chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Pt presented for medical care related to her anthrax vaccination that she received on 17 Feb 08, prior to deploying.  Previous to this, for both of her two (2) anthrax shots, she developed large local reactions requiring incise and drainage per the pt.  Today she notes that, after receiving the vaccine, she had developed a large swelling of the area that was very painful to even light touch.  She noted that this was different from the first two in that it developed so quickly.  She denied any difficulties breathing or other rash.  Upon examination, the area of vaccination (right mid-lateral upper arm just ont he lateral border of the biceps) was extremely indurated with swelling measuring about 12cm in diameter and raised approximately 1 cm.  There was some fluctuance, warmth, and extreme tenderness.  The area was incised but only bloody return.  Cultures were not available to rule out cellulitis and the patient was started on Cipro for possible cellulitis (pt is PCN-allergic).
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Anorexia, Crying, Discomfort, Hypersomnia, Pyrexia
Clinical narrative: Patient exhibited distress by crying excessively for 6 hours following vaccination and did not eat during this time, neither of which are typical behaviors. He also spent more time than usual sleeping until the following day. A slight fever was detected, although not confirmed. Overall, patient seemed to be experiencing great discomfort and misery and was unable to be soothed.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Convulsion, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 37 year old female registered nurse with multiple sclerosis and allergy to ibuprofen who on 23-OCT-2007 was vaccinated with her first dose of Pneumovax 23, 0.5 ml, IM left deltoid.  Concomitant therapy included FLUZONE, which was given the same day, and BETASERON.  On 23-OCT-2007 the patient experienced erythema, swelling, and pain at the injection site after her first dose of Pneumovax 23.  She also had a fever and was unable to move her arm for three days.  On 07-DEC-2007, she began experiencing pain in her hands and seizures.  She was admitted to the hospital on 09-DEC-2007 and was diagnosed with thrombotic thrombocytopenic purpura.  She was released from the hospital on 08-JAN-2008, and was recovered.  The registered nurse considered thrombotic thrombocytopenic purpura to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  9/2/08 Reviewed hospital medical records of 12/09/07-01/07/2008. FINAL DX: refractory thrombotic thrombycytopenic purpura Records reveal patient experienced HA, numbness of arm & leg, difficulty ambulating, fall, reduced oral intake, decreased vocalization, fever, & confusion worsening over 2 days time.  Seen at outlying ER & transferred to higher level of care.  Admitted to ICU. ID, neuro consult done.   Tx w/plasmapheresis QD during hospitalization.  Also tx w/rituximab x 3 doses & high dose steroids & Imuran.  Treated briefly for presumed UTI.  Developed fever & had partial complex seizures 12/17/07 followed by postictal confusion. Plasmapheresis was increased to BID.  Very gradually improved & d/c to home
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Thrombotic thrombocytopenic purpura
Clinical narrative: Information has been received from a 37 year old female registered nurse with multiple sclerosis and allergy to ibuprofen who on 23-OCT-2007 was vaccinated with her first dose of Pneumovax 23, 0.5 ml, IM left deltoid.  Concomitant therapy included FLUZONE, which was given the same day, and BETASERON.  On 23-OCT-2007 the patient experienced erythema, swelling, and pain at the injection site after her first dose of Pneumovax 23.  She also had a fever and was unable to move her arm for three days.  On 07-DEC-2007, she began experiencing pain in her hands and seizures.  She was admitted to the hospital on 09-DEC-2007 and was diagnosed with thrombotic thrombocytopenic purpura.  She was released from the hospital on 08-JAN-2008, and was recovered.  The registered nurse considered thrombotic thrombocytopenic purpura to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  9/2/08 Reviewed hospital medical records of 12/09/07-01/07/2008. FINAL DX: refractory thrombotic thrombycytopenic purpura Records reveal patient experienced HA, numbness of arm & leg, difficulty ambulating, fall, reduced oral intake, decreased vocalization, fever, & confusion worsening over 2 days time.  Seen at outlying ER & transferred to higher level of care.  Admitted to ICU. ID, neuro consult done.   Tx w/plasmapheresis QD during hospitalization.  Also tx w/rituximab x 3 doses & high dose steroids & Imuran.  Treated briefly for presumed UTI.  Developed fever & had partial complex seizures 12/17/07 followed by postictal confusion. Plasmapheresis was increased to BID.  Very gradually improved & d/c to home
