chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Clubbing, Hyperhidrosis, Mobility decreased, Presyncope
Clinical narrative: Client held his breath while immunizations were being administered. I kept telling him to breathe - he became diaphoretic & developed clubbed hands - he insisted that he couldn't open his hands. I called 911 - when EMTs put O2 on him, his color returned & he had full use of both hands & arms . The pt. was a near syncopal episode not a syncopal episode - Mom refused transport since the pt. had no ins. & he was fine.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Anaphylactic reaction, Apnoea, Cyanosis, Death, Hypopnoea
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. 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 toxoids (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), MMR, IPV, and 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 male infant patient (age not reported) with medical history seizures, received an injection (route and site not reported) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, manufacturer and lot number unknown. On an unknown date within 20-30 minutes after receiving the vaccines the patient developed anaphylaxis. After a nap, the patient developed shallow breathing, and was found apneic, cyanotic and in respiratory distress. The patient died (date not reported). The pathology reported interstitial edema. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Oedema, Respiratory arrest
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. 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 toxoids (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), MMR, IPV, and 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 male infant patient (age not reported) with medical history seizures, received an injection (route and site not reported) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, manufacturer and lot number unknown. On an unknown date within 20-30 minutes after receiving the vaccines the patient developed anaphylaxis. After a nap, the patient developed shallow breathing, and was found apneic, cyanotic and in respiratory distress. The patient died (date not reported). The pathology reported interstitial edema. The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03332, and 2011-03333. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Chest discomfort, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that about ten minutes after the ZOSTAVAX (Merck) she was feeling nausea and dizziness, 911 was called and she was transported. The consumer felt that her symptoms were caused by the vaccine. Follow-up information has been received via telephone call from a 62 year old female consumer, who on 12-JAN-2011, was vaccinated with a dose of ZOSTAVAX (Merck). "2 minutes after getting the injection" she got very dizzy and woozy, felt itchy, stated she felt like she was fading, and developed red blotches on her face and neck. A pharmacist called an ambulance and the patient was taken to the emergency room where she was given a shot of prednisone (route of administration was not specified) and a shot of another medication (unspecified). The patient reported that her blood pressure was "a little funny" (value not reported). The patient reportedly spent five hours in the emergency room. Her adverse experience improved after stopping therapy, and the patient recovered on an unspecified date. Follow-up information received via telephone call from a licensed practical nurse (LPN) in a physician's office indicated that the female patient had a sulfa allergy, hyperlipidemia, gastroesophageal reflux disease (GERD). Concomitant medications included simvastatin (manufacturer unknown) and omeprazole. The patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669189/1389Z). No other vaccines were given concomitantly. The office did not treat the patient for the event; an office note from January 2011 simply showed that the patient had an allergic reaction, and that ZOSTAVAX (Merck) was now shown as a drug allergy. There was no copy of the emergency room (ER) record in the chart, so no further information was available. Upon internal review, dizziness, itchiness, felt like she was fading, red blotches on face and neck, and nausea requiring intervention were determined to be Other Important Medical Events. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure abnormal, Dizziness, Drug hypersensitivity, Feeling abnormal, Hypersensitivity
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that about ten minutes after the ZOSTAVAX (Merck) she was feeling nausea and dizziness, 911 was called and she was transported. The consumer felt that her symptoms were caused by the vaccine. Follow-up information has been received via telephone call from a 62 year old female consumer, who on 12-JAN-2011, was vaccinated with a dose of ZOSTAVAX (Merck). "2 minutes after getting the injection" she got very dizzy and woozy, felt itchy, stated she felt like she was fading, and developed red blotches on her face and neck. A pharmacist called an ambulance and the patient was taken to the emergency room where she was given a shot of prednisone (route of administration was not specified) and a shot of another medication (unspecified). The patient reported that her blood pressure was "a little funny" (value not reported). The patient reportedly spent five hours in the emergency room. Her adverse experience improved after stopping therapy, and the patient recovered on an unspecified