chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood glucose normal, Syncope
Clinical narrative: Fainted at about 09:50 AM on 8/18/11, was taken to holding area in the clinic, vitals signs/ACCU-CHEK were stable. Given 2 cartons of apple juice, 2 cookies, ADVIL 100 mg for abdominal cramp, she was having her periods and had not eaten breakfast. Recovered well and sent home.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Enema administration, Haematochezia, Intussusception, Lethargy
Clinical narrative: ROTARIX #2 given 8/9/11. 1 currant jelly stool, severe lethargy, crampy abd pain, bile emesis. Intussusception occurred 8/21/11. Radiology reduced partially 8/21. Radiology reduced fully 8/22.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: ROTARIX #2 given 8/9/11. 1 currant jelly stool, severe lethargy, crampy abd pain, bile emesis. Intussusception occurred 8/21/11. Radiology reduced partially 8/21. Radiology reduced fully 8/22.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Mom states 7 days after shot pt developed fever of 101, lasted 2 days. On 8/20 rash started, described as "blotches covering face, neck, legs, stomach, arms." Mom said rash gone on 8/24/2011.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial report was received on 19 August 2011 from another manufacturer national service center (service request number 1-4408792546). who received the report from a consumer. A 37 year-old female patient with an unreported past medical history had received a "DTP vaccine" (manufacturer, lot number, route and site of administration were not reported) on 11 May 2011 and an unspecified amount of time later, developed itching on her palms. The patient also developed hives, but not immediately after vaccination. She gradually started with itching on her palms. She was evaluated by her physician. Treatments included cortisone therapy. The hives persisted for a month and eventually the hives cleared up after starting treatment. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Initial report was received from a health care professional on 19 August 2011. A female patient (date of birth not reported) with no reported past medical history had received a "TDAP vaccine" (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the day of vaccination, experienced a seizure. The patient was taken to the ER (emergency room). No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This literature report with sparse information (initial receipt: 19-Aug-2011) concerns a male patient who died from Guillain-Barre syndrome after receiving influenza vaccination. Of note, the patient's daughter experienced a serious adverse event after receiving influenza vaccine (WAVES 2011029570).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Stated she woke up early AM 8/26 with headache, fever, chills and nausea. Local reaction of redness, warmth & firmness noted to upper outer left arm area. Redness measured at 50x30cm 8/26/11 at 8:30AM by Dr. at HD. Temp. 99.9 tymp. at 8:35 AM 8/26/11 at HD.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Nausea, Pyrexia
Clinical narrative: Stated she woke up early AM 8/26 with headache, fever, chills and nausea. Local reaction of redness, warmth & firmness noted to upper outer left arm area. Redness measured at 50x30cm 8/26/11 at 8:30AM by Dr. at HD. Temp. 99.9 tymp. at 8:35 AM 8/26/11 at HD.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Allergy test, Urticaria
Clinical narrative: Possible food allergy versus possible hives break up with MENACTRA (August 26th) -> hives 10 minutes after eating cheesy popcorn. BENADRYL - ORAPRED.
Age: 14.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Cold sweat, Dyskinesia, Fatigue, Lethargy
Clinical narrative: 1640. Tdap to RA, GARDASIL to LA. At approx 1641, pt c/o left arm pain. Become pale while sitting on edge of table. Assisted to lying position, pale, cool & moist. Doesn't respond to commands. Jerking motions noted to arms. Episode lasted x 30sec approx. After episode, pt lethargic and pale. BP 120/60. 1700 - c/o weak & tired. At 1705, HOB elevated, snacks on crackers. 1715 Pt  A & O, BP stable. Dc'd to mom.
