chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Wrong technique in drug usage process
Clinical narrative: We received from a health care professional the following information on 21 NOV 2007: A female patient was vaccinated with Fluvirin, batch-no. and date unknown, into the rotator cuff.  Patient has lost some functions of the affected arm.  Seriousness criterion: medically significant.  Causality: unrelated.  The wrong vaccine administration is more likely responsible for the complaints.  Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk ratio.  No measure necessary.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Anaemia, Blighted ovum, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner through the pregnancy registry concerning a 17 year old female with a history of an elective termination of a previous pregnancy, and with borderline anaemia, Trichomonas, and no drug allergies, who on 24-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included vitamins (unspecified), ferrous sulfate, and metronidazole. Subsequently, the patient was determined to be pregnant. No problems were reported. The patient's last menstrual period was reported as the end of June 2007. The patient was examined in the office. On 20-SEP-2007 the patient had a spontaneous abortion approximately "10 to 12 weeks" from the last menstrual period. The methods of conception were not examined. During the pregnancy the patient had Trichomonas which was treated with metronidazole 500mg, two times a day for 7 days. The treatment was started on 24-JUL-2007 and 20-SEP-2007. On 24-SEP-2007 an ultrasound was performed due to bleeding and the results showed empty gestational sac versus an embryonic pregnancy implying that an early spontaneous abortion was in progress. The patient had one previous pregnancy that resulted in an elective termination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound uterus, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner through the pregnancy registry concerning a 17 year old female with a history of an elective termination of a previous pregnancy, and with borderline anaemia, Trichomonas, and no drug allergies, who on 24-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included vitamins (unspecified), ferrous sulfate, and metronidazole. Subsequently, the patient was determined to be pregnant. No problems were reported. The patient's last menstrual period was reported as the end of June 2007. The patient was examined in the office. On 20-SEP-2007 the patient had a spontaneous abortion approximately "10 to 12 weeks" from the last menstrual period. The methods of conception were not examined. During the pregnancy the patient had Trichomonas which was treated with metronidazole 500mg, two times a day for 7 days. The treatment was started on 24-JUL-2007 and 20-SEP-2007. On 24-SEP-2007 an ultrasound was performed due to bleeding and the results showed empty gestational sac versus an embryonic pregnancy implying that an early spontaneous abortion was in progress. The patient had one previous pregnancy that resulted in an elective termination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Dysphagia, Muscular weakness, Speech disorder
Clinical narrative: 11/12/07-Blurred and double vision 11/13/07-worsening vision 11/17/07- muscle weakness, difficulty swallowing, dizzy, difficulty talking, hospitalized 12/17/07-records received for DOS 11/22-11/25/07-DC DX: Dizziness. Weakness of glossopharyngeal nerve with diminished cough and gag reflex. Dysarthria.  Neurology workup pending.Ten days prior to admission sudden onset of generalized weakness of upper arm and thigh region. No decrase in hand grip. Diplopia with blurred vision. Lightheadedness. Tongue felt thick and difficult to swallow. Six pound weight gain in 10 days. Increased fever blisters. Recent increase in dosage of Levoxyl.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: 11/12/07-Blurred and double vision 11/13/07-worsening vision 11/17/07- muscle weakness, difficulty swallowing, dizzy, difficulty talking, hospitalized 12/17/07-records received for DOS 11/22-11/25/07-DC DX: Dizziness. Weakness of glossopharyngeal nerve with diminished cough and gag reflex. Dysarthria.  Neurology workup pending.Ten days prior to admission sudden onset of generalized weakness of upper arm and thigh region. No decrase in hand grip. Diplopia with blurred vision. Lightheadedness. Tongue felt thick and difficult to swallow. Six pound weight gain in 10 days. Increased fever blisters. Recent increase in dosage of Levoxyl.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Flu injection given at 820 AM. Pt states she developed hives on arms and chest at 1000 AM. Took 2 Benadryl tablets. Feeling better. Rash improved. Per Dr, pt told to take Prednisone 60mg today and call in the AM with update.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site induration, Pain
Clinical narrative: Black & blue from area of shot to elbow.  Hard where shot was given.  Pain but bearable.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Gross inflammation/induration/tenderness (4"x6") to left deltoid region.
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Reoccurring hives, had shots on Thursday, first incident of hives on Friday AM & then twice more throughout the day; again x2 on Sat and again x2 on Sunday, stopped 6 00/p Sunday evening.  Temp 99.2 (ear), no difficulty breathing or swallowing at any time; patient was given Benadryl per MD on Sat and Sunday.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Bilateral hand swelling approximately 24 hours after Gardasil injection.
