chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RED WARM AREA TO RIGHT ARM WHERE MENACTRA WAS GIVEN(03/04/2009). PATIENT WAS SEEN BY DR. AND MOM WAS INSTRUCTED TO WATCH AREA FOR ANY CHANGE AND APPLY COOL COMPRESS, GIVE IBUPROFEN. RECHECK IF NOT BETTER.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Measles, Rash papular
Clinical narrative: Red bumps all over body that started 9 days after vaccine was given.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RED WARM AREA AROUND THE INJECTION SITE GIVEN IN THE RIGHT ARM. SEEN DR 09/06/2008 MOM WAS TOLD TO WATCH SITE AND APPLY COOL COMPRESS,GIVE IBUPROFEN AND APPLY TOPICORT BID.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Inflammation, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient received 4 vaccinations on 02-18-09.  Later in that same day, patient complained of right arm pain.  Per Mom, the deltoid site was erythematous, warm to touch, and slightly edematous.  Mom called the NP and was told it was probably a localized reaction to vaccination, but the inflammation continued to increase, and patient was taken to the NP on 02-20-09 where she was diagnosed with cellulits. Patient was prescribed Cephalexin for 10 days.  Mom reported today that patient has completed the antibiotic and the infection and inflammation are resolved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Patient received 4 vaccinations on 02-18-09.  Later in that same day, patient complained of right arm pain.  Per Mom, the deltoid site was erythematous, warm to touch, and slightly edematous.  Mom called the NP and was told it was probably a localized reaction to vaccination, but the inflammation continued to increase, and patient was taken to the NP on 02-20-09 where she was diagnosed with cellulits. Patient was prescribed Cephalexin for 10 days.  Mom reported today that patient has completed the antibiotic and the infection and inflammation are resolved.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inflammation, Injection site pain, Injection site scab, Injection site vesicles
Clinical narrative: PT. REC'D ZOSTER VAX. ON 1/29.09.  HIS WIFE CALLED CLINIC CHARGE NURSE 2/23/09 TO REPORT PT. HAD DEVELOPED A BLISTER WITH EXUDATE ON THE ARM HE'D GOTTEN THE SHOT IN.(RT.). SITE WAS NOW SCABBING OVER. SITE HAD ACHED PRIOR TO APPEARANCE TO BLISTER.  SHE FELT SHOT HAD CAUSED SHINGLES AND STATED MD AGREED.  NO CULTURE DONE.  PT. FELT WELL OTHERWISE.  AFEBRILE PER WIFE.
Age: 35.0
Sex: M
Vaccine: ANTH, FLUX, HEP, HEPA, SMALL, TYP, TYP
Symptoms: Amnesia, Blood cholesterol increased, Blood glucose increased, Unevaluable event
Clinical narrative: UNKNOWN
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood glucose increased, Chest X-ray normal, Dyspnoea, Electrocardiogram, Eosinophil count decreased
Clinical narrative: Patient received Gardasil and Menactra vaccinations on Friday, Feb. 27th at about 2 pm.  She also had completed a course of Zithromax, but had previously received 2 courses of this medication.  Patient felt fine throughout the weekend, but on Monday around 130 pm developed itching and slight rash.  Played golf from 4-5 pm and rash worsened with sweating.  That evening her mother gave her diphenhydramine and Calamine lotion which helped the rash decrease in size and decreased pruritis associated with the rash.  On Tuesday morning the rash was very light, but again worsened throughout the day and greatly increased in size after golf from 4-5 pm.  Mother described rash as now spread throughout body including abdomen, breasts, back, neck, and palms of hands and soles of feet.  Patient began having breathing difficulties and was brought to an urgent care facility around 7 pm.  She received epinephrine and IV methylprednisolone and was discharged after the breathing improved and the rash decreased in size.  At about 1230 am that night the patient again experienced breathing difficulites and worsened rash and presented to the ER.  She was given another dose of epi, IV steroids, and antihistamines.  Patient was sent home after improvement, but again presented Wed am, this time to the TEC.  Patient was admitted and received 2 more rounds of epi, scheduled methylprednisolone (25 mg IV q6h), scheduled hydroxyzine (50 mg po q6h), and Pepcid (20 mg IV q12h).  Patient weighed 54.2 kg.  Patient was discharged on Friday March 6th with an epi pen, prn hydroxyzine, oral steroids, H2 antag, etc.  