date. Follow-up information received via telephone call from a licensed practical nurse (LPN) in a physician's office indicated that the female patient had a sulfa allergy, hyperlipidemia, gastroesophageal reflux disease (GERD). Concomitant medications included simvastatin (manufacturer unknown) and omeprazole. The patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669189/1389Z). No other vaccines were given concomitantly. The office did not treat the patient for the event; an office note from January 2011 simply showed that the patient had an allergic reaction, and that ZOSTAVAX (Merck) was now shown as a drug allergy. There was no copy of the emergency room (ER) record in the chart, so no further information was available. Upon internal review, dizziness, itchiness, felt like she was fading, red blotches on face and neck, and nausea requiring intervention were determined to be Other Important Medical Events. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pruritus, Rash macular
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that about ten minutes after the ZOSTAVAX (Merck) she was feeling nausea and dizziness, 911 was called and she was transported. The consumer felt that her symptoms were caused by the vaccine. Follow-up information has been received via telephone call from a 62 year old female consumer, who on 12-JAN-2011, was vaccinated with a dose of ZOSTAVAX (Merck). "2 minutes after getting the injection" she got very dizzy and woozy, felt itchy, stated she felt like she was fading, and developed red blotches on her face and neck. A pharmacist called an ambulance and the patient was taken to the emergency room where she was given a shot of prednisone (route of administration was not specified) and a shot of another medication (unspecified). The patient reported that her blood pressure was "a little funny" (value not reported). The patient reportedly spent five hours in the emergency room. Her adverse experience improved after stopping therapy, and the patient recovered on an unspecified date. Follow-up information received via telephone call from a licensed practical nurse (LPN) in a physician's office indicated that the female patient had a sulfa allergy, hyperlipidemia, gastroesophageal reflux disease (GERD). Concomitant medications included simvastatin (manufacturer unknown) and omeprazole. The patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669189/1389Z). No other vaccines were given concomitantly. The office did not treat the patient for the event; an office note from January 2011 simply showed that the patient had an allergic reaction, and that ZOSTAVAX (Merck) was now shown as a drug allergy. There was no copy of the emergency room (ER) record in the chart, so no further information was available. Upon internal review, dizziness, itchiness, felt like she was fading, red blotches on face and neck, and nausea requiring intervention were determined to be Other Important Medical Events. No further information is available.
Sex: F
Vaccine: HEP, HEP
Symptoms: Autism, Decreased appetite, Encephalitis, Jaundice, Laboratory test
Clinical narrative: This case was reported by a consumer (the subject's mother), via an internet website, and described the occurrence of autism in a 4-day-old female subject who was vaccinated with HEPATITIS B (manufacturer unspecified). A physician or other health care professional has not verified this report. On 5 May 2000, when the subject was hours old, she received 1st dose of HEPATITIS B vaccine (details unknown). On 9 May 2000, 4 days after vaccination with HEPATITIS B vaccine, the subject experienced screaming syndrome and encephalitis. The consumer reported that the subject experienced screaming syndrome "because she had developed encephalitis from the vaccine". The subject experienced "ceaseless, inconsolable screaming that lasted all night and nearly all day for several days...and going on for about four days and night". At a later unspecified date, the subject developed autism. The consumer associated the development of autism with the encephalitis and screaming syndrome. This case was assessed as medically serious by GSK. At the time of reporting the event of autism was unresolved and the outcome of the screaming syndrome and encephalitis was unknown.
Sex: F
Vaccine: HEP, HEP
Symptoms: Lethargy, Screaming
Clinical narrative: This case was reported by a consumer (the subject's mother), via an internet website, and described the occurrence of autism in a 4-day-old female subject who was vaccinated with HEPATITIS B (manufacturer unspecified). A physician or other health care professional has not verified this report. On 5 May 2000, when the subject was hours old, she received 1st dose of HEPATITIS B vaccine (details unknown). On 9 May 2000, 4 days after vaccination with HEPATITIS B vaccine, the subject experienced screaming syndrome and encephalitis. The consumer reported that the subject experienced screaming syndrome "because she had developed encephalitis from the vaccine". The subject experienced "ceaseless, inconsolable screaming that lasted all night and nearly all day for several days...and going on for about four days and night". At a later unspecified date, the subject developed autism. The consumer associated the development of autism with the encephalitis and screaming syndrome. This case was assessed as medically serious by GSK. At the time of reporting the event of autism was unresolved and the outcome of the screaming syndrome and encephalitis was unknown.
