chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pulmonary oedema, Sudden death, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID ) # 356434 via a healthcare provider in response to a Freedom-of-Information request by GSK" and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk)  ACTHIB, (non-gsk) PREVNAR and (non-gsk) ROTATEQ. The subject's medical history included colic and thrush. Concurrent medical conditions included reflux (nos). On 15 July 2009 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown. On 9 August 2009, 25 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death nos, petechia on heart, pulmonary edema, co-sleeping, abdominal pain and candidiasis. According to Autopsy report issued on 29 December 2009, the date of death was 09 August 2009. Cause of death: Consistent with sudden unexplained death in infancy. Additional information abstracted: co-sleeping male infant with parental caregivers, petechia of heart, pulmonary edema, no evidence of congenital anomaly, no evidence of trauma, postmortem toxicological screen of the postmortem blood negative for drugs and ethanol, no gross lesion of mouth. Therapeutic procedures include endotracheal intubation and intravascular and intraosseus catheters. The subject was treated with tracheal intubation and intravenous therapy. The subject died on 9 August 2009 from sudden unexpected death in infancy. An autopsy was performed.  Postmortem toxicological screen of the postmortem blood negative for drugs and ethanol.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Choking, Irritability, Respiratory tract congestion, Respiratory tract inflammation, Sudden infant death syndrome
Clinical narrative: This case was reported by a consumer via regulatory authority (Food and Drug Administration (US) # 365428) and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX and PREVNAR (non-gsk). Concurrent medical conditions included lt hydronephrosis. Concurrent medications included AMOXICILLIN. This report was received from the Centers for Disease Control and Prevention (VAERS ID 365428) in response to a Freedom-of-Information request by GSK" and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX and PREVNAR (non-gsk). Concurrent medical conditions included lt hydronephrosis. Concurrent medications included AMOXICILLIN. On 16 October 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ROTARIX (unknown), unspecified dose of PREVNAR (unknown). On 4 November 2008, 19 days after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced fussy. On 5 November 2008, 20 days after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced death nos, choking, irritability, respiratory tract inflammation, and viral infection. At an unspecified time after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced congestion (unknown). The subject was fussy on 04 November 2008; he was hard to calm down in the morning at approximately 04:00 and was making sounds of choking. The subject was picked up and then was fine, he was taken to daycare that morning and at 16:30 he was being rushed to the emergency room. As of 22 December 2009, the death certificate stated the date of death was 05 November 2008, cause of death: Sudden Infant death syndrome (SIDS) at daycare. "Additional information abstracted: had been fussy and more congested lately. Chronic inflammation in the large airways likely due to viral infection".
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Viral infection
Clinical narrative: This case was reported by a consumer via regulatory authority (Food and Drug Administration (US) # 365428) and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX and PREVNAR (non-gsk). Concurrent medical conditions included lt hydronephrosis. Concurrent medications included AMOXICILLIN. This report was received from the Centers for Disease Control and Prevention (VAERS ID 365428) in response to a Freedom-of-Information request by GSK" and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX and PREVNAR (non-gsk). Concurrent medical conditions included lt hydronephrosis. Concurrent medications included AMOXICILLIN. On 16 October 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ROTARIX (unknown), unspecified dose of PREVNAR (unknown). On 4 November 2008, 19 days after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced fussy. On 5 November 2008, 20 days after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced death nos, choking, irritability, respiratory tract inflammation, and viral infection. At an unspecified time after vaccination with PEDIARIX, PREVNAR and ROTARIX, the subject experienced congestion (unknown). The subject was fussy on 04 November 2008; he was hard to calm down in the morning at approximately 04:00 and was making sounds of choking. The subject was picked up and then was fine, he was taken to daycare that morning and at 16:30 he was being rushed to the emergency room. As of 22 December 2009, the death certificate stated the date of death was 05 November 2008, cause of death: Sudden Infant death syndrome (SIDS) at daycare. "Additional information abstracted: had been fussy and more congested lately. Chronic inflammation in the large airways likely due to viral infection".
