chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Transfusion
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with anaemia who in 2003 was vaccinated with PNEUMOVAX 23.  Concomitant therapy included EXJADE and PROCRIT.  On 13-OCT-2008 the patient experienced soreness and redness at the site and extend toward the back of the arm.  On 16-OCT-2008, the patient recovered from soreness and redness at the site and extend toward the back of the arm.  On 17-OCT-2008, the patient had a decrease in her hemoglobin to 9.3 and required transfusion of 2 units of packed red blood cells.  The patient's hemoglobin is normally in the mid 10's.  Upon internal review, decrease hemoglobin of 9.3 requiring blood transfusion was determined to be an other important medical event.  No further information is available.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a 10 year old male who on an unknown date was vaccinated with MMR II (Enders-Edmonson, Jeryl Lynn, Wistar RA 27/3).  The consumer reported that the patient developed autism after getting MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The caller believes it was "overnight."  Caller reported a "woman in a parent group mentioned everyone she talked to whose kids have autism claimed it happened overnight after they got MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  There was no product quality complaint.  Upon internal review, autism was determined to be an other important medical event.  No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a physician concerning a 20 year old female with seizures and a history of brain surgery within the past few months who on about 1 & 1/2 month ago (approximately 09-Sep-2008) was vaccinated intramuscularly with the first dose of GARDASIL (0.5 mL, lot# and injection site not reported). The patient informed office that she had an increased frequency of seizures post-GARDASIL. No information is available about any single occurrences. The patient informed the office of the seizures during a follow-up visit, when she may have received the 2nd dose of GARDASIL. Physician believes that the seizures are not related to GARDASIL. At the time of the report (24-Oct-2008) the symptom of seizures is stable. Upon internal review, seizures determined to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on unspecified dates was given all three dose of GARDASIL during pregnancy.  Concomitant therapy included MENACTRA.  The nurse practitioner was not informed of the pregnancy until the patient was 6 months pregnant.  On an unspecified date, the patient had a miscarriage.  It was not sure how far into the pregnancy when the miscarriage took place.  Upon internal review, the miscarriage was considered to be an other important medical event (OME).  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with no pertinent medical history, allergies or drug reactions, who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL (lot no. 661044/0548X) 0.5 ml, IM. There was no concomitant medication. On 20-OCT-2008, two hours after vaccination, the patient had a seizure. The patient had no history of seizures. The nurse thought the patient may have gone to the emergency room. The physician had attempted to reach the patient's mother but has not gotten in touch with her yet. Upon internal review seizure was considered to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Consciousness fluctuating, Feeling cold, Heart rate decreased, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no previous medical history and allergies reported, who on 06-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5 mL. On 22-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # not provided) 0.5 mL. On 22-OCT-2008, the patient developed severe allergic reactions like unresponsiveness, in and out consciousness, heart rate down to 62 and cold immediately. On an unknown date, the patient recovered. The patient sought unspecified medical attention. The patient's adverse events were considered to be immediately life-threatening by the physician. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no previous medical history and allergies reported, who on 06-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5 mL. On 22-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # not provided) 0.5 mL. On 22-OCT-2008, the patient developed severe allergic reactions like unresponsiveness, in and out consciousness, heart rate down to 62 and cold immediately. On an unknown date, the patient recovered. The patient sought unspecified medical attention. The patient's adverse events were considered to be immediately life-threatening by the physician. Additional information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Appendicectomy, Appendicitis, Arthralgia, Back pain
Clinical narrative: Information has been received from a consumer, who is the mother of the patient, concerning her 14 year old daughter with sulfonamide allergy and a history of hypersensitivity who on 06-AUG-2008 or 08-AUG-2008 was vaccinated with GARDASIL for her first dose.  Concomitant therapy included montelukast sodium, (MSD), allergy shots once a week and ZYRTEC.  "A few days after receiving GARDASIL" the patient started to throw up once a week, was coughing and was losing her hair all over.  Then the patient started to have knee and back pain and then had gone to the emergency room on 28-SEP-2008.  At the hospital the patient was diagnosed with appendicitis and had emergency surgery to have her appendix removed.  The patient had been in hospital from 28-SEP-2008 to the following Monday.  The patient was still feeling tired, but she was recovering.  No further adverse effect information was provided.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Fatigue, Vomiting
