chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAP
Symptoms: Autism
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 1 year old male subject who was vaccinated with Infanrix and Hep B vaccine (Engerix B) for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. There were no concurrent medications. On 6/27/02, the subject received the 1st dose of Infanrix. On 8/27/02 the subject received the 2nd dose of Infanrix. On unspecified dates the subject received the 1st and 3nd dose of Engerix B. The consumer reported that at about age 1 and one half years of age on an unspecified date in 2003, the subject began showing symptoms of autism. The subject was seen by a physician and was diagnosed with autism on an unspecified date in 2004. Diagnostic test included genetic testing which showed no abnormalities and mercury levels testing, performed on an unspecified date in April 2006, that had a value of 0.1 percent, indication that the subject was not excreting mercury from his body. The subject was treated with cynocobalamin (Vitamin B12), fish oil and brain Child vitamins. At the time of the initial reporting, 11/6/06, the consumer reported that the subject, has begun speaking more and his symptoms seem to be improving. Autism was assessed as medically serious by manufacturer (OMIC).
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Malaise, Swelling
Clinical narrative: At approximately 2:00 pm his arm started feeling bad, but he kept working in the yard until 7:00 pm at which time he went inside and took a shower. His arm was swollen and he started getting chills. Monday he was better, but today he still feels a headache and he can't sleep on his arm.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on left thigh, faint spots appearing on forehead and buttock, fever or 101 degrees - 102 degrees last night
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Red, knot with fever in it cm right deltoid where flu shot was given! 3.5 cm by 3.5 cm
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Site of injection was sore, red, feverish, bruised. Induration measured by nurse practioner x4.5 cm
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Site of injection was sore, red, feverish, bruised. Induration measured by nurse practioner x4.5 cm
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis of right arm after injection administered
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK, DTP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Erythema, Pruritus, Rash, Rash macular
Clinical narrative: A five year old female pt had received a fourth dose, left arm, SC injection of Ipol, Lot number Y1030, a first dose, SC injection of ProQuad, lot number 652681/1134R, and a fifth dose, left arm IM injection of Infanrix, lot number AC14B036AA, on 7/27/06. On the same day, the pt experienced severe itching on the palms and soles of her feet and had abdominal pain. it was noted that the pt was also very flushed. The pt turned red, and her fact became puffy. She had no difficulty breathing. The pt was treated with Benadryl and observed for one hour. After one hour, the pt was still flushed, but the discomfort had disappeared. A nurse considered the event to be an allergic reaction. Unspecified medical attention was sought. The pt recovered from the event. Recovery date was reported as 9/7/06. The reporter considered the reaction to be an important medical event (OMIC).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK, DTP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: A five year old female pt had received a fourth dose, left arm, SC injection of Ipol, Lot number Y1030, a first dose, SC injection of ProQuad, lot number 652681/1134R, and a fifth dose, left arm IM injection of Infanrix, lot number AC14B036AA, on 7/27/06. On the same day, the pt experienced severe itching on the palms and soles of her feet and had abdominal pain. it was noted that the pt was also very flushed. The pt turned red, and her fact became puffy. She had no difficulty breathing. The pt was treated with Benadryl and observed for one hour. After one hour, the pt was still flushed, but the discomfort had disappeared. A nurse considered the event to be an allergic reaction. Unspecified medical attention was sought. The pt recovered from the event. Recovery date was reported as 9/7/06. The reporter considered the reaction to be an important medical event (OMIC).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK, DTP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: A five year old female pt had received a fourth dose, left arm, SC injection of Ipol, Lot number Y1030, a first dose, SC injection of ProQuad, lot number 652681/1134R, and a fifth dose, left arm IM injection of Infanrix, lot number AC14B036AA, on 7/27/06. On the same day, the pt experienced severe itching on the palms and soles of her feet and had abdominal pain. it was noted that the pt was also very flushed. The pt turned red, and her fact became puffy. She had no difficulty breathing. The pt was treated with Benadryl and observed for one hour. After one hour, the pt was still flushed, but the discomfort had disappeared. A nurse considered the event to be an allergic reaction. Unspecified medical attention was sought. The pt recovered from the event. Recovery date was reported as 9/7/06. The reporter considered the reaction to be an important medical event (OMIC).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK, DTP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Abdominal pain, Discomfort, Erythema, Flushing, Hypersensitivity
Clinical narrative: A five year old female pt had received a fourth dose, left arm, SC injection of Ipol, Lot number Y1030, a first dose, SC injection of ProQuad, lot number 652681/1134R, and a fifth dose, left arm IM injection of Infanrix, lot number AC14B036AA, on 7/27/06. On the same day, the pt experienced severe itching on the palms and soles of her feet and had abdominal pain. it was noted that the pt was also very flushed. The pt turned red, and her fact became puffy. She had no difficulty breathing. The pt was treated with Benadryl and observed for one hour. After one hour, the pt was still flushed, but the discomfort had disappeared. A nurse considered the event to be an allergic reaction. Unspecified medical attention was sought. The pt recovered from the event. Recovery date was reported as 9/7/06. The reporter considered the reaction to be an important medical event (OMIC).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK, DTP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Pruritus, Swelling face
