chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated intramuscularly with the third dose of Gardasil. The physician reported that the patient experienced numbness in her feet after receiving her third dose of Gardasil. The physician stated that the patient had Guillain-barre syndrome. It was reported that the patient was one of a set of triplets and all three received the three doses of Gardasil at the same time. However, only this patient experienced numbness. The physician did not provide any lot numbers. The patient sought unspecified medical attention. No additional information was provided. Upon internal review, it was determined that Guillain-barre syndrome was an other important medical event. In follow-up it was reported by a nurse that the patient received the first dose of Gardasil (Lot # 654389/0961F) on 27-DEC-2006. The patient received the second dose of Gardasil from the college student health center on 28-FEB-2007, (Lot # not known by physician). It was reported that the patient received the third dose of Gardasil (Lot # 657621/0387U) on 14-JUN-2007. ON 18-JUN-2007, the patient was seen in the office and complained of fatigue, headache, leg pain in both legs, and tingling in both feet and was referred to a neurology practice. It was reported that the chart notes indicated that the patient was admitted to the hospital on 25-JUN-2007 and was discharged on 26-JUN-2007 and received intravenous immunoglobulin (IVIG) 30 grams. No further information was available in the patient's chart. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Dyskinesia
Clinical narrative: Hx of chronic fatigue syndrome and myofascial pain syndrome.  Developed random, involuntary muscle jerking after AVA #1 and typhoid while deployed.  Also states that her preexisting CFS has exacerbated since receiving anthrax vaccinations.  Insomnia, fatigue, malaise >60 days, muscle pain, cognitive deficiency.
Age: 46.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Antinuclear antibody, Chronic fatigue syndrome, Cognitive disorder, Complement factor, Condition aggravated
Clinical narrative: Hx of chronic fatigue syndrome and myofascial pain syndrome.  Developed random, involuntary muscle jerking after AVA #1 and typhoid while deployed.  Also states that her preexisting CFS has exacerbated since receiving anthrax vaccinations.  Insomnia, fatigue, malaise >60 days, muscle pain, cognitive deficiency.
Age: 46.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Dyskinesia, Fatigue, Immunology test, Insomnia, Laboratory test
Clinical narrative: Hx of chronic fatigue syndrome and myofascial pain syndrome.  Developed random, involuntary muscle jerking after AVA #1 and typhoid while deployed.  Also states that her preexisting CFS has exacerbated since receiving anthrax vaccinations.  Insomnia, fatigue, malaise >60 days, muscle pain, cognitive deficiency.
Age: 46.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Malaise, Myalgia
Clinical narrative: Hx of chronic fatigue syndrome and myofascial pain syndrome.  Developed random, involuntary muscle jerking after AVA #1 and typhoid while deployed.  Also states that her preexisting CFS has exacerbated since receiving anthrax vaccinations.  Insomnia, fatigue, malaise >60 days, muscle pain, cognitive deficiency.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Cellulitis, Incorrect route of drug administration
Clinical narrative: Initial report received on 11 October 2007 from another manufacturer, report number A0686419A. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This case was reported by a healthcare professional and described the occurrence of cellulitis in an 11-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline), Havrix (GlaxoSmithKline), and Menactra (Sanofi Pasteur). The subject's medical history included allergy to Keflex and egg allergy. There were no concurrent medications. On 13 September 2007 the subject received the second dose of Boostrix (unknown), a booster dose of Havrix (unknown), and a booster dose of Menactra (unknown). On 13 September 2007, one of the three vaccines that the subject received was inadvertently administered via the incorrect route (subcutaneous). It was noted that the person who administered the vaccines did not document the injection site of each vaccine. on 13 September 2007, the same day that she was vaccinated with Boostrix, Havrix and Menactra, the subject experienced tissue cellulitis. This case was assessed as medically serious by GSK. The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin). At the time of reporting the outcome of the events was unspecified." The following lot numbers were documented in the structured field of the provided report: Menactra, lot number 02231AA (not a valid sanofi pasteur lot number); Boostrix, lot number AC5213008BA; and Havrix, lot number AHAVV115BA.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEPA, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 week old male with no preexisting physician diagnosed allergies, birth defects, or medical conditions, who on 01-AUG-2007 at 4:44 P.M., received an oral dose of Rotateq (lot # 656379/0506U). Concomitant vaccines included: intramuscular Pediarix (lot# ac21b161), intramuscular hepatitis A virus vaccine inactivated (lot #655397/0073u) and intramuscular Prevnar (lot # b54007a). There were no other concomitant medications. It was reported that he was not experiencing any illness at the time of vaccination. It was reported that after receiving the vaccine he had been admitted to the hospital on 22-AUG-2007, because he had bloody diarrhea and vomiting, the patient experienced intussusception and was hospitalized. Subsequently, he underwent surgical reduction of intussusception. It was reported that he was hospitalized for 3-5 days. Subsequently, it is reported that the patient recovered. Intussusception was considered