chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt. became pale, nearly LOC, off in w/d and given Rx by EMT - juice box, snack, rest. After 10-15 minutes, pt. was fine and back to class.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Nasal congestion, Pyrexia, Sinus operation
Clinical narrative: Patient had temp./fever starting about 66 hours after vaccination (T=100.9). Then was treated w/TYLENOL. Fever went up to 104 degrees (around 80 hours after vaccine) along w/nasal congestion/drainage. Fever resolved after 4th day post vacc.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), HEPAB, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: 1-6-10 had 2nd set imms, return 2 days later with c/o rash begins on forehead, progresses to chin. 1-20-10 presents with "spots". Dr here, dx "mild varicella reaction", not related to rash on face.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10 year old female with swelling/redness over L deltoid began on 2/12/10. Approx 4.5x2.5cm. Non-tender. Advised cool compresses and TYLENOL as needed. Pt seen in clinic on 2/13/10.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA, HIBV
Symptoms: Erythema, Induration
Clinical narrative: 15 cm diameter of redness and induration.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: erythema. warm 2 days after vaccine.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had TDaP on 1-20-10. She called the office on 1-27-10 with complaint of painful (R) upper arm. Some redness at site and warm to touch. Provider looked at and circled area. Patient came back next day and increased redness area 4 1/2 x 2 3/4 red swollen put on antibiotic KEFLEX 500 mg IID elevation and heat.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Erythematous papular rash head, neck, trunk, diaper area and legs, days after varicella vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: vomiting and fussiness
Age: 1.35
Sex: F
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Blood culture, CSF culture, Dysphagia, Eyelid ptosis, Guillain-Barre syndrome
Clinical narrative: Dx of Guillain-Barre Syndrome, at hospital. No hx illness prior to onset of symptoms. Had imms. 11-9-09. Symptoms muscle weakness, drooping eye lids, difficulty swallowing about 12-18-09. Symptoms progressively worsen. Admit to hospital 12-27-09.
Age: 1.35
Sex: F
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Lumbar puncture, Muscular weakness
Clinical narrative: Dx of Guillain-Barre Syndrome, at hospital. No hx illness prior to onset of symptoms. Had imms. 11-9-09. Symptoms muscle weakness, drooping eye lids, difficulty swallowing about 12-18-09. Symptoms progressively worsen. Admit to hospital 12-27-09.
Age: 0.86
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Head banging, Muscle rigidity, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Mother states had fever of 101 - 102. She gave him Tylenol for the fever. The child exhibited stiffness ad rigidity and was thrashing his head. These episode occured 3- 4 times a day for 2 weeks and then stopped. Mother stated she called her MD and was told to watch the child.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: none
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Mass, Pain
Clinical narrative: Severe pain started 4 hours post injection, Pain progressively got worse, developed knot at immunization site, limited Range of motion in shoulder due to pain
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Abdominal pain, Flatulence, Nausea
Clinical narrative: 41 year old female received H1N1 and seasonal flu vaccine (one in each deltoid muscle) on 1/28/2010 at 9 AM.  At 10 AM she developed intermittent abdominal cramping. This continued for 24 hours.  She also had increased gas, nausea but no vomiting. She stated she had normal bowel and bladder habits and was eating and drinking as normal.  She denied a fever.  She also stated she had not recently changed her diet or lifestyle habits. Her abdominal symptoms all resolved after 2 days.
Age: 1.48
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blood prolactin normal, Computerised tomogram normal, Electrocardiogram, Electroencephalogram normal, Full blood count normal
Clinical narrative: He was sitting and eating at the dinner table and he had a 30 sec to 1 minute episode of shaking, and stiff arms. No choking on food. He said a brief " hi" when he came out of it and then he was sleepy. This has never happened again, and he does not have a history of this. Grandmother had seizures with the pertussis immunization when she was little. He did get immunizations 1/28/2010 prior to this.