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 37 year old female registered nurse with multiple sclerosis and allergy to ibuprofen who on 23-OCT-2007 was vaccinated with her first dose of Pneumovax 23, 0.5 ml, IM left deltoid.  Concomitant therapy included FLUZONE, which was given the same day, and BETASERON.  On 23-OCT-2007 the patient experienced erythema, swelling, and pain at the injection site after her first dose of Pneumovax 23.  She also had a fever and was unable to move her arm for three days.  On 07-DEC-2007, she began experiencing pain in her hands and seizures.  She was admitted to the hospital on 09-DEC-2007 and was diagnosed with thrombotic thrombocytopenic purpura.  She was released from the hospital on 08-JAN-2008, and was recovered.  The registered nurse considered thrombotic thrombocytopenic purpura to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  9/2/08 Reviewed hospital medical records of 12/09/07-01/07/2008. FINAL DX: refractory thrombotic thrombycytopenic purpura Records reveal patient experienced HA, numbness of arm & leg, difficulty ambulating, fall, reduced oral intake, decreased vocalization, fever, & confusion worsening over 2 days time.  Seen at outlying ER & transferred to higher level of care.  Admitted to ICU. ID, neuro consult done.   Tx w/plasmapheresis QD during hospitalization.  Also tx w/rituximab x 3 doses & high dose steroids & Imuran.  Treated briefly for presumed UTI.  Developed fever & had partial complex seizures 12/17/07 followed by postictal confusion. Plasmapheresis was increased to BID.  Very gradually improved & d/c to home
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Condition aggravated, Herpes zoster, Laboratory test abnormal, Neuroblastoma, Skin lesion
Clinical narrative: It was reported in a published article, titled as stated above, that a 21 month old female with stage IV neuroblastoma, who was vaccinated with a dose of Varivax (Oka/Merck). One week later, chemotherapy (unspecified) was initiated. Approximately 5 weeks following vaccination with Varivax (Oka/Merck) the patient had a first appearance of skin lesions and was diagnosed with disseminated varicella-zoster infection. Despite acyclovir therapy, her varicella persisted, which raised concern for resistance. Polymerase chain reaction (PCR) of the virus isolated from the culture of a skin lesion was used to determine the origin of the varicella virus. Anti-viral resistance was determined by plaque assay and further elucidated by viral thymidine kinase enzymatic analysis. Polymerase chain reaction (PCR) of the virus isolated from the culture of a skin lesion was determined to be consistent with the Oka strain of the virus. In-vitro sensitivity analysis revelaed high-level resistance to acyclovir. Further characterized of the isolated strain confirmed a mutation of the viral thymidine kinase (TK) gene whose product did not exhibit detectable enzymatic activity. The patient was ultimately treated with foscarnet but did not demonstrate full resolution of the varicella until cessation of cytotoxic chemotherapy. Three months after cessation of initial chemotherapy, the patient experienced relapse of the neuroblastoma but was ultimately able to undergo autologous stem cell transplantation without varicella reactivation. Upon internal review, the patient's neuroblastoma was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Varicella zoster virus serology positive, Viral test
Clinical narrative: It was reported in a published article, titled as stated above, that a 21 month old female with stage IV neuroblastoma, who was vaccinated with a dose of Varivax (Oka/Merck). One week later, chemotherapy (unspecified) was initiated. Approximately 5 weeks following vaccination with Varivax (Oka/Merck) the patient had a first appearance of skin lesions and was diagnosed with disseminated varicella-zoster infection. Despite acyclovir therapy, her varicella persisted, which raised concern for resistance. Polymerase chain reaction (PCR) of the virus isolated from the culture of a skin lesion was used to determine the origin of the varicella virus. Anti-viral resistance was determined by plaque assay and further elucidated by viral thymidine kinase enzymatic analysis. Polymerase chain reaction (PCR) of the virus isolated from the culture of a skin lesion was determined to be consistent with the Oka strain of the virus. In-vitro sensitivity analysis revelaed high-level resistance to acyclovir. Further characterized of the isolated strain confirmed a mutation of the viral thymidine kinase (TK) gene whose product did not exhibit detectable enzymatic activity. The patient was ultimately treated with foscarnet but did not demonstrate full resolution of the varicella until cessation of cytotoxic chemotherapy. Three months after cessation of initial chemotherapy, the patient experienced relapse of the neuroblastoma but was ultimately able to undergo autologous stem cell transplantation without varicella reactivation. Upon internal review, the patient's neuroblastoma was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.8
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Lung disorder, Multiple allergies, Pneumonia, Secondary transmission
