chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site pain
Clinical narrative: Member was given Polio and MMR vaccinations in each arm. Member states he started feeling pain in L arm when he woke up this morning after receiving vaccines. No bruising, No swelling in local area, No fever, No n/v/d. Tender to touch. Member states he did have a few alcoholic beverages
Age: 12.0
Sex: M
Vaccine: MNQ, TD, MEN, MNQ
Symptoms: Erythema, Ocular hyperaemia, Pruritus, Rash, Rash maculo-papular
Clinical narrative: An initial report was received in the U.S.A. from a health care professional on 07/08/2005. A 12 year old male patient complained of red "blood shot" eyes and a red "splotchy rash" with "tiny dots" over torso and neck two days after he had received an intra-musclar injection of menactra in the left arm and an intra-muscular injection of Decavax in the right arm. He also complained of itching but denied fever. The child's mother reported that the following day the rash had lessened throughout the day and he had no further complications. The child did recover from this event.
Age: 12.0
Sex: M
Vaccine: MNQ, TD, MEN, MNQ
Symptoms: Ocular hyperaemia, Rash, Rash maculo-papular
Clinical narrative: An initial report was received in the U.S.A. from a health care professional on 07/08/2005. A 12 year old male patient complained of red "blood shot" eyes and a red "splotchy rash" with "tiny dots" over torso and neck two days after he had received an intra-musclar injection of menactra in the left arm and an intra-muscular injection of Decavax in the right arm. He also complained of itching but denied fever. The child's mother reported that the following day the rash had lessened throughout the day and he had no further complications. The child did recover from this event.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ, TD
Symptoms: Purpura
Clinical narrative: From initial information received on 06/28/2005 from a physician regarding an adverse event occurring in the U.S.A>, it was reported that an 18  year old male patient received his first dose of Menactra administered intra-muscularly in the right deltoid, a dose of Tubersol 5 TU administered intradermally in the left forearm and a dose of Hepatitis A vaccine administered in the left deltoid on 06/17/2005. Eleven days later on the morning of 06/28/2005, the patient developed generalized purpura. The patient was seen by a physican. It is unknown at this time whether the patient recovered from this event. From follow up information received on 07/19/2005, it was reported that the patient was on no medications or had any illness at the time of vaccination. He was vaccinated at a private doctor's office with private funds. Recovery status was not reported.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Medication error
Clinical narrative: From initial information received on 6/13/05 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a female patient received a dose of Menactra vaccine, lot number U1575AA, administered SC instead of IM in her left upper arm on an unspecified date. An unspecified amount of time later, the patient developed large redness of her left upper arm. At the time of this report, the patient recovered from these events. From additional information received on 7/5/05 it was reported that the patient was seen by a physician on an unspecified date. No further information is anticipated, this case is considered closed.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Bursitis, Hypokinesia, Myositis, Pain
Clinical narrative: Initial report received from a health care professional on 7/22/05. A 50 year old female patient received an IM injection of Decavac, lot number U1220BA, in the left arm on 6/27/05. One day later, she developed severe pain and decreased range of motion of her left arm. She was treated with non-steroidal anti-inflammatory medication and is undergoing physical therapy. An MRI of her left shoulder on 7/13/05 suggested myositis and bursitis of subdeltoid bursa reflecting injection into the deltoid and into the subdeltoid bursa. As per the reporter, it is unknown if the patient has recovered from these events. The reporter of this case is the same as for case 200501426. (OMIC)
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Bursitis, Joint range of motion decreased, Medication error, Myositis, Pain
Clinical narrative: Initial report received from a health care professional on 7/22/05. A 50 year old female patient received an IM injection of Decavac, lot number U1220BA, in the left arm on 6/27/05. One day later, she developed severe pain and decreased range of motion of her left arm. She was treated with non-steroidal anti-inflammatory medication and is undergoing physical therapy. An MRI of her left shoulder on 7/13/05 suggested myositis and bursitis of subdeltoid bursa reflecting injection into the deltoid and into the subdeltoid bursa. As per the reporter, it is unknown if the patient has recovered from these events. The reporter of this case is the same as for case 200501426. (OMIC)
