chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Multi-organ failure
Clinical narrative: This case was reported in a literature article and described the occurrence of multi-system organ failure in a 77-year-old subject of unspecified gender who was vaccinated with DTPa (with small D & P), (manufacturer unspecified), yellow fever vaccines (non-gsk) and seasonal influenza vaccine (non-gsk). Concurrent medical conditions included diabetes, factor v leiden deficiency, hyperlipidemia, hypertension and obesity. On an unspecified date, the subject received an unspecified dose of DTPa (with small D & P) (administration site and route unknown, batch number not provided, an unspecified dose of yellow fever vaccine (unknown) and an unspecified dose of seasonal influenza vaccine (Non-GSK) (unknown). 5 days after vaccination with DTPa (with small D & P), seasonal influenza vaccine (Non-GSK) and yellow fever vaccine, the subject experienced multi-system organ failure. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was probably related to vaccination with DTPa (with small D & P), yellow fever vaccine and seasonal influenza vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article.  Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Asthenia, Death, Drug administered to patient of inappropriate age, Multi-organ failure, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of multi-system organ failure in a 77-year-old subject of unspecified gender who was vaccinated with DTPa (with small D & P), (manufacturer unspecified), yellow fever vaccines (non-gsk) and seasonal influenza vaccine (non-gsk). Concurrent medical conditions included diabetes, factor v leiden deficiency, hyperlipidemia, hypertension and obesity. On an unspecified date, the subject received an unspecified dose of DTPa (with small D & P) (administration site and route unknown, batch number not provided, an unspecified dose of yellow fever vaccine (unknown) and an unspecified dose of seasonal influenza vaccine (Non-GSK) (unknown). 5 days after vaccination with DTPa (with small D & P), seasonal influenza vaccine (Non-GSK) and yellow fever vaccine, the subject experienced multi-system organ failure. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was probably related to vaccination with DTPa (with small D & P), yellow fever vaccine and seasonal influenza vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article.  Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 77.0
Sex: U
Vaccine: FLUX, TDAP, YF, FLUX, TDAP, YF, TDAP, YF, DTAP, FLUX, YF
Symptoms: Off label use, Pyrexia, Septic shock
Clinical narrative: This case was reported in a literature article and described the occurrence of multi-system organ failure in a 77-year-old subject of unspecified gender who was vaccinated with DTPa (with small D & P), (manufacturer unspecified), yellow fever vaccines (non-gsk) and seasonal influenza vaccine (non-gsk). Concurrent medical conditions included diabetes, factor v leiden deficiency, hyperlipidemia, hypertension and obesity. On an unspecified date, the subject received an unspecified dose of DTPa (with small D & P) (administration site and route unknown, batch number not provided, an unspecified dose of yellow fever vaccine (unknown) and an unspecified dose of seasonal influenza vaccine (Non-GSK) (unknown). 5 days after vaccination with DTPa (with small D & P), seasonal influenza vaccine (Non-GSK) and yellow fever vaccine, the subject experienced multi-system organ failure. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was probably related to vaccination with DTPa (with small D & P), yellow fever vaccine and seasonal influenza vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article.  Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia
Clinical narrative: severe muscle and joint pain, swelling of axillary lymph nodes, headache; ongoing X 2 days
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a now 63 year old female patient with sulfonamide allergy, diabetes and hyperlipidemia who on 25-JUL-2008 was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot# 659410/0412X, exp: 29-JUL-2009). Concomitant therapy included SYNTHROID and CRESTOR. The nurse reported that on an unspecified date "recently", the patient experienced "a case of shingles" around the patient's left eye. Nurse reported that the patient had been to see an ophthalmologist (name unspecified by nurse). The nurse reported that the patient came to see the physician, on 12-AUG-2011. Nurse reported that the patient was experiencing pain around the patient's left eye and the physician prescribed NEURONTIN for the patient's pain. No lab diagnostics study was performed. At the time of report, the outcomes of the adverse events were unknown. Patient was experiencing pain was considered to be significant disability or incapacity by the nurse. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a female who was vaccinated with a dose of GARDASIL (lot # not reported) when she was 3 to 4 weeks along in her pregnancy. The patient lost the baby during the twelfth or thirteenth week of gestation period. It was unknown if the patient sought medical attention. Upon internal review, lost the baby during the twelfth or thirteenth week of gestation period was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Convulsion, Electroencephalogram normal, Pyrexia