Clinical narrative: Information has been received from a mother concerning her 10-month-old son with no allergies, who was exposed to a sibling who was vaccinated on 09-Dec-1999 with a dose of Varivax (Oka/Merck).  The patient was not taking any medications.  On 02-Jan-2000 the patient was admitted to the hospital because he had pneumonia.  The mother reported that when her son left the hospital after the pneumonia, he was readmitted that night because he had spots on his scalp.  He was diagnosed with full blown varicella on his scalp, bottom, mouth, privates and eventually throughout his whole body.  He was in the hospital for 12 days.  A sweat test was performed on an unspecified date.  On an unspecified date, the patient recovered.  The patient now has lung problems, skin problems, allergies and asthma.  The patient goes in the hospital about twice a year for his asthma and pneumonia.  He has received the Pneumovax 23 vaccine (MSD) for the pneumonia which has helped.  No product quality complaint was involved.  Additional information received for the physician's office indicates that the patient was last seen in the office in 2005.  The records were sent to storage, and therefore there were no vaccination records available.  The R.N. also reported that the patient's sister developed adverse events following a vaccine administration (WAES# 0802USA02660).  Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: VARCEL
Symptoms: Skin disorder, Skin lesion, Sweat chloride test, Varicella
Clinical narrative: Information has been received from a mother concerning her 10-month-old son with no allergies, who was exposed to a sibling who was vaccinated on 09-Dec-1999 with a dose of Varivax (Oka/Merck).  The patient was not taking any medications.  On 02-Jan-2000 the patient was admitted to the hospital because he had pneumonia.  The mother reported that when her son left the hospital after the pneumonia, he was readmitted that night because he had spots on his scalp.  He was diagnosed with full blown varicella on his scalp, bottom, mouth, privates and eventually throughout his whole body.  He was in the hospital for 12 days.  A sweat test was performed on an unspecified date.  On an unspecified date, the patient recovered.  The patient now has lung problems, skin problems, allergies and asthma.  The patient goes in the hospital about twice a year for his asthma and pneumonia.  He has received the Pneumovax 23 vaccine (MSD) for the pneumonia which has helped.  No product quality complaint was involved.  Additional information received for the physician's office indicates that the patient was last seen in the office in 2005.  The records were sent to storage, and therefore there were no vaccination records available.  The R.N. also reported that the patient's sister developed adverse events following a vaccine administration (WAES# 0802USA02660).  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Apnoea, Full blood count normal, Haematochezia, Laboratory test, Stool analysis
Clinical narrative: Information has been received from a medical assistant concerning a 9 week old female with no pertinent medical history or drug allergies who on 05-FEB-2008 was vaccinated PO with her first 2.0 ml dose of Rotateq (lot# 658386/1734U).  There was no concomitant medication.  On 09-FEB-2008 the patient experienced bloody stools and questionable apnea and was hospitalized.  Lab diagnostic studies included stool studies which were pending, a metabolic panel and a CBC which showed normal results.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of severe migraines who on 20-AUG-2007 was vaccinated with a first dose of Gardasil (lot # not reported) 0.5 ml.  Subsequently, the patient experienced seizure like symptoms.  Unspecified medical attention was sought.  The outcome of the seizure like symptoms was not reported.  Upon internal review, seizure like symptoms was considered to be an Other Important Medical Event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Paralysis
Clinical narrative: Information has been received from a consumer concerning his daughter, a female with a history of drug hypersensitivity who in December 2007, was vaccinated with the first dose of Gardasil.  In February of 2008 the patient was vaccinated with the second dose of Gardasil.  Concomitant therapy included IMITREX and hepatitis A virus vaccine (unspecified).  Per the reporter, "four hours after the patient received the vaccines, she became paralyzed from the neck down, which lasted about 9 hours.  The patient also had numbness and tingling all over her body.  She was rushed to the emergency room and was released after the 9 hours.  The experience has improved but the patient still occasionally experiences numbness and tingling in her arms.  Also, sometimes when the patient goes to pick something up, she cannot because her arms and hands just won't move."  No lot number was provided and no further information was provided.  The reporter did state that he will call back with the lot number.  Paralysis was considered to be an other important medical event.  Additional information has been requested. 03/07/08 Vax record confirms Gardasil dose #1, Hep A#1. 03/19/2008 MR received for ER visit 2/6/2008 with Final Impression Generalized weakness-resolved. Pt presented to ER with c/o difficulty moving extremities x several hours. Pt states both arms and legs are weak with tingling. SOB now resolved.  Pt had migraine h/a earlier in the day, txd with Imitrex.  PE WNL. 4/4/2008 MR received from PCP for OV 2/7/2008 re: above ER visit.  Pt had 2 similar but milder episode of weakness on 2/7/08. PE WNL. DX:  Weakness; iron def anemia. To return if sx recur.  Pt not seen in office since 2/7/08 per office RN.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Laboratory test
