chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: DTAP, HEPA, MEN
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
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, 2011-11230, 2011-11231, 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 12-year-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported): DTaP, MENINGOCOCCAL VACCINE and Hep A. The patient was healthy. On an unknown date the patient developed chronic inflammatory demyelinating polyneuropathy <21 days after vaccination. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Age: 0.6
Sex: U
Vaccine: DTAP, HIBV, PPV
Symptoms: Myelitis transverse
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, 2011-11230, 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 .6-year-old infant (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) of DTaP, Hib vaccine and PCV7. The patient was reported as healthy. On an unknown date the patient developed transverse myelitis 14 days after the vaccine. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Age: 54.0
Sex: U
Vaccine: FLUX
Symptoms: Diplegia
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, 2011-11230, 2011-11231, 2011-11232, 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 54-year-old patient (sex 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 had a history of elevated cholesterol, hypertension, and shrimp allergy. On an unknown date the patient developed facial diplegia 7 days after the vaccines. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Age: 74.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Acute polyneuropathy
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, 2011-11230, 2011-11231, 2011-11232, and 2011-11233. "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 or adverse health events following immunizations". A 74-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) INFLUENZA vaccine and PPSV. The patient had a medical history of chronic proctitis. On an unknown date the patient developed acute polyneuropathy 1 day after the vaccines. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Death, Drug administered to patient of inappropriate age, Dyspnoea, Interstitial lung disease, Pulmonary hypertension
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: 2011-11264, 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 66-year-old female had received DTAP vaccine (manufacture, lot number, route site and date of administration not reported) and two days after vaccination, presented with shortness of breath, which worsened in the following six weeks. The patient died two months after vaccination; the cause of death was indicated to be pulmonary hypertension due to acute interstitial lung disease.  Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, Guillain-Barre syndrome, 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, 2011-11271, 2011-11272 and 2011-11371. Verbatim form the abstract: "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. Objective: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than or equal to 65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. Methods: 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 coded 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. Results: 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. Conclusion: 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 data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 71-year-old male who had received Tdap (manufacturer, lot number route site and date of administration not reported) and PPV (manufacturer, lot number route site and date of administration not reported) and 34 days later had the onset of symptoms for GBS (Guillain Barre Syndrome). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Off label use, VIIth nerve paralysis
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, 2011-11272 and 2011-11371. Verbatim form the abstract: "Background: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (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. Objective: 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. Methods: 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. Results: 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. Conclusion: 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 data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 67-year-old female patient had received Tdap (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was diagnosed with Bells Palsy. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Encephalitis, 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 2011-11371. Verbatim form the abstract: "Background: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (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. Objective: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than or equal to 65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. Methods: 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 coded 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. Results: 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. Conclusion: 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 data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 70-year-old female patient had received Tdap (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced encephalitis. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction, Palpitations
Clinical narrative: Initial report received from a health care professional on 16 November 2011. A female patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number not reported, on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date and immediately after the vaccine, the patient developed shortness of breath, lightheadedness and pounding of the heart which persisted. The patient was seen by a physician. The outcome was reported as not recovered. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Decreased appetite, Fatigue, Pertussis
Clinical narrative: Initial report received from a consumer on 16 November 2011. A 31-year-old female patient received an intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number not reported, on an unknown date in May 2008. The patient denied any medical history or concomitant medications. She had no known allergies. The patient denied any illness at the time of vaccination. The patient may have possibly received hepatitis vaccine within 4 weeks prior to the ADACEL. In August-September 2011, the patient developed persistent dry cough, fatigue, loss of appetite, and weight loss of eleven pounds. The patient was informed by a nurse that she had pertussis. This was following a blood test that recently was drawn. The patient had been ill for three months. The outcome was reported as not recovered. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Weight decreased
Clinical narrative: Initial report received from a consumer on 16 November 2011. A 31-year-old female patient received an intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number not reported, on an unknown date in May 2008. The patient denied any medical history or concomitant medications. She had no known allergies. The patient denied any illness at the time of vaccination. The patient may have possibly received hepatitis vaccine within 4 weeks prior to the ADACEL. In August-September 2011, the patient developed persistent dry cough, fatigue, loss of appetite, and weight loss of eleven pounds. The patient was informed by a nurse that she had pertussis. This was following a blood test that recently was drawn. The patient had been ill for three months. The outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 17 November 2011. A female patient (age not reported) received an intramuscular injection (site not reported) of FLUZONE, sanofi pasteur Inc. lot number UT450AA, on an unknown date in October 2011. On an unknown date, the patient developed pain in the injection site, numbness and tingling in the arm for 5-7 days. The outcome was reported as unknown. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: FLUN3
Symptoms: Full blood count normal, Hypoaesthesia, Metabolic function test normal, Neurological examination normal, Vitamin B12 normal
Clinical narrative: Sensation of numbness in hands and feet.  Chronic since day after vaccine.  Currently still present.  Neuro exam is normal.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Blood glucose increased, Blood pressure increased, Electrocardiogram normal, Headache
Clinical narrative: Reported day after flu shot she started having memory loss, muscle aches and headache. Took Motrin, headache and muscle aches were relieved. Still complains of memory loss. Reported increased blood sugar, states she ran out of Rx for metformin and didn't take any until 10/24. Went to ER 10/24 pm and blood sugar and pressure was elevated. They did EKG that was normal, and told her problems were not caused by flu shot.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Reported day after flu shot she started having memory loss, muscle aches and headache. Took Motrin, headache and muscle aches were relieved. Still complains of memory loss. Reported increased blood sugar, states she ran out of Rx for metformin and didn't take any until 10/24. Went to ER 10/24 pm and blood sugar and pressure was elevated. They did EKG that was normal, and told her problems were not caused by flu shot.