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-GSK) ACTHIB and (non-GSK) PREVNAR. On an unspecified date the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of PEDIARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown). At an unspecified time after vaccination with ACTHIB, PREVNAR and PEDIARIX, the subject experienced death nos. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Cause of death not confirmed by medical examiner.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Nausea
Clinical narrative: Initial report received from a health care professional via VAERS website (386406) on 30 Sep 2010: This poly medicated patient was vaccinated with MENVEO (batch number: 090901) on an unspecified date. On an unspecified date, the patient experienced chills, nausea, body ache and injection site redness and firm swelling. The patient used warm soaks, topical hydrocortisone cream, TYLENOL, and ibuprofen. The final outcome was reported as completely recovered on 26 Apr 2010.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: Initial report received from a health care professional via VAERS website (386406) on 30 Sep 2010: This poly medicated patient was vaccinated with MENVEO (batch number: 090901) on an unspecified date. On an unspecified date, the patient experienced chills, nausea, body ache and injection site redness and firm swelling. The patient used warm soaks, topical hydrocortisone cream, TYLENOL, and ibuprofen. The final outcome was reported as completely recovered on 26 Apr 2010.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Initial report received from a health care professional via VAERS website (393898) on 30 Sep 2010: This child was vaccinated with MENVEO (batch number: not reported) on an unspecified date. Ten minutes post vaccination, the child experienced nausea, was clammy and dizzy. The outcome of the event was reported as completely recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Initial report received from a health care professional via VAERS website (VAERS 397059) on 25 Oct 2010: This polymedicated patient with medical history of asthma, eczema and ADHD (attention deficit/hyperactivity disorder) was vaccinated with MENVEO (batch number unknown) and ADACEL (manufacturer unknown) on an unspecified date. He had increase hives, redness, swelling at bilateral arms/shoulders radiating to down arms at site of administration of MENVEO and ADACEL on an unspecified date. The outcome of the events was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from health authority (VAERS reference number 398563) on 25 Oct 2010: This patient with unknown medical history was vaccinated with MENVEO (batch number unknown) on an unspecified date. It was reported that, powder component received with sterile water instead of with liquid component which was supplied with vaccine. No adverse events were reported. The outcome of the event was not reported.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from health authority (VAERS reference number 398578) on 25 Oct 2010: This patient with unknown medical history was vaccinated with MENVEO (batch number unknown) on an unspecified date. It was reported that, powder component received with sterile water instead of with liquid component which was supplied with vaccine. No adverse events were reported. The outcome of the event was not reported.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Condition aggravated, Eczema, Reaction to previous exposure to any vaccine
Clinical narrative: Initial report was received from a health care professional on 16 August 2010. A six month old female patient with past medical history of eczema and hemangioma, and who had been taking topical AQUAPHOR, hydrocortisone and desonide concomitantly, had received a second dose intramuscular left thigh injection of PENTACEL, lot number C3573AA/C3404AA, and a second dose intramuscular right thigh injection of PREVNAR (manufacturer Wyeth, lot number E52353), and a second oral dose of ROTATEQ (manufacturer Merck, lot number 1440Y) on 25 May 2010 and 16 days later, she experienced an increased exacerbation of her eczema. The patient had been seen by a dermatologist and was reported to have been recovered. The patient had previously experienced the same event five days after she had received a first dose of PENTACEL (lot number C3573AA/C3404AA), and a first dose of PREVNAR (lot number E44520) and a first dose of ROTATEQ (lot number 0768Y) on 05 April 2010. No further information was provided at the time of this report. Follow-up information was received on 21 September 2010 from a healthcare professional. The patient had a dermatological evaluation on 05 April 2010, 10 April 2010, 15 April 2010, 11 May 2010 and 16 August 2010. On 05 May 2010 the patient was evaluated by a dermatologist and 1% hydrocortisone was changed to desonide on that date. The reporter stated the eczema was an "ongoing event, which appeared to be exacerbated by vaccines". The patient still had eczema, but has improved as of this report. Documents held by sender: none.
