chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, DTAP
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Erythema toxicum neonatorum, Gene mutation identification test positive, Laboratory test abnormal
Clinical narrative: Initial report received on 12 April 2010 from an article. "We report a female infant with recurrent biopsy-proven vesicobullous incontinentia pigmenti occurring after her 12-month and 18-month immunizations. To our knowledge, incontinentia pigmenti vesicobullous recurrence following immunizations has not been reported. We propose that vaccinations may serve as triggers for incontinentia pigmenti reactivation." An 18-month-old female infant with a history of incontinentia pigmenti (IP) received an injection of DTaP (manufacturer and lot number not reported), on an unspecified date. Three to 5 days after vaccination, vesicobullous lesions appeared within the residual linear patches that corresponded to sites of previous lesions from earlier skin eruptions. There were no verrucous lesions, fever or other systemic complaints. An ophthalmologic examination found no abnormalities. The patient's medical history included seizure and a rash that simultaneously started on the patient's third day of life. At that time, the patient was treated with phenobarbital for new onset seizures. Rash was described as erythematous papules and vesicles and was initially diagnosed as erythema toxicum neonatorum. But the patient experienced vesicobullous eruptions again at one month and at four months of age and biopsy and genetic testing demonstrated a mutation in nuclear factor (NF) -kB essential modular (NEMO) which confirmed a diagnosis of IP. The patient's mother had reported no eruptions following vaccinations (unspecified) at 2, 4 and 6 months of age. However at 12 months of age, vesicobullous lesions appeared one week after receiving multiple vaccines including Hib VACCINE (manufacturer and lot number not reported). MMR (manufacturer and lot number not reported) and PNEUMO CONJUGATE VACCINE (manufacturer and lot number not reported). Between the 12 month and 18 month vaccinations, the patient experienced two upper respiratory infections with fever, but without associated cutaneous eruptions. The authors concluded that late reactivation of the vesicobullous stage of IP was triggered by immunizations that served to stimulate TNF-alpha activation. This case is linked to case 2010-02116 which describes the event that occurred at 12 months of age (same patient, same reporter). Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, DTAP
Symptoms: Pyrexia, Rash erythematous, Respiratory tract infection, Skin lesion, Upper respiratory tract infection
Clinical narrative: Initial report received on 12 April 2010 from an article. "We report a female infant with recurrent biopsy-proven vesicobullous incontinentia pigmenti occurring after her 12-month and 18-month immunizations. To our knowledge, incontinentia pigmenti vesicobullous recurrence following immunizations has not been reported. We propose that vaccinations may serve as triggers for incontinentia pigmenti reactivation." An 18-month-old female infant with a history of incontinentia pigmenti (IP) received an injection of DTaP (manufacturer and lot number not reported), on an unspecified date. Three to 5 days after vaccination, vesicobullous lesions appeared within the residual linear patches that corresponded to sites of previous lesions from earlier skin eruptions. There were no verrucous lesions, fever or other systemic complaints. An ophthalmologic examination found no abnormalities. The patient's medical history included seizure and a rash that simultaneously started on the patient's third day of life. At that time, the patient was treated with phenobarbital for new onset seizures. Rash was described as erythematous papules and vesicles and was initially diagnosed as erythema toxicum neonatorum. But the patient experienced vesicobullous eruptions again at one month and at four months of age and biopsy and genetic testing demonstrated a mutation in nuclear factor (NF) -kB essential modular (NEMO) which confirmed a diagnosis of IP. The patient's mother had reported no eruptions following vaccinations (unspecified) at 2, 4 and 6 months of age. However at 12 months of age, vesicobullous lesions appeared one week after receiving multiple vaccines including Hib VACCINE (manufacturer and lot number not reported). MMR (manufacturer and lot number not reported) and PNEUMO CONJUGATE VACCINE (manufacturer and lot number not reported). Between the 12 month and 18 month vaccinations, the patient experienced two upper respiratory infections with fever, but without associated cutaneous eruptions. The authors concluded that late reactivation of the vesicobullous stage of IP was triggered by immunizations that served to stimulate TNF-alpha activation. This case is linked to case 2010-02116 which describes the event that occurred at 12 months of age (same patient, same reporter). Documents held by sender: None.