Clinical narrative: A five year old female pt had received a fourth dose, left arm, SC injection of Ipol, Lot number Y1030, a first dose, SC injection of ProQuad, lot number 652681/1134R, and a fifth dose, left arm IM injection of Infanrix, lot number AC14B036AA, on 7/27/06. On the same day, the pt experienced severe itching on the palms and soles of her feet and had abdominal pain. it was noted that the pt was also very flushed. The pt turned red, and her fact became puffy. She had no difficulty breathing. The pt was treated with Benadryl and observed for one hour. After one hour, the pt was still flushed, but the discomfort had disappeared. A nurse considered the event to be an allergic reaction. Unspecified medical attention was sought. The pt recovered from the event. Recovery date was reported as 9/7/06. The reporter considered the reaction to be an important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Pollakiuria, Thirst
Clinical narrative: Initial report received on 24 October 2006 from another manufacturer, report number WAES0609USA02106.  The initial reporter to this manufacturer was a health care professional.  A five-year old male patient, with a past medical history of wheezing, had received a fourth dose , subcutaneous injection of IPOL, lot number 1030 (not a valid manufacturer mentioned lot number); a first dose, subcutaneous injection of Pro Quad, lot number 652681/1134R; and a fourth dose, intramuscular injection of Infanrix, lot number AC14B036CA, on 26 July 2006.  There was no illness at the time of vaccination.  Forty-three days post-immunization, the patient experienced increased thirst, appetite and urination for one day.  The patient was diagnosed with diabetes and hospitalized for three days.  A urinalysis result was four plus glucose, and a fasting blood sugar was 259 with a home blood glucose machine.  The patient was discharged from the hospital and was to be seen by an endocrinologist.  The event was considered to be life threatening because "if the conditions was left untreated the patient could go into diabetic coma". The patient's diabetes was also considered to be disabling and an important medical event.  At the time of this report, the patient had not recovered. (OMIC)  02/01/2010 Patient was diagnosed with diabetes which is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus
Clinical narrative: Initial report received on 24 October 2006 from another manufacturer, report number WAES0609USA02106.  The initial reporter to this manufacturer was a health care professional.  A five-year old male patient, with a past medical history of wheezing, had received a fourth dose , subcutaneous injection of IPOL, lot number 1030 (not a valid manufacturer mentioned lot number); a first dose, subcutaneous injection of Pro Quad, lot number 652681/1134R; and a fourth dose, intramuscular injection of Infanrix, lot number AC14B036CA, on 26 July 2006.  There was no illness at the time of vaccination.  Forty-three days post-immunization, the patient experienced increased thirst, appetite and urination for one day.  The patient was diagnosed with diabetes and hospitalized for three days.  A urinalysis result was four plus glucose, and a fasting blood sugar was 259 with a home blood glucose machine.  The patient was discharged from the hospital and was to be seen by an endocrinologist.  The event was considered to be life threatening because "if the conditions was left untreated the patient could go into diabetic coma". The patient's diabetes was also considered to be disabling and an important medical event.  At the time of this report, the patient had not recovered. (OMIC)  02/01/2010 Patient was diagnosed with diabetes which is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Glucose urine, Increased appetite, Pollakiuria
Clinical narrative: Initial report received on 24 October 2006 from another manufacturer, report number WAES0609USA02106.  The initial reporter to this manufacturer was a health care professional.  A five-year old male patient, with a past medical history of wheezing, had received a fourth dose , subcutaneous injection of IPOL, lot number 1030 (not a valid manufacturer mentioned lot number); a first dose, subcutaneous injection of Pro Quad, lot number 652681/1134R; and a fourth dose, intramuscular injection of Infanrix, lot number AC14B036CA, on 26 July 2006.  There was no illness at the time of vaccination.  Forty-three days post-immunization, the patient experienced increased thirst, appetite and urination for one day.  The patient was diagnosed with diabetes and hospitalized for three days.  A urinalysis result was four plus glucose, and a fasting blood sugar was 259 with a home blood glucose machine.  The patient was discharged from the hospital and was to be seen by an endocrinologist.  The event was considered to be life threatening because "if the conditions was left untreated the patient could go into diabetic coma". The patient's diabetes was also considered to be disabling and an important medical event.  At the time of this report, the patient had not recovered. (OMIC)  02/01/2010 Patient was diagnosed with diabetes which is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Thirst, Urine analysis