Clinical narrative: generalized seizure with fever
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria, Vaccination site rash, Vaccination site reaction
Clinical narrative: 1 cm hive and 3 cm rash at site on left arm at vaccination site.   2 cm rash on Right arm at vaccination site. Administered 7.5 ml liquid Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, PNC13, VARCEL
Symptoms: Dyskinesia, Gaze palsy, Immediate post-injection reaction, Movement disorder, Nausea
Clinical narrative: CHILD HAD RECIVED DTaP, PCV, AND VAR IMMEDIATELY STARTED HAVING SEIZURE LIKE ACTIVITY LASTING 10-15 SECONDS (JERKING OF HEAD AND LEGS EYES ROLLED BACK IN HEAD, PT SAW SPOTS AND SLUMPED TO THE RIGHT) COMPLETELY PALE, AFTERWARDS EXPERIECED NAUSEA, CHILD HAD NOTHING TO EAT THAT MORNING, NO SHORTNESS OF BREATH, NO RASH NOTED, BP WAS 80/58 AND PULSE WAS 60 LAYED HER DOWN AND ELEVATED FEET AND ICE PACK TO NECK EMS CALLED AND EVALUATED AND MOM DECLINED TO GO TO ER.  SPOKE WITH MOM PM ON 8-11-11 PT WAS SLEEPING BUT OK SPOKE WITH PT ON 8-12-11 MOM STATED PT WAS ALSO SPOKE WITH MOM ON 8-16-11 MOM STATED OK
Age: 4.0
Sex: F
Vaccine: DTAPIPV, PNC13, VARCEL
Symptoms: Pallor, Posture abnormal, Visual impairment
Clinical narrative: CHILD HAD RECIVED DTaP, PCV, AND VAR IMMEDIATELY STARTED HAVING SEIZURE LIKE ACTIVITY LASTING 10-15 SECONDS (JERKING OF HEAD AND LEGS EYES ROLLED BACK IN HEAD, PT SAW SPOTS AND SLUMPED TO THE RIGHT) COMPLETELY PALE, AFTERWARDS EXPERIECED NAUSEA, CHILD HAD NOTHING TO EAT THAT MORNING, NO SHORTNESS OF BREATH, NO RASH NOTED, BP WAS 80/58 AND PULSE WAS 60 LAYED HER DOWN AND ELEVATED FEET AND ICE PACK TO NECK EMS CALLED AND EVALUATED AND MOM DECLINED TO GO TO ER.  SPOKE WITH MOM PM ON 8-11-11 PT WAS SLEEPING BUT OK SPOKE WITH PT ON 8-12-11 MOM STATED PT WAS ALSO SPOKE WITH MOM ON 8-16-11 MOM STATED OK
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: fever, vomiting and nausea, weak
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 10 August 2011. A 2-year-old female patient, with no relevant medical history, received the following vaccinations on 31 May 2011: a fourth intramuscular left deltoid injection of  DAPTACEL (lot number C3916AA); a fourth intramuscular left deltoid injection of ACTHIB (lot number UH175AA); and a second right deltoid injection of VAQTA (Merck, lot number 0124AA). She had no illness at the time of vaccination, and was taking a multivitamin with fluoride concomitantly. One day post-vaccination, on 01 June 2011, the patient developed a swollen left arm with a "10x9 cellulitic lesion" on the left upper arm. Per the reporter, both the DAPTACEL and ACTHIB had been administered in the same area. The patient was treated with AUGMENTIN, and symptoms subsequently resolved. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Abscess, Cellulitis, Drug hypersensitivity, Erythema, Swelling
Clinical narrative: Initial report received from a health care professional on 15 August 2011. A 2-year-old female patient with no pre-existing medical history, was seen for well child visit on 13 August 2011 and received a 4th left thigh dose of DAPTACEL (lot number C3618AA, route not reported) and 2 days later was found to have cellulitis with abscess, unspecified erythema, swelling, and it was reported the patient was "allergic to drug (unclassified)". The site of the events were not reported. The patient required a physician visit and was prescribed OMNICEF. It was not reported whether any diagnostic tests/laboratory data were performed. It was noted the patient had received a dose of PEDVAXHIB (Merck) with no reported adverse event on 02 July 2011. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Left shoulder became sore on Sunday 7/24.  By Monday the pain was severe in his left shoulder blade.  Went to ER on 07/25 and advised by MD to take 500 mg ibuprofen 4x a day.  No relief as of 07/27.  Recommended to follow-up with primary care provider.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain in extremity, Skin warm
Clinical narrative: Left arm pain on 07/09/2011 and 07/10/2011, became pink and warm to touch.  On 07/12/2011 presents to facility with left deltoid redness and warm to touch about 3-4" in width and 6-7" in length.  Referred to MD, follow-up call on 07/13/2011 prescribed antibiotics - z-pak.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria with Itching
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest pain
Clinical narrative: Chest pain, took Tylenol - didn't help.