Sex: F
Vaccine: MNQ
Symptoms: Culture throat, Pruritus, Rash generalised
Clinical narrative: Body, throat and arms itching.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Patients skin is puckered/indented at site of injection. Patient states no pain or itching or discoloration, she just noticed it about 1 month after being vaccinated.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Fall, Gaze palsy, Nuchal rigidity, Tremor
Clinical narrative: 12-5-07 615 AM woke, went to bathroom fell on floor < 3 sec. Mom found him whole body shaking, very tense, lying on back, neck rigid, eyes rolled back. Mother states lasted < 5 sec. Child woke stating "I fell down" - no temp.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Headache, Rash, Swelling, Urticaria
Clinical narrative: Swelling, red, rash, urticaria, hives (R) arm, HA.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Burning sensation, Pain in extremity, Tinnitus, Urticaria
Clinical narrative: Swelling, red, rash, urticaria, hives (R) arm, HA.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Pt experienced lightheadedness & a rapid heart rate.  1:27pm BP 146/94 AR 120; 1:35pm BP 130/80 AR 110; 2:10pm BP 120/82 AR 78; 2:35pm BP 128/78 AR 82
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Fever with 1st vaccine. Fever and c/o difficulty breathing during the night vaccine had been given. No medical attention was sought.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dermatitis contact, Drug hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: Site of injection has spread 3cm x 3.5cm erythematous area around it. States it's warm to touch with no pain.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: 11-13-07 Hurt like a tetanus shot - Benadryl (2 doses).  11-14-07 Red swollen from elbow to shoulder, painful to touch, took Benadryl (3 doses).  11-16-07 Went to MD, gave IM antibiotic.  11-18-07 Dr. started Levaquin.
Sex: M
Vaccine: JEV
Symptoms: Injection site pruritus, Osteoarthritis
Clinical narrative: Local itching at injection site within 12 hours with duration 7 days for JEV #1 and JEV #2.  Reports worsening of osteoarthritis in May and June following JEV #1 & JEV #2.
Sex: F
Vaccine: RUB
Symptoms: Familial risk factor, Joint lock, Mobility decreased
Clinical narrative: Information has been received from a health professional concerning herself (age unknown) with a family history of "rheumatoid arthritis and neurological disorders after receiving unknown vaccinations" who was vaccinated with a dose of rubella virus vaccine live (Wister RA 27/3) and the patient also stated that she received "the German measles vaccine after delivery of her first child".  Subsequently, for two months after the vaccination the patient's "joints would lock up" and when she was on the floor she was unable to get up.  Subsequently, the patient recovered from joints would lock up.  No medical attention was sought.  No product quality complaint.  No further information is available.
Age: 34.0
Sex: F
Vaccine: RUB
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 34-year-old female with hypertension and no allergies who in January 2005, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3).  In January 2005, following vaccination, the patient experienced a cellulitis reaction.  The injection site was red, warm to touch and painful.  Medical attention was sought.  The patient was treated with cephalexin (Keflex), ibuprofen and heat.  Subsequently, the patient recovered.  No product complaint was involved.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Allergy test negative, Laboratory test, Urticaria
Clinical narrative: Information has been received from a 24 year old female consumer with a history of hypothyroidism and allergy to penicillin who on 23-JUL-2003 was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3).  There were no concomitant medications.  The consumer stated that since she received her rubella virus vaccine live (Wistar RA 27/3), she has developed hives with several visits to the emergency room in the past years, without inpatient admissions to the hospital.  All testing, including allergy tests and blood tests, to determine the reason for the hives have been futile.  At the time of this report, the patient had not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Dyspnoea, Rash
Clinical narrative: Information has been received from a physician concerning a 29 year old female "two days post delivery", still hospitalized after giving birth, who was vaccinated with a dose of MERUVAX II (manufacturer unknown). As standard protocol, she did not have evidence of immunity to rubella. Concomitant therapy included MOTRIN. "Within 12 hours" of vaccination the patient developed a rash on her side. The next day the patient developed arthralgia and difficulty breathing. She went to the ER for medical attention and was given oral and IV steroids. It was reported that the patient's experience improved on therapy (steroid treatment). No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: RUB
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Epstein-Barr virus test, Fatigue
Clinical narrative: Information has been received from a nurse practitioner concerning a 48 year old male with no medical history or allergies who on 04-MAY-2007 was vaccinated with a 0.5 ml dose of MERUVAX II (Lot # 655408/0036U). Concomitant therapy included "numerous vitamin supplements". On 23-MAY-2007 the patient experienced joint aches, leg muscle contractions, and some fatigue. The patient's pain was not constant and it comes and goes. The pain was localized around the calves, knees and legs. it was reported that the patient was an amateur competitive cyclist who often biked about 30-40 miles a day. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/29/2007. Additional information has been received from the nurse pratitioner who stated that on 18-May-2007 the patient expereinced muscle cramping and joint ache during bike riding on 23-May-2007 the patient was seen in clinic on 10-Jul-2007 the patient was again seen in clinic for sinusitis symptoms. On 30-Jul-2007 patient was seen in clinic for ployjoint pain, fatigue. On 01-Aug-2007 the patient was seen in clinic and was very concerned regarding vaccine and felt it damaged his immune system. The patient was advised to follow-up his primary care provider for arthritic testing. At the time of report the patient had not recoverd. Additional information received from the patient indicated that several days after he received the vaccine (04-May-2007), he developed symptoms that was diagnosed as "a vaccine reaction". At the time of this report the patient had not recovered. Additional information received indicated that the consumer was interested in information concerning the negative vaccine reaction issues to his body he has experienced and what might develop in the future. No further information is expected.
