chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial report received on 26 November 2007 from another manufacturer (report # A0695247A) who had received the original report from the Food and Drug Administration (VAERS # 287108). Verbatim from report: "This case was reported by a regulatory authority (Food and Drug Administration (US) # 287108) and described the occurrence of could not breathe in a 15-year-old female subject who was vaccinated with Havrix, and Menactra for prophylaxis. On 01 August 2007, the subject received unspecified dose of Havrix (unknown) and unspecified dose of Menactra (unknown). On 01 August 2007, 3 minutes after vaccination with Havrix and Menactra, the subject experienced inability to breathe, dizziness, syncope, and seizure. The subject was seen in an emergency room. The subject's vital signs were normal and she was discharged from the emergency room. The verbatim text of the report indicated that: Client states can't hardly breathe, after sitting client down complained of dizziness on sitting back client started with tremors like seizure activity, pale, clammy, placed on floor unresponsive, responsive while on floor complained about being hot, brought in fan, elevated feet, gave Sprite (carbonated beverage). The reporter also noted that it was "hard to tell whether (the events were) vasovagal response, anxiety or allergic reaction." At the time of reporting the events were resolved. Comment: Syncope, seizure and vasovagal response were assessed as medically serious. The lot number for the Havrix was reported as AHAVB163AB. The lot number for the Menactra was unknown. The routes and sites of administration of both vaccines were unknown.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Anxiety, Cold sweat, Convulsion, Dizziness, Dyspnoea
Clinical narrative: Initial report received on 26 November 2007 from another manufacturer (report # A0695247A) who had received the original report from the Food and Drug Administration (VAERS # 287108). Verbatim from report: "This case was reported by a regulatory authority (Food and Drug Administration (US) # 287108) and described the occurrence of could not breathe in a 15-year-old female subject who was vaccinated with Havrix, and Menactra for prophylaxis. On 01 August 2007, the subject received unspecified dose of Havrix (unknown) and unspecified dose of Menactra (unknown). On 01 August 2007, 3 minutes after vaccination with Havrix and Menactra, the subject experienced inability to breathe, dizziness, syncope, and seizure. The subject was seen in an emergency room. The subject's vital signs were normal and she was discharged from the emergency room. The verbatim text of the report indicated that: Client states can't hardly breathe, after sitting client down complained of dizziness on sitting back client started with tremors like seizure activity, pale, clammy, placed on floor unresponsive, responsive while on floor complained about being hot, brought in fan, elevated feet, gave Sprite (carbonated beverage). The reporter also noted that it was "hard to tell whether (the events were) vasovagal response, anxiety or allergic reaction." At the time of reporting the events were resolved. Comment: Syncope, seizure and vasovagal response were assessed as medically serious. The lot number for the Havrix was reported as AHAVB163AB. The lot number for the Menactra was unknown. The routes and sites of administration of both vaccines were unknown.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Feeling hot, Pallor, Syncope, Syncope vasovagal, Tremor
Clinical narrative: Initial report received on 26 November 2007 from another manufacturer (report # A0695247A) who had received the original report from the Food and Drug Administration (VAERS # 287108). Verbatim from report: "This case was reported by a regulatory authority (Food and Drug Administration (US) # 287108) and described the occurrence of could not breathe in a 15-year-old female subject who was vaccinated with Havrix, and Menactra for prophylaxis. On 01 August 2007, the subject received unspecified dose of Havrix (unknown) and unspecified dose of Menactra (unknown). On 01 August 2007, 3 minutes after vaccination with Havrix and Menactra, the subject experienced inability to breathe, dizziness, syncope, and seizure. The subject was seen in an emergency room. The subject's vital signs were normal and she was discharged from the emergency room. The verbatim text of the report indicated that: Client states can't hardly breathe, after sitting client down complained of dizziness on sitting back client started with tremors like seizure activity, pale, clammy, placed on floor unresponsive, responsive while on floor complained about being hot, brought in fan, elevated feet, gave Sprite (carbonated beverage). The reporter also noted that it was "hard to tell whether (the events were) vasovagal response, anxiety or allergic reaction." At the time of reporting the events were resolved. Comment: Syncope, seizure and vasovagal response were assessed as medically serious. The lot number for the Havrix was reported as AHAVB163AB. The lot number for the Menactra was unknown. The routes and sites of administration of both vaccines were unknown.