Medical residents described rash as hives.  Patient reported no changes to diet or unusual outdoor triggers.  When looking at literature, it appeared the majority of documented cases with Menactra were within 24hrs, but when looking at a study of Australian teenage girls receiving Gardasil, it appeared several of the cases were delayed in nature (up to a several days).  Please contact PharmD for literature links.  We felt given history of Zithromax and the literature made Gardasil most likely contributing factor.  Unknown lot numbers of immun. as they were given at clinic.  Please contact representative with questions or pediatric clinic for lot #'s.  4/10/09 Received hospital medical records of 3/4-3/6/2009. FINAL DX: anaphylaxis, resolved, suspect Gardasil reaction. Records reveal patient experienced intermittent hives, itching, chest pain & respiratory distress.  Had been seen in urgent care x 3 for same over 2 days & tx w/epi & oral steroids & antihistamine.  Noted to have dyspnea, tachypnea & stridor on admit.  Tx w/IV epi, steroids & antihistamines.  Improved & d/c to home on tapering steroids, epi pen & w/instruction for allergy referral.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Full blood count normal, Hyperhidrosis, Lymphocyte count increased, Metabolic function test normal, Neutrophil count
Clinical narrative: Patient received Gardasil and Menactra vaccinations on Friday, Feb. 27th at about 2 pm.  She also had completed a course of Zithromax, but had previously received 2 courses of this medication.  Patient felt fine throughout the weekend, but on Monday around 130 pm developed itching and slight rash.  Played golf from 4-5 pm and rash worsened with sweating.  That evening her mother gave her diphenhydramine and Calamine lotion which helped the rash decrease in size and decreased pruritis associated with the rash.  On Tuesday morning the rash was very light, but again worsened throughout the day and greatly increased in size after golf from 4-5 pm.  Mother described rash as now spread throughout body including abdomen, breasts, back, neck, and palms of hands and soles of feet.  Patient began having breathing difficulties and was brought to an urgent care facility around 7 pm.  She received epinephrine and IV methylprednisolone and was discharged after the breathing improved and the rash decreased in size.  At about 1230 am that night the patient again experienced breathing difficulites and worsened rash and presented to the ER.  She was given another dose of epi, IV steroids, and antihistamines.  Patient was sent home after improvement, but again presented Wed am, this time to the TEC.  Patient was admitted and received 2 more rounds of epi, scheduled methylprednisolone (25 mg IV q6h), scheduled hydroxyzine (50 mg po q6h), and Pepcid (20 mg IV q12h).  Patient weighed 54.2 kg.  Patient was discharged on Friday March 6th with an epi pen, prn hydroxyzine, oral steroids, H2 antag, etc.  Medical residents described rash as hives.  Patient reported no changes to diet or unusual outdoor triggers.  When looking at literature, it appeared the majority of documented cases with Menactra were within 24hrs, but when looking at a study of Australian teenage girls receiving Gardasil, it appeared several of the cases were delayed in nature (up to a several days).  Please contact PharmD for literature links.  We felt given history of Zithromax and the literature made Gardasil most likely contributing factor.  Unknown lot numbers of immun. as they were given at clinic.  Please contact representative with questions or pediatric clinic for lot #'s.  4/10/09 Received hospital medical records of 3/4-3/6/2009. FINAL DX: anaphylaxis, resolved, suspect Gardasil reaction. Records reveal patient experienced intermittent hives, itching, chest pain & respiratory distress.  Had been seen in urgent care x 3 for same over 2 days & tx w/epi & oral steroids & antihistamine.  Noted to have dyspnea, tachypnea & stridor on admit.  Tx w/IV epi, steroids & antihistamines.  Improved & d/c to home on tapering steroids, epi pen & w/instruction for allergy referral.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Neutrophil count increased, Pruritus, Rash generalised, Urticaria, White blood cell count increased