Age: 11.0
Sex: F
Vaccine: TTOX
Symptoms: Activities of daily living impaired, Aphasia, Wheelchair user
Clinical narrative: A consumer reported that the mother of an 11-year-old female said that her daughter received a tetanus vaccine 7 years ago and ended up in a wheelchair, and cannot talk or take care of herself. Source does not want to be contacted and provided no further information.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Blood glucose increased, Computerised tomogram, Computerised tomogram abdomen abnormal, Condition aggravated, Diabetic ketoacidosis
Clinical narrative: Patient says was admitted to hospital with ovarian cyst after receiving GARDASIL. Reviewed hosp records. Patient admitted 11/9/10 to 11/15/10 for diabetic ketoacidosis and found on abdominal ct to have (L) ovarian cyst 3.5cm & several small mesenteric lymph nodes.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Lymphadenitis, Ovarian cyst
Clinical narrative: Patient says was admitted to hospital with ovarian cyst after receiving GARDASIL. Reviewed hosp records. Patient admitted 11/9/10 to 11/15/10 for diabetic ketoacidosis and found on abdominal ct to have (L) ovarian cyst 3.5cm & several small mesenteric lymph nodes.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Bacterial infection, Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed extreme swelling with warmness on child's left upper arm and took him (child) to ER at hospital around midnight (early on 8/16/11). Child was Dx'd "bacterial infection, cellulitis due to vaccination, not allergic reaction" and was prescribed Keflex, tid for 10 days with Benadryl, prn. On 8/16/11 11:00am, grand mother and the child came to the public health center where he had vaccinated and reported of the incident.  At the time, child was afebrile, left arm was swelling but not "extreme" with mild warmness. The child was alert, not complaining of pain and left clinic ambulatory with grand mother. At 4pm, mom was notified by the phone that VAERS would be made by nurse (me) and she accepted the action. No further complaints were heard from mom.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: severe swelling, hardening of area and redness at injection site; itching at site; headache; as of 08/18/2011 these symptoms still exist
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Convulsion
Clinical narrative: Mother reports that approximately 10 minutes after receiving vaccines patient had a seizure while in the car on the way home from the clinic.  Upon return to home patient was ok, BP was ok, Heart rate was ok, mother called patient's physician to report incident.  Patient slept short while they reported feeling better.  No previous seizure history.  No previous reaction to vaccine reported.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Per Mom, noticed Rt shoulder rash in AM of 8/17, after receiving PCV13 vaccine in this location the previous afternoon (pt received 3 doses of PCV7 in 2008 with no reaction). No fever, no vomiting, but some possible loose stools (but not watery). Tolerating well PO, no chest pain, No SOB. Mom gave diphenhydramine. On exam, Rt deltoid skin slight warm to touch, well demarcated erythematous slight indurated rash; aprox 5x5cm. Some central tiny vesicles clusters noticed) non-pitting and very tender to palpation.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Per Mom, noticed Rt shoulder rash in AM of 8/17, after receiving PCV13 vaccine in this location the previous afternoon (pt received 3 doses of PCV7 in 2008 with no reaction). No fever, no vomiting, but some possible loose stools (but not watery). Tolerating well PO, no chest pain, No SOB. Mom gave diphenhydramine. On exam, Rt deltoid skin slight warm to touch, well demarcated erythematous slight indurated rash; aprox 5x5cm. Some central tiny vesicles clusters noticed) non-pitting and very tender to palpation.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Cough, Dizziness, Dyspnoea, Injection site pain
Clinical narrative: Clt. called in on 8/17 to report that Tdap injection site was swollen to the size of a golf ball, but swelling was coming down, clt. stated that on 8/14 AM she had stomach upset-nausea, felt dizzy, short of breath, had wheezing cough & pain to inj. site. Stated that after doing a breathing treatment her shortness of breath and wheezing stopped and she felt better. She stated she had not sought medical care.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Wheezing
Clinical narrative: Clt. called in on 8/17 to report that Tdap injection site was swollen to the size of a golf ball, but swelling was coming down, clt. stated that on 8/14 AM she had stomach upset-nausea, felt dizzy, short of breath, had wheezing cough & pain to inj. site. Stated that after doing a breathing treatment her shortness of breath and wheezing stopped and she felt better. She stated she had not sought medical care.
