chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain, Anaphylactic reaction, Depressed level of consciousness, Hypotension, Urticaria
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), measles, mumps, and rubella (MMR), inactivated polio virus (IPV), and hepatitis B virus (HBV). In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systemic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31. 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A pediatric female patient (age not reported) with no medical history, received the following vaccination on an unknown date with unknown manufacturers and unknown lot numbers: an injection (route and site not reported) of  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, and an injection (route and site not reported) of MMR. On an unknown date within minutes to hour after receiving the vaccines, the patient developed anaphylaxis with symptoms of abdominal pain, hives, decreased consciousness, and hypotension. The patient was treated with epinephrine, and diphenhydramine. The outcome was reported as recovery to previous immunization state (PIS). The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Oropharyngeal pain, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial case was retrieved from the scientific literature on 08 June 2011.The agency was established in 1986 in response to the vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing Td, DPT and DTaP, MMR II, IPV, and HBV. In 2009, the agency charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, we undertook a systematic analysis of the agencies anaphylaxis case experience. The agency administrative database was queried for all cases submitted to the agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A pediatric male patient (age not reported) with medical history of 30 weeks premature, cataracts, lens replacement, latex allergy and IgE positive to gelatin, received the following vaccination on an unknown date with unknown manufacturers and unknown lot numbers: an injection (route and site not reported) of DTaP vaccine, an injection (route and site not reported) of IPV, an injection (route and site not reported) of Hepatitis A virus, and an injection (route and site not reported) of MMR II. On an unknown date within 2 hours after receiving the vaccines the patient developed anaphylaxis with symptoms of cough, sore throat, welts, shortness of breath, wheezing and urticaria. The patient was treated with diphenhydramine and oral steroids. The outcome was reported as recovery to previous immunization state. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Wheezing
Clinical narrative: SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial case was retrieved from the scientific literature on 08 June 2011.The agency was established in 1986 in response to the vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing Td, DPT and DTaP, MMR II, IPV, and HBV. In 2009, the agency charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, we undertook a systematic analysis of the agencies anaphylaxis case experience. The agency administrative database was queried for all cases submitted to the agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A pediatric male patient (age not reported) with medical history of 30 weeks premature, cataracts, lens replacement, latex allergy and IgE positive to gelatin, received the following vaccination on an unknown date with unknown manufacturers and unknown lot numbers: an injection (route and site not reported) of DTaP vaccine, an injection (route and site not reported) of IPV, an injection (route and site not reported) of Hepatitis A virus, and an injection (route and site not reported) of MMR II. On an unknown date within 2 hours after receiving the vaccines the patient developed anaphylaxis with symptoms of cough, sore throat, welts, shortness of breath, wheezing and urticaria. The patient was treated with diphenhydramine and oral steroids. The outcome was reported as recovery to previous immunization state. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Vaccine given in Right upper arm SQ. 1 minute later noted area of swelling, raised welt, below injection site. Swelling measured 1/2 inch long by 1/4 inch wide. No other symptoms noted. Given oral BENADRYL and monitored in office. No further reactions noted.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR
Symptoms: Febrile convulsion
Clinical narrative: Within about 60hrs of DTaP, MMR vaccine patient developed a simple febrile sz. ? secondary to vaccine or viral illness.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Biopsy, Blister, Blood test abnormal, Carbohydrate antigen 125, Dizziness
Clinical narrative: Had an immediate reaction seemed subtle, of blisters, swollen tongue, dizzy then boils which lead to horrific herniated blister on navel, that led to ultrasound only to find ovarian tumor and red eyes. Next ovarian stage 3C borderline cancer. Compromised immune system systemic.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Electroencephalogram, Furuncle, Immediate post-injection reaction, Immune system disorder, Nuclear magnetic resonance imaging
Clinical narrative: Had an immediate reaction seemed subtle, of blisters, swollen tongue, dizzy then boils which lead to horrific herniated blister on navel, that led to ultrasound only to find ovarian tumor and red eyes. Next ovarian stage 3C borderline cancer. Compromised immune system systemic.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Ocular hyperaemia, Ovarian neoplasm, Swollen tongue, Ultrasound abdomen abnormal, X-ray
Clinical narrative: Had an immediate reaction seemed subtle, of blisters, swollen tongue, dizzy then boils which lead to horrific herniated blister on navel, that led to ultrasound only to find ovarian tumor and red eyes. Next ovarian stage 3C borderline cancer. Compromised immune system systemic.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Local swelling
Clinical narrative: Local swelling, Rt thigh, after 6-7 hours of vaccination, swelling gradually subsided after 72 hours. No other symptoms or signs.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 4 inches redness at site, hot and painful with low grade fever.