Clinical narrative: Initial report received on 24 October 2006 from another manufacturer, report number WAES0609USA02106.  The initial reporter to this manufacturer was a health care professional.  A five-year old male patient, with a past medical history of wheezing, had received a fourth dose , subcutaneous injection of IPOL, lot number 1030 (not a valid manufacturer mentioned lot number); a first dose, subcutaneous injection of Pro Quad, lot number 652681/1134R; and a fourth dose, intramuscular injection of Infanrix, lot number AC14B036CA, on 26 July 2006.  There was no illness at the time of vaccination.  Forty-three days post-immunization, the patient experienced increased thirst, appetite and urination for one day.  The patient was diagnosed with diabetes and hospitalized for three days.  A urinalysis result was four plus glucose, and a fasting blood sugar was 259 with a home blood glucose machine.  The patient was discharged from the hospital and was to be seen by an endocrinologist.  The event was considered to be life threatening because "if the conditions was left untreated the patient could go into diabetic coma". The patient's diabetes was also considered to be disabling and an important medical event.  At the time of this report, the patient had not recovered. (OMIC)  02/01/2010 Patient was diagnosed with diabetes which is a life-long illness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Initial report received on 10/24/06 from another manufacturer,report number WAES0609USA03730, who had received the original report from a physician. A four year old female pt, with no current illnesses, pre existing allergies, birth defects or medical conditions, had received a fourth dose of Ipol, lot number 40991 (route and site of administration not reported), and a first dose, left arm, 0.5ml, SC injection of ProQuad, lot 6504040/0661F, on 9/6/06. Concomitant vaccine included a fifth dose, left deltoid, IM injection of Infanrix, lot number AC14A011AA. Two days post immunization, the pt experienced a large local reaction on the left arm. It was noted to have the look of red cellulitis and had a 7cm almost circumferential induration at the ProQuad site, mid humerus. The adverse experience did not involve the Infanrix vaccination site. Unspecified medical attention was sought and the pt was treated with Keflex. no relevant diagnostic or lab test were performed. Subsequently, the pt recovered three days later, on 9/11/06. Per the reporter, no product quality complaint was involved. The physician reported to the other manufacturer that the pt had received her first dose of ProQuad on 12/10/2003. The reporting physician considered the pts experience to be an other important medical event (OMIC). At the time of this report, additional information has been requested by the other manufacturer.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Initial report received on 10/24/06 from another manufacturer,report number WAES0609USA03730, who had received the original report from a physician. A four year old female pt, with no current illnesses, pre existing allergies, birth defects or medical conditions, had received a fourth dose of Ipol, lot number 40991 (route and site of administration not reported), and a first dose, left arm, 0.5ml, SC injection of ProQuad, lot 6504040/0661F, on 9/6/06. Concomitant vaccine included a fifth dose, left deltoid, IM injection of Infanrix, lot number AC14A011AA. Two days post immunization, the pt experienced a large local reaction on the left arm. It was noted to have the look of red cellulitis and had a 7cm almost circumferential induration at the ProQuad site, mid humerus. The adverse experience did not involve the Infanrix vaccination site. Unspecified medical attention was sought and the pt was treated with Keflex. no relevant diagnostic or lab test were performed. Subsequently, the pt recovered three days later, on 9/11/06. Per the reporter, no product quality complaint was involved. The physician reported to the other manufacturer that the pt had received her first dose of ProQuad on 12/10/2003. The reporting physician considered the pts experience to be an other important medical event (OMIC). At the time of this report, additional information has been requested by the other manufacturer.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intestinal ischaemia, Intussusception, Necrosis
Clinical narrative: A five month old female pt, with no current illnesses, past medical history, or allergies, had received a second dose of ActHib, lot number UE930AA (manufacturer lot # Z0580-2), a second dose of Ipol, lot number V1166, a second dose of Tripedia, lot number U1397AB, a second dose of Prevnar, lot number B08683E, and a second oral dose of Rotateq, lot number 653754/0139F, on 9/1/06. Sixteen days post immunization, on 9/17/06 at 8:34 am, the pt had an initial exam that showed bloody stools and intussusception, and was hospitalized for five days. The pt received a water soluble contrast enema. It was reported the pt recovered. The event required an ER visit and caused prolongation of hospitalization. Per the other manufacturer, additional information is not expected.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: A five month old female pt, with no current illnesses, past medical history, or allergies, had received a second dose of ActHib, lot number UE930AA (manufacturer lot # Z0580-2), a second dose of Ipol, lot number V1166, a second dose of Tripedia, lot number U1397AB, a second dose of Prevnar, lot number B08683E, and a second oral dose of Rotateq, lot number 653754/0139F, on 9/1/06. Sixteen days post immunization, on 9/17/06 at 8:34 am, the pt had an initial exam that showed bloody stools and intussusception, and was hospitalized for five days. The pt received a water soluble contrast enema. It was reported the pt recovered. The event required an ER visit and caused prolongation of hospitalization. Per the other manufacturer, additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Patient immediately felt pain down right arm, pain increased during afternoon.  Patient went to emergency room in evening and received morphine injection.  As of 11-7-2006 in evening symptoms are improving.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient on the same day (several hours later) vaccine was administered started having generalized seizures and fever.  Patient was admitted to Hospital for 7 days. Other diagnose: pneumonia.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Right arm swollen/erythema/headache 9 hours after vaccine given. Provider was not aware at vaccination time that patient had a history of lupus.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: 1410 Tetanus shot given shortly thereafter developed symptoms of light headiness, felt faint, pallor, diaphoresis, warmth, loss of consciousness approximately 2 seconds. Thought to be due to prior donation legs elevated. 200 cc juice given full recovery, vital signs normal at 1520.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Syncope
