chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Right arm swollen and very tender to palp over deltoid area. No mass noted, no s/s of infection noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT DELTOID SWOLLEN ABOUT SIZE OF 4X5CM AND RED.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling hot, Hypersensitivity, Nausea, Nervousness
Clinical narrative: Patient states 30 minutes after injection she started feeling very nauseous, shakey, and hot. One hour later she started vomiting with fever (fever not measured with thermometer) and feeling very tired. Symptoms lasted for the rest of the day (4-18-08). Patient woke next morning feeling better but her allergies were acting up.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient states 30 minutes after injection she started feeling very nauseous, shakey, and hot. One hour later she started vomiting with fever (fever not measured with thermometer) and feeling very tired. Symptoms lasted for the rest of the day (4-18-08). Patient woke next morning feeling better but her allergies were acting up.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose within 3 hours. 104 degree fever within 36 hours. Significant pain at injection site within 12 hours. Headache within 4 hours - lasted 3 days. Body ache within 24 hours. Skin (upper arm) red and very swollen within 48 hours.
Age: 53.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Itchy face and lips after vaccine.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp of 105F, 11 1/2 hrs post vaccine administration.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Impaired work ability, Laboratory test, Muscle fatigue, Nuclear magnetic resonance imaging
Clinical narrative: On Sun. 11/11/07 in the morning started having pains in tops of feet, then progressed to soles of feet, then up calves to backs of thighs.  Continues to have pain in legs, esp. knees and legs feel very fatigued which is making it difficult for him to work.  He has had back pain before this so Dr. ordered MRI of back.  Saw Neurosurgeon who told him he could not see any reason for his leg problems or his back pain. Had to quit his job due to pain in legs.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On Sun. 11/11/07 in the morning started having pains in tops of feet, then progressed to soles of feet, then up calves to backs of thighs.  Continues to have pain in legs, esp. knees and legs feel very fatigued which is making it difficult for him to work.  He has had back pain before this so Dr. ordered MRI of back.  Saw Neurosurgeon who told him he could not see any reason for his leg problems or his back pain. Had to quit his job due to pain in legs.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Blood culture, Full blood count, Metabolic function test, Oedema peripheral, Pyrexia
Clinical narrative: 4 days after Immunizations patient presented with fever and vomiting. 8 days after immunizations patient presented with hives and swelling in feet, hands, and face. Patient was admitted to Medical Center 4/23/08 in the evening for swelling. Patient is currently taking Benadryl, Adderax, Prelone, and Motrin. 4/25/08-records received for DOS 4/23/08-seen two times in ED for welts on axilla, groin and abdomen. Swelling hands and feet, pain when walking. Hands, feet and left knee hot and enematous. Hives over entire body.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Swelling face, Urine analysis, Urticaria, Vomiting
Clinical narrative: 4 days after Immunizations patient presented with fever and vomiting. 8 days after immunizations patient presented with hives and swelling in feet, hands, and face. Patient was admitted to Medical Center 4/23/08 in the evening for swelling. Patient is currently taking Benadryl, Adderax, Prelone, and Motrin. 4/25/08-records received for DOS 4/23/08-seen two times in ED for welts on axilla, groin and abdomen. Swelling hands and feet, pain when walking. Hands, feet and left knee hot and enematous. Hives over entire body.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Fever of 104, joint pain, vomiting.  Seen at Medical Care Center, treatment: Ibuprofen, Phenergan. "Parents were told not to have DTaP immunization any further." (She had actually received Tdap.)