Age: 48.0
Sex: M
Vaccine: RUB
Symptoms: Full blood count normal, Immune system disorder, Muscle contractions involuntary, Muscle spasms, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 48 year old male with no medical history or allergies who on 04-MAY-2007 was vaccinated with a 0.5 ml dose of MERUVAX II (Lot # 655408/0036U). Concomitant therapy included "numerous vitamin supplements". On 23-MAY-2007 the patient experienced joint aches, leg muscle contractions, and some fatigue. The patient's pain was not constant and it comes and goes. The pain was localized around the calves, knees and legs. it was reported that the patient was an amateur competitive cyclist who often biked about 30-40 miles a day. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/29/2007. Additional information has been received from the nurse pratitioner who stated that on 18-May-2007 the patient expereinced muscle cramping and joint ache during bike riding on 23-May-2007 the patient was seen in clinic on 10-Jul-2007 the patient was again seen in clinic for sinusitis symptoms. On 30-Jul-2007 patient was seen in clinic for ployjoint pain, fatigue. On 01-Aug-2007 the patient was seen in clinic and was very concerned regarding vaccine and felt it damaged his immune system. The patient was advised to follow-up his primary care provider for arthritic testing. At the time of report the patient had not recoverd. Additional information received from the patient indicated that several days after he received the vaccine (04-May-2007), he developed symptoms that was diagnosed as "a vaccine reaction". At the time of this report the patient had not recovered. Additional information received indicated that the consumer was interested in information concerning the negative vaccine reaction issues to his body he has experienced and what might develop in the future. No further information is expected.
Age: 48.0
Sex: M
Vaccine: RUB
Symptoms: Pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Rubella antibody negative, Vaccination complication
Clinical narrative: Information has been received from a nurse practitioner concerning a 48 year old male with no medical history or allergies who on 04-MAY-2007 was vaccinated with a 0.5 ml dose of MERUVAX II (Lot # 655408/0036U). Concomitant therapy included "numerous vitamin supplements". On 23-MAY-2007 the patient experienced joint aches, leg muscle contractions, and some fatigue. The patient's pain was not constant and it comes and goes. The pain was localized around the calves, knees and legs. it was reported that the patient was an amateur competitive cyclist who often biked about 30-40 miles a day. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/29/2007. Additional information has been received from the nurse pratitioner who stated that on 18-May-2007 the patient expereinced muscle cramping and joint ache during bike riding on 23-May-2007 the patient was seen in clinic on 10-Jul-2007 the patient was again seen in clinic for sinusitis symptoms. On 30-Jul-2007 patient was seen in clinic for ployjoint pain, fatigue. On 01-Aug-2007 the patient was seen in clinic and was very concerned regarding vaccine and felt it damaged his immune system. The patient was advised to follow-up his primary care provider for arthritic testing. At the time of report the patient had not recoverd. Additional information received from the patient indicated that several days after he received the vaccine (04-May-2007), he developed symptoms that was diagnosed as "a vaccine reaction". At the time of this report the patient had not recovered. Additional information received indicated that the consumer was interested in information concerning the negative vaccine reaction issues to his body he has experienced and what might develop in the future. No further information is expected.
Sex: M
Vaccine: RUB
Symptoms: Chronic fatigue syndrome, Fibromyalgia, Rash, Thyroid disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male who in 1999 was vaccinated with a dose of MERUVAX II. The patient was not sure if the rubella vaccine he received was rubella virus vaccine live or not. On an unspecified date (after receiving the vaccine) the patient developed "a lot of problems", a rash, fibromyalgia, chronic fatigue syndrome and "thyroid problems". At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Headache, Rash, Swelling, Urticaria
Clinical narrative: Burning in lungs, Hives rt arm-severe burning Right arm fr elbow up very-painful Ringing in ears
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Burning sensation, Pain in extremity, Tinnitus, Urticaria
Clinical narrative: Burning in lungs, Hives rt arm-severe burning Right arm fr elbow up very-painful Ringing in ears
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash ("whelps")-arm-onset 10/27/07-per mother's report-contacted PMD--gave Benadryl & went to ER-rash also on neck area--improvement past Benadryl--mother says PMD told her that rash might not be related to vaccine. Rash resolved & no further problems.
