chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Infection parasitic, Muscle spasms, Neurological symptom, Pain
Clinical narrative: Started having neurological symptoms (right thigh movement in 2001 and middle finger on right hand in Nov started having pain in back of legs, sweating, muscle spasms, Jan 2002 pain started increasing depressed and confusion. Went to different Dr. was finally diagnosed with Lyme's disease. I have been on different antibiotics since may and developed cyst on the back of my tendons and big amounts and now have spondyparthropathy type ?
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Meningitis
Clinical narrative: Four generalized clonic-tonic seizures 7 days after administration of MMR II and Varivax.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pulmonary congestion, Pyrexia, Rhinorrhoea
Clinical narrative: 18 mo infant with cold x 2-3 days, temp 99.2 deg, playing-came in for routine check up and got DTaP. Tonsils were red-strep screen neg, eating well, went home, playing, got in mom's lap and had tonic clonic sz with 105.3 deg temp lasting 2-5 minutes. Alert on arrival to ER-received Rocephin in hospital, neck supple, asymptoms-lots of upper airway congestion and clear rhinorrhea. Never had spine tap.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abnormal behaviour, Abnormal faeces, Agitation, Anorexia, Blood glucose
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Body temperature increased, CSF protein, Chest X-ray normal, Computerised tomogram head, Convulsion
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Corneal abrasion, Culture, Electroencephalogram abnormal, Erythema, Full blood count
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Haemoglobin abnormal, Hyperhidrosis, Lumbar puncture, Lymphocyte count increased, Milia
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Monocyte count increased, Neutrophil count decreased, Platelet count increased, Pyrexia, Urine analysis normal
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urine output decreased, White blood cell count increased
Clinical narrative: 12/7/02 office visit about 11am and immunizations given. 12/8/02 to ER about 10:30pm fussy, cranky, not eating, and doesn't seem himself. Admitted to hospital. 12/9/02 child had seizure, neurologist consulted, and saw child. Child was transferred to another hospital. 12/10/02 neurologist assumed primary care of child while at the hospital. 12/18/02 continues to be hospitalized.  Reported on 03/31/2003: "The patient is a two month old white male transferred to ER after episodes at home of flailing his arms back.  Patient's eyes were open and dilated.  The patient had no apnea or loss of consciousness.  He had a foul-smelling stool at the time.  The patient had a fever and was diaphoretic with the episode.  These episodes happened every two hours while at the ER.  The patient received an EEG which showed seizure activity according to history.  The patient's feeding had decreased as wwell as his urinary output.  While in the ER, the patient was given Valium, Ativan and phenobarbital.  He had a postietal temperature of 100.8 rectally.  Of note, the patient received his two month immunizations on the morning of 12/07/2002.  Past Medical History: Thirty-seven and a half week gestation, 7 pound 12 ounce, spontaneous vaginal delivery, no complications.  No past surgical history.  Newborn screen was negative.  Medications: Mylicon.  NKDA. Immunizations: Up to date.  Family History: Non contributory.  Social History: The patient lives with mom and dad.  There is smoking in the house.  Developmentally considered to be normal.  Physical Examination: Temperature: 37.4; Heart rate: 169; Respiratory rate: 27; Blood pressure: 110/71; O2 saluration: 100% on room air; mass 5.6kg, lenth 61cm, head circumference: 38cm.  Physical examination was significant for erythema on the patient's back, milia on the forehead and proximal right corneal abrasion, otherwise exam was negative.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Received a call from above employee stating that she received Flu shot yesterday 11/4/02 and towards the evening, noticed itchy-like reddish spots all over her body. Plans to contact MD about this reactions today.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrointestinal disorder, Injection site oedema, Pelvic pain
Clinical narrative: Within one day-swelling-half dollar size- around site of vaccine. Beginning 12/10/02-much gastrointesfinal discomfort and pelvic pain-resulting in trips to gynecologist and ER.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: One day after flu shot c/o SOB. Saw PCP on third day after shots. Treated with Proventil. Condition improved within 4 days.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Carbuncle, Skin ulcer
Clinical narrative: Carbuncle lesions on right arm, lower abdomen and lower extremities, Onset 3 days after shot Still present 9 days later. Tx with Keflex (began today) 500mg PID X 10 days.
