chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: HEPAB, TD, TYP, YF
Symptoms: Confusional state, Delirium, Headache, Pneumonitis, Sinus disorder
Clinical narrative: This case was received from a health professional on 22 July 2008. A 66-year-old male patient, with a history of aortic valve replacement and benign prostatic hypertrophy, received the following vaccinations on 02 July 2008: YF-VAX, TYPHIM VI, DIPHTHERIA and TETANUS TOXOID (manufacturer unknown), Hepatitis A (manufacturer unknown), and Hepatitis B (manufacturer unknown). Lot numbers, routes/sites of administration, and number of previous doses was unknown. The patient was admitted to the hospital on 21 July 2008, 19 days after vaccination, with delirium, confusion, and a temperature of 102 degrees. He had reportedly complained of a frontal headache two days prior to admission. White blood count on admission was 16.7, and 14.0 the following day. A CT of the head showed thickness of the sinuses, and a chest x-ray revealed patchy pneumonitis at the left base. Treatment included Augmentin, and temperature had decreased to 99 degrees the day after admission. Concomitant medications included Flonase, aspirin, Nexium, lorazepam, and hydrochlorothiazide. The patient remained in the hospital at the time of the report, and had not yet recovered.  9/16/08 Reviewed hospital medical records of 7/21-7/26/2008. FINAL DX: aseptic meningoencephalitis, suspect yellow fever vaccine Records reveal patient experienced increasing confusion & abnormal behavior with staring spells & inappropriate questions.  Neuro & cardio consults done.  Tx w/IV & oral antibiotics.  LP done.  Gradually improved & d/c home.  9/16/08 Reviewed PCP medical records of 7/21/08. FINAL DX: none provided Records reveal patient experienced intermittent HA & intermittent fever x 2 weeks with behavioral change & mild disorientation.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Full blood count normal, Headache, Liver function test normal, Muscular weakness
Clinical narrative: Initial report was received on 22 July 2008 from a health care professional. A 45-year-old female patient with a history of allergy to Lotrimin cream, developed fatigue that same day she had received a first dose subcutaneous left deltoid injection of YF VAX, lot number UF303AA. The following day (12 July 2008), the fatigue increased, and she developed a severe headache, shortness of breath and became feverish (temperature not reported). The following day (13 July 2008), she developed nausea and her headache decreased, but her fatigue increased. Her symptoms were noted to have been improving on 14 July 2008, however the fatigue continued. On 19 July 2008, the patient developed an 8mm circular rash on her trunk and extremities which expanded over her body. On 21 July 2008, she had worsening muscle weakness and was unable to lift her arms to type. It was not reported if the patient had received any concomitant vaccines. The patient was evaluated by a physician and her CBC and liver function studies had been normal. According to the reporter, they had been seeing an increase in the number of Lyme, West Nile, and Ehrlichiosis in their area. The patient had been referred to her regular health care physician for further evaluation and may be admitted to the hospital to facilitate evaluation and follow-up. Her recovery status at the time of the report was reported as unknown.  8/15/08 Reviewed employee health medical records. FINAL DX: none provided Records reveal patient experienced HA, felt unwell, rash all over, extreme fatigue, pale, shortness of breath, impaired ADLs, sluggish, nausea, loose stool, puffiness & water retention in face & hands.  ID & travel clinic consults done.  Referred to PCP (new). Tx w/antibiotics for possible Lyme disease empirically.  Travel out of country was d/c.     10/21/08 Reviewed PCP medical records of 7/22-7/24/2008. FINAL DX: viral syndrome w/exanthem, fatigue, malaise & SOB. Records reveal patient experienced viral illness w/macular rash, HA, low grade fever, sore neck muscles, SOB x approx 5 days when seen 7/22. Had been out of country 6/2008 & had tick bite 5/2008.  Tx w/antibiotics.  RTC 7/24 feeling better & rash fading.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Nausea, Pyrexia