Age: 1.48
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Metabolic function test normal, Musculoskeletal stiffness, Somnolence, Tremor
Clinical narrative: He was sitting and eating at the dinner table and he had a 30 sec to 1 minute episode of shaking, and stiff arms. No choking on food. He said a brief " hi" when he came out of it and then he was sleepy. This has never happened again, and he does not have a history of this. Grandmother had seizures with the pertussis immunization when she was little. He did get immunizations 1/28/2010 prior to this.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Pain immediately after Tdap injection left deltoid and pain has persisted since then especially with pressure such as sleeping on that side or when he lifts his arm
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site erythema, Injection site haemorrhage, Injection site warmth, Musculoskeletal pain
Clinical narrative: Fever 101.8, weakness, ecchymosis, redness & warmth at injection site size of palm of hand, pain radiating into shoulder blade
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 101.8, weakness, ecchymosis, redness & warmth at injection site size of palm of hand, pain radiating into shoulder blade
Age: 26.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Cellulitis, Erythema multiforme, Headache, Influenza like illness
Clinical narrative: 26 year-old previously healthy male with right shoulder pain/swelling/erythema after PNEUMOVAX vaccination 3 days ago. On Friday, 3 days prior to admission, he received PNEUMOVAX in the right deltoid region (also a flu shot on left deltoid region). The next day, Saturday, he had flu-like symptoms (generalized weakness, subjective fever, mild nausea), along with 10/10 right lateral deltoid pain, along with swelling and erythema, especially at the site of vaccination. The symptoms persisted through Sunday as well. Thus, he came to the ED. Was seen in module and directly admitted to hospital for cellulitis and r/o necrotizing fasciitis. Symptoms: 1. Headache. 2. Myalgia 3. Fever 4. Skin Rash 5. Erythema Multiforme 6. Nausea Vomiting 7. cellulitis.
Age: 26.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain, Myalgia
Clinical narrative: 26 year-old previously healthy male with right shoulder pain/swelling/erythema after PNEUMOVAX vaccination 3 days ago. On Friday, 3 days prior to admission, he received PNEUMOVAX in the right deltoid region (also a flu shot on left deltoid region). The next day, Saturday, he had flu-like symptoms (generalized weakness, subjective fever, mild nausea), along with 10/10 right lateral deltoid pain, along with swelling and erythema, especially at the site of vaccination. The symptoms persisted through Sunday as well. Thus, he came to the ED. Was seen in module and directly admitted to hospital for cellulitis and r/o necrotizing fasciitis. Symptoms: 1. Headache. 2. Myalgia 3. Fever 4. Skin Rash 5. Erythema Multiforme 6. Nausea Vomiting 7. cellulitis.
Age: 26.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Nausea, Pyrexia, Rash, Swelling, Vomiting
Clinical narrative: 26 year-old previously healthy male with right shoulder pain/swelling/erythema after PNEUMOVAX vaccination 3 days ago. On Friday, 3 days prior to admission, he received PNEUMOVAX in the right deltoid region (also a flu shot on left deltoid region). The next day, Saturday, he had flu-like symptoms (generalized weakness, subjective fever, mild nausea), along with 10/10 right lateral deltoid pain, along with swelling and erythema, especially at the site of vaccination. The symptoms persisted through Sunday as well. Thus, he came to the ED. Was seen in module and directly admitted to hospital for cellulitis and r/o necrotizing fasciitis. Symptoms: 1. Headache. 2. Myalgia 3. Fever 4. Skin Rash 5. Erythema Multiforme 6. Nausea Vomiting 7. cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Musculoskeletal stiffness, Pruritus
Clinical narrative: Vaccine given 2/18/10, pt noticed next-day redness, itchiness, warn to touch. 2/24/2010 arm started feeling stiff.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Pt. given HIBERIX instead of HIB through nurse error. Unknown at this time if pt. had adverse rx'n-will have Dr. phone family.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Full blood count normal, Induration, Local reaction
Clinical narrative: 2/22 Local reaction -quarter size with central broken vesicle on (L) lat. thigh . 2/23/10 Red indurated pruritic area larger than yesterday.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, White blood cell count
Clinical narrative: 2/22 Local reaction -quarter size with central broken vesicle on (L) lat. thigh . 2/23/10 Red indurated pruritic area larger than yesterday.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis
