chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PPV, VARCEL
Symptoms: Culture negative, Injection site erythema, Lip swelling, White blood cell count increased
Clinical narrative: 2/29 - Vaccine given.  3/1 - Swollen lips, bilateral thigh redness - put on Keflex, Benadryl.  3/3 - Lips better on Benadryl, left thigh still red - sent to ER.  Hospitalized for IV antibiotics.  6/2/08 Reviewed hospital medical records for 3/5-3/8/2008. FINAL DX: cellulitis s/p immunizations Records reveal patient experienced redness, warmth, pain, induration, bruising & swelling of left thigh injection site w/difficulty walking.  Had been transferred from outlying hospital for ped ortho evaluation for possible abscess.  Continued on IV antibiotics & was changed to vancomycin due to concern for MRSA after which patient improved markedly.  D/C to home on oral antibiotics.  4/15/08 Reviewed hospital medical records for 3/3-3/5//08. FINAL DX: cellulitis, pain, increased inflammatory markers Records reveal patient experienced fever, felt unwell, runny nose, decreased appetite, swollen lips.  There was redness, warmth, tenderness, induration, bruising & swelling left thigh injection site w/difficulty walking x 2 days.  Seen by PCP & dx w/cellulitis at injection site.  Tx w/antibiotics but worsened.  Seen again by PCP & sent to hospital for admit.  Tx w/IV antibiotics & had some improvement in cellulitis but still had exquisite pain of left leg.  Transferred to higher level of care for peds ortho evaluation.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: "No adverse event"
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash macular
Clinical narrative: "Red blotches" over body - started with "one little dot" - above also occurred after 4 month vaccines (1-8-08).
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever of 101 deg reported with tenderness at injection site
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Gait disturbance, Malaise, Pain in extremity, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Received vaccines 2/20/08. The next night had fever of 102 deg and not feeling well. Took ibuprofen which decreased fever. On 2/20/08 legs started feeling achey and by 2/24/08 they hurt. Reports hurt most in calves of legs. Mother and child reported 8 cm scale of 0-10 for pain. Mother and child shuffled when walked because of pain. Talked to agency somewhere who has a nurse to talk to that nurse thought it should be reported. legs were better on 2/25/08 and now normal. Did take child to Dr. for c/o sore throat and was put on z-pack. Dr 2/25/08
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itchy, red rash below injection site on left deltoid.  Benadryl, Ranitidine, Triamcinolone  CRM, Medrol dosepak.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Tdap given by RN. After 4 wk developed itchiness, red raised fine rash approx 2cm at injection site.
Age: 24.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Upper respiratory tract infection
Clinical narrative: Employee notified Emp Health on 3/12 that she was seen in UVA ED for redness soreness and significant swelling of left arm @ injection site for Tdap on 3/6-2 days after given injection-no probs with site until then-Also dev URI sx. Was given Vicodin, ibuprofen and released. Still with palpable one inch diam nodule @ (L) inj site with 6cm area mild swelling.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Started vomiting middle of night since 4AM. Also some diarrhea. Low grade fever 99. Taking fluids. F/U if not better 1-2 days or sooner if worse.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: On 3/10/08, pt was given Infanrix and MMR vaccine in left arm. Deltoid and tricep area of arm-red and warm and swollen. Pt is to return to office 3/13/08 to re-evaluated arm for infection
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Rash
Clinical narrative: Red rash on torso (anterior and posterior).  Hydroxyzine.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Light version od chicken pox 2 wks after she vacc. with varicella
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left UE swollen, red, warm around vaccine site compared with immunization reaction vs cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: localized swelling and erythema; deltoid to elbow
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling to RVL
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Barium enema, Barium enema abnormal, Diarrhoea, Intussusception, Laparoscopy
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Abdominal mass, Abdominal tenderness, Barium enema abnormal, Decreased activity, Dehydration
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Diarrhoea, Enema administration, Full blood count abnormal, Haematochezia, Haematocrit normal
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Irritability, Laparoscopy, Red blood cell count normal, Small intestinal intussusception reduction