Clinical narrative: Information has been received from a physician concerning an approximately 22 week old female (reported as 5.5 months) who was vaccinated with the first dose of ROTATEQ (reported as "individually pouched single-dose tube").  There was no concomitant medication.  The physician reported that the patient received the first dose of ROTATEQ at 4 months and 6 weeks later developed rotavirus gastroenteritis and was hospitalized.  The patient recovered on an unspecified date.  There was no product quality complaint.  The rotavirus gastroenteritis was considered to be another important medical event.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test
Clinical narrative: Information has been received from a physician concerning a 1 year old male who was vaccinated with a first, second and third dose of Rotateq.  "About three weeks ago," on approximately 23-JAN-2008, the patient experienced a documented case of rotavirus and was hospitalized.  It was noted that the patient improved but present status was not provided.  No product quality complaint was involved.  No other information was provided.  The patient's rotavirus was considered to be immediately life-threatening, and disabling by the reporter.  Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Vomiting projectile
Clinical narrative: Pt had severe projectile vomiting 48 hours after recieving vaccine, had bloody stools 72 hours after recieving vaccination and was diagnosed with Intussusception of the intestines 78 hours after receiving vaccination. 2/25/08-records received for DOS 2/18-2/19/08-DC DX: Intussusception. Presented to ED with projectile vomiting and inability to take PO and 2 episodes of bloody stools fever of 101.0 (R).
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Diagnostic procedure, Enema administration, Haematochezia
Clinical narrative: Pt had severe projectile vomiting 48 hours after recieving vaccine, had bloody stools 72 hours after recieving vaccination and was diagnosed with Intussusception of the intestines 78 hours after receiving vaccination. 2/25/08-records received for DOS 2/18-2/19/08-DC DX: Intussusception. Presented to ED with projectile vomiting and inability to take PO and 2 episodes of bloody stools fever of 101.0 (R).
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Neutrophil count, Oral intake reduced, Pyrexia
Clinical narrative: Pt had severe projectile vomiting 48 hours after recieving vaccine, had bloody stools 72 hours after recieving vaccination and was diagnosed with Intussusception of the intestines 78 hours after receiving vaccination. 2/25/08-records received for DOS 2/18-2/19/08-DC DX: Intussusception. Presented to ED with projectile vomiting and inability to take PO and 2 episodes of bloody stools fever of 101.0 (R).
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Small intestinal obstruction, Urinary system X-ray, Vomiting projectile, X-ray abnormal
Clinical narrative: Pt had severe projectile vomiting 48 hours after recieving vaccine, had bloody stools 72 hours after recieving vaccination and was diagnosed with Intussusception of the intestines 78 hours after receiving vaccination. 2/25/08-records received for DOS 2/18-2/19/08-DC DX: Intussusception. Presented to ED with projectile vomiting and inability to take PO and 2 episodes of bloody stools fever of 101.0 (R).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Deafness unilateral
Clinical narrative: Information has been received from a nurse concerning her 17 year old granddaughter with a history of amoxicillin allergy who on an unknown date in 2007 was vaccinated with an unknown number of doses of Gardasil (lot # not reported). Sometime 2007 the patient experienced hearing loss in her left ear. At the time of this report, the patient's hearing loss in her left ear persisted. The patient was seen twice by a physician and it was suggested that she be rechecked for the hearing loss in one year. The nurse (grandmother) had limited information. Upon internal review, the hearing loss was considered to to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a certified nurse midwife concerning an 18 year old female who on an unspecified date was vaccinated with dose unspecified of Gardasil. On an unspecified date, the patient fainted in the physician's office waiting room after receiving the vaccination. The patient hit her head on the counter and sustained unspecified head trauma. The patient was hospitalized. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL first dose of Gardasil. Concomitant vaccination included Recombivax. Subsequently, the patient was pregnant. In November 2007, the patient had a miscarriage at approximately 16 weeks. The gestation period at the time of the first dose was unknown. The patient was hospitalized for approximately 2-3 days. No laboratory diagnostics were performed. The patient did not discontinue her dosing schedule. The patient was vaccinated with a second dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: <24 HRS. PATIENT REPORTED INCREASED SWELLING AND REDNESS AT THE VACCINATION SITE AND WARM TO TOUCH. ITCHING ALL OVER BODY.  SWELLING DECREASED ON DAY 4, REDNESS TURNED TO PURPLISH.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: Phone call from client 1/7/08.  Complains of pain @ injection site immediately with vaccine; rested arm for "a few days" then restarted yoga, stretching & exercising.  Pain has continued & noted some weakness in arm "when lifting sideways".  As of 1/24/08, it is still painful but patient has not yet been to MD.