Age: 1.46
Sex: M
Vaccine: FLU3
Symptoms: Cough, Erythema, Nasal congestion, Pharyngitis, Pyrexia
Clinical narrative: High temperature, Cough. c/o low grade fever and cough which appeared on 11/16/2002. 2 days after vaccination. Pt was seen on 11/18/2002. He was in satisfactory condition. No fever. Physical findings: nasal congestion and erythema of posterior wall of pharings. Dx URI, pharyngitis. Rx: Rediscare 3/4 t sp Q ID, Motrin QID PRN
Age: 1.46
Sex: M
Vaccine: FLU3
Symptoms: Upper respiratory tract infection
Clinical narrative: High temperature, Cough. c/o low grade fever and cough which appeared on 11/16/2002. 2 days after vaccination. Pt was seen on 11/18/2002. He was in satisfactory condition. No fever. Physical findings: nasal congestion and erythema of posterior wall of pharings. Dx URI, pharyngitis. Rx: Rediscare 3/4 t sp Q ID, Motrin QID PRN
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: I was working in the ER. At the end of my shift, I asked the OB nurse to give me my flu shot. She did and 1 - 1.5 hours after I broke out in hives all over. this has never happened prior.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Irritability, Pyrexia, Stupor
Clinical narrative: Fever (not well documented) X 1 week after shot @ 2 months, Very fussy 1st 3-4 hours after shot, Had generalized tonic Clonic seizure 3-4 hours after shots, lasting 2-3 minutes, "Dazed"  X 24 hours after seizure
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess drainage, Injection site mass, Skin discolouration
Clinical narrative: Developed 'lump" then white spot per mother, Began draining, 2 months post vaccine still draining, visible scarring approx .5 X 10 cm, Palpable area 1.5
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelling, Erythematous, Warm, Very painful
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Abnormal behaviour, Antisocial behaviour, Insomnia, Irritability, Screaming
Clinical narrative: Parent report that about 1week after receiving Varivax & DTaP, the child had a very abrupt behavioral change, which reverted just as abruptly about 1 week later. Has not reoccured, Spells of inconsolable screaming, head banging, not making eye contact, poor sleep, intense irritablity, Not reported until this date- has been apparently fine for the past 2weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Day 2 after injection. LA with itch, redness, and warmth. These Sx went away gradually but returned today 12/27, 9 days after injection.
Age: 8.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Convulsion, Hypotonia, Tremor
Clinical narrative: Initially seen 09/19/2002 for spell went limp, shaking, questionable seizure. As vomtable not normal afterwards. Has undergone extensive work- up. Unclear if events were seizure vs reflux. Eventually thought to be seizure.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Injection site pain
Clinical narrative: Vaccine at 1400 hours at deltoid mass. Pain stated about 1 hour later at 1/10 on pa scale.  Increase d over next 12 hours to 7/10 pa at worst. 75% loss of strength in right arm esp with abduction/ flexion/retraction of UE. pa decrease with ice and indemarthacin (56mg)
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Fever x 2 days, extreme irritability x 2 days. Rash, Emesis
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Mild case of varicella
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Nausea, Sinusitis
Clinical narrative: After i received the flu shot in early Nov 2002, I became nauseous and dizzy. Today is Mon. Dec. 23,2002 and I continue to be nauseous, dizzy and my balance is bad. When I close my eyes, i spin , I also got a severe sinus infection. I was quite and felling very good until I received the flu shot
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Dyskinesia, Syncope
Clinical narrative: Approx. 1 min after immunization administered, child had syncopal episode with head deviated to right, RFA flexed and rigid and generalized tonic chronic movements of all extremities x apprx. 10 - 15 sec. no post ictal s/s a/ox 3 VSS P76 R 16 BP 110/68 Reg 101 SaO2 99%
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site oedema
Clinical narrative: Some lateral swelling to left upper thigh and without redness. No treatment given.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Bacterial infection, Herpes zoster, Urinary tract infection, Viral infection
Clinical narrative: MD first saw pt June 04, 2002  Wt 111 1/2 B/P 140/14 Proc. 07/18/2002 Wt 108, B/p 120/76. on 09/05/2002 Wt 106 B/p 132/51 P 92 UTI diagnosis given Cipro  Wt 106 1/2 B/P 146/66.  p 92 09/19/2002. 10/10/2002 given Flu shot resisted e Coli 10/22/2002 became ill on 10/19/2002, diagnosed with Herpes Zoster Wt 104lbs.