Clinical narrative: 1410 Tetanus shot given shortly thereafter developed symptoms of light headiness, felt faint, pallor, diaphoresis, warmth, loss of consciousness approximately 2 seconds. Thought to be due to prior donation legs elevated. 200 cc juice given full recovery, vital signs normal at 1520.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: On call doctor was called on 10/23/06 that the pt was brought to ER (hospital) and pt was dead already. History of diarrhea and vomiting.  11/14/06 Received medical records from PCP including med record from OB/GYN of mother which reveals Mom was 23yo, g4, p2 with PMH of gonorrhea & chlamydia, HSV I & II, Grp B strep.  Developed thrush on 8/25/06 visit & treated. On 10/17 date of vax visit weight was 12 lbs 9 oz, length 23, head 15.5.  Child was noted to be healthy at that time. 6/12/07 Received autopsy report which reveals COD as dehydration due to gastroenteritis & manner of death as natural.  Dehydration from severe diarrhea was contributing factor.  Parent reported patient had been vomiting along w/diarrhea since 10/21 (received vaccines on 10/17).  Parent also admitted to use of drugs (crank) up until her 5th month of pregnancy when prenatal care began.  Parent reported that allergy to formula may have been contributory as patient was on his 3rd type of formula.  Coroner investigation reveals no milk allergy was reported in pcp medical records.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: On call doctor was called on 10/23/06 that the pt was brought to ER (hospital) and pt was dead already. History of diarrhea and vomiting.  11/14/06 Received medical records from PCP including med record from OB/GYN of mother which reveals Mom was 23yo, g4, p2 with PMH of gonorrhea & chlamydia, HSV I & II, Grp B strep.  Developed thrush on 8/25/06 visit & treated. On 10/17 date of vax visit weight was 12 lbs 9 oz, length 23, head 15.5.  Child was noted to be healthy at that time. 6/12/07 Received autopsy report which reveals COD as dehydration due to gastroenteritis & manner of death as natural.  Dehydration from severe diarrhea was contributing factor.  Parent reported patient had been vomiting along w/diarrhea since 10/21 (received vaccines on 10/17).  Parent also admitted to use of drugs (crank) up until her 5th month of pregnancy when prenatal care began.  Parent reported that allergy to formula may have been contributory as patient was on his 3rd type of formula.  Coroner investigation reveals no milk allergy was reported in pcp medical records.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: On call doctor was called on 10/23/06 that the pt was brought to ER (hospital) and pt was dead already. History of diarrhea and vomiting.  11/14/06 Received medical records from PCP including med record from OB/GYN of mother which reveals Mom was 23yo, g4, p2 with PMH of gonorrhea & chlamydia, HSV I & II, Grp B strep.  Developed thrush on 8/25/06 visit & treated. On 10/17 date of vax visit weight was 12 lbs 9 oz, length 23, head 15.5.  Child was noted to be healthy at that time. 6/12/07 Received autopsy report which reveals COD as dehydration due to gastroenteritis & manner of death as natural.  Dehydration from severe diarrhea was contributing factor.  Parent reported patient had been vomiting along w/diarrhea since 10/21 (received vaccines on 10/17).  Parent also admitted to use of drugs (crank) up until her 5th month of pregnancy when prenatal care began.  Parent reported that allergy to formula may have been contributory as patient was on his 3rd type of formula.  Coroner investigation reveals no milk allergy was reported in pcp medical records.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Death about 2 days after 4 month vaccination, no apparent cause know. Autopsy pending.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Muscle atrophy, Paralysis, Tendinous contracture
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/25/06 from a health care professional. A three year old female pt had received a right thigh injection of Ipol, lot number W1582-2, on 11/9/05. Fourteen days post vaccination, the pt developed paralysis of the left lower leg calf area with progressive atrophy of the left leg and contracture of the Achilles tendon. No additional information was provided. At the time of this report, the pt had not recovered.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial report received on 10/26/06 from a health care professional. A 49 year old pt, with a history of asthma and allergy to penicillin, Keflex, Ceclor, Anaprox, Clindamycin, Vancomycin, and sulfa drugs, had received an IM injection of Fluzone SV 2006-2006, lot number U2199AA, on 10/26/06 at 14:35pm. The site and route of administration was not reported. Ten minutes post immunization, the pt experienced left side numbness from the lip to the ear that was progressing to the left eye. The pt denied any dysphagia or dyspnea. Diagnostic and treatments received were not reported. The reporter considered these adverse events as other medical important events (OMIC). The recovery of the pt is unk.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/27/06 from a health care professional. A 15 year old male pt, with no concurrent illnesses, and a history of reactive airways disease, and allergy to Sulfa drugs and Penicillin, had received a left arm, IM injection of Fluzone SV 2006-2007 USP, lot number U2257AA, on 10/25/2006 at 16:45pm. At approx 17:45pm, one hour post immunization, the pt went to the ER with generalized hives and shortness of breath. He was treated with Solu Medrol, Benadryl IV, and Albuterol nebulizer. Diagnost6ics performed were not reported. At the time of this report, the pt had recovered.
