chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Info has been received from a pharmacist concerning a pt who on 4/23/04 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Suspect concomitant therapy included a 2nd dose of hepatitis B virus vaccine. On approximately 4/23/04, 'sometime between vaccination and the morning of 4/26/04', the pt developed hives, a generalized rash and facial swelling. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Hypokinesia, Medication error, Pain
Clinical narrative: Info has been received from a physician concerning his 61 year old wife who on 7/19/04 was vaccinated with a dose of hepatitis A virus vaccine inactivated. The physician felt that the injection was given to high in the should and the needle may have hit bone or tendon near the site. His wife has had severe pain and decreased mobility of her shoulder near the injection site since the vaccination. He noted that she was negative for swelling, redness or warmth at the site. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Medication error
Clinical narrative: Info has been received from a physician concerning a 40 year old female physician with ragweed allergy who on 7/26/04 was vaccinated with a pediatric dose of hepatitis A virus vaccine inactivated (0.5ml), IM. Concomitant therapy included Allegra. Subsequently, the pt developed a sore shoulder. The pt recovered. Additional info has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling, Urticaria
Clinical narrative: Information was received from a consumer concerning her approximately 9 year old daughter with a possible sulfa allergy who in 2002 was vaccinated with a dose of HEPA. Subsequently "within minutes" the patient broke out in hives, swelling in her face, swelling at injection site and body and redness at injection site.  Unspecified medial attention was sought.  The patient recovered within six hours after receiving the vaccination.  A product quality complain was not involved.  Additional information was requsted.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Info has been received from a nurse concerning a 5 year old male pt who on an unspecified date was vaccinated with a dose of hepatitis A virus vaccine inactivated. That same day, the pt broke out in a rash all over his body. The nurse reported that the pt started school the same day and did not know if the rash was related to vaccine or not. Unspecified medical attention was sought. The pt took Benadryl and the rash disappeared. Additional info has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme abnormal, Infection
Clinical narrative: Info has been received from a physician concerning a 17 year old male who on 8/16/04, was vaccinated with hepatitis A virus vaccine inactivated (lot 648219/0024P). On 9/13/04, the pt "came back to the office" with "minimal right upper quadrant pain". The pt also had "slightly elevated" liver enzymes (SGOT=41; SGPT=591 and IgM for hepatitis A was also positive. Unspecified medical attention was sought. No product quality complaint involved. Follow-up reported that the pt was "diagnosed with infectious mononucleosis, therefore increased LFT's cannot be attributed to vaccine (hepatitis A virus vaccine inactivated". Follow-up information from the physician stated that the pt "had mononucleosis and she does not think (the hepatitis A virus vaccine inactivated) had anything to do with the adverse event/elevated liver enzymes". No further info is expected.
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning an adult female who in approximately September 2004 was vaccinated with a dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Subsequently the patient was exposed to someone with hepatitis A. A serology test showed that the patient was positive for hepatitis A and her liver function test was elevated. The patient sought unspecified medical attention. There was no produce quality complaint involved.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 50 year old female with no known drug allergies, a history of a knee operation (*post op bilateral knee*) in October 2004 and hypothyroidism who on 13-Jan-2005 was vaccinated in the left deltoid with a first dose of hepatitis A virus vaccine inactivated (Lot# 648035/0085P). Concomitant therapy included ibuprofen (ADVIL) and acetaminophen (TYLENOL) as needed. On 14-Jan-2005 the patient developed "welts from level of bra to waist." It was reported that the patient had no shortness of breath and that she will see the doctor on 18-January-2005. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The nurse reported with follow-up information indicating that the patient recovered on 17-Jan-2005.  There was no produce quality complaint involved.  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Area was red and warm to touch. Size: 7.0cm. round.  Patient was vomiting the night of the injection. Was given Benadryl allergy 25mg po Q 6 hours as needed.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Approximately 2 hr post receiving Typhoid vaccine in right deltoid pt. experienced "numbness" and "puffiness" distal to immunization site to wrist area.  Pt. states had pain at injection site at onset of immunization. Pt. denies any previous vaccine related reactions.