Age: 28.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia, Respiratory distress
Clinical narrative: see attached slip written out by pt......injection Wed. Arm pain started Thursday am. Temp started about 10:00 am. Thursday pm, temp 103 degrees. Respiratory distress, chest pain, pulse 120. Chest x-ray clear. No wheezing. Friday temp 100-101. Saf 100-101 Shoulder red and swollen from shoulder to elbow. Sunday T 99-100 red and swollen S-E Monday T 99 red and swollen S-E
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema
Clinical narrative: LR6 Local Redness extending below elbow day #3 after vaccination.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: The day after receiving vaccination the patient developed a red, bumpy, itchy rash on the arm of vaccination, that continued to spread two days after vaccination.  Saw MD the day after vaccination and was treated with prednisone.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Drug toxicity
Clinical narrative: A legal complaint was received from an attorney who alleges that an 18 month old female received haemophilus B conjugate vaccine, Acel-Imune, and MMR vaccines on 4/23/97. According to the legal complaint, the child experienced unspecified injury as part of exposure to thimerosal. No further information was available.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. No other info is available. Upon internal review, autism was considered an other important medical event (OMIC). Additional info has been requested.  Reported on 02/20/2003: "Information has been received from a consumer concerning her son who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient developed autism.  No other information is available.  Upon internal review, autism was considered an other important medical event.  Follow up information has been received from the patient's mother, stating that she is "not sure why we are requesting this" (the prescribing physician contact information) and that she "believes (her) call was misconstrued."  Additional information is not expected.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Mental retardation severity unspecified, Neurological symptom, Social avoidant behaviour
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a female who on 4/29/99 was vaccinated, at the age of 9 months, with a dose of hepatitis B vaccine recombinant (yeast) (batch #not reported) that reportedly contained 12.5 micrograms of toxic mercury in the preservative thimerosal. Other immunizations reported include the first and second doses of hepatitis B vaccine, recombinant (ENGERIX B) (no lot number reported) received on 7/29/98, and 10/1/98 that each contained 12.5 micrograms of toxic mercury; the first, second, third and fourth doses of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) (no lot number reported) received on 10/1/98, 12/3/98, 1/22/99, and 2/10/00 that each contained 25 micrograms of toxic mercury; and first, second, third, and fourth doses of haemophilus B conjugate vaccine (ACTHIB) (batch # not reported) received on 10/1/98, 12/3/98, 1/22/99, and 7/29/99 that each contained 25 micrograms of toxic mercury. Subsequently, the patient experienced mercury poisoning allegedly as a result of having received vaccines containing toxic mercury that were administered to the patient between 7/29/98 and 2/10/00. To date, the patient had received the neurological, social and developmental milestones anticipated for a child of her age. The patient's mercury poisoning persisted. Upon internal review, mercury poisoning was considered an other important medical event (OMIC). No further information is available.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Cellulitis, Chills, Erythema, Feeling hot
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old Caucasian female patient who on 10/8/02 at approximately 2:30PM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), in the left deltoid. There was no illness at the time of the vaccination. On 10/10/02 the patient presented to the doctor's office with 1-2 days history of a skin lesion. The patient had a body temperature of 97.0 degrees F. The location of the lesion was reported to be the left upper arm extending from the elbow up into the axilla and down to her upper lateral chest wall. It was also noted that the patient experienced chills the night of vaccination. The patient initially felt bad and experienced pain and itching in the