Sex: M
Vaccine: HEP, HEP
Symptoms: Full blood count normal, Injection site discolouration, Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen leg in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKLine). On 21 April 2010 at 18:45 the subject received 1st dose of ENGERIX B at 10 mcg in the right thigh. After midnight, the baby's leg was red and swollen. At the morning assessment at 07:33 (22 April 2010) the baby's leg showed red purple with blisters. A CBC and chest x-ray were done with no dates or results specified. The baby was evaluated several times. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention) and possibly related to treatment with ENGERIX B. Circumcision was performed and the baby had a dusky spell (turned blue). Outcome was not reported. The subject was to be started on erythromycin.
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen leg in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKLine). On 21 April 2010 at 18:45 the subject received 1st dose of ENGERIX B at 10 mcg in the right thigh. After midnight, the baby's leg was red and swollen. At the morning assessment at 07:33 (22 April 2010) the baby's leg showed red purple with blisters. A CBC and chest x-ray were done with no dates or results specified. The baby was evaluated several times. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention) and possibly related to treatment with ENGERIX B. Circumcision was performed and the baby had a dusky spell (turned blue). Outcome was not reported. The subject was to be started on erythromycin.
Sex: M
Vaccine: HEP, HEP
Symptoms: Chest X-ray, Circumcision, Cyanosis, Full blood count, Injection site discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen leg in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKLine). On 21 April 2010 at 18:45 the subject received 1st dose of ENGERIX B at 10 mcg in the right thigh. After midnight, the baby's leg was red and swollen. At the morning assessment at 07:33 (22 April 2010) the baby's leg showed red purple with blisters. A CBC and chest x-ray were done with no dates or results specified. The baby was evaluated several times. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention) and possibly related to treatment with ENGERIX B. Circumcision was performed and the baby had a dusky spell (turned blue). Outcome was not reported. The subject was to be started on erythromycin.
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen leg in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKLine). On 21 April 2010 at 18:45 the subject received 1st dose of ENGERIX B at 10 mcg in the right thigh. After midnight, the baby's leg was red and swollen. At the morning assessment at 07:33 (22 April 2010) the baby's leg showed red purple with blisters. A CBC and chest x-ray were done with no dates or results specified. The baby was evaluated several times. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention) and possibly related to treatment with ENGERIX B. Circumcision was performed and the baby had a dusky spell (turned blue). Outcome was not reported. The subject was to be started on erythromycin.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Mom called office 4/22/10 stated that pt contacted her from school. Had a bad headache but also while sitting at the table with left arm resting on table thumb became numb then each finger then hand became numb. numbness spread up arm. Mom states it resolved in 45 mins completely - Per mom pt had all imms given on 4/21/10 in left arm but per nurse who saw pt they were not.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Pt developed herpes zoster - RUE.
Age: 1.4
Sex: M
Vaccine: HIBV
Symptoms: Injection site haematoma, Injection site induration, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, irritability, nickle-sized bruising at injection site w/ firm raised lump, mild rash on left arm and forehead. Treated with Tylenol.
Age: 1.4
Sex: M
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: Fever, irritability, nickle-sized bruising at injection site w/ firm raised lump, mild rash on left arm and forehead. Treated with Tylenol.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Tremor
Clinical narrative: MOTHER REFERS THE CHILD DEVELOPED INVOLUNTARY TREMORS IN FACE THE SAME DAY OF VACCINATION. WAS TAKEN TO THE HOSPITAL. **PATIENT HAD CONTINUED TO RECIEVE THE SAME VACCINES AND HAD NOT DEVELOPED ANY ADVERSE REACTIONS IN THE SUBSEQUENT VACCINATIONS.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain in hands/swelling; swelling in legs; Hosp. admit due to DVT in leg. Multiple physician appointments for leg/hand swelling and pain; labs. Physician diagnosed related to H1N1 vaccine.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Incorrect dose administered
Clinical narrative: Patient received adult dose of Hepatitis A vaccine instead of pediatric dose
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site urticaria, Pyrexia, Rash
Clinical narrative: Fever 104 about 2 hours after vaccination treated with TYLENOL & MOTRIN.  Then patient broke out in a rash with hives on the left leg.  Treated with BENADRYL.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Facial palsy