Clinical narrative: Information has been received from a consumer, who is the mother of the patient, concerning her 14 year old daughter with sulfonamide allergy and a history of hypersensitivity who on 06-AUG-2008 or 08-AUG-2008 was vaccinated with GARDASIL for her first dose.  Concomitant therapy included montelukast sodium, (MSD), allergy shots once a week and ZYRTEC.  "A few days after receiving GARDASIL" the patient started to throw up once a week, was coughing and was losing her hair all over.  Then the patient started to have knee and back pain and then had gone to the emergency room on 28-SEP-2008.  At the hospital the patient was diagnosed with appendicitis and had emergency surgery to have her appendix removed.  The patient had been in hospital from 28-SEP-2008 to the following Monday.  The patient was still feeling tired, but she was recovering.  No further adverse effect information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Conjunctivitis, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received, for the Pregnancy Registry for GARDASIL (lot number #660393/0067X), from a 15 year old female with a history of anxiety attacks and latent tuberculosis infection (+PPD, negative chest X-ray) and concurrent medical condition of cold who was vaccinated with the second dose of GARDASIL on 30-SEP-2008. Other medication used during this pregnancy included MOTRIN, POLYTRIM, ZOLOFT, SUDAFED and prenatal vitamins (unspecified). It was subsequently learned that the patient was pregnant at the time. Her LMP was 02-SEP-2008. A pregnancy test was performed. On 28-JUL-2008, urine HCG test was negative. On 17-OCT-2008 urine HCG was faint positive and serum HCG was positive (126.7). The patient experienced spontaneous abortion on 22-OCT-2008. The duration from LMP to abortion was more than 7 weeks. The patient sought unspecified medical attention. Follow-up information has been received from a physician who reported that the patient received the second dose of GARDASIL On 30-SEP-2008. It was reported that the patient had history of latent tuberculosis infection and concurrent medical condition of cold. The patient took isoniazid for the treatment of tuberculosis. During this pregnancy the patient took MOTRIN, POLYTRIM drops for the treatment of conjunctivitis, ZOLOFT for the treatment of depression, SUDAFED for the treatment of cold and prenatal vitamins (unspecified). On 22-OCT-2008 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was considered to be a other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received, for the Pregnancy Registry for GARDASIL (lot number #660393/0067X), from a 15 year old female with a history of anxiety attacks and latent tuberculosis infection (+PPD, negative chest X-ray) and concurrent medical condition of cold who was vaccinated with the second dose of GARDASIL on 30-SEP-2008. Other medication used during this pregnancy included MOTRIN, POLYTRIM, ZOLOFT, SUDAFED and prenatal vitamins (unspecified). It was subsequently learned that the patient was pregnant at the time. Her LMP was 02-SEP-2008. A pregnancy test was performed. On 28-JUL-2008, urine HCG test was negative. On 17-OCT-2008 urine HCG was faint positive and serum HCG was positive (126.7). The patient experienced spontaneous abortion on 22-OCT-2008. The duration from LMP to abortion was more than 7 weeks. The patient sought unspecified medical attention. Follow-up information has been received from a physician who reported that the patient received the second dose of GARDASIL On 30-SEP-2008. It was reported that the patient had history of latent tuberculosis infection and concurrent medical condition of cold. The patient took isoniazid for the treatment of tuberculosis. During this pregnancy the patient took MOTRIN, POLYTRIM drops for the treatment of conjunctivitis, ZOLOFT for the treatment of depression, SUDAFED for the treatment of cold and prenatal vitamins (unspecified). On 22-OCT-2008 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was considered to be a other important medical event. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Initial information was received on 22 October 2008 from a health care professional. A 34 year-old female with a puncture wound of her foot received a left deltoid intramuscular injection of DECAVAC (lot number U2067BA) on 20 October 2008. The patient's last dose was in 2003. Her physician prescribed amoxicillin on 20 October 2008 for the puncture wound. On 21 October 2008 the patient developed redness and warmth at the injection site with no swelling, left arm pain, inability to lift hand without pain, and numbness in the left fifth finger. The recovery status of the patient was not reported. Documents held by sender: None
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Initial information was received on 22 October 2008 from a health care professional.  A 4 month-old male patient received a second dose of DTaP.  Lot number, route, site and date of vaccination was not reported.  Following the vaccination, the patient had seizure activity. The patient's recovery status was not reported.  No further information was provided.  Documents held by sender: None.