area. On 10/10/02 it was reported that the patient now feels better but the area of redness became larger. It caused the patient pain to raise her arm. There was redness in the entire left deltoid region with a red streak extending into the axilla and down into the left chest. Edema was noted in the elbow area with erythema. Warmth was also noted in the left deltoid region. There was no induration. The area was tender to palpatation. There was regional lymphadenopathy in the anterior axillary node, one node palpated which was tender. The patient was diagnosed with cellulitis. The patient was treated with cephalexin (Keflex) for 10 days and desloratadine (Clarinex). There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event OMIC). It was also reported that another patient (WAES0210USA01927) had been vaccinated from the same lot and had localized reactions at the injection site. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Lymphadenopathy, Pain, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old Caucasian female patient who on 10/8/02 at approximately 2:30PM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), in the left deltoid. There was no illness at the time of the vaccination. On 10/10/02 the patient presented to the doctor's office with 1-2 days history of a skin lesion. The patient had a body temperature of 97.0 degrees F. The location of the lesion was reported to be the left upper arm extending from the elbow up into the axilla and down to her upper lateral chest wall. It was also noted that the patient experienced chills the night of vaccination. The patient initially felt bad and experienced pain and itching in the area. On 10/10/02 it was reported that the patient now feels better but the area of redness became larger. It caused the patient pain to raise her arm. There was redness in the entire left deltoid region with a red streak extending into the axilla and down into the left chest. Edema was noted in the elbow area with erythema. Warmth was also noted in the left deltoid region. There was no induration. The area was tender to palpatation. There was regional lymphadenopathy in the anterior axillary node, one node palpated which was tender. The patient was diagnosed with cellulitis. The patient was treated with cephalexin (Keflex) for 10 days and desloratadine (Clarinex). There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event OMIC). It was also reported that another patient (WAES0210USA01927) had been vaccinated from the same lot and had localized reactions at the injection site. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old Caucasian female patient who on 10/8/02 at approximately 2:30PM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), in the left deltoid. There was no illness at the time of the vaccination. On 10/10/02 the patient presented to the doctor's office with 1-2 days history of a skin lesion. The patient had a body temperature of 97.0 degrees F. The location of the lesion was reported to be the left upper arm extending from the elbow up into the axilla and down to her upper lateral chest wall. It was also noted that the patient experienced chills the night of vaccination. The patient initially felt bad and experienced pain and itching in the area. On 10/10/02 it was reported that the patient now feels better but the area of redness became larger. It caused the patient pain to raise her arm. There was redness in the entire left deltoid region with a red streak extending into the axilla and down into the left chest. Edema was noted in the elbow area with erythema. Warmth was also noted in the left deltoid region. There was no induration. The area was tender to palpatation. There was regional lymphadenopathy in the anterior axillary node, one node palpated which was tender. The patient was diagnosed with cellulitis. The patient was treated with cephalexin (Keflex) for 10 days and desloratadine (Clarinex). There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event OMIC). It was also reported that another patient (WAES0210USA01927) had been vaccinated from the same lot and had localized reactions at the injection site. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning an 85 year old Caucasian female with no relevant medical history or illness at the time of vaccination who on 9/18/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent IM in the upper left arm (lot 641115/1159L). On 9/18/02 at 20:00, the pt developed marked redness, swelling, and pain at the injection site. The pt sought unspecified medical attention and was treated with antibiotics for supposed cellulitis. The pt subsequently recovered. The reporting physician felt that the pt's injection site swelling, redness, pain, and cellulitis were considered other medical events (OMIC). No additional info is expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 85 year old Caucasian female who on 10/10/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), IM in the left deltoid. There was no illness at the time of vaccination. The patient reported redness and swelling the next day after shot. The area was also reported to be warm to touch. The patient was treated with Keflex for 7 days. There were no relevant diagnostic tests or laboratory data. It was reported that the patient recovered. The reporter considered the patient's experience to be an other important medical event (OMIC). It was also reported that another patient (WAES0210USA01552) developed cellulitis and was vaccinated from the same lot. The reporter requested that the lot be checked. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Asthenia, Bacterial infection, Chest pain, Drug effect increased
Clinical narrative: Pt reported to ER c/o wheezing, fever and erythema/swelling of L upper extremity. Pt seen in ER 11/5/02. Admitted to inpatient medical unit for IV normal saline, Rocephin, Levaquin, Benadryl, Tylenol and Solu-Medrol. Annual follow up on 02/04/04: "It is unknown if the pt recovered from the adverse events.  We have ad no further communication with this pt. Discharge summary states dyspnea, pneumonia, wheezing, anxiety, increased drug effect, weak, chest pain. msv
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Leukocytosis, Pneumonia
Clinical narrative: Pt reported to ER c/o wheezing, fever and erythema/swelling of L upper extremity. Pt seen in ER 11/5/02. Admitted to inpatient medical unit for IV normal saline, Rocephin, Levaquin, Benadryl, Tylenol and Solu-Medrol. Annual follow up on 02/04/04: "It is unknown if the pt recovered from the adverse events.  We have ad no further communication with this pt. Discharge summary states dyspnea, pneumonia, wheezing, anxiety, increased drug effect, weak, chest pain. msv
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Wheezing
Clinical narrative: Pt reported to ER c/o wheezing, fever and erythema/swelling of L upper extremity. Pt seen in ER 11/5/02. Admitted to inpatient medical unit for IV normal saline, Rocephin, Levaquin, Benadryl, Tylenol and Solu-Medrol. Annual follow up on 02/04/04: "It is unknown if the pt recovered from the adverse events.  We have ad no further communication with this pt. Discharge summary states dyspnea, pneumonia, wheezing, anxiety, increased drug effect, weak, chest pain. msv
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Pyrexia, Serum sickness, Urticaria
Clinical narrative: A report was received from a health care professional on 12/17/02 concerning a 32 year old female vaccinee who experienced serum sickness one day after receiving Fluvirin on 11/15/02. It was reported that the vaccinee had received an influenza vaccine for the past five years with the date of last vaccination reported as 2001. Concomitant medication reported included unspecified birth control pills. On the 11/16/02 the vaccinee developed hives and was treated with methylpredinisolone for seven days with improvement. After treatment with methylprednisolone was complete on approximately 11/23/02 the hives returned and the vaccinee was treated with prednisone (dose unk). On 12/6/02 the vaccinee began to experience swelling in the ankles, knees and shoulders and experienced a fever (temp unk). On 12/6/02 the vaccinee was hospitalized where the attending physician diagnosed serum sickness. The vaccinee was treated with unspecified IV steroids, methylprednisolone and ciprofloscin for five days. The vaccinee was discharged from hospital on 12/8/02. It was reported that the symptoms had improved but had not resolved. The reporter has assessed the relationship of the vaccine to the event as probable.   Follow up on 02/27/2003: "A report was received from a health care professional which stated that the vaccinee had also experienced wrist swelling and had a fever of 101C approximately 2 weeks following vaccination.  The vaccinee had recovered at the time of the report."