Age: 5.0
Sex: M
Vaccine: DPP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Golf ball sized swelling in left deltoid area with extreme heat and redness. Treatment: ice pack, Benadryl, ibuprofen, Tylenol
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Smallpox administered 29 Apr 05.  Member noted non-pyretic body rash day #14.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, TTOX, HEP, HEPA, TD
Symptoms: Arthralgia, Hypoaesthesia, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Within 48 hours, developed pain, redness to left shoulder extending periscapular area with distal extensions to elbow. Pain extended to 4th and 5th digits, axilla, paresthesia to 4th and 5th digit. Afebrile course. TX with Cephalaxin 500mg, NSAID's, Narcotics, scapular and shoulder local anesthesic, Medrol Dosepak.  Erythema induration resolved over 10 days, pain and paresthesis resolved over 11 weeks.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, TTOX, HEP, HEPA, TD
Symptoms: Demyelination, Erythema induratum, Injection site hypersensitivity, Injection site induration, Neuropathy
Clinical narrative: Within 48 hours, developed pain, redness to left shoulder extending periscapular area with distal extensions to elbow. Pain extended to 4th and 5th digits, axilla, paresthesia to 4th and 5th digit. Afebrile course. TX with Cephalaxin 500mg, NSAID's, Narcotics, scapular and shoulder local anesthesic, Medrol Dosepak.  Erythema induration resolved over 10 days, pain and paresthesis resolved over 11 weeks.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, TTOX, HEP, HEPA, TD
Symptoms: Pain, Paraesthesia
Clinical narrative: Within 48 hours, developed pain, redness to left shoulder extending periscapular area with distal extensions to elbow. Pain extended to 4th and 5th digits, axilla, paresthesia to 4th and 5th digit. Afebrile course. TX with Cephalaxin 500mg, NSAID's, Narcotics, scapular and shoulder local anesthesic, Medrol Dosepak.  Erythema induration resolved over 10 days, pain and paresthesis resolved over 11 weeks.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 13 month old male pt who experienced high fever at 104.5 degrees F injection site cellulitis, decreased activity and was irritable. At 13 months of age, the pt received the third dose on 13May05. The pt also received a dose of IPOL on 13May05. The pt's concurrent illness includes single functional kidney. The pt previously experienced hypersensitivity while taking Ativan (lorazepam tablet). Indication for Prevnar was immunization. Product was administered on 13May05. Dose regimen was 1 dose (IM). Additional suspect medication included IPOL. Concomitant medications were not reported. The pt experienced a high fever of 104.5 degrees F, decreased activity, and was irritable on 14May05. Left lateral thigh injection site became red, hot to touch and raised. The pt was taken to ER twice on 14May05. He was diagnosed with injection site cellulitis. Initial treatment included Cleocin, which he did not tolerate. He then was switched to Cefzil (cefprozil). The site of administration for both vaccines was the left lateral thigh. The pt recovered from all events (2005). No additional information was available at the time of this report.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Feeling hot, Hypokinesia, Injection site erythema, Injection site reaction
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 13 month old male pt who experienced high fever at 104.5 degrees F injection site cellulitis, decreased activity and was irritable. At 13 months of age, the pt received the third dose on 13May05. The pt also received a dose of IPOL on 13May05. The pt's concurrent illness includes single functional kidney. The pt previously experienced hypersensitivity while taking Ativan (lorazepam tablet). Indication for Prevnar was immunization. Product was administered on 13May05. Dose regimen was 1 dose (IM). Additional suspect medication included IPOL. Concomitant medications were not reported. The pt experienced a high fever of 104.5 degrees F, decreased activity, and was irritable on 14May05. Left lateral thigh injection site became red, hot to touch and raised. The pt was taken to ER twice on 14May05. He was diagnosed with injection site cellulitis. Initial treatment included Cleocin, which he did not tolerate. He then was switched to Cefzil (cefprozil). The site of administration for both vaccines was the left lateral thigh. The pt recovered from all events (2005). No additional information was available at the time of this report.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 13 month old male pt who experienced high fever at 104.5 degrees F injection site cellulitis, decreased activity and was irritable. At 13 months of age, the pt received the third dose on 13May05. The pt also received a dose of IPOL on 13May05. The pt's concurrent illness includes single functional kidney. The pt previously experienced hypersensitivity while taking Ativan (lorazepam tablet). Indication for Prevnar was immunization. Product was administered on 13May05. Dose regimen was 1 dose (IM). Additional suspect medication included IPOL. Concomitant medications were not reported. The pt experienced a high fever of 104.5 degrees F, decreased activity, and was irritable on 14May05. Left lateral thigh injection site became red, hot to touch and raised. The pt was taken to ER twice on 14May05. He was diagnosed with injection site cellulitis. Initial treatment included Cleocin, which he did not tolerate. He then was switched to Cefzil (cefprozil). The site of administration for both vaccines was the left lateral thigh. The pt recovered from all events (2005). No additional information was available at the time of this report.