Age: 26.0
Sex: M
Vaccine: IPV, MMR, YF
Symptoms: Erythema, Pruritus, Skin ulcer
Clinical narrative: 3 vaccines administered between 10:15 AM and 10:30 AM on 8-1-05. At 10:40 AM, client c/o 5 red, raised lesions on face and neck, 10-15mm in size. Also, c/o puritis. Denied SOB. Two Benadryl 25 mg. administered by mouth. At 11:00 AM lesions resolved. Client denies puritis and SOB. Bilateral lungs clear to  ascultation. Client departed health unit.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Mother found infant dead in her crib at 6AM. 7/22 Coroner said infant died around 2AM. Infant was fed at 11:30 and mother heard nothing all night. Infant had no fever etc following imm. To ER by ENS, MD stated cause of death as unk on death certificate. Mother said they said if was probably SIDS. Death Certificate received and stated patient experienced unevaluated reaction.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Initial report received from a health care professional on 7/26/05. A 20 year old female patient had received a first dose of Menactra, lot number U1657AA, administered in the left deltoid on 7/21/05. One day later, she developed a severe headache and a fever of 105 degrees F. She also had a 5cm area of induration at the injection site. The patient was seen in the physician's office on 7/26/05, where it was noted that her left deltoid was red and warm to touch. The patient was advised to use ice on the injection site and to take ibuprofen. At the time of the office visit, the patient's headache had resolved and she was feeling better. She has since recovered from the events. (OMIC)
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pneumonia, Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash in 2 hours waist down; 101 fever in 6 hours. Seen in ER at 11 PM, fever 102-103. Rash head to toe; raised, red. MD felt as if from immunization. Seen MD next day. Rash arms and face and legs. Developed pneumonia.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Coma, Nausea, Somnolence
Clinical narrative: Woke up 9/26/03 at 6 Am. Mother thought she was going to throw up, but became unresponsive. Called ambulance. Taken to hospital. Seen by Doctor. CAT scan done, negative UA, negative. No temp on admission to hospital. Just appeared drowsy. Was kept in hospital most of day. Discharged that evening 9/25/03.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Convulsion, Musculoskeletal stiffness, Opisthotonus, Pyrexia
Clinical narrative: 8hrs after imm received pt had episode of seizure like activity, arched back, extremities flex, apnea, 5-6x 1 mid x imm. To ER hospital x 3 days observation. Temp on adm 100.5 (R). No s/s seizure since 1st episode.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Corneal lesion, Crying, Eye disorder, Gaze palsy, Infection
Clinical narrative: Pt rec'd imm 3/1/05 did not have any problems. Then on 3/14/05, pt was taken to family doctor for eye infection. He was prescribed Cephalexin and some sulfa eye gtts. He had a low grade temp 100.8 and was also on Tylenol for this. Pt received antibiotic, eye gtts 2 x on 3/14 and 3x on 3/15/05. After 9:15PM dose of meds on 3/15/05, pt went to sleep. He awoke at 9:45PM screaming uncontrollably for about 30 mins and his eyes rolled back. Pt was taken to the ER and subsequently admitted to hosp for overnight observation. By the time pt arrived at ER he had settled down and had no more episodes of screaming. Ct scan of head and CXR were done on 3/15/05. CT showed no acute intracranial abnormality identified, abnormal soft tissue of nasopharynx and opacification of the maxillary sinuses. CXR showed mild perihilar infiltrates are questioned on the lateral projection. Pt was dismissed from hospital 3/16/05 and continued Cephalexia but not the sulfa eye gtts. GM states that pt is doing well now just has nasal congestion. Pt has appt 3/23/05 with family doctor at which time a referral will be made to hospital for eval. Information from Discharge summary states corneal lesion, groggy. msv
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Leukocytosis, Nasal congestion, Pyrexia, Screaming, Stupor
Clinical narrative: Pt rec'd imm 3/1/05 did not have any problems. Then on 3/14/05, pt was taken to family doctor for eye infection. He was prescribed Cephalexin and some sulfa eye gtts. He had a low grade temp 100.8 and was also on Tylenol for this. Pt received antibiotic, eye gtts 2 x on 3/14 and 3x on 3/15/05. After 9:15PM dose of meds on 3/15/05, pt went to sleep. He awoke at 9:45PM screaming uncontrollably for about 30 mins and his eyes rolled back. Pt was taken to the ER and subsequently admitted to hosp for overnight observation. By the time pt arrived at ER he had settled down and had no more episodes of screaming. Ct scan of head and CXR were done on 3/15/05. CT showed no acute intracranial abnormality identified, abnormal soft tissue of nasopharynx and opacification of the maxillary sinuses. CXR showed mild perihilar infiltrates are questioned on the lateral projection. Pt was dismissed from hospital 3/16/05 and continued Cephalexia but not the sulfa eye gtts. GM states that pt is doing well now just has nasal congestion. Pt has appt 3/23/05 with family doctor at which time a referral will be made to hospital for eval. Information from Discharge summary states corneal lesion, groggy. msv
