chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest pain, Electrocardiogram ST segment elevation, General symptom, Laboratory test normal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pericardial rub, Rash maculo-papular, Troponin
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Extrasystoles, Full blood count normal, General symptom
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Liver function test normal, Metabolic function test normal, Middle insomnia, Mitral valve incompetence
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Palpitations, Pericarditis, Pleural effusion, Rash, Rash erythematous
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash maculo-papular, Rash pruritic, Red blood cell sedimentation rate normal, Sleep disorder, Tricuspid valve incompetence
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin normal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 426645-1. Primary Smallpox vaccine and Anthrax vaccines on 6/24/2011. No recent illness; PMH GERD off medication for several weeks. He reported a "normal take" to SPV site. The following history was obtained via electronic medical records and new patient questionaires: On 7/1/2011 (day 10) he noted a prurtic red bump like rash to his chest. On 7/3/2011 (day 12) he presented to nearby base ER complaining of this rash, and a non-descript headache with chest pain and shortness of breath x1 day. He reported being awakened from sleep with 5/10 sharp piercing constant left-substernal pressure-like chest pain that radiated into his back with sensation of heart beating out of chest and skipping (palpitations). This chest pain worsened with lying flat, exertion, coughing or deep breathing. His pain eased by sitting up and with positional changes. He denied any fever, GI/GU, musculoskeletal or neurological symptoms. His exam documented him to be in mild distress with a positive friction rub and pruritic maculopapular rash to chest area otherwise normal exam. He was initially treated with GI cocktail with worsening chest pain to 8/10, then TORADOL IM which improved his chest pain. Duration of shortness of breath sensation was 3 hours (O2 sats 99% RA); duration of chest pain from onset was 7 hours. He was admitted with diagnosis of acute pericarditis with nonspecific skin rash. On 7/21/2011 he remained pain and rash free with a normal exam (no friction rub or rash) and was cleared by cardiology for full duty and deployability. Maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with TORADOL dose in ED, sx's improved w/ learning forward.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Induration, Oedema peripheral
Clinical narrative: Childs right upper arm was red, swollen & warm to the touch from top of the deltoid down to just above the elbow. Symptoms were presented here approx. 24 hours after immunization. Mother states child was admitted to the hospital for cellulitis, and treated with IV antibiotics, followed by oral antibiotics.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Childs right upper arm was red, swollen & warm to the touch from top of the deltoid down to just above the elbow. Symptoms were presented here approx. 24 hours after immunization. Mother states child was admitted to the hospital for cellulitis, and treated with IV antibiotics, followed by oral antibiotics.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Alopecia, Arthralgia
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Constipation, Diarrhoea, Dizziness, Dysphonia
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Food allergy, Heart rate irregular, Irritability
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pain, Pruritus generalised, Rash, Temperature intolerance
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Ultrasound abdomen normal, Urticaria, Visual impairment
Clinical narrative: Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Age: 39.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Arthralgia, Chest pain, Electrocardiogram normal, Fatigue, Malaise
Clinical narrative: Chest pain, localized skin reaction, arthralgia, generalized malaise, fatigue and muscle ache.
Age: 39.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Myalgia, Skin reaction
Clinical narrative: Chest pain, localized skin reaction, arthralgia, generalized malaise, fatigue and muscle ache.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Patient's arm formed a knot at the injection site immediately after giving injection. Asked patient to stay & put ice at site, but he did not. Told him to put ice on it & get emergency help if any more rxn. occurs. Saw patient next day & reaction had subsided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Effusion, Erythema, Pain, Pruritus, Rash
Clinical narrative: Pt experience pruritus, pain, effusion, rash started second day after shingles vaccine injection left upper arm. Neg respiratory sx or angioedema. 9 x 6.5 cm mildly erythematic area mild effusion, warm to touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Pt experience pruritus, pain, effusion, rash started second day after shingles vaccine injection left upper arm. Neg respiratory sx or angioedema. 9 x 6.5 cm mildly erythematic area mild effusion, warm to touch.