Age: 3.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Enema administration, Intussusception, Synovitis
Clinical narrative: Seriousness criteria: Other-Medically significant A three-year-old female patient, with no repeated medical history, received a left arm intramuscular injection of Fluzone (lot number U2465AA) on 15 November 2007. Approximately five hours later, she developed toxic synovitis, and was seen in the emergency department where she was treated with pain medication. She was still experiencing toxic synovitis the following day, and prescribed to the emergency department again where she was treated with additional pain medications. On 17 November 2007 she developed intussusception, which was successfully reduced with an air enema. The reporter considered the events to be resolved.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Surgery
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 week old female with no pertinent medical history of drug allergies who on 16-JUL-2007 and 21-SEP-2007 was vaccinated PO with her first and second doses of Rotateq (lot# 657661/0973U). On 29-OCT-2007 the patient presented to the office with acute onset of vomiting during the previous night. That morning, the patient experienced frank bright red blood from rectum and listlessness. On that same day the patient was admitted to a hospital where she was found to have intussusception by air contrast enema, which was unsuccessful. Surgical intervention was required to reduce the intussusception. On 08-NOV-2007 the patient recovered. Intussusception was considered to be immediate life-threatening and an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Enema administration, Intussusception, Listless, Rectal haemorrhage, Surgery
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 week old female with no pertinent medical history of drug allergies who on 16-JUL-2007 and 21-SEP-2007 was vaccinated PO with her first and second doses of Rotateq (lot# 657661/0973U). On 29-OCT-2007 the patient presented to the office with acute onset of vomiting during the previous night. That morning, the patient experienced frank bright red blood from rectum and listlessness. On that same day the patient was admitted to a hospital where she was found to have intussusception by air contrast enema, which was unsuccessful. Surgical intervention was required to reduce the intussusception. On 08-NOV-2007 the patient recovered. Intussusception was considered to be immediate life-threatening and an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 week old female with no pertinent medical history of drug allergies who on 16-JUL-2007 and 21-SEP-2007 was vaccinated PO with her first and second doses of Rotateq (lot# 657661/0973U). On 29-OCT-2007 the patient presented to the office with acute onset of vomiting during the previous night. That morning, the patient experienced frank bright red blood from rectum and listlessness. On that same day the patient was admitted to a hospital where she was found to have intussusception by air contrast enema, which was unsuccessful. Surgical intervention was required to reduce the intussusception. On 08-NOV-2007 the patient recovered. Intussusception was considered to be immediate life-threatening and an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Listless, Rectal haemorrhage
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 week old female with no pertinent medical history of drug allergies who on 16-JUL-2007 and 21-SEP-2007 was vaccinated PO with her first and second doses of Rotateq (lot# 657661/0973U). On 29-OCT-2007 the patient presented to the office with acute onset of vomiting during the previous night. That morning, the patient experienced frank bright red blood from rectum and listlessness. On that same day the patient was admitted to a hospital where she was found to have intussusception by air contrast enema, which was unsuccessful. Surgical intervention was required to reduce the intussusception. On 08-NOV-2007 the patient recovered. Intussusception was considered to be immediate life-threatening and an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Surgery, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 week old female with no pertinent medical history of drug allergies who on 16-JUL-2007 and 21-SEP-2007 was vaccinated PO with her first and second doses of Rotateq (lot# 657661/0973U). On 29-OCT-2007 the patient presented to the office with acute onset of vomiting during the previous night. That morning, the patient experienced frank bright red blood from rectum and listlessness. On that same day the patient was admitted to a hospital where she was found to have intussusception by air contrast enema, which was unsuccessful. Surgical intervention was required to reduce the intussusception. On 08-NOV-2007 the patient recovered. Intussusception was considered to be immediate life-threatening and an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Loss of consciousness
Clinical narrative: Experienced near syncope immediately after injection - followed by dizziness, headache, nausea up to 8 hours after.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: Experienced near syncope immediately after injection - followed by dizziness, headache, nausea up to 8 hours after.
Age: 40.0
Sex: U
Vaccine: FLUX, HPV4
Symptoms: Burning sensation, Dysphagia, Erythema, Headache, Hypersensitivity
Clinical narrative: Allergic reaction within 20 minutes went to ER. Treated then back to the ER several times then admitted to the hospital for two days. Treatedd with 125 mg. Prednisone IV and zantac and bendryl. Ended up back at ER and admitted again for two days Tremors horrible headache treated with antibiotic had spinal tap done. Still Having allergic reaction 10 weeks later. Still on prednisone bendryl and zantac. Still having allergic reation. Red burning face itching, swollen neck face and throat. Tremors still, and cant swallow sometimes, blurry vision. I was given the HPV Vaccine by accident then given the flu shot right after. I was supposed two have the flu shot only.  12/28/07 Reviewed hospital ER medical records of 10/2/2007 which reveal patient experienced facial swelling, redness, itchy skin, dizziness, anxiety & dyspnea x 1 day.  Tx w/steroids & antihistamine.  Improved & d/c to home. FINAL DX: allergic reaction w/angioedema & bronchospasm, secondary to drug.