Age: 4.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Pharyngolaryngeal pain, Urticaria
Clinical narrative: Patient broke out in hives approximately 2 hours after vaccine administration.  Had hives on torso & neck.  Also complained of a sore throat, but had that complaint off and on for 3 days prior.  Patient's doctor notified, Benadryl to be given at home.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: red,raised hives, itching, Shortness of breath, hoarseness, feet swollen. Pt seen in the office 24 hrs after receiving Influenza injection. Pt was given a steroid shot and given Prednisone pack.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Tdap administered to patient on 10/22/07 and 11/19/07.  The second dose was incorrectly ordered due to: the patient could not recall the first immunization 1 month prior; and the patient's medical record could also not be found on the 11/19/07 clinic visit.  No adverse reaction has been reported at this time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: THE PATIENT EXPERIENCED HEADACHE ALL DAY ON THE DAY AFTER THE VACCINE WAS ADMINISTERED.  THEN SHE EXPERIENCED NAUSEA AND LOCALIZED HOT, RAISED, BRIGHT RED AREA AT INJECTION SITE, APPROX. 4" IN LENGTH.  PATIENT NOTICED IT 2 DAYS AFTER VACCINE ADMINISTERED.  NO FEVER.  WENT TO E.R. WHERE SHE WAS TOLD BY 2 DIFFERENT MD'S TO APPLY WARM AND COLD COMPRESSES AND DID NEITHER SINCE INFORMATION WAS CONTRADICTORY.  DID TAKE TYLENOL.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Syncope
Clinical narrative: Within a couple of minutes of receiving vaccination, patient fainted and became stiff.  Episode lasted less than a minute.  No physical injury-patient remained in the chair.  CHC physician examined patient and her feet were elevated.  Patient was given juice and observed for 15 minutes.  Patient became alert and oriented.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Within 2 hours after immunizations, developed "big red lump" left upper arm, just to the side of the immunization site for DTaP. Area was "very hard, very sore, hot to touch."  Lump 2 1/2 " in diameter.  Next morning temperature was 102.8 axillary.  Lowest temperature that day was 100.8 ax.  Motrin given according to "regular schedule."  Ice applied to site.  2 days later (today - December 6th), mom states she does not think child has a fever.  Left upper arm still very sore, very hot, very hard. The rest of the arm is not swollen.  Mom states she will not have any more DTaP given to the child.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Tension headache
Clinical narrative: Pt noted prolonged tension type headache 2 and 13 days after flu vaccine.
Age: 42.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Patient came to the Clinic (where he rec'd his vaccine)12/4/07 for another purpose and reported that after the vaccine 11/8, he had significant swelling in right upper arm, severe pain, and decreased shoulder movement d/t pain. He self-treated w/ ice, ibuprofen, and homeopathic remedy with marked improvement, but still some pain. On exam, 26 days post vaccine, he did have a fullness/swelling in the medial aspect of the upper arm, no discrete adenopathy, no warmth or erythema. He also exhibited some pain on motion, as when he dressed/undressed for exam. I advised him to continue his current sx management, as it is working, and i will re-examine him when he returns to our clinic 12/27, again for another reason.  I also advised him to see his primary clinic if he experiences fever, worsening of symptoms, or new symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Asthenia, Confusional state, Gaze palsy, Somnolence
Clinical narrative: After 3 days of immunization, the baby girl was confused and weak. For around an hour she had general weakness, sleepiness and the eyes were roll back. She was sent to the emergency room and there she recovered.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Infection at site of injection (redness, tenderness, itching, swelling).  Treated with oral antibiotics.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Secondary transmission
Clinical narrative: Patient's 5 year old Daughter was vacinated with Chicken Pox vaccine in July to allow her to attend school in the fall. The patient had not previously had the chicken pox and got the vaccine strain of chicken pox from her daughter in early August. Patient was not warned that she could acquire chicken pox from her daughter after her daughter was vaccinated. Course of illness lasted longer than a month.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: left arm at administration site red, sl.swollen, warm to touch.  Seen in ER.  Prescribed Keflex, Diflucan.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Body temperature increased, Headache, Malaise, Myalgia