to be immediately life-threatening by the reporter. No product quality complaint was reported. No further information was available. Additional information has been requested. A lot check has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEPA, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Inappropriate schedule of drug administration, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 week old male with no preexisting physician diagnosed allergies, birth defects, or medical conditions, who on 01-AUG-2007 at 4:44 P.M., received an oral dose of Rotateq (lot # 656379/0506U). Concomitant vaccines included: intramuscular Pediarix (lot# ac21b161), intramuscular hepatitis A virus vaccine inactivated (lot #655397/0073u) and intramuscular Prevnar (lot # b54007a). There were no other concomitant medications. It was reported that he was not experiencing any illness at the time of vaccination. It was reported that after receiving the vaccine he had been admitted to the hospital on 22-AUG-2007, because he had bloody diarrhea and vomiting, the patient experienced intussusception and was hospitalized. Subsequently, he underwent surgical reduction of intussusception. It was reported that he was hospitalized for 3-5 days. Subsequently, it is reported that the patient recovered. Intussusception was considered to be immediately life-threatening by the reporter. No product quality complaint was reported. No further information was available. Additional information has been requested. A lot check has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEPA, PNC, RV5
Symptoms: X-ray
Clinical narrative: Information has been received from a physician concerning a 13 week old male with no preexisting physician diagnosed allergies, birth defects, or medical conditions, who on 01-AUG-2007 at 4:44 P.M., received an oral dose of Rotateq (lot # 656379/0506U). Concomitant vaccines included: intramuscular Pediarix (lot# ac21b161), intramuscular hepatitis A virus vaccine inactivated (lot #655397/0073u) and intramuscular Prevnar (lot # b54007a). There were no other concomitant medications. It was reported that he was not experiencing any illness at the time of vaccination. It was reported that after receiving the vaccine he had been admitted to the hospital on 22-AUG-2007, because he had bloody diarrhea and vomiting, the patient experienced intussusception and was hospitalized. Subsequently, he underwent surgical reduction of intussusception. It was reported that he was hospitalized for 3-5 days. Subsequently, it is reported that the patient recovered. Intussusception was considered to be immediately life-threatening by the reporter. No product quality complaint was reported. No further information was available. Additional information has been requested. A lot check has been requested.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, RV5
Symptoms: Apnoea, Blood lead increased, Brain injury, Diastolic dysfunction, Gastroenteritis viral
Clinical narrative: Vaccines were given for 2 month and 4 month shots. They were given on October 9, 2007 at approximately 9:30am. She was given DTAP, Prevnar, Comvax, Polio, and Rotovirus (orally). Patient was fussy after shots were given. We arrived home around 12:30 that afternoon and she was inconsolable. I gave her Tylenol and put her in bed and she slept for about 2 hours. She woke up and around 3:30pm I fed her a bottle. She instantly threw it up. I called the dr.and he told me it was probably viral. I was giving her a bath when she had a silent seizure and went limp and stopped breathing. She came to and was still limp nad then she quit breathing and tured pale again. I shook her to arouse her and then blew air in her mouth. She came back and we were off to the nearest hospital. In Medical Center, patient had 3 more episodes where she would get blue and stop breathing. She was air lifted to Hospital where they told us she was very sick and could die. Her heart had taken a severe blow to whatever was causing this. FYI: On June 5, 2007 patient had a heart surgery to repair a coarchtation of the aorta and on July 15, 2007 had another heart surgery of which was open heart, to repair and Anomolous Left Coronary Artery. Her heart was still in recovery and couldn't take whatever was happening to her because of the vaccine. From hospital she was air lifted to another Hospital in another city where she is today. She almost died from getting a certain vaccine. And immunologist was sent to us and we went over everything from patient's birth up until now, she did research and discovered all of this stemmed from the AP part of the DTAP vaccine.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, RV5
Symptoms: Intubation
Clinical narrative: Vaccines were given for 2 month and 4 month shots. They were given on October 9, 2007 at approximately 9:30am. She was given DTAP, Prevnar, Comvax, Polio, and Rotovirus (orally). Patient was fussy after shots were given. We arrived home around 12:30 that afternoon and she was inconsolable. I gave her Tylenol and put her in bed and she slept for about 2 hours. She woke up and around 3:30pm I fed her a bottle. She instantly threw it up. I called the dr.and he told me it was probably viral. I was giving her a bath when she had a silent seizure and went limp and stopped breathing. She came to and was still limp nad then she quit breathing and tured pale again. I shook her to arouse her and then blew air in her mouth. She came back and we were off to the nearest hospital. In Medical Center, patient had 3 more episodes where she would get blue and stop breathing. She was air lifted to Hospital where they told us she was very sick and could die. Her heart had taken a severe blow to whatever was causing this. FYI: On June 5, 2007 patient had a heart surgery to repair a coarchtation of the aorta and on July 15, 2007 had another heart surgery of which was open heart, to repair and Anomolous Left Coronary Artery. Her heart was still in recovery and couldn't take whatever was happening to her because of the vaccine. From hospital she was air lifted to another Hospital in another city where she is today. She almost died from getting a certain vaccine. And immunologist was sent to us and we went over everything from patient's birth up until now, she did research and discovered all of this stemmed from the AP part of the DTAP vaccine.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, RV5