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Irritability, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 13 month old male pt who experienced high fever at 104.5 degrees F injection site cellulitis, decreased activity and was irritable. At 13 months of age, the pt received the third dose on 13May05. The pt also received a dose of IPOL on 13May05. The pt's concurrent illness includes single functional kidney. The pt previously experienced hypersensitivity while taking Ativan (lorazepam tablet). Indication for Prevnar was immunization. Product was administered on 13May05. Dose regimen was 1 dose (IM). Additional suspect medication included IPOL. Concomitant medications were not reported. The pt experienced a high fever of 104.5 degrees F, decreased activity, and was irritable on 14May05. Left lateral thigh injection site became red, hot to touch and raised. The pt was taken to ER twice on 14May05. He was diagnosed with injection site cellulitis. Initial treatment included Cleocin, which he did not tolerate. He then was switched to Cefzil (cefprozil). The site of administration for both vaccines was the left lateral thigh. The pt recovered from all events (2005). No additional information was available at the time of this report.
Age: 29.0
Sex: F
Vaccine: TYP, YF
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Pt received yellow fever and typhoid vaccines at SHC on 02/01/05, 1-2 days post vaccination, she developed fatigue that has persisted for 3 months. For 7 days during this period she had diarrhea which responded to Cipro. SX persist at this writing.
Age: 4.0
Sex: F
Vaccine: DTP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no medical history or allergies, who on 4/26/05 was vaccinated into the right leg with a dose of hepatitis A virus vaccine inactivated (lot # 648885/0157P). Suspect concomitant medication given into the right anterior thigh included a dose of MMR (lot # 647861/0851P). Other concomitant therapy given in the left leg included a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. There was no illness at the time of vaccination. On 4/27/05, the patient developed right leg redness, swelling, and her leg was also slightly tender and hot. The patient was diagnosed with cellulitis. The physician stated that the patient's reaction was not a typical reaction and that the cellulitis was probably related to either the dose of hepatitis A virus vaccine inactivated or the dose of MMR. The physician confirmed that the patient required medical treatment with oral antibiotics in order to prevent a more serious outcome. No diagnostic laboratory tests were performed. The physician had seen the patient since she was treated and she has fully recovered. No product quality complaint was involved. Cellulitis was considered to be an other important medical event (OMIC). No further information is expected.
Age: 4.0
Sex: F
Vaccine: DTP, HEPA, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no medical history or allergies, who on 4/26/05 was vaccinated into the right leg with a dose of hepatitis A virus vaccine inactivated (lot # 648885/0157P). Suspect concomitant medication given into the right anterior thigh included a dose of MMR (lot # 647861/0851P). Other concomitant therapy given in the left leg included a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. There was no illness at the time of vaccination. On 4/27/05, the patient developed right leg redness, swelling, and her leg was also slightly tender and hot. The patient was diagnosed with cellulitis. The physician stated that the patient's reaction was not a typical reaction and that the cellulitis was probably related to either the dose of hepatitis A virus vaccine inactivated or the dose of MMR. The physician confirmed that the patient required medical treatment with oral antibiotics in order to prevent a more serious outcome. No diagnostic laboratory tests were performed. The physician had seen the patient since she was treated and she has fully recovered. No product quality complaint was involved. Cellulitis was considered to be an other important medical event (OMIC). No further information is expected.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bronchitis, Pneumonitis, Pyrexia, Respiratory distress, Rhinorrhoea
Clinical narrative: Previously on 4/14, baby seen for runny nose and fever (T 100.3), chest clear, clear mucus from nose. On 4/15, presented with T 101.8, RR 76 positive retractions, wheezing all fields. Given Xopenex 0.63 via nebulizer with improvement. Transferred to hospital, then to another hospital. Diagnosis respiratory distress in critical care service Believed to have viral pneumonitis with evidence of laryngotracheobronchitis. Discharged with significant amounts of bronchodilator prescription for 2 days.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Viral infection, Wheezing
Clinical narrative: Previously on 4/14, baby seen for runny nose and fever (T 100.3), chest clear, clear mucus from nose. On 4/15, presented with T 101.8, RR 76 positive retractions, wheezing all fields. Given Xopenex 0.63 via nebulizer with improvement. Transferred to hospital, then to another hospital. Diagnosis respiratory distress in critical care service Believed to have viral pneumonitis with evidence of laryngotracheobronchitis. Discharged with significant amounts of bronchodilator prescription for 2 days.