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anorexia, Dyskinesia, Emotional disorder, Frustration, Head banging
Clinical narrative: 1. Body rash 24 hours after fever 2. High fever (102 F to 104 F) 3 days after immunization.  (first 2 days was 99 F to 100 F and then gone on the 3rd day until the 4th day when he spiked 103 F) for 2 days and 101.5 F for 2 days 3. Restlessness and hyperactivity and easily frustrated with extreme emotional upset 4. Vomiting 5. Lethargic, Sleeping for 18 to 20 hours for 3 days 6. Head banging on floor, walls and people holding him and the onset of repetitive movements (flaps arms, rubbing hands on textures continuously, screams frequently, walks in circles when aggravated or tired or pats his hands on his head) 7. Loss of Appetite 8. Blisters in back of throat 9. Flu symptoms without the flu. 10. Trips to Doctor's Office and ER
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersomnia, Influenza like illness, Lethargy, Oropharyngeal blistering, Psychomotor hyperactivity
Clinical narrative: 1. Body rash 24 hours after fever 2. High fever (102 F to 104 F) 3 days after immunization.  (first 2 days was 99 F to 100 F and then gone on the 3rd day until the 4th day when he spiked 103 F) for 2 days and 101.5 F for 2 days 3. Restlessness and hyperactivity and easily frustrated with extreme emotional upset 4. Vomiting 5. Lethargic, Sleeping for 18 to 20 hours for 3 days 6. Head banging on floor, walls and people holding him and the onset of repetitive movements (flaps arms, rubbing hands on textures continuously, screams frequently, walks in circles when aggravated or tired or pats his hands on his head) 7. Loss of Appetite 8. Blisters in back of throat 9. Flu symptoms without the flu. 10. Trips to Doctor's Office and ER
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Restlessness, Screaming, Vomiting
Clinical narrative: 1. Body rash 24 hours after fever 2. High fever (102 F to 104 F) 3 days after immunization.  (first 2 days was 99 F to 100 F and then gone on the 3rd day until the 4th day when he spiked 103 F) for 2 days and 101.5 F for 2 days 3. Restlessness and hyperactivity and easily frustrated with extreme emotional upset 4. Vomiting 5. Lethargic, Sleeping for 18 to 20 hours for 3 days 6. Head banging on floor, walls and people holding him and the onset of repetitive movements (flaps arms, rubbing hands on textures continuously, screams frequently, walks in circles when aggravated or tired or pats his hands on his head) 7. Loss of Appetite 8. Blisters in back of throat 9. Flu symptoms without the flu. 10. Trips to Doctor's Office and ER
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Rash papular
Clinical narrative: Patient received smallpox vaccination on 11 Apr 08.  On 21 Apr 08 patient developed erythematous papules on chest/back/lower portion of neck.  Patient with 1 day of chills, no fever, no chest pain.  Patient had been having increasing erythema/swelling at injection site.  On follow-up on 24 Apr 08 patient asymptomatic, no new papules-many had decreased in intensity.  Inflammation around vaccine site had also decreased.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paraesthesia, Seroconversion test negative
Clinical narrative: States she had immediate tingling in fingers when shot was given. Now has pain in the arm and unable to move it.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Rt lateral thigh 15 x 30cm erythema and induration that is hot to the touch, dx is cellulitis, cool pack to affected area, deflex 250mg/5cc 6cc po qid x 10days.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient complained of a gumball size ring, soft-medium in texture on the left side of arm near the deltoid area. The ring is accompanied by redness and tenderness as reported by patient. Patient received three vaccines on the left arm on 04/23/2008 at approximately 11:30 a.m. The three vaccines administered on the left arm were: Hepatitis B (IM), the Td (IM), and the Varicella (SQ). The patient also received a Hepatitis A(IM) and a MMR(SQ) on the right arm. Immediately after administering the vaccines, redness was noted on both subcutaneous sites (left and right arm). There were also 1 centimeter rings near the injection sites. Patient did not complain of pain or any other symptoms with the rings. Patient was given instructions and left the clinic. On 04/24/2008 at approximately 11:55 a.m. patient called the clinic to report that she had gumball size rings on her left deltoid. The rings were associated with redness and tenderness. The patient did not complain of any other symptoms. Patient stated that she is not allergic to any medications, foods or vaccines. It is unknown as to whether or not patient is taking prescribed medications.
Age: 24.0
Sex: M
Vaccine: JEV, RAB
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient states that he noted itching on left arm "a few days" at JE vaccine administration site.  JE site was covered by a band aid, and he removed it.  Subsequently he noted "hives" developing all over the arm, which resolved spontaneously.
