chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: It injection sight was bulging, red and hot to the touch.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: 3-4 hrs after vaccination began low grade fever, aches, and heavy coughing. 24 hrs later and it has all gotten worse. My wife and daughter have the same.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TD, VARCEL
Symptoms: Abdominal pain, Abdominal rigidity, Convulsion, Dyskinesia, Hypotonia
Clinical narrative: Pt. was given gardasil 10/15/08 at 1700 hrs,  immediately fainted and body jerked once body went limp from fainting. I believe Pt. had a seizure.  Within hours, suffered from severe abdominal pain where pt was guarding abdominal.  Clinic contacted 1000 hours on 10/16/08.  Instructed to return Pt to office at 1300 hrs. Pt was placed on bland diet and prescribed pedilite, and zantac 75 mg bid.  2330 hours, Pt. suffered severe abdominal pain and taken to hospital.  Pain rated 9 out of 10.  Given Lidocaine to numb pain,  no labs were performed.  Pt described pain as, "Pain is like when your foot falls asleep and you feel pins and needles in your foot.  Only the pain is much worse,  like 10 times worse."  Pt. is still have abdominal pain.  10/24/08 office note received from PCP with vax rec.  11/10/08 ER record received for 10/16/2008 with Dx: Abdominal pain. Pt presented with c/o abdominal pain since receiving vax 1 day prior. Pt reportedly fainted after the HPV injection and then developed severe abdominal pain described as pins and needles. PE WNL. Tx with Maalox/Lidocaine po with improvement and d/c home.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TD, VARCEL
Symptoms: Immediate post-injection reaction, Paraesthesia, Syncope
Clinical narrative: Pt. was given gardasil 10/15/08 at 1700 hrs,  immediately fainted and body jerked once body went limp from fainting. I believe Pt. had a seizure.  Within hours, suffered from severe abdominal pain where pt was guarding abdominal.  Clinic contacted 1000 hours on 10/16/08.  Instructed to return Pt to office at 1300 hrs. Pt was placed on bland diet and prescribed pedilite, and zantac 75 mg bid.  2330 hours, Pt. suffered severe abdominal pain and taken to hospital.  Pain rated 9 out of 10.  Given Lidocaine to numb pain,  no labs were performed.  Pt described pain as, "Pain is like when your foot falls asleep and you feel pins and needles in your foot.  Only the pain is much worse,  like 10 times worse."  Pt. is still have abdominal pain.  10/24/08 office note received from PCP with vax rec.  11/10/08 ER record received for 10/16/2008 with Dx: Abdominal pain. Pt presented with c/o abdominal pain since receiving vax 1 day prior. Pt reportedly fainted after the HPV injection and then developed severe abdominal pain described as pins and needles. PE WNL. Tx with Maalox/Lidocaine po with improvement and d/c home.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Cold sweat, Convulsion, Diarrhoea, Dry mouth
Clinical narrative: SEVERE VOMITING - DIARRHEA WHICH IS DAILY SINCE 1999 (10 TIMES PER DAY). COLD SWEATS AND MUSCLE SPASMS/CONVULSIONS AND HOT FLASHES.  BURNING SENSATIONS IN MY STOMACH, FACE, AND VEINS.  I ALSO HAVE DRY MOUTH AND CAN'T SMELL TOO WELL ANYMORE.  ADDITIONALLY I HAVE NO SENSE OF TASTE AMYMORE. I HAVE A CONSTANT FEAR OF DYING DUE TO THIS DEFECTIVE VACCINE.  I KNOW THAT I WILL NEVER BE THE SAME AGAIN AND I WOULD GREATLY APPRECIATE ANY INFORMATION REGARDING COMPENSATION AND/OR HELP FOR THESE DEADLY SIDE EFFECTS.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Dysgeusia, Fear of death, Hot flush, Muscle spasms, Parosmia
Clinical narrative: SEVERE VOMITING - DIARRHEA WHICH IS DAILY SINCE 1999 (10 TIMES PER DAY). COLD SWEATS AND MUSCLE SPASMS/CONVULSIONS AND HOT FLASHES.  BURNING SENSATIONS IN MY STOMACH, FACE, AND VEINS.  I ALSO HAVE DRY MOUTH AND CAN'T SMELL TOO WELL ANYMORE.  ADDITIONALLY I HAVE NO SENSE OF TASTE AMYMORE. I HAVE A CONSTANT FEAR OF DYING DUE TO THIS DEFECTIVE VACCINE.  I KNOW THAT I WILL NEVER BE THE SAME AGAIN AND I WOULD GREATLY APPRECIATE ANY INFORMATION REGARDING COMPENSATION AND/OR HELP FOR THESE DEADLY SIDE EFFECTS.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: SEVERE VOMITING - DIARRHEA WHICH IS DAILY SINCE 1999 (10 TIMES PER DAY). COLD SWEATS AND MUSCLE SPASMS/CONVULSIONS AND HOT FLASHES.  BURNING SENSATIONS IN MY STOMACH, FACE, AND VEINS.  I ALSO HAVE DRY MOUTH AND CAN'T SMELL TOO WELL ANYMORE.  ADDITIONALLY I HAVE NO SENSE OF TASTE AMYMORE. I HAVE A CONSTANT FEAR OF DYING DUE TO THIS DEFECTIVE VACCINE.  I KNOW THAT I WILL NEVER BE THE SAME AGAIN AND I WOULD GREATLY APPRECIATE ANY INFORMATION REGARDING COMPENSATION AND/OR HELP FOR THESE DEADLY SIDE EFFECTS.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Immediate post-injection reaction, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Immediately following shot I developed fever, muscle aches, runny nose, cough. Flu like symptoms!