Sex: F
Vaccine: HPV4
Symptoms: Mental retardation
Clinical narrative: Information has been received on a TV show from a reporter concerning the little daughter of a lady who on an unknown date, was vaccinated with a dose of GARDASIL (route, dose and lot number not reported). On an unknown date, the mother told to the reporter that her little daughter took the vaccine injection and she suffered from mental retardation thereafter. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. This is one of several reports received from the same source. Upon internal review, mental retardation was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colitis ulcerative, Food allergy, Migraine, Ovarian failure, Paraplegia
Clinical narrative: Information has been received from a company via a consumer who posted her daughter's experience on internet. The consumer reported that her daughter with a medical history of double pneumonia and finger laceration who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced ovarian failure, peripheral vision loss, ulcerative colitis, allergic to most food, goes in to shock frequently. She became paraplegic on occasions and had 24/7 migraines. The patient has had numerous ER visits since GARDASIL. Before the vaccination the patient was in the ER twice in her life. Once for double pneumonia and once when she cut her finger. Since vaccination, the patient was frequent fliers and her life was at risk daily from all the food allergies. The reporter stated her daughter's life and health had been destroyed by the vaccine. At the time of the report the outcomes of the events were unknown. Food allergies were considered to be life threatening by the reporter. Upon internal review, goes in to shock frequently, peripheral vision loss and paraplegic on occasions were determined to be other important medical events. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Quality of life decreased, Shock, Visual field defect
Clinical narrative: Information has been received from a company via a consumer who posted her daughter's experience on internet. The consumer reported that her daughter with a medical history of double pneumonia and finger laceration who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced ovarian failure, peripheral vision loss, ulcerative colitis, allergic to most food, goes in to shock frequently. She became paraplegic on occasions and had 24/7 migraines. The patient has had numerous ER visits since GARDASIL. Before the vaccination the patient was in the ER twice in her life. Once for double pneumonia and once when she cut her finger. Since vaccination, the patient was frequent fliers and her life was at risk daily from all the food allergies. The reporter stated her daughter's life and health had been destroyed by the vaccine. At the time of the report the outcomes of the events were unknown. Food allergies were considered to be life threatening by the reporter. Upon internal review, goes in to shock frequently, peripheral vision loss and paraplegic on occasions were determined to be other important medical events. No further information is available.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic shock, Pain, Swelling
Clinical narrative: Initial report was received 13 September 2011 from a health care professional. A cluster of an unknown number of employees had received FLUZONE (unspecified); lot number, route, site and dates of administration not reported. The employees complained of increased reactions following vaccination which included increased swelling, soreness and anaphylactic shock. According to the reporter, "one employee had to be taken by ambulance to the hospital. Approximately 6 of these episodes have happened". No additional information was provided at the time of the report. Outcomes were not reported. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Joint swelling
Clinical narrative: Initial report was received on 15 September 2011 from a health care professional. A 66-year-old male patient had received an intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number UH457AA on 13 September 2011 and two days later his right knee became red and swollen. He was evaluated by a physician and prescribed prednisone. Laboratory and diagnostic test data was reported as "none". Concurrent illness, concomitant medications and past medical history were reported as "none". Outcome was unknown. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Arthritis, Erythema
Clinical narrative: Initial report was received on 15 September 2011 from a health care professional. A 66-year-old male patient had received an intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number UH457AA on 13 September 2011 and two days later his right knee became red and swollen. He was evaluated by a physician and prescribed prednisone. Laboratory and diagnostic test data was reported as "none". Concurrent illness, concomitant medications and past medical history were reported as "none". Outcome was unknown. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccines during visit 9/15/11. Noticed arm swelling, redness, heat at vaccine site 24 hrs later (R) arm. Pt seen in ER & given KEFLEX & BACTRIM DS. Dx with cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Respiratory tract congestion, Vomiting, Wheezing
Clinical narrative: Cough/congestion/wheezing/vomiting (seen in ER).