Age: 86.0
Sex: F
Vaccine: PPV, TD
Symptoms: Arthropathy, Hyperlipidaemia, Hypertension, Hypokalaemia, Hypothyroidism
Clinical narrative: Client c/o pain immediately following injection. Later called reporting swollen arm at injection site and pain, Ice pack and anti inflammatory suggested. Family says takes Tylenol. Later that night client c/o increased pain, edema, looked pale, so they took her to ER where she was admitted for infection. 12/19/06-records received and reviewed. DC Summary: DC DX: arthus reaction to repeat pneumovax hypokalemia Secondary diagnoses: hypertension hyperlipidemia hypothyroidism osteoporosis degenerative joint disease On admission had significant pain in right should at the administration site and a fluctuant soft tissue mass over the right deltoid and acromial area. Arthrocentesis into the subacromial space yielded 40cc of purulent cloudy fluid, joint space was not accessed. Fluid showed WBC 107,000 and a Gram stain without organism and 4+ WBC. This is a significant immunological reaction to repeat Pneumovax administration (previous doses 10/98 and 2005 and 10/23/06
Age: 86.0
Sex: F
Vaccine: PPV, TD
Symptoms: Infection, Injection site oedema, Injection site pain, Laboratory test abnormal, Osteoporosis
Clinical narrative: Client c/o pain immediately following injection. Later called reporting swollen arm at injection site and pain, Ice pack and anti inflammatory suggested. Family says takes Tylenol. Later that night client c/o increased pain, edema, looked pale, so they took her to ER where she was admitted for infection. 12/19/06-records received and reviewed. DC Summary: DC DX: arthus reaction to repeat pneumovax hypokalemia Secondary diagnoses: hypertension hyperlipidemia hypothyroidism osteoporosis degenerative joint disease On admission had significant pain in right should at the administration site and a fluctuant soft tissue mass over the right deltoid and acromial area. Arthrocentesis into the subacromial space yielded 40cc of purulent cloudy fluid, joint space was not accessed. Fluid showed WBC 107,000 and a Gram stain without organism and 4+ WBC. This is a significant immunological reaction to repeat Pneumovax administration (previous doses 10/98 and 2005 and 10/23/06
Age: 86.0
Sex: F
Vaccine: PPV, TD
Symptoms: Pallor, Type III immune complex mediated reaction, White blood cell disorder
Clinical narrative: Client c/o pain immediately following injection. Later called reporting swollen arm at injection site and pain, Ice pack and anti inflammatory suggested. Family says takes Tylenol. Later that night client c/o increased pain, edema, looked pale, so they took her to ER where she was admitted for infection. 12/19/06-records received and reviewed. DC Summary: DC DX: arthus reaction to repeat pneumovax hypokalemia Secondary diagnoses: hypertension hyperlipidemia hypothyroidism osteoporosis degenerative joint disease On admission had significant pain in right should at the administration site and a fluctuant soft tissue mass over the right deltoid and acromial area. Arthrocentesis into the subacromial space yielded 40cc of purulent cloudy fluid, joint space was not accessed. Fluid showed WBC 107,000 and a Gram stain without organism and 4+ WBC. This is a significant immunological reaction to repeat Pneumovax administration (previous doses 10/98 and 2005 and 10/23/06
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Accident, Back pain, Chest discomfort, Dizziness, Flushing
Clinical narrative: Pneumonia vaccine given on right deltoid then while discharge instructions were begin given, noted pt having flushed face, voiced dizzy, pressure on her chest, complaint of severe pain to pelvic area to the lower back, VS 174/74, P 85, RR20. Pt was calm and denied any other symptoms prior to vaccine. records received. DOS 10/15-10/19/06 Reason for admission: treament of left hip fracture. Fell at work, tripped over a cord.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Fracture, Hypoxia, Injury, Pelvic pain
Clinical narrative: Pneumonia vaccine given on right deltoid then while discharge instructions were begin given, noted pt having flushed face, voiced dizzy, pressure on her chest, complaint of severe pain to pelvic area to the lower back, VS 174/74, P 85, RR20. Pt was calm and denied any other symptoms prior to vaccine. records received. DOS 10/15-10/19/06 Reason for admission: treament of left hip fracture. Fell at work, tripped over a cord.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abscess