Age: 14.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Pain in extremity, Pallor, Unresponsive to stimuli
Clinical narrative: 1640. Tdap to RA, GARDASIL to LA. At approx 1641, pt c/o left arm pain. Become pale while sitting on edge of table. Assisted to lying position, pale, cool & moist. Doesn't respond to commands. Jerking motions noted to arms. Episode lasted x 30sec approx. After episode, pt lethargic and pale. BP 120/60. 1700 - c/o weak & tired. At 1705, HOB elevated, snacks on crackers. 1715 Pt  A & O, BP stable. Dc'd to mom.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Dry skin, Exfoliative rash, Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: H/o folliculitis and mild eczema; received small pox vaccine left arm 8/4/2011; a wk later started to have itchy rash starting around the vaccine site which continually spread to from left arm to chest/back/right arm; mostly dry itchy scaly rash; seems to be slowly spreading down to his forearm and abdomen; no fevers/cough; has been feeling well o/w.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Patient received 2nd dose of GARDASIL and then had a rash from head to toe that lasted for 3-4 wks.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Fainting, syncope.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: 2 days after Hep A vaccination, pt seen in ER for hives all over body - mom states ER dr said Hep A shot caused it. Script for steroid given.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history, who on 27-JUL-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) IM and a second dose of GARDASIL (Lot # 666118/1539Y) IM on 06-OCT-2010. The nurse reported that after the patient received her second dose, on approximately 16-OCT-2010, "within one and a half weeks", the patient noted numbness in her arm around the injection site which lasted for three days. Immediately following this, on approximately 19-OCT-2010 the patient experienced stabbing pain in that same arm to the point where she could not lift her arm above her head for three days. The nurse saw her on 14-FEB-2011 and noted she had "pretty much recovered". Follow up information has been received from the nurse concerning the patient who after the second dose of GARDASIL experienced arm numbness in a 10 cm by 6 cm area surrounding injection site. Then the patient developed a sharp pain in her arm 1 week after that second dose. The patient could not extend her arm without pain lasted 3 weeks. The patient had a magnetic resonance imaging which showed normal results. The patient's symptoms had resolved prior to next visit with the nurse. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Irritability, Pain
Clinical narrative: Pale, racing heart immediately after injection.  Irritable, tired, vomit at from 6:00 AM to 8:00 PM on 8/30/2011.  Fever 101, chills, body aches, racing heart rate.  Visit physician 12:00 noon.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pallor, Palpitations, Pyrexia, Vomiting
Clinical narrative: Pale, racing heart immediately after injection.  Irritable, tired, vomit at from 6:00 AM to 8:00 PM on 8/30/2011.  Fever 101, chills, body aches, racing heart rate.  Visit physician 12:00 noon.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chills, Crying, Dizziness, Injection site rash, Irritability
Clinical narrative: Pale, racing heart immediately after injection.  Irritable, tired, vomit at from 6:00 AM to 8:00 PM on 8/30/2011.  Fever 101, chills, body aches, racing heart rate.  Visit physician 12:00 noon.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Pale, racing heart immediately after injection.  Irritable, tired, vomit at from 6:00 AM to 8:00 PM on 8/30/2011.  Fever 101, chills, body aches, racing heart rate.  Visit physician 12:00 noon.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Oropharyngeal pain
Clinical narrative: Itching at site of injection.  Turned bright red about 1 inch in diameter around injection site and was very hot and tender to the touch.  Sore throat started at 9:30PM and was diagnosed with Strep throat and upper respiratory infection the next day on 08/27/2011.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngitis streptococcal, Streptococcus test positive, Upper respiratory tract infection
Clinical narrative: Itching at site of injection.  Turned bright red about 1 inch in diameter around injection site and was very hot and tender to the touch.  Sore throat started at 9:30PM and was diagnosed with Strep throat and upper respiratory infection the next day on 08/27/2011.