Age: 0.35
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood glucose increased, Grand mal convulsion, Vomiting, Vomiting projectile
Clinical narrative: Many project vomits 21 a day to 8 a day for 5 day other are possible reaction due Dtap and prior Grand mal seizure 6/11/00 Hib possible for immediate reaction after talk with CDC in 2007.  05/08/2008 MR received for several ER visits dated 6/13/2000 and 2 visits 6/17/2000 with DX: Vomiting (6/13 and 6/17 #1) and Status Epilepticus, Probable cerebral insult, respiratory failure. Initially seen 6/13/00 with c/o spitting up every feed. D/C home on Pedialyte.  Returned 6/17/00 with c/o vomiting x 1 week.  PE WNL except somewhat pale. To f/u with PMD. Returned later that day with c/o pallor, weakness and poor intake. Pt noted to be in critical condition upon admission.  PE (+) for pallor, shallow respirations, posturing, roaming eye movements, decreased breath sounds and only responsive to painful stim. Small contusion noted on forehead. Pt given O2 then intubated.  Pupils initially equal, then developed anisocoria, then equal following intubation. Transported to higher level of care.  5/12/08 PCP records received for DOS 6/12/00 with Impression:  Suspicious hx of neonatal seizures. In for WCC with report of "abnormal movements"-upward rolling of the eyes and jerking of upper limbs 1 day prior to exam. PE WNL. Child was active and smiling. Poor weight gain noted (5th percentile).  6/12/2008 MR received from transfer hospital for DOS 6/17-7/28/2000 with sx c/w Shaken Baby Syndrome.  Infant received from local hospital with altered mental status, h/o vomiting/diarrhea, now with bulging fontanelle.  On mechanical ventilation and on Fosphenetoin.  PE (+) for lethargy, 2x2 cm ecchymosis on R frontal area, bulging fontanelle, coarse BS and decreased air entry at L lung base, heart sounds with intermittant gallop with inspiration, bradycardia and posturing. GCS 4 on admission. R pupil 4mm and fixed. Admitted to ICU. Ophth exam (+) for retinal hemorrhages. No surgical intervention required for intracranial trauma.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: none.         This child did not have any adverse effects that have been reported, the vaccine had expired on 4/5/2008 and it was given on 4/24/2008. This dose will be repeated in 30 days. Our state immunization coordinator instructed me to complete this report
Age: 1.87
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema
Clinical narrative: Child experienced a large reddened area around injection site. Mom notice 4hrs after injection her child started limping while walking. Mom presented to clinic with child. Mom encouraged to ice the reddened area and give baby Tylenol.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Oral contraception, Urticaria
Clinical narrative: SEVERE COUGH, URTICARIAL RASH ABOUT 10 HRS POST VACCINE ADMINISTRATION, ? MILD ANAPHYLACTOID RXN.
Age: 0.78
Sex: M
Vaccine: PNC
Symptoms: Contusion, Telangiectasia
Clinical narrative: Easy bruising for a few days after the PCV 7 shot.  Patient has cutis marmorata telangiectatic congenita.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 13 mm X 9 mm area of erythema and mild swelling noted at injection site.  Mother noted mild erythema and swelling the evening of the 23 May which had increased over night.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Zostavax administered 4/8/08. Patient presented with 20 cm diameter erythematous area on 4/11/08. HC 1% cream recommended and used by patient. On 4/23/08 inflamed area has extended from elbow, to shoulder. Began Diprolene cream and oral Zyrtec.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis, Erythema, Rash
Clinical narrative: Zostavax administered 4/8/08. Patient presented with 20 cm diameter erythematous area on 4/11/08. HC 1% cream recommended and used by patient. On 4/23/08 inflamed area has extended from elbow, to shoulder. Began Diprolene cream and oral Zyrtec.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Mom states "After 2nd HPV that evening broke out in wheals and itched that afternoon after shot." Mom gave Benadryl.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Varicella
Clinical narrative: Chicken Pox Vesicles - confirmed by MD evaluation
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Reddened area on (L) thigh. Prescribed Keflex 250/5 1 tsp po bid x 10 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pruritus, Skin warm
Clinical narrative: swelling of left arm, itchy, warm to touch. No fever.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 7 cm by 5 cm swollen with induration rt upper thigh lateral area
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Vomiting projectile
Clinical narrative: Protracted vomiting
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Rash macular