Symptoms: Aorta coarctation repair, Apnoea, Cardiac operation, Convulsion, Coronary artery disease
Clinical narrative: Vaccines were given for 2 month and 4 month shots. They were given on October 9, 2007 at approximately 9:30am. She was given DTAP, Prevnar, Comvax, Polio, and Rotovirus (orally). Patient was fussy after shots were given. We arrived home around 12:30 that afternoon and she was inconsolable. I gave her Tylenol and put her in bed and she slept for about 2 hours. She woke up and around 3:30pm I fed her a bottle. She instantly threw it up. I called the dr.and he told me it was probably viral. I was giving her a bath when she had a silent seizure and went limp and stopped breathing. She came to and was still limp nad then she quit breathing and tured pale again. I shook her to arouse her and then blew air in her mouth. She came back and we were off to the nearest hospital. In Medical Center, patient had 3 more episodes where she would get blue and stop breathing. She was air lifted to Hospital where they told us she was very sick and could die. Her heart had taken a severe blow to whatever was causing this. FYI: On June 5, 2007 patient had a heart surgery to repair a coarchtation of the aorta and on July 15, 2007 had another heart surgery of which was open heart, to repair and Anomolous Left Coronary Artery. Her heart was still in recovery and couldn't take whatever was happening to her because of the vaccine. From hospital she was air lifted to another Hospital in another city where she is today. She almost died from getting a certain vaccine. And immunologist was sent to us and we went over everything from patient's birth up until now, she did research and discovered all of this stemmed from the AP part of the DTAP vaccine.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, RV5
Symptoms: Cyanosis, Echocardiogram abnormal, Hypotonia, Irritability, Pallor
Clinical narrative: Vaccines were given for 2 month and 4 month shots. They were given on October 9, 2007 at approximately 9:30am. She was given DTAP, Prevnar, Comvax, Polio, and Rotovirus (orally). Patient was fussy after shots were given. We arrived home around 12:30 that afternoon and she was inconsolable. I gave her Tylenol and put her in bed and she slept for about 2 hours. She woke up and around 3:30pm I fed her a bottle. She instantly threw it up. I called the dr.and he told me it was probably viral. I was giving her a bath when she had a silent seizure and went limp and stopped breathing. She came to and was still limp nad then she quit breathing and tured pale again. I shook her to arouse her and then blew air in her mouth. She came back and we were off to the nearest hospital. In Medical Center, patient had 3 more episodes where she would get blue and stop breathing. She was air lifted to Hospital where they told us she was very sick and could die. Her heart had taken a severe blow to whatever was causing this. FYI: On June 5, 2007 patient had a heart surgery to repair a coarchtation of the aorta and on July 15, 2007 had another heart surgery of which was open heart, to repair and Anomolous Left Coronary Artery. Her heart was still in recovery and couldn't take whatever was happening to her because of the vaccine. From hospital she was air lifted to another Hospital in another city where she is today. She almost died from getting a certain vaccine. And immunologist was sent to us and we went over everything from patient's birth up until now, she did research and discovered all of this stemmed from the AP part of the DTAP vaccine.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, RV5
Symptoms: Surgery, Viral infection, Vomiting
Clinical narrative: Vaccines were given for 2 month and 4 month shots. They were given on October 9, 2007 at approximately 9:30am. She was given DTAP, Prevnar, Comvax, Polio, and Rotovirus (orally). Patient was fussy after shots were given. We arrived home around 12:30 that afternoon and she was inconsolable. I gave her Tylenol and put her in bed and she slept for about 2 hours. She woke up and around 3:30pm I fed her a bottle. She instantly threw it up. I called the dr.and he told me it was probably viral. I was giving her a bath when she had a silent seizure and went limp and stopped breathing. She came to and was still limp nad then she quit breathing and tured pale again. I shook her to arouse her and then blew air in her mouth. She came back and we were off to the nearest hospital. In Medical Center, patient had 3 more episodes where she would get blue and stop breathing. She was air lifted to Hospital where they told us she was very sick and could die. Her heart had taken a severe blow to whatever was causing this. FYI: On June 5, 2007 patient had a heart surgery to repair a coarchtation of the aorta and on July 15, 2007 had another heart surgery of which was open heart, to repair and Anomolous Left Coronary Artery. Her heart was still in recovery and couldn't take whatever was happening to her because of the vaccine. From hospital she was air lifted to another Hospital in another city where she is today. She almost died from getting a certain vaccine. And immunologist was sent to us and we went over everything from patient's birth up until now, she did research and discovered all of this stemmed from the AP part of the DTAP vaccine.
