chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On either 28 March 2011, 29 March 2011, 2 April 2011, 8 April 2011 or 13 April 2011 the subject received unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced injection site inflammation, swelling injection site and injection site soreness. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 7 children experienced the same side effects after receiving KINRIX vaccine. The vaccine was administered on 28 March, 29 March, 2 April, 8 April, and 13 April 2011. This is case 7 of 7; see case IDs A0924034A, A0924036A-A0924040A for details of the other reports.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Fever, Chills, Nausea, sore joints, pain at injection site, stomach ache, diarrhea, tiredness, headache,
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, Chills, Nausea, sore joints, pain at injection site, stomach ache, diarrhea, tiredness, headache,
Age: 0.34
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Rash generalised, Rash maculo-papular
Clinical narrative: 5 month old boy received usual 4 month vaccines at clinic on 4/27/11, spiked temp to 102 that night (axillary) and broke out in generalized maculopapular rash on body on 4/28 - 4/29. Otherwise asymptomatic.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Computerised tomogram head, Computerised tomogram normal, Gaze palsy, Protrusion tongue, Tremor
Clinical narrative: Mom report 20sec of body shaking, eye rolling, tongue protrusions one hour after administration of vaccines. Admitted and observed without further events.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased activity, Gait disturbance, Intention tremor, Vomiting
Clinical narrative: Intention tremor of upper extremities beginning several hours after vaccine. Decreased activity level. Vomited several times 2 days after vaccine. Tripping more than usual.
Age: 1.74
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4/13/11 18 cm by 10 cm area of erythema, induration differential warmth on (L) thigh. (L) mid thigh circumference 35cm compared to 27.5cm on the (R).
Age: 1.01
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Diffuse skin rash, some increase in fussiness
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, diaphoresis lasting 1 hour 40 minutes. Div. Med. Director notified. Placed in donor chair, legs elevated, ice packs, water.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Red swollen hot injection site.  Dizziness, chills, tired, achey, headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red swollen hot injection site.  Dizziness, chills, tired, achey, headache.
Age: 32.0
Sex: F
Vaccine: DTP
Symptoms: Chills, Confusional state, Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Chills, muscle weakness, nausea, mental confusion. 9:00 AM (4/29/2011) site of injection is swollen and red and hot to touch. Benadryl taken @ 6:00 pm after trip to clinic due to still suffering from symptoms. Dr gave perscription for antibiotic due to concern of infection at site of injection.
Age: 32.0
Sex: F
Vaccine: DTP
Symptoms: Injection site warmth, Muscular weakness, Nausea
Clinical narrative: Chills, muscle weakness, nausea, mental confusion. 9:00 AM (4/29/2011) site of injection is swollen and red and hot to touch. Benadryl taken @ 6:00 pm after trip to clinic due to still suffering from symptoms. Dr gave perscription for antibiotic due to concern of infection at site of injection.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Tinnitus, Urticaria
Clinical narrative: Initial report was received on 18 April 2011 from another manufacturer, report number WAES 1103USA00040.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from an office manager/medical assistant concerning an approximately 12 month old female patient with allergy to ZITHROMAX developed rash and no pertinent medical history, who on 10-AUG-2007 was vaccinated with a dose of MMR II (Lot # 656428/0203U EXP 24-JUN-2009).  There was no concomitant medication.  The medical assistant reported that the patient was now experiencing hearing loss in her left ear.  "Shortly" after vaccination, the patient developed a rash and 1 day fever.  The patient was seen by an Otolaryngologist in November 2010 and received steroids as treatment.  At the time of the report, the patient had not recovered from hearing loss in her left ear.  The outcome of rash was unknown.  Follow up information has been received in the form of medical records concerning a 12 months old female patient who on 10-AUG-2007 received a dose of MMR II, a dose of VARIVAX (Merck), a dose of ACTHIB and a dose of PREVNAR.  On 12-AUG-2007 the patient developed a fever which was treated with TYLENOL and resolved in one day.  The patient had also developed a fine red rash with macules on her trunk, back, genital area and slightly down her legs on 12-AUG-2007 (also reported as 14-AUG-2007) along with diarrhea and was seen by her physician on 15-AUG-2007.  The patient was noted to have some yellow nasal congestion.  The patient was treated with BENADRYL and CLARITIN in the doctor's office.  The diagnosis was urticaria possibly secondary to immunization.  The patient was seen in the doctor's office on 20-AUG-2007.  On 18-AUG-2007 the rash returned to the patients trunk, back, genital area and around her mouth and neck, which had cleared up 2 days prior.  The fever also returned.  The patient had a sore on the roof of her mouth which the doctor thought might be fungal.  