Sex: F
Vaccine: HEP, HEP
Symptoms: Autism, Encephalitis, Screaming
Clinical narrative: This case was reported by a consumer (the subject's mother), via an internet website, and described the occurrence of autism in a 4-day-old female subject who was vaccinated with HEPATITIS B (manufacturer unspecified). A physician or other health care professional has not verified this report. On 5 May 2000, when the subject was hours old, she received 1st dose of HEPATITIS B vaccine (details unknown). On 9 May 2000, 4 days after vaccination with HEPATITIS B vaccine, the subject experienced screaming syndrome and encephalitis. The consumer reported that the subject experienced screaming syndrome "because she had developed encephalitis from the vaccine". The subject experienced "ceaseless, inconsolable screaming that lasted all night and nearly all day for several days...and going on for about four days and night". At a later unspecified date, the subject developed autism. The consumer associated the development of autism with the encephalitis and screaming syndrome. This case was assessed as medically serious by GSK. At the time of reporting the event of autism was unresolved and the outcome of the screaming syndrome and encephalitis was unknown.
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, JEV1, ANTH, JEV1, SMALL
Symptoms: Dizziness, Injection site erythema, Injection site inflammation, Injection site papule, Swelling
Clinical narrative: The following information has been downloaded from VAERS on 14 Jun 2011. A 26 year old male received his first IXIARO vaccination (batch number JEV09L36A) i.m. on 07 Apr 2011. 9 days later, on 16 Apr 2011, patient developed swelling, redness, inflammation and lightheadedness around smallpox vaccination site. The swelling decreased, but multiple small papules emerged around the area, approximately 10 x 10 cm. He was hospitalized for one day. The patient did not receive other medication and has no current illnesses. Patient had recovered by 18 Apr 2011 (time of report).
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, JEV1, ANTH, JEV1, SMALL
Symptoms: Dizziness, Injection site erythema, Injection site papule, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: The following information has been downloaded from VAERS on 14 Jun 2011. A 26 year old male received his first IXIARO vaccination (batch number JEV09L36A) i.m. on 07 Apr 2011. 9 days later, on 16 Apr 2011, patient developed swelling, redness, inflammation and lightheadedness around smallpox vaccination site. The swelling decreased, but multiple small papules emerged around the area, approximately 10 x 10 cm. He was hospitalized for one day. The patient did not receive other medication and has no current illnesses. Patient had recovered by 18 Apr 2011 (time of report).
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, JEV1, ANTH, JEV1, SMALL
Symptoms: Dizziness, Injection site erythema, Injection site inflammation, Rash papular
Clinical narrative: The following information has been downloaded from VAERS on 14 Jun 2011. A 26 year old male received his first IXIARO vaccination (batch number JEV09L36A) i.m. on 07 Apr 2011. 9 days later, on 16 Apr 2011, patient developed swelling, redness, inflammation and lightheadedness around smallpox vaccination site. The swelling decreased, but multiple small papules emerged around the area, approximately 10 x 10 cm. He was hospitalized for one day. The patient did not receive other medication and has no current illnesses. Patient had recovered by 18 Apr 2011 (time of report).
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Epistaxis, Petechiae, Platelet count decreased
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Blood folate, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Blood iron normal, Chest X-ray normal, Computerised tomogram abnormal, Cytomegalovirus test positive, Ecchymosis
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Epstein-Barr virus antigen positive, HIV test negative, HLA marker study, Haptoglobin normal, Idiopathic thrombocytopenic purpura
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Immunoglobulin therapy, Intensive care, International normalised ratio, Iron binding capacity total, Lymphocyte count
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Metabolic function test normal, Parasite blood test, Petechiae, Platelet count decreased, Platelet function test normal
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Prothrombin time normal, Serum ferritin, Serum ferritin normal, Splenomegaly, Toxoplasma serology negative
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Vitamin B12
Clinical narrative: Petechiae rash, nosebleed x 1 day.