Age: 46.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Erythema, Feeling hot, Induration, Pain of skin, Pyrexia
Clinical narrative: First noticed sore spot on scalp. This was an induration approximately 2.5 cm in diameter. By 6:45 PM had red welts across forehead similar to hives.  At 8:00 AM on 11/23/2011 had raised red area across forehead with swelling to left side of face and jaw.  Maintained fever of 100 while taking Tylenol.  Had warm sensation over left side of body. Pt. stated that symptoms were resolving slowly.
Age: 46.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: First noticed sore spot on scalp. This was an induration approximately 2.5 cm in diameter. By 6:45 PM had red welts across forehead similar to hives.  At 8:00 AM on 11/23/2011 had raised red area across forehead with swelling to left side of face and jaw.  Maintained fever of 100 while taking Tylenol.  Had warm sensation over left side of body. Pt. stated that symptoms were resolving slowly.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site warmth
Clinical narrative: REDNESS AND WARMTH AT INJECTION SITE. DIARRHEA.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood culture negative, C-reactive protein increased, Cellulitis
Clinical narrative: Pt developed pain, then erythema at the injection site.  This was followed by a fever 2 days later.  Size of Erythema was not observed by me but described as "upper arm." She was seen in ER 10/02/2011 and hospitalized for Cellulitis vs Vaccine Reaction.  Treated with antibiotics and supportive care. Discharged 10/04/2011.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Neutrophil percentage increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Pt developed pain, then erythema at the injection site.  This was followed by a fever 2 days later.  Size of Erythema was not observed by me but described as "upper arm." She was seen in ER 10/02/2011 and hospitalized for Cellulitis vs Vaccine Reaction.  Treated with antibiotics and supportive care. Discharged 10/04/2011.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: Pt developed pain, then erythema at the injection site.  This was followed by a fever 2 days later.  Size of Erythema was not observed by me but described as "upper arm." She was seen in ER 10/02/2011 and hospitalized for Cellulitis vs Vaccine Reaction.  Treated with antibiotics and supportive care. Discharged 10/04/2011.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Started with fever of 101, stuffy nose, sore throat, cough, nausea. Fever continued until Sunday, November 27, 2011. On Friday, November 25, 2011 at 7:00 PM she was covered from head to toe in a measles rash. Rash was completely gone by Sunday, November 27, 2011.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash morbilliform
Clinical narrative: Started with fever of 101, stuffy nose, sore throat, cough, nausea. Fever continued until Sunday, November 27, 2011. On Friday, November 25, 2011 at 7:00 PM she was covered from head to toe in a measles rash. Rash was completely gone by Sunday, November 27, 2011.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dyskinesia, Hypoaesthesia, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: Numbness in arm tingling extremities are blue and purple muscle spasms head jerks.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: Numbness in arm tingling extremities are blue and purple muscle spasms head jerks.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Chills, Cold sweat, Nausea
Clinical narrative: Stomach hurting, pale, clammy, nauseous, vomiting, chills, weak, vomiting.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Vomiting
Clinical narrative: Stomach hurting, pale, clammy, nauseous, vomiting, chills, weak, vomiting.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain in left leg following immunizations given the day before.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pruritus, Rash macular
Clinical narrative: Reports itching and slight headache.  Note pink blotching areas on forearms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Hives all over body, itchy and sore.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pain, Vomiting
Clinical narrative: Nausea, aching, flu like symptoms, vomiting diarrhea for two days.