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Somnolence, Urinary system X-ray, Vomiting, White blood cell count increased, X-ray gastrointestinal tract normal
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of Rotateq. Within 7 to 10 days after vaccination, the patient experienced intussusception and underwent surgery. It was unknown how many doses of Rotateq the patient received. The outcome was unknown. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal haemorrhage, Melaena
Clinical narrative: Information has been received from an investigator concerning a 67-year-old male with an unknown medical history who entered a study, titled as stated above. On 07-JAN-2008 the patient was randomized and received a one time subcutaneous dose of 0.65 mL of Zostavax (Oka/Merck). Concomitant therapy was unknown. On 19-Feb-2008 the subject was hospitalized for a GI bleed as described as melana. The subject was discharged from the hospital on 21-Feb-2008. At this time, relationship of GI bleed to study therapy is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who in 2007 was vaccinated with a dose of Gardasil. Concomitant suspect vaccination included Varivax. Subsequently, the patient was pregnant. It was reported that "a couple days" post vaccination the patient had a miscarriage. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Alanine aminotransferase increased, Haematochezia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on approximately 26-FEB-2008 was vaccinated PO with his second dose of Rotateq. Suspect vaccination included "other four month shots" a dose of PREVNAR, a dose of Recombivax HB (manufacturer unknown) and a dose of PedvaxHIB (manufacturer unknown). On 29-FEB-2008 about 2 to 3 days after vaccination, the patient experienced fever and blood in stool. The patient's mother brought the patient into the physician office and was then sent to the hospital. At the hospital the patient had lab work done which showed the patient's ALT level was above 1000 and the patient was hospitalized. On 07-MAR-2008 the patient was scheduled to be discharged from the hospital. Subsequently, the patient recovered on an unspecified date. It was noted that during hospitalization the patient was seen by a specialist who did not believe it was intussusception. There was no product quality complaint. The events were considered to be disabling by the physician. Additional information has been requested.  3/25/08 Reviewed vax record. 4/15/08 Reviewed ER records of 3/5/08. FINAL DX: salmonella enteritis Records reveal patient experienced fever, decreased appetite, cough bloody stools x 1 day.  Exam revealed sunken fontanelle & eyes.  D/C to home on oral antibiotics.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood ethanol normal
Clinical narrative: Arrived @ ER in cardiac arrest @ 6pm apparently choked while being fed.  Autopsy Dx = SIDS. 3/17/08-Autopsy report received-COD-Sudden Infant Death Syndrome. Apparently had been healthy. Parent had been lying on bed with child feeding it with a bottle when both he and the child apparently went to sleep. The 4 year old sibling noticed child was face down in crook of parent's arm and turned the child and woke father. Autopsy revealed a normally developed and well cared for appearing child, no evidence of injury, no congential or acquired condition that might explain her death was found. The circumstances raise the possibilty of accidental asphyxia but it does not appear from account available that in the position described the child's breathing would necessarily be compromised.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception, Respiratory failure
Clinical narrative: He was diagnosed with intussusception 2/2/08 with respiratory failure. Intussusception relieved via air contrast and reduction. 3/14/08-DC summary received for DOS 2/2/08- 2/5/08-DX Inutssusception. Afternoon of admission became fussy, refused to eat and developed pale lips. Intubated.  Respiratory failure secondary to intussusception. Extubated with stridor improved to room air.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Brachial plexopathy, Herpes zoster, Hyperaesthesia, Musculoskeletal pain
Clinical narrative: Dx: severe brachial plexopathy due to shingles. 12/10/07 came in with pain left neck - shoulder, hypersensitive skin, 3 small vesicles/erythema rash (L) neck. Pain and paresthesias progressed - LUE - neuropathy (L) brachial plexus with sensory and motor involvement. Slowly improving with phys therapy, gabapentin, analgesics.  4/4/08 Reviewed clinic records of 5/2007-3/2008. FINAL DX: severe left brachial plexopathy, likely secondary to herpes zoster infection, improving. Records reveal patient experienced good general health on 8/24/07.  Neck, hip & back pain 11-12/07 x 5 days & felt to be shingles.  Developed numbness, tingling, burning, shooting pain in shoulder, upper back, down left arm from neck.  Pain interferred w/sleep & was sleeping in chair.  Also has numbness left arm/hand & decreased ROM.  No improvement w/meds.  Dx w/sensory & motor neuropathy of LUE.  MRI & referred to neuro.  Neuro exam revealed left arm weakness w/significantly diminished strength in biceps, deltoid & grip.  Left arm muscle atrophy noted. Referred to PT & started neurontin.  Improved as of last note 3/11/08. Follow-up: Continues with some muscle weakness b/t shoulder girdle mild paresthesia. No pain. Has been able to D/C NEURONTON.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Nerve conduction studies, Neuropathy, Paraesthesia, Rash erythematous