Age: 14.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: He received the shot on 8/7/07. Two weeks later he broke out in chickenpox, high fever-duration 1 week I did call the clinic to report it.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood glucose decreased, Blood thyroid stimulating hormone, Borrelia burgdorferi serology negative, Culture urine negative
Clinical narrative: Adacel administered 9/19/07.  Next day felt sick - weak, nauseated, with decreased appetite.  Blood sugars low.  Has persisted through present day.  Cleans homes - has to rest after she's done.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Differential white blood cell count normal, Escherichia infection, Full blood count, Laboratory test normal
Clinical narrative: Adacel administered 9/19/07.  Next day felt sick - weak, nauseated, with decreased appetite.  Blood sugars low.  Has persisted through present day.  Cleans homes - has to rest after she's done.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nausea, Red blood cell sedimentation rate normal, Urinary tract infection, Urine analysis normal
Clinical narrative: Adacel administered 9/19/07.  Next day felt sick - weak, nauseated, with decreased appetite.  Blood sugars low.  Has persisted through present day.  Cleans homes - has to rest after she's done.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelled up the size of an egg, red, and very itchy. The itching drove me nuts because it hurt to touch it so I didn't want to scratch it. The swelling, redness and pain have gone away but it still itches.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Similar reaction on previous exposure to drug, Urticaria, Vomiting
Clinical narrative: Vaccine given approx. 7:40am on 10-18-07.  Approx. 5:30pm, nausea, vomiting and hives.  Took Benadryl w/some relief.  10-19-07 8:00am, pt called office - feeling better, just weak.  Called again at 9:00am stating hives are returning.  Seen in office at 10:00am, dx: serum sickness.  Pt now remembers having similar reaction last year to flu vaccine (never reported it).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: localized cellulitis within hours of vaccine administration.  In addition felt "feverish" for approximately 24-36 hours after vaccine administration.  Also, within hours developed nausea, vomiting and severe headache.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Rash generalised
Clinical narrative: Patient experienced rash all over her body.  The day after the shot, she said she had cold chills and aching.  The patient was instructed by the pharmacist on duty to take benadryl and to contact her primary care physician.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, hot, swollen (cellulitis; at vaccine site.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Anxiety, Confusional state, Convulsion, Inflammation, Obsessive-compulsive disorder
Clinical narrative: Recieved chickenpox vaccination on 8/20/07, 10 hours later was experiencing seizure-like movements that were involuntary,OCD type behavior(ex. pacing in a circle not being able to stay still),cofused and anxious feelings.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pruritus
Clinical narrative: Patient was given injection in upper left arm on 10/16/2007.  Approximately 4 hours later, the patient started having some swelling in that area.  On 10/17, Nurse noticed that the area was still swolen but patient denied any pain, so an ice pack was provided.  The swelling increased, and the patient began to report burning pain and itching.  Benadryl 25 mg was given, but the pain and swelling still increased, so another Benadryl 25 mg was given as well as Lortab for the pain and ice packs were continued to decrease the swelling.  By the next day, the upper left arm injection site swelling had reduced to baseline and patient reported no more pain or itching.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pruritus, Rash erythematous
Clinical narrative: RED RASH EXTENDING DOWN LEFT ARM HEAD FEELS ITCHY NUMBNESS IN LEFT ARM
Age: 1.0
Sex: F
Vaccine: FLU3, HBHEPB, HEPA, PNC
Symptoms: Irritability, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 104.0 and irritability starting about 12 hours after multiple immunizations (Vaqta, Fluzone, Comvax, Prevnar).  No other symptoms.  Exam unremarkable, urinanalysis normal.  All symptoms resolved in <24 hours.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Aneurysm, Haemorrhage intracranial, Headache, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no relevant medical history reported who on 04-OCT-2007 was vaccinated with the first dose Gardasil (lot 656049/0187U). On 06-OCT-2007, the patient was seen at the office complaining of severe headache and vomiting. The patient was transferred to the hospital by ambulance and was admitted. A diagnosis of cranial bleeding due to an aneurysm was made. The patient underwent surgery. At the time of reporting, the patient was recovering. The patient's aneurysm and intracranial bleeding were considered disabling, immediately life-threatening, and other important medical events. Additional information has been requested. 11/09/07-records received for DOS 10/6/07-seen in ED of transfering facility-Acute 4 hour onset o occipital headache, constant crescendo-decresendo. Nausea vomiting, Headache exacerbated with movement of head, radiating to neck. Awake, alert, oriented X3.  12/06/07-records received from receiving facility for DOS 10/09-10/31/07-DC DX:SAH/IVH secondary to right paravermian/posterior fossa AVM. Procedure:angio cerebral artery-and suboccipital craniectomy, resection of tumor, surgical resection placement of VP shunt. Transferred to rehabilitation facility
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Insomnia