Clinical narrative: Following Herpes Zoster Vaccine-had diminished hearing for about 3 months. Hearing gradually returned to normal.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: An employee received the seasonal influenza vacc in her right deltoid and within one hour she experienced hives on the right side of her body.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: An employee received the seasonal INFLUENZA vacc and noticed hives 2 days later. The hives were still apparent about a week later. She had a similar reaction a few years ago but it was much worse at that time. She also reacted to contact lens solution years ago. Both contain preservative and she was going to discuss it with her primary doctor.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Drug exposure during pregnancy, Hypertension, Induced labour, Laboratory test normal
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 19 year old female patient with hypertension, asthma and obesity, no drug reactions/allergies, who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included lisinopril (manufacturer unknown) and montelukast sodium. On 16-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and was pregnant. The patient was due for the third dose on 21-JAN-2009 but did not receive it due to her pregnancy. The patient had a prenatal panel (normal). The patient came in for an OB visit. Her LMP was on 30-SEP-2008 and her EDD was 07-JUL-2009. Follow-up information was received from a staff person at nurse practitioner's office. It was reported that the patient was induced secondary to developing hypertension, and she had a vaginal birth on 24-JUN-2009 at term. The patient was seen in the office on 02-JUL-2009 for evaluation of her blood pressure and was treated with medication (unspecified) for hypertension by one of the physicians at that visit. The patient returned for further evaluation on 07-JUL-2009 and it was noted in the chart that both the mother and her baby were both doing well. The patient was last seen on 10-AUG-2009 by another physician in the practice for her postpartum visit and there was no indication of any problems for mother or baby. Follow up information has been received from the nurse practitioner that reported that the 19 year old female patient with chronic hypertension and with superimposed pre-eclampsia in her pregnancy was induced. On 24-JUN-2009, the patient was admitted to the hospital and was induced; the patient had a vaginal delivery of a healthy baby. There were no adverse events for the baby. On 28-JUN-2009 the patient and her baby were discharged to home. It was noted that on 09-JUL-2010 chart note, the baby was nursing well and that the baby was doing well. The nurse practitioner stated that "everything looked fine". Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pre-eclampsia
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 19 year old female patient with hypertension, asthma and obesity, no drug reactions/allergies, who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included lisinopril (manufacturer unknown) and montelukast sodium. On 16-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and was pregnant. The patient was due for the third dose on 21-JAN-2009 but did not receive it due to her pregnancy. The patient had a prenatal panel (normal). The patient came in for an OB visit. Her LMP was on 30-SEP-2008 and her EDD was 07-JUL-2009. Follow-up information was received from a staff person at nurse practitioner's office. It was reported that the patient was induced secondary to developing hypertension, and she had a vaginal birth on 24-JUN-2009 at term. The patient was seen in the office on 02-JUL-2009 for evaluation of her blood pressure and was treated with medication (unspecified) for hypertension by one of the physicians at that visit. The patient returned for further evaluation on 07-JUL-2009 and it was noted in the chart that both the mother and her baby were both doing well. The patient was last seen on 10-AUG-2009 by another physician in the practice for her postpartum visit and there was no indication of any problems for mother or baby. Follow up information has been received from the nurse practitioner that reported that the 19 year old female patient with chronic hypertension and with superimposed pre-eclampsia in her pregnancy was induced. On 24-JUN-2009, the patient was admitted to the hospital and was induced; the patient had a vaginal delivery of a healthy baby. There were no adverse events for the baby. On 28-JUN-2009 the patient and her baby were discharged to home. It was noted that on 09-JUL-2010 chart note, the baby was nursing well and that the baby was doing well. The nurse practitioner stated that "everything looked fine". Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: Patient received seasonal influenza vaccine on 10/1 in her left arm. She reported neck stiffness, muscle aches, and numbness and tingling in her fingers (on both hands) the day following vaccination. She sought care in the ER, but did not mention a diagnosis, tests performed, or an admission or discharge date.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Immediate post-injection reaction, Pain, Rash