Age: 0.74
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: slight fever in the evening, fever spike of 102 by 2am on 6/19, fever continued until 06/20
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: right deltoid area is very tender, indurated, warm  Cellulitis versus hypersensitivity reaction to Tdap. Febrile at home Her updated medication list for this problem includes:    Cephalexin 500 Mg Caps (Cephalexin) ..... One capsule by mouth three times daily for ten days as of tomorrow
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: right deltoid area is very tender, indurated, warm  Cellulitis versus hypersensitivity reaction to Tdap. Febrile at home Her updated medication list for this problem includes:    Cephalexin 500 Mg Caps (Cephalexin) ..... One capsule by mouth three times daily for ten days as of tomorrow
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient presents reporting arm discomfort and swelling since receiving Tdap on 6/17/11 in right arm. There is a hard slightly raised area that is about baseball sized on right deltoid, some some diffuse pink coloration. Is not hot to the touch. Patient states that it was swollen down to her elbow previously, and more red and sore, but that it has been gradually improving and is much better now. Has been applying ice.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient presents reporting arm discomfort and swelling since receiving Tdap on 6/17/11 in right arm. There is a hard slightly raised area that is about baseball sized on right deltoid, some some diffuse pink coloration. Is not hot to the touch. Patient states that it was swollen down to her elbow previously, and more red and sore, but that it has been gradually improving and is much better now. Has been applying ice.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Intensive care, Mechanical ventilation, Mobility decreased
Clinical narrative: On ventilator, no use of arms, hands & legs & feet-in intensive care in two hospitals. Had a seizure in hospital and sent to another for extended treatment. Went to rehab at rehab center. Will have MRI shortly at medical center. Staying parents till the MRI.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swelling at site of injection. Reported 2 days later went to doctors office 2 days later and diagnosed cellulitis. Given BACTRIM DS and symptoms improved after 3rd dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 8 x 10 cm area of erythema and induration at injection site (R. hip). No fever or pain at site.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Localized redness developed within 1 hour of the VARIVAX injection on her left arm. It grew to be 20 cm x 27 cm assoc with fever - BACTRIM 800/160 is helping. Fever gone over last 12 hrs. Pt feeling better.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Urticaria
Clinical narrative: Hives and blisters for 4 days after VARIVAX was administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema
Clinical narrative: 9.5 x 6cm erythema Right thigh.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Back pain, Body temperature increased, Lethargy, Pain
Clinical narrative: Day after vaccine, felt weak, achy & lethargic. Temp of 99.6 also c/o back pain. Can't handle smells mom cleaning with strong product.
Age: 0.51
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: High fever with fussiness, pain/redness & swelling at injection site.
Age: 58.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Chronic pain, back, shoulder, neck, arms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema & induration at site of iz placement. About 10cm in size.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: A consumer reported she obtained information from the internet concerning a 15 year old female consumer hypersensitive to allergens, who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and Lot # not reported). Concomitant therapy included ORTHO TRI-CYCLEN LO. On an unspecified date the patient developed itching and urtica of feet and hands. It was unspecified if the patient sought medical attention. It was reported the events were serious with persisting consequences. At the time of the report, the patient's outcome was unknown. Upon internal review itching and urtica of feet and hands were considered to be an other important medical events. This is one of several reports from the same source. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient received ZOSTAVAX vaccine 6-14-11 - on 6-15-11 she noticed an injection site reaction, redness, itching.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Chills
Clinical narrative: Child received Typhoid vaccine on 6-15-11 - 2 hrs later developed uncontrollable shivering. No fever - no local reaction noticed. (child had been seen & dx with strep on 6-14-11).
