chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with a history of reflux as a young child and no known drug allergies, who on 20-DEC-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient felt nauseous and "not quite right." On 20-FEB-2008 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 20-FEB-2008 after the vaccination the patient almost passed out, was nauseous, diaphoretic, and had a severe headache on the way home from the office. The nurse reported that it was not a vagal response. On 21-FEB-2008 the patient felt dizzy and had tachycardia upon arrival to the emergency room. The patient was treated with one liter of saline (previously reported as IV fluids), and a dose of ZOFRAN. The patient felt somewhat better. The client was then given contrast for the abdominal scan, and was nauseous again. An abdominal CT scan was performed and was normal. A pregnancy test was negative. An EKG was performed and was normal. The patient was not hospitalized. It was reported that the patient had lost 5 to 6 pounds and could not eat or drink without feeling nauseous. The patient's mother reported that she did not think the patient's nausea was related to vaccination with Gardasil. The mother believed that the patient "has something like an acid reflux and the Gardasil initiated it." The patient was seen by a gastroenterologist and started the patient on REGLAN and PREVACID. At the time of the report, the patient had not recovered. No product quality complaint was involved. The nurse considered the nausea, dizziness, diaphoresis, weight loss, and not being able to eat or drink to be other important medical events. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: TTOX
Symptoms: Death
Clinical narrative: Initial report received on 03 March 2008 from another manufacturer, report number MCN54683. The initial reporter to this manufacturer was a health care professional. "This spontaneous case was received via a company representative, reported by a physician and concerns a 46 year old male patient who had an unexplained death after taking Peg-Interferon Alfa 2A (Pegasys), Ribavirin (manufacturer unknown) for hepatitis C and tetanus vaccine as a prophylaxis. On an unknown date, the patient commenced treatment with Peg-Interferon Alfa 2A and Ribavirin. About a week back, the patient cut himself and went to the hospital. He was administered a tetanus vaccine. The patient died shortly after that due to unknown reason. No further information was available. "
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Skin lesion, Swelling face, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 22 February 2008 from a health care provider.  A female patient, age not specified, had received a right deltoid injection of Fluzone SV 2007-2008, lot number U2443AA, on 21 February 2008.  The patient had received a left gluteal, intramuscular injection of Tetanus Toxoid Adsorbed Preservative-free, lot number U1715BA, on 05 February 2008.   Fourteen hours following the 21 February 2008 vaccination, the patient experienced facial swelling and urticarial lesions of the right upper thigh and right elbow.  "Blotchy patches" were also reported.  The patient was evaluated by a physician and treated with intramuscular Benadryl, intramuscular Solu-Cortef, and subcutaneous epinephrine.  All symptoms resolved within 60 minutes.  Diagnostic testing was none.  The patient was discharged with Allegra D and prednisone.  At the time of this report, the patient had recovered.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture negative, Injection site erythema, Pain in extremity, White blood cell count increased
Clinical narrative: Had influenza vaccine late afternoon 2/15/08. Had some leg pain that night. Woke up the next morning with leg pain and redness at immunization site. Redness progressed - was seen in ER and admitted to hospital for thigh cellulitis. Received IV antibiotics.  9/16/08 Reviewed hospital medical records for 2/17-2/18/2008. FINAL DX: cellulitis Records reveal patient experienced sleeplessness, crying, lethargic, decreased energy, diet refusal, swelling & redness left thigh, Fever & limping.  No reaction to prior immunizations.  Tx w/IV antibiotics & had allergic reaction to Vancomycin.  Improved & d/c to home w/pcp follow up next day.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: 2/29/08 - Mom states last night child had high fever and had seizures and was taken to hospital after receiving immunizations here earlier that afternoon. Child stayed overnight - Mom states ER doctor - states that immunization did cause fever and seizure. 3/01/08 Mom states child was discharged on 2/29/08 and child is much better.  4/1/08 Reviewed hospital ER medical records of 2/29/2008. FINAL DX: febrile seizure Records reveal patient experienced shaking & blank stare for approx 1 hour.  Fever x 1 day s/p vaccines despite antipyretics.  No further seizure activity in ER & d/c to home to f/u w/PCP.
Age: 24.0
Sex: U
Vaccine: SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient received the small pox vaccine on or about 21 Feb 08;  on or about 1 March 08 he started having chest pains; he presented to medical attention on 4 March 08 and had diffuse ST elevation on ECG.  Cardiac enzymes positive with a peak trop of 33.  His myopericarditis responded well to Motrin.  Echo was normal.  He was discharged from the hospital after two days chest pain free.