Age: 21.0
Sex: M
Vaccine: FLU3, HEPAB, MEN, MMR, PPV
Symptoms: Dyspnoea, Hypersensitivity, Pruritus, Swelling, Urticaria
Clinical narrative: Patient broke out in hives all over his body; major itching and swelling about 30-40 minutes after receiving vaccination. Discharge summary states allergic reaction, dyspnea. msv
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site mass, Rash
Clinical narrative: Rash on back and chest. Right leg has a lump where vaccine was given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Red, swollen area 2x3" wide on left arm. Advil and Benadryl and warm compresses.
Age: 1.28
Sex: F
Vaccine: DT, HBHEPB
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen area 6x6cm, Left thigh measures 30.5cm. No discharge, pt ambulatory, warm to touch.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Erythema, Injection site oedema, Pain
Clinical narrative: Erythematous swelling (R) arm noted within 24 hours of DTaP. No fever; only minimal pain. 9cmx6 1/2cm erythematous non-tender swelling deltoid region. No LNE
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Child had varicella vaccine @ 13 months of age- Developed chicken pox disease 05/27/05.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: 2 days after vaccination with MMR, Varivax, Hib- Pt  developed bright red, irregularly shaped macular papular rash on torso, face, and thighs. Asymptomatic. No change with Benadryl.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fever 102F  with rash on 04/27/05. Presented @ office 04/29/05 with multiple discrete red papules on trunk and vesicles. 2x3cm red induration on R anterior thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Rash macular
Clinical narrative: Decreased energy, L arm hot, red blotchy and swollen upper arm only, no fever.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Nasopharyngitis, Otitis media, Pyrexia, Rash
Clinical narrative: after 1 day fever to 103 F, rash started 05/25/05. Also now has cold and ROM DX past week.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Skin warm
Clinical narrative: Arm very hard, warm, not red, no fever.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Headache, Hypersensitivity, Injection site induration
Clinical narrative: Red arm- hypersensitivity reaction. Follow up 7/19/05: Left arm also swollen, warm to touch, painful, itchy, firm to touch. Also complained of headache 2 weeks after vaccine received. It was mild and resolved.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Red arm- hypersensitivity reaction. Follow up 7/19/05: Left arm also swollen, warm to touch, painful, itchy, firm to touch. Also complained of headache 2 weeks after vaccine received. It was mild and resolved.
Age: 1.21
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Vaccine administered on 08/2/00- Fever on 05/10/05, vessicle noted 05/11/05- Rapid outbreak of vessicles on trunk, scalp, face, mouth, continued to develop new lesions 05/15/05-> 100 lesions; typical varicella appearence.
Age: 1.62
Sex: F
Vaccine: DTAP
Symptoms: Erythema multiforme, Injection site induration, Injection site oedema
Clinical narrative: 5.5 x6cm  erythematous patch with similar sized inudurated mass @ injection site.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site hypersensitivity, Vasodilatation
Clinical narrative: 3/4 of thigh red and warm. Child uses leg, No pain.
Age: 8.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Abdominal pain upper, Cough, Eye swelling, Urticaria
Clinical narrative: Hives onset 4-5 hours after vaccine. Stomach pain, cough and eye swelling.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Diarrhoea, Gastrointestinal pain, Pain
Clinical narrative: Temp 102 F, body aches, Wednesday. Temp 100F, 2:00 Thursday also had GI sx- diarrhea and pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema, Oedema peripheral
Clinical narrative: Large firm erythematous swelling of entire rigth upper arm and proximal part of lower arm.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site oedema, Oedema peripheral
Clinical narrative: Pt has swollen left upper arm/deltoid- cold compresses and Keflex.