Clinical narrative: Patient received Gardasil and Menactra vaccinations on Friday, Feb. 27th at about 2 pm.  She also had completed a course of Zithromax, but had previously received 2 courses of this medication.  Patient felt fine throughout the weekend, but on Monday around 130 pm developed itching and slight rash.  Played golf from 4-5 pm and rash worsened with sweating.  That evening her mother gave her diphenhydramine and Calamine lotion which helped the rash decrease in size and decreased pruritis associated with the rash.  On Tuesday morning the rash was very light, but again worsened throughout the day and greatly increased in size after golf from 4-5 pm.  Mother described rash as now spread throughout body including abdomen, breasts, back, neck, and palms of hands and soles of feet.  Patient began having breathing difficulties and was brought to an urgent care facility around 7 pm.  She received epinephrine and IV methylprednisolone and was discharged after the breathing improved and the rash decreased in size.  At about 1230 am that night the patient again experienced breathing difficulites and worsened rash and presented to the ER.  She was given another dose of epi, IV steroids, and antihistamines.  Patient was sent home after improvement, but again presented Wed am, this time to the TEC.  Patient was admitted and received 2 more rounds of epi, scheduled methylprednisolone (25 mg IV q6h), scheduled hydroxyzine (50 mg po q6h), and Pepcid (20 mg IV q12h).  Patient weighed 54.2 kg.  Patient was discharged on Friday March 6th with an epi pen, prn hydroxyzine, oral steroids, H2 antag, etc.  Medical residents described rash as hives.  Patient reported no changes to diet or unusual outdoor triggers.  When looking at literature, it appeared the majority of documented cases with Menactra were within 24hrs, but when looking at a study of Australian teenage girls receiving Gardasil, it appeared several of the cases were delayed in nature (up to a several days).  Please contact PharmD for literature links.  We felt given history of Zithromax and the literature made Gardasil most likely contributing factor.  Unknown lot numbers of immun. as they were given at clinic.  Please contact representative with questions or pediatric clinic for lot #'s.  4/10/09 Received hospital medical records of 3/4-3/6/2009. FINAL DX: anaphylaxis, resolved, suspect Gardasil reaction. Records reveal patient experienced intermittent hives, itching, chest pain & respiratory distress.  Had been seen in urgent care x 3 for same over 2 days & tx w/epi & oral steroids & antihistamine.  Noted to have dyspnea, tachypnea & stridor on admit.  Tx w/IV epi, steroids & antihistamines.  Improved & d/c to home on tapering steroids, epi pen & w/instruction for allergy referral.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in jaw
Clinical narrative: The morning after receiving the Tdap, along with a trivalent flu shot, the patient reported jaw pain on the left side that "hurt like hell" and persisted for several days.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: area became swollen and red, several hours after administration of vaccine.  Area became painful.There was quite a bit of swelling around the entire upper arm.  I saw the arm on the 2nd day and it was still swollen and reddened.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Headache, Photophobia, Pyrexia
Clinical narrative: Patient developed fever and light sensitive headache after receiving vaccines
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Epstein-Barr virus test negative, Full blood count normal, Influenza serology negative, Myalgia, Pyrexia
Clinical narrative: Sudden onset full body myalgia and fever 102 less than 24 hours after injections.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local side effect at injection site (R arm): round, erythematous without pustular lesion 1.5 cm x 1.5 cm and tenderness on Right arm.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Erythema, Rash
Clinical narrative: 10 min after administrating ROTATEQ baby developed redness on face - chest & back. Administered @ 11:50 am - rash 12 pm (on 3-6-09).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Pain in extremity, Paraesthesia
Clinical narrative: The day post vaccine child c/o pain (sharp) in right hand (vaccine given in left arm) then later in day child c/o pins & needle parasthesia X 4 extremities & sharp pain both lower legs.  Helped by warm bath.  Pulse was 120 @ event.