Clinical narrative: macular rash of arms - (not at site of inj.) No SOB, trouble swallowing or other complaints.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Anorexia, Dizziness, Fatigue, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: (10 prior). Parent gave dose of Children's Tylenol prior to vaccination. One hour after DTaP complained of "stiffness" whole body, dizzy, tired, lack of appetite, rapid heart rate and fever. Fever was highest at 103 deg. Tylenol given every 4 hrs. Vomit x1 during night. Today, fever is down, talking, seems "O.K." No swelling and redness where shot given. Referred to PMD for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: (10 prior). Parent gave dose of Children's Tylenol prior to vaccination. One hour after DTaP complained of "stiffness" whole body, dizzy, tired, lack of appetite, rapid heart rate and fever. Fever was highest at 103 deg. Tylenol given every 4 hrs. Vomit x1 during night. Today, fever is down, talking, seems "O.K." No swelling and redness where shot given. Referred to PMD for evaluation.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass
Clinical narrative: Left deltoid area lump where the immunization was given.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives, tight throat, given Epi 1/100 0.3cc IM and Benadryl 50mg IM.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received 4th DTaP in (R) thigh on 4/22. By 4/23 (R) thigh swollen to 2 1/2 cm > than (L) and red. By 4/24 ambulating fine, swelling down to 2cm.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pharmaceutical product complaint, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of extensive swelling of vaccinated limb in multiple subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date between the end of November 2007 until 18 January 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling of vaccinated limb that was described as "severe arm swelling at injection site with redness", injection site redness, unspecified adverse reactions and pharmaceutical product complaint. At the time of reporting the outcome of the extensive swelling of the vaccinated limb, injection site redness and unspecified adverse reactions were unspecified. Per the source document it was also noted that "multiple patients report adverse reactions to immunization." It was also noted that the FLULAVAL had not been compromised and had been stored properly. The report questioned if issues with this lot number had been reported by other facilities or was her facility the only one. Lot number AFLLA032AA
Sex: U
Vaccine: FLU3
Symptoms: Pharmaceutical product complaint, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 of L. At an unspecified time after vaccination with FLULAVAL, the subject experienced adverse event event and pharmaceutical product complaint. At the time of reporting the outcome of the unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if "there were any hot lots." The nurse reported that she was not going to use any more FLULAVAL. It was noted that this was a legal case. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705244A and A0705245A for details.
Sex: U
Vaccine: FLU3
Symptoms: Pharmaceutical product complaint, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if "there were any hot lots." The nurse reported that she was not going to use any more FLULAVAL. It was noted that this was a legal case. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705245A for details.
Sex: U
Vaccine: FLU3
Symptoms: Pharmaceutical product complaint, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the event unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if "there were any hot lots." The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705244A for details.
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: This case was reported by a healthcare professional, who was also the vaccination subject, that described the occurrence of arm soreness in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2007, the subject received an unspecified dose of FLULAVAL (unknown, left deltoid). On 20 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness and arm weakness. The reporting healthcare professional/subject reported that she has experienced left arm soreness and weakness since receiving the FLULAVAL vaccine. At the time of reporting the events were unresolved.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Influenza serology positive, Sinusitis, Upper respiratory tract infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of upper respiratory symptoms in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy and sinusitis. Concurrent medications included SYNTHROID, ATENOLOL, ZYRTEC, BEXTRA and NASONEX. On 24 October 2007 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. In December 2007, after vaccination with FLULAVAL, the subject experienced upper respiratory symptoms, sinusitis and bronchitis. In January 2008, with continued symptoms, the subject had a quanitative blood test where she tested positive for influenza A and B. The subject experienced a systemic reaction. At the time of reporting the events were unresolved. Follow-up information was received on 14 March 2008, via healthcare professional, who reported the events had resolved. The healthcare professional clarified that the laboratory results reflected a positive titer for influenza A and B and the patient had not necessarily contracted influenza. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza in two to three subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). The reporter did not have the specific number of subjects or demographics for these subjects. On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced influenza A and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza serology positive, Virus culture positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of positive influenza B cultures in a female subject aged between 80 and 89 old who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2007 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 26 February 2008, several months after vaccination with FLULAVAL, the subject experienced positive B influenza cultures. A nasal culture was done. The subject was diagnosed with influenza B. The strain of the B was not known. At the time of reporting the outcome of the events was unspecified. This event occurred in two different subjects with the master being this case and the other with number A0713052A.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza serology positive, Virus culture positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of positive influenza B cultures in a female subject aged between 80 and 89 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2007 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 26 February 2008, several months after vaccination with FLULAVAL, the subject experienced positive B influenza cultures. A nasal culture was done. The subject was diagnosed with influenza B. The strain of the B was not known. At the time of reporting the outcome of the events was unspecified. This event occurred in two different subjects with the master case being case number A0713041A.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of insomnia in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 03 January 2008, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced insomnia. According to the reporter, the subject was referred to a sleep specialist. At the time of reporting the event was unresolved.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Intestinal resection, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 6 month old patient with no pertinent medical history or drug allergies who on 21-AUG-2007 and 25-OCT-2007 was vaccinated with the first and second doses of Rotateq (lot# 656379/0505U, 657520/0670U).  There was no concomitant medication.  On 25-NOV-2007 the patient experienced intussusception characterized by blood in the stool and was hospitalized.  The patient had surgery conducted on 26-NOV-2007 and part of the patient's bowel was removed.  It was noted that the office was called for medical attention.  No labs or diagnostic  studies were performed.  Subsequently, the patient recovered.  It was noted that the third dose of Rotateq was not given.  There was no product quality complaint.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Chest X-ray abnormal, Computerised tomogram abnormal, Epstein-Barr virus test negative, Full blood count normal
Clinical narrative: Information has been received on request from an agency regarding a 20 year old female with no previous illnesses and allergies to penicillin, sulfamethoxazole (+) trimethoprim (SEPTRA), and cefaclor (CECLOR), who on 24-NOV-2006 was vaccinated with a first dose of GARDASIL.  In May 2007 the patient was vaccinated with a second dose of GARDASIL.  In January 2008 the patient was vaccinated IM in the right arm with a third dose of GARDASIL (Lot# 659055/1522U).  Concomitant therapy included amphetamine aspartate/amphetamineS04/dex (ADDERALL TABLETS), topiramate (TOPAMAX) and ethinyl estradiol (+) etonogestrel (NUVARING).  Subsequently, it was noted that the patient experienced a weight loss of 10 pounds, and enlarged supravlavicular lymph nodes around 01-FEB-2008.  The lymph nodes grew slightly larger by 11-MAR-2008.  The patient was seen by the family physician.  A complete blood count and chest x-ray were performed.  The patient's chest x-ray was abnormal, a 4 x 7.4cm mediatinal mass was noted.  A computer axial tomography (CT) showed grossly enlarged lymph nodes.  A biopsy was performed on the lymph nodes and was positive for Hodgkin's lymphoma.  The patient was awaiting an appointment with oncology for staging and plan of care.  It was reported that component HHV-6 was a known causative agent for Hodgkin's lymphoma and was contained in recombinant HPV vaccine.  It was also reported that the patient had been previously vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and subsequently experienced prolonged crying.  At the time of the report, the outcome of the patient was unknown.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the lab and was released.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hodgkin's disease, Lymphadenopathy, Mediastinal mass, Weight decreased