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Decreased appetite, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Started symptoms post immunization: Headache about eyes, Back neck sore, tired, not sleep well, shoulder and hips ache, decreased appetite, nausea with out vomiting, sweating.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Nausea, Neck pain
Clinical narrative: Started symptoms post immunization: Headache about eyes, Back neck sore, tired, not sleep well, shoulder and hips ache, decreased appetite, nausea with out vomiting, sweating.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt calls and states she received TD shpt around 8: this am, it is now 11:00 and she has a red rash on her neck, that itches. She has called her DR and was told to take 25mg Benadryl.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Ecchymosis, Injection site nodule
Clinical narrative: Ecchymosis right outer thigh. Firm 1.5cm nodule beneath ecchymosis. No evidence of infection, Referred to Dr.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient had slight cold and cough when received his 2nd Varicella given 1 month after 1st Varicella in PM of 10/19/2004.  Woke up next AM with complaint of body aches in entire body, redness and swelling.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Erythema, Pyrexia, Swelling
Clinical narrative: Redness in left leg from thigh to foot with swelling - unconsolable crying for 3 hours 08/09/2004 - temperature 103.  08/10/2004 and another episode of unconsolable crying for 3 hours.  Temperature not relieved by Tylenol, 2 doses.  Physician notified - Tylenol and Benadryl advised.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Mother stated she noticed the area this AM around 8AM on infants face, arms, legs and hands.  Few on center of chest and upper back.  Arms, hands, and legs broke out heavily.  The areas were around 1/4 - 1/2 cm in size circular and flat in shape and no area touched.  Infant had no temperature and was eating and drinking.
Age: 0.39
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site pain
Clinical narrative: Very sore at site of injection.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site induration, Swelling
Clinical narrative: Patients left arm was swollen, red, warm and hard to touch - no rash noted.  Diagnosed with Cellulitis.  Treated with Augmentin 600mg/5ml, UML twice a day for 10 days, Atarax as needed.  Mom reports rash before this.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Patients mother called 12/28/2004 and stated patient showed her a rash, described as whelps on arms, abdomen and a few on back.  Patient not sure how long she has had rash.  States injection site is clear.  Denies any itching or swelling.  Mother states she is trying to rule out cause of rash.  Mother states she plans to call private doctor.  States patient has not been in any distress.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left swollen, red, hot to touch arm badly noted 11:30, 06/16/2005 - Immunization given approximately 11:30 06/15/2005.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Headache, Injection site infection, Swelling
Clinical narrative: Received immunizations 01/18/2005.  Later that day left arm was red and swollen.  Next day left arm more swollen and hot to touch - swelling spread to elbow.  Also headache.  Mother took child to doctor on 01/20/2005, doctor diagnosed with infection at injection site.  No meds given.
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient developed fever 105 degrees - had seizure.  Seen in ER - radiographic diagnostic tests showed no abnormalities.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Mom states child received several immunizations on 07/06/2005 - noticed rash, itching, upper arms and shoulder Saturday, increased today - denies fever.  Advised give Benadryl.  07/13/2005 Gave Benadryl - rash dried up, no visit.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Crying, Erythema, Infection, Injection site oedema, Pain
Clinical narrative: 07/15/2005 Stepmom called with report of crying, pain, edema at injection site at 4PM.  Later child taken to ER with diagnosis of "a little bit of infections and prescribed antibiotic."  Redness, edema, pain at left deltoid.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Skin discolouration, Swelling
Clinical narrative: Patients mother took patient to ER 2 days after vaccine administration.  Patient was diagnosed with Cellulitis and given Keflex.  Skin to right arm slightly swollen and discolored today.
