chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Off label use, Pyrexia, Septic shock
Clinical narrative: This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same for case numbers: 2011-11265, 2011-11267, 2011-11271, 2011-11272 and 2011-11371. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal  to 65 years who received TDAP vaccine 'off label' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off label' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 77-year-old male patient had received on the same date DTAP vaccine (manufacturer, lot number, route and site of administration not reported) and yellow fever vaccine ( manufacturer, lot number, route and site of administration not reported) and 2 days later presented with fever, nausea and generalized weakness. The patient was hospitalized for one week after vaccination and died 19 days after vaccination for multiorgan failure due to septic shock. Documents held by sender: None.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Multi-organ failure
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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 other searches. Causality assessment using the modified agency 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 77-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) of DTaP, INFLUENZA VACCINE and YELLOW FEVER VACCINE. The patient had a history of factor V leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. On an unknown date the patient developed multisystem organ failure 5 days after the vaccines. the causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Asthenia, Death, Drug administered to patient of inappropriate age, Multi-organ failure, Nausea
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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 other searches. Causality assessment using the modified agency 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 77-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) of DTaP, INFLUENZA VACCINE and YELLOW FEVER VACCINE. The patient had a history of factor V leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. On an unknown date the patient developed multisystem organ failure 5 days after the vaccines. the causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Off label use, Pyrexia, Septic shock
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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 other searches. Causality assessment using the modified agency 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 77-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) of DTaP, INFLUENZA VACCINE and YELLOW FEVER VACCINE. The patient had a history of factor V leiden deficiency, hyperlipidemia, diabetes, obesity and hypertension. On an unknown date the patient developed multisystem organ failure 5 days after the vaccines. the causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Grip strength decreased, Influenza like illness, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: Patient returns with severe pain in left arm and some numbness and tingling in hand.  States that it had steadily worsened over the past couple days.  Sent to urgent care for further eval and given Vicodin, Toradol per MD there.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Nausea, Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient returns with severe pain in left arm and some numbness and tingling in hand.  States that it had steadily worsened over the past couple days.  Sent to urgent care for further eval and given Vicodin, Toradol per MD there.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient returns with severe pain in left arm and some numbness and tingling in hand.  States that it had steadily worsened over the past couple days.  Sent to urgent care for further eval and given Vicodin, Toradol per MD there.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient returns with severe pain in left arm and some numbness and tingling in hand.  States that it had steadily worsened over the past couple days.  Sent to urgent care for further eval and given Vicodin, Toradol per MD there.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Human chorionic gonadotropin positive, Injection site rash, Maternal exposure during pregnancy, Rash
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female with no pertinent medical history and no drug reaction who on 07-OCT-2011 was vaccinated with first dose of VARIVAX (Merck) (lot# unspecified). There was no concomitant medication. The patient was found to be pregnant on 31-OCT-2011 by a urine pregnancy test. The date of last menstrual period was 15-SEP-2011. The estimated delivery is 21-JUN-2012. On 08-OCT-2011 (the day after received the vaccine), the patient developed a rash at the injection site and on her back. The patient sought medical attention by office visit. No treatment was given for her adverse events. At the time of reporting, the patient's outcome was unknown. Follow up information has been received which reported that the patient suffered a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Limb discomfort, Mobility decreased
Clinical narrative: On 11/27/11, patient came into the pharmacy stating she had arm discomfort, mobility impaired. She went to her MD 8-10 days after vaccination. MD thought it was from injection near a nerve. He referred her to a neurologist for further consultation and testing.
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine increased, Malaise, Renal disorder
Clinical narrative: Initial report received from a health care professional on 16 November 2011. A female patient (age not reported) received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on an unknown date. The patient has never had an adverse reaction to the flu vaccine and has received one previously. Her medical history and concomitant medications were not reported. The day after the vaccination the patient became very sick and was admitted to the hospital following laboratory testing which showed an elevated creatine. She was experiencing kidney problems and needed to go on steroids and chemotherapy as part of her treatment. She was currently in the hospital. The patient was being treated by an infectious disease doctor who stated that this was extremely rare. The outcome was not reported. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Apparent life threatening event, Asthenia, Cough, Disability, Drug administered to patient of inappropriate age
Clinical narrative: This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11267, 2011-11271, and 2011-11272. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received TDAP vaccine 'off label' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off label' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 77-year-old female patient had received DTAP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was diagnosed with generalized weakness and cough. The patient was not hospitalized but according to the report she had not recovered and the event was considered to be life threatening resulting in permanent disability. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Off label use
Clinical narrative: This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11267, 2011-11271, and 2011-11272. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received TDAP vaccine 'off label' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off label' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 77-year-old female patient had received DTAP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was diagnosed with generalized weakness and cough. The patient was not hospitalized but according to the report she had not recovered and the event was considered to be life threatening resulting in permanent disability. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident
Clinical narrative: Initial report was received on 10 November 2011 from a consumer who received the report from the patient. A female patient (age not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time after receiving the vaccine, experienced a stroke and was hospitalized for ten days (dates not reported). Treatments were not reported. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: HEP, IPV, PPV
Symptoms: Abscess bacterial
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. The reporter for this case is the same as for case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A six month-old patient (gender not reported) with a history of eczema had received on an unspecified date the following vaccines: IPV (manufacturer, lot number, route and site of administration not reported), HEP B (manufacturer, lot number, route and site of administration not reported) and PCV7 (manufacturer, lot number, route and site of administration not reported) and seven days later, developed a pyogenic abscess. The causality was assessed as probably related. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: None.