Age: 61.0
Sex: M
Vaccine: TYP
Symptoms: Feeling abnormal, Nausea, Vomiting
Clinical narrative: Client states that he woke up at 7:00 - 7:30 extremely nauseated and dizzy. 0 emesis. This lasted until around 12:00 noon.  The client stated that he didn't feel himself the rest of the day, but felt fine the next day.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Raised reddened area at site of injection within 20 minutes of vaccine. No vesicles appeared at this time. 12:05 pm vaccine given, 12:10pm c/o itch, 12:15 pm reddened area appeared.
Age: 6.0
Sex: M
Vaccine: TD
Symptoms: Burning sensation, Pain, Rash, Swelling, Urticaria
Clinical narrative: Severe Swollen Rash and Hives painful burning sensation that began on vaccinated arm and spread to both arms and rear end.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Pt with fainting feeling after vaccine injury to the head with the fall.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Cough, Headache, Hypersensitivity
Clinical narrative: Received Tdap .5 cc IM to RA at 4:40pm - 4:50pm pt c/o chest discomfort, after pt. coughing forcefully. Pt. denied any recent cough/resp. illnesses. 5pm per attending Dr. - admin BENADRYL 50mg. p.o. 5:10pm Albuterol Inhaler. 5:15pm: Pt. states decreased chest discomfort, sl. decrease in HA, c/o still coughing - dry.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: Watery diarrhea x 1 week, decreased feeding.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Tender and warm back of right arm 6 x 8 cm almost at axillary area.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Fever x 2 days after vaccination. Temp max 101. Headache x 1 day relieved with TYLENOL & MOTRIN. 3rd day diarrhea.
Age: 0.14
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Culture stool, Erythema multiforme, Faeces discoloured, Full blood count
Clinical narrative: frequent crying, three green bowel movements that left rash then erythema multiforme appeared 3:00 PM and spread all over body
Age: 0.14
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: frequent crying, three green bowel movements that left rash then erythema multiforme appeared 3:00 PM and spread all over body
Age: 19.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chills, Fatigue, Full blood count, Haematocrit, Haemoglobin
Clinical narrative: Rash on (R) upper arm c/w shingles - early- feverish, chills, fatigue - 2 wks after Varicella vaccine.
Age: 19.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster, Injection site rash, Injection site reaction, Platelet count, Pyrexia
Clinical narrative: Rash on (R) upper arm c/w shingles - early- feverish, chills, fatigue - 2 wks after Varicella vaccine.
Age: 19.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: White blood cell count
Clinical narrative: Rash on (R) upper arm c/w shingles - early- feverish, chills, fatigue - 2 wks after Varicella vaccine.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Lethargy, Nausea, Night sweats, Palpitations
Clinical narrative: Became weak and lethargic. Racing heart rate high fever and extreme night sweats. One day after injection, still very weak beginning to feel nauseous.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Became weak and lethargic. Racing heart rate high fever and extreme night sweats. One day after injection, still very weak beginning to feel nauseous.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: Onset of symptoms started with severe headache mid afternoon day of immunization.  Symptoms progressed to generalized body aches, nausea, fever/chills, swollen glands in neck and sore throat, fatigue by evening and persisted to following day.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Streptococcus test
Clinical narrative: Onset of symptoms started with severe headache mid afternoon day of immunization.  Symptoms progressed to generalized body aches, nausea, fever/chills, swollen glands in neck and sore throat, fatigue by evening and persisted to following day.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Onset of symptoms started with severe headache mid afternoon day of immunization.  Symptoms progressed to generalized body aches, nausea, fever/chills, swollen glands in neck and sore throat, fatigue by evening and persisted to following day.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Gait disturbance, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: He started with a fever.  Had the fever until the middle of the night Saturday morning.  Started with the fever again Saturday afternoon and had it until early Sunday morning.  Had the fever again Sunday night until Monday morning complained that his feet hurt and his hands hurt and he really did not want to walk.  He did not have a fever Monday night but he got up Tuesday morning with a Rash all over his torso, arms face, and legs.  It is very itchy.