Age: 0.35
Sex: F
Vaccine: HIBV, IPV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Similar reaction on previous exposure to drug, Skin discolouration
Clinical narrative: About 2 hours after vaccine, thighs turned purple/dark red, baby cried inconsolably for 2-3 hours.  Then resolved.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Culture throat, Differential white blood cell count, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Rash post vaccines stable w/o anaphylaxis or other sxs. No suggestive of HSP. Persisting rash on legs L/buttock and right face. New fatigue.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Mononucleosis heterophile test, Rash, Urine analysis
Clinical narrative: Rash post vaccines stable w/o anaphylaxis or other sxs. No suggestive of HSP. Persisting rash on legs L/buttock and right face. New fatigue.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a physician concerning a male patient with pain who in November 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # and route not reported) 0.65 ml. Concomitant therapy included ALEVE, BROMDAY, vitamin D (unspecified), CIALIS, erythromycin, folic acid, methotrexate sodium (since 1992), vitamins (unspecified), PERCOCET and SIMPONI. The physician reported that the week of 15-AUG-2011, the patient was diagnosed with shingles. The physician reported that the lesions were on his face in the eye area and that it was the worst case he had ever seen. The physician also reported that on an unspecified date, the patient was given VALTREX 1 g, tablet three times per day for one week, for the treatment of the event. At the time of the report, the patient was recovering. Shingles on his face in the eye area were considered to be disabling by the physician. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure before pregnancy, Pharyngitis streptococcal, Pregnancy test positive
Clinical narrative: Information has been received for the Pregnancy Registry for VARIVAX (Merck), from a certified medical assistant concerning a 17 year old female patient with hypertension, anxiety and psoriasis, with no known allergies or drug reaction, who in 1999, was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported) 0.5 ml, subcutaneously, and then, on 08-JUN-2011, she received the second dose of VARIVAX (Merck) (lot # 669227/1563Z, Exp. Date 11-NOV-2012) 0.5 ml, subcutaneously. Concomitant medication included "possible injections by dermatologist for psoriasis and topical creams for psoriasis". The certified medical assistant reported that on 02-AUG-2011 and on 03-AUG-2011, a home pregnancy test and a urine pregnancy test in the office were performed, respectively, which were positive. The patient's last menstrual period was on the week of 20-JUN-2011. Expected date of delivery was on approximately 26-MAR-2011. Follow up information has been received via complete questionnaire from an advanced registered nurse practitioner (ARNP) who reported that the 17 year old female patient had no previous pregnancies. On an unspecified date, the patient experienced strep throat. The patient was prescribed ARROX as treatment for strep throat during her pregnancy. On 11-AUG-2011 a serum beta-human chorionic gonadotropin test was performed (result: 20238 - positive). The ARNP also reported that on 13-AUG-2011 the patient had a miscarriage, before being seen by her OB/GYN. The patient was seen at the ER and it was determined that the patient was expecting twins. It was unknown if the products of conception were examined. It was reported that the patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck) containing vaccine. It was also reported that the patient had no varicella or herpes zoster symptoms post vaccination. Upon internal review spontaneous abortion was considered to be an other important medical event. No further information is available.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Twin pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received for the Pregnancy Registry for VARIVAX (Merck), from a certified medical assistant concerning a 17 year old female patient with hypertension, anxiety and psoriasis, with no known allergies or drug reaction, who in 1999, was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported) 0.5 ml, subcutaneously, and then, on 08-JUN-2011, she received the second dose of VARIVAX (Merck) (lot # 669227/1563Z, Exp. Date 11-NOV-2012) 0.5 ml, subcutaneously. Concomitant medication included "possible injections by dermatologist for psoriasis and topical creams for psoriasis". The certified medical assistant reported that on 02-AUG-2011 and on 03-AUG-2011, a home pregnancy test and a urine pregnancy test in the office were performed, respectively, which were positive. The patient's last menstrual period was on the week of 20-JUN-2011. Expected date of delivery was on approximately 26-MAR-2011. Follow up information has been received via complete questionnaire from an advanced registered nurse practitioner (ARNP) who reported that the 17 year old female patient had no previous pregnancies. On an unspecified date, the patient experienced strep throat. The patient was prescribed ARROX as treatment for strep throat during her pregnancy. On 11-AUG-2011 a serum beta-human chorionic gonadotropin test was performed (result: 20238 - positive). The ARNP also reported that on 13-AUG-2011 the patient had a miscarriage, before being seen by her OB/GYN. The patient was seen at the ER and it was determined that the patient was expecting twins. It was unknown if the products of conception were examined. It was reported that the patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck) containing vaccine. It was also reported that the patient had no varicella or herpes zoster symptoms post vaccination. Upon internal review spontaneous abortion was considered to be an other important medical event. No further information is available.