Age: 5.0
Sex: U
Vaccine: PNC13
Symptoms: Death, Pneumococcal infection
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A 5-year-old patient (gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient developed a Streptococcus pneumoniae infection and died. It is unknown if an autopsy was performed. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site streaking, Injection site vesicles
Clinical narrative: Initial report was received from a health care professional on 15 November 2011. An 11-year-old male patient with no reported past medical history had received on 11 November 2011 an intramuscular left arm injection of MENACTRA, lot number U4243AA and an intramuscular left arm injection of ADACEL, lot number U4137AA (sanofi pasteur ltd lot number C3990) and unspecified amount of time later, experienced injection site reaction of red, warm and tender to touch. The patient developed blisters around the site and a streak down the arm. The patient was diagnosed with cellulitis. Treatment included antibiotics. Concomitant medications were vitamins. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 15 November 2011. An 11-year-old male patient with no reported past medical history had received on 11 November 2011 an intramuscular left arm injection of MENACTRA, lot number U4243AA and an intramuscular left arm injection of ADACEL, lot number U4137AA (sanofi pasteur ltd lot number C3990) and unspecified amount of time later, experienced injection site reaction of red, warm and tender to touch. The patient developed blisters around the site and a streak down the arm. The patient was diagnosed with cellulitis. Treatment included antibiotics. Concomitant medications were vitamins. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Initial report was received from a health care professional on 15 November 2011. An 11-year-old male patient with no reported past medical history had received on 11 November 2011 an intramuscular left arm injection of MENACTRA, lot number U4243AA and an intramuscular left arm injection of ADACEL, lot number U4137AA (sanofi pasteur ltd lot number C3990) and unspecified amount of time later, experienced injection site reaction of red, warm and tender to touch. The patient developed blisters around the site and a streak down the arm. The patient was diagnosed with cellulitis. Treatment included antibiotics. Concomitant medications were vitamins. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Pharyngeal oedema
Clinical narrative: Initial report was received on 15 November 2011 from another manufacturer national service center (service request number 1-4616113286), who received the report from a health care professional. A male patient (age not reported) with an unreported past medical history had received a tetanus vaccine (manufacturer, lot number, route and site of administration were not reported) and a Penicillin injection (manufacturer not reported) on an unspecified date 30 years ago. His throat later swelled up (time to onset unspecified). Treatments were provided (unspecified). No further information was provided and at the time of the report. The patient's outcome was reported as recovered (date unspecified). Documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Pneumonia
Clinical narrative: Initial report received from a health care professional on 15 November 2011. This reporter also reported another adverse event, which was captured in case number 2010-02044. A male patient (age not reported) received the fourth injection of DTaP, manufacturer and lot number not reported, on 06 October 2006. Two months later, he developed pneumonia which was believed to be an adverse reaction to the vaccine by the patient's mother. The outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: PER
Symptoms: Cough, Pertussis
Clinical narrative: Initial report received from a lay press report on 14 November 2011. A female patient (age not reported) received an injection of PERTUSSIS VACCINE, manufacturer and lot number not reported, on an unknown date. On an unknown date the patient developed whooping cough which she contracted from a child with a "milder" form. The patient was immunized against whooping cough. The patient had an intense and body wracking cough. The outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Disturbance in attention, Feeling abnormal, Gait disturbance
Clinical narrative: Initial report received from a consumer on 15 November 2011. A male patient (age not reported) received an injection of FLUZONE, sanofi pasteur Inc. lot number U1905AA, on 28 October 2005. The patient had a history of hepatitis C and completed treatment with interferon. The patient had no other vaccines within 4 weeks of the FLUZONE. The next day after receiving the FLUZONE, the patient developed a strange feeling, and then developed rash, tongue swelling, difficulty in walking, hard to concentrate. Three days later the patient received an injection of PNEUMOVAX, manufacturer and lot number not reported. The day after the PNEUMOVAX, the patient's previous reactions of feeling strange and difficulty walking became worse. The patient was unable to move for 4 hours and then after the 4 hours was able to slowly move but had severe pain. The patient had joint pain and the sensation of burning feet. The patient had a diagnosis of neuropathy and has continued to worsen over the years. The outcome was reported as not recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Movement disorder, Neuropathy peripheral, Rash, Swollen tongue
Clinical narrative: Initial report received from a consumer on 15 November 2011. A male patient (age not reported) received an injection of FLUZONE, sanofi pasteur Inc. lot number U1905AA, on 28 October 2005. The patient had a history of hepatitis C and completed treatment with interferon. The patient had no other vaccines within 4 weeks of the FLUZONE. The next day after receiving the FLUZONE, the patient developed a strange feeling, and then developed rash, tongue swelling, difficulty in walking, hard to concentrate. Three days later the patient received an injection of PNEUMOVAX, manufacturer and lot number not reported. The day after the PNEUMOVAX, the patient's previous reactions of feeling strange and difficulty walking became worse. The patient was unable to move for 4 hours and then after the 4 hours was able to slowly move but had severe pain. The patient had joint pain and the sensation of burning feet. The patient had a diagnosis of neuropathy and has continued to worsen over the years. The outcome was reported as not recovered. Documents held by sender: None.