Clinical narrative: Abscess in falciform ligament requiring surgery x 2, 5 days after Rotateq. MR received from pediatrician reveals a 2 month well-baby exam of 8/31/06 with vax. given. Mom c/o infant spitting, gagging, gassines, straining and grunting. Phone record of call from mother of 8/12/06 as above but also c/o infants belly appearing bloated and harder than normal. PMH: Mother reports that birth mother had bacterial infection after giving birth.  Five days s/p vaccines mother reports no BM x 2 days, abdomen seems swollen, hard to touch.  Formula changed.  Six days s/p vaccines TC from mom  reporting continued constipation and fussiness as well as bruising and swelling around the umbilicus.  Refered to Emergency Dept. at local Hospital.   Hospital MR received revealing  a 2 month old admitted through the ER for c/o bluish discoloration around the umbilicus, purulent drainage, low grade fever, constipation and increased fussiness. Dx: Omphalitis tx'd with antibiotics.  Exploratory Lap was performed with D&E of abscess cavity.  Abscess of falciform ligament discovered.  Discharged 3 days later. ER visit 1 month later for recurrant abscess along the surgical incision.  Surgical exploration of the wound was performed where it was washed and packed with iodoform gauze and triple antibiotic ointment. Post-operative diagnosis: Stitch abscess along the surgical wound.  Later 4 month exam documents umbilical scar from surgery for abscess of the falciform ligament, as well as new onset of ptosis.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyloric stenosis, Vomiting
Clinical narrative: Pt developed pyloric stenosis 10/30/2006, vomiting, diarrhea.  MR received from pediatrician which included hospital H&P of 10/30/2006 and various diagnostics. Two month well baby visit of 10/26/2006 WNL with mother's c/o infant being "gassy" and constipated. Vax. including Rotateq given.  F/U exam on 10/30/2006 reveals multiple episodes (up to 20/day) of forceful vomiting and spitting up, as well as dehydration. Questionable olive-shaped mass in upper abdomen upon palpation.  Admitted to hospital with dx. of vomiting of bloody emesis and dehydration.  Surgery-pyloromyotomy on  10/31/06.  Discharge DX: 1) Pyloric Stenosis, s/p pyloromyotomy.  2) Rotavirus, acute gastroenteritis.  Second admission one week later for vomiting and GERD s/p pyloromyotomy.Feedings were resumed which the infant tolerated well and he was d/c'd with a  Discharge DX: Vomiting s/p pylorotomy, pylorospasm versus GERD.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Depressed level of consciousness, Disorientation, Hypersensitivity, Laboratory test abnormal
Clinical narrative: Pt passed out approx 5 min after vaccine administration, for about 1 minute. Felt well, returned to work at approx 30 mins after vaccine admin. didn't feel well and became disoriented. Had amnesia for next few hours until hospitalization. Was hospitalized x 24 hours and had w/u including MRI, Lab, Exam all neg. 12/8/06 Received medical records from hospital which reveal patient  had flu shot at work & became confused approx 2 hours s/p flu shot.  Patient had been ill & left work day before flu vax.  Was admitted to hospital 10/24/06 & remained overnight for observation.  Neuro consult done Final Dx: Acute mental status changes & increased bilirubin.  Allergy to flu shot.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Malaise, Vaccination complication
Clinical narrative: Pt passed out approx 5 min after vaccine administration, for about 1 minute. Felt well, returned to work at approx 30 mins after vaccine admin. didn't feel well and became disoriented. Had amnesia for next few hours until hospitalization. Was hospitalized x 24 hours and had w/u including MRI, Lab, Exam all neg. 12/8/06 Received medical records from hospital which reveal patient  had flu shot at work & became confused approx 2 hours s/p flu shot.  Patient had been ill & left work day before flu vax.  Was admitted to hospital 10/24/06 & remained overnight for observation.  Neuro consult done Final Dx: Acute mental status changes & increased bilirubin.  Allergy to flu shot.
Age: 24.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Myalgia
Clinical narrative: Pt received Td injection on Saturday November 4th .Pt presented 8 Nov with induration and erythema over right deltoid 40x45mm (golf ball size).  She states it was "twice as big on Monday" (6 Nov).  She states she felt burning pain over right deltoid approximately 1 hour after injection received.  She states swelling and readness with muscle pain peaked 48 hours later.  She also states she had "tiny blisters" over site. Blisters were not visible on 8 Nov.