Clinical narrative: Information has been received on request from an agency regarding a 20 year old female with no previous illnesses and allergies to penicillin, sulfamethoxazole (+) trimethoprim (SEPTRA), and cefaclor (CECLOR), who on 24-NOV-2006 was vaccinated with a first dose of GARDASIL.  In May 2007 the patient was vaccinated with a second dose of GARDASIL.  In January 2008 the patient was vaccinated IM in the right arm with a third dose of GARDASIL (Lot# 659055/1522U).  Concomitant therapy included amphetamine aspartate/amphetamineS04/dex (ADDERALL TABLETS), topiramate (TOPAMAX) and ethinyl estradiol (+) etonogestrel (NUVARING).  Subsequently, it was noted that the patient experienced a weight loss of 10 pounds, and enlarged supravlavicular lymph nodes around 01-FEB-2008.  The lymph nodes grew slightly larger by 11-MAR-2008.  The patient was seen by the family physician.  A complete blood count and chest x-ray were performed.  The patient's chest x-ray was abnormal, a 4 x 7.4cm mediatinal mass was noted.  A computer axial tomography (CT) showed grossly enlarged lymph nodes.  A biopsy was performed on the lymph nodes and was positive for Hodgkin's lymphoma.  The patient was awaiting an appointment with oncology for staging and plan of care.  It was reported that component HHV-6 was a known causative agent for Hodgkin's lymphoma and was contained in recombinant HPV vaccine.  It was also reported that the patient had been previously vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and subsequently experienced prolonged crying.  At the time of the report, the outcome of the patient was unknown.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the lab and was released.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy lymph gland, Chest X-ray abnormal, Computerised tomogram abnormal, Full blood count normal, Hodgkin's disease
Clinical narrative: Information has been received on request from an agency regarding a 20 year old female with no previous illnesses and allergies to penicillin, sulfamethoxazole (+) trimethoprim (SEPTRA), and cefaclor (CECLOR), who on 24-NOV-2006 was vaccinated with a first dose of GARDASIL.  In May 2007 the patient was vaccinated with a second dose of GARDASIL.  In January 2008 the patient was vaccinated IM in the right arm with a third dose of GARDASIL (Lot# 659055/1522U).  Concomitant therapy included amphetamine aspartate/amphetamineS04/dex (ADDERALL TABLETS), topiramate (TOPAMAX) and ethinyl estradiol (+) etonogestrel (NUVARING).  Subsequently, it was noted that the patient experienced a weight loss of 10 pounds, and enlarged supravlavicular lymph nodes around 01-FEB-2008.  The lymph nodes grew slightly larger by 11-MAR-2008.  The patient was seen by the family physician.  A complete blood count and chest x-ray were performed.  The patient's chest x-ray was abnormal, a 4 x 7.4cm mediatinal mass was noted.  A computer axial tomography (CT) showed grossly enlarged lymph nodes.  A biopsy was performed on the lymph nodes and was positive for Hodgkin's lymphoma.  The patient was awaiting an appointment with oncology for staging and plan of care.  It was reported that component HHV-6 was a known causative agent for Hodgkin's lymphoma and was contained in recombinant HPV vaccine.  It was also reported that the patient had been previously vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and subsequently experienced prolonged crying.  At the time of the report, the outcome of the patient was unknown.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the lab and was released.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Weight decreased
Clinical narrative: Information has been received on request from an agency regarding a 20 year old female with no previous illnesses and allergies to penicillin, sulfamethoxazole (+) trimethoprim (SEPTRA), and cefaclor (CECLOR), who on 24-NOV-2006 was vaccinated with a first dose of GARDASIL.  In May 2007 the patient was vaccinated with a second dose of GARDASIL.  In January 2008 the patient was vaccinated IM in the right arm with a third dose of GARDASIL (Lot# 659055/1522U).  Concomitant therapy included amphetamine aspartate/amphetamineS04/dex (ADDERALL TABLETS), topiramate (TOPAMAX) and ethinyl estradiol (+) etonogestrel (NUVARING).  Subsequently, it was noted that the patient experienced a weight loss of 10 pounds, and enlarged supravlavicular lymph nodes around 01-FEB-2008.  The lymph nodes grew slightly larger by 11-MAR-2008.  The patient was seen by the family physician.  A complete blood count and chest x-ray were performed.  The patient's chest x-ray was abnormal, a 4 x 7.4cm mediatinal mass was noted.  A computer axial tomography (CT) showed grossly enlarged lymph nodes.  A biopsy was performed on the lymph nodes and was positive for Hodgkin's lymphoma.  The patient was awaiting an appointment with oncology for staging and plan of care.  It was reported that component HHV-6 was a known causative agent for Hodgkin's lymphoma and was contained in recombinant HPV vaccine.  It was also reported that the patient had been previously vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and subsequently experienced prolonged crying.  At the time of the report, the outcome of the patient was unknown.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the lab and was released.  Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: PNC, MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male who was vaccinated MMR II and subsequently experienced autism.  No additional information was provided.  Follow-up information has been received concerning a 17-month-old male with developmental delays including language delay and a history of bed wetting, who was vaccinated with a first dose of MMR II (Enders-Edmonston) on 23-Jul-2003.  On 31-May-2007 the patient received a second dose of MMR II (Enders-Edmonston), (lot# 654685/0987F) and a fourth dose of poliovirus vaccine live oral.  It was reported that "he has always had developmental delays".  