Age: 0.56
Sex: M
Vaccine: HIBV
Symptoms: Asthenia, Crying, Hypotonia, Irritability, Lethargy
Clinical narrative: Became limp, weak, lethargic and irritable--crying and whimpering.  Developed fever around 9:00 p.m. He has continued to have intermittent fever for 4 days so far, and is vomiting today (6/21/2011).
Age: 0.56
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Became limp, weak, lethargic and irritable--crying and whimpering.  Developed fever around 9:00 p.m. He has continued to have intermittent fever for 4 days so far, and is vomiting today (6/21/2011).
Age: 1.65
Sex: F
Vaccine: MMR
Symptoms: Cough, Influenza virus test negative, Irritability, Mood altered, Pyrexia
Clinical narrative: Developed a croup-type cough for several days, was irritable and moody. Took her to the doctor at 2 weeks after vaccine. She then developed runny nose and fever 3 weeks after vaccine.  Symptoms were not improving. Administered homeopathy about a month after the vaccine, which finally relieved the symptoms.
Age: 1.65
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Developed a croup-type cough for several days, was irritable and moody. Took her to the doctor at 2 weeks after vaccine. She then developed runny nose and fever 3 weeks after vaccine.  Symptoms were not improving. Administered homeopathy about a month after the vaccine, which finally relieved the symptoms.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: 15mm area on (R) thigh at injection site; red and hot, but not tender. 8 days later, the area is still 10cm x 10cm & bluish discoloration. Pt. was treated with KEFLEX on 6.13.11 for reaction.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Rash generalised, Rash maculo-papular
Clinical narrative: Cried for 11 hours  - had rash (generalized maculopapular) - could have been viral (had had mild decreased appetite for 2 days before shots).
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Child awoke with a rash that started on her trunk & spread to face & extremities. Her fever in the office was 101. She is slightly cranky but no meds given. The palms & soles do not have a rash.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Gait disturbance, Irritability, Sleep disorder
Clinical narrative: Child refusing to walk, irritability, cranky behavior the same evening. Fever (?) same night. Woke up several times at night from possible pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Interstitial lung disease
Clinical narrative: Case number PHHY2011AR51518 is an initial spontaneous report received from health authority on 07 Jun 2011. This report refers to a 41-year-old female patient. She was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. One day after vaccination, she experienced interstitial pneumonitis and was hospitalized on an unspecified date. She received antibiotics and anti-influenza treatment. Outcome and causality were not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Ultrasound foetal, Ultrasound scan abnormal
Clinical narrative: Case number PHHY2011AR50356 is an initial spontaneous report from Health Authority (Ministry of health) on 07 Jun 2011: This report refers to a 22-year-old female patient. She received FLUVIRIN (batch number not reported). On an unknown date, she presented with spontaneous abortion. After ultrasound, diagnosis was made as retained dead fetus syndrome.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Full blood count, Injection site erythema, Injection site warmth
Clinical narrative: Shot given on 6/16/11, became red on 6/16/11. 6/17/11 redness increased and was warm to touch, applied ice. 6/18/11 site became worse. Had CBC and started prednisone on 6/18/11, 600mg ibuprofen and 50mg BENADRYL. Arm looking better on 6/20/11.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of elevated liver function tests in a 26-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Hydrocodone. On an unspecified date the subject received 3rd dose of ENGERIX B in the left arm. At an unspecified time after vaccination with ENGERIX B, the subject experienced elevated liver function test. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Furuncle, Injection site erythema, Injection site induration
Clinical narrative: MD stated that a boil had formed at site of injection - area of skin around site (about 1" x 1/2") was red & hard.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Received MMR 6/1/11. Developed fever, HA, myalgia, rash, post cervical cn about 6/10/11 lasted about 5 day.