Clinical narrative: Dx: severe brachial plexopathy due to shingles. 12/10/07 came in with pain left neck - shoulder, hypersensitive skin, 3 small vesicles/erythema rash (L) neck. Pain and paresthesias progressed - LUE - neuropathy (L) brachial plexus with sensory and motor involvement. Slowly improving with phys therapy, gabapentin, analgesics.  4/4/08 Reviewed clinic records of 5/2007-3/2008. FINAL DX: severe left brachial plexopathy, likely secondary to herpes zoster infection, improving. Records reveal patient experienced good general health on 8/24/07.  Neck, hip & back pain 11-12/07 x 5 days & felt to be shingles.  Developed numbness, tingling, burning, shooting pain in shoulder, upper back, down left arm from neck.  Pain interferred w/sleep & was sleeping in chair.  Also has numbness left arm/hand & decreased ROM.  No improvement w/meds.  Dx w/sensory & motor neuropathy of LUE.  MRI & referred to neuro.  Neuro exam revealed left arm weakness w/significantly diminished strength in biceps, deltoid & grip.  Left arm muscle atrophy noted. Referred to PT & started neurontin.  Improved as of last note 3/11/08. Follow-up: Continues with some muscle weakness b/t shoulder girdle mild paresthesia. No pain. Has been able to D/C NEURONTON.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Dx: severe brachial plexopathy due to shingles. 12/10/07 came in with pain left neck - shoulder, hypersensitive skin, 3 small vesicles/erythema rash (L) neck. Pain and paresthesias progressed - LUE - neuropathy (L) brachial plexus with sensory and motor involvement. Slowly improving with phys therapy, gabapentin, analgesics.  4/4/08 Reviewed clinic records of 5/2007-3/2008. FINAL DX: severe left brachial plexopathy, likely secondary to herpes zoster infection, improving. Records reveal patient experienced good general health on 8/24/07.  Neck, hip & back pain 11-12/07 x 5 days & felt to be shingles.  Developed numbness, tingling, burning, shooting pain in shoulder, upper back, down left arm from neck.  Pain interferred w/sleep & was sleeping in chair.  Also has numbness left arm/hand & decreased ROM.  No improvement w/meds.  Dx w/sensory & motor neuropathy of LUE.  MRI & referred to neuro.  Neuro exam revealed left arm weakness w/significantly diminished strength in biceps, deltoid & grip.  Left arm muscle atrophy noted. Referred to PT & started neurontin.  Improved as of last note 3/11/08. Follow-up: Continues with some muscle weakness b/t shoulder girdle mild paresthesia. No pain. Has been able to D/C NEURONTON.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash, Rash maculo-papular
Clinical narrative: Within 24 hrs of receiving Fluzone flu vaccine developed rash (L) upper chest and neck, then (R) maculopapular "drug" rash in appearance. Employee contacting private physician.  Headache also. (Reported 11-1-07)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Pruritus
Clinical narrative: Patient stated she became dizzy the night after shot and it lasted x 2 days. She states her arm was red and itchy. She received shot 3-6-08, she called and reported 3-10-08
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Bronchitis, Chest X-ray abnormal, Cough, Headache
Clinical narrative: Took on 2/2/08, came down sick morning of 7th sore throat, joint aches, cough, sweating, cold, running nose, headache, acute bronchitis. Urgent care center for chest xrays that where found out the bronchitis.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Hyperhidrosis, Malaise, Nasopharyngitis, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Took on 2/2/08, came down sick morning of 7th sore throat, joint aches, cough, sweating, cold, running nose, headache, acute bronchitis. Urgent care center for chest xrays that where found out the bronchitis.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Local reaction
Clinical narrative: Localized reaction only. Resolved
Age: 31.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Back pain, Myalgia, Pain in extremity, Rash, Skin discolouration
Clinical narrative: Skin infection with rash, skin discoloration aches muscle in legs pain lower back
Age: 31.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Skin infection
Clinical narrative: Skin infection with rash, skin discoloration aches muscle in legs pain lower back