Clinical narrative: According to the patient, she did not have any problems immediately following her seasonal flu shot, except a mild pain. On 10/17/09, she developed rashes on her left hip and it was diagnosed and treated as shingles which lasted almost 10 days. She does not have history of shingles in past but she suffered from an episode of chickenpox during her childhood. She does not have history of any adverse event following vaccination in past. She is currently taking medications for anxiety and depression.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: The patient received both the seasonal and pneumonia vaccines on 1/20/10, both in the left arm, one 5 cm below the tip of the shoulder, the other 3 cm below the first (she is unsure which was which). Within a few hours, she noticed swelling, redness and pain in her left arm extending 3-5cm below the lowest vaccine site to about 5 cm above her wrist. She did not have any tingling, numbness or itching. She immediately took BENADRYL. She called her physician who told her to take ibuprofen, apply heat and elevate her arm. Her swelling and pain gradually subsided and completely resolved on 1/31/10.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Hypoaesthesia, Injection site erythema
Clinical narrative: The patient received the regular seasonal vaccine in her left arm, approximately 5 cm from the tip of the shoulder. She began experiencing pain down her entire left arm and a 5 mm red dot at the injection site the night after receiving her injection. There was no local swelling. She began to experience numbness in both legs, worse below her knees, particularly in her feet. She also complained of an upset stomach and diarrhea for 7-10 days following the vaccine as well as fatigue that still persists. The pain and numbness in her limbs resolved about one month after the vaccine. She did not seek medical care or receive any treatment for any of her symptoms.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: The patient received the regular seasonal vaccine in her left arm, approximately 5 cm from the tip of the shoulder. She began experiencing pain down her entire left arm and a 5 mm red dot at the injection site the night after receiving her injection. There was no local swelling. She began to experience numbness in both legs, worse below her knees, particularly in her feet. She also complained of an upset stomach and diarrhea for 7-10 days following the vaccine as well as fatigue that still persists. The pain and numbness in her limbs resolved about one month after the vaccine. She did not seek medical care or receive any treatment for any of her symptoms.
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Muscle twitching, Musculoskeletal pain, Myofascitis, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: The patient received the seasonal flu shot in left arm and H1N1 shot in the right arm, ~3 inches from the tip of shoulder on 12/11/2009. He did not have any local swelling, redness, pain or tingling/numbness immediately following the vaccine. On 12/16/2009, he woke up with with severe pain in his right shoulder and twitching of the muscles in his right arm which was not focused in any particular area. He sought medical care, and was treated with steroids. Both an x-ray and MRI were negative for brachial neuritis. He is currently being tentatively diagnosed as a case of myofascitis. He is scheduled to undergo another MRI of cervical spine to rule out brachial neuritis, in a few weeks. His symptoms have lessened with treatment.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthma, Chills, Condition aggravated, Erythema, Fatigue
Clinical narrative: The patient received the vaccine in his left arm around tow inches below the shoulder on 12/07/09 at 10:00 am. His mother picked him up at 3:30 and his arm was red and itching. The next morning the redness spread and his arm was swelled and hot to the touch. His mother treated him with BENADRYL but no avail. He also reported fever, chills, fatigue, irritability, sore throat, runny nose and headache. His arm stayed red four or five days. He was brought to see the doctor. His mother reported he has had problems with his asthma since vaccination, which his doctor contributed to the damp, cold weather. Yet, his mother reported him having no problems with his asthma to this type of weather before.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache, Irritability, Oedema peripheral, Oropharyngeal pain, Pruritus
Clinical narrative: The patient received the vaccine in his left arm around tow inches below the shoulder on 12/07/09 at 10:00 am. His mother picked him up at 3:30 and his arm was red and itching. The next morning the redness spread and his arm was swelled and hot to the touch. His mother treated him with BENADRYL but no avail. He also reported fever, chills, fatigue, irritability, sore throat, runny nose and headache. His arm stayed red four or five days. He was brought to see the doctor. His mother reported he has had problems with his asthma since vaccination, which his doctor contributed to the damp, cold weather. Yet, his mother reported him having no problems with his asthma to this type of weather before.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rhinorrhoea, Skin warm