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Immediately following shot I developed fever, muscle aches, runny nose, cough. Flu like symptoms!
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Cough, Dyspnoea, Electrocardiogram
Clinical narrative: Started by week feeling. Throat felt as if closing, coughing trying to catch breath. Lips felt tingling and numb (this would come and go).
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia oral, Throat tightness
Clinical narrative: Started by week feeling. Throat felt as if closing, coughing trying to catch breath. Lips felt tingling and numb (this would come and go).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Pain in extremity, Skin warm
Clinical narrative: Day of vaccination arm was so sore I could not lift it high enough to brush my teeth.  The following morning the upper arm became violently red and hot to the touch.  During the day it seemed to calm down but on Saturday morning the area was most of the upper arm and I went to ER at Community Hospital.  The doctor gave me a perscription for an antibiotic and instructions to take them IF it worsened but did not think it was celulitis.  I purchased the Rx but on Sunday the redness had mostly turned to yellow bruising so I did not take the Rx.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Flushing, Headache, Immunisation reaction
Clinical narrative: PT REPORTS "FEELING FLUSHED & ITCHY" ABOUT 10 MINUTES AFTER INJECTION, THEN THE FOLLOWING DAY EXPERIENCING HEADACHE, NAUSEA AND FATIGUE WHICH KEPT HER IN BED FOR THE NEXT FEW DAYS. SYMPTOMS RESOLVED AFTER A WEEK OR MORE. SHE DID GO TO AN URGENT CARE FACILITY & REPORTS BEING ASSURED IT WAS A REACTION TO FLU IMMUNIZATION.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pruritus
Clinical narrative: PT REPORTS "FEELING FLUSHED & ITCHY" ABOUT 10 MINUTES AFTER INJECTION, THEN THE FOLLOWING DAY EXPERIENCING HEADACHE, NAUSEA AND FATIGUE WHICH KEPT HER IN BED FOR THE NEXT FEW DAYS. SYMPTOMS RESOLVED AFTER A WEEK OR MORE. SHE DID GO TO AN URGENT CARE FACILITY & REPORTS BEING ASSURED IT WAS A REACTION TO FLU IMMUNIZATION.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: fever documented at 38.8C (101.8F) within 3 hours post vaccination, treated with acetaminophen, persisted approx. 7 hours; frequent vomiting began 4 hours post vaccination with over 20 instances, ceased after 10 hours; extreme lethargy and irritability also noted
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Heart rate normal, Pruritus generalised, Urticaria
Clinical narrative: Patient recieved vaccine.  Approximately 45min later patient complained of generalized itching.  At this time 50mg of oral diphenhydramine was given.  10 mins later patient begin to break out in hives. 50mg of IM diphenhydramine was given and paramedics called.  Upon arrival of paramedics patient had normal vital signs and symptoms hives and itching were disappering. Patient refused any additional medical care.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Hypertension
Clinical narrative: Difficulty breathing, shortness of breath, unable to take deep breaths. High blood pressure.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Severe nausia, violent chills, fever for 24 hours10
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Erythema, Oedema peripheral, Pain
Clinical narrative: 10-15-08 light fever 99.7 then starting around 11pm chills & fever 103.1 with body aches. 10-16-08 1:00pm seen by nurse red, swollen, warm & tender to touch approx. 6 X 9 cm area on upper left arm, temp 99.7 and advise to take ibuprofen and place cool packs to arm. 10-17-08 11am fever resolved, tenderness & redness resolving, no body aches
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: 10-15-08 light fever 99.7 then starting around 11pm chills & fever 103.1 with body aches. 10-16-08 1:00pm seen by nurse red, swollen, warm & tender to touch approx. 6 X 9 cm area on upper left arm, temp 99.7 and advise to take ibuprofen and place cool packs to arm. 10-17-08 11am fever resolved, tenderness & redness resolving, no body aches
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: 10-15-08 7:00am feeling chills, fatigue, arm tender. 9:00am seen by nurse left upper arm warm & tender to touch, red & swollen area approx 6 X 8cm. Advised to take ibuprofen & place cool packs on red area. 10-17-08 Feeling almost normal with red/tender area resolving.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: 10-15-08 7:00am feeling chills, fatigue, arm tender. 9:00am seen by nurse left upper arm warm & tender to touch, red & swollen area approx 6 X 8cm. Advised to take ibuprofen & place cool packs on red area. 10-17-08 Feeling almost normal with red/tender area resolving.