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a physician concerning a 20 year old female patient, who in October 2009, "6 months ago", was vaccinated with the first dose of GARDASIL (route and lot number not provided). A couple of weeks after 1st dose, the patient got pregnant. The patient also developed Bell's Palsy after receiving the first dose but had a miscarriage sometime after developing Bell's Palsy. It was reported that the Bell's Palsy was getting better at the time of reporting. The patient's outcome regarding the miscarriage was unknown. The patient sought unspecified medical attention via office visit. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Systemic lupus erythematosus
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The consumer mentioned her daughter had a severe adverse reaction to GARDASIL and asked how people have reported lupus. At the time of the report, the outcome was unknown. Upon internal review, lupus was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1), HEPA, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Pt briefly fainted after received 3 vaccines. Loss of consciousness for 5-10 seconds immediately after 3rd vaccine administered.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Bacterial infection, Blood culture positive, CSF test abnormal, Gram stain, Haemophilus infection
Clinical narrative: Information has been received from a physician concerning a 6 month old female patient with asthma, hip dysplasia and no drug reactions/allergies, who on 17-DEC-2009 and 17-FEB-2010 was vaccinated with the first and second dose of PEDVAXHIB respectively. Concomitant therapy included albuterol. On 04-APR-2010 the patient was seen in the emergency room through 05-APR-2010. Blood cultures and spinal tap were performed at the emergency room, both were positive for Haemophilus. In the evening of 05-APR-2010, the patient was transferred to a hospital when was admitted to the pediatric intensive care unit. The physician did mention the child's father reported that his other daughter had meningitis that required a shunt to be placed. The timing as to when the patient's sibling had meningitis was unknown. At the time of the report the patient had not recovered. Follow up information was received via a telephone call, from a registered nurse who reported that on 17-DEC-2009, the patient was administered the first dose of PEDVAXHIB (lot # 657705/1438U). On 17-FEB-2010, the patient received the second dose of PEDVAXHIB (lot # 664098/1292Y). On the same day, the patient was vaccinated with the second dose of ROTATEQ (lot # 664688/1182Y). Concomitant vaccine included PEDIARIX (lot# AC21B19288). The registered nurse stated that the patient's discharge summary from the medical center included the following laboratory test results: Blood culture, positive for Haemophilus influenzae, Cerebrospinal fluid (CSF) results, positive for Haemophilus influenzae and Critical results: Gram-Negative Coccobacilli. The registered nurse stated that there was no diagnosis reflected in the Discharge summary. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Haemophilus test positive, Intensive care, Lumbar puncture
Clinical narrative: Information has been received from a physician concerning a 6 month old female patient with asthma, hip dysplasia and no drug reactions/allergies, who on 17-DEC-2009 and 17-FEB-2010 was vaccinated with the first and second dose of PEDVAXHIB respectively. Concomitant therapy included albuterol. On 04-APR-2010 the patient was seen in the emergency room through 05-APR-2010. Blood cultures and spinal tap were performed at the emergency room, both were positive for Haemophilus. In the evening of 05-APR-2010, the patient was transferred to a hospital when was admitted to the pediatric intensive care unit. The physician did mention the child's father reported that his other daughter had meningitis that required a shunt to be placed. The timing as to when the patient's sibling had meningitis was unknown. At the time of the report the patient had not recovered. Follow up information was received via a telephone call, from a registered nurse who reported that on 17-DEC-2009, the patient was administered the first dose of PEDVAXHIB (lot # 657705/1438U). On 17-FEB-2010, the patient received the second dose of PEDVAXHIB (lot # 664098/1292Y). On the same day, the patient was vaccinated with the second dose of ROTATEQ (lot # 664688/1182Y). Concomitant vaccine included PEDIARIX (lot# AC21B19288). The registered nurse stated that the patient's discharge summary from the medical center included the following laboratory test results: Blood culture, positive for Haemophilus influenzae, Cerebrospinal fluid (CSF) results, positive for Haemophilus influenzae and Critical results: Gram-Negative Coccobacilli. The registered nurse stated that there was no diagnosis reflected in the Discharge summary. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction, Skin lesion