Age: 13.0
Sex: F
Vaccine: YF
Symptoms: CSF test, Dehydration, Lumbar puncture, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Fever, seen for dehydration 6/20/11, neck stiffness, arm hurting.
Age: 13.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, White blood cell count
Clinical narrative: Fever, seen for dehydration 6/20/11, neck stiffness, arm hurting.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abscess, Erythema, Injection site reaction, Local reaction, Necrosis
Clinical narrative: Patient developed a marked local reaction to the immunization shot. She subsequently developed a raised, erythematous lesion that deteriorated into a about 3 cm x 6 cm abscess with necrotic skin centrally. The lesion has been drained and may require skin graft.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Skin lesion
Clinical narrative: Patient developed a marked local reaction to the immunization shot. She subsequently developed a raised, erythematous lesion that deteriorated into a about 3 cm x 6 cm abscess with necrotic skin centrally. The lesion has been drained and may require skin graft.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abscess drainage, Injection site abscess, Injection site necrosis
Clinical narrative: Patient developed a marked local reaction to the immunization shot. She subsequently developed a raised, erythematous lesion that deteriorated into a about 3 cm x 6 cm abscess with necrotic skin centrally. The lesion has been drained and may require skin graft.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash occurred on (L) arm near the injection site; rash covered underside of (L) upper arm, persisted x 1 week, treated with oral antihistamine and topical steroid cream.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Hypersensitivity, Hypoaesthesia, Mobility decreased, Muscular weakness
Clinical narrative: Patient had received a Tetanus injection this past week. On Saturday afternoon he began to lose control and strength of his left arm and hand. Has difficulty lifting his hand and turning pages. He states now he can wiggle his fingers a little bit. He still has numbness in his 2 little fingers. Dr. thinks that this is an allergic reaction from the Tetanus. He states it should continue to get better, patient can continue to move it around and massage it. If it does not get any better to give us a call back. States that patient is to have no more tetanus injections in the future. This will written on his chart.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Macule, Rash macular, Skin lesion, Skin warm
Clinical narrative: Area of 10cm macular lesions, warm to touch, splotchy no fluctuance - likely reaction treated with ice pack & MOTRIN. Will return to clinic if worsening.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Circulatory collapse, Death, Dyspnoea, Epistaxis
Clinical narrative: Information has been received from the author of a literature article concerning an infant male patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient was unresponsive in car and he developed nose bleed and respiratory arrest. The patient presented with the anaphylactic reaction 2-3 hours after vaccination. The tryptase level was 79, which met the minor criteria of the Brighton Collaboration (BC) case definition of anaphylaxis. It was reported that the patient outcome was death. The causality was level 2 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with RECOMBIVAX HB (manufacturer unknown). It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Hyperhidrosis, Loss of consciousness, Respiratory arrest, Tryptase, Unresponsive to stimuli
Clinical narrative: Information has been received from the author of a literature article concerning an infant male patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient was unresponsive in car and he developed nose bleed and respiratory arrest. The patient presented with the anaphylactic reaction 2-3 hours after vaccination. The tryptase level was 79, which met the minor criteria of the Brighton Collaboration (BC) case definition of anaphylaxis. It was reported that the patient outcome was death. The causality was level 2 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with RECOMBIVAX HB (manufacturer unknown). It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death, Epistaxis, Respiratory arrest, Tryptase increased
Clinical narrative: Information has been received from the author of a literature article concerning an infant male patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient was unresponsive in car and he developed nose bleed and respiratory arrest. The patient presented with the anaphylactic reaction 2-3 hours after vaccination. The tryptase level was 79, which met the minor criteria of the Brighton Collaboration (BC) case definition of anaphylaxis. It was reported that the patient outcome was death. The causality was level 2 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with RECOMBIVAX HB (manufacturer unknown). It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from the author of a literature article concerning an infant male patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient was unresponsive in car and he developed nose bleed and respiratory arrest. The patient presented with the anaphylactic reaction 2-3 hours after vaccination. The tryptase level was 79, which met the minor criteria of the Brighton Collaboration (BC) case definition of anaphylaxis. It was reported that the patient outcome was death. The causality was level 2 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with RECOMBIVAX HB (manufacturer unknown). It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death