Age: 0.89
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Convulsion, Crying, Electroencephalogram normal, Inappropriate schedule of drug administration, Listless
Clinical narrative: Initial report received 12 October 2010 from a consumer, who is also the patient's parent which involved a case of misuse (i.e., inappropriate schedule of vaccine administered). A 10-month-old female patient who had no concurrent illness and no past medical history, had received a first dose intramuscular thigh injection of PENTACEL (lot number unknown) at 10:00 AM on 21 April 2010 and the next day at 5:30 PM, she experienced a seizure which lasted approximately 30 seconds, fever (temperature not specified) and uncontrollable crying. On 23 April 2010, she experienced another episode where she was listless and not focusing which lasted 20 seconds. The patient experienced two additional episodes where she had become non responsive for approximately 10 seconds; once on 17 June 2010 and once on 17 September 2010. On 30 September 2010, an EEG was performed and showed no neurological issues. The patient had no known allergies. Her reported birth weight was three pounds six ounces. Her past vaccination history included one dose of Hepatitis B received at birth with no adverse events experienced following vaccination. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 0.89
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Unresponsive to stimuli, Vision blurred
Clinical narrative: Initial report received 12 October 2010 from a consumer, who is also the patient's parent which involved a case of misuse (i.e., inappropriate schedule of vaccine administered). A 10-month-old female patient who had no concurrent illness and no past medical history, had received a first dose intramuscular thigh injection of PENTACEL (lot number unknown) at 10:00 AM on 21 April 2010 and the next day at 5:30 PM, she experienced a seizure which lasted approximately 30 seconds, fever (temperature not specified) and uncontrollable crying. On 23 April 2010, she experienced another episode where she was listless and not focusing which lasted 20 seconds. The patient experienced two additional episodes where she had become non responsive for approximately 10 seconds; once on 17 June 2010 and once on 17 September 2010. On 30 September 2010, an EEG was performed and showed no neurological issues. The patient had no known allergies. Her reported birth weight was three pounds six ounces. Her past vaccination history included one dose of Hepatitis B received at birth with no adverse events experienced following vaccination. At the time of the report, the patient had not recovered. Documents held by sender: None.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Convulsion
Clinical narrative: Initial report was received 03 November 2010 from a health care professional. A male infant (age not reported) had received PENTACEL, lot number C3784AB (lot number, route, site and date of administration not reported) and an unspecified amount of time later, he experienced seizures. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMRV, PNC13
Symptoms: Blood test abnormal, Food allergy, Urticaria
Clinical narrative: Information has been received from a physician concerning her 15 month old female daughter, who on "18-AUG-2010 or 19-AUG-2010" was vaccinated with a first 0.5 ml dose of PROQUAD (Oka/Merck upgrade process) (Lot # not reported), SQ, and on 18-NOV-2010 was vaccinated with a second 0.5ml dose of PROQUAD (Oka/Merck upgrade process) ( Lot # not reported), SQ. Concomitant therapy included PREVNAR 13, PENTACEL and FLUZONE. They were administered in September 2010, a month before of PROQUAD (Oka/Merck upgrade process) was administered. The physician stated that on 03-DEC-2010 her daughter experienced hives on the mouth and eyes. A blood work was performed, which was positive for peanut allergy. Physician mentioned that this could have been a life threatening reaction, if her daughter had not been treated with BENADRYL right away. Physician also stated that her daughter would have a significant disability/incapacity because this would be a lifelong type of allergy in which an EPIPEN would have to be carried along with BENADRYL and the diet for her daughter would have to be strict. The physician mentioned that her daughter had received HEPATITIS A inactivated at age 12 months on 03-SEP-2010, HEPATITIS B "as an infant" and 3 doses of ROTATEQ last year in 2009. On 03-DEC-2010 the patient recovered from the hives. Hives on the mouth and eyes, were considered to be disabling and an other important medical event. The patient sought medical attention by a doctor's office visit. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash pruritic
Clinical narrative: Itching, blotched skin torso/neck followed by severe redness. Next day blistering, swelling, hot to touch, scaly wrinkled skin. Now peeling with red remaining under skin.  Took Benadryl from 1/1/2011 continuing through 1/5/2011.  Have call into dr's office for futher treatment/diagnosis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blister, Erythema, Pruritus, Rash macular, Skin exfoliation
Clinical narrative: Itching, blotched skin torso/neck followed by severe redness. Next day blistering, swelling, hot to touch, scaly wrinkled skin. Now peeling with red remaining under skin.  Took Benadryl from 1/1/2011 continuing through 1/5/2011.  Have call into dr's office for futher treatment/diagnosis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin warm, Skin wrinkling, Swelling