Age: 7.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site rash, Rash papular, Urticaria
Clinical narrative: At 2 months, patient had rash at location of immunization. At 4 months with no alcohol or band aids used, patient had rash on legs where shots were given. At 6 months, patient developed rash on L thigh which spread to generalized papular urticaria.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Pt received #2 GARDASIL vaccine inj 2-17-09.  1st injection was given at another clinic.  Pt called 2-25-09 & stated shortly after she got home felt an " all over itching sensation".  Denied any rash on other sx.  Pt stated the itching was mild, lasted one week & went away on its own.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting occurred after having vaccines.  Vomiting lasted about 10 hours.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Vomiting occurred after having vaccines.  Vomiting lasted about 10 hours.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and low grade fever occurred after receiving vaccines, vomited X 1.
Age: 34.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Livedo reticularis, Rash macular, Skin discolouration
Clinical narrative: 8 days post yellow fever vaccination (SQ) member noted a small area of redness at the site  of his vaccination. By this afternoon the area of redness had increased to about 2"x 2". There was no pain, burning, itching, or swelling. The rash is macular, red mottled in character with a few 1/2 - 3/4" areas of lighter tan coloration. There is no palpable pain or in duration. While there had been no issue at the time of his vaccination, two days later he noted significant pain at the site while his blood pressure was being taken. He has never had difficulty with any vaccinations in the past. The day earlier he received a Typhoid vaccination in the same arm (but IM in the deltoid). He denies any systemic symptoms. Symptoms: Rash, Focal.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site cellulitis
Clinical narrative: Left upper arm cellulitis - treated with SEPTRA Ds and NAPROSYN.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Cellulitis
Clinical narrative: Left upper arm cellulitis - treated with SEPTRA Ds and NAPROSYN.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: Arthralgia - severe, malaise- severe, fatigue severe, headache- moderate, swelling/induration, redness, diarrhea, chills-moderate, pain-severe- took 500mg acetaminophen every 4-6hrs..
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Induration, Malaise, Pain, Swelling
Clinical narrative: Arthralgia - severe, malaise- severe, fatigue severe, headache- moderate, swelling/induration, redness, diarrhea, chills-moderate, pain-severe- took 500mg acetaminophen every 4-6hrs..
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Pt received TDAP. He developed fever & headache x 4 days. Per mom they brought him to urgent care. Now he is better.
Age: 66.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approx 4 hours after injection patient experienced redness and a hard area about the size of a fist. Swelling from injection site to wrist. Warm to the touch and very painful. Took Advil and cold compresses. 5 days later no symptoms.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Fatigue, Headache, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Moderate fever for several days then "chicken pox" rash which eventually spread over entire body, fatigue - I (her mother) have ended up with about 10 "chicken pox", headache and itching.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Moderate fever for several days then "chicken pox" rash which eventually spread over entire body, fatigue - I (her mother) have ended up with about 10 "chicken pox", headache and itching.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Haematocrit increased, Lymphocyte percentage decreased, Platelet count increased, Rash
Clinical narrative: Crystallia sudamina rash developed on body trunk and upper extremities 30 min after administration. Vaccine is Trimovax of Sanofi Pasteur Lot No shown below.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Stool analysis normal, White blood cell count increased
Clinical narrative: Crystallia sudamina rash developed on body trunk and upper extremities 30 min after administration. Vaccine is Trimovax of Sanofi Pasteur Lot No shown below.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Joint swelling, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Stiffness, very painful and swollen wrists, hands, and knee for duration of close to 2 weeks, appearing 2 weeks and 5 days after administration of vaccine.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, TYP
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Mobility decreased, Paraesthesia oral