Sex: M
Vaccine: DTP
Symptoms: Brain injury
Clinical narrative: Initial information received from another manufacturer (inquiry number 1-182158319). The other company received the information from a consumer (the patient's parent) on 26 October 2008.A male patient received "DTP" (manufacturer unknown), lot number not reported, and experienced "brain damage" an unspecified amount of time later. Recovery status was not reported. No other information was provided. Additional information is not expected. List of documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood culture negative, Cellulitis, Chills, Erythema, Incorrect route of drug administration
Clinical narrative: Initial non-serious case received from another manufacturer on 07 October 2008 who received the report from a health care provider. A 54-year-old male patient developed fever and chills one day after receiving an injection of DTaP (trade name, manufacturer, lot number, route/site of administration not reported). His one arm was red and swollen from injection site to elbow. It was indicated that the patient developed cellulitis. No additional information was provided. Follow-up information was received 27 October 2008 from a health care professional. Upon review of new follow-up information received, it was determined this case meets seriousness criteria and has been upgraded to serious. The patient had been a 62-year-old male (previously reported as 54-years-old) and he had received a subcutaneous (incorrect route) left arm injection of ADACEL, lot number C2966AA and a subcutaneous right arm injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 12 September 2008 (previously reported as 13 August 2008). According to the reporter, the patient had not experienced any reaction at the PNEUMOVAX right arm vaccination site. The onset date for the adverse event was reported as 13 September 2008 (previously reported as 14 August 2008). The patient was evaluated by his physician on 17 September 2008 and had been prescribed Keflex. On 19 September 2008, there had been no improvement and the patient's condition worsened by spreading into the axilla and frontal chest areas. The patient had been sent to the emergency room, where they left "(eloped)" without treatment "AMA" (against medical advice). The patient was contacted by staff the following day on 20 September 2008 at which time the patient stated "it was better". Lab results included WBC 12.0, and blood cultures which showed no growth in five days. Concomitant medications included Lasix and Zocor. It was reported the patient had no pre-existing medical conditions and he had not been ill at the time of vaccination. According to the reporter, the patient recovered from the event. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia, White blood cell count increased
Clinical narrative: Initial non-serious case received from another manufacturer on 07 October 2008 who received the report from a health care provider. A 54-year-old male patient developed fever and chills one day after receiving an injection of DTaP (trade name, manufacturer, lot number, route/site of administration not reported). His one arm was red and swollen from injection site to elbow. It was indicated that the patient developed cellulitis. No additional information was provided. Follow-up information was received 27 October 2008 from a health care professional. Upon review of new follow-up information received, it was determined this case meets seriousness criteria and has been upgraded to serious. The patient had been a 62-year-old male (previously reported as 54-years-old) and he had received a subcutaneous (incorrect route) left arm injection of ADACEL, lot number C2966AA and a subcutaneous right arm injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 12 September 2008 (previously reported as 13 August 2008). According to the reporter, the patient had not experienced any reaction at the PNEUMOVAX right arm vaccination site. The onset date for the adverse event was reported as 13 September 2008 (previously reported as 14 August 2008). The patient was evaluated by his physician on 17 September 2008 and had been prescribed Keflex. On 19 September 2008, there had been no improvement and the patient's condition worsened by spreading into the axilla and frontal chest areas. The patient had been sent to the emergency room, where they left "(eloped)" without treatment "AMA" (against medical advice). The patient was contacted by staff the following day on 20 September 2008 at which time the patient stated "it was better". Lab results included WBC 12.0, and blood cultures which showed no growth in five days. Concomitant medications included Lasix and Zocor. It was reported the patient had no pre-existing medical conditions and he had not been ill at the time of vaccination. According to the reporter, the patient recovered from the event. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Full blood count, Malaise, Neutrophil percentage, Oedema peripheral