Clinical narrative: Itching, blotched skin torso/neck followed by severe redness. Next day blistering, swelling, hot to touch, scaly wrinkled skin. Now peeling with red remaining under skin.  Took Benadryl from 1/1/2011 continuing through 1/5/2011.  Have call into dr's office for futher treatment/diagnosis.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: A little over 2 hours after receiving the shot, I experience severe pain and stiffness in my left shoulder (the arm in which I was injected).  The pain and stiffness was so severe that I was unable to lift my arm or otherwise rotate my shoulder.  I went back to my general physician on 10/21/2010 and received a steroid shot.  I was referred to an orthopedic, whom I saw on 10/22. X-rays were clear; I received a cortisone injection in my shoulder and was prescribed an anti-inflammatory for 3 weeks.  Went back to the orthopedic 3 weeks later because pain was not gone; I had regained some motion, but it was still painful to move my shoulder.  The orthopedic prescribed physical therapy, which I began one month later.  I currently go to physical therapy once a week (total treatment plan right now is 5 sessions).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: A little over 2 hours after receiving the shot, I experience severe pain and stiffness in my left shoulder (the arm in which I was injected).  The pain and stiffness was so severe that I was unable to lift my arm or otherwise rotate my shoulder.  I went back to my general physician on 10/21/2010 and received a steroid shot.  I was referred to an orthopedic, whom I saw on 10/22. X-rays were clear; I received a cortisone injection in my shoulder and was prescribed an anti-inflammatory for 3 weeks.  Went back to the orthopedic 3 weeks later because pain was not gone; I had regained some motion, but it was still painful to move my shoulder.  The orthopedic prescribed physical therapy, which I began one month later.  I currently go to physical therapy once a week (total treatment plan right now is 5 sessions).
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site rash, Swelling
Clinical narrative: Patient has had a red rash for 4 days. It was first noticed on the right leg. Got shots with PROQUAD and DTAP on Thursday and then the redness and swelling started on Friday and has not spread. He has not had this rash before.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEPA
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Stomach ache, fever, headache
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching - Dr ordered BENADRYL & TYLENOL/f/up as needed w/office.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Grip strength decreased, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: A day or 2 after shot - numbness & burning in hand shooting pain - unable to raise arm above head cannot grasp with and pain.
Age: 5.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, VARCEL
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Itching, whelping of the abdomen, legs, hands, feet, back, began on 1/4, observed at the Health Dept. on 1/5/11.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lymphadenopathy, Neck pain, Pain, Pain in extremity
Clinical narrative: Had flu shot 10-4-10; c/o swollen gland (resolved), and pain in (L) upper arm; pain when moving arm up laterally & often travels from neck to fingers. Seen by Ortho doctor in December 2010; states she has a "frozen shoulder" set off by flu vaccine.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Had flu shot 10-4-10; c/o swollen gland (resolved), and pain in (L) upper arm; pain when moving arm up laterally & often travels from neck to fingers. Seen by Ortho doctor in December 2010; states she has a "frozen shoulder" set off by flu vaccine.
Age: 59.0
Sex: F
Vaccine: PNC, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse reactions.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. woke up following morning 12/29/10, injection site red, swollen, hot, itching at the site, 12/30/10 pt. seen by Dr. for this. Started on Cephalexin. Pt. instructed to notify us to complete VAERS spoke with pt Monday 1/3/10 looking much better, clearing up.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Carcinoma in situ, Cervical dysplasia, Loop electrosurgical excision procedure
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reaction and allergies who on an unspecified day was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included oral contraceptive. In December 2009, some time after the first dose of GARDASIL, the patient had an abnormal Papanicolaou (pap) smear. The smear revealed a "CIM-3 abnormality with carcinoma in situ." On 12-FEB-2010 the physician performed a LEAP procedure on the patient. On 08-SEP-2010 this patient's follow-up smear revealed that no HPV was present. The physician also mentioned that the patient received a second dose of GARDASIL (lot number not provided) late on 10-NOV-2010. At time of the report the patient was recovered. Upon internal review, a "CIM-3 abnormality with carcinoma in situ". was determined to be an other important medical event. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Foot operation, Herpes zoster, Limb operation, Pruritus