Age: 32.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Deltoid area of left arm which received Tdap vaccine began to swell and become very painful, there was mild warmth of the area. After another 10 minutes, patient reported ache in back of neck and mental "cloudiness". Medical attention was not required. She was feeling better after about 3 hours. After one week her left arm is still sore.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Pt. had MMRV on 8/15/11 and Mom called on 8/18/11 and stated pt. has approx. 2 inch red raised area to the back of right arm where MMRV was given.  Also stated pt. began vomiting on the evening of 8/16/2011.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: "Migrating" hives.  First inside upper left arm, next day inside upper right arm, next day inside upper thighs and hip. Some days nothing.  Today hive under left eye. Moves around, spraying with Benadryl relieve itching.  Very minor inconvenience.
Age: 4.0
Sex: F
Vaccine: DTAP, DTP, IPV, MMR, VARCEL
Symptoms: Cough, Headache, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: fever, rapid heartbeat, cough, swelling and redness in the area of vaccine, a little rash in the chest, headache. treatment: acetaminophen oral suspension
Age: 4.0
Sex: F
Vaccine: DTAP, DTP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: fever, rapid heartbeat, cough, swelling and redness in the area of vaccine, a little rash in the chest, headache. treatment: acetaminophen oral suspension
Age: 23.0
Sex: M
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: rash
Age: 1.0
Sex: F
Vaccine: MMR, PPV, TYP
Symptoms: Discomfort, Laboratory test, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Spots on Face (red rash)on 8/15,  8/16/2011 red rash on stomach, face, fever 101,  8/17/2011 red rash on arms, legs, stomach, face, fever 102.7. 8/18/2011 rash every where including palms of hands soles of feet. Less skin showing than rash. Discomforted, swelling of face fever 100.9  Treatment: DR. sent away for labwork, waiting it out with Tylenol if fever increases.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, TYP
Symptoms: Swelling face
Clinical narrative: Spots on Face (red rash)on 8/15,  8/16/2011 red rash on stomach, face, fever 101,  8/17/2011 red rash on arms, legs, stomach, face, fever 102.7. 8/18/2011 rash every where including palms of hands soles of feet. Less skin showing than rash. Discomforted, swelling of face fever 100.9  Treatment: DR. sent away for labwork, waiting it out with Tylenol if fever increases.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperaesthesia, Injection site erythema, Pain, Rash macular
Clinical narrative: CONTACTED BY CLIENT'S MOTHER. CLIENT WAS VACCINATED ON 8-12-11 AND HAS A BASEBALL SIZED RED CIRCLE TO THE BACKSIDE OF LEFT ARM, WHERE VARICELLA WAS ADMINSTERED. THE "SPLOTCHY" AREA WAS 1ST NOTICED ON SATURDAY NIGHT (8-13-11). CLIENT HAS GOOD RANGE OF MOTION, ONLY PAINFUL TO TOUCH. MOTHER ADMINISTERED MOTRIN AND BENADRYL ON SUNDAY NIGHT (8-14-11). PLAN: MONITOR THE SITE IN CASE OF REDNESS/PAIN SPREADS BEYOND EXISTING BORDERS. WILL ICE AND GIVE MOTRIN, BENADRYL PRN. FOLLOW UP WITH PCP IF SYMPTOMS WORSEN.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: 5/7/11 p.m., infant had emesis x 3, diarrhea x 1 with a "small amount" of blood in stool. No fever or other symptoms. Seen at local ER, ultrasound showed intussuception. Transferred to Pediatric ER. Admitted; air enema successfully reduced intussuception. Kept npo overnight with IV fluids. Discharged 5/10/11 in good health. This is per admitting hospital's record and report from mother at 7/22/11 visit with Pediatrician.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 5/7/11 p.m., infant had emesis x 3, diarrhea x 1 with a "small amount" of blood in stool. No fever or other symptoms. Seen at local ER, ultrasound showed intussuception. Transferred to Pediatric ER. Admitted; air enema successfully reduced intussuception. Kept npo overnight with IV fluids. Discharged 5/10/11 in good health. This is per admitting hospital's record and report from mother at 7/22/11 visit with Pediatrician.