Age: 32.0
Sex: F
Vaccine: DTP, HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Vaccinated 1/23/08, On 1/25 ct noted "Bruising, redness, hot to touch, sore, itching welts" Sx began at location of TDAP and spread down "shoulder to elbow". (TDAP given at prox. location on L delt; hep A given 2 inches distal on L deltoid).  On 1/26 Ct went to ER and was given "antihistamines, ibuprofen, Keflex, and anti-itching cream". On 1/30/08 sx had resolved to "size of quarter" and on 2/19/08, ct reports sx resoloved had competely 2 weeks post vaccination.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Pain, Pruritus, Rash, Urticaria
Clinical narrative: 3 to 4 weeks after MMR vaccine her lower back broke out in with pus filled vesicles that were painful.  In the following days she developed hives on her arm, neck, torso (front & back).  A pinprick red rash developed on her leg and inside of her elbows.  She went to the Clinic.  He told her it looked like two different causes to her rash.  She did not tell him she had had the MMR vaccine during the visit.  He started her on a week of prednisone.  The client experienced considerable relief with the treatment. She does still have the pinprick rash on her neck and she takes Benadryl before going to bed because the itchiness increases through the night.  Sometimes the Benadryl doesn't work.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Nausea, Vomiting
Clinical narrative: Pt. called the afternoon of injection with c/o severe cramps, nausea and vomiting. (Did also start menses.) Called pt. back this am and is doing better.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Face injury, Fall, Mouth haemorrhage
Clinical narrative: Client received third dose of HPV vaccine.  Her brother received vaccines after she did.  About ten minutes passed between the time she got her shot and the family was leaving the clinic.  While walking down the hall to exit, patient fell forward and collapsed on her face.  Bleeding from mouth, scraped chin.  Unable to determine source of bleeding because child could not open her mouth more than 1/2 inch.  After juice and cold compresses were used, parents left to take her to emergency room.  Used wheelchair to go to car.  3/25/08 Reviewed hospital medical records of 2/18-2/20/2008. FINAL DX: Multiple mandible fractures, surgically reduced. Records reveal patient experienced syncope s/p vaccination.  Seen at outlying ER & transferred to higher level of care.  In recuperative stage. Jaw was broken, surgically repaired. Last contract with client was 3/11/08. Mouth was rubber-banded together - still healing.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, No reaction on previous exposure to drug, Syncope, Tooth injury, X-ray
Clinical narrative: Client received third dose of HPV vaccine.  Her brother received vaccines after she did.  About ten minutes passed between the time she got her shot and the family was leaving the clinic.  While walking down the hall to exit, patient fell forward and collapsed on her face.  Bleeding from mouth, scraped chin.  Unable to determine source of bleeding because child could not open her mouth more than 1/2 inch.  After juice and cold compresses were used, parents left to take her to emergency room.  Used wheelchair to go to car.  3/25/08 Reviewed hospital medical records of 2/18-2/20/2008. FINAL DX: Multiple mandible fractures, surgically reduced. Records reveal patient experienced syncope s/p vaccination.  Seen at outlying ER & transferred to higher level of care.  In recuperative stage. Jaw was broken, surgically repaired. Last contract with client was 3/11/08. Mouth was rubber-banded together - still healing.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: CHILD FELL AND FAINTED AFTER VACCINE ADMINISTRATION.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Body temperature increased, Decreased appetite, Myalgia, Parosmia
Clinical narrative: Temperature 39.7 C, Muscle pain and soreness of the posterior of the thighs and hips (both sides), smells a fishy odor that is causing a decrease in appetite. Continues to have symptoms. Instructed to use Tylenol by family physician, husband complained that it did not help with the pain and soreness but did help the temperature.  Advised to use ibuprofen instead.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Menorrhagia
Clinical narrative: Patient complained of increased abdominal pain and heavy menses occurring 10-14 days after receiving Gardasil #1 and #2.  Menses at other times were not affected.
Age: 44.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Employee reports that following his tetanus vaccination in November, he developed pain and impaired range of motion/function to his left arm. Symptoms developed approximately 1 week after the injection, which was administered on 11/29/07 in the left deltoid muscle.  At that time, he reports that he noted pain radiating from his left shoulder to his elbow, and his arm was "weak".  He states that he had difficulty abducting his left arm, however he was able to move his left shoulder in all other range movements.  He states that he was unable to lift items with his left arm for a period of a "few weeks".  He reports that these symptoms have slowly improved over time, and at this time he is able to demonstrate active range of motion to the left shoulder and arm without evidence of limitation.  He states that he currently experiences "pain from my shoulder to my elbow when I cough".