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling
Clinical narrative: Under the arm was swollen the day following the vaccination, That evening swelling extended past the elbow, This now 36 hours after vaccination. Around 24 hours post vacc, the swelling decreased. Swelling increased again about 6 hrs later later.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Left deltoid immediately swelled once flu vaccine was administered. Ice pack given. (Pt) said he was okay and insisted on returning to his desk
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: after injection of influenza vaccine into leftdeltoid, immediate swelling occurred. Ice pack again
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Right deltoid immediately swelled once flu vaccine was administered. Ice pack applied.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: right deltoid immediately swelled once flu vaccine was administered. ice pack given/applied. (The pt) released to go home. Swelling reduced.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: After injection of influenza vaccine into the left deltoid, imnmediate swelling occurred. Ice pack given
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 1;25 pm left deltoid small amount of swelling noted hardened area around swelling. Bruise noted 3:45 pm, swelling reduced area not as hardened.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Malaise, Nausea
Clinical narrative: 11/15/02 09:45 AM: Client called in with c/o nausea + hot flashes, Stated she "just did not feel good". 11:00 AM: Did leave work early + went to her mom's house because client was not feeling well + did not want to drive home to Nassau, States went home later that evening + was feeling somewhat better, 11/15/02: States is doing fine now
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Petechiae
Clinical narrative: Small many petechiae in 1/3 inferior of the legs  X 3 days
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Injection site warmth, Neck pain, Skin discolouration
Clinical narrative: Pain at injection site, 50 cent size, pink + hot. Pain down arm up back of neck, Ice park topically, Declines Benadryl makes her drowsy. 11/01/2002  client out wk, States went home, took Benadryl,  Red area did not not increased in size. Tired with soreness in neck & arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Paraesthesia, Vasodilation procedure
Clinical narrative: Had vaccine 10/28, 3:15pm. On 10/29/02 late in day noticed site hot and tender, no redness or fever. Also had pain into neck and numbness in right arm. Saw MD who prescribed antibiotic - Amoxiclau 875mg BID and Meclizine 12.5mg TIO. Began to feel better after 2 doses of antibiotic. 11/1/02 stated everything "ok".
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: 11/21/02 sudden onset of n/v, chills, muscle ache, HA, fatigue. 11/22/02 felling much better. Does not intend to seek medical attention.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Vasodilation procedure
Clinical narrative: Noticed right arm red after taking band aid off today. Received flu vaccine yesterday. No pain. "Right arm feels warm and hard lumps present".
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema
Clinical narrative: Developed erythemaous, swollen area (4x4cm) on left upper arm
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Left arm pain
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Arm hurts, throbbing up/down arm and over to neck area. No redness or swelling noted.
Age: 1.25
Sex: F
Vaccine: DTAPH, IPV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Laboratory test abnormal
Clinical narrative: Presented to ER 11/28/02 with febrile seizure (temp 103.7). Discharged 11/29/02 et readmitted same day with 2nd seizure et had 3rd seizure post admittance (temp 104). Onset low grade fever 11/25/02.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Initial light headed, dizzy, 1.5 hour later flushed feeling, chilled, nausea, headache, hot, cold, sweaty, photophobia, phonophobia, achiness
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Photophobia, Vasodilation procedure
Clinical narrative: Initial light headed, dizzy, 1.5 hour later flushed feeling, chilled, nausea, headache, hot, cold, sweaty, photophobia, phonophobia, achiness
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Injection site mass, Pyrexia
Clinical narrative: Local hard knot and fever 101.5 fussy; persistent for 24 hours
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Oedema, Vasodilation procedure
Clinical narrative: Red, swollen, hot, lumpy knot firm round nodule.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Vasodilation procedure
Clinical narrative: Two days after immunization left deltoid area became red, hot and swollen. (12/19/02)
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Local reaction by pt report with swelling, erythema and overall feeling of low grade fever. Resolved mostly by four days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Swollen/red/hot/hard 12/20/02 12x13cm-diffuse well demarcated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: Red/hot/hard/itchy/lump with swelling diffuse 10x9cm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: Red/hot/hard/itchy/lump with swelling diffuse 10x9cm.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus
Clinical narrative: Itchy spots on face, belly, back, arms, about < 20 developed to blisters.
Age: 0.3
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Agitation, Decreased appetite, Pyrexia
Clinical narrative: Fever and crying all day. Does not seem to want to eat much baby food.
Age: 0.3
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Agitation, Crying, Drug toxicity
Clinical narrative: Fever and crying all day. Does not seem to want to eat much baby food.
Age: 0.3
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Agitation, Decreased appetite, Pyrexia
Clinical narrative: High pitched crying-continuous. Hard to settle down.