Age: 0.94
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: FEVER LAST NIGHT 103.1 AUX, RED SPOT ON THE INJECTION SITE
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Antinuclear antibody negative, Asthenia, Blood glucose normal, Borrelia test negative, Complement factor C3
Clinical narrative: Paresthesias/weakness (peripheral neuropathy) left arm
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Complement factor C4, Electromyogram, Electrophoresis protein, Glycosylated haemoglobin, Laboratory test normal
Clinical narrative: Paresthesias/weakness (peripheral neuropathy) left arm
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Liver function test normal, Nerve conduction studies, Neuropathy peripheral, Paraesthesia, Treponema test negative
Clinical narrative: Paresthesias/weakness (peripheral neuropathy) left arm
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Arrhythmia, Blood test, Cardiac pacemaker insertion, Cellulitis, Clostridial infection
Clinical narrative: Vaccine was given in right arm, after the vaccine, the right arm was sore, the next three days I was unable to move it. On 07/17/2011 I was admitted to the hospital due to a huge red, painful, swelling spot at the vaccination site, and a fever of 102.0. The doctors diagnosed my problem as cellulitus, an infection under the skin caused by the vaccine. I was given antibiotics to get rid of this adverse event which later caused a c-diff infection and I was hospitalized again. I then began to experience arrythmia problems resulting in a pacemaker implant.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Echocardiogram, Electrocardiogram, Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: Vaccine was given in right arm, after the vaccine, the right arm was sore, the next three days I was unable to move it. On 07/17/2011 I was admitted to the hospital due to a huge red, painful, swelling spot at the vaccination site, and a fever of 102.0. The doctors diagnosed my problem as cellulitus, an infection under the skin caused by the vaccine. I was given antibiotics to get rid of this adverse event which later caused a c-diff infection and I was hospitalized again. I then began to experience arrythmia problems resulting in a pacemaker implant.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Vaccine was given in right arm, after the vaccine, the right arm was sore, the next three days I was unable to move it. On 07/17/2011 I was admitted to the hospital due to a huge red, painful, swelling spot at the vaccination site, and a fever of 102.0. The doctors diagnosed my problem as cellulitus, an infection under the skin caused by the vaccine. I was given antibiotics to get rid of this adverse event which later caused a c-diff infection and I was hospitalized again. I then began to experience arrythmia problems resulting in a pacemaker implant.
Age: 77.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: Injection site won't stop bleeding.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Muscular weakness, Pain
Clinical narrative: Initially pain and swelling at injection site, treated with warm pack and pain reliever on 4/30/11.  Parent called again on 5/23/11, no redness or swelling, tender and sore when moving, continued care recommended fu in 1-2 weeks if not better.  Patient seen again on 7/12/11 had pain with palpation of the deltoid muscle and had left shoulder weakness of the biceps and deltoid.  Gripe was okay.  Recommend physical therapy and consider MRI.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Initially pain and swelling at injection site, treated with warm pack and pain reliever on 4/30/11.  Parent called again on 5/23/11, no redness or swelling, tender and sore when moving, continued care recommended fu in 1-2 weeks if not better.  Patient seen again on 7/12/11 had pain with palpation of the deltoid muscle and had left shoulder weakness of the biceps and deltoid.  Gripe was okay.  Recommend physical therapy and consider MRI.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash, Itching, Swelling
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug exposure during pregnancy, Pregnancy test negative
Clinical narrative: Client was seen for 7th grade immunization for school. Reviewed questions and information with client and parent, ask client was she pregnant client stated no, while giving injections mother stated she was concern about daughter because she think her daughter haven't have her menses since May.  At this time I already gave the client a Tdap vaccination and MCV4 vaccination.  I didn't get a chance to give the client the varcella vaccination.  I told the client mother that I think she need to get a pregnancy test before I can give the client the varicella injection. Instructed client and mother to go thru family planning clinic for a pregnancy test.  Client pregnancy test was positive.  After reviewing the recommendation for pregnant women, tdap recommendation is to give a pregnant women tdap late second trimester or third trimester.  We are are not sure what trimester client is in, possibly early second trimester.