Age: 25.0
Sex: F
Vaccine: HEP, TD
Symptoms: Arthralgia, Vomiting
Clinical narrative: Vomiting with severe pain in joints, especially spine.  Aching especially in joints.  Denies rash.  Attributes vomiting to severe pain rather than immediate effect of vaccines.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Had a second wheezing attack to MMR immunization, was seen in ER evening of 07/30/2005 with labored breathing, cough and wheezing.  Symptoms began 07/27/2005 after receiving MMR was given HHN.  Follow up appointment with PCP on 08/01/2005 not in distress.  Treated with short tapering course of oral steroids, Prelone and oral Albuterol
Age: 16.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Infection, Pharyngitis, Pruritus, Rash, Rhinitis
Clinical narrative: Got Varicella disease. cold symptoms, pustula, itchy rash
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Chills, Fatigue, Hot flush, Injection site erythema
Clinical narrative: 07/28/2005 - Same day as injection- arm swollen, red at injection site.  07/29/2005 - Next day - Injection site better - complaint of nausea "dry heaves", cold/hot flashes, weakness.  08/01/2005 - 4 days later at clinic arm swollen at entire bicept/tricept, temperature 97.9 orally - chills / fever, fatigue.  08/03/2005 - Feeling alot better.
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Nausea, Pyrexia, Retching
Clinical narrative: 07/28/2005 - Same day as injection- arm swollen, red at injection site.  07/29/2005 - Next day - Injection site better - complaint of nausea "dry heaves", cold/hot flashes, weakness.  08/01/2005 - 4 days later at clinic arm swollen at entire bicept/tricept, temperature 97.9 orally - chills / fever, fatigue.  08/03/2005 - Feeling alot better.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypotension, Lethargy, Rash, Swelling face
Clinical narrative: Vomiting, hypotensive lethargic generalized rash and redness, puffy under eyes, ears red and puffy color pale around eyes.  Benadryl 1/2 teaspoon by mouth, epinephrine 0.25q, Solumedrol 40mg IM.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: Vomiting, hypotensive lethargic generalized rash and redness, puffy under eyes, ears red and puffy color pale around eyes.  Benadryl 1/2 teaspoon by mouth, epinephrine 0.25q, Solumedrol 40mg IM.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Pain
Clinical narrative: Became painful and tender about 07:30PM last night.  Mother gave Motrin for pain and applied cool rag.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The patient developed chickenpox.  He scratched them and it lead to impetigo.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site reaction, Skin burning sensation
Clinical narrative: Administered DTap RD 18/02/2005, IPV RD 08/02/2005. Mother reports 08/03/2005 Child complained of burning, but no redness seen. 08/04/2005 woke up, upper 1/2 of RD Erythemia, warm and generalized induration no change in general energy/behavior
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Coma, Fall, Tremor
Clinical narrative: Approx. 4:00 pm on 7/13 was walking on river bank and slipped. Mom didn't witness him hitting his head. After sitting for a minute started shaking all over for a few seconds No LOC. He would not respond to mom or EMS personnel
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Oedema
Clinical narrative: Pt had large swollen Right thigh no respiratory compromise noted.
Age: 18.0
Sex: U
Vaccine: HEP, MEN
Symptoms: Dyspnoea, Heart rate decreased, Heart rate irregular, Hyperhidrosis, Peripheral coldness
Clinical narrative: cold sweaty palm dyspnea and unable to breath, weak pulse + RR > 60/m HR hard to detect because of so weak. given Epinephrine  1x1000 (a 3ml a kd) shot in one min and call 911 and transfer ER of Hospital.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Local reaction to right arm where DTaP was given. Keflex was prescribed.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Urticarial rash 20 minutes after receiving immunizations.