Age: 24.0
Sex: U
Vaccine: SMALL
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Patient received the small pox vaccine on or about 21 Feb 08;  on or about 1 March 08 he started having chest pains; he presented to medical attention on 4 March 08 and had diffuse ST elevation on ECG.  Cardiac enzymes positive with a peak trop of 33.  His myopericarditis responded well to Motrin.  Echo was normal.  He was discharged from the hospital after two days chest pain free.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Given vaccine at approximately 3pm on 3/4/08 on 3/5/08 in the afternoon developed appproximately a 4X2 inch hardened, reddened and warm to touch area where the varicella vaccine was administered.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Nasal congestion, Neck pain, Sinus congestion, Vaccine positive rechallenge
Clinical narrative: PATIENT HAD HER SECOND HPV VACCINE (GARDASIL) AND DEVELOPED PAIN AND SWELLING IN THE LEFT SIDE OF HER NECK, AND NASAL AND SINUS CONGESTON ON THE LEFT SIDE (SHOT GIVEN IN LEFT DELTOID).  SYMPTOMS BEGAN 24 HOURS AFTER VACCINE WAS GIVEN.  SHE HAD IDENTICAL SYMPTOMS BEGINNING 36 HOURS AFTER HER INITIAL GARDASIL SHOT, AND WE CONSIDERED ADVERSE REACTION BUT SINCE IT WAS A STRANGE SET OF SYMPTOMS WE TREATED IT AS AN UPPER RESPIRATORY/SINUS CONDITION AND IT RESOLVED. HOWEVER, SINCE IT RECURRED WITH HER SECOND VACCINE DOSE, IT MUST BE RELATED TO THE VACCINE. SHE IS FINE NOW.
Age: 60.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Joint swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Approximately two and a half weeks after receiving rubella vaccine the patient began having pain in right ankle and both hands.  On 2/18/08 her ankle was swollen to double it's normal size, 2/22/08 still having arthritis symptoms in hands, her left is so swollen, she doesn't recognize it.  She is unable to wear her rings on her fingers.  On 2/29/08 she described her arthritic symptoms as resolving, the swelling had decreased and she is able to wear her rings.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Convulsion, Intensive care, Intubation, Pyrexia
Clinical narrative: Prolonged seizures with fever less than 24 hours after administration of Dtap, MMR, Varicella, Hepatits A and Pneumococcal conjugate vaccines. Required multiple anticonvulsants and endotracheal intubation with transfer to PICU for further care.  03/20/2008 MR received including WCC of 3/5/08 and ER visit 3/6/08 and subsequent F/U. Child transported to ER in status epilepticus x 35 minutes.  Temp 102.0 on arrival, actively seizing with mucus at mouth, (+) pallor, rhonchorous respirations.  Pt intubated and txd with phenobarbital, ativan, and fosphenytoin.  Transfered to higher level of care. 5/20/2008 D/C Summary received for DOS 3/6-14/2008 with D/C DX:  Atypical Febrile Seizures.  Extubated on 3/8/08 with post-extubation stridor and sx of bronchiolitis with respiratory distress.  Improvement noted with pulmonary tx and solumedrol. Seen in ER again 3/15/08 and 3/16/08 for fever, emesis and diarrhea. DX: AGE. Follow-up: Doing well at follow-up on new seizure medication.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Injection site vesicles, Skin tightness, Skin warm
Clinical narrative: Seen in our office on 2/21/08 for 5 year old WCU.  Received Varivax #2.  On 2/22/08 in the evening noticed area of redness, warm to touch, "felt tight'.  On 2/23/08 blister at injection site (clear fluid).  Diagnosed with post varicella cellulitis.  Treated with Augmentin.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Hyperhidrosis, Irritability, Pyrexia, Vomiting
Clinical narrative: Fever 102F last pm and today. Sweating, vomited up bottle of formula this am, and diarrhea this am, and very fussy and won't settle down.  3/19/08 Reporter called back to report that patient still having health problems but had not been hospitalized.  Not gaining weight.  When last seen this week, had oral & diaper thrush & was irritable.  Pediatrician making formula change & if no improvement will refer to GI specialist.
Age: 1.05
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Aggression, Autism, Autism spectrum disorder, Feeling abnormal, Head banging
Clinical narrative: At the time of the family pediatrician visit at 11 months he was fine and talking up to 3 word phrases, but we lost our health insurance so at the time of his 1 year I took him to the clinic and they administered many vaccines in several doses, on the leg.  He soon became very despondent lost all words, did not respond either just sat in a foggy state or tantrumed, and banged his head, by 18 months it was very apparent and the symptoms continued to get worse and eventually was diagnosed with Autism,  PDD-NOS.  03/21/2008 Autism screening by school system dated 12/11/2006 received from parent. Testing c/w dx of an Autism Spectrum Disorder. Pt displays disruptions in the areas of play and interest in materials, language and communication, relating to others and use of sensory modalities. 1/20/2010 Patient still has autism/autism like symptoms. Language delay-behaviour/social difficulties/sensory dysfunction. He is getting better with therapy, but he still struggleing and is not as expected as typical.
