chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Injection site warmth, Pallor
Clinical narrative: Localized shot rxn. 4.5 x 4.5cm (L) thigh ant/lateral. 3.5 x 1.5 cm (R) thigh ant/lateral. (+) blanching, warm, NT.
Age: 1.07
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: MOTHER REPORTS CHILD HAS CHICKEN POX. PT WAS SEEN IN OFFICE ON 06/16/2011 AT 11:00 AM BY DR. AND IT WAS CONFIRMED THAT HE DOES HAVE THE VARICELLA VIRUS.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore, red arm.  Chills.  Sore muscles and fever.  Took Vicodin and went to bed at 8;30 PM. After three days, arm is still sore and red. Fever and muscle pain is gone.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Swelling face
Clinical narrative: Child had a swollen left cheek and fever of 102. The parotid was not swollen. Child was irritable for about 3 days with fever.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Slow response to stimuli
Clinical narrative: Parents stated that she was "sort of out of it, like not as responsive on that day" and then she was uncharacteristically irritable for a few weeks".  They did not report this until the 4 month visit when considering the next vaccines.  They said she was "back to her normal self, but that it was gradual and they couldn't say when the irritability was completely gone".
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: fever >101
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: 13 X 8 cm area of induration and erythema and fever 100.1
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest pain, Loss of consciousness, Obesity
Clinical narrative: Pt had a brief LOC after he was alert approx 20 min. after he received 3 vaccines. He was observed for another hour. Grandma called on 6-15-11 to report that the pt had experienced CP 3 days ago after running. Reassurance provided. Pt's caregiver was instructed to come in if persistent C.P.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Pt had a 14 hr cry spell - OTC TYLENOL not helpful. No fever or other - inconsolable cry x 14 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received vaccine in (L) upper arm, on 6/14 pain started Tues. night. Redness & swelling noted Wed.
Age: 32.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Injection site pain, Pain, Paraesthesia, Swelling
Clinical narrative: Pt states soreness and swelling within hours of injection. Has had mild constant dull nonradiating pain in arm (Left) at site of injection. Has had intermittent tingling sensation in entirety of forearm and hand involving all fingers. Unresolved at this time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis
Clinical narrative: large amount of cellulitis 3.5 in x 2.5 in on right upper arm
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Nausea, emesis, dizziness, pallor. Immediately placed in supine position & raised legs. Provided cool cloth to head & offered water to drink. BP 92/60, HR 80. Continued to monitor for 30 minutes until pt improved to pre-vaccination status.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: DEVELOPED A RED SWOLLEN HOT AREA AT THE SITE OF INJECTION. THE AREA WAS LARGE EXTENDING HALF OF HER UPPER ARM. NEXT DAY HAD FEVER, HEADACHE AND ACHES.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: DEVELOPED A RED SWOLLEN HOT AREA AT THE SITE OF INJECTION. THE AREA WAS LARGE EXTENDING HALF OF HER UPPER ARM. NEXT DAY HAD FEVER, HEADACHE AND ACHES.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain, Pyrexia
Clinical narrative: 12 hours of fever 103 d, denies other sx except achy
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Arm sore, swollen, placed ice pack on arm.  By 11:30 PM had chills, nausea.  Took ibuprofen, slept until am. By 1:30 PM 6/14/11 again arm very sore, red, chills, nausea, fever 101.4.  Took more ibuprofen, called Employee Health Clinic. Advised to see medical provider but wanted to wait to see if symptoms would improve. Arm swollen and red on 6/15/11. Went to see doctor and was placed on antibiotics.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Arm sore, swollen, placed ice pack on arm.  By 11:30 PM had chills, nausea.  Took ibuprofen, slept until am. By 1:30 PM 6/14/11 again arm very sore, red, chills, nausea, fever 101.4.  Took more ibuprofen, called Employee Health Clinic. Advised to see medical provider but wanted to wait to see if symptoms would improve. Arm swollen and red on 6/15/11. Went to see doctor and was placed on antibiotics.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain, Pyrexia, Skin warm
Clinical narrative: Initial swelling, then 5 inch by 4 inch area near shot side became red, hot to touch and EXTREMELY sore. Later, I felt very ill (achy) and feverish.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Initial swelling, then 5 inch by 4 inch area near shot side became red, hot to touch and EXTREMELY sore. Later, I felt very ill (achy) and feverish.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Joint swelling, Pain in extremity