Age: 1.16
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Diarrhoea, Lethargy, Pyrexia, Vomiting
Clinical narrative: Seven days after receiving DTAP, HIB, Prevnar, MMR, and Varicella, began to vomit, have diarrhea approximately 10 times daily, fever up to 104, lethargy.  Went to ER received antiematic supposatories antipyrestic.  Recovered 05/29/2005.  Mother states was told by PMD was probably MMR and not to get any more.
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Skin warm
Clinical narrative: 2x3 area of redness at injection site.  Area hot and tender to touch.  Assessed by provider and advise to contact PH, as per voicemail left on imms. line.  Patient feels its MMR site, not varicella.  Ice as needed, advised.  Patient contacted 05/13/2005 at 1440 hours, no further progress.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Skin nodule
Clinical narrative: Erythema 3x4 cm, nodules and temp. 100.2 oral.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Patient states that she began feeling like she had a sore throat.  On 05/27/2005 she could not swallow.  Patient went to the hospital.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Haematoma
Clinical narrative: Hematoma in left deltoid and warm to touch. Per MD's instructions, to apply warm compress and to give Benadryl every 6 hours.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Skin ulcer, Viral infection
Clinical narrative: Breakthrough varicella. 40 lesion on skin 6/3/05. Fever 6/2/05.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Oedema peripheral, Rash
Clinical narrative: Pt received Hep B #2 on Thursday 6/2/05 at 1pm, by 6/3/05 2pm she began experiencing adverse rxn sx.  Pt describes feeling severe joint pain, edema of the hands and feet, and rash on legs and arms.  Today 6/6/05, rash has subsided but joint pain and fatigue is still present.  I have made an appt for MD evaluation today @ 2pm.  Pt has been taking a Goody Powder combo with aspirin and acetaminophen.  I have instructed pt to d/c this and to use only plain Tylenol or Ibuprofen for joint pain.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Staring
Clinical narrative: Mother informed the doctor that child became limp, eyes were glazed over, and child staring into space. This episode lasted for 30 seconds but the above symptoms happened three times on 9-9-04.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Patient experienced shortness of breath and nailbed cyanosis.  Symptoms were relieved at home with a nebulizer treatment.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Patient received Pneumovax IM in left deltoid on 3/23/05.  The next morning, patient had limited range of motion in left arm and site of injection was swollen red and very tender to touch.  Constant and radiating pain in left arm.  Patient evaluated.  Treated empirically with Keflex x 7 days for cellulitis vs drug reaction.  Patient did not return for worsening of symptoms.  Symptoms presumed to have resolved.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient received Pneumovax IM in left deltoid on 3/23/05.  The next morning, patient had limited range of motion in left arm and site of injection was swollen red and very tender to touch.  Constant and radiating pain in left arm.  Patient evaluated.  Treated empirically with Keflex x 7 days for cellulitis vs drug reaction.  Patient did not return for worsening of symptoms.  Symptoms presumed to have resolved.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Convulsion, Irritability, Pyrexia
Clinical narrative: Patient started running a fever that got up to 102.5 about 4 days after receiving the shots.  On the third day she ran a fever of 103.5 and that evening she woke up fussing.  We went in to get her out of bed and changed her diaper, then we sat her up on the changing table and that is when she threw herself backward and went in to a full seizure.  She was in full convulsions for about 2 min.
Age: 22.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Pruritus, Rash, Skin striae
Clinical narrative: This 22 year old reports receiving his PPD on 5/20/2005 to the left forearm.  It was read 3 days later as negative with no rash, redness, induration, nodule noted.  Approximately two days later he noticed a red streak bumpy rash about the PPD site.  There was minimal pruritis, no swelling, nodules or blisters noted. He denies use of a bandaid to the site, new detergents, soaps, clothing or being bitten by any insect.  He was afebrile without red streaks.  This "bump" became 3 small streaks on 6/3/05.  He contacted allergy and immunology who referred him to the HC for evaluation. He also received HEP A #2 and IPV vaccination w/o complaints.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Left arm: red, hot to touch, pea size knot, slightly swollen, some itchiness, no soreness as reported by parent.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient got vaccine on Thursday, she noticed hives on face,and arms on Saturday morning.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site mass, Injection site warmth, Paraesthesia
Clinical narrative: This case was reported by a nurse and described the occurrence of anaphylactic reaction in a 25 year old female subject who received hepatitis B vaccine recombinant. On an unspecified date in March 2005, on or before 3/25/05, the patient received the first dose of Engerix B in the arm (lot AHBVO077AB). At an unspecified time following the first dose of Engerix B, on 3/25/05, the subject experienced tingling in the fingers of the injected arm and an injection site reaction characterized as a red lump that was warm to touch. The subject was diagnosed with anaphylactic reaction and was treated with an unspecified antibiotic. The events resolved on 4/3/05. The nurse considered the events to be related to vaccination with Engerix B. Comment: Anaphylactic reaction was assessed as medically serious (OMIC).