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: Fever 102 F, chills, later on at night some rapid heartbeat which dissipated after an hour or so.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Culture throat negative, Diarrhoea, Nausea, Sinusitis, Streptococcus test
Clinical narrative: Nurse spoke to dad 9-14-11 at 7:20 PM, child given first dose of Omnicef at 3:10p. Vomiting & loose stool began at 5:30pm and another episode at 7p. Was advised to withhold dose until next day. Nurse spoke to mom at ~1:00pm on 9-15-11 who reported that he had a large episode of diarrhea shortly after Omnicef dose given, no diarrhea, and now experiencing nausea. He had Omnicef in the past, the last time having GI symptoms at the end of the course of treatment, she did not report the symptoms. She requested a new antibiotic. Zithromax was called to the pharmacy. Patient seen on 9-17-11 with dad, who reported that both parents started noticing tics the evening of 9-14-11 that coninue at 9-17 visit.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test negative, Tic, Vomiting
Clinical narrative: Nurse spoke to dad 9-14-11 at 7:20 PM, child given first dose of Omnicef at 3:10p. Vomiting & loose stool began at 5:30pm and another episode at 7p. Was advised to withhold dose until next day. Nurse spoke to mom at ~1:00pm on 9-15-11 who reported that he had a large episode of diarrhea shortly after Omnicef dose given, no diarrhea, and now experiencing nausea. He had Omnicef in the past, the last time having GI symptoms at the end of the course of treatment, she did not report the symptoms. She requested a new antibiotic. Zithromax was called to the pharmacy. Patient seen on 9-17-11 with dad, who reported that both parents started noticing tics the evening of 9-14-11 that coninue at 9-17 visit.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cyanosis, Hypersensitivity, Loss of consciousness
Clinical narrative: PATIENT'S MOTHER REFERS THAT ABOUT 2 TO 3 HOURS AFTER VACCINATION THE BOY WAS TAKING A BATH AND THE MOTHER FOUND HIM CYANOTIC AND LOST CONSCIOUSNESS. SHE TOOK HIM TO EMERGENCY ROOM.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling hot, Flushing, Throat tightness
Clinical narrative: Within 5 minutes of getting vaccine, reported feeling flushed and warm.  B/P 200/80.  Within minutes complained of tightness in throat.  Was taken via ambulance to local hospital.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Reported to employee health that she had red raised area on left thigh where vaccine was given, complainied of hot, painful. Instructed to watch. She later sought treatment by emergency MD that prescribed clindamycin for "cellulitis" at vaccine site.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dermatitis infected, Urticaria
Clinical narrative: Hives (itchy, small round bumps) appeared at upper inner thigh area. Each day for the next four days more hives appeared, spreading down legs past the knees and up the torso to waist line, with a few single bumps appearing on upper arms, ankles, arm pits, and shoulder blades. Hives are still present, but being controlled by Claritin (AM), Benadryl (PM), and Betamethasone Dipropionate cream (.05%) because I cannot take Prednisone.  Also taking Cephalexin 25 MG as some appear to be infected.
Age: 30.0
Sex: F
Vaccine: FLU3, HEPAB, HPV4
Symptoms: Injection site erythema, Lip swelling, Pruritus, Urticaria
Clinical narrative: Patient broke out in hives with localized redness to right arm (where vaccination was administered).  Patient had mild lip swelling, without difficulty breathing.  Pt stated that she was very "itchy."  Symptoms alleviated with administration of 50mg IM Benadryl at injection site (approximately 30 minutes from administration of vaccination).
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Abdominal pain, Blood culture, Blood test, Diarrhoea, Fatigue
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Abdominal pain, Blood amylase, Blood creatine phosphokinase, Blood culture, Chills
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Diarrhoea, Differential white blood cell count, Ear pain, Full blood count, Headache
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Lipase, Metabolic function test, Nausea, Pyrexia, Urine analysis
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 73.0
Sex: F
Vaccine: TYP, HEPA, TYP
Symptoms: Vomiting
Clinical narrative: She took the live oral Typhoid vaccine (Vivotif) at home in 3 doses (did not take the 4th due to the severe side effects) Fever up to 102, nausea, vomiting, abdominal pain, diarrhea, headache, severe fatigue all still ongoing after 2 weeks.