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: 4 cm area of redness with slightly warm at site of Varicella injection. No drainage. 3-8-08 Dx: Allergic reaction to inj. Topicort Creme given. Date of Varicella 3-7-08
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema, Pyrexia, Skin warm
Clinical narrative: Fever, chills, edema, redness, warm to touch. 11cm x 12cm firm shoulder to above elbow.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Left arm - swollen and red at vaccine site, golf ball size. Warm compresses.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: skin with 1 1/2 cm x 4 cm erythema/induration mid upper (L) arm
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Speech disorder
Clinical narrative: Family member concern of immunization causing lack of experience language between and 18-24 months; Request filled out an request of grandmother
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Skin warm
Clinical narrative: (+) Erythema, (+) Warmth
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Red rash developed 8 days following varicella injection on the left thigh
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site bruising
Clinical narrative: DTaP given 3/4/08 and patient seen 3-7-08 for small 0.5cm bruise right deltoid at injection site. 2cm below bruise, 7cm diam mild redness/dependent erythema, no warmth, no induration, no complained of pain/itch.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Pain developed at injection site at 24 hrs after injection. At 48 hrs, pt developed an area of erythema around the proximal arm.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed at injection site 2d later. Infant placed on abx and followed up.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Erythema, Injection site swelling, Rash
Clinical narrative: One day post vaccine. Right thigh swollen from hip to knee. Developed a flat red rash. Rash continued to spread. Took to family doctor and was started on OTC Benadryl. Swelling subsided 4 days post vaccination.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Allergy test negative, Blister, Rash, Swelling face
Clinical narrative: 11-19-07 - Received MMR, Varicella, Prevnar and Influenza. 48 hours later broke out in blistery rash and facial swelling. Steroid therapy in ER. 2/25/08 - Received Dtap and Hep A 24 hours later broke out in blistery rash.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: At 1 week, discrete pink macular-papular rash entire body, confluent on face.  Asymptomatic.  May have been Amoxicillin reaction.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability
Clinical narrative: Fussiness, possible seizure without fever.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Laryngospasm, Muscle spasms
Clinical narrative: Mother brought patient to the health center for her 3rd Gardasil immunization on 01-15-2008. At that time mother reported that 24 hours after receiving the HPV and MCV4 on 09-25-2007 she had patient in the ER with vocal cord spasms. She was not put on any medications and required no further treatment. Three phone calls were made to the parent to get further information, but none were returned.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Tendonitis, X-ray
Clinical narrative: Tendonitis of the shoulder.  I took 2 months of oral anti inflammatory meds, and PT.  Next month I was sent to an ortho doctor he gave me a shot and 1 month of pt. The next month same thing.  No MRI was done an xray was done.  Now I am dx with bursitis and they want to do an MRI after 4 months.  I was told by emplyoee nurses that they had 3 other case reported  and that they found it was the vaccine that caused it and not the technique of the RN.  Anyway my shoulder is still not back up to 100% like it was prior to the shot.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Rash, Urticaria
Clinical narrative: Rash and hives on chest, arms and legs developed approximately 2 weeks after being vaccinated.  Treated with OTC antihistamines without success and then given a Medrol Dose Pack.  No fever ever present.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest X-ray abnormal, Death, Laboratory test abnormal, Mental status changes, Respiratory distress