Clinical narrative: Information has been received from an 87 year old female patient, with Crohns disease, no drug reactions or allergies and a history of nerve damage to left leg after a hip replacement, who "approximately two to two and a half years ago" (in approximately May 2008), was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included "various" (unspecified medications). "A month ago" (on approximately 11-OCT-2010) the patient had shingles. The patient stated that the physician looked at them to determine that it was shingles. The patient had been using "SYCHOVIA ointment" (manufacturer unspecified) and "the medicine", but neither seemed to work. Additionally, the patient had very mild itching off and on, no pain, and something on the left side of her leg; but she had surgery on that part of the leg, she did not know if that is a result of that. It was not a very severe reaction. She thought she may have picked the shingles up at the hospital while she was having surgery on her left foot. It showed up while she was on rehabilitation at the hospital, right after the surgery. At the time of the report, the patient had not recovered; her condition had improved "very little". Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no relevant drug reactions/allergies and with no pertinent medical history who on 07-OCT-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number reported). Concomitant therapy included influenza virus vaccine (unspecified). It was reported that the patient received her first dose of the vaccine and she was pregnant with a last menstrual period of 04-SEP-2009 (EDD: 11-JUN-2010). Urine pregnancy test was performed and was positive (unspecified date). The patient sought medical attention by an office visit. Follow up information has been received from a nurse. It was reported that the patient terminated the pregnancy early on, in her first trimester. The nurse reported that the patient and her family decided for multiple reasons, not as a result of her having had the GARDASIL during pregnancy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review termination of the pregnancy was considered to be an other important medical event. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Labour induction, Pregnancy test negative, Prolonged pregnancy
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 22-SEP-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot number reported as 662664/0981X, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23. There was no concomitant medication. At the time of this report, the patient was pregnant. Physician assistant believed the day of conception was the day of the first dose of GARDASIL. A pregnancy test was performed on 22-SEP-2009 and the result was negative. The patient sought medical attention through a prenatal office visit. The patient's last menstrual period was 08-SEP-2009. Expected date of delivery was 15-JUN-2010. Follow up information has been received via telephone call from an obstetric nurse indicating that the patient's pregnancy was "relatively uncomplicated". She had a choroid plexus cyst noted on her mid-trimester fetal ultrasound but everything was normal at the follow-up ultrasound. The patient was scheduled for an induction on 24-JUN-2010, the nurse suspected it was because she would have been 41 weeks gestation, and she could not find any other indication when asked. The induction resulted in a primary cesarean section on 24-JUN-2010, and the patient delivered a baby in good health. She stated there was no congenital anomalies. The nurse confirmed that both the baby and the mother were in good health at her post-partum visit, and the mother recovered from her cesarean without complications. The infant's experience has been captured in WAES 0911USA02673B1. Upon internal review the induction that resulted in a primary cesarean section was considered to be another important medical event. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 22-SEP-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot number reported as 662664/0981X, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23. There was no concomitant medication. At the time of this report, the patient was pregnant. Physician assistant believed the day of conception was the day of the first dose of GARDASIL. A pregnancy test was performed on 22-SEP-2009 and the result was negative. The patient sought medical attention through a prenatal office visit. The patient's last menstrual period was 08-SEP-2009. Expected date of delivery was 15-JUN-2010. Follow up information has been received via telephone call from an obstetric nurse indicating that the patient's pregnancy was "relatively uncomplicated". She had a choroid plexus cyst noted on her mid-trimester fetal ultrasound but everything was normal at the follow-up ultrasound. The patient was scheduled for an induction on 24-JUN-2010, the nurse suspected it was because she would have been 41 weeks gestation, and she could not find any other indication when asked. The induction resulted in a primary cesarean section on 24-JUN-2010, and the patient delivered a baby in good health. She stated there was no congenital anomalies. The nurse confirmed that both the baby and the mother were in good health at her post-partum visit, and the mother recovered from her cesarean without complications. The infant's experience has been captured in WAES 0911USA02673B1. Upon internal review the induction that resulted in a primary cesarean section was considered to be another important medical event. No further information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Congenital choroid plexus cyst, Drug exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from an OB nurse concerning a baby whose 23 year old mother, with no medical history or preexisting allergies, was vaccinated IM on 22-SEP-2010 with a 0.5 ml first dose of GARDASIL, (Lot no. not reported). Her LMP was on 08-SEP-2010. No concomitant therapies were mentioned. Nurse reported that an ultrasound performed on the mother's mid-trimester showed a choroid plexus cyst. The nurse stated that "everything was normal at the follow-up ultrasound". On 24-JUN-2010, the mother delivered a baby in good health. Nurse reported that there were no congenital anomalies. Nurse confirmed that baby and the mother were in good health at her post-partum visit. The mother's experience has been captured in WAES 0911USA02673. Upon internal review choroid plexus cyst was considered to be a congenital anomaly. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland abnormal, Chemotherapy, Hodgkin's disease