Age: 28.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: RASH FROM FLAT AND DRY TO RAISED TO PURULENT OFF AND ON, 2 DAYS AFTER VACCINATION.  RUNNING A FEVER OFF AND ON.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Confusional state, Disorientation, Dyspnoea, Heart rate increased
Clinical narrative: Fever, paleness, difficulty breathing, fast heart beat, disoriented, confusion, weakness, swelling of glands all within minutes of getting the shot.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pallor, Pyrexia
Clinical narrative: Fever, paleness, difficulty breathing, fast heart beat, disoriented, confusion, weakness, swelling of glands all within minutes of getting the shot.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Bronchiolitis, Cough, Decreased appetite, Eye disorder, Pyrexia
Clinical narrative: Mother reports that the day following the immunizations the child developed a runny nose, cough and fever that required a doctor visit. The child has subsequently been put on Pulmicort, Zyrtec, and Albuterol. He was hospitalized for 24 hours with a temp of 105 degrees in late May.  He has been seeing his primary physician almost weekly since April. Continues on medications and has coughing and wheezing symptoms. 11/07/05 Review of medical records indicates diagnosis of bronchiolitis. Additional symptoms include poor appetite and a candida diaper rash. 11/07/2005 hospital records reviewed. Added information that a blocked nasal lacrimal duct was noted on left.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Rash, Rhinorrhoea, Wheezing
Clinical narrative: Mother reports that the day following the immunizations the child developed a runny nose, cough and fever that required a doctor visit. The child has subsequently been put on Pulmicort, Zyrtec, and Albuterol. He was hospitalized for 24 hours with a temp of 105 degrees in late May.  He has been seeing his primary physician almost weekly since April. Continues on medications and has coughing and wheezing symptoms. 11/07/05 Review of medical records indicates diagnosis of bronchiolitis. Additional symptoms include poor appetite and a candida diaper rash. 11/07/2005 hospital records reviewed. Added information that a blocked nasal lacrimal duct was noted on left.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, TD
Symptoms: Medication error
Clinical narrative: Error in vaccine administration. Td administered to a 5 year old rather than DTaP. Telephone call to CDC medical consultant, who recommended child be given the correct DTaP dose at same visit as Td given.  DTaP given. No adverse events observed at the clinic visit.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Infection, Optic neuritis, Rheumatoid arthritis, Visual disturbance
Clinical narrative: This case was reported in a literature article and described the occurrence of optic neuritis in a 15 year old male subject who was vaccinated with hepatitis B vaccine for prophylaxis. In one family branch a grandparent, initially thought (from butterfly rash) to have lupus, and a second cousin have Crohn's disease. On an unspecified date the subject received second dose of Hepatitis B vaccine. At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced a compound adverse event, acute optic neuritis (vision degradation to 20/400) and rheumatoid arthritis that had resolved with prompt treatment. Three years later, an idiopathic similar episode occurred, possibly from an asymptomatic infection, again it had resolved. The sequence suggested that a particular persisting memory based immune response mode would have been established by the abbreviated vaccination scheduled. This case was assessed as medically serious (OMIC). The author considered the events were almost certainly related to vaccination with Hepatitis B vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Headache, Pyrexia
Clinical narrative: Client developed temp 101.6 and headache. Mother states temp went up between 102-103 Friday and began going down on Saturday. Able to go to school on Monday 0 Temp
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Lacrimation increased, Ocular hyperaemia, Optic neuritis, Vision blurred
Clinical narrative: 7/25/05 Right eye red, watery - vision blurred - no trauma - referred to Ophthalmology. Admitted to hospital. Diagnosed with Optic neuritis on 7/28/05. Treated with IV steroids and antibiotics.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 3 small hives at injection site. Benadryl given hives subsided.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Condition aggravated, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Right arm redness and swelling,itchy, hot to touch. Hot pack if swelling persists. start Keflux 500t/d. increased swelling started antibiotic