Age: 59.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Pruritus generalised, Rash
Clinical narrative: Around 9 am 11/24/11 she started itching on her head and then her body. She thought it was dry skin and started to put lotion on and found bumps on her groin area, mid-drift and from her shoulders down to ther wrist.  She then took hydroxyzine 25 mg about 12:30 pm and this helped the itching and the bumps decreased in size and color.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Confusional state, Dysarthria, Headache, Malaise
Clinical narrative: Playful then c/o R leg tingling x 20 min, ate little for lunch @ 12:30, then c/o R sided mouth tingling, then R facial palsy/asymmetry confusion. Slurred speech, No headache. 1p Gave Ibuprofen; 2:30p C/o headache 3p naproxen; 'Not feeling well'. Ate small amount dressing/ potatoes. Laid down 30 min; 5p ibuprofen: HA increased; 6p home, started a movie. 6:30p emesis, then movie. Odansatron (Zofran) 7:10p headache >- to bed. Rest 5-10 min, but HA increasing. 7:30p ibuprofen; 7:40p emesis (full Ib tab thrown up). 8:15 head 2 ER. 9p in ER, exam & plan Migraine protocol HA 5/10. 9:15p IV in, HA 3/10, no upset stomach. 9:45p IV Benadryl, Toradol HA relief, c/o stomach pain, HR 100 10:05p emesis, then HR < 77.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Paraesthesia, Paraesthesia oral, VIIth nerve paralysis, Vomiting
Clinical narrative: Playful then c/o R leg tingling x 20 min, ate little for lunch @ 12:30, then c/o R sided mouth tingling, then R facial palsy/asymmetry confusion. Slurred speech, No headache. 1p Gave Ibuprofen; 2:30p C/o headache 3p naproxen; 'Not feeling well'. Ate small amount dressing/ potatoes. Laid down 30 min; 5p ibuprofen: HA increased; 6p home, started a movie. 6:30p emesis, then movie. Odansatron (Zofran) 7:10p headache >- to bed. Rest 5-10 min, but HA increasing. 7:30p ibuprofen; 7:40p emesis (full Ib tab thrown up). 8:15 head 2 ER. 9p in ER, exam & plan Migraine protocol HA 5/10. 9:15p IV in, HA 3/10, no upset stomach. 9:45p IV Benadryl, Toradol HA relief, c/o stomach pain, HR 100 10:05p emesis, then HR < 77.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspepsia, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Chills, fever, heartburn, redness, welt and soreness at injection site.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Chills, fever, heartburn, redness, welt and soreness at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, Hot, Swelling, hard around injection site. Received Flu vaccination on 9/7/2011.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swelling, hard at injection sight. Received pneumonia vaccination on 9/12/2011.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia, Paralysis, Weight bearing difficulty
Clinical narrative: Pt's father reports "paralysis" and that she was unable to bear weight on her legs.  She had a tingling in her feet and a gnawing pain in her left arm, left shoulder and left leg.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Red, warm to touch, painful, chills, itching, fever.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Red, warm to touch, painful, chills, itching, fever.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Injection site pain, Lacrimation increased, Pain
Clinical narrative: Swollen, red, high fever, headache, painful, running eyes and nose. Site painful to elbow around up to armpit.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: Swollen, red, high fever, headache, painful, running eyes and nose. Site painful to elbow around up to armpit.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Complaints of itching, swollen, red area.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling in both hands and both feet. Persisted for 2 weeks. Symptoms have returned. No treatment. I was not asked if I wished to receive the high dose vaccine and it was administered without my knowledge.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Red and blotchy, low grade fever ache, rash/hives all over body.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Red and blotchy, low grade fever ache, rash/hives all over body.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: CSF test, Chest X-ray, Dysphonia, Dyspnoea, Rhinorrhoea
Clinical narrative: Developed runny nose and hoarseness in throat as well as pressure in throat like her airway was "shutting off" and some S.O.B. No rash, itching, cough, or swelling of tongue or lips.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Developed runny nose and hoarseness in throat as well as pressure in throat like her airway was "shutting off" and some S.O.B. No rash, itching, cough, or swelling of tongue or lips.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gastric disorder, Injection site swelling, Urticaria, Vomiting
Clinical narrative: Covered in hives, vomiting, dizzy, stomach, site swelling.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Very tired, redness at site, swelling. Dr. prescribed antibiotics and a high dose of anti-inflammatory as well.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Severe pain left arm at site of injection radiating down arm to hand and up arm to neck.  Pain in linear distribution, worsened by moving arm or touching certain spots.  Maximum severity 2 hours after injection.  Has persisted with only slight improvement.