Clinical narrative: Pain, swelling in arm; "5" on scale of 10. Had to make visit next day, hospitalized 3 days Fever 102.7, chills, rigors, malaise. Sepsis. Pt. had acute myelogenous leukemia.  12/1/08 MR received for DOS9/22-27/2008 with D/C Dx:  Sepsis in an immune compromised pt.  Cellulitis of the R arm/forearm.  Immunocompromised, due to Acute Myelogenous Leukemia.  Chronic bronchiectasis.  AML with complex cytogenetics.  Pancytopenia.  Hyponatremia.  Chronic obstructive airways disease.  GERD.  Diastolic dysfunction. Pt presented with fevers, chills, rigors and redness, swelling and pain to the R arm which began w/in 24 hrs of receiving Pneumovax.  Tchycardic and febrile on admission with redness, swelling and warmth on the R arm. Tx with IV abx with improvement noted. Dx with possible pneumonia following CXR with LLL infiltrate. Will continue to receive IV abx as outpt.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Sepsis, White blood cell count decreased
Clinical narrative: Pain, swelling in arm; "5" on scale of 10. Had to make visit next day, hospitalized 3 days Fever 102.7, chills, rigors, malaise. Sepsis. Pt. had acute myelogenous leukemia.  12/1/08 MR received for DOS9/22-27/2008 with D/C Dx:  Sepsis in an immune compromised pt.  Cellulitis of the R arm/forearm.  Immunocompromised, due to Acute Myelogenous Leukemia.  Chronic bronchiectasis.  AML with complex cytogenetics.  Pancytopenia.  Hyponatremia.  Chronic obstructive airways disease.  GERD.  Diastolic dysfunction. Pt presented with fevers, chills, rigors and redness, swelling and pain to the R arm which began w/in 24 hrs of receiving Pneumovax.  Tchycardic and febrile on admission with redness, swelling and warmth on the R arm. Tx with IV abx with improvement noted. Dx with possible pneumonia following CXR with LLL infiltrate. Will continue to receive IV abx as outpt.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Ct was given a TDAP by accident. Ct is pregnant. Ct is HIV positive.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Fainted after GARDASIL #1 within 5 min of admin - then moved from chair to bed without problems. Recovered within 20 min - no further problems reported.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Presyncope
Clinical narrative: Nearly fainted after GARDASIL #1 (After watching sister faint). Recovered within 10 min of laying down - Did not lose consciousness.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Fatigue and sore injection site evening of Day #1 also sweats at night, Days #2-4 continued fatigue, mild malaise. Days 4-6 worsening URI and mild flu-like symptoms the worst being coughing especially at night Day #7, symptoms appear to be improving. No fever, no aches, self-started Rx with Azithromycin pack on Day #5 as well as cough suppressants and expectorant (OTC DELSYM, NYQUIL).
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Night sweats, Upper respiratory tract infection
Clinical narrative: Fatigue and sore injection site evening of Day #1 also sweats at night, Days #2-4 continued fatigue, mild malaise. Days 4-6 worsening URI and mild flu-like symptoms the worst being coughing especially at night Day #7, symptoms appear to be improving. No fever, no aches, self-started Rx with Azithromycin pack on Day #5 as well as cough suppressants and expectorant (OTC DELSYM, NYQUIL).
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: 10/12/08 - Symptoms of fatigue, tired, chills, fever (101.4), lasted approx. 6-8 hours.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Lasting 6+ days! Horrible flu-like symptoms: High fever, chills, sweating, headache, fatigue, aching body, nausea, very painful sore throat, runny nose, cough that inhibited sleep. NYQUIL, MOTRIN, and DELSYM cough - Nothing helped - greatly.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Insomnia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Lasting 6+ days! Horrible flu-like symptoms: High fever, chills, sweating, headache, fatigue, aching body, nausea, very painful sore throat, runny nose, cough that inhibited sleep. NYQUIL, MOTRIN, and DELSYM cough - Nothing helped - greatly.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Lasting 6+ days! Horrible flu-like symptoms: High fever, chills, sweating, headache, fatigue, aching body, nausea, very painful sore throat, runny nose, cough that inhibited sleep. NYQUIL, MOTRIN, and DELSYM cough - Nothing helped - greatly.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache
Clinical narrative: Severe chills, headache, fatigue, cough. MOTRIN, TYLENOL, ROBITUSSIN.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injected limb mobility decreased, Myalgia, Pyrexia
Clinical narrative: Client stated she had fever, chills, and muscle aches for 3 days after shot. Continues to have limited mobility to (L) arm 11 days after shot.