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Migraine, Pruritus, Vomiting
Clinical narrative: Right arm redness and swelling,itchy, hot to touch. Hot pack if swelling persists. start Keflux 500t/d. increased swelling started antibiotic
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Hypersensitivity, Pyrexia, Somnolence
Clinical narrative: Per parent report, temp 103 for 2 days responded to Tylenol. Bright red rash everywhere. Sleepy. did not bring child in for appt. Child now fine.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR
Symptoms: Injection site oedema, Injection site reaction, Urticaria
Clinical narrative: Patient developed localized swelling and hive immediately after MMR injection Pt did not have any respiratory distress, She was playful after vaccination. Ice was applied, Swelling was noticeable but hive got smaller. Mom was advised to call if any shortness of breath, wheezing, color change.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Drug ineffective
Clinical narrative: Hib given at 27 days of age leaving infant with a questionable immunity to Hib vaccine. Follow information dated 8/16/05 states there was no adverse event, other than the possibility of the child not obtaining immunity to Hib due to the vaccine being administered at 28 days of age.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: vaccinated July 24th am parent noted left thigh where DTAP and IPV vaccine were given was swollen, red and indurated. Grandmother measured leg difference - left thigh and calf swollen 2 inches greater than right, child started on Benadryl, called clinic Monday am, child seen Left thigh swollen, area of injection indurated. Medial aspect of left thigh, by 26 redness gone, decrease of swelling, still had induration at site of injection. No systemic symptoms, no pain by 26th.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: She developed an 11 x 14 cm slightly indurated erythematous area on right upper lateral thigh one day after receiving DTaP and MMR injection in that thigh.
Age: 0.51
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Several Hours after receiving Prevnar, developed redness, Swelling at site. No other symptoms. was seen in office the next day. PE c/w above. Was recovered by 08/04/2005
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Rash pustular
Clinical narrative: 6x4 cm erythema, induration Left thigh at site of DTaP injection 08/03/05. Tender small pustral at injection site. parent and child on liberal warm packs and started on Augmentin at 42mg/kg 2D with follow up in 48 hours.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Right thigh red swollen hot to touch, Keflex 290 T/D, 08/04/2005 increased redness, increased Keflex to 500mg B/D, better 08/05/2005, 08/08/2005 better.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Rash on neck and upper chest. Slight itching Had MMR 07/17/1978
Age: 1.3
Sex: M
Vaccine: DTAPH, HIBV, PNC
Symptoms: Medication error
Clinical narrative: Pt expired vaccine TriHiBit (DTaP + HIB) parents have been left message to call clinic, no contact, will continue to contact or revaccinate at 18 month well check. 08/08/2005 spoke with mom. She will walk in for revaccination on or before 15 month.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Medication error
Clinical narrative: Pt received expired vaccine, TriHiBit (DTaP + HIB) contacted mom, child will be brought in on or before 18 month well check for revaccination.
Age: 1.56
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Medication error
Clinical narrative: Pt was given expired vaccine on 07/22/2005 TriHiBit (DTaP + Hib) Error was discovered 07/25/2005. Meds expired 07/12/2005. No adverse reaction. Pt mother notified. Revaccination on 08/05/2005
Age: 1.27
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Medication error
Clinical narrative: Patient received expired vaccine (DTAP, HIB) Trihibit.  Mom notified by phone she will be walking in this week for re-vaccination.
Age: 1.26
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Medication error
Clinical narrative: Patient given expired vaccine Trihibit (DTAP and HIB).  Attempted to contact family by phone, unsuccessful, will contact by mail.  Spoke with Mom 08/08/2005 patient will return at 18 months for repeat vaccines.