Clinical narrative: This female subject was enrolled in the prophylactic open study 107682 (HPV-018). On 02 April 2007, the subject received the 1st dose of HPV 16 and 18 (IM left upper deltoid), the dose of Aventis Pasteur's Menactra (IM, right lower deltoid) and the dose of Boostrix (IM right upper deltoid). On 08 May 2007 and 14 November 2007, the subject received the 2nd and 3rd dose of HPV  (IM left upper deltoid). On 25 November 2007, 11 days after the 3rd of HPV 16-18, seven months after the 1st dose of Boostrix and seven months after the 1st dose of Menactra, this 13-year-old subject developed febrile rash. The subject was hospitalised. The subject was treated with adrenaline, diphenhydramine hydrochloride and corticosteroid. The event was unresolved at time of reporting. The investigator considered there was no reasonable possibility that the febrile rash may have been caused by Boostrix or Menactra but the investigator considered that there was a reasonable possibility that the febrile rash may have been caused by HPV 16-18. Investigator Comments: On 21 November 2007, the subject stated she had headache, muscle pain and weakness. On 25 November 2007, the rash started on legs during the evening. On 26 November 2007, the subject came to clinic with a rash covering most of her body. Given Epinephrine and told to take Benadryl. Return to clinic on 27 November 2007 in AM. On 27 November 2007, the rash was worse, subject had temperature of 39.4 C and general malaise. She was sent to hospital ER for evaluation where she was admitted. Per mother, the subject was given a steroids IV and discharged with Prednisone and Motrin. Information received on 28 November 2007 following a phone call with her grandmother; the subject had a temperature of 38.6 C yesterday afternoon. She stated that she was admitted for 3 days of treatment. The doctors there felt it was related to the HPV vaccine. The subject was feeling better and the rash has decreased. On 28 November 2007, the subject was going to be discharged in this afternoon. She stated that the ER doctor diagnosed "serum sickness".
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Rash, Rash papular, Serum sickness, Urticaria, White blood cell count increased
Clinical narrative: This female subject was enrolled in the prophylactic open study 107682 (HPV-018). On 02 April 2007, the subject received the 1st dose of HPV 16 and 18 (IM left upper deltoid), the dose of Aventis Pasteur's Menactra (IM, right lower deltoid) and the dose of Boostrix (IM right upper deltoid). On 08 May 2007 and 14 November 2007, the subject received the 2nd and 3rd dose of HPV  (IM left upper deltoid). On 25 November 2007, 11 days after the 3rd of HPV 16-18, seven months after the 1st dose of Boostrix and seven months after the 1st dose of Menactra, this 13-year-old subject developed febrile rash. The subject was hospitalised. The subject was treated with adrenaline, diphenhydramine hydrochloride and corticosteroid. The event was unresolved at time of reporting. The investigator considered there was no reasonable possibility that the febrile rash may have been caused by Boostrix or Menactra but the investigator considered that there was a reasonable possibility that the febrile rash may have been caused by HPV 16-18. Investigator Comments: On 21 November 2007, the subject stated she had headache, muscle pain and weakness. On 25 November 2007, the rash started on legs during the evening. On 26 November 2007, the subject came to clinic with a rash covering most of her body. Given Epinephrine and told to take Benadryl. Return to clinic on 27 November 2007 in AM. On 27 November 2007, the rash was worse, subject had temperature of 39.4 C and general malaise. She was sent to hospital ER for evaluation where she was admitted. Per mother, the subject was given a steroids IV and discharged with Prednisone and Motrin. Information received on 28 November 2007 following a phone call with her grandmother; the subject had a temperature of 38.6 C yesterday afternoon. She stated that she was admitted for 3 days of treatment. The doctors there felt it was related to the HPV vaccine. The subject was feeling better and the rash has decreased. On 28 November 2007, the subject was going to be discharged in this afternoon. She stated that the ER doctor diagnosed "serum sickness".