She was diagnosed with hives that were possibly viral.  The patient was prescribed nystatin (manufacturer unknown) swabs, and the patient was to restart the BENADRYL and the CLARITIN.  On 23-FEB-2011 the patient had a consultation with a physician for asymmetric sensorineural hearing loss and tinnitus in her left ear.  Steroid therapy had been unsuccessful.  On 11-MAR-2011 the patient was seen by a physician to follow up on her hearing loss which was felt to be unchanged from the prior visit.  The physician felt that the hearing loss would become progressive and recommended hearing aid placement.  As of the time of this report it is unknown the outcome of diarrhea, rash/hives possibly viral and fever.  The patient has not recovered from sensorineural hearing loss or tinnitus.  The patient's sensorineural hearing loss in her left ear was considered to be disabling by the medical assistant.  Additional information has been requested.  All available medical records will be provided upon request."  Documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Culture tissue specimen, Impetigo, Molluscum contagiosum, Papule
Clinical narrative: Initial report received on 30 July 2010 via a QScan search on the VAERS database, under reference number 384016.  A 25-year-old male patient required emergency room or doctor visit (ER) after he developed suspected vaccinia lesions on 01 March 2010.  The patient had been exposed during a wrestling match with a military person who had received ACAM2000 (lot number not reported) on an unspecified date.  Specimens were collected from the patient and tested PCR positive for vaccinia.  The patient recovered.  The reporter for this case is the same for case number 2010-04089.  Follow-up information was retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had been vaccinated with ACAM2000.  The events for the other 3 patients are captured in case numbers 2010-04089, 2011-02467, and 2011-02468.  The information for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  This case pertains to one of the wrestlers.  The patient was a 26-year-old male (previously reported as 25) with no underlying risk factors.  On 1 March 2010, 2 days after wrestling, the patient developed lesions along the face, neck, chest and arm.  He was subsequently seen by his private physician, who prescribed trimethoprim/sulfamethoxazole for presumed methicillin-resistant Staphylococcus aureus.  On 11 March 2010 his physician referred him to a dermatologist; molluscum contagiosum and impetigo were included in the differential diagnosis, and a culture was sent to a local laboratory.  The dermatologist notified the public health department of the patient's possible exposure to VACV (vaccinia virus) and the patient was evaluated by a public health physician on 12 March 2010.  On examination, the patient was noted to have clinically compatible VACV lesions, including popular umbilicated lesions with overlying vesicles and a few pustules.  Follow-up continued through resolution of the lesions, approximately 3 weeks.  A tissue sample was obtained by unroofing a vesicle, collecting the tissue, performing slide touch preps of the unearthed base of the vesicle, and obtaining viral swabs by using pox collection kits which had been distributed through the state department of health.  The specimen was tested by real-time PCR, and preliminary results indicated VAVC.  Test results were subsequently confirmed, and a complete hemagglutinin gene was sequenced by the CDC (Centers for Disease Control and Prevention) and was identical to that of ACAM2000.  Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Polymerase chain reaction, Rash pustular, Secondary transmission, Skin lesion, Staphylococcal infection
Clinical narrative: Initial report received on 30 July 2010 via a QScan search on the VAERS database, under reference number 384016.  A 25-year-old male patient required emergency room or doctor visit (ER) after he developed suspected vaccinia lesions on 01 March 2010.  The patient had been exposed during a wrestling match with a military person who had received ACAM2000 (lot number not reported) on an unspecified date.  Specimens were collected from the patient and tested PCR positive for vaccinia.  The patient recovered.  The reporter for this case is the same for case number 2010-04089.  Follow-up information was retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had been vaccinated with ACAM2000.  The events for the other 3 patients are captured in case numbers 2010-04089, 2011-02467, and 2011-02468.  The information for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  This case pertains to one of the wrestlers.  The patient was a 26-year-old male (previously reported as 25) with no underlying risk factors.  On 1 March 2010, 2 days after wrestling, the patient developed lesions along the face, neck, chest and arm.  He was subsequently seen by his private physician, who prescribed trimethoprim/sulfamethoxazole for presumed methicillin-resistant Staphylococcus aureus.  On 11 March 2010 his physician referred him to a dermatologist; molluscum contagiosum and impetigo were included in the differential diagnosis, and a culture was sent to a local laboratory.  The dermatologist notified the public health department of the patient's possible exposure to VACV (vaccinia virus) and the patient was evaluated by a public health physician on 12 March 2010.  On examination, the patient was noted to have clinically compatible VACV lesions, including popular umbilicated lesions with overlying vesicles and a few pustules.  Follow-up continued through resolution of the lesions, approximately 3 weeks.  A tissue sample was obtained by unroofing a vesicle, collecting the tissue, performing slide touch preps of the unearthed base of the vesicle, and obtaining viral swabs by using pox collection kits which had been distributed through the state department of health.  The specimen was tested by real-time PCR, and preliminary results indicated VAVC.  Test results were subsequently confirmed, and a complete hemagglutinin gene was sequenced by the CDC (Centers for Disease Control and Prevention) and was identical to that of ACAM2000.  Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia test positive, Vaccinia virus infection