Clinical narrative: Initial and follow up information has been received from a Registered Nurse concerning a 21 year old female patient who in November 2010, was vaccinated with a first dose of GARDASIL (lot # unknown). The nurse reported that the patient was scheduled to start chemotherapy, some time in January 2011. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention.   A telephone call was made to the registered nurse and she also stated the patient has a medical history of methamphetamine addiction, smoking cigarettes and HPV. Her mother and her mother's uncle both had lymphoma. The patient was vaccinated with a first dose of GARDASIL in November 2010 on an unknown date and the nurse stated that the patient said she due for her second dose in January 2011. Subsequently, the patient had a lymph node biopsy on 04-NOV-2010 that confirmed a diagnosis of Hodgkin's lymphoma. She started chemo on 18-NOV-2010. She was not admitted and is being treated as an outpatient. Upon internal review Hodgkin's lymphoma was considered to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient, with no pertinent medical history and no drug reactions or allergies, who in November 2008, was vaccinated with a first dose of GARDASIL (lot # 0947X, expire date 05-JUL-2010), 0.5 ml, intramuscularly. Concomitant therapy included vitamins. Subsequently, the patient realized she was pregnant. On an unspecified date, blood test and ultrasound (also reported as: ultrasound) were performed for routine prenatal care. The patient delivered a healthy male on 07-OCT-2009. During delivery, on 07-OCT-2009, the patient required IV and oxygen. In January 2010, the patient was vaccinated with the second dose of GARDASIL (lot # 1423X, expire date 20-JUN-2011), 0.5 ml, intramuscularly. "No adverse symptoms noted". On 11-NOV-2010, she was vaccinated with the third dose of GARDASIL (lot #, expire date not reported), 0.5 ml, intramuscularly. The registered nurse considered IV and oxygen requirements during delivery to be other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Lumbar puncture abnormal, Malaise, Rash generalised, Unresponsive to stimuli
Clinical narrative: Initial report received from a health care professional on 30 December 2010. A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA. The patient's medical history and concomitant medications were reported as unknown. On 30 December 2010, the patient was not feeling well. The next day she was found unresponsive with a rash on the body. She was taken to the hospital. The patient had a spinal tap at the hospital which was reported as "Did not look good". The outcome was reported as not recovered. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Culture positive, Lumbar puncture abnormal, Malaise, Meningococcal infection, Neisseria test positive
Clinical narrative: Initial report received from a health care professional on 30 December 2010. A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA. The patient's medical history and concomitant medications were reported as unknown. On 30 December 2010, the patient was not feeling well. The next day she was found unresponsive with a rash on the body. She was taken to the hospital. The patient had a spinal tap at the hospital which was reported as "Did not look good". The outcome was reported as not recovered. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ, FLU3, MNQ, TDAP
Symptoms: Rash generalised, Unresponsive to stimuli
Clinical narrative: Initial report received from a health care professional on 30 December 2010. A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA. The patient's medical history and concomitant medications were reported as unknown. On 30 December 2010, the patient was not feeling well. The next day she was found unresponsive with a rash on the body. She was taken to the hospital. The patient had a spinal tap at the hospital which was reported as "Did not look good". The outcome was reported as not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 29-JUL-2010 was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). The physician stated that on 29-JUL-2010 after receiving the dose of GARDASIL the patient experienced fainting, banging her head on a counter, having a seizure and blacking out for about a minute. Physician also said that patient was taken via ambulance to a nearby unspecified hospital where she received unspecified treatment and was released later the same day. Fainting, banging her head on a counter, having a seizure and blacking out were considered to be an other important medical event by the physician. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Coma
Clinical narrative: Last year, the patient received an unspecified influenza vaccine (manufacturer unknown). After receiving the influenza vaccine, the patient 'went into a coma' on an unknown date. Unspecified treatment was given for the adverse event. The patient fully recovered from the event. The reporter considered event serious due to hospitalisation.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Febrile convulsion, Gaze palsy, Musculoskeletal stiffness, Tremor