Clinical narrative: The patient received the vaccine in his left arm around tow inches below the shoulder on 12/07/09 at 10:00 am. His mother picked him up at 3:30 and his arm was red and itching. The next morning the redness spread and his arm was swelled and hot to the touch. His mother treated him with BENADRYL but no avail. He also reported fever, chills, fatigue, irritability, sore throat, runny nose and headache. His arm stayed red four or five days. He was brought to see the doctor. His mother reported he has had problems with his asthma since vaccination, which his doctor contributed to the damp, cold weather. Yet, his mother reported him having no problems with his asthma to this type of weather before.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Herpes zoster, Photophobia
Clinical narrative: Patient received the H1N1 vaccine injection on 10/28/09 and remembers developing a sensitivity to light and a headache on the Wednesday after her vaccine on 11/4/09. She sought medical care on 11/7/09 and was diagnosed with Shingles affecting her right cornea without facial involvement. She received treatment for two months and her symptoms resolved. She was also found to have a benign papilloma in her right breast during the second week of November. Her tumor was successfully removed on 12/7/09.
Age: 1.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthma, Breath sounds abnormal, Cough, Irritability, Wheezing
Clinical narrative: The patient's mother reports that the infant received his H1N1 vaccine injection on 12/3/09. On 12/5/09 the mother noticed noisy breathing, irritability, wheezing and a cough and took the baby to a physician who diagnosed him with asthma. On 12/9/09 another visit to an ENT doctor led to a diagnosis of a respiratory viral infection as well as asthma. He was prescribed a VENTOLIN inhaler QID and fluven 2 puffs BID. The patient had no prior history of asthma or allergies, though he was scheduled to have a sleep study in April to assess possible breathing difficulties during sleep. His symptoms have since resolved.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: The patient reported developing hives the same day as her vaccination. She sought care at an emergency room for the hives. The hives lasted for three days.
Age: 0.9
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PPV
Symptoms: Grip strength decreased, Hypokinesia
Clinical narrative: Initial case received from a physician on 17 February 2010. A 1-year-old female patient received the following vaccines in July 2009: a right arm injection of ACTHIB (lot number UF369AA); an injection of PEDIARIX (GSK, lot number AC21B127AA); an injection of influenza vaccine (manufacture and lot number not reported; reported as "not sanofi pasteur" product); and a right thigh injection of pneumococcal vaccine (manufacturer reported as Merck, lot number U2639AA; however, this lot corresponds to MENACTRA, and clarification has been requested). The patient had no known allergies or medical conditions, and was not ill at the time of vaccination. One month post-vaccination, in August 2009, the baby developed decreased grip strength in her left hand. In February 2010 she presented with loss of grip in her left hand and loss of some movement in her left leg. The event was ongoing at the time of the report. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal, Premature labour
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature baby
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature labour, Premature rupture of membranes
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal, Premature labour
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0 / 0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. The reporter for this case is the same as for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0 / 0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. The reporter for this case is the same as for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature baby
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0 / 0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. The reporter for this case is the same as for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature labour, Premature rupture of membranes
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0 / 0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. The reporter for this case is the same as for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Autopsy, Bacterial infection, Death, Joint sprain, Lumbar puncture abnormal
Clinical narrative: Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Meningitis meningococcal, Meningococcal infection, Polymerase chain reaction
Clinical narrative: Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Autopsy, Death, Headache, Meningococcal infection, Nausea