Age: 1.05
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Social avoidant behaviour, Speech disorder developmental
Clinical narrative: At the time of the family pediatrician visit at 11 months he was fine and talking up to 3 word phrases, but we lost our health insurance so at the time of his 1 year I took him to the clinic and they administered many vaccines in several doses, on the leg.  He soon became very despondent lost all words, did not respond either just sat in a foggy state or tantrumed, and banged his head, by 18 months it was very apparent and the symptoms continued to get worse and eventually was diagnosed with Autism,  PDD-NOS.  03/21/2008 Autism screening by school system dated 12/11/2006 received from parent. Testing c/w dx of an Autism Spectrum Disorder. Pt displays disruptions in the areas of play and interest in materials, language and communication, relating to others and use of sensory modalities. 1/20/2010 Patient still has autism/autism like symptoms. Language delay-behaviour/social difficulties/sensory dysfunction. He is getting better with therapy, but he still struggleing and is not as expected as typical.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Inappropriate schedule of drug administration, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Received Varicella in left arm and first day had quartersize reddened swollen area by the next day the shoulder area was inflammed and injection site had blisters forming (4) red and could not touch the skin.  Got a migraine and Zomig did not help.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site vesicles, Migraine, Oedema peripheral
Clinical narrative: Received Varicella in left arm and first day had quartersize reddened swollen area by the next day the shoulder area was inflammed and injection site had blisters forming (4) red and could not touch the skin.  Got a migraine and Zomig did not help.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mother called and reported that 14 days following immunization, an itchy, raised rash had appeared in the area of injection of MMR and Varicella. Sibling had same immunizations on same date and was having same rash in area of SQ injections.
Age: 1.04
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Convulsion, Eye rolling, Movement disorder, Oxygen saturation, Screaming
Clinical narrative: "Pt with microcephaly and seizure disorder was in bed asleep when he awoke screaming and having rhythmic movements. His eyes would roll back and his arms would extend to the side and then violently flex in toward his chest while his legs where doing the same thing. "Per guardian, pt had not had a seizure in 3 months. Diastat was given during the episode which did not seem to directly help. Family called 911 and pt was transported to ED. Abdomen with chest xrays were performed. No further treament given.
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mother called 14 days after immunization an area of itchy raised rash around the area of placement of MMR and Varicella. Sibling immunized on the same date w/same vaccines and same lot# also had this rash around injection site.
Age: 1.03
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Constipation, Dyspnoea, Irritability, Pain, Pyrexia
Clinical narrative: Severe fussiness, pain, fever, trouble breathing, rash, constipation, vomiting.  04/18/08 Reviewed PCP medical records, consultations & vax records. FINAL DX: Autism spectrum disorder w/macrocephaly. Records reveal patient experienced recurrent OM & URIs. Had not completely reolved OM on 3/8/06.  Returned to offive 3/9/06 w/irritability, respiratory distress w/retractions & wheezing, cough, nasal congestion.  Dx w/acute bronchiolitis. Tx w/nebs.  Continued to have recurrent bilateral OM & asthma & also developed viral xanthem.  Referred to ENT.  8/06 sleep difficulties, kicking & screaming after recently changed to whole milk.  Changed back to soy milk w/some improvement.  Concerns for speech delay first noted 8/23/06 & referred for eval.  Fever & viral respiratory illness 9/2006 w/acute bilateral OM w/purulent effusions.  Unable to clear w/repeated oral antibiotics into 10/2006. Tx w/IM antibiotics, referred again to ENT & PE tubes done 11/2006. Continued to have recurrent OM after PE tubes placed.  10/2007 not making progress in ST, parallel repetitive playing in daycare.  When seen for eval of macrocephaly recommended further testing which revealed ASD.  Patient on DAN protocol, gluten/dairy free diet, continuing ST/OT & attending early intervention daycare.  Referred for additional allergy testing.