Clinical narrative: Initial report received on 22 December 2010 from an investigator participating an a trial. An 11-month-old male subject who at the time of vaccination had mild cold symptoms of a cough and runny nose however, upon examination the primary investigator noted "no congestion, wheezing, nor airway issue. Mild cold ok to proceed with vaccine", experienced a febrile seizure eight hours after receiving a second dose of either INFLUENZA VIRUS VACC QUAD A & B or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B or FLUZONE 2010-2011 (route and site of administration not reported) on 14 December 2010. Lot number was not reported. The subject had not experienced any adverse event after the first injection of the study vaccine. The subject's parents reported he had an axillary temperature of 101.5, his eyes rolled back, his body became stiff and he was shaking. The subject was evaluated by a paramedic and received corrective treatment with TYLENOL, however he was not hospitalized. The subject was evaluated by his primary care physician the next day and per the mother the physician felt the subject had a febrile seizure, which he stated were not "uncommon" after vaccination. The subject was reported as recovered on 14 December 2010. According to the investigator seriousness was "Other: Important medical event specify Adverse Event of special interest per protocol". The subject was not discontinued from the study as a result of this adverse event. The Investigator assessed the event as related to the trial product but not related to the trial procedures. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Eyelid function disorder, Guillain-Barre syndrome, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received from a health care professional on 22 December 2010. A 63-year-old male patient received on 22 November 2010 an injection (route and site not reported) of ADACEL, lot number not reported. The patient had a history of mild hypertension and rotator cuff tear. The patient's concomitant medications were reported as unknown. The patient had no illness at the time of vaccination and no known allergies. On 11 December 2010, the patient experienced severe low back pain and was seen in the Emergency Room (ER). On 13 December 2010, the patient was seen by a physician in the office for lumbar radiculitis with weakness of the lower extremities. The patient had an immediate magnetic resonance imaging (MRI) on 13 December 2010 which was unremarkable. On 20 December 2010, the patient experienced weakness of the lower extremities and facial paralysis (can't grin) with difficulty closing eye lids. On 20 December 2010, the patient was admitted to the hospital. Currently on 22 December 2010, he was being treated in the hospital for Guillain-Barre Syndrome. The outcome was reported as unknown. Documents held by sender: None.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Radiculitis lumbosacral, VIIth nerve paralysis
Clinical narrative: Initial report received from a health care professional on 22 December 2010. A 63-year-old male patient received on 22 November 2010 an injection (route and site not reported) of ADACEL, lot number not reported. The patient had a history of mild hypertension and rotator cuff tear. The patient's concomitant medications were reported as unknown. The patient had no illness at the time of vaccination and no known allergies. On 11 December 2010, the patient experienced severe low back pain and was seen in the Emergency Room (ER). On 13 December 2010, the patient was seen by a physician in the office for lumbar radiculitis with weakness of the lower extremities. The patient had an immediate magnetic resonance imaging (MRI) on 13 December 2010 which was unremarkable. On 20 December 2010, the patient experienced weakness of the lower extremities and facial paralysis (can't grin) with difficulty closing eye lids. On 20 December 2010, the patient was admitted to the hospital. Currently on 22 December 2010, he was being treated in the hospital for Guillain-Barre Syndrome. The outcome was reported as unknown. Documents held by sender: None.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity, Respiratory distress
Clinical narrative: Initial report received from a health care professional on 22 December 2010. A group of two 11-year-old patients' (sex not provided) received on an unknown date an injection (route and site not reported) of ADACEL, lot number not reported. The patient's were seen in an allergy clinic for food allergies and other allergic diseases (not specified). On an unknown date and within one hour of vaccination, the patient's developed respiratory distress as part of an allergic reaction. No further information was provided. The outcome was not reported. The reporter in this case also reported another adverse event following ADACEL; information for this patient can be found in case 2010-07121. Documents held by sender: None.
Age: 16.0
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity, Respiratory distress
Clinical narrative: Initial report received from a health care professional on 22 December 2010. A 16-year-old patient (sex not provided) received on an unknown date an injection (route and site not reported) of ADACEL, lot number not reported. The patient was seen in an allergy clinic for food allergies and other allergic diseases (not specified). On an unknown date and within one hour of vaccination, the patient developed respiratory distress as part of an allergic reaction. No further information was provided. The outcome was not reported. The reporter in this case also reported another adverse event following ADACEL; information for this patient can be found in case 2010-07120. Documents held by sender: None.