Clinical narrative: Information has been received from a healthcare worker concerning a 22 year old female who was vaccinated with three doses of Gardasil. The first dose on 20-MAR-2007 (lot #655503/0012U), the second dose on 30-MAY-2007 (lot #657736/0389U) and the third dose on 19-SEP-2007 (lot #658563/1063U). There was no concomitant medication. on 19-SEP-2007 the patient experienced 1.5 cm "knot" in her left deltoid at the injection site and pain at the injection site. The injection site is extremely tender to touch, with some redness and slightly blue in color. The patient is having problems sleeping because of the pain. The first and third doses were administered in her left deltoid and the second dose was administered in her right deltoid. On 15-OCT-2007 an ultrasound of the injection site area was performed which showed a solid mass. It was reported that the patient's events were considered to be disabling. No further information is available. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Information has been received from a healthcare worker concerning a 22 year old female who was vaccinated with three doses of Gardasil. The first dose on 20-MAR-2007 (lot #655503/0012U), the second dose on 30-MAY-2007 (lot #657736/0389U) and the third dose on 19-SEP-2007 (lot #658563/1063U). There was no concomitant medication. on 19-SEP-2007 the patient experienced 1.5 cm "knot" in her left deltoid at the injection site and pain at the injection site. The injection site is extremely tender to touch, with some redness and slightly blue in color. The patient is having problems sleeping because of the pain. The first and third doses were administered in her left deltoid and the second dose was administered in her right deltoid. On 15-OCT-2007 an ultrasound of the injection site area was performed which showed a solid mass. It was reported that the patient's events were considered to be disabling. No further information is available. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a 72 year old female consumer with a penicillin allergy, depression, hypertension and Lennox-Gastaut syndrome who on 26-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck). Concomitant therapy included sertraline HCl (ZOLOFT), lamotrigine (LAMICTAL) and verapamil. On 30-SEP-2007 the patient developed a raised macular papular rash. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Follow up information from the physician on 08-OCT-2007 indicated that the patient was not vaccinated at his office. Follow up information received on 09-OCT-2007 from a certified medical assistant indicated that the patient was seen in the office for her rash which was described as an erythematous, pruritic rash on the extremities. The patient was treated with cetirizine hydrochloride (ZYRTEC). No further information was provided. The medical assistant considered treatment with cetirizine hydrochloride (ZYRTEC) to be an intervention to prevent serious criteria (OME). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a 25 year old female, who in approximately April 2007, was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient became pregnant. The patient's last menstrual period was 09-Jul-2007, with an estimated date of delivery was 14-Apr-2008. Subsequently, on an unspecified date, the patient had a miscarriage at 10 weeks. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a 25 year old female with headaches, depression, and no drug allergies, who on 23-FEB-2007 and 24-APR-2007 was vaccinated with a first dose and second dose of Gardasil, respectively. Concomitant medication included citalopram hydrobromide (CELEXA) and cyclobenzaprine hydrochloride (MSD). Subsequently, after receiving the first two vaccinations the patient reported she was 5 weeks pregnant. It was noted that the patient discontinued the dosing schedule. The patient's last menstrual period was 07-JUL-2007, the estimated conception date was approximately 21-JUL-2007, and the estimated delivery date was approximately 14-APR-2007. On 17-SEP-2007 the patient had an ultrasound due to bleeding and the results of the test were reported as fetal demise. On 20-SEP-2007 the patient had a spontaneous abortion at 10 weeks. The products of conception were examined and reported as immature chorionic villi with decidua. It was unknown if the fetus was normal. The patient did not have any previous pregnancies. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Exposure to communicable disease, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a 66 year old male medical technologist with no pertinent medical history, and an allergy to both iodine and penicillin who on 19-SEP-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included simvastatin (MSD) and amlodipine besylate (+) benazepril hydrochloride (LOTREL). The patient reported that on 21-SEP-2007, two days after administration of Zostavax (Oka/Merck), he developed chickenpox. The patient reported developing a "a rash" on his face, scalp, chest, hands, feet, throat and ears. The patient also reported having a high fever, sore throat, a swollen face and some hearing loss. The patient noted he had been exposed to zoster from his wife two weeks prior to his outbreak. The patient reported that on 01 OCT 2007 he had recovered from all of his symptoms, except for his hearing loss. Medical attention was sought via telephone. There were no lab diagnostic studies performed. There was no product quality complaint. The reporter considered the adverse events to be disabling. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Varicella