Age: 1.03
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Severe fussiness, pain, fever, trouble breathing, rash, constipation, vomiting.  04/18/08 Reviewed PCP medical records, consultations & vax records. FINAL DX: Autism spectrum disorder w/macrocephaly. Records reveal patient experienced recurrent OM & URIs. Had not completely reolved OM on 3/8/06.  Returned to offive 3/9/06 w/irritability, respiratory distress w/retractions & wheezing, cough, nasal congestion.  Dx w/acute bronchiolitis. Tx w/nebs.  Continued to have recurrent bilateral OM & asthma & also developed viral xanthem.  Referred to ENT.  8/06 sleep difficulties, kicking & screaming after recently changed to whole milk.  Changed back to soy milk w/some improvement.  Concerns for speech delay first noted 8/23/06 & referred for eval.  Fever & viral respiratory illness 9/2006 w/acute bilateral OM w/purulent effusions.  Unable to clear w/repeated oral antibiotics into 10/2006. Tx w/IM antibiotics, referred again to ENT & PE tubes done 11/2006. Continued to have recurrent OM after PE tubes placed.  10/2007 not making progress in ST, parallel repetitive playing in daycare.  When seen for eval of macrocephaly recommended further testing which revealed ASD.  Patient on DAN protocol, gluten/dairy free diet, continuing ST/OT & attending early intervention daycare.  Referred for additional allergy testing.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Herpes zoster
Clinical narrative: Flu shot given on 10/25/07.  On 10/29/07 developed shingles.  Treated with antiviral, made full recovery.  I don't think the flu shot "caused" the shingles, but may have resulted in a weakened immune system that would allow shingles to develop.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Apnoea, Diarrhoea, Saliva altered, Vomiting
Clinical narrative: PATIENT DEVELOPED WATERY DIARRHEA 3/1/08, VOMITED ONCE 3/2/08 AND AGAIN ONCE 3/3/08.  SALIVA WAS THICK.  HAD 4 EPISODES OF APNEA, SETTING OFF MONITOR 3/2/08 DURING THE NIGHT, THEN MOM NOTED HE HAD NUMEROUS TIMES OF NOT BREATHING FOR UP TO 13 SECONDS THE MORNING OF 3/3/08.  PATIENT WAS TOLD TO GO TO THE ER.  PATIENT WAS CONTINUING TO BREASTFEED WELL Q2-3H AND GET PEDIALYTE IN BETWEEN FEEDINGS PER INSTRUCTION GIVEN BY DR. WHEN PARENTS CALLED HER 3/1/08.  ACCORDING TO FATHER, PATIENT DID NOT HAVE ANY APNEA EPISODES OR VOMITING IN THE ER, O2 SATS WERE GOOD.  TOLD THE VOMITING/DIARRHEA WAS LIKELY REACTION TO THE ROTAVIRUS VACCINE RECEIVED 2/28/08.  PATIENT DID NOT HAVE ANY DIARRHEA OR VOMITING AFTER LEAVING THE ER 3/3/08 ABOUT 5 PM.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Erythema, Lacrimation increased, Local reaction
Clinical narrative: Within 8 hours, patient had chills, aching, watery eyes, and later developed fever.  She said she had tight breathing and stiff neck.  About 30 hours later she developed a local reaction --swelling, redness, and itching.  She did not call the pharmacy until two days after the injection was administered.  I asked if she had contacted a physician or if she visited the ER.  She replied that she had not.  I spoke to her a couple other times.  She was still having symptoms on 2/25/2008.  By 3/05/2008 her symptoms were gone.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Musculoskeletal stiffness, Pain, Pruritus, Pyrexia
Clinical narrative: Within 8 hours, patient had chills, aching, watery eyes, and later developed fever.  She said she had tight breathing and stiff neck.  About 30 hours later she developed a local reaction --swelling, redness, and itching.  She did not call the pharmacy until two days after the injection was administered.  I asked if she had contacted a physician or if she visited the ER.  She replied that she had not.  I spoke to her a couple other times.  She was still having symptoms on 2/25/2008.  By 3/05/2008 her symptoms were gone.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Within 8 hours, patient had chills, aching, watery eyes, and later developed fever.  She said she had tight breathing and stiff neck.  About 30 hours later she developed a local reaction --swelling, redness, and itching.  She did not call the pharmacy until two days after the injection was administered.  I asked if she had contacted a physician or if she visited the ER.  She replied that she had not.  I spoke to her a couple other times.  She was still having symptoms on 2/25/2008.  By 3/05/2008 her symptoms were gone.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Lacrimation increased, Local reaction, Malaise, Musculoskeletal stiffness
Clinical narrative: Within 8 hours, patient had chills, aching, watery eyes, and later developed fever.  She said she had tight breathing and stiff neck.  About 30 hours later she developed a local reaction --swelling, redness, and itching.  She did not call the pharmacy until two days after the injection was administered.  I asked if she had contacted a physician or if she visited the ER.  She replied that she had not.  I spoke to her a couple other times.  She was still having symptoms on 2/25/2008.  By 3/05/2008 her symptoms were gone.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Within 8 hours, patient had chills, aching, watery eyes, and later developed fever.  She said she had tight breathing and stiff neck.  About 30 hours later she developed a local reaction --swelling, redness, and itching.  She did not call the pharmacy until two days after the injection was administered.  I asked if she had contacted a physician or if she visited the ER.  She replied that she had not.  I spoke to her a couple other times.  She was still having symptoms on 2/25/2008.  By 3/05/2008 her symptoms were gone.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Asperger's disorder, Asthenia, Convulsion, Crying, Eye rolling
Clinical narrative: Received 1st DTaP on 12/10/1998.  Cried for 48 hours and had a seizure on 12/12/1998 at which time he stopped breathing and went limp and his eyes rolled back into his head.  This lasted for approx. 30 seconds. We took him immediately to the ER and followed up with our family dr the following day.  We took him to a pediatric neurologist within that week where it was determined that his seizure was a direct result of the pertussis component of the DTaP.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Respiratory arrest
Clinical narrative: Received 1st DTaP on 12/10/1998.  Cried for 48 hours and had a seizure on 12/12/1998 at which time he stopped breathing and went limp and his eyes rolled back into his head.  This lasted for approx. 30 seconds. We took him immediately to the ER and followed up with our family dr the following day.  We took him to a pediatric neurologist within that week where it was determined that his seizure was a direct result of the pertussis component of the DTaP.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Convulsion
Clinical narrative: Patient had seizure in the evening after flu vaccine.  Had just taken Benadryl/Maalox/Viscous Udocaine and Tylenol - unknown if seizure due to meds vs. vaccine.