Age: 40.0
Sex: U
Vaccine: FLUX, HPV4
Symptoms: Laboratory test, Local swelling, Lumbar puncture, Pruritus, Swelling face
Clinical narrative: Allergic reaction within 20 minutes went to ER. Treated then back to the ER several times then admitted to the hospital for two days. Treatedd with 125 mg. Prednisone IV and zantac and bendryl. Ended up back at ER and admitted again for two days Tremors horrible headache treated with antibiotic had spinal tap done. Still Having allergic reaction 10 weeks later. Still on prednisone bendryl and zantac. Still having allergic reation. Red burning face itching, swollen neck face and throat. Tremors still, and cant swallow sometimes, blurry vision. I was given the HPV Vaccine by accident then given the flu shot right after. I was supposed two have the flu shot only.  12/28/07 Reviewed hospital ER medical records of 10/2/2007 which reveal patient experienced facial swelling, redness, itchy skin, dizziness, anxiety & dyspnea x 1 day.  Tx w/steroids & antihistamine.  Improved & d/c to home. FINAL DX: allergic reaction w/angioedema & bronchospasm, secondary to drug.
Age: 40.0
Sex: U
Vaccine: FLUX, HPV4
Symptoms: Tremor, Vision blurred, Wrong drug administered, X-ray
Clinical narrative: Allergic reaction within 20 minutes went to ER. Treated then back to the ER several times then admitted to the hospital for two days. Treatedd with 125 mg. Prednisone IV and zantac and bendryl. Ended up back at ER and admitted again for two days Tremors horrible headache treated with antibiotic had spinal tap done. Still Having allergic reaction 10 weeks later. Still on prednisone bendryl and zantac. Still having allergic reation. Red burning face itching, swollen neck face and throat. Tremors still, and cant swallow sometimes, blurry vision. I was given the HPV Vaccine by accident then given the flu shot right after. I was supposed two have the flu shot only.  12/28/07 Reviewed hospital ER medical records of 10/2/2007 which reveal patient experienced facial swelling, redness, itchy skin, dizziness, anxiety & dyspnea x 1 day.  Tx w/steroids & antihistamine.  Improved & d/c to home. FINAL DX: allergic reaction w/angioedema & bronchospasm, secondary to drug.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Dysphagia, Erythema, Hypersensitivity, Local swelling, Skin tightness
Clinical narrative: Allergic Reaction red face swollen neck and face tight throat itcing, throat closing, hives. Face turned red and hot next day at work. Three days later throat closing, face red, couldn't swallow. Went to the ER. Prednisone zantac benadryl. When I went off prednisone I went back into allergy attack, my PA I see put me back on prednisone. Went to the ER once more. I am still having the same symptoms just not as often. It has been 10 weeks since the injections.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Skin warm, Swelling, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Allergic Reaction red face swollen neck and face tight throat itcing, throat closing, hives. Face turned red and hot next day at work. Three days later throat closing, face red, couldn't swallow. Went to the ER. Prednisone zantac benadryl. When I went off prednisone I went back into allergy attack, my PA I see put me back on prednisone. Went to the ER once more. I am still having the same symptoms just not as often. It has been 10 weeks since the injections.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Dyspnoea, Erythema, Pruritus generalised
Clinical narrative: Allergic Reaction red face swollen neck and face tight throat itcing, throat closing, hives. Face turned red and hot next day at work. Three days later throat closing, face red, couldn't swallow. Went to the ER. Prednisone zantac benadryl. When I went off prednisone I went back into allergy attack, my PA I see put me back on prednisone. Went to the ER once more. I am still having the same symptoms just not as often. It has been 10 weeks since the injections.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Laboratory test, Pain in jaw
Clinical narrative: 1st shot:  2/25/2003.  2nd shot 9/7/07.  3d shot 9/20/07.  2 days following receipt of his 3rd Anthrax shot, pt reports onset of pain, 1st in his jaw, only with opening.  That pain continues.  About 2 weeks ago he began to have pain in his elbows w/ exacerbatoin of pain during flexion or extension of elbow as well as with pronation or supination of wrists.  Wrist pain began at the same time as elbow pain and increases with any motion at the wrists.  Pain is 8/10 sharp, non-radiating.  For the 1st 2 weeks after the shot, he had bilateral knee pain which made him limp.  He continues to have sever pain in those joints when squatting.  The pain is such that he requires assistance to stand back up.  He has no h/o similar pain in any of his joints.  Pt has tx'd pain at home with ibuprofen 800mg tabs.  1-2 hours after taking the tab, his pain resolves for about 4 hours before returning to full strength.