Age: 0.18
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC
Symptoms: Haematochezia
Clinical narrative: Received Rotavirus (ROTATEQ) vaccine on 10/6/08 mom noted small amount of blood in stool on 10/8/08 and then on 10/9/08 a pink color in stool. Mom phoned into office on 10/9/08. No treatment needed-advised mom to observe and call back if more blood noted or baby gets vomiting or abdominal pain. 10/9-8pm-2 little specks blood in stool 10/10-mucousy stool. 2pm
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Dysphonia, Headache, Injection site rash, Rash erythematous
Clinical narrative: Increasing tightness of throat, red rash all over body but most pronounced on trunk, headache, stomach discomfort, dry mouth. Injection was at 11 am. at the Pharmacy.  I was aware of the beginning of the rash around the injection site around 8 pm.  Unable to sleep.  Realized that I needed to go to urgent care at 6:15 am due to thickness in throat causing very hoarse voice and red rash on body. Went to Urgent Care Department at 7 am.  Received IV Saline with 3 injections of medication.  One was benedryl.  Don't recall the other two.  Stayed in urgent care until my throat loosened up (about 1 1/2 hours).  Went home with prescriptions for Prednisone, Ranitidene HCL, and Zyrtec.  At the time of this report, 10:30 pm, red rash continues. The throat is resolving.  Dry mouth is resolving.  Headache has resolved.  11/11/08 Reviewed ER medical records of 10/19/2008. FINAL DX: allergic dermatitis & throat swelling likely due to flu shot Records reveal patient experienced generalized raised morbilliform maculopapular rash, throat swelling, voice hoarse, abdominal bloating.  Tx w/antihistamine & steroids.  Improved & d/c to home on tapering steroids
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Sleep disorder, Stomach discomfort, Throat tightness
Clinical narrative: Increasing tightness of throat, red rash all over body but most pronounced on trunk, headache, stomach discomfort, dry mouth. Injection was at 11 am. at the Pharmacy.  I was aware of the beginning of the rash around the injection site around 8 pm.  Unable to sleep.  Realized that I needed to go to urgent care at 6:15 am due to thickness in throat causing very hoarse voice and red rash on body. Went to Urgent Care Department at 7 am.  Received IV Saline with 3 injections of medication.  One was benedryl.  Don't recall the other two.  Stayed in urgent care until my throat loosened up (about 1 1/2 hours).  Went home with prescriptions for Prednisone, Ranitidene HCL, and Zyrtec.  At the time of this report, 10:30 pm, red rash continues. The throat is resolving.  Dry mouth is resolving.  Headache has resolved.  11/11/08 Reviewed ER medical records of 10/19/2008. FINAL DX: allergic dermatitis & throat swelling likely due to flu shot Records reveal patient experienced generalized raised morbilliform maculopapular rash, throat swelling, voice hoarse, abdominal bloating.  Tx w/antihistamine & steroids.  Improved & d/c to home on tapering steroids
Sex: M
Vaccine: HIBV, RV5, UNK
Symptoms: Intestinal obstruction
Clinical narrative: Information has been received from a physician concerning a male patient who was born prematurely who on 08-APR-2008 was vaccinated orally with ROTATEQ.  Concomitant vaccinations on the same day included PEDVAXHIB (MSD) and "other 2 month vaccinations."  On 13-APR-2008 the patient experienced a bowel obstruction and was hospitalized.  It was unspecified if lab studies were performed.  Subsequently, the patient recovered on an unspecified date.  It was noted that the patient's twin brother did not experience any complications after receiving ROTATEQ.  There was no product quality complaint involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: General physical health deterioration, Mechanical ventilation, Pneumonia primary atypical
Clinical narrative: Information has been received from a physician concerning a 65 year old female who in June 2008, was vaccinated with PNEUMOVAX 23. Concomitant therapy included heart medication (unspecified). Two days later, the patient developed walking pneumonia. The patient quickly deteriorated after that was hospitalized and placed on a ventilator. Duration of hospitalization was not reported. The patient was recovering "was doing fine". Walking pneumonia was considered to be disabling, immediately life-threatening and as an other important medical event. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Full blood count, Hepatic enzyme, Metabolic function test, Pneumonia aspiration, Tachycardia
Clinical narrative: Information has been received from a pharmacist concerning a 27 year old male with no medical history or drug allergies reported, who on 13-OCt-2008 was vaccinated with PNEUMOVAX 23 (Lot # 660718/0551X). Concomitant therapy included influenza virus vaccine (unspecified). The patient was admitted to the hospital because he developed tachycardia along with aspiration pneumonia and vomiting after receiving PNEUMOVAX 23. Laboratory tests performed included comprehensive metabolic panel, hepatic enzyme and cell blood count (results not provided). At the time of this report, on 14-OCT-2008, the patient was not recovered. Tachycardia along with aspiration pneumonia and vomiting were considered to be disabling. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 27 year old male with no medical history or drug allergies reported, who on 13-OCt-2008 was vaccinated with PNEUMOVAX 23 (Lot # 660718/0551X). Concomitant therapy included influenza virus vaccine (unspecified). The patient was admitted to the hospital because he developed tachycardia along with aspiration pneumonia and vomiting after receiving PNEUMOVAX 23. Laboratory tests performed included comprehensive metabolic panel, hepatic enzyme and cell blood count (results not provided). At the time of this report, on 14-OCT-2008, the patient was not recovered. Tachycardia along with aspiration pneumonia and vomiting were considered to be disabling. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Antibody test positive, Antinuclear antibody positive, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 6 weeks and 5 days from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) negative with this second termination. the patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D & C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a first spontaneous termination after the vaccination at 13 weeks from the last menstrual period. (WAES# 0810USA01794) Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 6 weeks and 5 days from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) negative with this second termination. the patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D & C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a first spontaneous termination after the vaccination at 13 weeks from the last menstrual period. (WAES# 0810USA01794) Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with GARDASIL and lost her vision in "2007". The physician was not the patient's provider. The physician found this case out from a ski instructor who taught blind children. The event was reported as disabling. Attempts are being made to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Antibody test, Antinuclear antibody positive, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 13 weeks from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) positive with the first termination. The patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D &C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a second spontaneous termination after the vaccination at 6 weeks and 5 days from the last menstrual period. (WAES# 0810USA02664). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 13 weeks from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) positive with the first termination. The patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D &C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a second spontaneous termination after the vaccination at 6 weeks and 5 days from the last menstrual period. (WAES# 0810USA02664). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician and a nurse, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female consumer who in June 2007, was vaccinated with her first dose of GARDASIL, IM. Subsequently, she became pregnant. This was the patient's first pregnancy. She was hospitalized for a caesarean section due to "low transfer". On 03-JUN-2008 the patient delivered a healthy baby. Then on 15-JUL-2008 she received her second dose of GARDASIL (lot # 658560/1062U). On 07-OCT-2008 the patient has an intrauterine device insertion. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Immediate post-injection reaction, Measles antibody, Mumps antibody test, Rash pruritic
Clinical narrative: Information has been received from a 32 year old female patient with no known allergies or pertinent medical history who on 03-APR-2008 was vaccinated with a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wister RA 27/3). There was no concomitant medication. it was noted that the patient had a "weird" feeling immediately after getting the vaccine." After 4-5 hours, her "tongue was fuzzy and swollen" and her throat started closing. The patient received epinephrine and BENADRYL intravenously to ease her symptoms. Subsequently, the patient recovered on an unspecified date. It was also noted that the patient had an itchy rash over her arms and upper body for 30 days after getting the vaccination. Thirty days after vaccination the patient had a titer drawn. The results were not reported. There was no product quality complaint involved. Upon internal review "tongue was fuzzy and swollen" and "throat started closing" were considered to be an other important medical events. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody test, Swollen tongue, Throat tightness, Tongue disorder
Clinical narrative: Information has been received from a 32 year old female patient with no known allergies or pertinent medical history who on 03-APR-2008 was vaccinated with a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wister RA 27/3). There was no concomitant medication. it was noted that the patient had a "weird" feeling immediately after getting the vaccine." After 4-5 hours, her "tongue was fuzzy and swollen" and her throat started closing. The patient received epinephrine and BENADRYL intravenously to ease her symptoms. Subsequently, the patient recovered on an unspecified date. It was also noted that the patient had an itchy rash over her arms and upper body for 30 days after getting the vaccination. Thirty days after vaccination the patient had a titer drawn. The results were not reported. There was no product quality complaint involved. Upon internal review "tongue was fuzzy and swollen" and "throat started closing" were considered to be an other important medical events. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Alanine aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood thyroid stimulating hormone normal, Echocardiogram normal