Clinical narrative: Local rxn round approximately 7.5 cm lesion c/w local rxn; possible early cellulitis will follow closely.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning an 83 year old female with allergies to codeine and morphine and no medical history, who on 10-MAR-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 664864/1365Y). Concomitant therapy included alendronate sodium (MSD), nitroglycerin, calcium (unspecified) (+) vitamin D (unspecified), ANTIVERT, atenolol, simvastatin (manufacturer unknown) aspirin, digoxin, COUMADIN, omeprazole, and KAYEXALATE. On 10-MAR-2010 the patient developed a cellulitis like reaction at the injection site. The patient complained of the site being itchy, red, hot and swollen. The patient was put on KEFLEX and CLARITIN for the treatment. No laboratories studies performed. The patient sought medical attention through her physician. At the time of this report the patient was recovering. Follow up information has been received from the medical assistant who indicated that the patient was a retired female who on 10-MAR-2010, was vaccinated with the first dose of PNEUMOVAX 23 (lot # 664864/1365Y) into her left deltoid at 11:00 AM. No illnesses were reported prior to the time of vaccination. On 10-MAR-2010, at 09:30 PM the patient's upper left arm got red, tender and hot with cellulitis. A clinical evaluation was done in the office and treatment was done with antibiotics and ice. The patient recovered on approximately 20-MAR-2010. The reporter considered the patient's upper left arm red, tender and hot with cellulitis to be other important medical events. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning an 83 year old female with allergies to codeine and morphine and no medical history, who on 10-MAR-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 664864/1365Y). Concomitant therapy included alendronate sodium (MSD), nitroglycerin, calcium (unspecified) (+) vitamin D (unspecified), ANTIVERT, atenolol, simvastatin (manufacturer unknown) aspirin, digoxin, COUMADIN, omeprazole, and KAYEXALATE. On 10-MAR-2010 the patient developed a cellulitis like reaction at the injection site. The patient complained of the site being itchy, red, hot and swollen. The patient was put on KEFLEX and CLARITIN for the treatment. No laboratories studies performed. The patient sought medical attention through her physician. At the time of this report the patient was recovering. Follow up information has been received from the medical assistant who indicated that the patient was a retired female who on 10-MAR-2010, was vaccinated with the first dose of PNEUMOVAX 23 (lot # 664864/1365Y) into her left deltoid at 11:00 AM. No illnesses were reported prior to the time of vaccination. On 10-MAR-2010, at 09:30 PM the patient's upper left arm got red, tender and hot with cellulitis. A clinical evaluation was done in the office and treatment was done with antibiotics and ice. The patient recovered on approximately 20-MAR-2010. The reporter considered the patient's upper left arm red, tender and hot with cellulitis to be other important medical events. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR, PNC13
Symptoms: No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Fever with Tmax of 103 with onset within 24 hours;  this was 5th dose of Prevnar using new Prevnar 13;  3 months between 4th and 5th dose;  no previous adverse reaction to Prevnar
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Electroencephalogram, Headache, Pyrexia, Tic
Clinical narrative: headache, fever, Temp 103-104 x 3wks. Saw family MD. Rec. medication for fever. After fever normal (3wks) began having eye & mouth gestures. Saw neurologist, hosp. 3 days for testing. No seizures. Motor tics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Rt leg w/2 small papules at site surrounded by a flat non-tender patch of redness.  No infx noted.  Expected to resolve over next 1-2 wks.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling at site of injection.  Area of erythema 3" X 4.5".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days after immunization presented to clinic with left arm swollen, red, warm to touch below deltoid injection site of DTAP see diagram; Initially TX as Cellulitis but maybe immunization RXN.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Swelling of left thigh initially adjacent to injection site then 2 days later generalized swelling of upper thigh? if red given partially subcut. Antibiotic started 4/19.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Muscle spasms, Nausea
Clinical narrative: "Diarrhea/cramping", nausea.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Cellulitis, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: L. deltoid inflamed indurated and warm to touch. Area approx. 10 cm. @ injection site. Low-grade temp, slight nausea. Dx: cellulitis and abscess tx: KEFLEX 500MG.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: L. deltoid inflamed indurated and warm to touch. Area approx. 10 cm. @ injection site. Low-grade temp, slight nausea. Dx: cellulitis and abscess tx: KEFLEX 500MG.
Age: 55.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Dyspnoea, Feeling cold, Influenza, Pneumonia
Clinical narrative: At first had chills and fever and cold all over the body in Lung and Chest area coughing and coughing up mucus and weight loss and now in upper body chest congestion, breathing problem.