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old male patient who had alpha-galactosidase prior to getting vaccinated, and who sometime last week, on approximately 15-AUG-2011 was vaccinated with a 0.5ml dose of MMR II (route, site, dose and lot number not provided) and on the same day received a dose of VARIVAX (route, site, dose and lot number not provided), a dose of INFANRIX and a dose of HIBERIX. The registered nurse reported that within 15 minutes of vaccination, the patient experienced an anaphylactic reaction. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, anaphylactic reaction was considered to be an other important medical event. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: arm was swollen at injection site, red in color halfway down arm, sore to touch
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: local reaction: swelling, itching and redness and injection site (right upper arm)
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Pallor, Posture abnormal, Syncope
Clinical narrative: Brief syncopal episode. sitting in waiting room and came to Mother at check out with c/o 'I don't feel right'. She slumped in sitting position beside her Mom, not striking anything on the way down. She was diaphoretic, lips pale initially, hugging the waste can and trying to vomit but she had eaten no breakfast. She was helped to an exam room by the RN. BP 100/50 HR 97. She quickly recovered and drank some juice. After 20-30 min she was d/c ambulatory from clinic with her Mother.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Paraesthesia, Tension
Clinical narrative: Pt reported onset of trouble breathing with tensing and tingling in hands and arm the evening of the vaccine. Hand wanted to "curl into a ball". Lasted off/on x 24 hours. No treatment.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, aches, headache, fatigue, weakness, soreness, redness, swelling where shot was given
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, aches, headache, fatigue, weakness, soreness, redness, swelling where shot was given
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Itching on abdomen, progressing to neck, arms, legs, groin, shoulders, back. Hives erupted on back around 10:00pm with complaints of tongue tingling. Medicated with Benadryl, Tylenol, and given cool shower.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Blood culture, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Started running a fever at school.  Temp of 103.  Given Motrin went down to 97.3  Complained of stomach hurting but didn't eat breakfast. No rash, No pain at site.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Cold sweat, Crying, Dehydration, Hypersomnia, Lacrimation decreased
Clinical narrative: Constant vomiting Cool, clammy skin Decreased urination Wasn't producing tears when crying Slept more than usual Was on the verge of dehydration
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: Constant vomiting Cool, clammy skin Decreased urination Wasn't producing tears when crying Slept more than usual Was on the verge of dehydration
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pt woke up with her arm painful, swollen and hot at injection site. On the third day, the pain went around her shoulder to the other arm, and her left arm from her elbow up was swollen. She felt feverish and nauseated, had cold chills, and a headache for 2-3 days after injection. She came into the health dept on 8/15/11. Her arm above her elbow was tight, hot, swollen, and red. She denied fever, headache and nausea at that time. She went home and used ice packs, and ibuprofen. After 1 week she was back to normal and she denies any problems now.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Musculoskeletal pain, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Pt woke up with her arm painful, swollen and hot at injection site. On the third day, the pain went around her shoulder to the other arm, and her left arm from her elbow up was swollen. She felt feverish and nauseated, had cold chills, and a headache for 2-3 days after injection. She came into the health dept on 8/15/11. Her arm above her elbow was tight, hot, swollen, and red. She denied fever, headache and nausea at that time. She went home and used ice packs, and ibuprofen. After 1 week she was back to normal and she denies any problems now.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin tightness, Skin warm
Clinical narrative: Pt woke up with her arm painful, swollen and hot at injection site. On the third day, the pain went around her shoulder to the other arm, and her left arm from her elbow up was swollen. She felt feverish and nauseated, had cold chills, and a headache for 2-3 days after injection. She came into the health dept on 8/15/11. Her arm above her elbow was tight, hot, swollen, and red. She denied fever, headache and nausea at that time. She went home and used ice packs, and ibuprofen. After 1 week she was back to normal and she denies any problems now.