Clinical narrative: Initial report was received 03 October 2008 from a health care professional. An 18-year-old male patient with no pre-existing medical conditions had received a first dose, right deltoid intramuscular injection of ADACEL, lot number C2996AA and a first dose left deltoid intramuscular injection of MENACTRA, lot number U2580AA on 12 August 2008 and 48 hours later, he developed increased fatigue, a sore throat, headaches, and general body aches which were continuing "on and off" at the time of the report. The patient had not been ill at the time of vaccination. The patient had been evaluated twice by his physician (evaluation results not reported). At the time of the report, the patient had not recovered from the event. Follow-up information was received 06 October 2008 and 13 October 2008 from a health care professional. Based on this new information received, it was determined this case meets seriousness criteria and has been upgraded. From information received on 06 October 2008, the reporter stated the patient had received MENACTRA and ADACEL vaccines on the same day. The following day (also reported as 14 August 2008), the patient developed fevers, headaches and myalgias which lasted four to five days. At the time of the report on 06 October 2008, the patient had been experiencing fatigue and headaches for two months. Additional information pertaining to the symptoms of sore throat, fever, and myalgias was not provided. Extensive blood work-up had been performed which was negative and the physician believed the reported events were secondary to the vaccinations. From follow-up information received on 13 October 2008, laboratory tests performed on 03 October 2008 had been normal with the exception of CBC findings for RDW 11.1% (ref 11.5-15) and MPV 11.70fL (ref 7.40-10.40); Chem 14 were normal with the exception of ALP 75U/L (ref 98-317), ALT 29U/L (ref 30-65), TBIL 1.2mg/dL (ref 0.0-1.0) and NA 132 mmol/L (ref 136-145). TSH (0.88) was normal and a MONO screen was negative. The patient had an echocardiography performed on 10 October 2008. Per the report, the echocardiography was indicated due to fatigue and exertional dyspnea. Results of the echocardiography indicated the chamber sizes, wall thickness and left ventricular function appeared normal. Valvular morphology and function appeared normal. There had been no mass, thrombus or effusion. Doppler results: pulse wave, continuous wave and color flow Doppler demonstrated normal antegrade velocities. There were no significant regurgitant lesions. The patient had no illnesses, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered. Documents held by sender: Lab and diagnostic test results.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Full blood count normal, Headache, Laboratory test abnormal, Laboratory test normal
Clinical narrative: Initial report was received 03 October 2008 from a health care professional. An 18-year-old male patient with no pre-existing medical conditions had received a first dose, right deltoid intramuscular injection of ADACEL, lot number C2996AA and a first dose left deltoid intramuscular injection of MENACTRA, lot number U2580AA on 12 August 2008 and 48 hours later, he developed increased fatigue, a sore throat, headaches, and general body aches which were continuing "on and off" at the time of the report. The patient had not been ill at the time of vaccination. The patient had been evaluated twice by his physician (evaluation results not reported). At the time of the report, the patient had not recovered from the event. Follow-up information was received 06 October 2008 and 13 October 2008 from a health care professional. Based on this new information received, it was determined this case meets seriousness criteria and has been upgraded. From information received on 06 October 2008, the reporter stated the patient had received MENACTRA and ADACEL vaccines on the same day. The following day (also reported as 14 August 2008), the patient developed fevers, headaches and myalgias which lasted four to five days. At the time of the report on 06 October 2008, the patient had been experiencing fatigue and headaches for two months. Additional information pertaining to the symptoms of sore throat, fever, and myalgias was not provided. Extensive blood work-up had been performed which was negative and the physician believed the reported events were secondary to the vaccinations. From follow-up information received on 13 October 2008, laboratory tests performed on 03 October 2008 had been normal with the exception of CBC findings for RDW 11.1% (ref 11.5-15) and MPV 11.70fL (ref 7.40-10.40); Chem 14 were normal with the exception of ALP 75U/L (ref 98-317), ALT 29U/L (ref 30-65), TBIL 1.2mg/dL (ref 0.0-1.0) and NA 132 mmol/L (ref 136-145). TSH (0.88) was normal and a MONO screen was negative. The patient had an echocardiography performed on 10 October 2008. Per the report, the echocardiography was indicated due to fatigue and exertional dyspnea. Results of the echocardiography indicated the chamber sizes, wall thickness and left ventricular function appeared normal. Valvular morphology and function appeared normal. There had been no mass, thrombus or effusion. Doppler results: pulse wave, continuous wave and color flow Doppler demonstrated normal antegrade velocities. There were no significant regurgitant lesions. The patient had no illnesses, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered. Documents held by sender: Lab and diagnostic test results.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Mean platelet volume increased, Monocyte count normal, Pain, Pharyngolaryngeal pain, Red blood cell morphology normal