Age: 44.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Muscular weakness, Pain in extremity, Radiculitis brachial
Clinical narrative: Employee reports that following his tetanus vaccination in November, he developed pain and impaired range of motion/function to his left arm. Symptoms developed approximately 1 week after the injection, which was administered on 11/29/07 in the left deltoid muscle.  At that time, he reports that he noted pain radiating from his left shoulder to his elbow, and his arm was "weak".  He states that he had difficulty abducting his left arm, however he was able to move his left shoulder in all other range movements.  He states that he was unable to lift items with his left arm for a period of a "few weeks".  He reports that these symptoms have slowly improved over time, and at this time he is able to demonstrate active range of motion to the left shoulder and arm without evidence of limitation.  He states that he currently experiences "pain from my shoulder to my elbow when I cough".
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Influenza, Injection site erythema, Injection site mass
Clinical narrative: Quarter size bump at injection site for approx one month, with redness and swelling. Got the flu the 2 days later for 10 days with symptoms of Fever of 102, chills, aches, headache, congestion, sore throat.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Nasal congestion, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Quarter size bump at injection site for approx one month, with redness and swelling. Got the flu the 2 days later for 10 days with symptoms of Fever of 102, chills, aches, headache, congestion, sore throat.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eosinophil count increased, Monocyte count decreased, Platelet count increased, Pyrexia, Rash generalised
Clinical narrative: 2/15 vaccinated:  rash (flat) appeared on neck behind ears, abdomen, buttocks, chest; none on arms/legs - within 24 hrs.  fever <101R on evening of day of vaccine; given tepid bath; not given analgesic; seen in ER on advice of nurse consultant.  Blood work normal; Sunday rash generalized; IV antibiotics @ ER; both Sat & Sun. WBC elevated  2/18 rash fading/ 2/19 child normal.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: White blood cell count increased
Clinical narrative: 2/15 vaccinated:  rash (flat) appeared on neck behind ears, abdomen, buttocks, chest; none on arms/legs - within 24 hrs.  fever <101R on evening of day of vaccine; given tepid bath; not given analgesic; seen in ER on advice of nurse consultant.  Blood work normal; Sunday rash generalized; IV antibiotics @ ER; both Sat & Sun. WBC elevated  2/18 rash fading/ 2/19 child normal.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Electrocardiogram, Myalgia, Neck pain
Clinical narrative: 10 days after smallpox vaccination patient with myalgias, neck ache, chest discomfort.  Admitted with EKG changes, grey zone troponins, elevated c-reactive protein.  Symptoms decreased after approximately 3-4 days. 03/21/08-records received for DOS 2/12-2/15/08-DC DX: Pericarditis. Resolving cellulitis at vaccine site.  Admitted with 3 days of flu like symptoms to include fatigue, generalized muscle aches, congestion, diaphoresia, fevers, headache and chest pressure, lightheadedness and presyncope, hand tingling. Mild blurred vision and photo/phono phobia. Erythema right shoulder at site of vaccination.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: 10 days after smallpox vaccination patient with myalgias, neck ache, chest discomfort.  Admitted with EKG changes, grey zone troponins, elevated c-reactive protein.  Symptoms decreased after approximately 3-4 days. 03/21/08-records received for DOS 2/12-2/15/08-DC DX: Pericarditis. Resolving cellulitis at vaccine site.  Admitted with 3 days of flu like symptoms to include fatigue, generalized muscle aches, congestion, diaphoresia, fevers, headache and chest pressure, lightheadedness and presyncope, hand tingling. Mild blurred vision and photo/phono phobia. Erythema right shoulder at site of vaccination.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: PATIENT HAD SYNCOPAL EPISODE AFTER VACCINE WAS ADMINISTERED.