Clinical narrative: Became highly anxious after vaccines given.  Reported tingling in mouth, numbness in feet, and diff. breathing. States couldn't move legs.  Epinephrine inj. given verbalizes relief after 20 min, left area after 30 min.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abnormal behaviour, Fatigue, Headache, Hypersomnia, Menorrhagia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 01-NOV-2006, an 18 year old female with seasonal and sinus allergies, was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653978/0955F) and was vaccinated with influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant medications included: NASONEX, PSEUDOVEN substituted for ENTEX, CLARITIN and triamcinolene acetonide. It was reported that patient experienced headaches, periods were very erratic. She would have them every 14 days at times, and others just spotting. Very bad cramps and periods were heavier after the first GARDASIL shot. Was not her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept a lot during the day which she never did. Never had any other problems prior to the GARDASIL shots. She received all three shots in the series. Last shot was 02-MAY-2007. Illness at the time of vaccination: It was reported that patient went in for sinusitis and had a sore throat. She had bad sinus allergies. But they still gave her the shots. Previous vaccinations illnesses: None. The listing indicated that one or more of the events resulted in death. A standard lot check investigation was performed. All in-process quality checks for the lot 653978/0955F 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 center and was released. No further information is available. The original reporting source was not provided. The VAERS ID # is 337797.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Menstrual disorder, Metrorrhagia, Muscle spasms
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 01-NOV-2006, an 18 year old female with seasonal and sinus allergies, was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653978/0955F) and was vaccinated with influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant medications included: NASONEX, PSEUDOVEN substituted for ENTEX, CLARITIN and triamcinolene acetonide. It was reported that patient experienced headaches, periods were very erratic. She would have them every 14 days at times, and others just spotting. Very bad cramps and periods were heavier after the first GARDASIL shot. Was not her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept a lot during the day which she never did. Never had any other problems prior to the GARDASIL shots. She received all three shots in the series. Last shot was 02-MAY-2007. Illness at the time of vaccination: It was reported that patient went in for sinusitis and had a sore throat. She had bad sinus allergies. But they still gave her the shots. Previous vaccinations illnesses: None. The listing indicated that one or more of the events resulted in death. A standard lot check investigation was performed. All in-process quality checks for the lot 653978/0955F 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 center and was released. No further information is available. The original reporting source was not provided. The VAERS ID # is 337797.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abnormal behaviour, Death, Fatigue, Headache, Hypersomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 01-NOV-2006, an 18 year old female with seasonal and sinus allergies, was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653978/0955F) and was vaccinated with influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant medications included: NASONEX, PSEUDOVEN substituted for ENTEX, CLARITIN and triamcinolene acetonide. It was reported that patient experienced headaches, periods were very erratic. She would have them every 14 days at times, and others just spotting. Very bad cramps and periods were heavier after the first GARDASIL shot. Was not her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept a lot during the day which she never did. Never had any other problems prior to the GARDASIL shots. She received all three shots in the series. Last shot was 02-MAY-2007. Illness at the time of vaccination: It was reported that patient went in for sinusitis and had a sore throat. She had bad sinus allergies. But they still gave her the shots. Previous vaccinations illnesses: None. The listing indicated that one or more of the events resulted in death. A standard lot check investigation was performed. All in-process quality checks for the lot 653978/0955F 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 center and was released. No further information is available. The original reporting source was not provided. The VAERS ID # is 337797.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Menorrhagia, Menstrual disorder, Menstruation irregular, Muscle spasms
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 01-NOV-2006, an 18 year old female with seasonal and sinus allergies, was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653978/0955F) and was vaccinated with influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant medications included: NASONEX, PSEUDOVEN substituted for ENTEX, CLARITIN and triamcinolene acetonide. It was reported that patient experienced headaches, periods were very erratic. She would have them every 14 days at times, and others just spotting. Very bad cramps and periods were heavier after the first GARDASIL shot. Was not her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept a lot during the day which she never did. Never had any other problems prior to the GARDASIL shots. She received all three shots in the series. Last shot was 02-MAY-2007. Illness at the time of vaccination: It was reported that patient went in for sinusitis and had a sore throat. She had bad sinus allergies. But they still gave her the shots. Previous vaccinations illnesses: None. The listing indicated that one or more of the events resulted in death. A standard lot check investigation was performed. All in-process quality checks for the lot 653978/0955F 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 center and was released. No further information is available. The original reporting source was not provided. The VAERS ID # is 337797.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Death, Epistaxis, Feeling cold