Clinical narrative: Information has been received from a 66 year old male medical technologist with no pertinent medical history, and an allergy to both iodine and penicillin who on 19-SEP-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included simvastatin (MSD) and amlodipine besylate (+) benazepril hydrochloride (LOTREL). The patient reported that on 21-SEP-2007, two days after administration of Zostavax (Oka/Merck), he developed chickenpox. The patient reported developing a "a rash" on his face, scalp, chest, hands, feet, throat and ears. The patient also reported having a high fever, sore throat, a swollen face and some hearing loss. The patient noted he had been exposed to zoster from his wife two weeks prior to his outbreak. The patient reported that on 01 OCT 2007 he had recovered from all of his symptoms, except for his hearing loss. Medical attention was sought via telephone. There were no lab diagnostic studies performed. There was no product quality complaint. The reporter considered the adverse events to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MNQ, MMRV, MNQ
Symptoms: Body temperature increased, Grand mal convulsion, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from an investigator concerning a 12-month-old male who entered study. On 04-SEP-2007 the patient was vaccinated subsequently in the left arm with a first dose of 0.5 ml of ProQuad (Oka/Merck upgrade process) (lot3 656445/1482F). Suspect vaccination included a second intramuscular injection in the right thigh of Menactra (lot# U21722AA). On 22-SEP-2007 the patient developed a fever "but was acting fine" and his parents treated with acetaminophen (TYLENOL). On 23-Sep-2007, the patient developed a rectal temperature of 104.9 degrees Fahrenheit, and experienced a grand-mal seizure lasting "a few minutes". He was noted to be post-focal for five minutes following the seizure. The seizure was reported by his mother, who is a pediatrician. His parents treated with fever with acetaminophen (TYLENOL) and a sponge bath, and the fever resolved the following day. No additional seizures were noted. Per the investigator, the patient had no history of febrile seizures. He recovered and continued in the trial. According to the investigator, the event was not related to Menactra. The reporting investigator felt that febrile seizure was related to ProQuad (Oka/Merck upgrade process). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MNQ, MMRV, MNQ
Symptoms: Body temperature increased, Febrile convulsion, Grand mal convulsion, Inappropriate schedule of drug administration, Medication error
Clinical narrative: Information has been received from an investigator concerning a 12-month-old male who entered study. On 04-SEP-2007 the patient was vaccinated subsequently in the left arm with a first dose of 0.5 ml of ProQuad (Oka/Merck upgrade process) (lot3 656445/1482F). Suspect vaccination included a second intramuscular injection in the right thigh of Menactra (lot# U21722AA). On 22-SEP-2007 the patient developed a fever "but was acting fine" and his parents treated with acetaminophen (TYLENOL). On 23-Sep-2007, the patient developed a rectal temperature of 104.9 degrees Fahrenheit, and experienced a grand-mal seizure lasting "a few minutes". He was noted to be post-focal for five minutes following the seizure. The seizure was reported by his mother, who is a pediatrician. His parents treated with fever with acetaminophen (TYLENOL) and a sponge bath, and the fever resolved the following day. No additional seizures were noted. Per the investigator, the patient had no history of febrile seizures. He recovered and continued in the trial. According to the investigator, the event was not related to Menactra. The reporting investigator felt that febrile seizure was related to ProQuad (Oka/Merck upgrade process). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MNQ, MMRV, MNQ
Symptoms: Postictal state, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from an investigator concerning a 12-month-old male who entered study. On 04-SEP-2007 the patient was vaccinated subsequently in the left arm with a first dose of 0.5 ml of ProQuad (Oka/Merck upgrade process) (lot3 656445/1482F). Suspect vaccination included a second intramuscular injection in the right thigh of Menactra (lot# U21722AA). On 22-SEP-2007 the patient developed a fever "but was acting fine" and his parents treated with acetaminophen (TYLENOL). On 23-Sep-2007, the patient developed a rectal temperature of 104.9 degrees Fahrenheit, and experienced a grand-mal seizure lasting "a few minutes". He was noted to be post-focal for five minutes following the seizure. The seizure was reported by his mother, who is a pediatrician. His parents treated with fever with acetaminophen (TYLENOL) and a sponge bath, and the fever resolved the following day. No additional seizures were noted. Per the investigator, the patient had no history of febrile seizures. He recovered and continued in the trial. According to the investigator, the event was not related to Menactra. The reporting investigator felt that febrile seizure was related to ProQuad (Oka/Merck upgrade process). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Excessive eye blinking, Tardive dyskinesia, Tic
Clinical narrative: Initial report received from a patient's parent on 08 October 2007. An 7-year-old male with history of Pervasive Development Disorder and unspecified environmental allergies received a left deltoid intramuscular injection of Daptacel (Lot number C2657AA) on 07 August 2007. By that evening, the patient began showing signs of eye blinking, facial tics and uncontrolled movement which was more pronounced by the next day. The parent reported that the patient was suffering from possible tardive dyskinesia. The patient was seen by a physician and was referred to a neurologist whom he has seen three to four times. The patient was treated with Cogentin. Outcome was reported as 'not recovered'. No additional information had been provided at the time of this report.