Clinical narrative: Information has been received from the author of a literature article concerning an infant male patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient was unresponsive in car and he developed nose bleed and respiratory arrest. The patient presented with the anaphylactic reaction 2-3 hours after vaccination. The tryptase level was 79, which met the minor criteria of the Brighton Collaboration (BC) case definition of anaphylaxis. It was reported that the patient outcome was death. The causality was level 2 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with RECOMBIVAX HB (manufacturer unknown). It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Computerised tomogram head, Computerised tomogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. On 09-NOV-2010 in the middle of the night he suffered another 'grand mal' seizure. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to unknown. The patient was unable to drive for 7 months due to a history of seizures. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from Physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome. Follow up 2 (10-Jun-2011): patient initials updated, additional AE, additional event description, outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. On 09-NOV-2010 in the middle of the night he suffered another 'grand mal' seizure. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to unknown. The patient was unable to drive for 7 months due to a history of seizures. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from Physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome. Follow up 2 (10-Jun-2011): patient initials updated, additional AE, additional event description, outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Condition aggravated, Grand mal convulsion, Impaired driving ability, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. On 09-NOV-2010 in the middle of the night he suffered another 'grand mal' seizure. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to unknown. The patient was unable to drive for 7 months due to a history of seizures. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from Physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome. Follow up 2 (10-Jun-2011): patient initials updated, additional AE, additional event description, outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. On 09-NOV-2010 in the middle of the night he suffered another 'grand mal' seizure. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to unknown. The patient was unable to drive for 7 months due to a history of seizures. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from Physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome. Follow up 2 (10-Jun-2011): patient initials updated, additional AE, additional event description, outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Grand mal convulsion, Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. On 09-NOV-2010 in the middle of the night he suffered another 'grand mal' seizure. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to unknown. The patient was unable to drive for 7 months due to a history of seizures. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from Physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome. Follow up 2 (10-Jun-2011): patient initials updated, additional AE, additional event description, outcome.
Sex: U
Vaccine: HPVX, HPV4
Symptoms: Convulsion, Dizziness, Gaze palsy, Migraine, Moaning
Clinical narrative: Information has been received from a physician concerning a patient who approximately in June 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The physician reported that "last week" in June 2011, the patient experienced seizure after being administered GARDASIL. No lab diagnostics studies were performed. Unspecified treatment was given for the experience. At the time of the report, the patient recovered (date unknown). Action taken regarding to GARDASIL was discontinued on an unspecified date. The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HPVX, HPV4
Symptoms: Muscle rigidity, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning a patient who approximately in June 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The physician reported that "last week" in June 2011, the patient experienced seizure after being administered GARDASIL. No lab diagnostics studies were performed. Unspecified treatment was given for the experience. At the time of the report, the patient recovered (date unknown). Action taken regarding to GARDASIL was discontinued on an unspecified date. The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HPVX, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a patient who approximately in June 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The physician reported that "last week" in June 2011, the patient experienced seizure after being administered GARDASIL. No lab diagnostics studies were performed. Unspecified treatment was given for the experience. At the time of the report, the patient recovered (date unknown). Action taken regarding to GARDASIL was discontinued on an unspecified date. The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.