Age: 31.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Pt was given Anthrax, Typhoid & Hep B and about 30-45 mins later began to experience numbness & tingling in (R) side of her face & (R) arm. Pt was given BENADRYL w/some relief and monitored/observed in clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Pt had Tdap & MENACTRA vaccines 6/9/11. Given both at left deltoid. Arm red, swollen & itchy. Measures 15 x 16 cm.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Haematoma
Clinical narrative: Patient received vaccines MENACTRA and HPV - nurse gave vaccines, stepped back from patient fell off table. Hit left side (parietal) on floor (+) hematoma - check by Dr - vitals checked frequently due to feeling weak, pale 90/60 110/90 110/80 110/80 attempted to sit child upright became lightheaded. Child can't remember incident. Child states he feels confused - Dr in to evaluate child 110/78 last BP child remains in supine position. Patient was sent for Stat CT scan with Stat read. We are sending patient by family car office staff will walk patient to car. He is going straight to hospital for STAT MRI. The HPV vaccine was given 1st (R) deltoid MENACTRA (L) deltoid. Received results from hospital that CT scan is normal.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: In upper (R) leg; 11 x 10 cm area of erythema; mild swelling, warmth surrounding injection site. Patient prescribed with ATARAX 10mg/5mL; 3/4 tsp every 6 hours for itch/swelling.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt fainted about 5 minutes after administration of HPV. Pt did not fully lose consciousness went back to room and waited 30 min. before leaving. Drank apple juice and applied ice pack to back of neck. Pt left fully recovered.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Blood test, Diarrhoea, Dyspnoea, Headache
Clinical narrative: High fever (6 days) - breathing problems & wheezing, pale, very weak, rapid heartbeat, nausea, diarrhea, headaches.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Nausea, Pallor, Pyrexia, Wheezing
Clinical narrative: High fever (6 days) - breathing problems & wheezing, pale, very weak, rapid heartbeat, nausea, diarrhea, headaches.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination complication, Wrong drug administered
Clinical narrative: High fever (6 days) - breathing problems & wheezing, pale, very weak, rapid heartbeat, nausea, diarrhea, headaches.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Diarrhoea, Palpitations, Pharyngeal hypoaesthesia
Clinical narrative: Vaccine given 0800 & experienced symptoms of palpitations, abdominal cramping, diarrhea. Treated in ER with BENADRYL IV for HR 150's. Also c/o "numbness" in back of throat. No further symptoms after ER visit.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever T max 102, chills, nausea, vomiting, starting the night of vaccination 5/16/11. Patient was out of work 5/17/11 to 5/20/11.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, warmth, erythema in area of vaccination 2 days after it was placed, placed on KEFLEX 5/27/11.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial test positive, Blood urine present, Chills, Condition aggravated, Culture urine positive
Clinical narrative: Employee developed fever, chills, headache, nausea same day after receiving vaccine. Treated in ER on 6-07-11. Employee also had Urinary Tract Infection and was treated for this on discharge from E.R.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Escherichia test positive, Headache, Nausea, Nitrite urine present, Protein urine
Clinical narrative: Employee developed fever, chills, headache, nausea same day after receiving vaccine. Treated in ER on 6-07-11. Employee also had Urinary Tract Infection and was treated for this on discharge from E.R.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urinary tract infection, Urine analysis abnormal, Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Employee developed fever, chills, headache, nausea same day after receiving vaccine. Treated in ER on 6-07-11. Employee also had Urinary Tract Infection and was treated for this on discharge from E.R.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Urobilinogen urine increased, White blood cell count, White blood cells urine positive
Clinical narrative: Employee developed fever, chills, headache, nausea same day after receiving vaccine. Treated in ER on 6-07-11. Employee also had Urinary Tract Infection and was treated for this on discharge from E.R.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Laboratory test, Nuclear magnetic resonance imaging brain, Sudden hearing loss
Clinical narrative: Sudden onset hearing loss - Treated by doctor.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm very sore. Very warm to the touch, arm appears a little swollen and red. Pt was given restricted duty.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Next day temp 103.2 rectal, due to age -> necessitated trip to ER.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Egg size bump at injection site. Sore to touch.
Age: 1.22
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Injection site rash, Somnolence
Clinical narrative: Pt arrived in urgent care with temp max 40.3 slight rash around injection sites on thighs, high pitch cry. Ibuprofen given. He slept a bit, had juice, temp at discharge 37.1. No breathing difficulty.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Mom called one day post event. States site where varicella was given was edematous, red and hot. Swollen the size of her palm. Mom told to put cooling measures. Call Dr. if worsens.