Age: 55.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Productive cough, Pyrexia, Respiratory tract congestion, Weight decreased
Clinical narrative: At first had chills and fever and cold all over the body in Lung and Chest area coughing and coughing up mucus and weight loss and now in upper body chest congestion, breathing problem.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Dysarthria, Dyspnoea, Muscular weakness, Skin exfoliation
Clinical narrative: Weakness in arms and legs, slurred speech, short of breath, skin peeling, after 7 days of injection. Hospitalized for one month. Medication injected through IV and physical therapy. Hospitalized again for 5 days same treatment.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Rash papular, Urticaria
Clinical narrative: Rash - (urticarial & papular) in 10 cm + 6 cm area around injection site.  Began 3 days after shot -> still there at day 5.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: Administered TDAP on 3/31.  Patient developed red, itchy, maculo papular rash on all sun-exposed areas except face on 4/2.  Rash still visible 4/5.  Advised BENADRYL, rash improved.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given TDAP instead of TD.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt given MENINGOCOCCAL vaccine in right deltoid on Thursday 4/15/10 at 4 PM.  On Friday 4/16 in PM - noticed upper arm, red, swollen & hot.  Seen in clinic noon on Sat. 4/17.  Given cold compress, told to repeat & take TYLENOL if needed.
Age: 1.29
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Blister, Cough, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: Pt has scattered vesicles with erythematous bases with some on face scabbing and ones on trunk forming. Vesicles on face since 4/18/10 - fever x 1wk with cough and runny nose. Supportive treatment.
Age: 1.29
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Scab
Clinical narrative: Pt has scattered vesicles with erythematous bases with some on face scabbing and ones on trunk forming. Vesicles on face since 4/18/10 - fever x 1wk with cough and runny nose. Supportive treatment.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Patient passed out after (GARDASIL) injection given.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Pain, Urticaria
Clinical narrative: 17Apr10 -Start with huge hive, bad headache, and slight pain when breathing - only on the right side. 19Apr10- was seen by healthcare provider - administered antibiotic.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: Rash over entire body, except face started on 17 Apr 10 - Went ER on 17 Apr 10, quarantined for 4 hours to rule out smallpox.  BENADRYL & MOTRIN clinic visit on 19 Apr 10 - HYDROXYZINE - 25 mg RANITIDINE 150 mg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria, Wheezing
Clinical narrative: Initial report received on 16 April 2010 from a health care professional. A 4-year-old male patient had received on 24 September 2009 a fourth intramuscular dose of DAPTACEL (lot number C3157AA), and a third intramuscular dose of IPOL (lot number D0052-2). The lot number for IPOL is not a valid Sanofi pasteur lot number for this product. The patient denied any concurrent illnesses, but has medical history of allergy to eggs, wheat, soy, corn, beef, shrimp, and milk products. Patient denied use of any concomitant medications, and had not experience any adverse events with prior vaccinations. Within minutes of receiving the vaccinations on 24 September 2009, the patient developed generalized hives and wheezing. He was evaluated by a physician and treated with nebulizer treatments (trade name not provided) and Benadryl. It was not reported whether the patient had recovered or not. Documents held by sender: None
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Coronary artery dilatation, Echocardiogram abnormal, Kawasaki's disease, Pericardial effusion, Pyrexia
Clinical narrative: Fever, eventually diagnosed as Kawasaki disease
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: REDNESS, SWELLING, PAIN AT SITE. FEVER, NAUSEA, DECREASED APPETITE
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: REDNESS, SWELLING, PAIN AT SITE. FEVER, NAUSEA, DECREASED APPETITE
Age: 0.31
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever (100 degrees) for 36 hours, extreme fussiness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Heart rate normal, Oxygen saturation normal, Pruritus
Clinical narrative: Thirty minutes after receiving the vaccine the patient reported that the palms of her hands were itching.  A few more minutes passed and the patient stated she was experiencing tightness in her chest.  Her breathing also became more labored.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Inconsolable crying x 3 hrs - l thigh red & swollen shot area extending to knee.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC13, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Inconsolable crying x 3 hrs - l thigh red & swollen shot area extending to knee.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Infection, Local reaction
Clinical narrative: Localized reaction to Varicella with secondary infx.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt. received ADACEL at appt 4/15/10.  Noted firmness at injection site within an hour.  Also noted pain/swelling.  Spread over several days to larger area.  Appt 4/22/10 noted with 7 cm X 9 cm red/hot arm.  Positive arthralgia, mild nausea, and headache day 1-4.  No fever.  Treated with PREDNISONE - to call if problems continue.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pt. received ADACEL at appt 4/15/10.  Noted firmness at injection site within an hour.  Also noted pain/swelling.  Spread over several days to larger area.  Appt 4/22/10 noted with 7 cm X 9 cm red/hot arm.  Positive arthralgia, mild nausea, and headache day 1-4.  No fever.  Treated with PREDNISONE - to call if problems continue.