Clinical narrative: Initial report was received 03 October 2008 from a health care professional. An 18-year-old male patient with no pre-existing medical conditions had received a first dose, right deltoid intramuscular injection of ADACEL, lot number C2996AA and a first dose left deltoid intramuscular injection of MENACTRA, lot number U2580AA on 12 August 2008 and 48 hours later, he developed increased fatigue, a sore throat, headaches, and general body aches which were continuing "on and off" at the time of the report. The patient had not been ill at the time of vaccination. The patient had been evaluated twice by his physician (evaluation results not reported). At the time of the report, the patient had not recovered from the event. Follow-up information was received 06 October 2008 and 13 October 2008 from a health care professional. Based on this new information received, it was determined this case meets seriousness criteria and has been upgraded. From information received on 06 October 2008, the reporter stated the patient had received MENACTRA and ADACEL vaccines on the same day. The following day (also reported as 14 August 2008), the patient developed fevers, headaches and myalgias which lasted four to five days. At the time of the report on 06 October 2008, the patient had been experiencing fatigue and headaches for two months. Additional information pertaining to the symptoms of sore throat, fever, and myalgias was not provided. Extensive blood work-up had been performed which was negative and the physician believed the reported events were secondary to the vaccinations. From follow-up information received on 13 October 2008, laboratory tests performed on 03 October 2008 had been normal with the exception of CBC findings for RDW 11.1% (ref 11.5-15) and MPV 11.70fL (ref 7.40-10.40); Chem 14 were normal with the exception of ALP 75U/L (ref 98-317), ALT 29U/L (ref 30-65), TBIL 1.2mg/dL (ref 0.0-1.0) and NA 132 mmol/L (ref 136-145). TSH (0.88) was normal and a MONO screen was negative. The patient had an echocardiography performed on 10 October 2008. Per the report, the echocardiography was indicated due to fatigue and exertional dyspnea. Results of the echocardiography indicated the chamber sizes, wall thickness and left ventricular function appeared normal. Valvular morphology and function appeared normal. There had been no mass, thrombus or effusion. Doppler results: pulse wave, continuous wave and color flow Doppler demonstrated normal antegrade velocities. There were no significant regurgitant lesions. The patient had no illnesses, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered. Documents held by sender: Lab and diagnostic test results.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Red cell distribution width normal, Ultrasound Doppler normal
Clinical narrative: Initial report was received 03 October 2008 from a health care professional. An 18-year-old male patient with no pre-existing medical conditions had received a first dose, right deltoid intramuscular injection of ADACEL, lot number C2996AA and a first dose left deltoid intramuscular injection of MENACTRA, lot number U2580AA on 12 August 2008 and 48 hours later, he developed increased fatigue, a sore throat, headaches, and general body aches which were continuing "on and off" at the time of the report. The patient had not been ill at the time of vaccination. The patient had been evaluated twice by his physician (evaluation results not reported). At the time of the report, the patient had not recovered from the event. Follow-up information was received 06 October 2008 and 13 October 2008 from a health care professional. Based on this new information received, it was determined this case meets seriousness criteria and has been upgraded. From information received on 06 October 2008, the reporter stated the patient had received MENACTRA and ADACEL vaccines on the same day. The following day (also reported as 14 August 2008), the patient developed fevers, headaches and myalgias which lasted four to five days. At the time of the report on 06 October 2008, the patient had been experiencing fatigue and headaches for two months. Additional information pertaining to the symptoms of sore throat, fever, and myalgias was not provided. Extensive blood work-up had been performed which was negative and the physician believed the reported events were secondary to the vaccinations. From follow-up information received on 13 October 2008, laboratory tests performed on 03 October 2008 had been normal with the exception of CBC findings for RDW 11.1% (ref 11.5-15) and MPV 11.70fL (ref 7.40-10.40); Chem 14 were normal with the exception of ALP 75U/L (ref 98-317), ALT 29U/L (ref 30-65), TBIL 1.2mg/dL (ref 0.0-1.0) and NA 132 mmol/L (ref 136-145). TSH (0.88) was normal and a MONO screen was negative. The patient had an echocardiography performed on 10 October 2008. Per the report, the echocardiography was indicated due to fatigue and exertional dyspnea. Results of the echocardiography indicated the chamber sizes, wall thickness and left ventricular function appeared normal. Valvular morphology and function appeared normal. There had been no mass, thrombus or effusion. Doppler results: pulse wave, continuous wave and color flow Doppler demonstrated normal antegrade velocities. There were no significant regurgitant lesions. The patient had no illnesses, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered. Documents held by sender: Lab and diagnostic test results.