Age: 1.52
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given Hep A vaccine (2nd dose) 3 month after 1st dose. A minimum of 6 months is required between doses, this was not observed.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: After injection was given red rash appear and raised bump at the injection site.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Mass, Rash erythematous
Clinical narrative: Pt. developed red rash and raised bump right after the injection.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Biopsy skin abnormal, Dermatitis contact, Hypersensitivity, Infected bites, Polymerase chain reaction
Clinical narrative: PATIENT WAS SEEN IN OFFICE 06/08/2011 C/O RASH ON EXTREMITIES AND TORSO X 2WEEKS. WAS DIAGNOSED WITH CONTACT DERMATITIS AND PRESCRIBED ACCLOVATE OINTMENT. WAS SEEN AGAIN IN OFFICE ON 06/13/2011 C/O RASH BEING WORSE. WAS REFERRED TO DERMATOLOGIST WHO THOUGHT RASH WAS A PROBABLE PAPULAR HYPERSENSITIVITY REACTION  OR QUESTIONABLE SCABIES. ORAL STEROIDS AND ELEMITE WAS PRESCRIBED. PT FOLLOWED UP WITH DERMATOLOGIST 2 DAYS LATER WHO THEN STATED RASH LOOKED "DIFFERENT" AND AT TIME THOUGHT IT MAY BE VARICELLA. A BIOPSY AND CULTURE OF THE AREA WAS DONE. ON 06/21 PT SEEN FOR FOLLOW UP. NO IMPROVEMENT OF RASH. CONTINUES TO SPREAD TO OTHER AREAS OF BODY. BIOPSY REPORT SAYS CONSISTENT WITH INSECT BITES HOWEVER THE CULTURE PCR SHOWED POSITIVE VARICELLA. PATIENT HAS STARTED ACYCLOVIR TODAY.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Varicella post vaccine, Varicella virus test positive, Viral test negative
Clinical narrative: PATIENT WAS SEEN IN OFFICE 06/08/2011 C/O RASH ON EXTREMITIES AND TORSO X 2WEEKS. WAS DIAGNOSED WITH CONTACT DERMATITIS AND PRESCRIBED ACCLOVATE OINTMENT. WAS SEEN AGAIN IN OFFICE ON 06/13/2011 C/O RASH BEING WORSE. WAS REFERRED TO DERMATOLOGIST WHO THOUGHT RASH WAS A PROBABLE PAPULAR HYPERSENSITIVITY REACTION  OR QUESTIONABLE SCABIES. ORAL STEROIDS AND ELEMITE WAS PRESCRIBED. PT FOLLOWED UP WITH DERMATOLOGIST 2 DAYS LATER WHO THEN STATED RASH LOOKED "DIFFERENT" AND AT TIME THOUGHT IT MAY BE VARICELLA. A BIOPSY AND CULTURE OF THE AREA WAS DONE. ON 06/21 PT SEEN FOR FOLLOW UP. NO IMPROVEMENT OF RASH. CONTINUES TO SPREAD TO OTHER AREAS OF BODY. BIOPSY REPORT SAYS CONSISTENT WITH INSECT BITES HOWEVER THE CULTURE PCR SHOWED POSITIVE VARICELLA. PATIENT HAS STARTED ACYCLOVIR TODAY.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: STARTED WITH PAIN AND SWELLING AT INJ SITE PROGRESSING TO TINGLING FINGERS OF SAME ARE TO NUMBNESS IN ARMPIT AREA. NEXT DAY EXPERIENCED ABOVE SX PLUS FATIGUE AND WEAKNESS
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia
Clinical narrative: STARTED WITH PAIN AND SWELLING AT INJ SITE PROGRESSING TO TINGLING FINGERS OF SAME ARE TO NUMBNESS IN ARMPIT AREA. NEXT DAY EXPERIENCED ABOVE SX PLUS FATIGUE AND WEAKNESS
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Consciousness fluctuating, Syncope
Clinical narrative: Pt was given 4 different injections & after about 5 min when pt was getting off table, she sat down in a chair and fainted, was out for 45 sec & was in & out of consciousness x at least - 20-30 min - was transported to hospital.