Age: 1.53
Sex: M
Vaccine: HEP
Symptoms: Autism, Medication error
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of autism in a 2 year old male subject who was vaccinated with hepatitis B vaccination recombinant for prophylaxis. On an unspecified date after 8/21/02 and before 10/02, the subject received a dose of diphtheria, tetanus and acellular pertussis vaccine as the first dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in October 2002, the subject received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (lot DTPA572A2) as the second dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in February 2002, the subject received a dose of Infanrix (DTPA576A2) as the third dose in the diphtheria, tetanus and acellular pertussis vaccination series. This is longer than the recommended interval of four to eight weeks between the second and third doses of Infanrix. On an unspecified date in February 2003, the subject received a dose of Infanrix (lot DTPA583A2) as the fourth dose in the diphtheria, tetanus and acellular pertussis vaccination series. On 9/22/03, the subject received the first dose of Engerix B (lot 53882 - incorrect lot number). On 3/1/04, the subject received the second dose of Engerix B (lot 55282 - incorrect lot number). This is longer than the recommended interval of one month between the first and second doses of Engerix B. On unspecified date before 5/26/05, the subject also received injections of 7-valent pneumococcal conjugate vaccine and Haemophilus influenzae type B conjugate vaccine. On an unspecified date in 2005 on or before 5/26/05, the subject was diagnosed with autism. The outcome of the autism was not reported. Comment: Autism was assessed as medically serious (OMIC).
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Convulsion
Clinical narrative: Seizure
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Convulsion
Clinical narrative: Seizure
Age: 41.0
Sex: F
Vaccine: HEPA, MMR, MNQ
Symptoms: Dyspnoea, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: Patient called on 6/6/05 to report symptoms which started 6/3/05. States she had achiness, fatigue, and labored breathing which have resolved. Had fever which peaked at 100.9 and is now afebrile. Reports bumpy rash on back, face, scalp, and ears which is fading and a swollen pre-auricular node on left. No swelling, erythema, heat or pain at injection site.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: Itchy and redness on abdomen, trunk. Maculopapular type rash.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 23-MAY-1996 was vaccinated with a dose of varicella virus vaccine live (lot # 609287/0393B). Subsequently, on 06-DEC-1997, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074).
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 23-MAY-1996 was vaccinated with a dose of varicella virus vaccine live (lot # 609287/0393B). Subsequently, on 06-DEC-1997, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074).
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 26-JUN-1996 was vaccinated with a dose of varicella virus vaccine live (lot # 608657/0419B). Subsequently, on 06-JUN-1997, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01048, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074).
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 26-JUN-1995 was vaccinated with a dose of varicella virus vaccine live (lot # 608657/0419B). Subsequently, on 06-AUG-1997, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01049, WAES0409USA01050, WAES0409USA01048, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074).  No further informatio is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 09-SEP-1995 was vaccinated with a dose of varicella virus vaccine live (lot # 609287/0393B). Subsequently, on 13-DEC-1997, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01049, WAES0409USA01048, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074). Follow-up - Patient's DOB and age not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 09-AUG-1995 was vaccinated with a dose of varicella virus vaccine live (lot # 609283/0428B). Subsequently, on 06-DEC-1997, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01048, WAES0409USA01047, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074). No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 16-OCT-1995 was vaccinated with a dose of varicella virus vaccine live (lot # 609287/0393B). Subsequently, on 18-JUN-1997, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01048, WAES0409USA01046, WAES0409USA01047, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074).