Age: 0.73
Sex: F
Vaccine: DTAP
Symptoms: Cough, Insomnia
Clinical narrative: Persistent dry cough - through the night (would wake her) and through the day. Set of coughs ~every 5-10 minutes during the day. It seems to be better at night now - not waking her and only a few coughs heard (before we are sleeping and don't hear her). Taking Respiguard Glycerile plus Elderberry (2 droppers/day)and Ledum Palustre (2/day) for a week to see if cough improves.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 16x11 cm warm, red, slightly edematous smooth patch at anterior (R) thigh -> A/IMP - cellulitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness, X-ray limb
Clinical narrative: Patient received vaccines Tdap, MENACTRA & Varicella on 8/24/11. Pain on (R) arm occurred that night. Morning on 8/25/11 (R) arm swollen, red, tender. Mother reports redness & swelling progressively work. Seen at clinic on 8/26/11.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fatigue, fever, diarrhea, loss of appetite, arm soreness.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Chills, Malaise, Pain, Pallor, Pyrexia
Clinical narrative: Pt. woke up not feeling well, mom states that pt had chills and fever >102 degrees, body aches. Mom wanted pt check out in the Emergency Department. Pt did not have fever but was pale and complained of chills. ED doctor could not find a relationship with the vaccine but the pt. mother insisted on getting him checked out.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Pt. woke up not feeling well, mom states that pt had chills and fever >102 degrees, body aches. Mom wanted pt check out in the Emergency Department. Pt did not have fever but was pale and complained of chills. ED doctor could not find a relationship with the vaccine but the pt. mother insisted on getting him checked out.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site pustule, Oedema peripheral, Tenderness
Clinical narrative: Imms Monday AM, no problem Tues. Wed evening entire arm (shoulder to wrist) erythematous & moderately swollen, tender with ? yellow pustule at injection site. (Routine imms procedure confirmed by medical assistant). Resolved after 48 hours more.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Death
Clinical narrative: Pt. wife reports pt. died.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pruritus, Swelling face, Swollen tongue
Clinical narrative: 2-3 hours following injection, patient had diffuse pruritus, facial swelling, tongue swelling & difficulty breathing. Reported to ED and received SOLUMEDROL IV and BENADRYL.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Dyspnoea, Hypersensitivity, Hypoaesthesia, Paraesthesia
Clinical narrative: 2-3 hours following injection, patient had diffuse pruritus, facial swelling, tongue swelling & difficulty breathing. Reported to ED and received SOLUMEDROL IV and BENADRYL.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia oral, Pruritus, Sensation of heaviness, Swelling face, Swollen tongue
Clinical narrative: 2-3 hours following injection, patient had diffuse pruritus, facial swelling, tongue swelling & difficulty breathing. Reported to ED and received SOLUMEDROL IV and BENADRYL.
Age: 1.51
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Blood culture negative, Convulsion, Culture negative, Culture urine negative, Sputum culture
Clinical narrative: Pt had seizure approximately 30 hrs after DTaP given admitted for sepsis work-up.
Age: 1.51
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Pt had seizure approximately 30 hrs after DTaP given admitted for sepsis work-up.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Band neutrophil count, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Culture urine negative
Clinical narrative: Infant developed fever 100.4 approx. 24 hrs post vaccination. Also developed 2 cm area erythema, mild warmth, and induration at injection site ((L) superior thigh).
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Full blood count, Haemoglobin normal, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Infant developed fever 100.4 approx. 24 hrs post vaccination. Also developed 2 cm area erythema, mild warmth, and induration at injection site ((L) superior thigh).
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Lymphocyte percentage, Neutrophil count, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Infant developed fever 100.4 approx. 24 hrs post vaccination. Also developed 2 cm area erythema, mild warmth, and induration at injection site ((L) superior thigh).
Age: 0.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram head, Computerised tomogram normal, Culture urine negative
Clinical narrative: Seizure (tonic/clonic) with fever approximately 8 hours after vaccination. Underwent full workup in ER. Received ceftriaxone x 1.
Age: 0.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Seizure (tonic/clonic) with fever approximately 8 hours after vaccination. Underwent full workup in ER. Received ceftriaxone x 1.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time, Full blood count normal, International normalised ratio normal, Metabolic function test normal, Prothrombin time normal
Clinical narrative: 8/22 - noted discrete pairs of flat small pink dots above left knee. Over the next few days, more appeared. Ones previously present became larger and redder. 8/29 - Noted more spots on left leg below as well as above knee and appearance of new spots above right knee. 8/30 - Spots appeared below both knees. Redder and now elevated. No itching or pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 8/22 - noted discrete pairs of flat small pink dots above left knee. Over the next few days, more appeared. Ones previously present became larger and redder. 8/29 - Noted more spots on left leg below as well as above knee and appearance of new spots above right knee. 8/30 - Spots appeared below both knees. Redder and now elevated. No itching or pain.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Not sure EXACT time of onset - above is an approximation.  One day (w/in 24hrs of injection) after injection, child broke out in hives all over his trunk.  Next day (2 days after injection) hives had spread up neck to face; down legs and around injection site; and on arms. Doctor was called at w/in an hour of parents noticing the hives on Wednesday, Aug. 24th.  Doctor advised liquid Benadryl 3x in the next 24hr period which parents complied to.  Child complained of extreme itchiness with the hives with little relief from the Benadryl.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states arm extremely painful that they could not move it. Recommended pt go to emergency room.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Raised red area around injection site sore to the touch and itchy. Treatment - ice pack to area and Hydrocortisone cream.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Fever 102.3-102.4 x 4 days. (L) thigh indurated/red/hard/hot. TYLENOL PRN.