Age: 1.86
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Pt given Flu vaccine (R) thigh on 2/13/07. Mother reports that rash began (R) thigh about 1 hr later, spread to other leg, trunk, arms. No itchy, no trouble breathing. Pt has been on Amoxicillin since 12/6/07 for (R) otitis media. No h/o egg allergy.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Acarodermatitis, Erythema, Pruritus, Rash, Rash pruritic
Clinical narrative: After second immunization with Gardasil, patient developed pruritus arms, trunk, legs - at time erythema - unresponsive to OTC creams. Benadryl. Then had third immunization - pruritus even worse. At Student Health given Prednisone - helped on higher dose only. Rash now sand paper appearance arms, legs, trunk - pruritic. PArient found to have scabies by dermatologist. So not a GARDISIL reaction
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Medication error
Clinical narrative: Patient with 115mm x 88mm area of redness surrounding Varicella vaccine injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Inflammation, Pain in extremity
Clinical narrative: Pt called 3/6/08 in morning wanting to know information on flu shot she was given. She said that ever since receiving vaccine she has had chronic pain in her arm. Her doctor said she had an inflammatory disease and patient wanted to know if was brought on by flu vaccine.
Age: 38.0
Sex: M
Vaccine: FLU3, HEPAB, TYP
Symptoms: Diarrhoea, Nausea
Clinical narrative: 2 days after 1st oral cap Typhoid: lower GI gurgling liquid diarrhea x 2 wks-> took one day off work. Occurs late morning and early afternoon 1130-1600, occasional nausea, after the initial 2 week diarrhea progressed to soft stool with continuous abdominal gurgles.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Local cellulitis
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site atrophy
Clinical narrative: Loss of underlying tissue at the site of Gardasil vaccine on left upper arm area.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling
Clinical narrative: Loss of underlying tissue at the site of Gardasil vaccine on left upper arm area.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Full blood count, Laboratory test normal
Clinical narrative: Dizziness only at night when goes to bed. Is fine during day.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Mother calling in stating pt had 103 degree fever controlled by Tylenol and Advil. 03/06/2008, with an enlarging, red, painful and swollen area at the site of arm, lateral SC area. She is also using Benadryl 12.5 mg/tsp. Advised to take Benadryl to 50 mg tid and apply ice and perhaps topical Benadryl or anti-itch cream; site redness openly encircling entire area. See PMD if does not clear. Advised we would submit VAERS rpt.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left deltoid region red and hot - getting larger.  No induration, no fluctuance, no MIS.  Treatment: Ibuprofen, Benadryl, cold compresses.  Prescribed Omnicef if not improved in 24 hours.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Body temperature increased, Full blood count normal, Rash, Rash macular, Skin discolouration
Clinical narrative: About 2 hrs after receipt of vaccine, patient spiked temp to 103 deg. had purple feet and blotchy red rash. Seen in ED. Vomited x 3- RR 60, Hr 160's, fretful- Rash legs only. 24 hr F/u - decreased Temp, decreased fussiness. Still with rash- Cleared with Benadryl.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Lacrimation increased
Clinical narrative: 03/05/06 10 am shot given, symptoms came about 5pm, water drain from eyes, no itching, symptoms subsided approx 4-5 hours later. No problem this morning 03-06-08
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Induration, Oedema peripheral, Tenderness
Clinical narrative: 1-18-00 left deltoid red, swollen, tender sl. frim 'diffuse border'; 1-19-08 Rev'd much improved
Age: 1.6
Sex: M
Vaccine: DTAP, PNC
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: ? Cellulitis - line drawn (L) shoulder, skin reddened, induration 4" x 3" on 1-11-08. Rechecked on 1-12-08, much improved.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema, Induration
Clinical narrative: 1-18-08 Left arm min. redness, warmth; sl. induration, nontender
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Vaccine given to pt. 20 minutes later pt passed out on floor, immediately responded to name. Blood pressure stable. Dr arrived. Pt ok at 15 minutes. Vital signs stable before pt left office.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 61year old male with a PMH sig for low back pain, hx MVA w/facial trauma, and 1.5ppd cig smoker. no documented PFTs or diagnosis of COPD, was vaccinated with pneumococcal vaccine 11/30/06 and was vaccinated again 1/10/08. On 1/11/08, patient called primary care nurse with complaints of red, swollen area of the arm in which he received the vaccine. Pt went to the DO and received diphenhydramine.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Keloid scar
Clinical narrative: Erythema at injection site with keloid formation after.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Local reaction, Pyrexia, Swelling
Clinical narrative: Had a localized reaction, redness, swelling, fever.  Patient taken to ER.  Followed up with PCP 2/28/08.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Pt developed swollen eyelid with breathing difficulty.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Erythema, swelling, multiple vesicles at site of Varicella #2.  Pain.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Large red raised area on rt thigh.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye rolling, Facial spasm, Muscle spasms
Clinical narrative: Facial jerks and upper body jerks + eyes deviating upward after receiving vaccines 1/16/08.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash, Rash papular, Skin exfoliation
Clinical narrative: Fever 101, onset within 8 hours of injection for 24 hours.  Papules erupting on head, neck and trunk on 02/29/08 (72 hours after injection).  03/03/08 rash resolved on face, legs and stomach.  Skin peeling on upper thighs.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Swelling face, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: 1020 Mother called from car, just received varicella - throat itching. See attached.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hive around injection site, resolved in 15 min.