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 01-NOV-2006, an 18 year old female with seasonal and sinus allergies, was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653978/0955F) and was vaccinated with influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant medications included: NASONEX, PSEUDOVEN substituted for ENTEX, CLARITIN and triamcinolene acetonide. It was reported that patient experienced headaches, periods were very erratic. She would have them every 14 days at times, and others just spotting. Very bad cramps and periods were heavier after the first GARDASIL shot. Was not her normal spunky and happy self. She was very tired and the last few weeks before she passed away, she slept a lot during the day which she never did. Never had any other problems prior to the GARDASIL shots. She received all three shots in the series. Last shot was 02-MAY-2007. Illness at the time of vaccination: It was reported that patient went in for sinusitis and had a sore throat. She had bad sinus allergies. But they still gave her the shots. Previous vaccinations illnesses: None. The listing indicated that one or more of the events resulted in death. A standard lot check investigation was performed. All in-process quality checks for the lot 653978/0955F 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 center and was released. No further information is available. The original reporting source was not provided. The VAERS ID # is 337797.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diet refusal, Faeces discoloured, Haematochezia, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pallor, Surgery, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Appendicectomy, Computerised tomogram abdomen abnormal, Dehydration, Diet refusal, Enema administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Explorative laparotomy, Faeces discoloured, Haematochezia, Ileostomy, Intestinal anastomosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Irritability, Lethargy, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Surgery, Vomiting, Weight decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 month old male patient who on 20-OCT-2008 was vaccinated with a dose of ROTATEQ (lot#661685/0967X) orally. Concomitant therapy included haemophilus B conjugated vaccine (unspecified) (lot#UF505AA) on left leg intramuscularly, PEDIARIX (lot# HC21B150AA) on left leg, and PREVNAR (lot# D05881). On 20-OCT-2008, the patient was in good health. On 16-DEC-2008 the patient woke up during the night, fussy, and did not want to eat. Starting vomiting yellow liquid, got pale, and returned to the clinic to see the doctor, who thought it might be a stomach flu. The diagnosis was probable viral infection. Patient went back home and the situation did not improve. He was not holding anything in his tummy, and in the morning 17-DEC-2008 patient was very dehydrated, had black, pasty, bloody stools. Patient returned to the doctor's office and then he went to the outlying ER. CT of abdomen was performed and noted to be abnormal. On 18-DEC-2008 the patient was transferred to another hospital where attempts to reduce IS with barium enema were unsuccessful. There he had intussusception surgery. Final diagnosis was ileoileal intussusception, s/p exp. lap, bowel resection and ileoileostomy anastamosis, appendectomy. Medical records revealed patient experienced vomiting for 2 days, dark stool, lethargy and weight loss. Patient progressed well and was discharged home. He recovered well and "is now doing fine". On 23-JAN-2009 the patient returned to clinic, s/p IS surgery in good health with surgical scar healing. The listing indicated that one or more of the events required hospitalization and/or were considered to be immediately life-threatening. Original Reporting source was not provided. VAER # 338111. A standard lot check 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood product transfusion, Body temperature increased, Cardiac monitoring, Cardiac murmur, Culture urine negative
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Disorientation, Eye swelling, Kawasaki's disease, Lethargy
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Ocular hyperaemia, Ocular vasculitis, Pyrexia
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Somnolence, Tachycardia, Thermometry
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Ultrasound scan abnormal, Unresponsive to stimuli, Urinary tract infection
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture negative, Blood product transfusion, C-reactive protein increased, CSF cell count normal, Coronary artery aneurysm
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture urine negative, Echocardiogram abnormal, Kawasaki's disease, Platelet count increased, Pyrexia
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Upper respiratory tract infection, White blood cell count increased
Clinical narrative: Vaccines given at 2 mo checkup 12/05/08. On 12/09 developed fever, eval with blood, urine & CSF negative. Defervesced Fever again 12/15, prompted return visit to office & ED at hospital. RSV testing positive. Diagnosed with Kawasaki disease on 12/26/08, treated IVIG x 2 courses, ASPERIN, has coronary artery aneurysms. Being followed closely by cardiology. Plan to report echo - deferred due to URI symptoms. Inflammatory labs better. Most Echo unchanged (Jan 09). In recovery phase.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling. Visual lesion on upper, left arm 3mm. in size. See enclosed photos.