Age: 1.03
Sex: M
Vaccine: FLU3, PNC
Symptoms: Infection, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left Quadricep revealed an area of induration, erythema and warmth that measures 3cm in the vertical and 2cm in the horizonal.  Seems to withdraw on touching area.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Muscle tightness, Pain
Clinical narrative: I am aware that it is expected to have soreness at insertion site/ redness. However for 6 days I have had muscle tightness/ knots and soreness on my entire left side (my back up into my neck). I have been taking ibuprofen 800mg every 6 hrs with minimal relief.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Headache, Influenza virus test negative, Neck pain, Pyrexia
Clinical narrative: Severe head and neck pains, joint aches, vomiting, 3 day fever. On 11/17/11 had onset of face paralysis (Bells Palsy was diagnosed) that effected left side: brow, eyelid & blinking, nose and mouth.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis, Vomiting
Clinical narrative: Severe head and neck pains, joint aches, vomiting, 3 day fever. On 11/17/11 had onset of face paralysis (Bells Palsy was diagnosed) that effected left side: brow, eyelid & blinking, nose and mouth.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Muscle spasms
Clinical narrative: Severe Chills - Muscle cramps.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Activated partial thromboplastin time prolonged, Blood creatine phosphokinase increased, Blood creatinine increased, Blood fibrinogen decreased, Body temperature increased
Clinical narrative: Per records, patient was in 5 mile run and passed out--HR>180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cardioversion, Disseminated intravascular coagulation, Encephalopathy, Hepatic enzyme increased, Intensive care
Clinical narrative: Per records, patient was in 5 mile run and passed out--HR>180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Leukocytosis, Loss of consciousness, Pain, Prothrombin time prolonged, Renal failure
Clinical narrative: Per records, patient was in 5 mile run and passed out--HR>180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rhabdomyolysis, Thrombocytosis, Troponin I increased
Clinical narrative: Per records, patient was in 5 mile run and passed out--HR>180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Intense pain into shoulder, neck and arm. Prescribed pain meds, muscle relaxants when went to urgent care.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Smear cervix, Ultrasound scan
Clinical narrative: My daughter was given the Gardasil shot this year, she has stopped her period completely and has not recovered it. She had the last shot in October of 2011 and still no period so I got concerned and took her two different Dr.'s. My daughter has has two ultrasounds and a pap smear to see what is going on. I have her going to an actual OB/GYN and having her seen and see if there is a way to force her period other than medicines, we already have tried that. My daughter had healthy periods and was regular till she received the shot and I am upset and concerned because it wasn't written as a side affect. I have did research online and my daughter is not the only one, there are a number of females that has experienced the same thing and are also concerned.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Member states noticed bumps on hands and side on 27 Nov 2011.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Received both flu and pneumonia vaccinations in the right arm. The right arm ballooned up swelled up and warm to the touch. Went to urgent care. Dr. prescribed antibiotics.
Age: 83.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Very sore arm at injection site and the joint above.  The above continued for 8 to nine weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Pyrexia
Clinical narrative: Within seconds, the injection site started to itch.  Within about a half-hour, I developed a severe headache that has continued unabated for over five hours.  I have a slight fever as well - 2.5 degrees above normal for me.
Age: 66.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Eye pain, Headache, Joint swelling, Oedema peripheral
Clinical narrative: Left temporal headache and eye pain; then few days later: one episode of vertigo and "vibration" in head and 3 swollen pos left ear nodes. Severe hand, feet and ankle pain and swelling on 11/24, worse in AM; progressively subsiding every day since but not resolved yet.
Age: 66.0
Sex: F
Vaccine: MMRV
Symptoms: Pain in extremity, Vertigo, Vibratory sense increased
Clinical narrative: Left temporal headache and eye pain; then few days later: one episode of vertigo and "vibration" in head and 3 swollen pos left ear nodes. Severe hand, feet and ankle pain and swelling on 11/24, worse in AM; progressively subsiding every day since but not resolved yet.