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: This case was reported by a healthcare professional, via sales representative, and described the occurrence of Guillain Barre syndrome in a male subject of unspecified age who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Medical history and concurrent conditions were unknown.  It was also unknown if the subject had experienced any adverse events following previous vaccinations.  In November 2007 the subject received 1st dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject developed Guillain Barre syndrome which was reported to include paralysis.  It was reported that the paralysis occurred approximately five minutes after vaccination with Flulaval.  The subject was hospitalized and his status was unknown.  The reporter considered that the events were disabling.  At the time of reporting the outcome of the events was unspecified.  The reporter considered that the Guillain Barre syndrome was unrelated to Flulaval.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram abnormal, Haematochezia, Intussusception
Clinical narrative: Intussusception  12/11/07 Reviewed hospital medical records which reveal patient experienced irritability, decreased oral intake, lethargy & bloody stools.  Had been on antibiotics  & neb treatments prior to admission for respiratory s/s.  Admitted 12/1-12/3/2007 to PICU for observation s/p IS reduction.  Progressed well but had fever of 101. Scheduled to see pcp next day.  FINAL DX: Intussusception, enema reduced.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness/swelling approx 10 cm in diameter, on left thigh.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: CSF culture negative, CSF test normal, Clonus, Convulsion, Electroencephalogram normal
Clinical narrative: Patient had low grade fever beginning 8/27/07 of uncertain origin.  Was treated with Amoxicillin for uncertain reason with no response.  On 9/3/07 he had several seizures with clonic movements and some perioral cyanosis.  Taken to ER and given Ativan.  Hospitalized for one day and then released.  /8/2008 MR received for DOS 9/3-6/2007 with D/C DX:  Complex Febrile Seizures. Child presented to ER in status epilepticus and respiratory distress following a 2 day hx of fever. At home pt had a 5 miute seizure consisting of mouth twitching, drooling, and eye blinking with R arm and leg clonic movements and perioral cyanosis. IN ER another seizure lasting >20 minutes.  Pt was intubated. Rash and posturing noted. Pt weaned to RA 9/4/07 and back to baseling prior to d/c.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Metabolic function test normal, Nuclear magnetic resonance imaging normal, Pyrexia, White blood cell count increased
Clinical narrative: Patient had low grade fever beginning 8/27/07 of uncertain origin.  Was treated with Amoxicillin for uncertain reason with no response.  On 9/3/07 he had several seizures with clonic movements and some perioral cyanosis.  Taken to ER and given Ativan.  Hospitalized for one day and then released.  /8/2008 MR received for DOS 9/3-6/2007 with D/C DX:  Complex Febrile Seizures. Child presented to ER in status epilepticus and respiratory distress following a 2 day hx of fever. At home pt had a 5 miute seizure consisting of mouth twitching, drooling, and eye blinking with R arm and leg clonic movements and perioral cyanosis. IN ER another seizure lasting >20 minutes.  Pt was intubated. Rash and posturing noted. Pt weaned to RA 9/4/07 and back to baseling prior to d/c.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Later the day of vaccination or early the next day patient had rash up arm of vaccination
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: PT HAD PNEU SHOT THURSDAY 11/8/07 SITE STARTED TURNING RED FRIDAY 11/9/07.  THIS WAS PT'S 2ND PNEU SHOT. PT HAD STATED AT TIME OF INJ THAT SHE HAD NOT HAD ONE.  PT'S ARM RED,WARM(NO SWELLING) ON INSIDE OF ARM TO ELBOW ALL WEEKEND. BETTER MON BUT CLINIC CLOSED. PT CALLED TUES AND WAS ASKED TO COME TO CLINIC. ARM STILL PINK BUT PT DENIES ANY PAIN ADVISED NOT TO GET ANOTHER PNEU SHOT
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Cough, Dizziness, Fatigue, Pharyngolaryngeal pain
Clinical narrative: soar throat,dizziness and fatigue,coughing,chest hurting in front in back when I coughed,
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Nausea, Rash, Rash generalised, Vomiting
Clinical narrative: 12-10-2007 10am second dose of varicella given, within five minutes nausea vomiting began along with rash on hands and armpits and buttocks.1005 benadryl 25mg administered. rash spread to entire body denies difficulty breathing. people notified.1030am sleeping rash remains. Report for vaers completed.11am continues to sleep,rash abating.1145am rash almost gone patient discharged home.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Eye swelling, Insomnia, Lymphadenopathy, Paraesthesia, Pruritus
Clinical narrative: Aug 18-Slight rash on Left arm, 19th more rash noted, swollen lymph nodes in groin, 20th- eyes swollen, chin itchy, visited ER, given IV epinephrine, prednisone, and benedryl, 21st- feeling better, 22nd- itching and rash, face swollen, got medrol dose pack at student health, 25th- couldn't sleep with hands and feet tingling.  Resolved by 26th.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Swelling face