Clinical narrative: Initial report was received on 22 July 2008 from a health care professional. A 45-year-old female patient with a history of allergy to Lotrimin cream, developed fatigue that same day she had received a first dose subcutaneous left deltoid injection of YF VAX, lot number UF303AA. The following day (12 July 2008), the fatigue increased, and she developed a severe headache, shortness of breath and became feverish (temperature not reported). The following day (13 July 2008), she developed nausea and her headache decreased, but her fatigue increased. Her symptoms were noted to have been improving on 14 July 2008, however the fatigue continued. On 19 July 2008, the patient developed an 8mm circular rash on her trunk and extremities which expanded over her body. On 21 July 2008, she had worsening muscle weakness and was unable to lift her arms to type. It was not reported if the patient had received any concomitant vaccines. The patient was evaluated by a physician and her CBC and liver function studies had been normal. According to the reporter, they had been seeing an increase in the number of Lyme, West Nile, and Ehrlichiosis in their area. The patient had been referred to her regular health care physician for further evaluation and may be admitted to the hospital to facilitate evaluation and follow-up. Her recovery status at the time of the report was reported as unknown.  8/15/08 Reviewed employee health medical records. FINAL DX: none provided Records reveal patient experienced HA, felt unwell, rash all over, extreme fatigue, pale, shortness of breath, impaired ADLs, sluggish, nausea, loose stool, puffiness & water retention in face & hands.  ID & travel clinic consults done.  Referred to PCP (new). Tx w/antibiotics for possible Lyme disease empirically.  Travel out of country was d/c.     10/21/08 Reviewed PCP medical records of 7/22-7/24/2008. FINAL DX: viral syndrome w/exanthem, fatigue, malaise & SOB. Records reveal patient experienced viral illness w/macular rash, HA, low grade fever, sore neck muscles, SOB x approx 5 days when seen 7/22. Had been out of country 6/2008 & had tick bite 5/2008.  Tx w/antibiotics.  RTC 7/24 feeling better & rash fading.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Biopsy bone marrow, Chills, Epstein-Barr virus test
Clinical narrative: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Gingival bleeding, Haemoptysis, Haemorrhage, Headache
Clinical narrative: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Insomnia, Intermittent claudication, Petechiae, Platelet count decreased
Clinical narrative: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet transfusion, Purpura, Pyrexia, Serum sickness, Vaginal haemorrhage
Clinical narrative: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count decreased
Clinical narrative: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial report received on 30 November 2007 from a health care professional. A 35-year-old female patient had received an intramuscular injection of ADACEL, lot number C2842AA, on 24 October 2007. Site of administration was not provided. The patient's last menstrual period was 20 October 2007. It was determined that the patient was pregnant. The estimated date of delivery was uncertain at the time of this report. Current medications included Nasonex. Per the reporter, the patient did not experience any adverse event. Follow-up information was received from the health professional on 16 June 2008. In addition to ADACEL, the patient also received an intramuscular injection of FLUZONE (lot number U2437AA) on 24 October 2007. The reporter did not consider the patient to be pregnant at the time of vaccination, as the date of last menstrual was 20 October 2007 and the patient received the vaccines on 24 October 2007. No additional information was provided. Follow-up information received on 25 July 2008 from the original reporter who is a health care professional. The ADACEL and FLUZONE SV 2007-2008 administered to the patient on 24 October 2007 were the first, and fifth doses the patient had received of these vaccines respectively. The patient's estimated date of delivery was on July 28, 2008; however the patient experienced a spontaneous abortion (also reported as miscarriage) approximately two months post-vaccination of one single fetus beginning in December 2007 that was confirmed on 02 January 2008. The patient was less than 20 weeks gestation. The reason for the spontaneous abortion was not known, but the patient's Beta HCG's levels had been decreasing in value that indicated a "miscarriage." The patient had not received any prior treatments for infertility, and had not experienced any illnesses during the pregnancy. No prenatal testing had been completed. At the time of this report, it was "unknown" if the patient had recovered. After review of this new information, this case was upgraded to serious.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 85 year old female with no known allergies, who on 18-MAR-2008 was vaccinated subcutaneously with "1 vial " of ZOSTAVAX. There was no concomitant medication. In April 2008 and again in May or June 2008, the patient developed shingles after receiving ZOSTAVAX. The patient saw the physician. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered from the AEs (date not specified by the reporter). There was no product quality complaint. Follow up information was received from the physician concerning a 88 year old female with no medical history, no known allergies who was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced herpes zoster twice since the immunization. On 10-JUL-2008, the patient recovered. There was no illness at the time of vaccination. No laboratory/diagnostic tests were performed. The reporting physician felt that the patient's herpes zoster was serious as an other important medical event. No further information is available.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Herpes zoster, Inappropriate schedule of drug administration, Myalgia