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Hypoaesthesia, Paraesthesia
Clinical narrative: We received from a health care professional the following information on 29 NOV 2007: A 55-year-old female patient born on 29 SEP 1952, was vaccinated with Fluvirin (batch no. 81274) i.m. on an unspecified date. The patient had stroke after getting flu vaccine. She got tingling and numbness in the same arm as the vaccine was given right after vaccination. The patient was hospitalised (dates are unknown).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Back pain, Blister, Herpes zoster, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning an approximately 55 year old female pharmacist who administers Zostavax and developed shingles. It was reported that on 21-NOV-2007, she developed a pain in her back and arms. Later, blisters developed on her back. It was reported that she was evaluated by her physician who diagnosed her with shingles and told her it was because she had been administering zoster vaccine live. The varicella zoster virus identification program was offered to the reporter, who stated that, he who let the patient know about the program and she would initiate contact if interested. It was reported that at the time of this report, the patient had not recovered. A product quality complaint was not reported. Shingles was considered to be disabling by the reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Palatal oedema, Pharyngeal oedema, Pharyngitis, Pruritus
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on 07-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (658603/1081U). Concomitant therapy included lisinopril (PRINIVIL), vitamin D (unspecified) and rosuvastatin calcium (CRESTOR). On 19-NOV-2007 the patient experienced itchy spots on the right side of face. Physician did not specify if the spots were a rash. On 30-NOV-2007 the patient went to the ER because she could not breath properly. Patient was diagnosed with "uvulitis of throat." Patient was given Benadryl and steroids. Patient was not hospitalized. Patient reported to the physician that she felt congested and the physician reported that the patient had a swollen pharynx and swollen uvula. Physician also reported that the patient visited an eye doctor (date was not provided) and was diagnosed with a cornea ulcer. Patient remains on steroids. Uvulitis of the throat was considered an Other Important Medical Event. The events are improving in regards to outcome. No product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Ulcerative keratitis
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on 07-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (658603/1081U). Concomitant therapy included lisinopril (PRINIVIL), vitamin D (unspecified) and rosuvastatin calcium (CRESTOR). On 19-NOV-2007 the patient experienced itchy spots on the right side of face. Physician did not specify if the spots were a rash. On 30-NOV-2007 the patient went to the ER because she could not breath properly. Patient was diagnosed with "uvulitis of throat." Patient was given Benadryl and steroids. Patient was not hospitalized. Patient reported to the physician that she felt congested and the physician reported that the patient had a swollen pharynx and swollen uvula. Physician also reported that the patient visited an eye doctor (date was not provided) and was diagnosed with a cornea ulcer. Patient remains on steroids. Uvulitis of the throat was considered an Other Important Medical Event. The events are improving in regards to outcome. No product quality complaint. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: TC from client. She got cellulitis; fluzone - U2243AA (R) deltoid; pneumovax - 100SF (R) deltoid; hospitalized for 4 days.   12/11/07 Reviewed hospital medical records which reveal patient experienced intractable right arm pain & fever x 1 day.  Admitted 11/10-11/12/2007. Temp on admit 101.5.  Right deltoid was indurated, blotchy, erythematous, warm & exquistitely tender to palpation.  Tx w/IV antibiotics.  Developed hypotension, weakness & nausea while hospitalized but arm pain improved.  D/C to home on continued oral antibiotics.  Patient returned to PCP on 11/16.  Antibiotic was causing N/V.  Continued to have pain of RUE but much less.  Denied any prior reaction to flu shot 7 this was first pneumo shot.  Exam at that time revealed erythema & tenderness of right deltoid.  Antibiotic d/c'd at that time w/only 1 day left. FINAL DX: intractable right arm pain & fever probably secondary to a reaction caused by either the Pneumovax or influenza vaccine.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Lumbar puncture, Paraesthesia
Clinical narrative: Tingling in fingers and toes moved up into hands and feet. Saw Dr. - referred to seen Dr. 1/8/08-records received for DOS 11/24/11/29/07-DX DC: Guillain-Barre sydrome. Admitted with progressive weakness over four to five days onset approximately two weeks after received flu vaccine. Noticed tingling in extremities, began in his feet and gradually worked up his legs and into his hands. Difficulty with walking unable to maintain gait and fell. Treated with IVIG. At discharge able to ambulate with a walker.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody, Dyskinesia, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Demylinated peripheral neuropathy treatment: IV IGG, Lyrica, Ultracet  2/5/08 Reveiwed only EMG & lab reports from hospital.  EMG report states pt dx w/demyelinating neuropathy, improved w/IVIG but continued to have residual numbness of feet & fingers.  T/C to med recs to request complete med recs. 2/22/08 Received only EMG/NCS dated 12/28/2006 which was abnormal & indicative of an acquired demyelinating sensory motor polyneuropathy c/w GBS; however, early CIDP could not be excluded.  Pt w/ 4 wk hx of progressive numbness of feet & hands w/weakness starting 2 wks s/p flu vax.  Neuro exam on 12/28/06 revealed left hip flexor weakness, DTRs 1+ in arms & absent in legs & sensory gradient to pin prick at knee level.  T/C to med recs to check status of complete med recs as requested.  4/8/08 Reviewed PCP medical records which were just the neurologist reports of 12/22/2006-1/5/2007. FINAL DX: acute demyelinating neuropathy, probable GBS. Patient had developed subacute progressive tingling in hands/feet & difficulty w/fine motor movements with significant discomfort.  Exam of 12/22/07 revealed LUE weakness, slight LE weakness, LE absent reflexes, LE & hands diminished sensation, wide based guarded gait.  Referred for labs, LP & EMG/NCS.  Developed severe positional headache.  Referred for IVIG x 5 days. Per 60 day follow up: Permanent nerve damage in lower legs, ankles, feet, (both legs), arms, elbows, wrists and hands. Loss of feeling numbness, tingling, burning, pain.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Apnoea, Blood culture negative, Convulsion, Culture urine negative, Full blood count normal
Clinical narrative: Infant had fever, body stiffening and APNEA (Seizure).  12/14/07 Reviewed hospital medical records which reveal patient experienced staring episode then began shaking all extremities then stopped breathing.  Then started crying inconsolably.  Postictal in ER.  Admitted 11/21-11/22/2007. Sepsis w/u & LP done.  No further seizure activity in hospital but was very sleepy.  Temp on admit 39.8.  Received IM antibiotics.  D/C to home on continued antipyretic to f/u w/pcp. FINAL DX: febrile seizure.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Musculoskeletal stiffness, Pyrexia, Urine analysis normal
Clinical narrative: Infant had fever, body stiffening and APNEA (Seizure).  12/14/07 Reviewed hospital medical records which reveal patient experienced staring episode then began shaking all extremities then stopped breathing.  Then started crying inconsolably.  Postictal in ER.  Admitted 11/21-11/22/2007. Sepsis w/u & LP done.  No further seizure activity in hospital but was very sleepy.  Temp on admit 39.8.  Received IM antibiotics.  D/C to home on continued antipyretic to f/u w/pcp. FINAL DX: febrile seizure.