Age: 1.01
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: 7 days after vaccine administration, child developed low-grade fever then diffuse measles-like rash with centrifugal spread, but is now resolving spontaneously. No vesicles or open ulcers/wounds seen. No sick contacts.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthma, Injection site erythema, Injection site swelling, Wheezing
Clinical narrative: Redness, swelling at injection site with asthma exacerbation (wheezing).
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Dyspnoea, Papule, Swelling, Tongue eruption
Clinical narrative: Patient presented with numereous vesicle/papules on tongue & lips; moderate/severe swelling with some difficulty breathing after receiving smallpox vaccination. Patient medivac to hospital on 8/6/2011, for definitive treatment. Patient was admitted and placed under the observation of hospital's providers.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Activities of daily living impaired, Pruritus, Rash macular, Rash pruritic, Sleep disorder
Clinical narrative: Eczema vacinatum; without spreading itching rash for 1-week. Patient with macular rash on chest/back/upper extremities/hands. Patient complaint of profuse itching affecting sleep and work activity.  Symptomatic treatment provided with Atarax 25mg Qhs, Allegra 180mg daily and light duty for 3 days.
Age: 1.01
Sex: F
Vaccine: MMRV, PPV
Symptoms: Urticaria
Clinical narrative: Hives
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Generalised vaccinia
Clinical narrative: Patient presented with generalized vaccinia patches (approx 4x4cm) with 2-4mm vesicles with surrounding erythema on L.arm/chest wall/back.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: Eczema vaccination; numerous scattered 2-4 mm vesicles/papules (approx 20) located on deltoid area/axilla/arm, spreading rash without pain/itching. Patient treated with Motrin 400 mg PRN and given Light Duty x5 days.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site macule, Injection site papule, Injection site rash
Clinical narrative: Patient developed maculo-papular rash on both thighs where vaccines administered within 24 hrs of receiving the vaccines. Rash resolving 3 weeks later. No fever, leg swelling, redness, or other symptoms. Patient's mom made physician aware 3 weeks later.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Vaccine was given to patient. After 1 minute after administration, patient began experiencing chest pain. Patient took 1 NTG tablet and pain improved. Taken to ER.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pain x 1 month then rash the pain started approx. 2 weeks after injection. Prednisone 20mg taper.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Pt was given an expired flu shot. Given 8/18/11, expired 6/30/11.
Age: 0.52
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Developmental delay, Emotional distress, Infantile spasms
Clinical narrative: Pt received DTAP shot on July 3, 2008. On July 4th, pt was inconsolable. On July 5th, patient's parents witnessed the first seizure activity which was later diagnosed as infantile spasms. He is doing well but has developmental delays.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: MMR given IM instead of SC. Review of CDC/info indicated no need to repeat dose, valid dose.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported on 08/30/11 at 8:14pm an adverse event regarding site of injection of ZOSTAVAX involving redness, soreness, tenderness & swelling. Advised patient to use NSAIDS (ALEVE or Ibuprofen) & Antihistamine (CLARITIN, BENADRYL, ZYRTEC).
Age: 18.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myalgia, Rash erythematous
Clinical narrative: Myalgias, erythematous rash that started on 8/28/11, a few days after 8/24/11 vaccine left arm. Given antibiotic.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Ataxia, Blood magnesium normal, Blood phosphorus, Cataplexy, Dysarthria
Clinical narrative: Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Faecal incontinence, Fall, Full blood count normal, Lumbar puncture abnormal, Metabolic function test
Clinical narrative: Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Narcolepsy, Sleep study abnormal, Somnolence, Urinary incontinence
Clinical narrative: Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs.