Clinical narrative: Information has been received from a physician concerning a 44 year old white female, weight 209lb, height 54 inches, with hypothyroidism and lipid disorder and no known drug allergies and a history of chicken pox in childhood and chronic recurring bouts of shingles who on the morning of 25-MAY-2007 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the left arm.  Concomitant therapy included VALTREX.  In February, 2008, therapy with VALTREX stopped.  (Also reported VALTREX used through 31-AUG-2007).  On 15-May-2008, the patient developed shingles on her back and trunk, chills and myalgia.  The patient rated her pain a 7 on a scale of 0 (least) to 10 (most).  The shingles lasted for 7 days.  The maximum temperature was 99.2F.  The patient restarted VALTREX.  Subsequently the patient recovered.  The patient sought unspecified medical attention.  The reporting physician considered the recurrent shingles to be an other important medical event.  Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 44 year old white female, weight 209lb, height 54 inches, with hypothyroidism and lipid disorder and no known drug allergies and a history of chicken pox in childhood and chronic recurring bouts of shingles who on the morning of 25-MAY-2007 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the left arm.  Concomitant therapy included VALTREX.  In February, 2008, therapy with VALTREX stopped.  (Also reported VALTREX used through 31-AUG-2007).  On 15-May-2008, the patient developed shingles on her back and trunk, chills and myalgia.  The patient rated her pain a 7 on a scale of 0 (least) to 10 (most).  The shingles lasted for 7 days.  The maximum temperature was 99.2F.  The patient restarted VALTREX.  Subsequently the patient recovered.  The patient sought unspecified medical attention.  The reporting physician considered the recurrent shingles to be an other important medical event.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain in extremity, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a nurse and follow-up information was received from a physician concerning the nurse's 76 year old mother who on 25-JUN-2007 was vaccinated with one dose of ZOSTAVAX (Oka/Merck) (lot no. 656413/1477F).  Concomitant therapy included PREMPRO and SYNTHROID.  On 09-JUN-2008 the patient first experienced severe pain in her right leg which was followed by a shingles rash on her right side within twenty four hours.  The rash has resolved but the patient has "splotches" where the rash was and was experiencing numbness in her lower right leg.  The physician reported in follow up that "the patient did not have an adverse event.  She had a breakthrough case of shingles in the sciatic distribution and post herpetic neuralgia".  At the time of this report, the patient was not recovered.  The patient was seen by the physician to seek unspecified medical attention.  The physician considered a breakthrough case of shingles, numbness in the lower right leg and post herpetic neuralgia to be other important medical events.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Coagulation test normal, Coma, Convulsion, Thrombectomy
Clinical narrative: Following the vaccine a blood clot formed in my brain.  I suffered a stroke and a seizure.  An emergency thrombectomy was attempted.  I was in a coma for two weeks, followed by months of PT and OT.  I still suffer from seizures.  9/26/08 Reviewed hospital medical records of 8/9-8/29/2007. FINAL DX: superior sagittal sinus thrombosis; bilateral frontal hemorrhage. Records reveal patient experienced progressively worsening HA x 3 days w/visual changes, tinnitus & nausea.  Tx w/Benadryl, steroids & ASA at outlying hospital.  Developed right side facial & limb weakness, had generalized tonic-clonic seizure & was intubated prior to transfer. Had tongue laceration. Tx w/anticoagulant drip, antiseizure meds, antibiotics & steroids.  Interventional radiology debulked clot but unable to reestablish blood flow. Developed steroid induced diabetes & tx w/insulin.  Neuro & clinical exam slowly improved.  Extubated 8/22 & on tube feedings until 8/28 when transitioned to PO.  Transferred to inpatient rehab.