Clinical narrative: Pain and redness in lower legs. Swollen ankles later the next day treated by family doctor as cellulitis. Put on Antibiotic.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: 2 days after vaccine was administered 3 small lesions appeared on arm close to administration site. Also lesion on both lower and right quadrant of abdomen.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: 5-14-11 developed (Lt) arm swelling - red and hot over the Tdap injection site (Lt) delt. Pt. went to ER and was diagnosed with cellulitis. Treated with antibiotics.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Pt rec'd ZOSTAVAX shot 6/14/11. Pt states the following day she noticed her jaws & cheeks were puffy & lips & cheeks were swelling. Pt was advised.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm in deltoid region is painful, redness, swollen, and hardness with warmness to touch.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Red, raised, area. 8cm x 6cm on (L) upper arm.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) deltoid is mildly erythematous, warm, approx 4" x 5", non-tender, no local reactive lymphadenopathy - recommend ice/ibuprofen.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site macule, Injection site rash
Clinical narrative: Patient developed flat, red rash and bruising at site of injection. No complaints of pain, itching, or other symptoms.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Pt. received varicella et PPD on 6-14-11. Pt. presented 6-16-11 to have PPD read et notified nurse of possible reaction. Pt presented with a 5cm x 3.5cm area that is raised, red, et itching, surrounded by a pink parameter measuring 10cm x 7cm total. Area is tender touch and without warmth. Pt denies fever, nausea, et vomiting. Pt advised to use BENADRYL for itching et cold compress for pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: 5 x 5 cm area of erythema & edema & tenderness over (L) deltoid & 101 degrees fever last PM.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Received GARDASIL #1 6-14-11. 6-15-11 broke out in generalized hives (< 24 hours after vaccine). Tx'd with BENADRYL. Still experiencing (6-16-11).
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Pt had swelling & hives of his hands and feet on 6/15/11. He was treated at hospital ER with BENADRYL and prednisone.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 10 x 12 cm red area (R) arm at inj site. Area warm to touch. Tx'd with BENADRYL 50mg po q 6hrs and ADVIL PRN. Low grade fever over wknd.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Circulatory collapse, Death, Dyspnoea, Epistaxis
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A male infant patient (age not reported) with no medical history, received an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number unknown, and an injection (route and site not reported) HEPATITIS B VIRUS, manufacturer and lot number unknown. On an unknown date within 2-3 hours after receiving the vaccines the patient developed anaphylaxis. The patient became unresponsive in the car. He had a nosebleed and was found in respiratory arrest. The patient died (date not reported). The patient had a tryptase level of 79 ng/mL. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Hyperhidrosis, Loss of consciousness, Respiratory arrest, Tryptase, Unresponsive to stimuli
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A male infant patient (age not reported) with no medical history, received an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number unknown, and an injection (route and site not reported) HEPATITIS B VIRUS, manufacturer and lot number unknown. On an unknown date within 2-3 hours after receiving the vaccines the patient developed anaphylaxis. The patient became unresponsive in the car. He had a nosebleed and was found in respiratory arrest. The patient died (date not reported). The patient had a tryptase level of 79 ng/mL. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death, Epistaxis, Respiratory arrest, Tryptase increased
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A male infant patient (age not reported) with no medical history, received an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number unknown, and an injection (route and site not reported) HEPATITIS B VIRUS, manufacturer and lot number unknown. On an unknown date within 2-3 hours after receiving the vaccines the patient developed anaphylaxis. The patient became unresponsive in the car. He had a nosebleed and was found in respiratory arrest. The patient died (date not reported). The patient had a tryptase level of 79 ng/mL. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A male infant patient (age not reported) with no medical history, received an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number unknown, and an injection (route and site not reported) HEPATITIS B VIRUS, manufacturer and lot number unknown. On an unknown date within 2-3 hours after receiving the vaccines the patient developed anaphylaxis. The patient became unresponsive in the car. He had a nosebleed and was found in respiratory arrest. The patient died (date not reported). The patient had a tryptase level of 79 ng/mL. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A male infant patient (age not reported) with no medical history, received an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number unknown, and an injection (route and site not reported) HEPATITIS B VIRUS, manufacturer and lot number unknown. On an unknown date within 2-3 hours after receiving the vaccines the patient developed anaphylaxis. The patient became unresponsive in the car. He had a nosebleed and was found in respiratory arrest. The patient died (date not reported). The patient had a tryptase level of 79 ng/mL. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, and 2011-03333. Documents held by sender: None.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoeic attack, Condition aggravated, Death, Endotracheal intubation, Hypopnoea
