chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 6-month-old subject of unspecified gender who was vaccinated with Rotavirus vaccine (manufacturer unspecified). DTaP vaccine, Hepatitis B vaccine, Hib vaccine, PCV7 vaccine (non-gsk) and IPV (non-gsk). Concurrent medical conditions included febrile illness. On an unspecified date, the subject received an unspecified dose of Rotavirus vaccine (route unknown, batch number not provided), an unspecified dose of DTaP vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided), an unspecified dose of PCV7 (NON-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 5 days after vaccination with DTaP vaccine, Hepatitis B vaccine, Hib vaccine, PCV7 vaccine (NON-GSK), IPV (Non-GSK) and Rotavirus vaccine, the subject experienced acute disseminated encephalomyelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A: same literature article.  Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 17.0
Sex: U
Vaccine: DTAP, HEPA, MEN
Symptoms: Meningitis aseptic
Clinical narrative: This case was reported in a literature article and described the occurrence of aseptic meningitis in a 17-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), Tdap and Meningococcal vaccine (non-gsk). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Tdap (administration site and route unknown, batch number not provided), and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). Less than 30 days after vaccination with Tdap, Hepatitis A vaccine and Meningococcal vaccine (Non-GSK), the subject experienced aseptic meningitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unrelated to vaccination with Hepatitis A vaccine, Tdap and Meningococcal vaccine (Non-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searched and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators review 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 16.0
Sex: U
Vaccine: HEPA, MEN, TDAP
Symptoms: Meningitis aseptic
Clinical narrative: This case was reported in a literature article and described the occurrence of aseptic meningitis in a 16-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTPA (with small D+ P) and meningococcal acwy vaccine (non-gsk). Concurrent medical conditions included allergies. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of DTPA (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). 18 hours after vaccination with DTPA (with small D + P), Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced aseptic meningitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unrelated to vaccination with Hepatitis A vaccine, DTPA (with small D + P) and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that he CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 64.0
Sex: U
Vaccine: TDAP
Symptoms: Acute disseminated encephalomyelitis, Encephalitis
Clinical narrative: This case was reported in a literature article and described the occurrence of encephalitis in a 64-year-old subject of unspecified gender who was vaccinated with tetanus toxoid, DTPa (with small D &P), (manufacturer unspecified). Concurrent medical conditions included high cholesterol and smoker. On an unspecified date, the subject received an unspecified dose of DTPa (with small D & P) (administration site and route unknown, batch number not provided). 3 days after vaccination with DTPa (with small D & P), the subject experienced encephalitis and acute disseminated encephalomyelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author considered the events were unlikely to be related to vaccination with DTPa (with small D & P). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 21.0
Sex: U
Vaccine: HPV2
Symptoms: Amyotrophic lateral sclerosis, Cervicobrachial syndrome, Guillain-Barre syndrome, Pharyngeal disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of amyotrophic lateral sclerosis in a 21-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). The subject's medical history included purpura fulminans and varicella. Concurrent medical conditions included hypothyroidism and motor developmental delay. On an unspecified date, the subject received an unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). 270 days after vaccination with HPV vaccine, the subject experienced amyotrophic lateral sclerosis and pharyngeal-cervical brachial variant Guillain Barre syndrome. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author considered the events were unlikely to be related to vaccination with HPV vaccine. This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 0.6
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Myelitis transverse
Clinical narrative: This case was reported in a literature article and described the occurrence of transverse myelitis in a 7-month-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified), Hib vaccine and PREVNAR (non-gsk). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of DTaP (administration site and route unknown, batch number not provided), an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of PREVNAR (NON-GSK) (unknown). 14 days after vaccination with DTaP, Hib vaccine and PREVNAR (NON-GSK), the subject experienced transverse myelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with DTaP, Hib vaccine and PREVNAR (NON-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 12.0
Sex: U
Vaccine: HEPA, MEN, TDAP
Symptoms: Demyelinating polyneuropathy
Clinical narrative: This case was reported in a literature article and described the occurrence of chronic inflammatory demyelinating polyneuropathy in a 12-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTPa (with small D + P) and meningococcal acwy vaccine (non-gsk). On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). Less than 21 days after vaccination with DTPA (with small D + P), Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced chronic inflammatory demyelinating polyneuropathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with Hepatitis A vaccine, DTPA (with small D + P) and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 13.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Myelitis transverse
Clinical narrative: This case was reported in a literature article and described the occurrence of transverse myelitis in a 13-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), varicella virus vaccine (non-gsk). Concurrent medical conditions included asthma, eczema and seasonal allergy. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 18 days after vaccination with Hepatitis A vaccine and Varicella virus vaccine (Non-GSK), the subject experienced transverse myelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with Hepatitis A vaccine and Varicella virus vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that he CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling to (R) thigh - 7cm x 10cm redness with 2cm x 2cm knot to area - area warm to touch & tender.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: C/o neck pain, body aches, lo grade temp 24 hours post immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Significant swelling, redness & blister formation that drained (L) lower thigh. Resolved over few days.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: Tdap administered on 8/10/11 to left deltoid. Employee states developed hives around injection site on 8/16/11. By 8/17/11 hives converged into one large erythematous indurated area approx 7.5cm in diameter.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Gaze palsy, Immediate post-injection reaction, Pallor, Petit mal epilepsy, Posture abnormal