Age: 60.0
Sex: M
Vaccine: PNC
Symptoms: Cholecystectomy, Intestinal obstruction
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a bowel obstruction and cholecystectomy. Vaccination took place on 06/13/2007. According to physician, the relationship is none. We would be happy to fax you the study's SAE report. Fax requests to Jen at 612.625.0080. ID G105056.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Generalized itchy rash on abdomen, legs and arms. Benadryl po.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Ataxia, Lumbar puncture normal, Nuclear magnetic resonance imaging abnormal, Vomiting
Clinical narrative: Ataxia and vomiting after bath
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site discomfort, Injection site erythema
Clinical narrative: Upper left arm was red & swollen and had a lot of pain & discomfort, especially at night. Felt very weak & tired 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for antibiotic clindamycin. Follow up with Dr. on 9/19/2011. Hospital diagnosis: cellulitis.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Upper left arm was red & swollen and had a lot of pain & discomfort, especially at night. Felt very weak & tired 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for antibiotic clindamycin. Follow up with Dr. on 9/19/2011. Hospital diagnosis: cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site discomfort, Injection site erythema
Clinical narrative: Upper left arm was red & swollen & had a lot of pain & discomfort. Difficult to sleep. Felt very weak & tired from 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for BACTRIM DS 800mg & KEFLEX 500mg for 10 days.  Follow up with Dr. on 9/15/2011. Hospital diagnosis: cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Upper left arm was red & swollen & had a lot of pain & discomfort. Difficult to sleep. Felt very weak & tired from 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for BACTRIM DS 800mg & KEFLEX 500mg for 10 days.  Follow up with Dr. on 9/15/2011. Hospital diagnosis: cellulitis.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling of upper arm (at site of injection) from elbow to shoulder- warm to touch pt seen by MD who prescribed antibiotic.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant reporting on her mother in law a 73 year old female patient who in September 2010 "a year ago", was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). It was reported that the patient sought medical attention by seeing the physician who performed physical examination. The medical assistant stated that after her mother-in-law received the ZOSTAVAX (Merck) she suffered a case of shingles (date unspecified) which caused her to be admitted in the hospital. The medical assistant mentioned that she was not certain how long her mother-in-law was in the hospital, but her mother-in-law had recovered completely on an unspecified date. Additional information has been requested.
Age: 0.13
Sex: F
Vaccine: DTAPIPV, HIBV, RV5
Symptoms: Computerised tomogram, Condition aggravated, Dandy-Walker syndrome, Device malfunction, Hydrocephalus
Clinical narrative: Information has been received from a consumer concerning her 2 month old daughter with no known drug allergies who in approximately OCT-2010 was vaccinated with ROTATEQ (dose, date unspecified) and PEDVAXHIB (dose, date and route unspecified) and a dose of DTAP-IPV (dose, date, manufacturer unspecified). On 29-DEC-2010 the patient was diagnosed with Dandy Walker Syndrome which caused the patient to experience hydrocephaly and she was hospitalized. While hospitalized the consumer reported her daughter had surgery to place a ventricular-peritoneal shunt. The consumer reported that her daughter was hospitalized a second time to have a new shunt placed because the first shunt malfunctioned. The consumer reported that her daughter was currently recovering and was stable. The primary reporter considered the Dandy Walker Syndrome to be an other important medical event as well as immediately life-threatening. MRI and CAT scan were performed (results not reported). Additional information has been requested.
Age: 0.13
Sex: F
Vaccine: DTAPIPV, HIBV, RV5
Symptoms: Nuclear magnetic resonance imaging, Surgery, Ventriculo-peritoneal shunt
Clinical narrative: Information has been received from a consumer concerning her 2 month old daughter with no known drug allergies who in approximately OCT-2010 was vaccinated with ROTATEQ (dose, date unspecified) and PEDVAXHIB (dose, date and route unspecified) and a dose of DTAP-IPV (dose, date, manufacturer unspecified). On 29-DEC-2010 the patient was diagnosed with Dandy Walker Syndrome which caused the patient to experience hydrocephaly and she was hospitalized. While hospitalized the consumer reported her daughter had surgery to place a ventricular-peritoneal shunt. The consumer reported that her daughter was hospitalized a second time to have a new shunt placed because the first shunt malfunctioned. The consumer reported that her daughter was currently recovering and was stable. The primary reporter considered the Dandy Walker Syndrome to be an other important medical event as well as immediately life-threatening. MRI and CAT scan were performed (results not reported). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Mental retardation
Clinical narrative: Information has been received from a doctor of psychology concerning an unknown number of patients of unknown age and gender. The patient's relevant medical history, past drug therapy and concomitant medications were unknown. On an unknown dates, were vaccinated with unknown doses of GARDASIL with frequencies and for indications unknown (route, dose and lot number not reported). On an unknown date, the doctor of psychology reported that she heard a report on the news on 13-SEP-2011 in which the speaker mentioned that GARDASIL caused mental retardation. It was unknown if the patients sought medical attention and if there was any laboratory data. At the time of the report it was unknown if these patients continued on GARDASIL and the statuses of their mental retardation. This is one of several reports received from the same source. Upon internal review, mental retardation was determined to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Onset of symptoms 12-24h after vaccination of fever 102 degrees F, chills, rigors - swelling, erythema, pruritus at vaccination site progressively worsening - emergency room visit - treated with antibiotic.