Clinical narrative: Information has been received from a physician concerning a 14 week old male patient with medical history of premature birth, congenital heart and lung disease and reflux and with no drug reaction/allergies who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ. Concomitant medications included: ZANTAC and vitamins (unspecified) (POLY-VI-SOL). The patient spit half the first dose out. On 24-FEB-2011 the patient died at home. It was unknown if the patient had sought medical attention. No specified treatment was given to the patient. There was no lab diagnostic test performed. The information about the lot number and the cause of death were unknown. Follow up information has been received from the physician concerning the 14 week old male patient with no drug reaction/allergies and medical history of premature birth (born at 25 weeks gestation), congenital heart and lung disease, reflux and a diagnosis of chronic dermatitis who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ (lot number 669071/1269Z) (dosing delayed due to pre-maturity). Concomitant vaccines included: PREVNAR 13 (lot number 915704) and PENTACEL (lot number C3815AA). During the night baby went into respiratory arrest and was rushed to the emergency room and died in emergency room (rather than at home as was previously reported) on 24-FEB-2011. An autopsy was performed but the physician said the results were with the legal department and the death certificate also with legal department so the physician could not provide a cause of death. The physician felt that the death was not related to the ROTATEQ vaccine. Upon internal review, respiratory arrest was considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Pulse absent, Respiratory rate decreased, Resuscitation, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 week old male patient with medical history of premature birth, congenital heart and lung disease and reflux and with no drug reaction/allergies who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ. Concomitant medications included: ZANTAC and vitamins (unspecified) (POLY-VI-SOL). The patient spit half the first dose out. On 24-FEB-2011 the patient died at home. It was unknown if the patient had sought medical attention. No specified treatment was given to the patient. There was no lab diagnostic test performed. The information about the lot number and the cause of death were unknown. Follow up information has been received from the physician concerning the 14 week old male patient with no drug reaction/allergies and medical history of premature birth (born at 25 weeks gestation), congenital heart and lung disease, reflux and a diagnosis of chronic dermatitis who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ (lot number 669071/1269Z) (dosing delayed due to pre-maturity). Concomitant vaccines included: PREVNAR 13 (lot number 915704) and PENTACEL (lot number C3815AA). During the night baby went into respiratory arrest and was rushed to the emergency room and died in emergency room (rather than at home as was previously reported) on 24-FEB-2011. An autopsy was performed but the physician said the results were with the legal department and the death certificate also with legal department so the physician could not provide a cause of death. The physician felt that the death was not related to the ROTATEQ vaccine. Upon internal review, respiratory arrest was considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Regurgitation, Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a 14 week old male patient with medical history of premature birth, congenital heart and lung disease and reflux and with no drug reaction/allergies who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ. Concomitant medications included: ZANTAC and vitamins (unspecified) (POLY-VI-SOL). The patient spit half the first dose out. On 24-FEB-2011 the patient died at home. It was unknown if the patient had sought medical attention. No specified treatment was given to the patient. There was no lab diagnostic test performed. The information about the lot number and the cause of death were unknown. Follow up information has been received from the physician concerning the 14 week old male patient with no drug reaction/allergies and medical history of premature birth (born at 25 weeks gestation), congenital heart and lung disease, reflux and a diagnosis of chronic dermatitis who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ (lot number 669071/1269Z) (dosing delayed due to pre-maturity). Concomitant vaccines included: PREVNAR 13 (lot number 915704) and PENTACEL (lot number C3815AA). During the night baby went into respiratory arrest and was rushed to the emergency room and died in emergency room (rather than at home as was previously reported) on 24-FEB-2011. An autopsy was performed but the physician said the results were with the legal department and the death certificate also with legal department so the physician could not provide a cause of death. The physician felt that the death