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: Following the vaccine a blood clot formed in my brain.  I suffered a stroke and a seizure.  An emergency thrombectomy was attempted.  I was in a coma for two weeks, followed by months of PT and OT.  I still suffer from seizures.  9/26/08 Reviewed hospital medical records of 8/9-8/29/2007. FINAL DX: superior sagittal sinus thrombosis; bilateral frontal hemorrhage. Records reveal patient experienced progressively worsening HA x 3 days w/visual changes, tinnitus & nausea.  Tx w/Benadryl, steroids & ASA at outlying hospital.  Developed right side facial & limb weakness, had generalized tonic-clonic seizure & was intubated prior to transfer. Had tongue laceration. Tx w/anticoagulant drip, antiseizure meds, antibiotics & steroids.  Interventional radiology debulked clot but unable to reestablish blood flow. Developed steroid induced diabetes & tx w/insulin.  Neuro & clinical exam slowly improved.  Extubated 8/22 & on tube feedings until 8/28 when transitioned to PO.  Transferred to inpatient rehab.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis right arm 2 hours varicella.  In hospital for 1 day, discharged with clindimycin.  9/11/2008 MR received for DOS 7/18-19/2008 with D/C DX:  Local vaccine reaction to chicken pox vaccine.  R/O arm cellulitis.   Pt presented from PCP office with 1 day hx of R arm swelling and pain.  The pm of the injection pt developed swelling and blisters forming at the injection site. Blisters draining clear fluid. (+) itching. Started on IV abx with improvement in erythema, induration and pain. D/C on po abx.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Mother stated that child was having respiratory difficulty, fever tmax 101.9.  Pt was given IV antibiotics to rule out bacteremia.  08/15/2008 MR received for DOS 5/17-20/2008 with D/C DX: Fever, r/o bacteremia.  Also suspected the chance of being reaction to the vaccines. Pt presented to ER with high fever beginning several hours after receiving vax and an episode of difficulty breathing. Admitted for sepsis w/u. Tx with abx until cx (-). Pt quickly became afebrile with benign exam.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Eye swelling, Swelling face
Clinical narrative: Facial/ocular swelling less than 24 hours after vaccines. No respiratory distress symptoms, no vomiting and no fevers. Lasted few days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Vaccine adm. 7/21/08.  7/25/08 - developed blisters on hands, arms, neck & groin.  Called MD - Rx BENADRYL 50mg Q6H.  Saw MD on 7/28/08.  Rx-hydroxyz HCl 10mg QHS.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Pain in extremity, Weight decreased
Clinical narrative: Fatigue, weight loss of 16 pounds, bilateral leg pain.  8/22/2008 MR received from PCP. OV 5/21/2008 for c/o 16lb wt loss over the past 6 weeks and fatigue. ROS (+) for headache, blurred vision, orthostatic hypotension, heart palpitations, muscle cramps, diarrhea after eating full meals, bilateral leg aches and weakness, dizziness on arising, decreased appetitite.  Pt describes not feeling fun and decreased participation in activities.  Feels cold and having difficulty with menstual cycles. PE (+) for nasal congestion. Assessment:  Weight loss-sinusitis vs depression vs chronic inflammatory process. OV 7/10/08 still c/o muscle weakness in upper thighs since 3rd Gardasil.  Other sx improving.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: C-reactive protein increased, Cyclic citrullinated peptide A increased, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Developed a progressive symmetrical arthritis.  Diagnosed Rheumatoid Arthritis in September 2007.  Symptoms began probably in Spring.  Treatment is ongoing.  8/18/2008 PCP recs received with vax rec.  Seen for WCC 1/29/07 with normal exam, no concerns. RTO 6/6/07 with c/o rash x 4wks. Light brown rash of circular lesions noted on upper back, chest. ? skin infection tx with Loprox. HPV #2 given. 10/10/2008 Rheumatology consult records received with DX: Rheumatoid Arthritis. Seen 10/15/07 with c/o joint pain and swelling, morning stiffness and decreased ROM mainly in the fingers, toes and hands with (+) RF and CCP.  PE (+) for joint swelling and tenderness, DTRs +1 in upper extremities.  Having difficulty with Ultimate Frisbee and climbing bunk bed. Return visit 11/16/07 with increased # of joints affected.  PE (+) for significant synovitis, knees now affected. Seen 3/27/08 with neck pain, likely muscular and mild hair loss. Tx: Plaquenil, Mtx, and TNF inhibitors with some relief.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Pt returned for 3rd dose of GARDASIL (HPV) vaccine and reported on questionnaire that she broke out in hives around injection site after 2nd dose on 4.07.08, relieved with ice pack. Denied any difficulty breathing. Indicated allergy to honey on 4.07.08. This writer decided not to give 3rd dose.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, VARCEL
