes Biologics Labs, lot number TD151) intramuscular in 2007. He went to his local MD (name not available to reporter) and had "tests" done. The reporter was not sure of the date of the onset of the symptoms, information of the treating physician or test done. The patient did not have any illness at the time of the vaccination. At the time of the report, the patient's recovery status was unknown.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 07-30-07 Call from Mother stated child c/o lt. arm sore, red at shot sight. No fever. No comfort measures done. Then next day 7/31 child c/o lt. upper arm hurts, red, hot to touch, temp. 101 by mouth, gave Tylenol. On 08/01/07 mom took child to see her doctor.  On 08/01/07 @ 1:20 pm PHN did recieve call from Med. Cl. that child presented and treated for Increased lt. deltoid red, swollen,hot to touch at inj. site only. Child sent home with mom given Rx. for Claritin 10mg/d po until s/sxs subside, to alternate tylenol and Motrin po q 4 hr until sx's subside. Cool pk. to up. lt. arm area p.r.n. No fever noted @ cl. visit. F/up as need. No other signs, symptoms noted.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: 07-30-07 Call from Mother stated child c/o lt. arm sore, red at shot sight. No fever. No comfort measures done. Then next day 7/31 child c/o lt. upper arm hurts, red, hot to touch, temp. 101 by mouth, gave Tylenol. On 08/01/07 mom took child to see her doctor.  On 08/01/07 @ 1:20 pm PHN did recieve call from Med. Cl. that child presented and treated for Increased lt. deltoid red, swollen,hot to touch at inj. site only. Child sent home with mom given Rx. for Claritin 10mg/d po until s/sxs subside, to alternate tylenol and Motrin po q 4 hr until sx's subside. Cool pk. to up. lt. arm area p.r.n. No fever noted @ cl. visit. F/up as need. No other signs, symptoms noted.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: 07-30-07 Call from Mother stated child c/o lt. arm sore, red at shot sight. No fever. No comfort measures done. Then next day 7/31 child c/o lt. upper arm hurts, red, hot to touch, temp. 101 by mouth, gave Tylenol. On 08/01/07 mom took child to see her doctor.  On 08/01/07 @ 1:20 pm PHN did recieve call from Med. Cl. that child presented and treated for Increased lt. deltoid red, swollen,hot to touch at inj. site only. Child sent home with mom given Rx. for Claritin 10mg/d po until s/sxs subside, to alternate tylenol and Motrin po q 4 hr until sx's subside. Cool pk. to up. lt. arm area p.r.n. No fever noted @ cl. visit. F/up as need. No other signs, symptoms noted.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Appendicectomy, Peritonitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old female who on 11-AUG-2007 was vaccinated SC with a 0.5 ml dose of Varivax. On 13-AUG-2007, two days after vaccination the patient experienced acute abdominal pain. The patient was admitted to the local hospital and a clinical diagnosis of acute appendicitis was made. The patient underwent an appendectomy. The appendix was found to be "normal" but there was redness of the peritoneum as well as free fluid in the abdomen. Culture of the free peritoneal fluid revealed no growth. The patient's white blood cell count was elevated to more than 20,000. The patient was discharged on amoxicillin and Lortab. The patient was examined in the office, post-operatively on 20-AUG-2007 and the exam revealed hemorrhagic macular lesions on both lower extremities and the right elbow. A diagnosis of Henoch-Schonlein purpura was made. The patient's white blood cell count remained elevated to 20,000, the platelets were normal and the patient was afebrile. A urinalysis was also undertaken (results not provided). A follow-up appointment was scheduled for 22-AUG-2007 but the patient did not report to the office for follow-up. At the time of the report the patient had not recovered. A product quality complaint was not involved. The patient's experiences were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Body temperature, Henoch-Schonlein purpura
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old female who on 11-AUG-2007 was vaccinated SC with a 0.5 ml dose of Varivax. On 13-AUG-2007, two days after vaccination the patient experienced acute abdominal pain. The patient was admitted to the local hospital and a clinical diagnosis of acute appendicitis was made. The patient underwent an appendectomy. The appendix was found to be "normal" but there was redness of the peritoneum as well as free fluid in the abdomen. Culture of the free peritoneal fluid revealed no growth. The patient's white blood cell count was elevated to more than 20,000. The patient was discharged on amoxicillin and Lortab. The patient was examined in the office, post-operatively on 20-AUG-2007 and the exam revealed hemorrhagic macular lesions on both lower extremities and the right elbow. A diagnosis of Henoch-Schonlein purpura was made. The patient's white blood cell count remained elevated to 20,000, the platelets were normal and the patient was afebrile. A urinalysis was also undertaken (results not provided). A follow-up appointment was scheduled for 22-AUG-2007 but the patient did not report to the office for follow-up. At the time of the report the patient had not recovered. A product quality complaint was not involved. The patient's experiences were considered to be disabling and life threatening by the reporter. Additional information has been requested.