Clinical narrative: Aug 18-Slight rash on Left arm, 19th more rash noted, swollen lymph nodes in groin, 20th- eyes swollen, chin itchy, visited ER, given IV epinephrine, prednisone, and benedryl, 21st- feeling better, 22nd- itching and rash, face swollen, got medrol dose pack at student health, 25th- couldn't sleep with hands and feet tingling.  Resolved by 26th.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Blood electrolytes normal, Blood glucose normal, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: 7 hours after receiving 6 immunizations, patient had 3 minute generalized seizure witnessed by mother.  Transported by ambulance to ED where evaluation ensued and was negative after exam and blood work up. Diagnosis: Presumed febrile seizure.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Three days after vaccination patient developed itching then rash.  Rash was unusually scattered and erythematous papular.  No blisters or pustules.  Areas of buttocks, legs, back.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram normal, Cough, Dizziness, Productive cough
Clinical narrative: 2-3 days p vaccine developed respiratory symptoms of cough, increased sputum , no T. on 11/14 seen by PA for symptoms. WBC 17,000. (Has hx of COPD, heavy smoker.)RX with antibiotic and prednisone. ON 11/19 seen for same symptoms plus weakness, "shaky".  Similar had occurred years before related to her Cardizem, so dose decreased.  11/21-continued weakness, seen by HCP, no motor deficits, CT scan nl.  12/6 still weak and dizzy, comes and goes, consider Guillan-Barre, to have neuro consult. 12/13/07-records received for DOS 10/31-12/11/07-C/O feeling tired , cough congestion, weak and shaky. Legs feel weak.  Impression: probable viral illness improving. Has had significant workup for weakness and tremor which appear to be an intention tremor. Unknown etiology could be stress. On visit day of vaccine C/O numbness to feet, feel like asleep.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, White blood cell count increased
Clinical narrative: 2-3 days p vaccine developed respiratory symptoms of cough, increased sputum , no T. on 11/14 seen by PA for symptoms. WBC 17,000. (Has hx of COPD, heavy smoker.)RX with antibiotic and prednisone. ON 11/19 seen for same symptoms plus weakness, "shaky".  Similar had occurred years before related to her Cardizem, so dose decreased.  11/21-continued weakness, seen by HCP, no motor deficits, CT scan nl.  12/6 still weak and dizzy, comes and goes, consider Guillan-Barre, to have neuro consult. 12/13/07-records received for DOS 10/31-12/11/07-C/O feeling tired , cough congestion, weak and shaky. Legs feel weak.  Impression: probable viral illness improving. Has had significant workup for weakness and tremor which appear to be an intention tremor. Unknown etiology could be stress. On visit day of vaccine C/O numbness to feet, feel like asleep.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: Approximately 5 hours after shot, right leg began to hurt - like running into a piece of furniture.  For two days patient was completely debilitated like having a severe case of arthritis in right hip and leg.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Nausea, Pain in extremity, Syncope
Clinical narrative: LIGHTHEADED, FAINTNESS, WEAKNESS, NAUSEA, COLAPSING, DIZZINESS, LEG PAIN
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash, Swelling
Clinical narrative: Shingles vaccine administered Friday at 2PM.Reaction started on the next day (Sat)about 4PM while I was driving a car to my house. As soon as entering my house about 6PM, I took 2 pills of Zyrtek. This removed the "bloom" of itching swolen spots in 2 hours. I use this medication when I occasionally get similar, but less extreme, rashes in some skin locations. After 40 hrs have passed since the successful medication result I have received no further reaction to the Shingles vaccination.Ignore 14.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest pain, Contusion, Dermatitis allergic, Dizziness, Haematoma
Clinical narrative: Pt c/o dizziness, lost consciousness and fell, hitting the back of his head on the floor. Loss of consciousness lasted 30-45 seconds. Although he denied s/s of neck/back/head injury (N/V, dizziness, ha, back/neck pain), he complained of chest pain that felt like "pins & needles". No difficulty breathing or respiratory distress noted. This RN did not observe any rash and pt did not c/o pruritis. Approximately 15 minutes after the episode, pt c/o difficultly visually focusing on objects far away. He was sent to the closest emergency room without incident, where he was diagnosed with 1.) vasovagal syncope  2.) single contusion with soft tissue hematoma to the scalp  3.) Probable allergic reaction with skin rash.   Pt was discharged to home with instructions to apply ice intermittently, take Benadryl 25mg PO every 6 hours for itching and to observe HEAD INJURY PRECAUTIONS.  Pt was also advised not to participate in sports the following day and to follow-up with PCP.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Paraesthesia, Syncope vasovagal, Vision blurred
Clinical narrative: Pt c/o dizziness, lost consciousness and fell, hitting the back of his head on the floor. Loss of consciousness lasted 30-45 seconds. Although he denied s/s of neck/back/head injury (N/V, dizziness, ha, back/neck pain), he complained of chest pain that felt like "pins & needles". No difficulty breathing or respiratory distress noted. This RN did not observe any rash and pt did not c/o pruritis. Approximately 15 minutes after the episode, pt c/o difficultly visually focusing on objects far away. He was sent to the closest emergency room without incident, where he was diagnosed with 1.) vasovagal syncope  2.) single contusion with soft tissue hematoma to the scalp  3.) Probable allergic reaction with skin rash.   Pt was discharged to home with instructions to apply ice intermittently, take Benadryl 25mg PO every 6 hours for itching and to observe HEAD INJURY PRECAUTIONS.  Pt was also advised not to participate in sports the following day and to follow-up with PCP.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Headache, Nausea, Pain in extremity, Pallor