Age: 13.0
Sex: F
Vaccine: IPV, TD
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient felt Nauseated, dizzy and vomited
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Irritability, Nasal congestion
Clinical narrative: Difficulty breathing, wheezing, hoarseness, stuffy nose, vomiting of 6 days duration. Two days post vaccination an onset of a fever (102-104) duration of 1.5 hours, aw well as all of the above). Currently has hoarseness, stuffy nose, minimal vomiting, irritability, and loss of appetite of 3 days duration.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Difficulty breathing, wheezing, hoarseness, stuffy nose, vomiting of 6 days duration. Two days post vaccination an onset of a fever (102-104) duration of 1.5 hours, aw well as all of the above). Currently has hoarseness, stuffy nose, minimal vomiting, irritability, and loss of appetite of 3 days duration.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Insomnia, Irritability
Clinical narrative: Child was fussy and could not sleep through the night.  Developed a fever of 102.5 and a swollen red nodule at injection site 2 inches in diameter.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Child was fussy and could not sleep through the night.  Developed a fever of 102.5 and a swollen red nodule at injection site 2 inches in diameter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Skin warm
Clinical narrative: Severe swelling, redness of the entire upper arm.  Hot to the touch.  Swelling in lymph nodes in the arm.  This has lasted for more than 7 days.
Age: 0.3
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Abscess sterile
Clinical narrative: This case was reported in a literature article and described the occurrence of sterile abscess in a 4-month-old subject of unspecified gender who was vaccinated with DTaP vaccine (manufacturer unspecified), PCV7 vaccine (non-gsk), Hib+HepB (non-gsk) and IPV (non-gsk). On an unspecified date, the subject received an unspecified dose of DTaP vaccine (administration site and route unknown, batch number not provided), an unspecified dose of PCV7 vaccine (NON-GSK) (unknown), an unspecified dose of Hib+HepB vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 21 days after vaccination with DTaP vaccine, Hib+HepB vaccine (Non-GSK), PCV7 vaccine (NON-GSK) and IPV (Non-GSK), the subject experienced sterile abscess. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was probably related to vaccination with DTaP vaccine, PCV7 vaccine (NON-GSK), Hib+HepB (Non-GSk) and IPV (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 14.0
Sex: U
Vaccine: HPV2
Symptoms: Autoimmune disorder, Muscle atrophy, Polyneuropathy
Clinical narrative: This case was reported in a literature article and described the occurrence of muscle atrophy in a 14-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). Concurrent medical conditions included delayed early gross motor. On an unspecified date, the subject received unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). 90 days after vaccination with HPV vaccine, the subject experienced primary muscular atrophy and autoimmune polyneuropathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author considered the events were unlikely to be related to vaccination with HPV vaccine. This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review additional  cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion. AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 15.0
Sex: U
Vaccine: HEPA, MEN
Symptoms: Vasculitis cerebral
Clinical narrative: This case was reported in a literature article and described the occurrence of vasculitis cerebral in a 15-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified) and meningococcal acwy vaccine (non-gsk). The subject's medical history included orbital trauma. Concurrent medical conditions included exercise induced asthma. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). 10 days after vaccination with Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced vasculitis cerebral (intracerebral vessel inflammation). This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unlikely to be related to vaccination with Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 26.0
Sex: U
Vaccine: HPV2
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of Bell's palsy in a 26-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with HPV vaccine, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Age: 63.0
Sex: U
Vaccine: DT, HEP, HEPA, YF
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of Bell's palsy in a 63-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), Hepatitis B vaccine, (non-gsk) Yellow fever vaccine and diphtheria tetanus vaccine (non-gsk). Past medical history not reported. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Yellow fever vaccine (unknown) and an unspecified dose of Diphtheria Tetanus vaccine (Non-GSK) (unknown). 1 day after vaccination with Diphtheria Tetanus vaccine (Non-GSK), Hepatitis A vaccine, Hepatitis B vaccine and Yellow fever vaccine, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.