Age: 7.0
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Unevaluable event
Clinical narrative: See hospital summary.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pallor
Clinical narrative: Pt. became weak and pale hours after receiving vaccine. Pt had ER visit & discharged same day. Talked with pt 9-19-11 and he is doing fine.
Sex: M
Vaccine: HPV4
Symptoms: Injection site reaction, Skin papilloma
Clinical narrative: GARDASIL given 7-15-11, patient returned today with a wart at the injection site. Cryofreeze was performed. (The wart appeared & started getting larger gradually over time).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema at site & surrounding about cm in diameter from injection site (+) warmth with erythema.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient developed left shoulder pain two hours after receiving injection. Continued with pain and decreased range of motion.
Age: 1.06
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever x 4 hours up to 103 with febrile seizure - 9 days after administration of MMR - Taken to ER - Physical exam normal - Fever down & released to home - Baby doing well.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Joint swelling, Rash, Urticaria
Clinical narrative: Rash, urticaria, joint swelling in hands and feet started about 12 hrs post vaccinations.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 09/17/2011 noticed reddened area on arm about 5 IN" in diameter at site of vaccination (right arm). Suggested take BENADRYL and contact her physician.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Has enlarged lymph node on clavicular area. C/O headache and fatigue (left side).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, 2-3" area of swelling, itching. Ice & BENADRYL
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abnormal behaviour, Loss of consciousness
Clinical narrative: Observed pt. nervous in clinic when receiving vaccines. Asked pt if he felt dizzy or lightheaded before leaving. Pt denied any problems. Advised pt with mother present to take it easy today and rest. Also to reread VIS forms given. Pt and mother verbalized understanding. Pt mother called at 1440 to clinic, spoke with nurse on phones. Pt mother stated to nurse on phone "when we got home he passed out and is acting weird". Mother stated he is awake and breathing. Mother was advised to call 911. Treatment unknown. Made phone call to pt. mother, no answer. Left message for mother to return call.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu vaccine administered in (L) arm on 9-8-11. Mom reports noticing on 9-9-11 redness, tenderness & swelling around it. Gave ibuprofen & BENADRYL x few days. On 9-15-11 mom checked and noticed redness no swelling. At OV on 9-16 area of redness 4" x 3", no induration, NT. Txed with KEFLEX.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient came to pharmacy 9/19/11 2:30 pm reporting redness & swelling & tenderness all around vaccinated arm. No fever, H.A. only little fatigue. Suggested to see doctor. Dr. advised about all other things to watch.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: On 9-15-11 pt was given a flu shot, and next day broke out with hives all over stomach, arms, legs. Dr. looked over and Rx'd prednisone, OTC BENADRYL.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus
Clinical narrative: Developed flushed feeling, itch without rash or difficulty breathing. Refused medical care.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Rhinorrhoea, Swollen tongue
Clinical narrative: Weird sensation in tongue felling like it was swelling. then had chills the next day w/ a running nose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Redness, hard tangerine size, slightly raised, hot to the touch. Pt used Benadryl topically.  Pt told to use Benadryl orally and if not better or worse then see MD.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: felt like she was burning up but temp was 98.0, arm hot at site and red, swollen and ache
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Muscle spasms, Muscular weakness
Clinical narrative: Extreme swelling at sight, leg cramps, neck muscle weakness. Pt was told to see MD.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red, swollen at site
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Musculoskeletal stiffness, Neck pain, Wheezing
Clinical narrative: Neck stiffness and pain that radiated to back and abdomen Wheezing started since 12:00 noon
Age: 44.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Throat irritation, Urticaria
Clinical narrative: Pt states she broke out in hives and her throat felt scratchy. Pt states went to hospital and given steroids, epinephrine, and Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: swollen and redness from shoulder to elbow
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Photophobia, Vomiting
Clinical narrative: Migraine headache, including sensitiviity to light, throwing up. Treated with Tylenol.  90% gone by 8am the next morning, 9/20/2011.