Clinical narrative: Patient received Hepatitis A and Varicella vaccines 2 days prior to presenting to the ED with respiratory distress and mental status changes.  The patient died 3 days later from influenza B.  There is no indication that the vaccines this patient received or any other vaccine could have had any relationship to the outcome, or is there any reason to believe from the history that anything other than the influenza and the patients underlying medical condition (Congential Heart Disease, Asplenia, CP) were related to the death.  However, we report all incidents of patients with a serious adverse event temporarily related to vaccine administration, whether or not there is a relationship.  6/2/08 Reviewed hospital discharge/death summary for 2/29-3/2/2008, FINAL DX: overwhelming influenza B sepsis & encephalopathy Records reveal patient experienced labored breathing, altered mental status x 1 day; coughing, rhinorrhea & fever x 2 days.  Seen by PCP & dx w/viral illness.  Conditioned worsened & became unresponsive at home. Taken to ER by EMT with oxygen saturation 70's (baseline high 80's).  In ER, noted to have frothy sputum.  Tx w/CPAP & nebs.  Improved & became responsive.  Then after another episode of bradycardia & hypotension, became unreponsive again.  Felt to be having sub-clinical seizures.  Admitted to PICU, intubated & coded several times.  On multiple pressors w/fixed & dilated pupils.  Family requested no further resuscitation efforts.  ME declined case & family declined autopsy.   6/3/08 Reviewed medical records for 2006 & additional medical records for 2008.  Records for 2/15-3/2/2008 reveal patient in usual state of health on day of vaccination.  Seen by PCP 2/29 w/fever 103.3 for 1-2 days; had not received flu shot due to prior facial swelling w/flu vaccine in 2006.  Dx w/viral illness.  Seen in ER later same day for cough, rhinorrhea & fever x 2 days & increased respiratory effort becoming unresponsive.  Admitted to PICU w/influenza w/pneumonia; respiratory failure; & congenital heart disease.  Neuro  & cardio consults done.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Viral test positive, Virus culture positive
Clinical narrative: Patient received Hepatitis A and Varicella vaccines 2 days prior to presenting to the ED with respiratory distress and mental status changes.  The patient died 3 days later from influenza B.  There is no indication that the vaccines this patient received or any other vaccine could have had any relationship to the outcome, or is there any reason to believe from the history that anything other than the influenza and the patients underlying medical condition (Congential Heart Disease, Asplenia, CP) were related to the death.  However, we report all incidents of patients with a serious adverse event temporarily related to vaccine administration, whether or not there is a relationship.  6/2/08 Reviewed hospital discharge/death summary for 2/29-3/2/2008, FINAL DX: overwhelming influenza B sepsis & encephalopathy Records reveal patient experienced labored breathing, altered mental status x 1 day; coughing, rhinorrhea & fever x 2 days.  Seen by PCP & dx w/viral illness.  Conditioned worsened & became unresponsive at home. Taken to ER by EMT with oxygen saturation 70's (baseline high 80's).  In ER, noted to have frothy sputum.  Tx w/CPAP & nebs.  Improved & became responsive.  Then after another episode of bradycardia & hypotension, became unreponsive again.  Felt to be having sub-clinical seizures.  Admitted to PICU, intubated & coded several times.  On multiple pressors w/fixed & dilated pupils.  Family requested no further resuscitation efforts.  ME declined case & family declined autopsy.   6/3/08 Reviewed medical records for 2006 & additional medical records for 2008.  Records for 2/15-3/2/2008 reveal patient in usual state of health on day of vaccination.  Seen by PCP 2/29 w/fever 103.3 for 1-2 days; had not received flu shot due to prior facial swelling w/flu vaccine in 2006.  Dx w/viral illness.  Seen in ER later same day for cough, rhinorrhea & fever x 2 days & increased respiratory effort becoming unresponsive.  Admitted to PICU w/influenza w/pneumonia; respiratory failure; & congenital heart disease.  Neuro  & cardio consults done.
Age: 10.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Site of Tdap has knot, red, raised, warm approximately 5.5cmx5cm.  Site of flu vaccine is red, raised and warm with 4.5cmx6.5cm area.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pain in extremity, Pallor, Syncope
Clinical narrative: Administered HPV (Gardasil) vaccine #1 in child's left deltoid. Patient fainted. I put ammonia under her nose. She woke up but was very pale and complained of her legs hurting. She then put her head between her legs and she began to feel better.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Developed moderate nausea, vomiting, diarrhea, chills and joint pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient noticed redness at injection site on 3/12/08.  Pinkish/red patch is 3 inches long and 1.5 inches wide.  The discoloration is mild and almost not noticeable.  There is no associated pain.  There is tenderness when agitated.  Patient called physician but was not seen.  Physician phoned in an antibiotic.
Age: 35.0
Sex: M
Vaccine: FLUN3, TD, TDAP
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Palpitations
Clinical narrative: Elevated heart rate, palpatations, light headedness, headache, feverish, nausea.
Age: 35.0
Sex: M
Vaccine: FLUN3, TD, TDAP
Symptoms: Pyrexia
Clinical narrative: Elevated heart rate, palpatations, light headedness, headache, feverish, nausea.