Sex: U
Vaccine: RV5
Symptoms: Adverse event
Clinical narrative: Information has been received concerning a patient who was vaccinated PO with a dose of ROTATEQ.  Subsequently the patient experienced an adverse experience.  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain upper, Diet refusal, Flatulence, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a bottle-fed female with chronic acid reflux (gastroesophageal reflux disease) who was vaccinated PO with her second dose of ROTATEQ (no lot# given).  There was no concomitant medication.  Subsequently the patient experienced "stomach pain, gas, cramping and was taking less formula."  The patient sought unspecified medical attention.  Subsequently after about 1 week, the patient recovered.  It was noted that the patient was "switched to another formula called ALIMENTUM."  There was no product quality complaint.  Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Abnormal faeces, Dermatitis diaper, Faeces discoloured, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 24-JAN-2008 was vaccinated with ROTATEQ.  Vaccinations received the same day included PEDVAXHIB (OMPC) (manufacturer unknown) and PREVNAR.  It was reported that all vaccines were given pediatric.  On 25-JAN-2008 the patient presented with diarrhea, smelly like rotavirus diarrhea, green.  There was no mucous, no blood and no vomiting.  The lot number was unavailable.  Additional information has been requested. 06/02/2008 Follow-up information was received from a physician and other health professional. It was reported that the 9 week old (also reported as 2 months) male patient was vaccinated with the first dose of ROTATEQ (657664/0975U) PO on 24-JAN-2008 at 10:00 AM. On 25-JAN-2008 at approximately 10:00 AM, the patient experienced diarrhea, foul odor, green in color and diaper rash after ROTATEQ ingestion. There was no illness at the time of vaccination. There were no pre-existing allergies, birth defects, or medical conditions. The patient recovered on approximately 10-FEB-2008. No further information is available.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Gait disturbance, Swelling
Clinical narrative: A 17-month-old male patient, with no concurrent illnesses, or pre-existing medical conditions, had received a intramuscular left thigh dose of DAPTACEL (lot number C2797AA), and a intramuscular left thigh dose of IPOL (lot number A0273) on 08 January 2008.  The following day, the patient developed redness and swelling well below the injection site on the left thigh.  The child was also limping.  The reporting physician stated the vaccines were reported as being administered intramuscularly, but could have been administered subcutaneously based on the symptoms.  The patient required a physician visit, and was re-evaluated by a physician on 10 January 2008 and noted to be already improving.  There were no diagnostic tests or laboratory data performed.  The recovery status of the patient was reported as recovered.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 20 March 2007, from a consumer, who is the patient.  56 year old female received on 25 April 2006 a dose of DECAVAC (lot# U1707BA), left deltoid.  It may have been subcutaneous to the back of the arm.  The patient had received many previous doses of DECAVAC.  She had received DECAVAC in intervals of 6 years, for travel.  Within three days her left deltoid became hot, swollen and sore.  Within 8 days of vaccination, swelling was under the left arm down to the elbow.  She saw a physician who said it was adverse event reaction.  Treated with antibiotics.  On 20 March 2007, 329 days post vaccination, she had 5 x 5.5 inches brown spot at injection site and still got itchy.  She was told by a physician to never get TD shot.  She required emergency room/doctor visit on 02 May 2006.  The patient had not recovered.  The patient medical history included: Mitral valve prolapse and allergy to sulfa drugs.  No illness at vaccination time.  No other vaccines were given prior to vaccination with DECAVAC.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: Initial report received on 20 March 2007, from a consumer, who is the patient.  56 year old female received on 25 April 2006 a dose of DECAVAC (lot# U1707BA), left deltoid.  It may have been subcutaneous to the back of the arm.  The patient had received many previous doses of DECAVAC.  She had received DECAVAC in intervals of 6 years, for travel.  Within three days her left deltoid became hot, swollen and sore.  Within 8 days of vaccination, swelling was under the left arm down to the elbow.  She saw a physician who said it was adverse event reaction.  Treated with antibiotics.  On 20 March 2007, 329 days post vaccination, she had 5 x 5.5 inches brown spot at injection site and still got itchy.  She was told by a physician to never get TD shot.  She required emergency room/doctor visit on 02 May 2006.  The patient had not recovered.  The patient medical history included: Mitral valve prolapse and allergy to sulfa drugs.  No illness at vaccination time.  No other vaccines were given prior to vaccination with DECAVAC.