Clinical narrative: Initial report received on 30 July 2010 via a QScan search on the VAERS database, under reference number 384016.  A 25-year-old male patient required emergency room or doctor visit (ER) after he developed suspected vaccinia lesions on 01 March 2010.  The patient had been exposed during a wrestling match with a military person who had received ACAM2000 (lot number not reported) on an unspecified date.  Specimens were collected from the patient and tested PCR positive for vaccinia.  The patient recovered.  The reporter for this case is the same for case number 2010-04089.  Follow-up information was retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had been vaccinated with ACAM2000.  The events for the other 3 patients are captured in case numbers 2010-04089, 2011-02467, and 2011-02468.  The information for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  This case pertains to one of the wrestlers.  The patient was a 26-year-old male (previously reported as 25) with no underlying risk factors.  On 1 March 2010, 2 days after wrestling, the patient developed lesions along the face, neck, chest and arm.  He was subsequently seen by his private physician, who prescribed trimethoprim/sulfamethoxazole for presumed methicillin-resistant Staphylococcus aureus.  On 11 March 2010 his physician referred him to a dermatologist; molluscum contagiosum and impetigo were included in the differential diagnosis, and a culture was sent to a local laboratory.  The dermatologist notified the public health department of the patient's possible exposure to VACV (vaccinia virus) and the patient was evaluated by a public health physician on 12 March 2010.  On examination, the patient was noted to have clinically compatible VACV lesions, including popular umbilicated lesions with overlying vesicles and a few pustules.  Follow-up continued through resolution of the lesions, approximately 3 weeks.  A tissue sample was obtained by unroofing a vesicle, collecting the tissue, performing slide touch preps of the unearthed base of the vesicle, and obtaining viral swabs by using pox collection kits which had been distributed through the state department of health.  The specimen was tested by real-time PCR, and preliminary results indicated VAVC.  Test results were subsequently confirmed, and a complete hemagglutinin gene was sequenced by the CDC (Centers for Disease Control and Prevention) and was identical to that of ACAM2000.  Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Death
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 17 year old female with allergy to animal fur and a history of hay fever on 04-JAN-2011 was vaccinated IM with a second dose of GARDASIL (lot # 666595/0096Z) into right arm and was vaccinated IM with a first dose of MENACTRA (lot # U3432AA) into left arm. Concomitant therapy included NORINYL. It was reported that patient deceased within 30 days of vaccine administration, (date not reported). The original reporting source was not provided. The VAERS ID # is 417137. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (666595/0096Z) 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. No further information is available.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity, Radiculitis brachial
Clinical narrative: Burning pain at injection site & radiating down arm to ring finger & middle finger. Then behind the arm, shoulder blade, scapula, supraspinatus & clavicle. Headache. Stiff neck. Swollen lymph nodes, armpit. Weakness in arm. Cannot lift arm, brush teeth, etc....Pain upon movement of arm & shoulder. Burning pain: shoulder, arms & chest.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Activities of daily living impaired, Headache, Injection site pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Burning pain at injection site & radiating down arm to ring finger & middle finger. Then behind the arm, shoulder blade, scapula, supraspinatus & clavicle. Headache. Stiff neck. Swollen lymph nodes, armpit. Weakness in arm. Cannot lift arm, brush teeth, etc....Pain upon movement of arm & shoulder. Burning pain: shoulder, arms & chest.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Burning pain at injection site & radiating down arm to ring finger & middle finger. Then behind the arm, shoulder blade, scapula, supraspinatus & clavicle. Headache. Stiff neck. Swollen lymph nodes, armpit. Weakness in arm. Cannot lift arm, brush teeth, etc....Pain upon movement of arm & shoulder. Burning pain: shoulder, arms & chest.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: (L) thigh, swollen and spreading cellulitis. Seen 4/22/11 in UC at clinic by PA.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood pressure decreased, Chills, Dizziness, Hot flush, Hyperhidrosis