On 15-Oct-2003 a language delay was noted.  Treatment and "hearing test was offered to patient's mother but she refused".  On 05-May-2004 speech delay was noted in the chart, "mom still refused to do anything".  On 09-Mar-2006, developmental delay, sensory integration disorder, speech delay noted.  OT and PT were underway at that time and it was noted "some degree of Autism".  It was also noted "mom refused evaluation".  The patient was last seen on 31-May-2007 for a 5 year visit where it was noted that he was going to summer school and was not potty trained.  It was reported that the mother believes that the autism was related to MMR II (Enders-Edmonston).  Upon internal review, autism is considered to be an other important medical event.  The patient's brother also experienced autism after being vaccinated with MMR II (Enders-Edmonston) (WAES # 0804USA01704).  Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: PNC, MMR
Symptoms: Autism, Developmental delay, Sensory disturbance, Speech disorder
Clinical narrative: Information has been received from a consumer concerning a male who was vaccinated MMR II and subsequently experienced autism.  No additional information was provided.  Follow-up information has been received concerning a 17-month-old male with developmental delays including language delay and a history of bed wetting, who was vaccinated with a first dose of MMR II (Enders-Edmonston) on 23-Jul-2003.  On 31-May-2007 the patient received a second dose of MMR II (Enders-Edmonston), (lot# 654685/0987F) and a fourth dose of poliovirus vaccine live oral.  It was reported that "he has always had developmental delays".  On 15-Oct-2003 a language delay was noted.  Treatment and "hearing test was offered to patient's mother but she refused".  On 05-May-2004 speech delay was noted in the chart, "mom still refused to do anything".  On 09-Mar-2006, developmental delay, sensory integration disorder, speech delay noted.  OT and PT were underway at that time and it was noted "some degree of Autism".  It was also noted "mom refused evaluation".  The patient was last seen on 31-May-2007 for a 5 year visit where it was noted that he was going to summer school and was not potty trained.  It was reported that the mother believes that the autism was related to MMR II (Enders-Edmonston).  Upon internal review, autism is considered to be an other important medical event.  The patient's brother also experienced autism after being vaccinated with MMR II (Enders-Edmonston) (WAES # 0804USA01704).  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, RV5, RV5
Symptoms: Barium double contrast, Cough, Diarrhoea, Irritability, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated PO with a dose of Rotateq (lot# no provided). In April 2008, the patient experienced intussusception and was hospitalized (length of stay not specified). Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated PO with a dose of Rotateq (lot# no provided). In April 2008, the patient experienced intussusception and was hospitalized (length of stay not specified). Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Muscle swelling
Clinical narrative: On March 22, I went to the hospital because I had gotten something in my eye causing severe scratches. I was given a tetanus/diphtheria shot about 4:00 PM. I have had them before and knew there would be some swelling, heat, and tenderness at injection site. By the next day it was very hot and swollen the size of a large egg. Three days later it was very hot and red with streaking over the entire upper arm and shoulder. I ran a low grade fever for about four days. It took almost three weeks for the swelling to go down and I still have a knot the size of a large grape. I noticed tonight that the muscle about three finger widths down is swollen and sore still. My sister-in-law is a nurse and said that I should report it. Is this something that I should be concerned about in the future when I get another tetanus? I have had at least three as an adult and never reacted like this before. This shot was given very high on my shoulder at the very top and I didn't know if that might be why it was such a bad reaction.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: On March 22, I went to the hospital because I had gotten something in my eye causing severe scratches. I was given a tetanus/diphtheria shot about 4:00 PM. I have had them before and knew there would be some swelling, heat, and tenderness at injection site. By the next day it was very hot and swollen the size of a large egg. Three days later it was very hot and red with streaking over the entire upper arm and shoulder. I ran a low grade fever for about four days. It took almost three weeks for the swelling to go down and I still have a knot the size of a large grape. I noticed tonight that the muscle about three finger widths down is swollen and sore still. My sister-in-law is a nurse and said that I should report it. Is this something that I should be concerned about in the future when I get another tetanus? I have had at least three as an adult and never reacted like this before. This shot was given very high on my shoulder at the very top and I didn't know if that might be why it was such a bad reaction.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Aphonia, Unresponsive to stimuli