Sex: M
Vaccine: DT
Symptoms: Anaphylactic reaction, Choking, Death, Dyspnoea, Endotracheal intubation complication
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The agency 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 Td, DPT, 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 geriatric male patient (age not reported) with a medical history of type 2 diabetes mellitus, hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass graft, dementia, and dysrhythmia, received an injection (route and site not reported) for Diphtheria and Tetanus Toxoids, lot number and manufacturer not reported, on an unknown date. On an unknown date within 30 minutes after receiving the vaccine, the patient developed anaphylaxis with symptoms of choking, shortness of breath, and face/neck/whole body swelling. The Emergency Medical Service (EMS) was unsuccessful in intubation. The patient became hypotensive and went into respiratory arrest. The patient received epinephrine x 3, atropine x 3, and remained an unsuccessful intubation. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: DT
Symptoms: Hypotension, Local swelling, Respiratory arrest, Swelling, Swelling face
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The agency 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 Td, DPT, 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 geriatric male patient (age not reported) with a medical history of type 2 diabetes mellitus, hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass graft, dementia, and dysrhythmia, received an injection (route and site not reported) for Diphtheria and Tetanus Toxoids, lot number and manufacturer not reported, on an unknown date. On an unknown date within 30 minutes after receiving the vaccine, the patient developed anaphylaxis with symptoms of choking, shortness of breath, and face/neck/whole body swelling. The Emergency Medical Service (EMS) was unsuccessful in intubation. The patient became hypotensive and went into respiratory arrest. The patient received epinephrine x 3, atropine x 3, and remained an unsuccessful intubation. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dizziness, Heart rate decreased, Nausea, Vomiting
Clinical narrative: About 5 mins after Td & MMR -> lightheaded, nausea, vomiting. Heart rate decreased 67. BP decreased 95/60 from 120/60 earlier. After about 20 mins reclining, was ambulatory & felt better. No rash, respiratory symptoms.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash papular, Varicella post vaccine, Vasculitic rash
Clinical narrative: Papula slightly vascular rash over entire trunk some on all extremities.
Sex: F
Vaccine: DT
Symptoms: Anaphylactic reaction, Anxiety, Arthritis, Dizziness, Erythema
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 toxoids (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), MMR, IPV, and 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. An adult female patient (age not reported) with a medical history of kidney stones, endometriosis, asthma, gastritis, migraines, urinary tract infections (UTI's), and allergies to cephazolin, sulfa drugs and allopurinol, received an injection (route and site not reported) of DIPHTHERIA AND TETANUS TOXOIDS, lot number and manufacturer not reported, on an unknown date. On an unknown date within seconds after receiving the vaccine, the patient developed anaphylaxis with symptoms of dizziness, nausea, erythematous rash over arms/chest, diaphoresis, wheezing, diffuse erythema, and respiratory distress. The patient was treated with epinephrine, diphenhydramine, and methylprednisolone. The outcome was reported chronic anxiety, arthritis, and dizziness (not recovered). The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: F
Vaccine: DT
Symptoms: Hyperhidrosis, Nausea, Rash, Rash erythematous, Respiratory distress
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 toxoids (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), MMR, IPV, and 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. An adult female patient (age not reported) with a medical history of kidney stones, endometriosis, asthma, gastritis, migraines, urinary tract infections (UTI's), and allergies to cephazolin, sulfa drugs and allopurinol, received an injection (route and site not reported) of DIPHTHERIA AND TETANUS TOXOIDS, lot number and manufacturer not reported, on an unknown date. On an unknown date within seconds after receiving the vaccine, the patient developed anaphylaxis with symptoms of dizziness, nausea, erythematous rash over arms/chest, diaphoresis, wheezing, diffuse erythema, and respiratory distress. The patient was treated with epinephrine, diphenhydramine, and methylprednisolone. The outcome was reported chronic anxiety, arthritis, and dizziness (not recovered). The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: F
Vaccine: DT
Symptoms: Wheezing
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 toxoids (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), MMR, IPV, and 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. An adult female patient (age not reported) with a medical history of kidney stones, endometriosis, asthma, gastritis, migraines, urinary tract infections (UTI's), and allergies to cephazolin, sulfa drugs and allopurinol, received an injection (route and site not reported) of DIPHTHERIA AND TETANUS TOXOIDS, lot number and manufacturer not reported, on an unknown date. On an unknown date within seconds after receiving the vaccine, the patient developed anaphylaxis with symptoms of dizziness, nausea, erythematous rash over arms/chest, diaphoresis, wheezing, diffuse erythema, and respiratory distress. The patient was treated with epinephrine, diphenhydramine, and methylprednisolone. The outcome was reported chronic anxiety, arthritis, and dizziness (not recovered). The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.