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Impaired work ability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional (also the consumer) and described the occurrence of fever in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). Approximately ten years ago, the subject received a dose of Flu vaccine (unknown). An unspecified amount of time following vaccination with flu vaccine, the subject developed fever and chills. The subject additionally missed work for a period of three days. At the time of reporting the events were resolved. In the reporter's opinion, the events of fever and chills were probably related to treatment with flu vaccine. A year later, the subject received the flu vaccine again and had a similar reaction. For details concerning this case, see suffix case A0751658A.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Concussion, Fall, Scan brain, Syncope
Clinical narrative: Syncope episode shortly after given, fell and sustained concussion. 12/2/08-records received for DOS 10/13/08-DC DX-Closed head injury/concussion. Admitted following a closed head injury from a syncopal episode. Loss of consciousness after vaccination. C/O pain and emesis. Coninued with emesis in ED as well as headache. Overnight observation.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: CSF test normal, Computerised tomogram normal, Convulsion, Full blood count normal, Scan brain
Clinical narrative: Seizure x 2, prolonged seizures, required multiple doses of rectal DIAZEPAM to stop. Admitted to hospital. Normal labs/Head CT but very mild temp to 100 degrees F was noted.   11/3/08-ED records received for DOS 10/15/08-presented with C/O witnessed new onset seizure with fixed gaze and right side arm/leg tickling. Generalized tonic-clonic seizure. Afebrile in ED. Discharged home from ED. DX-Seizure.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Urine analysis normal
Clinical narrative: Seizure x 2, prolonged seizures, required multiple doses of rectal DIAZEPAM to stop. Admitted to hospital. Normal labs/Head CT but very mild temp to 100 degrees F was noted.   11/3/08-ED records received for DOS 10/15/08-presented with C/O witnessed new onset seizure with fixed gaze and right side arm/leg tickling. Generalized tonic-clonic seizure. Afebrile in ED. Discharged home from ED. DX-Seizure.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Drooling, Musculoskeletal stiffness, Speech disorder
Clinical narrative: Began with stiff neck.  Had trouble speaking, could not say words also was drooling.  Gradually better over hours to days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Decreased appetite, Erythema, Feeling hot, Injection site erythema
Clinical narrative: 10/16/08 Pain/ tenderness at site left deltoid. Redness at site- 10/17/08 Increasing redness + warmth at site.  c/o nausea 10/16/08 in PM No emesis- appetite decreased.  Facial redness and warm feeling.  -> instructed by ED physician- apply ice/increase fluid intake.  10/19/08 No further complaints.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Nausea
Clinical narrative: 10/16/08 Pain/ tenderness at site left deltoid. Redness at site- 10/17/08 Increasing redness + warmth at site.  c/o nausea 10/16/08 in PM No emesis- appetite decreased.  Facial redness and warm feeling.  -> instructed by ED physician- apply ice/increase fluid intake.  10/19/08 No further complaints.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Hypotension, Oxygen supplementation
Clinical narrative: Low blood pressure low heart rate/pulse dizziness, sweating, pale color treated with O2 by paramedics
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Low blood pressure low heart rate/pulse dizziness, sweating, pale color treated with O2 by paramedics
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Dizziness, Vomiting
Clinical narrative: States she had vomiting, dizziness, and a temp of 98.9 for 1 hr. on 10/16/08
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Red line coming down from injection site, approx 2 1/2 Long + 1" wide, soreness at site. 10/20/2008 9:45am
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Discomfort, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, soreness, edema at injection site. fever, chills, Myalgia. Taking Advil for discomfort 10/20/2008 9:45am.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Redness, soreness, edema at injection site. fever, chills, Myalgia. Taking Advil for discomfort 10/20/2008 9:45am.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Cried for 6 hours after receiving vaccines on 8/14/2008. No Reaction
Age: 25.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Pruritus, Skin lesion
Clinical narrative: SM developed pruritic lesions on R arm approx 6 hrs after receiving his primary SPV in R arm.   He also received TWINRIX and Typhoid in the L arm.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Malaise, Pyrexia, Tremor
Clinical narrative: Chills,  fever,  malaise , shaking for 24 hrs, no cough. Had urisx prior to vaccine, Chest congestion no sore throat, no cough. Everything after injection 10/08/2008
Age: 14.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Acarodermatitis, Arthropod bite, Blister, Molluscum contagiosum, Rash papular