was not related to the ROTATEQ vaccine. Upon internal review, respiratory arrest was considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a 14 week old male patient with medical history of premature birth, congenital heart and lung disease and reflux and with no drug reaction/allergies who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ. Concomitant medications included: ZANTAC and vitamins (unspecified) (POLY-VI-SOL). The patient spit half the first dose out. On 24-FEB-2011 the patient died at home. It was unknown if the patient had sought medical attention. No specified treatment was given to the patient. There was no lab diagnostic test performed. The information about the lot number and the cause of death were unknown. Follow up information has been received from the physician concerning the 14 week old male patient with no drug reaction/allergies and medical history of premature birth (born at 25 weeks gestation), congenital heart and lung disease, reflux and a diagnosis of chronic dermatitis who on 23-FEB-2011 was vaccinated orally with the first dose of ROTATEQ (lot number 669071/1269Z) (dosing delayed due to pre-maturity). Concomitant vaccines included: PREVNAR 13 (lot number 915704) and PENTACEL (lot number C3815AA). During the night baby went into respiratory arrest and was rushed to the emergency room and died in emergency room (rather than at home as was previously reported) on 24-FEB-2011. An autopsy was performed but the physician said the results were with the legal department and the death certificate also with legal department so the physician could not provide a cause of death. The physician felt that the death was not related to the ROTATEQ vaccine. Upon internal review, respiratory arrest was considered to be an other important medical event. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Kinrix (DTaP/IPV) instead of Pediarix (DTaP/IPV/HepB). Patient tolerated the vaccine well. No fever or any illness reported by the mother.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Varicella virus test negative
Clinical narrative: Information has been received from a certified nurse midwife (CNM) for a VARIVAX (Merck), a pregnancy registry product, concerning a 15 years old female patient with a history of gestational hypertension and 3 months of postpartum. No drug and allergies reactions were known, who on 18-MAR-2011, was vaccinated with a dose of VARIVAX (Merck) (lot # not reported). Unspecified pregnancy test was done on an unknown date and the nurse reported that the patient was pregnant and she had not had a period during the postpartum time. Estimated date of delivery was in 2011. The patient received unspecified medical attention. No adverse event was reported. Follow up information has been received from the CNM via complete pregnancy questionnaire concerning the 15 year old patient, with one previous full-term delivery pregnancy with no birth defects and no history of stillbirth or miscarriage in any previous pregnancies. It was reported that patient's last menstrual period was on 01-JAN-2011 and estimated delivery date 08-OCT-2011. The CNM also indicated that on an unspecified date, the patient was tested for varicella antibodies before vaccination with VZV containing vaccine, which resulted negative. The CNM reported that the patient had no local reaction at vaccination site. It was unknown if the patient had varicella/herpes zoster symptoms post vaccination. It was reported that there were no complications during pregnancy. The CNM also reported that on an unspecified date, the patient had an elective termination of pregnancy. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: 3 min following vaccine administration pt was sitting on exam table and suddenly became pale, diaphoretic, and c/o feeling nauseous. She immed laid down and felt better within 5 min - *had not eaten or had anything to drink this am prior to appt*.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Decreased appetite, Erythema, Irritability, Oral disorder
Clinical narrative: Red swollen spots - blisters filled with fluid - fever - fussy - loss of appt - lesions in mouth - itchiness all over body - dry lesions - (pt) also tested (+) for pharyngitis. Treatment: ROCEPHIN 250mg, ZOVIRAX 200/5, AUGMENTIN 200/5, BACTROBAN, Triamcinolone.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pharyngitis, Pruritus generalised, Pyrexia, Skin lesion, Swelling
Clinical narrative: Red swollen spots - blisters filled with fluid - fever - fussy - loss of appt - lesions in mouth - itchiness all over body - dry lesions - (pt) also tested (+) for pharyngitis. Treatment: ROCEPHIN 250mg, ZOVIRAX 200/5, AUGMENTIN 200/5, BACTROBAN, Triamcinolone.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling 6 x 7 cm. Vaccine arm injection sites (Both) deltoid areas.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Full blood count normal, Injection site urticaria, Periorbital oedema, Radioallergosorbent test negative
Clinical narrative: Urticaria on trunk, arms, face, legs, signif itch. Temp to 103 F x 24 hours. Mild periorbital edema, all beginning about 6 hours after vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate normal, Urticaria
Clinical narrative: Urticaria on trunk, arms, face, legs, signif itch. Temp to 103 F x 24 hours. Mild periorbital edema, all beginning about 6 hours after vaccine administration.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Eating disorder, Enema administration, Haematochezia, Intussusception, Lethargy