Age: 19.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Dyspnoea, Oxygen saturation decreased
Clinical narrative: Initial report received from a health care professional on 08 October 2007. A 19-year-old female received a first left tricep subcutaneous injection of YF-VAX (lot number UF191AA) and a first dose of Twinrix (lot number AHABB100AA; route and site of administration not reported) on 08 October 2007. The patient's parent contacted the vaccine provider 45-60 minutes post vaccination, reporting that the patient was short of breath. The patient was advised to go to the Urgent Care Center. The patient's arterial blood oxygen saturation was 91% pre-treatment. The patient received treatment with Benadryl, epinephrine and a hand-held nebulizer. The shortness of breath resolved and outcome was reported as 'recovered'.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Rotateq vaccine given 8-13-07. Infant diagnosed and treated for intussusception 9/16/07.12/10/07-records received for DOS 9/16/07-DC DX: Intussusception. Barium enema reduction of colo-colonic intussusception with reflux of contrast into the terminal ileum. C/O vomiting and blood stools. Fussy.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood sodium decreased, Cellulitis, Chills, Mental status changes, Pyrexia
Clinical narrative: Pt is a 65 yo male, hyperlipidemia, cluster headaches, GERD, BPH who developed fever 102, chills 16 hours after vaccines given. Pt drink a lot of water and then developed decreased mental status. On exam cellulitis of (L) arm - triceps arm was noted.  10/23/07 Received pneumo lot #.  VAERS database updated w/same.  10/23/07 Received hospital medical records which reveal patient experienced swelling of left biceps with fever, chills, lethargy & altered mental status.  Admitted 10/13-10/15/2007.  Nephrology consulted for low Na & ID consult done.  Tx w/IV antibiotics.  Progressed well & d/c to home on oral antibiotics. FINAL DX: Cellulitis of left biceps, hyponatremia.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Pt is a 65 yo male, hyperlipidemia, cluster headaches, GERD, BPH who developed fever 102, chills 16 hours after vaccines given. Pt drink a lot of water and then developed decreased mental status. On exam cellulitis of (L) arm - triceps arm was noted.  10/23/07 Received pneumo lot #.  VAERS database updated w/same.  10/23/07 Received hospital medical records which reveal patient experienced swelling of left biceps with fever, chills, lethargy & altered mental status.  Admitted 10/13-10/15/2007.  Nephrology consulted for low Na & ID consult done.  Tx w/IV antibiotics.  Progressed well & d/c to home on oral antibiotics. FINAL DX: Cellulitis of left biceps, hyponatremia.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Encephalitis, Leukoencephalomyelitis
Clinical narrative: See attachment #1 symptoms of encephalomyelitis began 1 month post 5/22/07 vaccine visit.  10/30/07 Reviewed hospital medical records which reveal patient experienced left hemiparesis starting w/left leg dragging then spread to left arm.  Seen at outlying hospital where CT of brain was c/w tumor.  Transferred to higher level of care & admitted 9/1-9/7/2007.  Tx w/high dose IV steroids for ADEM s/p vaccinations noted to be in July, 2007.  LP done.  Improved almost immediately s/p steroids but continued to have weakness of left leg & dragging leg at d/c.  D/C to home on tapering steroids & PT/OT as outpatient w/follow-up in Neurology clinic & pcp. 11/2/07 Received vax record from pcp. which confirms dose & lot as reported. Follow-up: Child Primary Dr. last saw him in February 2008. He displayed no neurologic deficits and appeared to have recovered from encephalomyelitis symptoms. She states that patient is still taking prednisone and is under the care of Dr. (pediatric neurologist) at hospital. You can contact Dr. for further medical information. He is overseeing any future immunizations that patient will receive.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Blood chloride increased, Blood electrolytes normal, Blood potassium increased, Blood pressure immeasurable, Carbon dioxide decreased
Clinical narrative: Patient became lethargic, vomited then became unresponsive, mom brought her back to office where we could not find a good pulse or BP. So the nurse and I accompanied mom and patient to the ER/where she received IV fluids and IV steroids and slowly improved. Admitted for observation. 11/16/07-records received for DOS 10/16/07-admitted for observation. DX: Unresponsive. After vaccination she became fatigued and had an episode of vomiting and became unresponsive, pale and sweating while in lab of  the physician office. Mom returned her to clinic, she was observed to be blue around mouth, unresponsive and floppy. In ED tachycardic.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Full blood count normal, Lethargy, Pulse absent, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient became lethargic, vomited then became unresponsive, mom brought her back to office where we could not find a good pulse or BP. So the nurse and I accompanied mom and patient to the ER/where she received IV fluids and IV steroids and slowly improved. Admitted for observation. 