Clinical narrative: Papular rash with clear or fluid filled vesicles from head to toe.  Started 3 days after given Varicella vaccine.  DIDX: Varicella administered, Molluscum contapiosum, scalpis, Bug bites.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Inappropriate schedule of drug administration, Nausea
Clinical narrative: Swelling to point of doubling upper arm size, erythema 22 cm (yes 22 cm).  Intense headache lasting 5 days.  Nausea, dizziness, fainting feeling.  After one week erythema down to 5 cm diameter.  Raised, red, swollen as per above.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Swelling to point of doubling upper arm size, erythema 22 cm (yes 22 cm).  Intense headache lasting 5 days.  Nausea, dizziness, fainting feeling.  After one week erythema down to 5 cm diameter.  Raised, red, swollen as per above.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Throat tightness, Upper respiratory tract infection
Clinical narrative: 1 hr after vaccine - dev throat tightening, headache, 24-48 hrs of congestion, eyes swollen.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Tachycardia, Urticaria
Clinical narrative: Patient developed hives, Headache, Tachycardia and flushing. The following day she was seen in the emergency room and received Zantac 300mg, Prednisone  60mg and Vistaril 50mg  IM. She was placed on a tapering dose of prednisone for home use.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Welts Bilateral arms upper body
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pain
Clinical narrative: Chills, fever, muscle and joint aches, arm throbbing, BP 180 /90  P-197 (per pt report), nausea and dry heaves.  Pt had all Sx at home, not seen by healthcare provider.  Sx resolved after 4 hrs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Retching
Clinical narrative: Chills, fever, muscle and joint aches, arm throbbing, BP 180 /90  P-197 (per pt report), nausea and dry heaves.  Pt had all Sx at home, not seen by healthcare provider.  Sx resolved after 4 hrs.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: She immediately felt the needle go in. She felt the vaccine go in her deltoid. She felt some pain and she felt a sensation of the vaccine affecting her thumb. there was some numbness and pain in her thumb and deltoid lasting 8 days to date.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Received influenza injection 10-7-08 at 11:30 AM.  By 2:30 AM, 10-8-08, was having difficulty swallowing.  Went to ER.  Symptoms resolved by 5:30 AM.  No treatment.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Saliva altered, Throat irritation
Clinical narrative: phone call to VMA @ 3:30pm.  Patient c/o heart palpitations 1.5 hrs after vaccine administration, approx 1:00 pm.  Itching of throat, thick saliva began 3:00pm.  Informed patient she needs to go to ER or Report incident to MD, then be advised by MD.  MD instructed her to go to ER.  BENADRYL drip was started in ER, RCW +kg PRENISONE X 5 days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Area of left upper arm measuring 3" x 2 1/2" - pink, warm to touch and slightly firm.  Patient describes it as "sore". Area of injection is not included in this area and is slightly echymotic.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Diarrhoea, Erythema, Flatulence, Frequent bowel movements
Clinical narrative: Vaccine administered on 10/13/08, patient states approximately that evening experienced abdominal pain with flatulent and diarrhea next 48hrs had greater than 12 bowel movements, on 10/15/2008 awoke with arm swollen, red with pain and warm to touch.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Vaccine administered on 10/13/08, patient states approximately that evening experienced abdominal pain with flatulent and diarrhea next 48hrs had greater than 12 bowel movements, on 10/15/2008 awoke with arm swollen, red with pain and warm to touch.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Influenza, Myalgia
Clinical narrative: About 2-3 hrs. after shot all my joints and muscles began aching.  As the day went on I fell worse, In the middle of the night I woke up with extreme chills- no fever- and felt like the onset of flu.  This continued throughout the next day.  I felt like I have been run over by a truck.  I have never had any reactions before other than a sore arm.  I called the pharmacy the next day.  I don't want any compensation etc.  I just thought you folks should know.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient received FLUMIST on 10/09/2008.  Approx.  6 hrs later she developed hives on abdomen and a swollen lower lip.  seen in ER after giving BENADRYL and Sx then gone.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Lip swelling, Throat tightness, Urticaria
Clinical narrative: 6-8 hrs.  after immunization pt. states he had generalized hives, swelling of lips, thick feeling in his throat, and some minor chest pain.  Pt. took BENADRYL- symptoms resolved within 24 hrs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 3 1/2 cm x 3 1/2 cm induration at vaccine site;  warm to touch.  BENADRYL 25 mg po q 6 hours ordered by Dr.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pruritus, Injection site swelling
Clinical narrative: onset 09/24/08 - swollen injection site, warm to touch, HA, dizzy, feeling bad x 1 week, severe HA's x 3 days.  Hydrocortizone 1% cream to site for itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: onset 09/24/08 - swollen injection site, warm to touch, HA, dizzy, feeling bad x 1 week, severe HA's x 3 days.  Hydrocortizone 1% cream to site for itching.