Age: 0.3
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Agitation, Crying, Drug toxicity
Clinical narrative: High pitched crying-continuous. Hard to settle down.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm with erythema, edematous, warm to touch from axilla level to 3/4/ or arm.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Insomnia
Clinical narrative: Cannot get him to sleep through the night for several nights. Cries during the day.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Feeling abnormal, Insomnia, Pain
Clinical narrative: Cannot get him to sleep through the night for several nights. Cries during the day.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Insomnia
Clinical narrative: Not sleeping through the night, crying all the time, very unhappy seems to be in pain.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Feeling abnormal, Insomnia, Pain
Clinical narrative: Not sleeping through the night, crying all the time, very unhappy seems to be in pain.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Injection site erythema, Pyrexia
Clinical narrative: Fever, crying, very hard to settle down. Red thigh after shot.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Affect lability, Pyrexia
Clinical narrative: Fever, crying, very hard to settle down. Red thigh after shot.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Drug toxicity, Injection site erythema, Pyrexia
Clinical narrative: Fever- crying, hard to settle down for days after receiving vaccines
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Affect lability, Pyrexia
Clinical narrative: Fever- crying, hard to settle down for days after receiving vaccines
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Pyrexia, Sleep disorder
Clinical narrative: Not sleeping well. Wakes up through the night on the hour. red thigh. Fever.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Insomnia, Irritability
Clinical narrative: Lots of crying. Very red thigh area. Not sleeping very much. Wakes up through the nights
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Broke out in blister like lesions on 12/21/2002
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Coma, Injection site erythema, Insomnia
Clinical narrative: Miserable, no interest in eating or playing with toys. "Red thigh and not sleeping through the night"
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Pyrexia
Clinical narrative: Fever. Not eating-nursing well. Not keeping breast milk or formula down.
Age: 0.7
Sex: M
Vaccine: HEP
Symptoms: Crying, Drug toxicity, Pyrexia
Clinical narrative: Signs of fever and crying. Not looking good. Called doctor and nurse said to give a double dose of Motrin and call back the next day.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: According to father, patient had right sided seizure (jerking of hand and leg) on 12/13/02. Seen at ER; CBC, eletrolytes, CT head all normal. Patient seen by neurologist in ER. Received EEG which was done on 12/19/02. EEG NL; Patient stable.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient with localized swelling to left thigh with rash. Started 2 days after immunization.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Dysphemia, Headache, Nausea, Pyrexia
Clinical narrative: Developed chills/fever, nausea, headache and stammering/stuttering speech 10 days after vaccination. All symptoms resolved spontaneously with in 24 hours.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Infection, Pain
Clinical narrative: Within 2-3 days of vaccination the soreness at the administration site in my right arm was gone, but I began to feel pain in my right elbow when lifting objects.  Also, within 3 weeks I developed a prostate infection (I don't know if this is related to the vaccination, but it also a strange coincidence, if it is not).  The manufacturer of the influenza vaccination is Adventis, Lot #UO938AA.
Age: 1.15
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram abnormal, Hypokinesia, Mental retardation severity unspecified, Nervousness
Clinical narrative: My daughter's pediatrician does not believe that the flu vaccine caused my daughter's seizures, which occurred 14 days after the vaccine was given, approx. on 11/15/02 at 10:30am. My daughter was perfectly healthy with no colds or illness prior to the flu shot being given. 14 days later we have been in and out of the hospital(s) with her seizures and have had tests including: Catscan, spinal tap, EEG, and an MRI run at the hospital, where they could find no cause for the seizures. There is no family history of epilepsy or seizures on either parent's side. My daughter has stopped breathing for 5 mins. with her first seizure in which I called 9-1-1 and she was taken by ambulance to the Medical Center and released that afternoon. She returned home, had more seizures and was taken to The Hospital where she stayed 5 days.  She has since had to ride in an ambulance due to the seizure two more times.  She is on a very high dose of Phenabarbitol for her seizures and is still having trouble controlling them. I would like this to be investigated because I feel that the flu shot may have caused the seizures, because she did not have them before. Medical record states shaking, limp, mental retardation, irritable. msv