Clinical narrative: After receiving GARDASIL patient began to feel lightheaded followed by sweating and decrease blood pressure along with chills and hot flashes. Epinephrine 0.3 ml IM given as ordered by MD. 911 was called and patient was transferred to Emergency Dept.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood pressure decreased, Body temperature decreased, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: After receiving GARDASIL patient began to feel lightheaded followed by sweating and decrease blood pressure along with chills and hot flashes. Epinephrine 0.3 ml IM given as ordered by MD. 911 was called and patient was transferred to Emergency Dept.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: After receiving GARDASIL patient began to feel lightheaded followed by sweating and decrease blood pressure along with chills and hot flashes. Epinephrine 0.3 ml IM given as ordered by MD. 911 was called and patient was transferred to Emergency Dept.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: 1-2 minutes after IM GARDASIL, child became pale, diaphoretic, dizzy resolve 15 min; treatment: lying down.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm became red all the way down to patient's hand; swelling of arm also noted.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash left wrist, thigh, ribcage
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis
Clinical narrative: After receiving GARDASIL patients went to the lab. Felt lightheaded and starting sweating profusely as well as heart rate fell below 60. Epinephrine 0.3mg IM given as ordered by MD. Patient was transferred to Emergency Dept. for monitoring.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Body temperature decreased, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: After receiving GARDASIL patients went to the lab. Felt lightheaded and starting sweating profusely as well as heart rate fell below 60. Epinephrine 0.3mg IM given as ordered by MD. Patient was transferred to Emergency Dept. for monitoring.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Malaise, Syncope
Clinical narrative: After receiving GARDASIL patients went to the lab. Felt lightheaded and starting sweating profusely as well as heart rate fell below 60. Epinephrine 0.3mg IM given as ordered by MD. Patient was transferred to Emergency Dept. for monitoring.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood test, Discomfort
Clinical narrative: Information has been received from a pharmacist (Doctor of Pharmacy) concerning a 65 year old male who on 06-JAN-2011 was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (Merck) (lot #1381Z). On 07-JAN-2011 the patient experienced shoulder pain. The pain eventually spread to all his joints. The patient was very uncomfortable and weak. The patient was not able to pick up paper. The patient's physician diagnosed him with polymyalgia rheumatica. The patient was prescribed with prednisone as treatment. Blood test was performed, result unknown. At the time of this report, the patient was recovering from polymyalgia rheumatica. The patient sought medical attention by office visit. Polymyalgia rheumatica was considered to be disabling. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Polymyalgia rheumatica
Clinical narrative: Information has been received from a pharmacist (Doctor of Pharmacy) concerning a 65 year old male who on 06-JAN-2011 was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (Merck) (lot #1381Z). On 07-JAN-2011 the patient experienced shoulder pain. The pain eventually spread to all his joints. The patient was very uncomfortable and weak. The patient was not able to pick up paper. The patient's physician diagnosed him with polymyalgia rheumatica. The patient was prescribed with prednisone as treatment. Blood test was performed, result unknown. At the time of this report, the patient was recovering from polymyalgia rheumatica. The patient sought medical attention by office visit. Polymyalgia rheumatica was considered to be disabling. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose normal, Blood test abnormal, C-reactive protein normal, Joint stiffness, Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacist (Doctor of Pharmacy) concerning a 65 year old male who on 06-JAN-2011 was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (Merck) (lot #1381Z). On 07-JAN-2011 the patient experienced shoulder pain. The pain eventually spread to all his joints. The patient was very uncomfortable and weak. The patient was not able to pick up paper. The patient's physician diagnosed him with polymyalgia rheumatica. The patient was prescribed with prednisone as treatment. Blood test was performed, result unknown. At the time of this report, the patient was recovering from polymyalgia rheumatica. The patient sought medical attention by office visit. Polymyalgia rheumatica was considered to be disabling. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Oedema peripheral, Platelet count increased, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a pharmacist (Doctor of Pharmacy) concerning a 65 year old male who on 06-JAN-2011 was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (Merck) (lot #1381Z). On 07-JAN-2011 the patient experienced shoulder pain. The pain eventually spread to all his joints. The patient was very uncomfortable and weak. The patient was not able to pick up paper. The patient's physician diagnosed him with polymyalgia rheumatica. The patient was prescribed with prednisone as treatment. Blood test was performed, result unknown. At the time of this report, the patient was recovering from polymyalgia rheumatica. The patient sought medical attention by office visit. Polymyalgia rheumatica was considered to be disabling. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Pallor, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health care professional via GlaxoSmithKline (MFR # A0922928A) concerning a 10 weeks old male patient who on 09-FEB-2011, at around 12:00 received the first 0.5 ml dose of PEDIARIX (Lot # AC21B277AA) in the left leg. On the same date, the patient was vaccinated with the first dose of PEDVAXHIB (Lot # 666811/1688Z), PREVNAR (Lot # E12400) and ROTATEQ (Lot # 669070/1268Z). After vaccination, the patient experienced cyanosis, fever, pallor and vomiting and had to be taken to the hospital. The patient was taken to the emergency room. The health care professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered that the events were probably related to vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ. A lot check has been initiated. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood count normal, Electrocardiogram normal, Intensive care, Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with no relevant medical history who on 22-APR-2011, was vaccinated with the third dose of GARDASIL (Lot number not reported). There was no concomitant medication. The patient's relevant past drug history was unknown. On 22-APR-2011, about 4 hours later, the patient's mother contacted the physician and told him that her daughter complained of stomach pain and shortly thereafter had a syncopal episode. On the same date, the patient was took to a local emergency room (ER) and blood count, urinalysis and electrocardiogram were done. The results of every test were normal. On 22-APR-2011, while in the ER, about 4 hours after the first syncopal episode, the patient experienced stomach pain again followed by another syncopal episode. On 22-APR-2011, the patient was admitted to the Intensive Care Unit of the hospital. As of 22-APR-2011, the patient was doing okay per doctor's report. The stomach pain and syncopal episode were considered to be serious due to hospitalization. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with no relevant medical history who on 22-APR-2011, was vaccinated with the third dose of GARDASIL (Lot number not reported). There was no concomitant medication. The patient's relevant past drug history was unknown. On 22-APR-2011, about 4 hours later, the patient's mother contacted the physician and told him that her daughter complained of stomach pain and shortly thereafter had a syncopal episode. On the same date, the patient was took to a local emergency room (ER) and blood count, urinalysis and electrocardiogram were done. The results of every test were normal. On 22-APR-2011, while in the ER, about 4 hours after the first syncopal episode, the patient experienced stomach pain again followed by another syncopal episode. On 22-APR-2011, the patient was admitted to the Intensive Care Unit of the hospital. As of 22-APR-2011, the patient was doing okay per doctor's report. The stomach pain and syncopal episode were considered to be serious due to hospitalization. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blepharitis, Blister, Erythema, Erythema of eyelid, Papule
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Secondary transmission, Secretion discharge, Skin lesion, Slit-lamp examination
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blepharitis, Blister, Erythema, Erythema of eyelid, Exposure to vaccinated person
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Rash papular, Secondary transmission, Secretion discharge, Skin lesion
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Slit-lamp examination, Vaccinia virus infection
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Exposure to vaccinated person, Papule, Polymerase chain reaction, Pruritus
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011. It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine. The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02467; the case for the military service member is captured in 2011-02465. This case involves tertiary spread of vaccinia due to inadvertent inoculation. This case was coded as secondary transmission despite the reported term of tertiary transmission due to coding limitations. Abstract: During February and March 2010, the State Department of Health investigated secondary and tertiary vaccinia contact transmission from a military vaccinee to 4 close contacts. Identification of these cases underscores the need for strict adherence to postvaccination infection control guidance to avoid transmission of the live virus. On 23 February 2010, a military service member received ACAM2000 in preparation for deployment. On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached. On 5 March 2010, one of the exposed wrestlers participated in another wresting match with a 25-year-old male whose information is captured in this case. The patient had a history of recent mild eczema involving his hands; in addition, he was a roommate of the vaccinee. On 7 March 2010, 2 days after his wresting match with one of the exposed wrestlers from the 27 February 2010 match, he developed lesions, described as pruritic papules, on the chest, trunk, and arm. On 10 March 2010 