Symptoms: Headache, Neurological examination
Clinical narrative: Headache sent to Neurologist
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Patient received the varicella vaccine SC on right arm Wednesday A.M. On Thursday P.M., he noticed the site was swollen, red, and hot to the touch. He also became nauseated & vomited. When patient was seen in the office Friday A.M. the swelling measured 3 1/2 inches by 3 1/2 around. Pt was advised to ice the area and take Benadryl as needed.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vaccine positive rechallenge
Clinical narrative: Parent reports diarrhea for 2 weeks post 1st and 2nd dose of RotaTeq.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Dyspnoea, No reaction on previous exposure to drug, Throat irritation
Clinical narrative: Questionable reaction to DTP @ 3 months. No further reactions to vaccines as patient grew older. Remained in waiting room 20 minutes, started to leave complained of dizziness, weakness. No complaint of trouble breathing. Sat down remained another 20-30 minutes, no complaint and left. On way home complained throat itchy and broke out with hives. Went to personal physician and then on to ER per statement of mother and treated for vaccine reaction.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Questionable reaction to DTP @ 3 months. No further reactions to vaccines as patient grew older. Remained in waiting room 20 minutes, started to leave complained of dizziness, weakness. No complaint of trouble breathing. Sat down remained another 20-30 minutes, no complaint and left. On way home complained throat itchy and broke out with hives. Went to personal physician and then on to ER per statement of mother and treated for vaccine reaction.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Asthenia, Blood pressure, Chills, Dizziness, Heart rate normal
Clinical narrative: While in waiting area had asked for something to drink and couldn't drink water, chills and weak. Escorted to treatment room complaint of dizziness. Vital signs monitored and assessed patient while in room.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Oral intake reduced
Clinical narrative: While in waiting area had asked for something to drink and couldn't drink water, chills and weak. Escorted to treatment room complaint of dizziness. Vital signs monitored and assessed patient while in room.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blood pressure, Dizziness, Heart rate normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt became dizzy with tingling sensation "all over" 1-2 minutes post injections.  Pt proceeded to lose consciousness for 3-5 sec. with 1-2 secs. of twitching.  Pt regained consciousness immediately post injections and appears alert & oriented at this time.  HR-76 Resp Rate-20 B/P-120/78.  Waited 20 minutes after injections.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Muscle twitching, Paraesthesia, Respiratory rate
Clinical narrative: Pt became dizzy with tingling sensation "all over" 1-2 minutes post injections.  Pt proceeded to lose consciousness for 3-5 sec. with 1-2 secs. of twitching.  Pt regained consciousness immediately post injections and appears alert & oriented at this time.  HR-76 Resp Rate-20 B/P-120/78.  Waited 20 minutes after injections.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Bone pain, Cough, Dry mouth, Dysgeusia, Dysphonia
Clinical narrative: Patient states that within minutes of receiving Tdap he had a very bad taste (metallic) in his mouth and from day 1 - day 4 experienced body aches; sore bones. On a scale of 1-10 day 1 = 10 (pain), day 4 &5. By the 6th day all pain: body aches had ceased. From day 1 X 7 days patient has experienced raspy voice, dry mouth, at night coughs and shortness of breath.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Pain
Clinical narrative: Patient states that within minutes of receiving Tdap he had a very bad taste (metallic) in his mouth and from day 1 - day 4 experienced body aches; sore bones. On a scale of 1-10 day 1 = 10 (pain), day 4 &5. By the 6th day all pain: body aches had ceased. From day 1 X 7 days patient has experienced raspy voice, dry mouth, at night coughs and shortness of breath.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated arm feels warm to the touch, looks red and swollen; L deltoid.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Fatigue, Nausea, Pruritus, Urticaria
Clinical narrative: 07-27-08 pt states woke up in the night with severe itching around buttocks area. Noticed red raised whelps with yellow head. Also was very fatigued, very nauseous and had diarrhea. MD visit. NP called stating possible reaction to MMR. Depo Medrol and Predn. given.