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 24-MAY-1995 was vaccinated with a dose of varicella virus vaccine live (lot # 608319/0404B). Subsequently, on 18-DEC-1997, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, and WAES0409USA01074). No further informationis expected.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Insomnia, Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 12 month old female on 06-Oct-2004 at 4:30 pm was vaccinated IM in her right leg with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #648545/0271P). On 07-Oct-2004 at 8:00 am the patient developed a rash over her body with "round spots, raised somewhat", that was non-pruritic. The patient was very irritable, awakened earlier than normal and had a fever of 101 degrees F. It was reported that the patient's irritability lasted three days and the fever lasted one day. On 12-Oct-2004 the patient recovered from the rash. It was reported that the rash "had gradually faded". Unspecified medical attention was sought. The patient was treated with acetaminophen (TYLENOL).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, OPV, VARCEL, VARCEL
Symptoms: Blister, Cough, Erythema, Pyrexia, Rash papular
Clinical narrative: Information has been received from a health care worker concerning a 8 year old male who on 08/31/1999 was vaccinated with a dose of varicella virus vaccine live. The healthcare worker reported that on 02/03/2005 the pt developed chickenpox. Unspecified medical attention was sought and at the time of this report, the pt's chicken pox persisted. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, OPV, VARCEL, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health care worker concerning a 8 year old male who on 08/31/1999 was vaccinated with a dose of varicella virus vaccine live. The healthcare worker reported that on 02/03/2005 the pt developed chickenpox. Unspecified medical attention was sought and at the time of this report, the pt's chicken pox persisted. Additional information has been requested.
Age: 1.97
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature increased, Cough, Drug ineffective, Headache, Rhinorrhoea
Clinical narrative: Information has been received from a RN concerning a 5 year old white male who on 05/20/2001 was vaccinated with a first dose of varicella virus vaccine. On 02/22/2005 the pt developed lesions on his body numbering 8 that was preceded by a HA and low grade fever. At the same time, the pt developed sinusitis, a cough, and the sniffles. On 02/28/2005 the pt was treated with amoxicillin. At the time of the report it was not known if th pt had recovered. Additional information is not expected.
Age: 1.97
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Sinusitis, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 5 year old white male who on 05/20/2001 was vaccinated with a first dose of varicella virus vaccine. On 02/22/2005 the pt developed lesions on his body numbering 8 that was preceded by a HA and low grade fever. At the same time, the pt developed sinusitis, a cough, and the sniffles. On 02/28/2005 the pt was treated with amoxicillin. At the time of the report it was not known if th pt had recovered. Additional information is not expected.
Age: 1.97
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 5 year old white male who on 05/20/2001 was vaccinated with a first dose of varicella virus vaccine. On 02/22/2005 the pt developed lesions on his body numbering 8 that was preceded by a HA and low grade fever. At the same time, the pt developed sinusitis, a cough, and the sniffles. On 02/28/2005 the pt was treated with amoxicillin. At the time of the report it was not known if th pt had recovered. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male who was vaccinated SQ with a 0.5ml dose of varicella virus vaccine live when he was 12 months old. On approximately 02/21/2005 the pt presented to the office with chickenpox lesions. Unspecified medical attention was sought. There was no product quality complaint. Additonal information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2005.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who at 12 months old, was vaccinated with a dose of varicella virus vacciene live. Subsequently, the pt experienced chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Additonal information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old white male with no pre-existing allergies, birth defects, or medical conditions who on 08/16/1996 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There was no concomitant medication.  Subsequently the patient developed approximately 20-30 apparent pox lesions per telephone report from the mother.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccination.  The outcome was reported as recovered.  It was also noted that the patient's brother developed varicella after vaccination with varicella virus vaccine live.  No additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old white male with no medical history who on 08/16/1996 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There was no concomitant medication.  Subsequently the patient developed approximately 20-30 pox lesions after his brother with the same symptoms.  There were no relevant diagnostic tests or laboratory data.  The outcome was reported as recovered.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a male patient who, at 4 years old, was vaccinated with a dose of varicella virus vaccine live.  Subsequently, at 7 years old, the patient developed 200 chickenpox lesions.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Injection site erythema, Pyrexia, Rash papular, Swelling
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies who on 02/14/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included a dose of HIB conj-hepatitis B vaccine (MSD) administered in the same thigh and a dose of pneumococcal 4  (prevnar) administered in the other thigh.  On 02/16/2005, the patient experienced a red area with papules at the injection site.  He was seen on 02/28/2005 with a hard, red, swollen area with papules on it and a temperature of 100 degrees at home, 98.5 degrees in the office.  No treatment was required.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.