he sought treatment for the lesions. His physician thought the lesions appeared to be molluscum contagiosum, however given the patient's history he consulted an infectious disease physician who observed lesions compatible with vaccinia virus (VACV). At his public health evaluation on 12 March 2010, he was noted to have grouping of vesicular lesions with central umbilication on mildly erythematous bases on his trunk, with a solitary lesion near his left areola and on the volar aspect of his right forearm. VACV was clinically diagnosed. The patient was followed until he had complete lesion resolution, approximately 7 weeks. A tissue sample was obtained by unroofing a vesicle, collecting the tissue, performing slide touch preps of the unearthed base of the vesicle, and obtaining viral swabs by using pox collection kits which had been distributed through the state department of health. The specimen was treated by real-time PCR, and preliminary results indicated VAVC. Test results were subsequently confirmed, and a complete hemagglutinin gene was sequenced by the CDC (Centers for Disease Control and Prevention) and was identical to that of ACAM2000. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash vesicular, Secondary transmission, Skin lesion, Vaccinia virus infection, Viral test positive
Clinical narrative: Initial case retrieved from the scientific literature on 25 April 2011. It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine. The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02467; the case for the military service member is captured in 2011-02465. This case involves tertiary spread of vaccinia due to inadvertent inoculation. This case was coded as secondary transmission despite the reported term of tertiary transmission due to coding limitations. Abstract: During February and March 2010, the State Department of Health investigated secondary and tertiary vaccinia contact transmission from a military vaccinee to 4 close contacts. Identification of these cases underscores the need for strict adherence to postvaccination infection control guidance to avoid transmission of the live virus. On 23 February 2010, a military service member received ACAM2000 in preparation for deployment. On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached. On 5 March 2010, one of the exposed wrestlers participated in another wresting match with a 25-year-old male whose information is captured in this case. The patient had a history of recent mild eczema involving his hands; in addition, he was a roommate of the vaccinee. On 7 March 2010, 2 days after his wresting match with one of the exposed wrestlers from the 27 February 2010 match, he developed lesions, described as pruritic papules, on the chest, trunk, and arm. On 10 March 2010 he sought treatment for the lesions. His physician thought the lesions appeared to be molluscum contagiosum, however given the patient's history he consulted an infectious disease physician who observed lesions compatible with vaccinia virus (VACV). At his public health evaluation on 12 March 2010, he was noted to have grouping of vesicular lesions with central umbilication on mildly erythematous bases on his trunk, with a solitary lesion near his left areola and on the volar aspect of his right forearm. VACV was clinically diagnosed. The patient was followed until he had complete lesion resolution, approximately 7 weeks. A tissue sample was obtained by unroofing a vesicle, collecting the tissue, performing slide touch preps of the unearthed base of the vesicle, and obtaining viral swabs by using pox collection kits which had been distributed through the state department of health. The specimen was treated by real-time PCR, and preliminary results indicated VAVC. Test results were subsequently confirmed, and a complete hemagglutinin gene was sequenced by the CDC (Centers for Disease Control and Prevention) and was identical to that of ACAM2000. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen, warm, red and firm to touch from right shoulder down to right elbow.
Age: 0.8
Sex: F
Vaccine: DTAP
Symptoms: Cough, Diarrhoea, Eye discharge, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Diarrhea, Cold-like symptoms (coughing, dripping nose and a leaking left eye)
Age: 14.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Endotracheal intubation, Guillain-Barre syndrome, Immediate post-injection reaction, Lumbar puncture
Clinical narrative: Onset immediate, result GBS. Hospitalization, intubation, 6 treatments plasma exchange. Rehabilitation inpatient and outpatient July 2009 - May 2010. Still debilitating residual effects - will be lifelong health problems.
Age: 14.0
Sex: F
Vaccine: DTAP
Symptoms: Plasmapheresis
Clinical narrative: Onset immediate, result GBS. Hospitalization, intubation, 6 treatments plasma exchange. Rehabilitation inpatient and outpatient July 2009 - May 2010. Still debilitating residual effects - will be lifelong health problems.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Bedridden, Chills, Immobile, Pain
Clinical narrative: Within an hour after injection, severe pain over entire body and chills were experienced immobilizing patient (bed-ridden) for over a week. A trip to Dr. resulted in hospitalization due to adv. reaction.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: 4 cm area of fluctuant subcutaneous fluid at (L) lateral thigh, slightly raised, very tender, with multiple small (L) inguinal L nodes enlarged and tender to touch. OMNICEF Day 7.