Sex: M
Vaccine: HEPAB
Symptoms: Death
Clinical narrative: This case was reported by a lawyer and described the occurrence of death nos in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received 2nd dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced death nos. The subject died due to unknown cause. It was unknown whether an autopsy was performed.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Endotracheal intubation, Muscle rigidity, Respiratory failure
Clinical narrative: Respiratory failure requiring intubation with high flow oscillator due to severe muscle rigidity.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: Sore throat. Hoarse.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Mass, Oedema peripheral
Clinical narrative: 24 hours later patients left arm swelled, but he recovered then he noticed a tennis ball-like ball bulging from the elbow. He was administered shot on 8/6/11 but came into pharmacy on 8/24/11. I told him to see the MD right away. He said he doesn't have pain/but uncomfortable. Patient believes maybe he hit his elbow at work, he is a contractor. Since it happened 24 hrs. later I wanted to report this.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Adverse reaction, Aphagia, Back pain, Cough
Clinical narrative: Case number PHEH2011US01015 is a combined initial and follow-up spontaneous report received from a consumer and quality assurance department on 05 Aug 2011 and 10 Aug 2011 respectively: This report refers to a 96 years old female patient. Her medical history included infusion with RECLAST for the indication of osteoporosis at a dose of 5 mg per 100 ml two years ago in Dec 2009 (PHEH2011US00884). Her concomitant medications included SYNTHROID, Amlodipine, GLYBURIDE, LIPITOR and CITRICAL with vitamin D. She was vaccinated with a seasonal influenza vaccine (batch number: unknown) on an undetermined date and ended up getting flu which took her a while to get over. She forgot a lot of things because of her age and was not well. Couple of months ago she got nerve tests done at the recommendation of her doctor and she had a reaction to that too. She got a pinched nerve in her back around April or May (year unspecified) and had it for a month and a half. Also, she has muscle spasms on the inside of her thighs every once in awhile, and also had such pain down her lower back to her left legs and toes. She felt like she was climbing up a wall. It was too much pain and she couldn't eat, walk, or sleep. She had enough pain from osteoporosis. She got colds quite often, and she had a cold with coughing at the time of this report. Her colds did not go away fast, and she had to clear her throat all the time. Outcome of the events was not reported.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Influenza, Insomnia, Malaise, Memory impairment
Clinical narrative: Case number PHEH2011US01015 is a combined initial and follow-up spontaneous report received from a consumer and quality assurance department on 05 Aug 2011 and 10 Aug 2011 respectively: This report refers to a 96 years old female patient. Her medical history included infusion with RECLAST for the indication of osteoporosis at a dose of 5 mg per 100 ml two years ago in Dec 2009 (PHEH2011US00884). Her concomitant medications included SYNTHROID, Amlodipine, GLYBURIDE, LIPITOR and CITRICAL with vitamin D. She was vaccinated with a seasonal influenza vaccine (batch number: unknown) on an undetermined date and ended up getting flu which took her a while to get over. She forgot a lot of things because of her age and was not well. Couple of months ago she got nerve tests done at the recommendation of her doctor and she had a reaction to that too. She got a pinched nerve in her back around April or May (year unspecified) and had it for a month and a half. Also, she has muscle spasms on the inside of her thighs every once in awhile, and also had such pain down her lower back to her left legs and toes. She felt like she was climbing up a wall. It was too much pain and she couldn't eat, walk, or sleep. She had enough pain from osteoporosis. She got colds quite often, and she had a cold with coughing at the time of this report. Her colds did not go away fast, and she had to clear her throat all the time. Outcome of the events was not reported.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nasopharyngitis, Nerve compression, Nerve stimulation test, Pain in extremity