Clinical narrative: Immediately following the administration of MCV & HPV vaccine child appeared to have petit mal seizure - eyes rolled back, pale skin tone, arched back, arms & legs extended. Child became coherent approximately 45-60 seconds after event commenced.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Vaccine positive rechallenge
Clinical narrative: Immediately following the administration of MCV & HPV vaccine child appeared to have petit mal seizure - eyes rolled back, pale skin tone, arched back, arms & legs extended. Child became coherent approximately 45-60 seconds after event commenced.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Nerve injury, Pain in extremity, Syringe issue
Clinical narrative: Patient was given shot a little high on arm - think may have nerve damage was stuck twice by pharmacist. First syr. did not dispense vaccine. Patient arm very sore 2 days after.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Pruritus generalised, Rash, Streptococcus test
Clinical narrative: Mom states when pt got home yesterday after shots started itching all over and rash developed. Gave BENADRYL. No allergy to eggs. Not on any other medications.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: (R) arm with welt {4" circular erythematous warm}.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on face for 2 days. Took BENADRYL.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Suicidal ideation
Clinical narrative: Evening of vaccine pt developed sx of depression that worsened for 1 week to include suicidal thoughts.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt felt like he was going to faint - may have fainted for a few seconds. Felt very lightheaded for the rest of day - felt fine the following day.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Full blood count normal, Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. presented in office 8/9/11, 1 day after receiving vaccines with c/o pain redness & swelling in injection site on left arm. Symptoms started that am. On examination pt had erythematous wheal with 5cm induration, that afternoon pt. had fever, increased 102 and continued next couple of days. Symptoms gradually got better over 1wk. Area of redness totalled 13 x 15 cm in area.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt. presented in office 8/9/11, 1 day after receiving vaccines with c/o pain redness & swelling in injection site on left arm. Symptoms started that am. On examination pt had erythematous wheal with 5cm induration, that afternoon pt. had fever, increased 102 and continued next couple of days. Symptoms gradually got better over 1wk. Area of redness totalled 13 x 15 cm in area.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Local swelling, Myalgia, Pyrexia
Clinical narrative: (L) area swelling & induration noticed on 8/17/11. Fever 101.4. Myalgia.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Full blood count, Local reaction, Myalgia, Pain
Clinical narrative: Local rxn 4 x 4 inches (L) arm rxn. Myalgia, fatigue (+), no fever, (+) glossitis,  (+) otalgia, (+) BOM on 8/17/11, (L) arm pain.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: C/o severe neck pain, nausea, h/a. Afebrile post immunization 36 hrs.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt's (R) arm at injection site became red - redness extended approximately 5" long & 2-3 " wide - red, warm & painful.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Pt returned to clinic 1 day after immunizations (8-16) with fever as high as 103.9. Swollen (L) thigh, firm (R) thigh at site of immunizations. Pt returned for recheck on 8-17 fever high of 101.6, swelling was improved at thighs.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Erythematous rash on bil arms.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness 6 hrs. after administration.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness several hrs. after administration. Started very soon after injection.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness hrs. after administration. Soreness lasting still to present (8-18-11 at 5:30pm).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness several hrs after administration.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema
Clinical narrative: Large erythematic area (9cm x 20cm) on (R) upper lateral arm. Treated with 7 days of LEVAQUIN 500mg. Too follow in one week or sooner if necessary.
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous, Viral infection
Clinical narrative: Father states noted fine red rash on trunk - front & back - in evening same day of shots. Cont next day with some rash on arms & fever of 101. Seen by PCP 8-12-11 (2 days after shots) Dr diagnosed prob. viral illness unrelated to shots. Child was also more fussy than usual - no apparent itching. Rash & fever gone by 8-14-11. As of 8-18-11 no further sx.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Malaise, Nausea, Pyrexia, Sinusitis, Vomiting
Clinical narrative: 8-5-11 to present running fever up to 104 degrees F. Excessive malaise, nausea & vomiting with activity. Dr. visit 8-16-11 with diagnosis of sinus infection, put on Z-pack, continues to have N/V today. Enc. mother to take to Dr. again. Has had 20lb wt loss since vaccination.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Weight decreased
Clinical narrative: 8-5-11 to present running fever up to 104 degrees F. Excessive malaise, nausea & vomiting with activity. Dr. visit 8-16-11 with diagnosis of sinus infection, put on Z-pack, continues to have N/V today. Enc. mother to take to Dr. again. Has had 20lb wt loss since vaccination.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hypersomnia, Lethargy, Nausea, Pyrexia, Sluggishness
Clinical narrative: 8-5-11 to present running fever up to 104 degrees F. Excessive malaise, nausea & vomiting with activity. Dr. visit 8-16-11 with diagnosis of sinus infection, put on Z-pack, continues to have N/V today. Enc. mother to take to Dr. again. Has had 20lb wt loss since vaccination.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: 8-5-11 to present running fever up to 104 degrees F. Excessive malaise, nausea & vomiting with activity. Dr. visit 8-16-11 with diagnosis of sinus infection, put on Z-pack, continues to have N/V today. Enc. mother to take to Dr. again. Has had 20lb wt loss since vaccination.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling face
Clinical narrative: Woke at 3am with facial swelling. Parent gave BENADRYL with reduction of swelling. No difficulty or obstruction to breathing. 8/18/11 still has swelling but decreasing in amount.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute lymphocytic leukaemia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute lymphocytic leukaemia, Anisocytosis, Asthenia, B-cell type acute leukaemia, Blood glucose increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lactate dehydrogenase increased, Blood phosphorus normal, Blood potassium decreased, Blood smear test abnormal, Blood uric acid increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Constipation, Decreased appetite, Emotional distress, Glossodynia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hyperglycaemia, Hypochromasia, Intensive care
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test abnormal, Lymphocyte percentage increased, Monocyte percentage decreased, Myelocyte percentage increased, Nasal congestion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neutrophil percentage decreased, Packed red blood cell transfusion, Pallor, Petechiae, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.