Clinical narrative: Pt's birth was normal. After 11 1/2 months pt was spelling. Say words correctly then approx. 1/2 month later, pt became a mute baby. He was then non-responsive. He now attends therapy PT, SP, OT.  MR received from PCP from 1/9/2003-5/30/2008. (Record is somewhat illegible). Seen 7/22/2003 for runny nose and cough x 5 days. Vax given. Occasional sick visits. 12 mon shots given 4/21/04. Parent expressed concerns re: developmental delays 4/25/06. Speech tx noted 7/31/06. 4yr check 7/02/07. PE WNL.  Dx Speech Delay 2/7/2008.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test, Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram
Clinical narrative: Child had fever increased to 104. On and off for few days. Had went to 102. 9th day after vaccines were given had seizure at 11:30-Sat-AM. Went to "hospital" where test were run for 2 days. Nothing was seen by that test 1st phys. thought no relation to vaccines; #2 Dr. felt it was.  5/2/08 Received hospital medical records for 4/19-4/21/2008. FINAL DX: febrile seizure, possibly viral in etiology & slight otitis media Records reveal patient experienced shaking movements of extremities, discoloration of face & mouth lasting approx 45 secs while in highchair in restaurant followed by period of being 'out of it'. Had intermittent fever since immunizations & developed maculopapular rash all over.  Had been seen by PCP 1 or 2 days after immunizations for otitis media & placed on antibiotics but intermittent fever continued.  Admit exam revealed URI symptoms w/purulent nasal discharge.  No further seizure activity noted & d/c to home on continued oral antibiotics.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Oxygen saturation, Pyrexia
Clinical narrative: Child had fever increased to 104. On and off for few days. Had went to 102. 9th day after vaccines were given had seizure at 11:30-Sat-AM. Went to "hospital" where test were run for 2 days. Nothing was seen by that test 1st phys. thought no relation to vaccines; #2 Dr. felt it was.  5/2/08 Received hospital medical records for 4/19-4/21/2008. FINAL DX: febrile seizure, possibly viral in etiology & slight otitis media Records reveal patient experienced shaking movements of extremities, discoloration of face & mouth lasting approx 45 secs while in highchair in restaurant followed by period of being 'out of it'. Had intermittent fever since immunizations & developed maculopapular rash all over.  Had been seen by PCP 1 or 2 days after immunizations for otitis media & placed on antibiotics but intermittent fever continued.  Admit exam revealed URI symptoms w/purulent nasal discharge.  No further seizure activity noted & d/c to home on continued oral antibiotics.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no known drug allergies and no past medical history, who on 08-JAN-2008 was vaccinated intramuscularly into the left deltoid with the second dose of Gardasil (Lot # 659439/1267U).  There was no concomitant medication, and no other shots were received that day.  No trauma to the arm was reported.  On 09-JAN-2008 the patient developed pain at the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness, tingling and weakness in the hand.  The patient was seen on 26-FEB-2008 and treated with over the counter medication ADVIL which decreased the pain.  Diagnostic testing included an MRI indicating a 5x11x9 millimeter and a small focus edema 1 to 2 centimeters deep in the subcutaneous fat of the lateral upper left arm.  No abnormal bone marrow or muscle.  Re-evaluation on 02-APR-2008 revealed tenderness over biceps, no erythema, no warmth, and no palpable cord.  Neurovascular exam was intact.  It was also reported that she had no problems on 05-NOV-2007 with the first dose of Gardasil.  The reporting physician considered the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness and tingling and weakness in the hand to be disabling and another important medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no known drug allergies and no past medical history, who on 08-JAN-2008 was vaccinated intramuscularly into the left deltoid with the second dose of Gardasil (Lot # 659439/1267U).  There was no concomitant medication, and no other shots were received that day.  No trauma to the arm was reported.  On 09-JAN-2008 the patient developed pain at the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness, tingling and weakness in the hand.  The patient was seen on 26-FEB-2008 and treated with over the counter medication ADVIL which decreased the pain.  Diagnostic testing included an MRI indicating a 5x11x9 millimeter and a small focus edema 1 to 2 centimeters deep in the subcutaneous fat of the lateral upper left arm.  No abnormal bone marrow or muscle.  Re-evaluation on 02-APR-2008 revealed tenderness over biceps, no erythema, no warmth, and no palpable cord.  Neurovascular exam was intact.  It was also reported that she had no problems on 05-NOV-2007 with the first dose of Gardasil.  The reporting physician considered the injection site pain radiating down to the fingertips, swelling of the left upper arm, numbness and tingling and weakness in the hand to be disabling and another important medical event.  Additional information has been requested.