Age: 40.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Flushing, Head banging
Clinical narrative: 27JUL09 about 15 minutes after receiving first AVA, first ENGERIX-B and second TYPHOID VI vaccinations (7/2009) began to "feel bad", felt a "rush going through her arms", was itchy with red flat blotchy flushed skin to arms, neck, and chest that developed into hives, was having difficulty breathing, and was lightheaded. Her dizziness was described as the room spinning with any head movement. She denied any blurry vision, sweating chest pain or tightness in her throat. Staff placed her flat, elevated her feet Her blood pressure was recorded as 146/90 pulse 86. Five minutes later BP was 122/77 pulse 81 (patient thinks her BP is usually 135/74). She was given IM EPI-PEN. She reported immediate improvement to breathing and dizziness following epinephrine. By the time the patient was transferred, the majority of symptoms has resolved. Provider documented shortness of breath with no wheezing and skin with "hives". She was given 10 mg of oral ZYRTEC and was monitored for 3-6 hours before release. A few hours prior to vaccinations and onset of symptoms she ate chicken salad with ranch dressing and diet coke. She has had these items at the same restaurant since without any adverse reaction. No new clothes, detergents, deodorants, perfumes, etc. No pollen, mold, dogs/cats, bee/insect, or latex allergies. She did not exercise prior to this reaction. Her hives gradually resolved over the next 10 days on ZYRTEC. She has had no reoccurrence since. She deployed in 2009 for two weeks and upon return was advised no civilian allergist could evaluate her for a potential AVA vaccine allergy. She was referred to hospital in Jan 2010. Records note further vaccinations in November 2009 with IM influenza and Jan 2010 with H1N1 with no adverse events reported.
Age: 40.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Laboratory test abnormal, No reaction on previous exposure to drug, Pruritus, Rash macular, Urticaria
Clinical narrative: 27JUL09 about 15 minutes after receiving first AVA, first ENGERIX-B and second TYPHOID VI vaccinations (7/2009) began to "feel bad", felt a "rush going through her arms", was itchy with red flat blotchy flushed skin to arms, neck, and chest that developed into hives, was having difficulty breathing, and was lightheaded. Her dizziness was described as the room spinning with any head movement. She denied any blurry vision, sweating chest pain or tightness in her throat. Staff placed her flat, elevated her feet Her blood pressure was recorded as 146/90 pulse 86. Five minutes later BP was 122/77 pulse 81 (patient thinks her BP is usually 135/74). She was given IM EPI-PEN. She reported immediate improvement to breathing and dizziness following epinephrine. By the time the patient was transferred, the majority of symptoms has resolved. Provider documented shortness of breath with no wheezing and skin with "hives". She was given 10 mg of oral ZYRTEC and was monitored for 3-6 hours before release. A few hours prior to vaccinations and onset of symptoms she ate chicken salad with ranch dressing and diet coke. She has had these items at the same restaurant since without any adverse reaction. No new clothes, detergents, deodorants, perfumes, etc. No pollen, mold, dogs/cats, bee/insect, or latex allergies. She did not exercise prior to this reaction. Her hives gradually resolved over the next 10 days on ZYRTEC. She has had no reoccurrence since. She deployed in 2009 for two weeks and upon return was advised no civilian allergist could evaluate her for a potential AVA vaccine allergy. She was referred to hospital in Jan 2010. Records note further vaccinations in November 2009 with IM influenza and Jan 2010 with H1N1 with no adverse events reported.