Clinical narrative: Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Neisseria test positive, Petechiae, Polymerase chain reaction, Vomiting
Clinical narrative: Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Angioedema, Arthralgia, Asthenia, Blood urine present, Body temperature increased
Clinical narrative: Initial case received 19 February 2010 from a physician (is also the patient). A 55 year old male patient with a medical history of hypertension and chronic urticaria with infrequent angioedema, received an injection (route and site not reported) of ADACEL (lot number C2889AA) on 29 January 2010. Immediately following vaccination the patient experienced injection site tenderness. Within a couple of days he experienced injection site swelling, shaking, chills, night sweats, joint tenderness and muscle tenderness. Then over the next week he experienced fatigue, headaches, increased night sweats, increased joint soreness and increased muscle soreness. He had a temperature ranging to "102." On an unspecified date following vaccination, the patient's pre-existing chronic urticaria with infrequent angioedema worsened. Concomitant medications included LIPITOR, ASA, MODURETIC and vitamin B 1000IU. He had no known allergies and had no illness at the time of vaccination. On an unspecified date the patient (physician) was seen by another physician, lab work showed an elevated sed rate of 64 and blood in urine. On an unspecified date, the patient reported that he had stopped taking LIPITOR 2 weeks ago (approximate date 05 February 2010). He was using TYLENOL and ibuprofen. At the time of this report the patient stated he felt the symptoms were improving, but still had body aches, muscle weakness, muscle soreness, decreased energy level, occasional night sweats and headaches. Documents held by sender: None.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Initial case received 19 February 2010 from a physician (is also the patient). A 55 year old male patient with a medical history of hypertension and chronic urticaria with infrequent angioedema, received an injection (route and site not reported) of ADACEL (lot number C2889AA) on 29 January 2010. Immediately following vaccination the patient experienced injection site tenderness. Within a couple of days he experienced injection site swelling, shaking, chills, night sweats, joint tenderness and muscle tenderness. Then over the next week he experienced fatigue, headaches, increased night sweats, increased joint soreness and increased muscle soreness. He had a temperature ranging to "102." On an unspecified date following vaccination, the patient's pre-existing chronic urticaria with infrequent angioedema worsened. Concomitant medications included LIPITOR, ASA, MODURETIC and vitamin B 1000IU. He had no known allergies and had no illness at the time of vaccination. On an unspecified date the patient (physician) was seen by another physician, lab work showed an elevated sed rate of 64 and blood in urine. On an unspecified date, the patient reported that he had stopped taking LIPITOR 2 weeks ago (approximate date 05 February 2010). He was using TYLENOL and ibuprofen. At the time of this report the patient stated he felt the symptoms were improving, but still had body aches, muscle weakness, muscle soreness, decreased energy level, occasional night sweats and headaches. Documents held by sender: None.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Muscular weakness, Myalgia, Night sweats
Clinical narrative: Initial case received 19 February 2010 from a physician (is also the patient). A 55 year old male patient with a medical history of hypertension and chronic urticaria with infrequent angioedema, received an injection (route and site not reported) of ADACEL (lot number C2889AA) on 29 January 2010. Immediately following vaccination the patient experienced injection site tenderness. Within a couple of days he experienced injection site swelling, shaking, chills, night sweats, joint tenderness and muscle tenderness. Then over the next week he experienced fatigue, headaches, increased night sweats, increased joint soreness and increased muscle soreness. He had a temperature ranging to "102." On an unspecified date following vaccination, the patient's pre-existing chronic urticaria with infrequent angioedema worsened. Concomitant medications included LIPITOR, ASA, MODURETIC and vitamin B 1000IU. He had no known allergies and had no illness at the time of vaccination. On an unspecified date the patient (physician) was seen by another physician, lab work showed an elevated sed rate of 64 and blood in urine. On an unspecified date, the patient reported that he had stopped taking LIPITOR 2 weeks ago (approximate date 05 February 2010). He was using TYLENOL and ibuprofen. At the time of this report the patient stated he felt the symptoms were improving, but still had body aches, muscle weakness, muscle soreness, decreased energy level, occasional night sweats and headaches. Documents held by sender: None.