Age: 1.1
Sex: M
Vaccine: FLU3
Symptoms: Croup infectious
Clinical narrative: Initial report received on 27 December 2010 from an investigator participating in a trial. A 13-month-old male subject with an ongoing medical condition of constipation developed croup four days after receiving a first dose injection (route and site not reported) of either, INFLUEZA VIRUS VACC QUAD A & B or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B or FLUZONE No Preservative 2010-2011 on 22 December 2010. Lot number was not reported. On 26 December 2010, four days after receiving the vaccine, the investigator received a call from the subject's mother who stated that the subject was being admitted to the hospital the same day for croup. At the time of the report, the event remained ongoing and the subject continued in the study. According to the investigator, the event was considered to be related to the study vaccine. The investigator planned to request medical records for review and more information. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oedema mouth, Oesophagitis, Swollen tongue
Clinical narrative: Withing 10 minutes of vaccination client reported difficulty breathing, swelling of mouth, tongue, esophagus. Sometime later the client reported having a severe reaction when she ate frosting that had egg in it. Client reported having 5 Emergency room visits.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Rash papular
Clinical narrative: I have a rash on torso I am unsure of whether or not this was caused by the Flu shot I received.  Rash looks like hundreds of small bumps (small looking pimples).
Age: 2.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Injection site pain, Irritability, Neck pain, Pyrexia
Clinical narrative: Pneumococcal conjugate and hib vaccine received on 12/29/10. Day of vaccine patient was irritable and had low temp common reaction but right leg very tender. You couldn't even brush by the site without him being in a lot of pain. Pain persisted but slowly improved over next couple days. Then 1/3/11, he woke from his afternoon nap around 4:30pm with neck pain and only able to look to the right. He was held all afternoon if he was put down would cry in obvious pain. He was given Tylenol. Unsure if he had a temperature. He had a good appetite for dinner. When I returned from work at 8pm I assessed him. He was still in a lot of pain. Unable to look straight ahead. I took him to ED for evaluation. He was afebrile, ears and throat looked normal. We were discharged home. He is slowly improving but but still unable to look easily to the left after 2 days. We will follow up with his new pediatrician Monday 1/10/11.
Age: 2.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Tenderness
Clinical narrative: Pneumococcal conjugate and hib vaccine received on 12/29/10. Day of vaccine patient was irritable and had low temp common reaction but right leg very tender. You couldn't even brush by the site without him being in a lot of pain. Pain persisted but slowly improved over next couple days. Then 1/3/11, he woke from his afternoon nap around 4:30pm with neck pain and only able to look to the right. He was held all afternoon if he was put down would cry in obvious pain. He was given Tylenol. Unsure if he had a temperature. He had a good appetite for dinner. When I returned from work at 8pm I assessed him. He was still in a lot of pain. Unable to look straight ahead. I took him to ED for evaluation. He was afebrile, ears and throat looked normal. We were discharged home. He is slowly improving but but still unable to look easily to the left after 2 days. We will follow up with his new pediatrician Monday 1/10/11.
Age: 0.26
Sex: F
Vaccine: HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: Fever between 100 and 102.3 degress F lasting for 2 days.
Age: 0.38
Sex: F
Vaccine: DTAP, RV5
Symptoms: Bacterial test negative, Brain oedema, Cardiac arrest, Computerised tomogram abnormal, Respiratory arrest
Clinical narrative: Cessation of respiration, cardiac arrest
Age: 0.38
Sex: F
Vaccine: DTAP, RV5
Symptoms: Scan brain, Viral test negative
Clinical narrative: Cessation of respiration, cardiac arrest
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Eye discharge, Ocular hyperaemia, Swollen tongue, Throat tightness
Clinical narrative: Patient received vaccine at 5pm. Two hours later she noticed her throat tightening, tongue swelling, conjunctivitis, eyes red and oozing. She called her PCP who said go to ER. They gave her oral BENADRYL.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TTOX
Symptoms: Asthenia, Convulsion, Dizziness, Ear, nose and throat examination normal, Loss of consciousness
Clinical narrative: My daughter received tetanus, meningitis, and a new vaccine called HPV (GARDASIL). Within 5 min. she passed out and had a seizure lasting approx. 10 seconds. She was extremely weak - dizzy for a few days after vaccinations.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Swelling, pain around the injection site and temperature to 100 degrees F
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Death
Clinical narrative: Death
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal dreams, Asthenia, Chills, Cough, Diarrhoea
Clinical narrative: Chills, fever, nausea, diarrhea, dizziness, near fainting, sore muscles all over, sore skin all over, paleness, drainage and coughing, thirst, weakness, inability to sleep, bad dreams during periodic few minutes of sleep. Symptoms persisting after 20 hours are tiredness and weakness.