Age: 40.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Burning sensation, Electromyogram, Insomnia, Muscular weakness, Pain
Clinical narrative: Vaccination on 10-20-06. Started experiencing burning sensations and weakness in both arms - with the right arm being significantly worse. The pain originated from the arm pits and went down the arms. From there the weakness got progressively worse and I started dropping things. Then it turned to excruciating throbbing pain which was so intense it was difficult to sleep. I was diagnosed with brachial neuritis and 13+ months later, still suffer from the effects. I have severe weakness and don't have full use of my thumb and index finger in my right hand. I also have weakness in both arms with the right arm being significantly worse. I also have sensory issues. I was told my condition will probably be permanent due to the severity. Per 60 day follow up: I am still suffering from Brachial Neuritis in my right arm and extending into my hand. My diagnosing Dr. feels this condition was by the vaccinations I received. He also feels the prognosis for recovering is not very good most likely be a permanent considering the lenght of time that has gone by and all the problems still have, and the extent of my problem.
Age: 40.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Radiculitis brachial, Sensory disturbance, Vaccination complication
Clinical narrative: Vaccination on 10-20-06. Started experiencing burning sensations and weakness in both arms - with the right arm being significantly worse. The pain originated from the arm pits and went down the arms. From there the weakness got progressively worse and I started dropping things. Then it turned to excruciating throbbing pain which was so intense it was difficult to sleep. I was diagnosed with brachial neuritis and 13+ months later, still suffer from the effects. I have severe weakness and don't have full use of my thumb and index finger in my right hand. I also have weakness in both arms with the right arm being significantly worse. I also have sensory issues. I was told my condition will probably be permanent due to the severity. Per 60 day follow up: I am still suffering from Brachial Neuritis in my right arm and extending into my hand. My diagnosing Dr. feels this condition was by the vaccinations I received. He also feels the prognosis for recovering is not very good most likely be a permanent considering the lenght of time that has gone by and all the problems still have, and the extent of my problem.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Cyanosis, Electrocardiogram, Lumbar puncture, Pyrexia
Clinical narrative: Fever to 101 F. Cyanosis, apnea estimated to last 30 seconds. Infant co-sleeping with mother who awoke to discover infant as above. Stimulation required. 12/17/07-records received for DOS 11/21-11/23/07-DC DX: Apparent life threatening event, rule out sepsis. Presented to ED after having episode where he turned blue and stopped breathing for approximately 30 seconds according to his parents. Developed fever up to 101 rectaly, some vomiting. No stool for 2 days. Noticed some eye rolling.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Death, Syncope
Clinical narrative: Patient collapsed while eating breakfast at home.  He was taken to the ER and pronounced dead.    12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home.  Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death.  1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.