Age: 24.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Thermal burn
Clinical narrative: Pt received Td injection on Saturday November 4th .Pt presented 8 Nov with induration and erythema over right deltoid 40x45mm (golf ball size).  She states it was "twice as big on Monday" (6 Nov).  She states she felt burning pain over right deltoid approximately 1 hour after injection received.  She states swelling and readness with muscle pain peaked 48 hours later.  She also states she had "tiny blisters" over site. Blisters were not visible on 8 Nov.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Sinus tachycardia
Clinical narrative: Progressive symmetric lower extremity motor weakness extending to the upper extremities (power 2/5 both upper and lower extremities) with gradual loss of deep tendon reflexes till they were absent. Clinical diagnosis of GUILLAIN-BARRE syndrome. Transferred to intensive care unit on 10/28/06. Did not require intubation. Developed autonomic dysfunction with variable blood pressure and intermittent sinus tachycardia. Started on plasmapheresis (total 6 sessions) on 10/28/06 and responded with recovery of motor strength.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria, Vomiting, Wheezing
Clinical narrative: 15 minutes after returning home the pt began vomiting followed by urticaria, wheeze and slight difficulty breathing.  Pt was immediately brought back to clinic and epinephrine was given as well as blow by O2 and oral benedryl.  Pt. was taken to ER where epinephrine was given again and admitted for 23hr observation.  Pt. was then refered to allergy clinic.  Suspected diagnosis: gelatin allergy (results pending). 11/28/06 Received medical records from hospital which reveal patient seen by PCP that day for routine check & vax.  Began vomiting when arrived home & developed itch all over.  Exam revealed facial flushing with fine papular rash severe itching, clear nasal discharge & swollen nasal mucous membranes, lung congestion & intermittent wheezing.  Tx with epi & Benadryl in PCP office & sent to ER for IV solumedrol but were unable to get IV access so was given oral steroids.  Gradually imrpoved with overnight observation.  Was referred for allergy testing. Final DX: acute anaphylaxis.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Crying, Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: Spouse called RN at home approximately 4 hrs. after shot, states left upper arm grossly swollen, redden and warm to touch. Size of a "baseball" painful to move arm and client is crying. treated with cold compress, Advil X4 tabs, and Benadryl X2 at home. 11/8 at 8 am, area still red and enlarged. Not as painful and planning to go to work today. No doctor seen yet.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Spouse called RN at home approximately 4 hrs. after shot, states left upper arm grossly swollen, redden and warm to touch. Size of a "baseball" painful to move arm and client is crying. treated with cold compress, Advil X4 tabs, and Benadryl X2 at home. 11/8 at 8 am, area still red and enlarged. Not as painful and planning to go to work today. No doctor seen yet.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Crying, Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: Left upper arm - grossly swollen, red area size of baseball. Warm to touch and painful to move arm. Reported by spouse at 6:47 PM evening of shot. Treated with cold compress, Advil and Benadryl.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Left upper arm - grossly swollen, red area size of baseball. Warm to touch and painful to move arm. Reported by spouse at 6:47 PM evening of shot. Treated with cold compress, Advil and Benadryl.
Age: 68.0
Sex: F
Vaccine: FLU3, HEP, TD
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: Approximately 9 hours after being vaccinated patient reported awaking with heart palpitations.  She went to the Emergency Department and reports that she was diagnosed with Atrial Fibrillation.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Immediately after receiving a dose of flu vaccine patients right arm developed approximately quarter sized area of swelling with pain.  There was no redness or discoloration.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling of left shoulder, collar bone, left neck area up to jaw.
Age: 0.38
Sex: M
Vaccine: DTAP, FLUX, HIBV, OPV
Symptoms: Apnoea, Bronchiolitis, Cough, Hypotonia, Pyrexia
Clinical narrative: 12/01/04: Dry cough, fever; seen at Dr's office. Diagnosed with "bronchiotitis." No medication prescribed. Advised to use humidifier.  12/02/04: Synagis shot given at home by hospise nurse. This was a regular procedure since he was premature. 12/02/04: I called doctor's office to cancel "well baby" appointment, because he had just been seen the day before for a bad cough. I didn't think he should keep his appointment for his immunizations when he was this sick. The nurse said that if I didn't keep the appointment that we would be dropped as a patient and charged for a missed appointment. I said that typically with my other children, doctors don't want to give immunizations when the child is sick and tell me to reschedule well-baby appointments. I took him in because of her threats. He was seen by the doctor that day. I re-stated my concern about giving him immunizations when he was sick. He convinced me that it would be fine.  He was given four more shots that day (listed below) 12/03/2004: My husband and I were up early because he had an early day at work. (4 am) When I checked on him, he seemed to be sleeping in an odd position. When I went to adjust him, his head fell back and he was limp and not breathing. We called 911. While we waited for the ambulance, they told me to breathe softly into his mouth. I did with no response.  In the emergency room, they tried to revive him, but he died.