Clinical narrative: Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible milk allergy. On 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasound of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen
Clinical narrative: Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible milk allergy. On 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasound of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Haematochezia, Intussusception, Somnolence
Clinical narrative: Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible milk allergy. On 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasound of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Abdominal pain upper, Crying, Irritability
Clinical narrative: He reacted to the Rotavirus vaccine. He had stomach pain, very severe crying in long episodes and extremely irritable this lasted for 8 days from the vaccine.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Local swelling & erythema.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a Medical Assistant concerning her female baby whose mother was vaccinated with GARDASIL, a Pregnancy Registry product. The patient was born at 36 weeks gestation via vaginal delivery with a "birth mark on her lip" classified as a "hemangioma". The baby's health otherwise was good, no other problems encountered. The baby weighed in at 6 lbs, 10 oz. At the time of the report, the outcome of hemangioma was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a pediatrician reported that the haemangioma was 2 mm in size. The pediatrician stated that the haemangeioma will grow for the first year. The patient's haemangioma was under a dermatologist's observation (dermatologist's name or contact information was not reported). The mother's experience was previously reported in WAES#1009USA03287. Upon internal review, haemangioma was considered to be a congenital anomaly. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician and nurse concerning a 22 year old female who on unspecified dates was vaccinated with all three 0.5 ml doses of GARDASIL (therapy route and lot # not provided). On an unspecified date, the patient tested positive for human papillomavirus (HPV). It was unknown whether patient sought medical attention. At the time of reporting, the patient's status was not provided. Follow-up information has been received on 07-JUN-2011 from a physician and medical records concerning a 22 year old female. No pre-existing allergies, birth defects, medical conditions and/or adverse events following prior vaccination were reported. On 20-SEP-2007, the patient received first dose of GARDASIL (lot # 658560/1062U) intramuscular injection. On 27-NOV-2007, the patient received her second dose of GARDASIL (lot # 659055/1522U) left arm. On 24-MAR-2008, the patient received her third dose of GARDASIL (lot # 659964/1978U) left arm. The physician noted on 08-MAR-2011 at 11:40, results from a cytology report of the cervix/endocervix showed atypical squamous cells of undetermined significance and human papillomavirus ad HPV (high risk for HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68). The physician considered the events to be other important medical events. The physician reported the patient had recovered. All available medical records will be provided upon request. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death, Thrombosis
Clinical narrative: A consumer reported that he/she read an internet concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient died of "clot blood" eight hours after vaccination. This is one of several reports from the same source. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse, for GARDASIL a Pregnancy Registry product concerning a 25 year old female patient who on 28-APR-2010 was vaccinated with the first dose of GARDASIL (Lot# 665607/1332Y exp date unknown) and on 01-JUL-2010 with the second dose of GARDASIL (Lot#665768/1354Y exp date unknown). The nurse reported that after receiving the 2 doses of GARDASIL the patient did two home pregnancy tests that were both positive. The patient's last menstrual period (LMP) was 13-JUN-2010 and her estimated date of delivery (EDD) was 20-MAR-2011. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse concerning the 25 year old female with no illness at time of vaccination who on 01-JUL-2010 was vaccinated intramuscularly at right deltoid with the second dose of GARDASIL (Lot#665768/1354Y). Secondary suspected vaccination included the first dose of BOOSTRIX (Lot# AC52B061BA) which received intramuscularly at left deltoid on 01-JUL-2010. The registered nurse stated that the patient was pregnant at that time but did not know of the pregnancy. Follow-up information has been received from a registered nurse who reported that the patient "miscarried about 1 month after GARDASIL was given" as disclosed (to her office) via verbal report. The source of this verbal report was unknown at time of return call. The reporter did not have on record any name of OB/GYN or general care physicians following patient. There was no record of fetal viability. Upon internal review, miscarried was considered to be an other important medical event. No further information is available.