Age: 7.5
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 10/23/08 pt saw school nurse for redness, soreness and warmth noted at vaccination site - Parent called Ped clinic 10/24/08 b/c site redness spreading Dr. saw site. RXN to flu shot given 10/22/08 ( BENADRYL ).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm started 10/7/08. When reaching for anything or moving left arm she feels pain. Taking ADVIL for pain but not helping. Using ice also not helping.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Injection site, red, swollen, warmth (fever) at site, itching
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Unconsolable cry approximately 3-4 hours after immunization lasting approximately 1 hour.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood test, Chest X-ray, Pyrexia, Urine analysis
Clinical narrative: One Friday Pt had low-grade temperature after imms and was given Infant Tylenol. Pt stayed Friday with Aunt and was picked up by father on Sat evening. Pt had low grade temperature until approx 11:00 Sat night with 103.3 gave more Tylenol at 11:30. Temp increased to 104.4 and was taken to ER at hospital. Blood and urine tested, chest x-ray. Was told by ER doctor to give Tylenol and Motrin and see FMD on Tuesday.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Hypoaesthesia, Injection site reaction
Clinical narrative: Child was given vaccine, two hours later complained of chills, child complained of numbness to both feet and hands, child dizzy and lightheaded, took next day to Ped Ped felt reaction to vaccine child also with 4 bouts of diarrhea. Numbness to leg/feet 2 days then gone.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Cough, Dyspnoea, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: Temp 101.2, vomitings, difficulty breathings, lung congestion, cough, sore throat. Thur - flu shot. Fri - pneumonia vac - Sat temp 101.2.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Temp 101.2, vomitings, difficulty breathings, lung congestion, cough, sore throat. Thur - flu shot. Fri - pneumonia vac - Sat temp 101.2.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Diarrhoea, Pyrexia, Urticaria
Clinical narrative: Pt is a 12 month old who developed hives 5 days after vaccine, then 5 days of diarrhea & fever. Exam was normal.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: R arm swollen and tender. Increase pain with movement. TX RLT: Ret Aralgran, Antihistamine
Age: 65.8
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Stomach discomfort
Clinical narrative: Within two hours, upset stomach, extended diarrhea that last for two days.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Fever of 102 degrees F with shaking chills and sweats started approx 12 hours after receiving flu shot; sore throat, cough, and headache started approx 24 hrs after flu shot - symptoms began to improve after 3 hours.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever of 102 degrees F with shaking chills and sweats started approx 12 hours after receiving flu shot; sore throat, cough, and headache started approx 24 hrs after flu shot - symptoms began to improve after 3 hours.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Pain, Skin warm, Urticaria
Clinical narrative: Pain, increased warmth, hives (L) shoulder 24 hours after injection in (L) upper arm. Suspect localized allergic Rx but covered with KEFLEX for possible injection and OTC BENADRYL.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oedema peripheral
Clinical narrative: Swelling L U leg - most of thigh from knee to inguinal area.
Age: 25.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Approx 12 hrs after vaccine. Pt had short episode of "palpitations". Heart rate to 150 at rest. Had URI at same time. Wasn't taking medications (except OCP's)
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pharyngeal oedema, Swollen tongue, Testicular pain, Testicular swelling
Clinical narrative: Patient was awakened by swelling of tongue and throat, swelling and pain in testicular area.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed redness, swelling, pain at injection site of 3rd anthrax shot approx one day post vaccination. Symptoms: Edema at injection site 50-120mm, erythema, swelling, pain.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Nuclear magnetic resonance imaging, Pyrexia, Speech rehabilitation
Clinical narrative: Fever, seizure. Administered: 10-28-08 1539. Symptoms: 10-29-08 after school. 11/12/2008 MR received for DOS 10/29-30/08 with DX:  Pneumonia, Fever, Possible seizure vs syncope. Pt presented after an episode of limpness and unresponsiveness where pt's eyes rolled up x several minutes. Vomited after. Post-ictal in ambulance. Temp 102'F in ER. Neuro consult Impression: Possible seizure vs vasosvagal event.  No signs of increased ICP. Tx with abx. Will get EEG as outpt.