Clinical narrative: 12-7-07 4:00 a.m. awoke with high fever, headache, and nausea. Also soreness in both arms.No changes noted in behavior. 2:30 p.m spoke to mother and they were just leaving the clinic. Continues to have fever 102.3, headache, and nausea. 12-8-07 fever 101 with headache, and nausea. 12-9-07 no fever or headache but little energy. 12-10-07 still at home with nausea and no fever or headache, but paleness.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: 12-7-07 4:00 a.m. awoke with high fever, headache, and nausea. Also soreness in both arms.No changes noted in behavior. 2:30 p.m spoke to mother and they were just leaving the clinic. Continues to have fever 102.3, headache, and nausea. 12-8-07 fever 101 with headache, and nausea. 12-9-07 no fever or headache but little energy. 12-10-07 still at home with nausea and no fever or headache, but paleness.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abasia, Aphasia, Balance disorder, Head lag, Lumbar puncture
Clinical narrative: SYMPTOMS VOMITING, UNABLE TO WALK, TALK UNABLE TO HOLD HIS HEAD VERY UNSTEADY AFTER 11HOURS OF HAVING THE HEB A, MMR, AND VARICELLA VACCINES. UNABLE TO KNOW THE MANUFACTURER OR THE LOT NUMBER NOT EVEN THE ROUTE DUE TO THE DOCTOR STATING THAT HIS OFFICE DID NOT KEEP RECORD OF THAT INFORMATION.  12/11/07 Reviewed ER medical records of 11/28/2007 which reveal patient experienced vomiting & unsteady gait starting that AM.  Transferred by ambulance to higher level of care. FINAL ER DX: ataxic gait, vomiting, left mastoiditis & otitis media. 12/18/07 Reviewed hospital medical records & pcp records submitted by parent.  Admitted 11/28-12/1/2007.  Patient had difficulty holding his head up, walking or playing.  Had decreased oral intake.  Appeared very weak.  Taken to pcp who referred to ER then transferred to higher level of care.  On admission had poor neck, trunk & hip girdle control.  Ataxic & unable to walk w/o falling to one side.  Neuro & ENT consults obtained.  Improved but had continued mild ataxia upon d/c to home w/pcp & neuro f/u.   FINAL DX: acute otitis media.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Otitis media acute, Vomiting
Clinical narrative: SYMPTOMS VOMITING, UNABLE TO WALK, TALK UNABLE TO HOLD HIS HEAD VERY UNSTEADY AFTER 11HOURS OF HAVING THE HEB A, MMR, AND VARICELLA VACCINES. UNABLE TO KNOW THE MANUFACTURER OR THE LOT NUMBER NOT EVEN THE ROUTE DUE TO THE DOCTOR STATING THAT HIS OFFICE DID NOT KEEP RECORD OF THAT INFORMATION.  12/11/07 Reviewed ER medical records of 11/28/2007 which reveal patient experienced vomiting & unsteady gait starting that AM.  Transferred by ambulance to higher level of care. FINAL ER DX: ataxic gait, vomiting, left mastoiditis & otitis media. 12/18/07 Reviewed hospital medical records & pcp records submitted by parent.  Admitted 11/28-12/1/2007.  Patient had difficulty holding his head up, walking or playing.  Had decreased oral intake.  Appeared very weak.  Taken to pcp who referred to ER then transferred to higher level of care.  On admission had poor neck, trunk & hip girdle control.  Ataxic & unable to walk w/o falling to one side.  Neuro & ENT consults obtained.  Improved but had continued mild ataxia upon d/c to home w/pcp & neuro f/u.   FINAL DX: acute otitis media.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Musculoskeletal stiffness
Clinical narrative: Stiff neck, edema at injection site treatment from chiropractor
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Migraine, Pain
Clinical narrative: States redness and induration at site of injection.  Severe migraine, body aches day after vaccination.  No temp noted 3 days after vaccination.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Documented case of Intussusecption 4 weeks after dose of Rotateq. 1/10/08-records received for DOS 12/4-12/7/07-DC DX: Intussusception. Hematochezia, resolved.Vomiting resolved. Physiologic anemia in infancy. C/O bright red blood from rectum, emesis, vomiting projectile in nature. Decreased appetite and increased sleep.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 4 TH HIB WAS GIVEN. PATIENT SHOULD HAVE RECEIVED IT AT 4 YEARS OF AGE.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bite, Convulsion, Head injury, Loss of consciousness, Tongue biting
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of Gardasil (Lot # 659437/1266U). The patient has no previous history of passing out. Subsequently the passed out hit her head on the floor, bit her lip, and bit through her tongue. The patient was passed out for up to one minute and experienced a brief seizure. The patient was monitored in the office for over one hour and then followed up with the patient over the next three days. The patient was recovered 3 days after receiving the vaccine and did not require stitches or any additional treatment. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tongue injury