Age: 1.45
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the investigator participating in post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3192BA received on 08 June 2010 and three prior doses of PENTACEL; lot number C3162BA received on 14 July 2009, lot number C3166AA received on 13 April 2009, and lot number C2881AA received on 23 February 2009 (lot numbers were consistent for DTAP-IPV component of PENTACEL; route and sites of administration not reported). The subject developed cold-like symptoms approximately 10 months after the last dose. On 08 April 2011, the subject developed a paroxysmal cough without a whoop. He also experienced posttussive vomiting. Laboratory testing included positive PCR on 14 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 April 2011 for five days. The subject was not hospitalized. At the time of final contact 20 April 2011, the subject's cough had resolved. The duration of the cough was reported at the time of as 18 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Age: 1.45
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the investigator participating in post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3192BA received on 08 June 2010 and three prior doses of PENTACEL; lot number C3162BA received on 14 July 2009, lot number C3166AA received on 13 April 2009, and lot number C2881AA received on 23 February 2009 (lot numbers were consistent for DTAP-IPV component of PENTACEL; route and sites of administration not reported). The subject developed cold-like symptoms approximately 10 months after the last dose. On 08 April 2011, the subject developed a paroxysmal cough without a whoop. He also experienced posttussive vomiting. Laboratory testing included positive PCR on 14 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 April 2011 for five days. The subject was not hospitalized. At the time of final contact 20 April 2011, the subject's cough had resolved. The duration of the cough was reported at the time of as 18 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Age: 0.86
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL (lot numbers not reported); dose 3 received on 28 March 2011, dose 2 received on 05 October 2010, and dose 1 received on 19 July 2010 (route not reported). The subject developed cold-like symptoms (onset not reported) and cough on 11 April 2011, approximately 14 days after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 03 May 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 02 May 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.86
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL (lot numbers not reported); dose 3 received on 28 March 2011, dose 2 received on 05 October 2010, and dose 1 received on 19 July 2010 (route not reported). The subject developed cold-like symptoms (onset not reported) and cough on 11 April 2011, approximately 14 days after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 03 May 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 02 May 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dyspepsia, Headache, Pain, Pyrexia
Clinical narrative: Fever up to 100.5 with Ibuprofen, body aches, chills, headache, SEVERE heartburn after 2nd day. Symptoms lasted about three days. Acid reducer taken for heartburn.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 6 x 2 1/2 cm light erythemic reaction  has a 2 cm red knot in center of left deltoid
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site swelling, Lymph node pain, Lymphadenopathy, Streptococcal infection
Clinical narrative: Left arm where Varivax was administered became swollen and temp of 100F. The next morning lymph nodes under both arms and in neck were swollen and very painful to the extent that he didn't want to put his arms down. This lasted for about 3 days. 5 days after this he was diagnosed with strep.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Not feeling good, no appetite, low grade fever, chills, fatigue.  Vomited later in day.  Barely could walk due to joint pain that night/sat morning.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gait disturbance, Pyrexia, Vomiting
Clinical narrative: Not feeling good, no appetite, low grade fever, chills, fatigue.  Vomited later in day.  Barely could walk due to joint pain that night/sat morning.