Age: 0.6
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial report received on 07 December 2007 from a nurse.  A seven-month-old infant male, who is a twin, and who was born premature weighing three pounds and eight ounces at birth, and who had no concurrent illnesses, had received on 06 November 2007, a dose of DAPTACEL (lot number C2607AA); a dose of IPOL (lot number A0170); a dose of PREVNAR (manufacturer Wyeth, lot number B08702D); and a dose of ROTATEQ (manufacturer Merck, lot number 1152U).  The routes and sites of administration were not reported.  Twenty eight days later, on 04 December 2007 at 10:00 a.m., the patient received a first, intramuscular, right thigh dose of Fluzone SV 2007-2008 (lot number U2528AA); and a second, intramuscular, left thigh dose of a medication called Synagis (manufacturer Melimmune, lot number 06E628/06H631).  The Synagis was being given against RSV infection since the patient had been born prematurely.  It was not reported when the first dose of Synagis was given.  On the evening of 04 December 2007, following the Fluzone and Synagis injections, the patient developed a "red face, like a wind burn."  The red face received within 48 hours (approximately 06 December 2007) without medical intervention.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Eye swelling
Clinical narrative: Initial report received on 05 December 2007 from a physician. A five-year-old female, with no concurrent illnesses, but who had a history of milk allergy, and asthma, had received a fourth dose of Daptacel (lot number C2760AA) on 05 December 2007 ("or 04 December 2007"). The route and site of administration was "unknown." One hour post-vaccination, the patient developed swelling around the eye and a cough. She was treated with Benadryl and a nebulizer treatment. The patient subsequently was evaluated by an allergist on 05 December 2007, and at that time, the patient had no residual symptoms. No diagnostic tests or laboratory data were performed. At the time of this report, the patient had recovered.
Age: 22.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Dehydration, Myalgia
Clinical narrative: Initial report received from a physician on 23 August 2007. A 22-year-old male patient was given Daptacel (lot number not reported) in August 2007 and developed mild nonspecific pain and achiness within the first 48 hours after the vaccination. These symptoms resolved but he developed muscle aches and joint pains on day 7. These symptoms resolved within 24 hours of their onset. It turns out that on day 7, he was working outdoors in >100 degree weather and he experienced dehydration. Once he was rehydrated and rested, he felt fine. The physician is no longer concerned that the symptoms are due to Daptacel. Follow-up information received on 15 October 2007 from a health care professional. The patient's date of birth was provided making the patient 22-years-old at the time of the event. Daptacel, lot number C2605AA, was administered in the left deltoid. Illness at the time of vaccination included viral symptoms. Past medical history was none.
Sex: U
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: A cluster of six unidentified adults received intramuscular injections of DAPTACEL (lot number C2605AA).  All six patients experienced redness and swelling at the injection site and fevers ranging from 99 - 100 degrees Fahrenheit.  All six patients recovered.  No additional details were provided.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Urticaria
Clinical narrative: This case was received from a health professional on 28 June 2007.  A five-year-old male patient with a medical history of amblyopia experienced red welts on the left arm after receiving an intramuscular left arm injection of DAPTACEL (lot number C2606AA) and intramuscular left arm injection of IPOL (lot number Z0326) on 20 June 2007.  A subcutaneous right arm injection of VARIVAX (Merck, lot number 0536U) was also administered on 20 June 2007.  On 22 June 2007, two days after administration, the patient developed a 16 to 18 cm area of red welts on the left arm at the site of the injection.  He was seen by his physician, and it was unknown if the events had recovered.  Follow-up information received on 25 July 2007 from the patient's treating physician.  The treating physician provided a diagnosis of cellulitis and a revised latency date of 21 June 2007 relating to the onset of left arm redness which measured 16-18cm at the site of injection.  Follow-up information verified the patient had recovered.  Follow up information received on 23 August 2007 from the patient's treating physician.  The patient had not received any antibiotic therapy for this event and the cellulitis had resolved on 27 June 2007.  The reporter clarified that VARIVAX had been administered intramuscularly in the patient's right arm.  No additional information had been reported.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Wrong drug administered
Clinical narrative: Cluster of 7 adult patients (no individual patient identification provided) developed cellulitis after receiving DAPTACEL (lot number unknown) in error, received from a pharmacist on 14 May 2007.  No further information was provided.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site mass, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 10 April 2007. A 4-year-old, patient (gender not reported) experienced an entire upper arm that became swollen, painful and warm to the touch after receiving Daptacel (lot number C2552AA, route and site of administration not reported) on 01 April 2007. As of 09 April 2007, most of the swelling had resolved, but a "hard lump" at the injection site remains. It was not reported if the patient recovered.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: Initial report received on 05 March 2007 from a health care professional.  A patient, whose reported age was "2", had received a fourth dose of DAPTACEL on an unknown date.  The lot number, route and site of administration was not provided.  At an unspecified amount of time later, the patient developed swelling (site not reported).  The recovery status of the patient is unknown.  The patient subsequently experienced severe right thigh swelling after the fifth dose of DAPTACEL on 09 January 2003, this event is reported in case 2006-00348.