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of Gardasil (Lot # 659437/1266U). The patient has no previous history of passing out. Subsequently the passed out hit her head on the floor, bit her lip, and bit through her tongue. The patient was passed out for up to one minute and experienced a brief seizure. The patient was monitored in the office for over one hour and then followed up with the patient over the next three days. The patient was recovered 3 days after receiving the vaccine and did not require stitches or any additional treatment. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 21-week-old female with no medical history who on 16-JAN-2007 (lot #655174/0848F) and 30-MAR-2007 (lot #656187/1237F) was vaccinated PO with the first and second 2.0 mL doses, respectively, of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  They physician reported that on 11-APR-2007, the patient developed intussusception.  The physician noted that there was no adverse event involved after the patient was vaccinated with the first dose.  At the time of this report, the outcome was unknown.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.12/20/07-records received for DOS 4/11-4/14/07-DC DX: Intussusception. Reduced by Barium contrast enema. Acute episode of vomiting, nonbloody nonbilious, approximately 20 episodes of emesis and an episode of abdominal pain. Lethargic, tachycardic with poor peripheral perfusion. Following enema patient passed a current jelly stool in ED.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 week old patient who on 02-NOV-2007 was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  On 30-NOV-2007 the patient experienced inconsolable crying and was seen by the reporting nurse practitioner and sent to the ER with a suspected possible intussusception and subsequently hospitalized.  Ultrasound studies and additional tests were performed.  Diagnosis was unknown at this time.  It was unknown if the patient was still hospitalized.  The outcome was unknown.  Additional information has been requested.  1/11/08 Received vax records from provider  which confirms RO dose & lot as 0942U, #1.  Additional vax info added for Prevnar, Pediarix & ActHib.  1/18/08 Reviewed hospital ER medical records of 11/30/07 which reveal patient experienced irritability, difficulty sleeping, & low grade fever.  Seen in clinic & referred to ER to r/o IS.   D/C to home from ER w/o final dx. FINAL DX: none provided other than fussiness.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received through the pregnancy registry from a physician concerning a 29 year old female with no medical history or allergies who on 22-MAY-2007 was vaccinated with a dose of Varivax (Oka/Merck). It was reported that the patient had a positive home pregnancy test on 24-MAY-2007. Her LMP was noted to be 18-MAY-2007 and her estimated delivery date was 22-FEB-2008. The physician reported that the patient was vaccinated by immigration authorities and not at the physician's office. No problem was reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received which stated that the patient had electively terminated the pregnancy on 15-JUL-2007. The patient had 2 previous pregnancies with 1 full-term birth. The patient had no previous history of miscarriage. There was no birth defect in any of previous pregnancies. Upon internal review, patient's elective termination of the pregnancy was considered as an other important medical event. No further information is expected.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Arthralgia, Asthenia, Dehydration, Dysgeusia, Oral pain
Clinical narrative: Information has been received from a 76 year old female with a history of chronic obstructive pulmonary disease and is allergic to codeine, who on 24-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Pneumococcal 23v polysaccharide vaccine (MSD), hepatitis B vaccine, recomb (MSD), "Q-Bar 10" (manufacturer unknown), aspirin and analgesic or anesthetic (unspecified). On 25-OCT-2007 the patient felt weak. On 01-NOV-2007 the patient stated that she was completely in and out of it and would fall asleep without knowing it, but she would come to with sharp pains in joints. The patient stated that she may have had a fever. On 02-NOV-2007 and 03-NOV-2007 the patient experienced paralysis in shoulders arms. Her mouth was sore and everything tasted bitter. The patient stated that she became dehydrated because she couldn't lift her arm to drink water. On 04-NOV-2007 the patient went to the emergency room and she received pain pills. The patient stated that the physician said that she may have Guillian Barre. The patient stated that she was still relatively weak but her arms and mouth were doing better. The patient stated that she took 9 aspirin every day and that she was getting relief. No additional informtion was provided. There were no lab diagnostics studies performed. The outcome was reported as recovering. There was no product quality complaint. Upon internal review, Guillian Barre was considered to be an other medical event. Additional information has been requested.  12/12/2007 Vax record received from PCP with note from date of vax.  Info entered in VAERS database. 12/31/2007 MR received for ER visit 11/4/2007 with dx: likely adverse reaction from immunizations.  Pt presented with c/o generalized body aches and chills. Assessment:  Joint and muscle aches or myalgias and arthralgias 2' to complications s/p immunizations. Instructed to return to ER for further problems.  Spoke with pt 12/11/07 who stated she was not dxd with Guillain Barre.