Age: 1.32
Sex: M
Vaccine: DTAP
Symptoms: Blister, Erythema, Local reaction, Swelling
Clinical narrative: Patient has a possible local reaction on thigh area from vaccine. Redness, swelling, watery blisters.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PPV
Symptoms: Chills, Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: High fever of 104.9 with chills after vaccines.
Age: 1.03
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Autism spectrum disorder, Blood test, Childhood disintegrative disorder, Hair metal test, Pyrexia
Clinical narrative: Symptoms equivalent to upper respiratory infection, as well as Rosiola (per doctor) and a fever that lasted for several weeks. Started digressing where milestones concerned. Diagnosed w/Autism Spectrum Disorder 11/07/06  4/21/08 Reviewed PCP medical records of 6/23/04-2/22/07.  No vaccine record included. FINAL DX: autism spectrum disorder Records reveal patient w/asymmetric cry & referred to peds neuro 6/23/04 for evaluation of congenital absence of depressor angularis ovis muscle palsy.  6/8/05 was well child visit w/o concerns except mild anemia.  Returned 6/10/05 w/fever, decreased appetite, rash, loose stools.  Dx w/viral syndrome/prickly heat rash. 7/25/06 MD concerned w/developmental delay, speech delay & possible autism.  Noted facial asymmetry. Parents refused developmental evaluation until 11/2006. ST/OT/psychologist eval 11/2006 revealed delayed social skills, decreased eye contact, cognitive skills delay, receptive/expressive language significantly delayed, global delays in motor/sensory skills, sterotypical repetitive behaviors.  Was to continue OT/ST & early intervention program.  4/22/08 Reviewed vax which confirms as reported.
Age: 1.03
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Roseola, Upper respiratory tract infection
Clinical narrative: Symptoms equivalent to upper respiratory infection, as well as Rosiola (per doctor) and a fever that lasted for several weeks. Started digressing where milestones concerned. Diagnosed w/Autism Spectrum Disorder 11/07/06  4/21/08 Reviewed PCP medical records of 6/23/04-2/22/07.  No vaccine record included. FINAL DX: autism spectrum disorder Records reveal patient w/asymmetric cry & referred to peds neuro 6/23/04 for evaluation of congenital absence of depressor angularis ovis muscle palsy.  6/8/05 was well child visit w/o concerns except mild anemia.  Returned 6/10/05 w/fever, decreased appetite, rash, loose stools.  Dx w/viral syndrome/prickly heat rash. 7/25/06 MD concerned w/developmental delay, speech delay & possible autism.  Noted facial asymmetry. Parents refused developmental evaluation until 11/2006. ST/OT/psychologist eval 11/2006 revealed delayed social skills, decreased eye contact, cognitive skills delay, receptive/expressive language significantly delayed, global delays in motor/sensory skills, sterotypical repetitive behaviors.  Was to continue OT/ST & early intervention program.  4/22/08 Reviewed vax which confirms as reported.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Deep vein thrombosis, Electrocardiogram, Pain in extremity, Ultrasound Doppler
Clinical narrative: Right lower leg D.V.T. Shot given 2/27/08 approx 10:30 am. On 2/28/08 pt noticed ache in (R) lower leg. Worsened daily and to ER 3/21/08- Doppler confirmed RLE DVT Deep right posterior tibial vein. 3/27/08-records received for DOS 3/2-3/3/08- DC DX: Acute right lower extremity deep venous thrombosis. Admitted with C/O right lower extremity pain and swelling that started 4 days ago with swelling in right calf and some local pain which has increased. C/O shortness of breath.  Follow-up: Pt also found to have Factor V Leiden Heterozygous (1 copy of gene).
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ventilation/perfusion scan
Clinical narrative: Right lower leg D.V.T. Shot given 2/27/08 approx 10:30 am. On 2/28/08 pt noticed ache in (R) lower leg. Worsened daily and to ER 3/21/08- Doppler confirmed RLE DVT Deep right posterior tibial vein. 3/27/08-records received for DOS 3/2-3/3/08- DC DX: Acute right lower extremity deep venous thrombosis. Admitted with C/O right lower extremity pain and swelling that started 4 days ago with swelling in right calf and some local pain which has increased. C/O shortness of breath.  Follow-up: Pt also found to have Factor V Leiden Heterozygous (1 copy of gene).