Age: 1.37
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Medication error
Clinical narrative: Patient received expired vaccine, Trihibit (DTAP and HIB).  Contacted Mom for re-vaccination.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Injection site red and swollen, warm to touch.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cough, Pyrexia, Vomiting
Clinical narrative: A day after immunization infant developed a cough fever and vomited.  Went to local hospital emergency room received IV fluids and came home.  Highest temperature 103.2.  Next day evaluated in the office - infant normal and asymptomatic.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Feeling hot, Somnolence, Vomiting
Clinical narrative: Prevnar administered left thigh. during evening hours, child felt warm, temperature not taken, drowsy, slept for 3 hours, then started vomiting, vomited 6 times.  Next AM 07/28, afebrile, normal activity, taking fluids.  Local site with redness no warmth.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TD
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: An initial report was received in the U.S.A. from a health care professional on 07/20/2005. A 13 year old male patient developed generalized hives two days after he had received intra-muscular injections of Menactra in the right arm, TD ADS ADULT in the left arm and Hepatitis A in the left arm. He does have a history of allergy to codeine. He was not seen by a health care professional, but self medicated with Benadryl. He was also prescribed Zyrtec. He has recovered.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: An initial report was received in the U.S.A. from a health care provider on 07/20/2005. An 18 year old male patient felt feverish but no temperature was taken after he had received his first does of Menactra, intramuscularly in the left deltoid. He also experienced profuse sweating. The date of vaccination and onset of reaction was not reported. He took ibupofen and the symptoms resolved.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypersensitivity, Rash
Clinical narrative: An initial report was received in the U.S.A. from a parent, who is employed by the health care provider on 07/20/2005. An 18 year old female patient developed headache and a rash on her lower back, under arms, back of knees and groin area two days after she had received an intra-muscular injection of Menactra in the right deltoid and an intra-dorsal injection of TUBERSOL in the left forearm. The rash was described as faint, pink small bumps. She does have a history of seasonal allergies for which she takes Zyrtec. She was treated with Motrin. It is unknown if she has recovered.
Age: 17.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Headache, Medication error, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: An initial report was received in the USA from a health care professional on 7/19/05. An 18 year old male patient experienced a fever of 103 degrees F, sore throat, nasal congestion and headache four days post vaccination after he had received a SC injection of Menactra, lot number U1641AA in the left arm and an IM injection of tetanus diphtheria, lot number TD131 in the left deltoid. The patient was prescribed Motrin and Tylenol and his fever was decreased to 101 degrees F. A CBC was done on 7/15/05 but results were not provided. The Menactra vaccine was administered incorrectly as SC instead of the IM route. It is unknown if the patient has recovered. Follow-up information received on 30-August-2005. This patient was 17 year old at the time of vaccination an the manufacturer for the tetanus diphtheria product is the Massachusetts Department of Health. The results of the CBC were provided - within normal limits. The patient did not have any significant medical history, was not on any medications and did not have any illness at the time of vaccination. The patient recovered from the adverse events.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Medication error
Clinical narrative: An initial report was received in the USA from a health care professional on 7/15/05. A 16 year old female patient complained of headache and joint pain of knees and elbows seven days after she had received SC injection of Menactra, lot number U1641AA, in the left arm. The vaccine was admnistered SC in stead of IM. She was treated with Motrin and her symptoms resolved. Follow-up information received on 30-August-2005. The patient received the vaccine on 10-June-2005 at 10:00 and the adverse events started 7 days later at 13:00. The patient also received MOTRIN concomitantly.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Medication error
Clinical narrative: An initial report was received in the USA from a health care professional on 7/27/05. An 11 year old male patient complained of redness, pain and warmth at the left arm injection site one day after he had received a SC injection of Menactra, lot number U1639AA, instead of the IM route. He also received TUBERSOL in the left forearm. Treatment was not reported. Reportedly, he has not recovered.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abortion
Clinical narrative: It was reported through a clinical trial in the USA that a 15 year old female subject was pregnant. Last menstrual period: 4/25/05, expected delivery date not provided. She has no previous obstetric history. Maternal drug exposure includes OrthoEvra Patch (5/8/05 - 5/30/05), Tylenol (5/6/05), Flonase (Mid March 2005 - present), Diazepam (6/1/05), Tylenol Arthritis(date not provided, Cyclobenzaprine HCl (6/1/05) and Flurbiprofen (5/31/05). The subject received her first dose of the study vaccine on 5/4/05, she did not experience any adverse event. The Adacel IND number 9266, has been added to this case. From additional information received on 7/8/05, it was reported that the subject had an elective abortion performed on 6/12/05. A home urine pregnancy test on 7/2/05 was reported as negative.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Chest pain, Diabetes mellitus, Difficulty in walking, Dyspnoea, Epistaxis
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fibromyalgia, Headache, Hypokinesia, Memory impairment, Mood altered
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Muscle contractions involuntary, Muscle twitching, Myalgia, Neck pain, Restless legs syndrome
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Sleep apnoea syndrome, Sleep disorder, Tinnitus
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.