11/16/07-records received for DOS 10/16/07-admitted for observation. DX: Unresponsive. After vaccination she became fatigued and had an episode of vomiting and became unresponsive, pale and sweating while in lab of  the physician office. Mom returned her to clinic, she was observed to be blue around mouth, unresponsive and floppy. In ED tachycardic.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: 12HRS AFTER VACCINATION THE FOLLOWING SYMPTOMS OCCURRED: NAUSEA/VOMITTING/CHILLS/ RIGHT SIDED HEADACHE/ LEFT SIDED BODY PAIN/ STIFF NECK, PROFOUND FATIGUE/ DIARRHEA. VOMITTING AND CHILLS LASTED FOR 4HRS.  THE REMAINING SYMPTOMS LASTED FOR 36 HRS.  FATIGUE, NAUSEA, AND DIARRHEA CONTINUE TO REMAIN 60 HRS AFTER RECEIVING THE VACCINE.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: 12HRS AFTER VACCINATION THE FOLLOWING SYMPTOMS OCCURRED: NAUSEA/VOMITTING/CHILLS/ RIGHT SIDED HEADACHE/ LEFT SIDED BODY PAIN/ STIFF NECK, PROFOUND FATIGUE/ DIARRHEA. VOMITTING AND CHILLS LASTED FOR 4HRS.  THE REMAINING SYMPTOMS LASTED FOR 36 HRS.  FATIGUE, NAUSEA, AND DIARRHEA CONTINUE TO REMAIN 60 HRS AFTER RECEIVING THE VACCINE.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema, Pain in extremity, Skin warm
Clinical narrative: On 10-17-07 noted edema, redness, warm to touch, and painful in left upper ext.  On 10-18-07 pt. assessed by Dr. (temp. 97.6, noted 6.5 X 3.0 cm induration and redness).  Applied ice and Naprosyn ordered.  Spoke with pt. on 10-19-07; s/s: edema, redness, pain, and warm to touch has decreased. No further s/s noted.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blister, Injection site vesicles
Clinical narrative: 1-2 mm thin-walled vesicles noted on shoulder anterior to injection sites 2 days after injections of HPV & Influenza. No fever, rash, or other systemic symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Eye swelling, Nasal congestion
Clinical narrative: swollen left eye, temperature of 101.7 followed by cough and nasal congestion
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 3 inch diameter area of erythema to left deltoid region. Warm to touch. No streaking. No drainage. Minimal swelling. Good, full range of motion. No changes in sensation or use of extremity. No rash, hives, respiratory complaints or itching.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 5cm erythematous,edematous, tender,warm nodule to site of injection.  Ice immediately improved symptoms and decreased edema.
Age: 1.57
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mother reports "wheals" which first appeared on legs, then spread to arms.  Mother applied Benadryl lotion to wheals, and they disappeared.  No other adverse sx. reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Expired fluzone given. Expiration date: June 30 2007.
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia aspiration, Vocal cord paralysis
Clinical narrative: We received via Merck USA the following information from a consumer on 10 OCT 2007: A women, no further data, received a flu shot (manufacturer and batch-number unknown) about ten years ago and experienced a paralized vocal cord and aspiration pneumonia (onset date and duration unknown). No further information available. Company assessment: Seriousness criterion: medically significant. Causality: insufficient date. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Obstruction, Urinary system X-ray, Vomiting
Clinical narrative: Diarrhea started on or about 10/12/07 followed by vomiting. Admitted to hospital 10/16/07. KUB showed obstruction - transferred to another hospital.  11/2/07 Reviewed hospital medical records from 1st hospital which reveal patient experienced intermittent diarrhea x 1 week w/reduced oral intake progressing to emesis & fever.  Admitted 10/16-10/17/2007 for rehydration due to probable gastroenteritis.  Had bloody stool after admit.  Transferred to higher level of care. FINAL DX: Intussusception.  Records faxed to CDC. 11/6/07 Received medical records from 2nd hospital which reveal patient experienced vomiting, fever & diarrhea for 8-10 days.  Admitted 10/17-10/18/07 for overnight observation s/p BE reduction of IS.  No d/c summary available, t/c to medical records for d/c date. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.  12/18/07 Received vax record which provided RO lot & dose # & confirmed other vax as reported.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Wheezing
Clinical narrative: Patient received flu shot 9/24/07 reported hoarse/wheeze/sob 10/6/07 hospitalized 10/12/07 released 10/18/07.  11/9/07 Reviewed hospital medical records which reveal patient experienced SOB, DOE, wheezing, progressive chest tightness, nausea, weakness, productive cough, sore throat, hoarseness & weight loss of 5-6 # over 2 weeks. Admitted 10/12-10/17/2007.  Pulmonary, ENT, GI & cardiac consults.  FINAL DX: Acute bronchitis.