Clinical narrative: Case number PHEH2011US01015 is a combined initial and follow-up spontaneous report received from a consumer and quality assurance department on 05 Aug 2011 and 10 Aug 2011 respectively: This report refers to a 96 years old female patient. Her medical history included infusion with RECLAST for the indication of osteoporosis at a dose of 5 mg per 100 ml two years ago in Dec 2009 (PHEH2011US00884). Her concomitant medications included SYNTHROID, Amlodipine, GLYBURIDE, LIPITOR and CITRICAL with vitamin D. She was vaccinated with a seasonal influenza vaccine (batch number: unknown) on an undetermined date and ended up getting flu which took her a while to get over. She forgot a lot of things because of her age and was not well. Couple of months ago she got nerve tests done at the recommendation of her doctor and she had a reaction to that too. She got a pinched nerve in her back around April or May (year unspecified) and had it for a month and a half. Also, she has muscle spasms on the inside of her thighs every once in awhile, and also had such pain down her lower back to her left legs and toes. She felt like she was climbing up a wall. It was too much pain and she couldn't eat, walk, or sleep. She had enough pain from osteoporosis. She got colds quite often, and she had a cold with coughing at the time of this report. Her colds did not go away fast, and she had to clear her throat all the time. Outcome of the events was not reported.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL, SMALL, SMALL, ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Electrocardiogram ST segment elevation, Myopericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 19-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 26 February 2011. Concomitant vaccines consisted of Anthrax 1 (other manufacturer, lot number not reported) received on 26 February 2011 and TYPHIM VI (manufacturer sanofi pasteur SA, lot number not reported) received on 24 February 2011. On 12 March 2011, the subject had both an ECG and Echocardiogram with abnormal findings and abnormal troponin I (00.67). That same day, the subject was diagnosed with Acute pericarditis, unspecified and Unspecified disease of pericardium. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL, SMALL, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Headache, Injection site pain, Injection site swelling
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 19-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 26 February 2011. Concomitant vaccines consisted of Anthrax 1 (other manufacturer, lot number not reported) received on 26 February 2011 and TYPHIM VI (manufacturer sanofi pasteur SA, lot number not reported) received on 24 February 2011. On 12 March 2011, the subject had both an ECG and Echocardiogram with abnormal findings and abnormal troponin I (00.67). That same day, the subject was diagnosed with Acute pericarditis, unspecified and Unspecified disease of pericardium. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL, SMALL, SMALL, ANTH, SMALL
Symptoms: Cardiac function test, Chest discomfort, Echocardiogram, Ejection fraction decreased, Pleuritic pain
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 19-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 26 February 2011. Concomitant vaccines consisted of Anthrax 1 (other manufacturer, lot number not reported) received on 26 February 2011 and TYPHIM VI (manufacturer sanofi pasteur SA, lot number not reported) received on 24 February 2011. On 12 March 2011, the subject had both an ECG and Echocardiogram with abnormal findings and abnormal troponin I (00.67). That same day, the subject was diagnosed with Acute pericarditis, unspecified and Unspecified disease of pericardium. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL, SMALL, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 19-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 26 February 2011. Concomitant vaccines consisted of Anthrax 1 (other manufacturer, lot number not reported) received on 26 February 2011 and TYPHIM VI (manufacturer sanofi pasteur SA, lot number not reported) received on 24 February 2011. On 12 March 2011, the subject had both an ECG and Echocardiogram with abnormal findings and abnormal troponin I (00.67). That same day, the subject was diagnosed with Acute pericarditis, unspecified and Unspecified disease of pericardium. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL, SMALL, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 19-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 26 February 2011. Concomitant vaccines consisted of Anthrax 1 (other manufacturer, lot number not reported) received on 26 February 2011 and TYPHIM VI (manufacturer sanofi pasteur SA, lot number not reported) received on 24 February 2011. On 12 March 2011, the subject had both an ECG and Echocardiogram with abnormal findings and abnormal troponin I (00.67). That same day, the subject was diagnosed with Acute pericarditis, unspecified and Unspecified disease of pericardium. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest discomfort, Dyspnoea, Intensive care, Troponin increased
Clinical narrative: This study case was received from the investigator on 19 August 2011. An 18-year-old male subject on 31 March 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported) and dose 2 of the anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. The subject received dose 1 of the anthrax vaccine on 21 March 2011. The subject had the following tests performed on 12 April 2011: an abnormal Troponin I of 10.27, an abnormal electrocardiogram (ECG), an abnormal echocardiogram and a normal magnetic resonance imaging (MRI) of the heart. On 19 April 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.