Age: 0.84
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, no diarrhea. 12-3-07 after returning home. 12-4-07 to ER 9 AM, seizures. 12/07/07-records received-from transferring facility for DOS 12/4/07-status epilepticus or seizure activity. Day before he started seeming sick, specifically vomited and had a fever. On morning of admission vomited again and seemed febrile. Intubated. At time of transfer had semi purposeful and less tonic contraction in muscles of arms and legs. No seizure activity in his eyes. Some skewed deviation. 12/12/07-records received for DOS 12/4-12/6/07- DC DX: Febrile Seizure.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pericarditis
Clinical narrative: Pericarditis diagnosed with EKG changes.  12/7/07 Reviewed clinic medical records which reveal patient experienced dussen onset diffusechest pain, inability to lie down or tke deep breaths.  Went to ER & admitted 12/2-12/3/2007 for cardiac w/u.  Seen in cardiology clinic 12/4/07   FINAL DX: acute pericarditis. 12/18/07 Received v/m from reporter w/vax lot #.  VAERS database updated w/same.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm red, sore, warm to touch.  Went to ER. Diagnosed Celluclitis.  Prescribed Keflex.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Facial pain, Pain in extremity, Tremor
Clinical narrative: Received Hep B on 12/4/07 at 8:30 AM. She experienced a lot of pain in upper arm almost immediately. By 12 noon the pain progressed to left side of face and to fingertips, and left half of trunk area. She noted redness on right clavicle and breast area.  She felt very shaky and her head was pounding.  The pain persisted until the next morning. The redness continued.  She saw her MD who ordered Benadryl 50 mg q4hrs for one dayand labwork.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Eye inflammation, Visual acuity reduced
Clinical narrative: Patient reports 3 month history of bilateral eye inflammation and decreased vision of unknown etiology since 9/07. Patient had Gardasil on 7/25/07 and 9/26/07. Currently, she is off work and unable to drive. She is being followed by a neurologist and opthalmologist. 12/26/07-records received for 11/8/07-Eye inflammation, off work for 2 months secondary to decreased vision, 1/14/08-records received-DX: papilledema and panuveitis. Began in right eye and then left eye. C/O progressive vision changes and eye burning.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin lesion
Clinical narrative: RECEIVED ZOSTER VAC ON WEDNESDAY THE 28TH OF NOV.  ON SAT. DEC 1ST SHE DEVELOPED PAINFUL, LESION ON HER SCALP.  HAS NEW LESIONS TO SCALP AND NEW LESION TO HER LEFT EYE LID. NO VISION CHANGES.  TREATED WITH VALTREX.  REFER TO OPTHAMOLOGY FOR EYE LESION SAME DAY AS EXAM.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No known adverse reactions.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sorness at site of injection that has continued from the day of the injection until now.(It still hurts to lay on that arm at night in bed.) Never any redness,swelling, radiating pain or swollen glands or fever.
Age: 1.5
Sex: U
Vaccine: DTAP, FLU3, HIBV, MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given two doses of MMR Proquad and Dtap, one on 8-31-07 and the other on 11-1-07.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: GENERALIZED PAPULAR RASH
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Vaccine was administered on 11/07/2007.  Pt stopped by pharmacy on 12/5/07 and let me know that her arm had been very sore and stiff since the injection.  She had no bruising, swelling, bleeding, etc, just stiffness and pain.  She did not complain of pain at time of injection.  She did state that it began after the injection.
Age: 6.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: 48 hours after immunization a 14 by 13 cm area of erythema and a 8 by 5 cm area of induration.  The area was itchy to the patient and not painful.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Disorientation, Eye pruritus, Eye swelling, Pyrexia
Clinical narrative: appx 6 hours after immunization given, patient started to feel swelling and itching in eyes which proceeded over the next few hours into high fever (105), chills, disorientation, and other frightening symptoms. Patient will never receive a vaccine again. He is not allergic to eggs.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Diet refusal, Irritability, Pyrexia, Retching
Clinical narrative: Began with severe screaming and flailing of arms & legs 2 hrs. after receiving vaccines.  Acted like he had abdominal pain, wouldn't drink bottle, gagging & dry heaving, febrile x10-12 hrs.  Tyl given q 4 hrs & ibuprofen q 6 hrs x24 hrs.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: Began with severe screaming and flailing of arms & legs 2 hrs. after receiving vaccines.  Acted like he had abdominal pain, wouldn't drink bottle, gagging & dry heaving, febrile x10-12 hrs.  Tyl given q 4 hrs & ibuprofen q 6 hrs x24 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, TTOX, VARCEL
Symptoms: Dizziness, Excoriation, Fall, Immediate post-injection reaction, Injection site pain
Clinical narrative: Injection site very sore. Malaise, fever, dizziness, immediately following injections. 24-25 hrs later, he fainted, fell and hit his chin and neck on stairs. 3 inch laceration (lower rt jawline) and 2 multiple abrasions on neck (lower rt jawline) and left side of face.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, TTOX, VARCEL
Symptoms: Malaise, Neck injury, Pyrexia, Skin laceration, Syncope
Clinical narrative: Injection site very sore. Malaise, fever, dizziness, immediately following injections. 24-25 hrs later, he fainted, fell and hit his chin and neck on stairs. 3 inch laceration (lower rt jawline) and 2 multiple abrasions on neck (lower rt jawline) and left side of face.