Age: 27.0
Sex: M
Vaccine: ANTH, MEN, YF
Symptoms: Dizziness, Immediate post-injection reaction, Vision blurred
Clinical narrative: Pt. states having lightheaded sx with blurry vision 2 Min after Anthrax Vaccination. Pulse about 82 BPM, breathing 20/ min. Pt states having no difficulty breathing. no food x 12 hours, patient received about 1 hr ago Yellow fever and Menningococcial Vaccines. All vaccines were given in Left Arm. Pt deferred from smallpox for 30 days.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, Syncope
Clinical narrative: HAD SYNCOPAL EPISODE, FELL TO GROUND STRIKING HEAD, HAD CT SCAN OF HEAD.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Cold sweat, Discomfort, Feeling hot, Headache, Injection site erythema
Clinical narrative: Patient reported temporal HA's, cold sweats at night, feeling warm (no temp taken), discomfort, swelling, redness and small blister at injection site Mon after having the injection the previous Fri.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site vesicles, Night sweats
Clinical narrative: Patient reported temporal HA's, cold sweats at night, feeling warm (no temp taken), discomfort, swelling, redness and small blister at injection site Mon after having the injection the previous Fri.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Headache, Hypertension, Myalgia
Clinical narrative: First day severe muscle and joint pain, second day severe neck and head pain, third day progressed to tachycardia and hypertension that required emergency treatment. Day 6 now and still progressive weakness and fever with all the above symptoms as well. Doctor has given steroids to treat reaction. Just started today. Still very sick with increasing severity of symptoms. 3/3/08 records received C/O weakness, fatigue tachycardia, hypertension, as possible reaction to influenza injection. Unable to keep fluids down, treated with IV fluids.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pyrexia, Tachycardia
Clinical narrative: First day severe muscle and joint pain, second day severe neck and head pain, third day progressed to tachycardia and hypertension that required emergency treatment. Day 6 now and still progressive weakness and fever with all the above symptoms as well. Doctor has given steroids to treat reaction. Just started today. Still very sick with increasing severity of symptoms. 3/3/08 records received C/O weakness, fatigue tachycardia, hypertension, as possible reaction to influenza injection. Unable to keep fluids down, treated with IV fluids.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Pain, Pain in extremity, Rash generalised
Clinical narrative: Pt called 2/4/08 c/o body and feet pain and rash all over. Feet swollen. Seen in ER. Given prednisone, Pepcid, and Benadryl with improvement.  May have been viral exanthum.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity, Rash generalised, Rash pruritic
Clinical narrative: Presented to office 2/19/08 with itchy rash all over and  hand and foot pain. Rash stared 2/17/08.  Given Medrol dose pak and Benadryl.
Age: 1.01
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC, RV5, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received Rotavirus in error on 2/13/2008 @ 12 mos of age.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX
Symptoms: Croup infectious, Dysphonia, Full blood count, Pyrexia, Screaming
Clinical narrative: Approximately 3 hours after leaving the doctors office the baby screamed for over 3 hours.  Was given Tylenol with no relief.  Low grade fever was noted.  One day later he became hoarse.  Doctors office felt it was not related to his immunizations.  That night he ended up in the ER with croup and was hospitalized for treatment for 1 more day.  04/07/2008 MR received for DOS 12/20/2008 with final DX:  Croup.  Minimal thrush. Child presented to ER with respiratory difficulties following a 2 day hx of hoarseness and nasal congestion.  Inspiratory stridor noted on PE as well as white patches in the mouth. Txd with racemic epi as well as albuterol with some improvement noted. Lungs CTA and breath sounds =, O2 sat 98% on RA prior to d/c.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX
Symptoms: Virus serology test
Clinical narrative: Approximately 3 hours after leaving the doctors office the baby screamed for over 3 hours.  Was given Tylenol with no relief.  Low grade fever was noted.  One day later he became hoarse.  Doctors office felt it was not related to his immunizations.  That night he ended up in the ER with croup and was hospitalized for treatment for 1 more day.  04/07/2008 MR received for DOS 12/20/2008 with final DX:  Croup.  Minimal thrush. Child presented to ER with respiratory difficulties following a 2 day hx of hoarseness and nasal congestion.  Inspiratory stridor noted on PE as well as white patches in the mouth. Txd with racemic epi as well as albuterol with some improvement noted. Lungs CTA and breath sounds =, O2 sat 98% on RA prior to d/c.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Influenza, Mechanical ventilation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 27-year-old male subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included attention deficit hyperactivity disorder, autism, bipolar, ocd and oppositional defiant disorder. Concurrent medications included Trazodone, Clonazepam (Clonopin), Lithium carbonate, Mirtazapine (Remeron), Polyethylene glycol (Miralax), Risperidone (Risperdal) and Quetiapine fumarate (Seroquel). On 31 October 2007 the subject received unspecified dose of Flulaval (.5 ml, intramuscular, left arm). On 8 February 2008, 100 days after vaccination with Flulaval, the subject experienced fever and cough. The subject had difficulty breathing and developed influenza type a (vaccination failure). The nurse reported that the subject possibly aspirated because his chest x-ray showed pneumonia on 11 February 2008. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with mechanical ventilation (ventilation) on 12 February 2008. At the time of reporting the events were worse.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 27-year-old male subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included attention deficit hyperactivity disorder, autism, bipolar, ocd and oppositional defiant disorder. Concurrent medications included Trazodone, Clonazepam (Clonopin), Lithium carbonate, Mirtazapine (Remeron), Polyethylene glycol (Miralax), Risperidone (Risperdal) and Quetiapine fumarate (Seroquel). On 31 October 2007 the subject received unspecified dose of Flulaval (.5 ml, intramuscular, left arm). On 8 February 2008, 100 days after vaccination with Flulaval, the subject experienced fever and cough. The subject had difficulty breathing and developed influenza type a (vaccination failure). The nurse reported that the subject possibly aspirated because his chest x-ray showed pneumonia on 11 February 2008. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with mechanical ventilation (ventilation) on 12 February 2008. At the time of reporting the events were worse.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Medication error, Nonspecific reaction, Vaccination failure
Clinical narrative: This case was reported by a physician (also the consumer) and described the occurrence of influenza illness in a male subject aged between 80 and 89 years old who was vaccinated with Flulaval (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Flulaval at 1.0 ml. Four months after vaccination with Flulaval, the subject developed a severe influenza illness. This was considered to be a vaccination failure. This event is medically serious according to GSK. The subject experienced a systemic reaction. There was a concern as to whether or not the medication had been properly stored. It was thought that the vaccine was not kept in the refrigerator. This was considered to be a medication error. At the time of reporting the influenza illness was resolved. The physician considered the events were probably related to vaccination with Flulaval. No additional events were reported.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ear pain, Facial pain, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Pain in face, ears.  Pain and weakness and numbness in legs.  Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge.  C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Pain in face, ears.  Pain and weakness and numbness in legs.  Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge.  C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Facial pain, Hypoaesthesia, Hypoaesthesia facial, Lethargy, Muscular weakness
Clinical narrative: Pain in face, ears.  Pain and weakness and numbness in legs.  Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge.  C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Pain in jaw
Clinical narrative: Pain in face, ears.  Pain and weakness and numbness in legs.  Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge.  C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: On 1-31-08 a day after I received the shot, about 12:30 my top lip started to swell & by 3:00 it was all across top lip & my bottom lip.  I went to emerg. room - 4 1/2 hr.  Was told I had reaction from shot not to ever get it again.  They had to treat me.  You can call them for results & med. given to me. 2/22/08-records received for DOS 1/30-2/1/08-ER Records DX: Angioedema suspect secondary to ACE inibitor. Do not feel this is related to racent vaccine. C/O upper lip swelling, nose tingling.
Age: 1.3
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site vesicles
Clinical narrative: Varivax given right thigh 01 24 08. On 02 07 08 parents reported clear vesicle lesions on right thigh. Seen in clinic that day. No further treatment.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Rash
Clinical narrative: Friends noticed rash above bilateral eyebrows, L cheek.  Rash observed by PHN above eyes bilaterally.  No urticaria, no hives, no rash/reaction at injection sites.  Headache began 10pm on 2/12/08 continuing through 2/13/08 when seen by PHN.
Age: 37.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Pain in extremity
Clinical narrative: Patient stated that left arm was painful >2 wks after injection; Denies local reaction, such as redness, irritation, swelling, fever
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, myalgias, arthralgias that do not respond to NSAIDS & last for up to 2 wks.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Came in on 2/11/08 for Bumps over the body for 2 days; Benadryl, Aveeno
Age: 48.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis left arm
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Productive cough, Sinus congestion, Vomiting
Clinical narrative: On 2/4/08 pt took 1st oral typhoid tab at 8pm.  On 2/5/08 B/T 10-11pm experienced severe diarrhea, vomiting that lasted all night.  C/O sinus plugged up & coughing up mucus and very tired; took Immodium.  On 2/8/08 reported event to health department.  States took no other of typhoid tabs, stomach settled but diarrhea persists.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large erythematous patch 13cm x 14cm around Varivax site
Age: 0.2
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Rash generalised, Vomiting
Clinical narrative: Vaccinated for Rotavirus on 1-21-08.  Within hours had explosive diarrhea and vomiting (projectile).  Patient refused to eat, and when she did, it would result in immediate diarrhea afterwards.  She was taken to the ER twice.  She required fluids for dehydration.  It has taken her two weeks to fully recover.  One week after vaccination she also developed a full body rash.