Age: 27.0
Sex: F
Vaccine: SMALL, YF
Symptoms: Chest X-ray, Chest pain, Electrocardiogram abnormal, Sinus arrhythmia, Sinus bradycardia
Clinical narrative: Member states 3 days after vaccination, experienced chest pains throughout chest & back.  Continued for 3 days.  Member seen by Dr  on 11/28/2011.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Haematoma, Infection, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Right arm became very swollen, very painful and red and hot.  So painful that she could not move it. Next morning went to the doctor and was told the arm was severely infected and started on antibiotics. Stated she had a large hematoma as well.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Right arm became very swollen, very painful and red and hot.  So painful that she could not move it. Next morning went to the doctor and was told the arm was severely infected and started on antibiotics. Stated she had a large hematoma as well.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Chest pain. Took two tabs of Nitor, went to ER.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Felt SOB and tighness of chest. Went to Urgent Care.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Skin warm, Swelling
Clinical narrative: Swelling to area and heat generated. When went to hospital diagnosed with cellulitis.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Erythema, Headache
Clinical narrative: Headache, body aches, low temp, no energy, runny nose, sore throat, lack of appetite, red face. 1st flu shot.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Headache, body aches, low temp, no energy, runny nose, sore throat, lack of appetite, red face. 1st flu shot.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cough, Dyspepsia, Erythema, Headache
Clinical narrative: High fever ranging between 100.6 and 103.5, Severe muscle and joint aches, headache, severe tenderness and soreness at injection site on right arm, redness of arm appox 6 inches by 4 inches in size and swelling, nausea, indigestion, coughing developed on 11/25/2011, elevated white cell blood count; taking 500Mg Cephalexin 3 times per day, and methylprednisolone 4mg.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Nausea, Oedema peripheral, Pyrexia
Clinical narrative: High fever ranging between 100.6 and 103.5, Severe muscle and joint aches, headache, severe tenderness and soreness at injection site on right arm, redness of arm appox 6 inches by 4 inches in size and swelling, nausea, indigestion, coughing developed on 11/25/2011, elevated white cell blood count; taking 500Mg Cephalexin 3 times per day, and methylprednisolone 4mg.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: High fever ranging between 100.6 and 103.5, Severe muscle and joint aches, headache, severe tenderness and soreness at injection site on right arm, redness of arm appox 6 inches by 4 inches in size and swelling, nausea, indigestion, coughing developed on 11/25/2011, elevated white cell blood count; taking 500Mg Cephalexin 3 times per day, and methylprednisolone 4mg.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Pt experienced throat tightness and difficulty breathing within 1 hour after receiving flu vaccine. She took BENADRYL and symptoms resolved.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Loss of consciousness
Clinical narrative: Pt came very close to passing out was in and out of conscious thought/communication. Felt like she was "not here" & was very hot. EMS checked her vitals, BG = Fine.
Age: 1.24
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Convulsion, Erythema, External ear inflammation, Pyrexia
Clinical narrative: Fever 103 - seizure. ER visit 11/14/11. Left ear red. 11/18/11 physician visit. Follow up both ears inflamed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Pain in arm has not dissipated since receiving vaccine. Unable to lift using (R) arm. Experienced pain in every day activities and pain wakes me up at night.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Died of apparent SIDS.
Age: 1.05
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Please see attached office visit. 11-21-11 - PC from mom - child woke up this am with a red bumpy rash all over his body, arms, legs, trunk, even palms of hands and sole of feet - acting fine child had MMR, VZ flu 10 days ago. No available appt in office. Mom to take child to ER for eval.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Asthenia, Blood culture positive, Injection site erythema, Myalgia
Clinical narrative: Fever for 2 nights 102.6. Muscle aches, could not walk, hives, paleness, weakness, temperature of 99.7 for 11 days so far & 102.6 at night. Left arm redness at injection site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pallor, Pyrexia, Streptococcus test positive, Urticaria
Clinical narrative: Fever for 2 nights 102.6. Muscle aches, could not walk, hives, paleness, weakness, temperature of 99.7 for 11 days so far & 102.6 at night. Left arm redness at injection site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture positive, Chills, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: Fever for 2 nights 102.6. Muscle aches, could not walk, hives, paleness, weakness, temperature of 99.7 for 11 days so far & 102.6 at night. Left arm redness at injection site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Pyrexia, Streptococcus test positive, Tremor
Clinical narrative: Fever for 2 nights 102.6. Muscle aches, could not walk, hives, paleness, weakness, temperature of 99.7 for 11 days so far & 102.6 at night. Left arm redness at injection site.