Age: 0.4
Sex: F
Vaccine: HIBV, PNC
Symptoms: Amino acid level, Carnitine, Grunting, Rash macular
Clinical narrative: Grunting after vaccines. Skin splotching.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Rash, Streptococcal identification test negative
Clinical narrative: Office visit on 7-29-08 with rash that started 5 days ago also decreased appetite.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Injection site pain, Oedema, Rash vesicular
Clinical narrative: Erythema, edema, pain at site after 24 hours (7/23).  Reported to Urgent Care, given antibiotics for Cellulitis.  7-24-08 - 14cm x 9cm area of erythema and edema with vesicular localized changes.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Blood pressure decreased, Dehydration, Dizziness, Nausea
Clinical narrative: Immediately upon removal of syringe during rabies vaccination donor became pale, faint c/o dizziness & weak.  C/O nausea & felt dehydrated.  Donor assisted to lay down & was given fluids.  Declined offer of food.  Donor condition improved rapidly with no further c/o.  VS at onset were BP 77/44 P 68.  VS at time of release 136/64 P 88.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Pallor, Syncope
Clinical narrative: Immediately upon removal of syringe during rabies vaccination donor became pale, faint c/o dizziness & weak.  C/O nausea & felt dehydrated.  Donor assisted to lay down & was given fluids.  Declined offer of food.  Donor condition improved rapidly with no further c/o.  VS at onset were BP 77/44 P 68.  VS at time of release 136/64 P 88.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Due to discrepancy in records, 3rd MMR given.  No adverse events reported.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt received MMR and Varicella on Lt and Rt arms. About 5 minutes later small hives appeared. Doctor was notified and child was given TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Arthralgia, Headache, Oedema peripheral, Skin warm
Clinical narrative: Mother reports noticing the L thigh being swollen 2x normal approx. 12 noon.  Leg is favored with walking & c/o pain knee area.  To clinic to be checked.  Lt leg visibly larger than Rt & warm to touch.  Measures 3.5cm larger directly above knee when knee flexed at right angle.  Same mottled area above knee along thigh.  No bruising.  C/O pain at medial proniscus area.  Ice pack applied and advised to call PMO.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema surrounding injection site.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Feeling hot, Local reaction
Clinical narrative: Back side of right upper arm, warm pink/red 3 cm circle. Local reaction: heat/ice, ibuprofen.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray, Erythema, Pharyngolaryngeal pain, Rash, Rash maculo-papular
Clinical narrative: 2 days following, patient had sore throat, onset of vesicular rash in left vulvar area.  3 days following, erythema uracular/papular rash over trunk, upper and lower extremities.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: 2 days following, patient had sore throat, onset of vesicular rash in left vulvar area.  3 days following, erythema uracular/papular rash over trunk, upper and lower extremities.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Blood pressure, Hepatitis C, Typhoid fever, Ulcer
Clinical narrative: High blood pressure, typhoid, ulcers, hepatitis C.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein normal, Alpha 1 foetoprotein normal, Complication of delivery, Drug exposure during pregnancy, Shoulder dystocia
Clinical narrative: Information has been received from a 31 year old female (also reported as 28 years old) through the Merck Pregnancy Registry who is a smoker with borderline hypertension. On 14-SEP-2000 (also reported in August 2000) the patient was vaccinated subcutaneously with the 0.5 ml first dose of VARIVAX. There was no concomitant medication. She believed her day of conception was 09-SEP-2000. She estimated that she received the vaccine five days into her pregnancy. Unspecified medical attention was sought.   Follow-up information was received from the physician to report that the patient's last menstrual period was 24-AUG-2000, and her estimated delivery date was 24-MAY-2001. Diagnostic/Lab tests included ultrasounds on 01-NOV-2000, and 22-DEC-2000, and MSAFP on 27-DEC-2000, that were all within normal limits. The patient had 4 previous pregnancies, one full term birth, and a miscarriage at 10 weeks. The patient had no Varicella of Herpes zoster symptoms post vaccination. On 29-MAY-2001 the patient delivered a normal, healthy male baby weighing 8 pounds 10 ounces. Complications during labor/delivery included shoulder dystocia of the infant. Additional information has been requested.  The patient reported "There were no complications with the birth and the boy had been in excellent health. Last fall, 2007, it was determined by the school district that the boy was learning at a much slower rate than his classmates".  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a 31 year old female (also reported as 28 years old) through the Merck Pregnancy Registry who is a smoker with borderline hypertension. On 14-SEP-2000 (also reported in August 2000) the patient was vaccinated subcutaneously with the 0.5 ml first dose of VARIVAX. There was no concomitant medication. She believed her day of conception was 09-SEP-2000. She estimated that she received the vaccine five days into her pregnancy. Unspecified medical attention was sought.   