Age: 22.0
Sex: U
Vaccine: HEPA, TD, TYP, YF
Symptoms: Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. The reporter for this case is the same as for case numbers 2011-11217, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 22 year-old patient (gender not reported) with a history of asthma had received on an unspecified date YELLOW FEVER VACCINE (manufacturer, lot number, route and site of administration not reported), TYPHOID VACCINE (manufacturer, lot number, route and site of administration not reported), DIPHTHERIA AND TETANUS TOXOIDS (manufacturer, lot number, route and site of administration not reported) and HEP A (manufacturer, lot number, route and site of administration not reported) and one day later developed Yellow Fever viscerotropic disease. The event was determined to be definitely related. No further information was available at the time of the report. The outcome was not reported. Documents held by sender: None.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Radiculitis brachial
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 6-month old infant (sex not reported) received an injection on an unknown date (route, site, manufacturer and lot number not reported) of DTaP. The patient had no medical history. On an unknown date the patient developed brachial neuritis 7 days after the vaccine. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Cerebellar ataxia
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. "Background: 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). Methods: 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. Results: 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 1.3-year-old patient (sex not reported) received the following injection on an unknown date (route, site, manufacturers and lot numbers not reported): DTaP, Hib VACCINE, HEP B, MMR, and VAR. The patient's medical history was reported as healthy. On an unknown date the patient developed cerebellar ataxia nine days after the vaccines. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 36.0
Sex: U
Vaccine: TD
Symptoms: Complex regional pain syndrome
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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 other searches. Causality assessment using the modified agency 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 36-year-old patient (sex not reported) received an injection (route and site not reported) of Td toxoids, manufacturer and lot number not reported, on an unknown date. The patient had a history of obesity. On an unknown date, the patient developed complex regional pain syndrome less than one day after the vaccine. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Fontanelle bulging, Irritability
Clinical narrative: This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: 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). Methods: 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. Results: 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 other searches. Causality assessment using the modified agency 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. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". An infant (age reported as 0.3 y) had received on an unspecified date the following vaccines: DTaP (manufacturer, lot number, route and site of administration not reported), Hib vaccine (manufacturer, lot number, route and site of administration not reported), IPV (manufacturer, lot number, route and site of administration not reported), HepB (manufacturer, lot number, route and site of administration not reported), PCV7 (manufacturer, lot number, route and site of administration not reported) and Rotavirus (manufacturer, lot number, route and site of administration not reported) and 0.3 days from vaccination, experienced a bulging fontanelle and was fussy. The causality was reported as possibly related. No further information was available at the time of the report. The outcome was not reported. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest pain, Cough, Diarrhoea, Dyskinesia
Clinical narrative: Injection 15 min Stomach cramps/diarrhea. Severe itching (not at injection site - opposite side) lasted 2 days,  terrible deep cough, hurting in chest, throat closing up, violent jerking. Called pharmacy to see if could take BENADRYL - took 1 25mg capsule. After jerking bad headache, fever 102 degrees lasted about 12 hrs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pruritus, Pyrexia, Throat tightness
Clinical narrative: Injection 15 min Stomach cramps/diarrhea. Severe itching (not at injection site - opposite side) lasted 2 days,  terrible deep cough, hurting in chest, throat closing up, violent jerking. Called pharmacy to see if could take BENADRYL - took 1 25mg capsule. After jerking bad headache, fever 102 degrees lasted about 12 hrs.
Age: 1.02
Sex: M
Vaccine: FLUX, MMR
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia, Rash
Clinical narrative: Little red dots started on face then everywhere turned into bad rash. Got worse over time. Went to doctor on 11/25/11 specified reaction to MMR recommended only a fever reducer. Had fever since beginning, also irritable, crying a lot, in a daze. As of last night getting better not as fussy.
Age: 1.02
Sex: M
Vaccine: FLUX, MMR
Symptoms: Rash erythematous
Clinical narrative: Little red dots started on face then everywhere turned into bad rash. Got worse over time. Went to doctor on 11/25/11 specified reaction to MMR recommended only a fever reducer. Had fever since beginning, also irritable, crying a lot, in a daze. As of last night getting better not as fussy.