Age: 29.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm swelling, redness, pain worsened one to 5 days after administration with improvement after taking Benadryl.  Was evaluated by MD, thought likely hypersensitivity.  Treatment with Benadryl/Moltrin.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Amenorrhoea
Clinical narrative: 3 month with no menstruation since vaccine was given (2-12-07).
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: The day after vaccine administered returned to our office with c/o vomiting that started the night after pt was vaccinated (same day). Vomiting continued to the day of presentation. Also with tactile fever and achiness. Recommended Tylenol.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Local reaction
Clinical narrative: 6cm x 3cm red raised area around injection site.  Area itchy, indurated and started several hours after receiving MENACTRA vaccine (local reaction).
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 5 cm diameter area of swelling and erythema just inferior to Varivax injection site- O.U to eval 3/10/08. No Rx-thought to be local reaction.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives to limbs and trunk 8-10 hr after vac. 50 mg Benadryl PO; Pepcid 40 mg PO; Prednisone 30 mg PO
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Bilateral upper arm pain and weakness with decreased strength.  Onset symptoms 2 days after Adacel administration.  On exam decreased strength abduction after 180 degrees both UE's.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles 2 weeks after receiving vaccine.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Axillary pain, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, C-reactive protein, Chest pain
Clinical narrative: 23 year old white male ADSM presents for medical evaluation and follow-up of chest pain after multiple vaccinations.  Chest pain started 03/07/2008, ended 03/11/2008.  Started some 11-12 days after receipt of primary SPV and other vaccinations.  Pain started 03/08/2008, ended 03/11/2008.  Left arm pain associated with left chest and left axillary pain.  Lymphadenopathy, axillary started 03/08/2008, ended 03/11/2008.  Painful left axillary adenopathy noted.  Nausea without vomiting started 03/08/2008, ended 03/08/2008.  Patient reported nausea without vomiting associated with his chest pain and diaphoresis.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Full blood count, Hyperhidrosis, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: 23 year old white male ADSM presents for medical evaluation and follow-up of chest pain after multiple vaccinations.  Chest pain started 03/07/2008, ended 03/11/2008.  Started some 11-12 days after receipt of primary SPV and other vaccinations.  Pain started 03/08/2008, ended 03/11/2008.  Left arm pain associated with left chest and left axillary pain.  Lymphadenopathy, axillary started 03/08/2008, ended 03/11/2008.  Painful left axillary adenopathy noted.  Nausea without vomiting started 03/08/2008, ended 03/08/2008.  Patient reported nausea without vomiting associated with his chest pain and diaphoresis.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Red blood cell sedimentation rate normal, Troponin
Clinical narrative: 23 year old white male ADSM presents for medical evaluation and follow-up of chest pain after multiple vaccinations.  Chest pain started 03/07/2008, ended 03/11/2008.  Started some 11-12 days after receipt of primary SPV and other vaccinations.  Pain started 03/08/2008, ended 03/11/2008.  Left arm pain associated with left chest and left axillary pain.  Lymphadenopathy, axillary started 03/08/2008, ended 03/11/2008.  Painful left axillary adenopathy noted.  Nausea without vomiting started 03/08/2008, ended 03/08/2008.  Patient reported nausea without vomiting associated with his chest pain and diaphoresis.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema abnormal, Enema administration, Faeces discoloured, Intussusception, Urinary system X-ray
Clinical narrative: On 3/09 began vomiting after eating, including formula. On 3/11 was referred to CMC ER by Dr.   XR suggestive of ileocolic intussusception, confirmed by air contrast enema.  Reduced after air contrast enema. Tolerated feeds well and discharged after 24 hr observation on 3/12.  No h/o bloody stools.3/28/08-records received for DOS 3/11/08-DX: Intussusception. Vomiting with every oral intake since day before. 3/12/08-Seen in ED C/O vomiting. Observed in Ed and discharged to home.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: On 3/09 began vomiting after eating, including formula. On 3/11 was referred to CMC ER by Dr.   XR suggestive of ileocolic intussusception, confirmed by air contrast enema.  Reduced after air contrast enema. Tolerated feeds well and discharged after 24 hr observation on 3/12.  No h/o bloody stools.3/28/08-records received for DOS 3/11/08-DX: Intussusception. Vomiting with every oral intake since day before. 3/12/08-Seen in ED C/O vomiting. Observed in Ed and discharged to home.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Back of left arm swollen 1 1/2" x 2", red, warm to touch.  Advised cool pack 20 min QID.  Advil every 6 hours.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Red rash on left leg.