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Information has been received from a 76 year old female with a history of chronic obstructive pulmonary disease and is allergic to codeine, who on 24-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Pneumococcal 23v polysaccharide vaccine (MSD), hepatitis B vaccine, recomb (MSD), "Q-Bar 10" (manufacturer unknown), aspirin and analgesic or anesthetic (unspecified). On 25-OCT-2007 the patient felt weak. On 01-NOV-2007 the patient stated that she was completely in and out of it and would fall asleep without knowing it, but she would come to with sharp pains in joints. The patient stated that she may have had a fever. On 02-NOV-2007 and 03-NOV-2007 the patient experienced paralysis in shoulders arms. Her mouth was sore and everything tasted bitter. The patient stated that she became dehydrated because she couldn't lift her arm to drink water. On 04-NOV-2007 the patient went to the emergency room and she received pain pills. The patient stated that the physician said that she may have Guillian Barre. The patient stated that she was still relatively weak but her arms and mouth were doing better. The patient stated that she took 9 aspirin every day and that she was getting relief. No additional informtion was provided. There were no lab diagnostics studies performed. The outcome was reported as recovering. There was no product quality complaint. Upon internal review, Guillian Barre was considered to be an other medical event. Additional information has been requested.  12/12/2007 Vax record received from PCP with note from date of vax.  Info entered in VAERS database. 12/31/2007 MR received for ER visit 11/4/2007 with dx: likely adverse reaction from immunizations.  Pt presented with c/o generalized body aches and chills. Assessment:  Joint and muscle aches or myalgias and arthralgias 2' to complications s/p immunizations. Instructed to return to ER for further problems.  Spoke with pt 12/11/07 who stated she was not dxd with Guillain Barre.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 5 year old male with a peanut allergy who was vaccinated with a dose of MMR II. Subsequently the patient experienced hives and had difficulty breathing from an anaphylactic reaction. The patient was seen by a pediatrician. The patient was treated with diphenhydramine HCl (BENADRYL), epinephrine and methylprednisolone (SOLU-MEDROL). Subsequently, the patient recovered. It was noted that the patient was given a dose of DTaP at a later time and developed the same reactions. There was no product quality complaint. The pharmacist considered hives, difficulty breathing and anaphylactic reaction to be an other important medical events (epinephrine). Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: This case was received from a health professional on 26 November 2007.  A male patient (age unspecified), with a history of gastrointestinal upset following egg consumption, received an intramuscular left deltoid injection of Fluzone (lot number U2527AA) on 19 November 2007.  Approximately 24 hours after vaccination, he complained of pain in both elbows.  On 21 November 2007, approximately 48 hours after vaccination, he developed a sore throat and mild, generalized muscle aches.  On 24 November 2007 he presented to the emergency department with pain and muscle spasms from his elbows to his fingertips, and decreased muscle strength in both arms.  Upon admission, his CPK was noted to be elevated at 2000 (units and reference ranges not provided).  Treatment included three doses of Benadryl, intravenous fluids, and cardiac monitoring.  The patient was discharged on 25 November 2007, at which time his symptoms were noted to be "greatly improved".  Per the reporter, the patient had no other medical history, was not ill at the time of vaccination, and was not taking any concomitant medications.
Sex: M
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: This case was received from a health professional on 26 November 2007.  A male patient (age unspecified), with a history of gastrointestinal upset following egg consumption, received an intramuscular left deltoid injection of Fluzone (lot number U2527AA) on 19 November 2007.  Approximately 24 hours after vaccination, he complained of pain in both elbows.  On 21 November 2007, approximately 48 hours after vaccination, he developed a sore throat and mild, generalized muscle aches.  On 24 November 2007 he presented to the emergency department with pain and muscle spasms from his elbows to his fingertips, and decreased muscle strength in both arms.  Upon admission, his CPK was noted to be elevated at 2000 (units and reference ranges not provided).  Treatment included three doses of Benadryl, intravenous fluids, and cardiac monitoring.  The patient was discharged on 25 November 2007, at which time his symptoms were noted to be "greatly improved".  Per the reporter, the patient had no other medical history, was not ill at the time of vaccination, and was not taking any concomitant medications.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 31 August 2007. A 42-year-old female patient with a medical history of a penicillin allergy, had received an intramuscular left deltoid injection of Fluzone SV 2007-2008, lot number U2436AA on 30 August 2007 and 15 minutes later, she complained of slight tightness in her throat. During assessment, the patients blood pressure was 120/80. The patient received corrective treatment with 25mg Benadryl administered orally five minutes after the event began. No further treatment was reported and the duration of the event had not been provided. The patient had received a prior dose of Fluzone in November 2006 however no information about prior adverse events after receipt of Fluzone had been provided. According to the reporter, the patient had recovered from the event. Follow-up information was received from the health professional on 26 November 2007. The patient's symptoms resolved within 15 to 20 minutes of Benadryl administration, and no additional treatment was necessary. No adverse events had been reported by the patient following previous dose of Fluzone. Per the reporter, the final diagnosis was "anaphylactic reaction". Due to the information received in the follow-up report, this case has been upgraded to serious.