Age: 40.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Vertigo
Clinical narrative: 27JUL09 about 15 minutes after receiving first AVA, first ENGERIX-B and second TYPHOID VI vaccinations (7/2009) began to "feel bad", felt a "rush going through her arms", was itchy with red flat blotchy flushed skin to arms, neck, and chest that developed into hives, was having difficulty breathing, and was lightheaded. Her dizziness was described as the room spinning with any head movement. She denied any blurry vision, sweating chest pain or tightness in her throat. Staff placed her flat, elevated her feet Her blood pressure was recorded as 146/90 pulse 86. Five minutes later BP was 122/77 pulse 81 (patient thinks her BP is usually 135/74). She was given IM EPI-PEN. She reported immediate improvement to breathing and dizziness following epinephrine. By the time the patient was transferred, the majority of symptoms has resolved. Provider documented shortness of breath with no wheezing and skin with "hives". She was given 10 mg of oral ZYRTEC and was monitored for 3-6 hours before release. A few hours prior to vaccinations and onset of symptoms she ate chicken salad with ranch dressing and diet coke. She has had these items at the same restaurant since without any adverse reaction. No new clothes, detergents, deodorants, perfumes, etc. No pollen, mold, dogs/cats, bee/insect, or latex allergies. She did not exercise prior to this reaction. Her hives gradually resolved over the next 10 days on ZYRTEC. She has had no reoccurrence since. She deployed in 2009 for two weeks and upon return was advised no civilian allergist could evaluate her for a potential AVA vaccine allergy. She was referred to hospital in Jan 2010. Records note further vaccinations in November 2009 with IM influenza and Jan 2010 with H1N1 with no adverse events reported.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 24 hours after receiving PCV 13 in left deltoid, area 0.5 cm red, warm and tender no fever. Saw MD 04/22/10 at 4pm Tx'ed KEFLEX and BENADRYL.
Age: 0.77
Sex: M
Vaccine: HEP, IPV, PNC
Symptoms: Emotional distress, Injection site erythema, Injection site induration, Injection site swelling, Irritability
Clinical narrative: Fussy after around 9 PM.  T 102 inconsolable.  Left thigh red & swollen at the injection site.  Gave TYLENOL.  4/21/10 seen in office, left thigh 1 cm redness X 1.5 cm induration.  Rx TYLENOL.  BENADRYL T 100.6 BIAXIN early LOM.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received DTAP & VZV on right arm, following morning right arm swollen & red & painful about 2 1/2 in X 4 in area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 4/20/2010 Moderate, other. Mother reported redness to left the size of a baseball the day after vaccine was administered.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Rash pruritic
Clinical narrative: Mother states approx 2 hours after receiving vaccine, child developed rash to arms, face upper trunk and neck. Itchy.  Mom denies SOB.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Pain at site of injection, Urticaria & warmth.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: SINCE AFTER THE SHOT I FEEL CONTINIOUS PAIN AT THE SPOT.WEDNESDAY NIGHT I STARTED EXPERIENCING UNCOMFORTABLE FEELING OF VIBRATION INTERVALLY IN MY 2 FEET ALL DAY AND NIGHT.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Dizziness, sleepiness, fatigue, blurred vision on 4/21/10. Fever 100.8. 4/23/10 pain to left arm and arm pit. Swelling to left axilla, started today.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Vision blurred
Clinical narrative: Dizziness, sleepiness, fatigue, blurred vision on 4/21/10. Fever 100.8. 4/23/10 pain to left arm and arm pit. Swelling to left axilla, started today.