Age: 69.0
Sex: M
Vaccine: TD
Symptoms: Blood creatine phosphokinase, Cardiac stress test, Erythema, Induration, Pain in extremity
Clinical narrative: Severe erythema to left arm and induration about 14cm in diameter.  Lower extremities with pain on palpation of muscles.  Starting 3/7/08.  Treatment Solumedrol 125mg IM; Medrol dose pack; Xyzal Rx; Zantac and Benadryl starting 3/10/2008.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 4-5 inch redness and swelling of right upper thigh.  1-2cm hard area at site of injection.  Benadryl, Advil and FCE.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Angioedema, Immediate post-injection reaction, Pruritus
Clinical narrative: Child received Hep A #1, MMR #2 and Varivax #2 3/6/08.  Within 4-5 minutes after vaccines child had small hives on face, legs and back.  No shortness of breath, no wheezing.  Benadryl given after 15-20 min.  Child feeling better, hives decreased, itching decreased, no shortness of breath.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: No adverse events
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen arm.
Sex: F
Vaccine: PPV
Symptoms: Attention deficit/hyperactivity disorder, Convulsion, Ear infection, Electroencephalogram, Migraine
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter with a possible drug reaction to penicillin who on 27-NOV-2001, when she was 6 days old, was accidentally vaccinated with a dose PNEUMOVAX 23 via injection (lot number, route and site of administration not specified).  There was no concomitant medication.  Since then the patient had pneumonia 2-3 times, numerous ear infections, and started getting severe seizures since she was 18 months old.  In the beginning she was getting the seizures 2-3 times a month, and now she has them once about every 6 months.  She has a gag reflex in the morning and throws up pretty much every morning.  She also has attention deficit/hyperactivity disorder (ADHD) and migraines.  The patient was born with a bit of jaundice but was otherwise a healthy baby.  Since she received PNEUMOVAX 23 "she's been having one health problem after another".  The patient also sees a neurologist.  On an unspecified date an electroencephalography was performed.  The results were not reported.  No additional information was provided.  Upon internal review severe seizures were considered an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Retching, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter with a possible drug reaction to penicillin who on 27-NOV-2001, when she was 6 days old, was accidentally vaccinated with a dose PNEUMOVAX 23 via injection (lot number, route and site of administration not specified).  There was no concomitant medication.  Since then the patient had pneumonia 2-3 times, numerous ear infections, and started getting severe seizures since she was 18 months old.  In the beginning she was getting the seizures 2-3 times a month, and now she has them once about every 6 months.  She has a gag reflex in the morning and throws up pretty much every morning.  She also has attention deficit/hyperactivity disorder (ADHD) and migraines.  The patient was born with a bit of jaundice but was otherwise a healthy baby.  Since she received PNEUMOVAX 23 "she's been having one health problem after another".  The patient also sees a neurologist.  On an unspecified date an electroencephalography was performed.  The results were not reported.  No additional information was provided.  Upon internal review severe seizures were considered an other important medical event.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Initial report received on 07 March 2008 from an other manufacturer, report # WAES 0803USA00147.  The other manufacturer received the original report from a physician.  Verbatim from the report.  "Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of Rotateq (lot # 656379/0505U).  Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot # AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh, and the first dose of PREVNAR (lot #B47300B) in the left thigh.  On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown).  On that same day an ultrasound was performed which revealed ileocolic intussusception.  Subsequently, the event resolved.  The reporter felt that ileocolic intussusception was possibly related to therapy with Rotateq, PEDIARIX, ACTHIB and PREVNAR.  Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician.  No further information is available."
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Initial report received on 07 March 2008 from an other manufacturer, report # WAES 0803USA00147.  The other manufacturer received the original report from a physician.  Verbatim from the report.  "Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of Rotateq (lot # 656379/0505U).  Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot # AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh, and the first dose of PREVNAR (lot #B47300B) in the left thigh.  On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown).  On that same day an ultrasound was performed which revealed ileocolic intussusception.  Subsequently, the event resolved.  The reporter felt that ileocolic intussusception was possibly related to therapy with Rotateq, PEDIARIX, ACTHIB and PREVNAR.  Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician.  No further information is available."