Age: 30.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Folliculitis, Rash pustular
Clinical narrative: 10/26/2006 smallpox vaccination by vaccinia innoculation. Pt reports 1 wk F NS 4d multifocal pustular eruptions upper torso, gluteal area, UE/ LE. ROS otherwise negative.  No conjunctival findings. HR 75. COR PULM unremarkable. Lesions as described, only original innoculum site on LUE with eschar. Bilateral axillary LN L>R. No relevant PMHx or family Hx. Apparently spouse healthy. No children.  Our clinical impression was generalized vaccinia, low severity. Discussed role of contact precautions at home and at work, avoidance of patient care, monitoring for superinfection with both patient and his PCM.  Patient subsequently evaluated by Dermatology. They felt rash more consistent with vaccination folliculitis. Appreciated their evaluation and reference. However, in setting of LN on R as well and systemic sx (F NS) may be a mixed syndrome, or atypical GV. No change to our recommendations. Patient has excellent following and we remain available for urgencies or questions.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Headache, Pruritus
Clinical narrative: Patient came in with a migraine headache. He was given an injection of toradol by CMA and observed for 20 minutes. He tolerated this well. He returned to exam room for TD booster, lot Number U1879BA because he was over due. He was observed for additional 10 mins when he began itching and turning red. He was examined by PA and given an injection of Benadryl. He was observed an additional 20 mins and then released to his wife to be driven home.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Patient had a very large (approx. 20 cm diameter) confluent, blanchable urticarial plaque at immunization site on left deltoid, that was moderately erythematous, tender, and warm to touch. Patient denies having any fever, chills, dyspnea, or other illness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Fatigue, Myalgia, Nasal congestion
Clinical narrative: Symptoms began 6 hours following the vaccination.  They began with a sore, scratchy throat followed by a 7 - 12+ day course of fever, sore throat, myalgia, nasal coongestion, cough, weakness, fatigue, runny nose, dry cough followed by a productive cough.  Symptoms of nasal/sinus congestion, runny nose, chest congestion, productive cough continue.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Symptoms began 6 hours following the vaccination.  They began with a sore, scratchy throat followed by a 7 - 12+ day course of fever, sore throat, myalgia, nasal coongestion, cough, weakness, fatigue, runny nose, dry cough followed by a productive cough.  Symptoms of nasal/sinus congestion, runny nose, chest congestion, productive cough continue.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Next Day:  large, red, itchy welts under arms, waist area, inner thighs gone the next day.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: PATIENT PRESENTED TO THE OFFICE WITH RASH ON CHIN ARMS AND BACK.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Received phone call from the patient. Complains pain on arm/shoulder on side immunization was given. Today 11/08//06 unable to lift arm above head. Takes Advil for the pain, which is persisting, hinders her dailly activities. Advised to see MD to assess and evaluate pain.
Age: 1.38
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Papular lesions on stomach x 1 day.  No fever Rash on trunk and legs at time of office visit today.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on arms and legs after flu shot. I noticed rash a little more than a day after shot.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Back pain, Headache, Hypoacusis
Clinical narrative: After Anthrax vaccinations developed stiffness and pain in hands.  Problems have continued from August 2004 till present (Nov 8, 2006).  Now have pain and numbness in hands and arms.  Also have numbness below the neck.  Have nerve damage due in part to the vaccine, and in part due to a fall on an obstacle course following the vaccine and an explosion.  Vaccine sensitized and damaged the service member's nerve system.  Service member now has chronic pain and chronic numbness issues.  Symptoms are still present and continuing after two years. 12/20/06-records received and reviewed. DX: neck and back pain chronic pain syndrome (myalgias unknown etiology. C/O stiffness of hands around August 2004, fell on obstacle course in August 2004 and upon getting up from ground he experienced numbness from neck down. He relates symptoms to an Anthrax vaccine received in 7/2004 and or a fall he sustained on 8/128/2004. Since that time has had problem with headaches, stiffness and pain in hands, feet and knees, numbness in hands and arms as well as subjective complaints of short term memory deficits and sluggishness in thinking. Seen once with neck and back pain after being hit by an IED. Experienced headaches and some hearing loss after blast. MRIs negative. Information received from the annual follow up indicates patient has not recovered. Chronic headaches, chronic fatigue, chronic pain throughout the body (nerves, muscles, joints, bones), chronic numbness below the neck, my entire nervous system seems impaired and my immune system alos seems weaker. I also have chronic low levels of vitamin D, despite high levels of it that I take. Please lobby to remove chemical adjuvants (such as squalene) from vaccines. Immunizations should be optional for military personnel. Per 60 day follow up: Chronic headaches, neck, back, and joint pain. Chronic numbness below the neck. Chronic fatigue. Entire nervous system seems damaged, diminished immune system, low vitamin D levels. Please lobby to remove chemical adjuvants (such as squalene) from vaccines. Immunizations should be optional for military personnel.