Age: 1.8
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: A 21 month old, male patient experienced severe (entire right thigh) swelling after he received DAPTACEL (lot number unknown) in the right thigh on 09 January 2003. It was unknown if any other vaccines were administered on the same day. The reporter did not have any other information and was not sure if a VAERS form was filled at that time. Follow-up information received on 05 March 2007 from a health care professional. The patient additionally had received a left thigh, intramuscular injection of a varicella vaccine on 09 January 2003. The trade name, manufacturer name, and lot number of that vaccine was not provided. The DAPTACELl that was given on 09 January 2003 was reported as being the fifth dose the patient had received, and it was administered intramuscularly. The adverse event of severe entire right thigh swelling began on 09 January 2003. The time of onset was not provided. The recovery status of the patient is still unknown. Reportedly, the patient had an adverse event of swelling after he received his "fourth dose" of DAPTACEL at age "2". This event is reported in case number 2007-00671.
Age: 65.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Chronic fatigue syndrome, Dizziness, Headache
Clinical narrative: Developed Chronic fatigue syndrome as manifested by joint pain, new onset headaches, sleep disorder, night sweats, abdominal pain, dizziness, muscle pain, debilitating fatigue, intermittent mouth and nasal lesions after receiving the vaccines.  These symptoms have continued and gradually worsened to the present.  Diagnosed with the Gulf War Syndrome by the VA and entered into formal research protocol in 2000.
Age: 65.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Night sweats, Skin lesion, Sleep disorder
Clinical narrative: Developed Chronic fatigue syndrome as manifested by joint pain, new onset headaches, sleep disorder, night sweats, abdominal pain, dizziness, muscle pain, debilitating fatigue, intermittent mouth and nasal lesions after receiving the vaccines.  These symptoms have continued and gradually worsened to the present.  Diagnosed with the Gulf War Syndrome by the VA and entered into formal research protocol in 2000.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Antibody test negative, Barium swallow, Blood alkaline phosphatase, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Information has been received from the government (VAERS # 271615 concerning a 1 year old male with a history of hives who on 26-DEC-2006 was vaccinated with ProQuad (Oka/Merck upgrade process (LOT 655846/1351F) and secondary suspect Vaqta mfr unknown (unspecified). Seven days after vaccination the patient presented with a fever. On 04-JAN-2007, the patient developed convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation and was hospitalized. Seizure disorder and encephalitis of unknown etiology (Doctors suspects possible viral though tests were negative were diagnosed 9 days post vaccination. The patient is now severely week on her entire left side and is unable to verbally communicate. Many diagnostics were done including barium swallow abnormal, blood alkaline phosphatase increased, blood test normal, brain scan normal, electroencephalogram abnormal, human herpes virus 6 serology. Two spinal taps showed nothing significant and two MRI showed involvement of both frontal cortexes-white matter disease/inflammation. The patient was hospitalized for 21 days and has not yet recovered. Convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation were considered to disabling and life threatening as were abnormal barium swallow, blood alkaline phosphatase increased brain scan abnormal and EEG abnormal. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Convulsion, Dysphagia, Echocardiogram normal, Electroencephalogram abnormal, Encephalitis
Clinical narrative: Information has been received from the government (VAERS # 271615 concerning a 1 year old male with a history of hives who on 26-DEC-2006 was vaccinated with ProQuad (Oka/Merck upgrade process (LOT 655846/1351F) and secondary suspect Vaqta mfr unknown (unspecified). Seven days after vaccination the patient presented with a fever. On 04-JAN-2007, the patient developed convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation and was hospitalized. Seizure disorder and encephalitis of unknown etiology (Doctors suspects possible viral though tests were negative were diagnosed 9 days post vaccination. The patient is now severely week on her entire left side and is unable to verbally communicate. Many diagnostics were done including barium swallow abnormal, blood alkaline phosphatase increased, blood test normal, brain scan normal, electroencephalogram abnormal, human herpes virus 6 serology. Two spinal taps showed nothing significant and two MRI showed involvement of both frontal cortexes-white matter disease/inflammation. The patient was hospitalized for 21 days and has not yet recovered. Convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation were considered to disabling and life threatening as were abnormal barium swallow, blood alkaline phosphatase increased brain scan abnormal and EEG abnormal. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. Additional information is not expected.