Age: 0.93
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Mother reports fever of 102, 101, and 99.1 for past 2 days (today is 4/23/10). Advised that physical exam on 4/22 was normal. Mother also reports lump on left thigh that developed after vaccination area of induration about 25-30 mm induration and redness.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), TDAP
Symptoms: Immediate post-injection reaction, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Patient follows up 3 days after H1N1 and Tdap vaccine given 4/20. Patient had immediate itching at H1N1 injection site, which worsened over the next 24 hrs with more itching and hives over entire body, at which time patient seen at ER and was given Prednisone and BENADRYL which improved hives. Reports no new food exposure/bites.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood calcium normal, Blood creatinine normal, Blood electrolytes normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Vaccine administered about 10:30 am. About 3:30-4 pm, she turned pale, limp, collapsed, lips blue, no tone which lasted 2-3 min per parents-911 called and brought her to hospital. Admitted for observation and had normal EKG, cardiac ECHO, EEG and labs. No further episodes and D/C the next day.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood urea normal, Cyanosis, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Vaccine administered about 10:30 am. About 3:30-4 pm, she turned pale, limp, collapsed, lips blue, no tone which lasted 2-3 min per parents-911 called and brought her to hospital. Admitted for observation and had normal EKG, cardiac ECHO, EEG and labs. No further episodes and D/C the next day.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Hypotonia, Laboratory test normal, Pallor, Syncope
Clinical narrative: Vaccine administered about 10:30 am. About 3:30-4 pm, she turned pale, limp, collapsed, lips blue, no tone which lasted 2-3 min per parents-911 called and brought her to hospital. Admitted for observation and had normal EKG, cardiac ECHO, EEG and labs. No further episodes and D/C the next day.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling
Clinical narrative: Swollen right arm, site where vaccine was administered.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Dizziness, Gaze palsy, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after injection -c/o feeling sick/nauseous. Eyes rolled back - C/o feeling faint. Blacked out x few seconds. Extremities stiffened - body spasms x 2. Buccal area - white. Forehead clammy - cheeks warm. Placed on floor with legs up. Tol. Powerade without diff. Color returned after 10' - Oriented to T. & P. Pulse 88 radially - Resp. unlabored. Instructed parent to notify pediatrician of event.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Malaise, Muscle spasms, Musculoskeletal stiffness, Nausea, Oral mucosal discolouration
Clinical narrative: Immediately after injection -c/o feeling sick/nauseous. Eyes rolled back - C/o feeling faint. Blacked out x few seconds. Extremities stiffened - body spasms x 2. Buccal area - white. Forehead clammy - cheeks warm. Placed on floor with legs up. Tol. Powerade without diff. Color returned after 10' - Oriented to T. & P. Pulse 88 radially - Resp. unlabored. Instructed parent to notify pediatrician of event.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Skin warm
Clinical narrative: Immediately after injection -c/o feeling sick/nauseous. Eyes rolled back - C/o feeling faint. Blacked out x few seconds. Extremities stiffened - body spasms x 2. Buccal area - white. Forehead clammy - cheeks warm. Placed on floor with legs up. Tol. Powerade without diff. Color returned after 10' - Oriented to T. & P. Pulse 88 radially - Resp. unlabored. Instructed parent to notify pediatrician of event.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt came back on Friday 23 with swelling redness in his Lt deltoid was given shot on 21st he has also had fever and upset stomach.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Hard, round, 2 inch red diameter.  1 short occurance of burning pain down arm.  TYLENOL, ice.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: The client denied any side effects or problems after receiving a 2nd ZOSTAVAX on 4-21-10. He did not remember receiving the 1st ZOSTAVAX on 10-31-08, which is on his vaccine Thor record. He called the day before, and drove from the city to receive the second ZOSTAVAX. On 4/21/2010 - the client was given a 2nd ZOSTAVAX.  He had "NO" adverse event from this so that is why the date and time was not completed under that section of the form.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Grand mal convulsion
Clinical narrative: 2 hrs after IZ noted to have tonic clonic seizure.  Negative for fever or rash.
Age: 65.0
Sex: F
Vaccine: TYP
Symptoms: Ear pain, Injection site pain, Musculoskeletal stiffness, Tenderness
Clinical narrative: Patient stated had pain & soreness at injection site this resolved by 4/17/10.  Upon awakening on Sunday noticed that she had a stiff neck left side.  Since then has had on & off sharp pains behind left ear and tenderness with pressure left base skull.  Advised to see physician today.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Dyspnoea, Salivary hypersecretion
Clinical narrative: Saliva build up in mouth, light headed and difficulty breathing.  Patient responded to BENADRYL 25mg IM and observation.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Irritability, Vomiting
Clinical narrative: Fussy the evening of the vaccine 3 episodes vomiting the following day wetter more explosive stools. Discussion of incidental D vs DTaP vs AGE
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Per mother recieved call from school stating child was complaining of arm pain.  Mother noted redness and swelling at injection site of Rt. arm at 8:00 PM.  Gave Tylenol for pain.  Today advised by provider to continue with Tylenol or ibuprofen for pain and to apply cool compresses.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Pain, muscle soreness, bruising, and swelling reported at site of injection, even after 5 days later.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Abdominal X-ray, Crying, Diet refusal, Enema administration, Eosinophil percentage
Clinical narrative: Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lymphocyte count normal
Clinical narrative: Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Monocyte percentage, Platelet count increased, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
Clinical narrative: Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Abdominal pain, Crying, Enema administration, Intussusception, Malaise
Clinical narrative: Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.