Follow-up information was received from the physician to report that the patient's last menstrual period was 24-AUG-2000, and her estimated delivery date was 24-MAY-2001. Diagnostic/Lab tests included ultrasounds on 01-NOV-2000, and 22-DEC-2000, and MSAFP on 27-DEC-2000, that were all within normal limits. The patient had 4 previous pregnancies, one full term birth, and a miscarriage at 10 weeks. The patient had no Varicella of Herpes zoster symptoms post vaccination. On 29-MAY-2001 the patient delivered a normal, healthy male baby weighing 8 pounds 10 ounces. Complications during labor/delivery included shoulder dystocia of the infant. Additional information has been requested.  The patient reported "There were no complications with the birth and the boy had been in excellent health. Last fall, 2007, it was determined by the school district that the boy was learning at a much slower rate than his classmates".  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised erythemic area 2 inches in diameter, site hot too teh touch - RL lateral tricept
Age: 13.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given - gave Prevnar instead of Boosterix - no adverse RXN
Age: 44.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Pruritus, Rash
Clinical narrative: Rash on feet and body, itching July 17-21, 2008 rash spreading by July 23, 2008 Pt saw nurse practitioner in July 23, 2008 adn was excused from work until July 28, 2008
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient waited for 15 minutes, did not have symptoms. Drove home, started having symptoms of fainting and dizziness. Parent reported that the child barely made it home without passing out. Had a difficult time getting out of the vehicle. Parent report that the child was feeling better later in the day.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Inflammation, Oedema peripheral, Skin warm
Clinical narrative: Recieved Varicella and Hepatitis A vaccine. While waiting in the lobby left arm (varicella) began to swell and became inflammed and hot to touch. Ice and Antibiotic ointment applied.  Inflammation and edema improved @ 11:15
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, Red, and Hot
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Fall, Laceration, Muscle twitching, Sluggishness
Clinical narrative: Approximately 1 minute after vaccination, patient fell forward onto floor and severed lip. Immediately began to twitch.  Patient appeared to be having seizure-like movements similar to absence seizure.  She was not verbally responsive however, patient was breathing spontaneously. The patient was moved from the floor into a chair after 5 minutes and was able to maintain eye contact. It took her approximately 10 minutes to respond verbally to her mother's commands.  The patient and parent were in the examination room more than 30 minutes after the incident, however patient remained sluggish.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Approximately 1 minute after vaccination, patient fell forward onto floor and severed lip. Immediately began to twitch.  Patient appeared to be having seizure-like movements similar to absence seizure.  She was not verbally responsive however, patient was breathing spontaneously. The patient was moved from the floor into a chair after 5 minutes and was able to maintain eye contact. It took her approximately 10 minutes to respond verbally to her mother's commands.  The patient and parent were in the examination room more than 30 minutes after the incident, however patient remained sluggish.
Age: 34.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash generalised
Clinical narrative: CLIENT CAME IN TO GET 3RD HEPATITIS B SHOT AND STATED THAT WHEN HE GOT HIS 2ND MMR SHOT, HE HAD TO GO TO EMERGENCY ROOM AND GET TREATED FOR "RASH" ALL OVER HIS BODY. HE STATED HE BELEIVES IT IS FROM THE MMR VACCINE, HE STATED THAT AFTER HE GOT HIS SECOND ONE, HE FOUND HIS CHILDHOOD SHOT RECORD WHERE HE HAD MEALSES ON 3/14/75 AND RUBELLA ON 5/16/75. HE ALSO STARTED THAT HE RECEIVED 2 MMR SHOTS FROM THE MILITARY BUT HE DOESN'T HAVE WRITTEN PROOF FOR THOSE.
Age: 0.29
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site warmth
Clinical narrative: Mother called the clinic 6-19-08 3:47pm to report patient's left leg was red and warm to touch from knee to hip and that she was crying unconsolably.  Patient had received Prevnar and Act Hib that morning.  Our records indicated that Act Hib was given in the left vastus lateralis.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: redness and swelling at injection site, itchy
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Erythema, Varicella
Clinical narrative: Mild symptoms of chicken pox, assessed by clinic one day after spots developed. Pt. displayed 4 small red fuid filled spots without signs of puss or scabing development. Pt. presented low grade temperature.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Back pain, Local reaction, Myalgia, Pyrexia, Swelling
Clinical narrative: Local reaction with swelling, followed by back pain, muscle aches, fever, no respiratory distress, numbness or tingling of lower extremities, no trauma