Age: 0.54
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Chest X-ray normal, Convulsion, Cyanosis, Gaze palsy
Clinical narrative: Pt was being fed lunch, seemed fussy. Approx 30 minutes later developed twitching of one leg then the other. Pt brought to office after dad noted full body twitching and deviating eyes. The patient is a 6 month old male who was present with a complaint of seizures notes: patient brought into office by father at 1:13pm. While feeding him carrots at lunch patient did not seem to like them. He cried a little. Dad stopped feeding him and gave him a bottle instead. Approximately 1/2 hours later he started twitching. First it was one leg, then the other and then it was his arms. He called our office and a sick visit was made. Patient then progressed to his entire body twitching and eyes devlating. Dad put patient in the car and drove him to our office. Denies cyanosis or apnea. No hx trauma or choking. No fever. No URI sx. He received DTap, IPV, Prevnar, Flu, Hib and Rotavirus vaccines yesterday. Pt was in status upon arrival to our office. He was having a generalized tonicclonic seizure with eye deviation to the right. No cyanosis. Oxygen was applied immediately and 911 was called. Temp 100.9 Temporal, Pox 92%-99%, HR 140-160, RR 32-40. Accucheck 86. Pt given rectal Valium by EMS at 1:26pm. Pt developed perioral cyanosis, no apnea. PPV applied for approx 3 minutes and then free flow oxygen was used. IV attempted x 1. There was no change in seizure status. Pt place on stretcher and transported to the ER. Rectal Valium was given again prior to leaving the office (?time of administration). ER and Hospitalist were notified.  02/23/2009 MR received for 1/23-24/2009 with DX: Status epilepticus vs complicated febrile seizure. Pt initially presented to PCP in status epilepticus where EMS was called and transported. Temp 100.9 in office. Rectal Diastat x 2.  Seizing ~1hr with lip cyanosis. Seizure resolved on arrival. Temp 101.4. Pt in sinus tach.  PE (+) for being initially unresponsive to touch, later sleepy with decreased tone.
Age: 0.54
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, RV5
Symptoms: Grand mal convulsion, Irritability, Muscle twitching, Respiratory rate increased, Status epilepticus
Clinical narrative: Pt was being fed lunch, seemed fussy. Approx 30 minutes later developed twitching of one leg then the other. Pt brought to office after dad noted full body twitching and deviating eyes. The patient is a 6 month old male who was present with a complaint of seizures notes: patient brought into office by father at 1:13pm. While feeding him carrots at lunch patient did not seem to like them. He cried a little. Dad stopped feeding him and gave him a bottle instead. Approximately 1/2 hours later he started twitching. First it was one leg, then the other and then it was his arms. He called our office and a sick visit was made. Patient then progressed to his entire body twitching and eyes devlating. Dad put patient in the car and drove him to our office. Denies cyanosis or apnea. No hx trauma or choking. No fever. No URI sx. He received DTap, IPV, Prevnar, Flu, Hib and Rotavirus vaccines yesterday. Pt was in status upon arrival to our office. He was having a generalized tonicclonic seizure with eye deviation to the right. No cyanosis. Oxygen was applied immediately and 911 was called. Temp 100.9 Temporal, Pox 92%-99%, HR 140-160, RR 32-40. Accucheck 86. Pt given rectal Valium by EMS at 1:26pm. Pt developed perioral cyanosis, no apnea. PPV applied for approx 3 minutes and then free flow oxygen was used. IV attempted x 1. There was no change in seizure status. Pt place on stretcher and transported to the ER. Rectal Valium was given again prior to leaving the office (?time of administration). ER and Hospitalist were notified.  02/23/2009 MR received for 1/23-24/2009 with DX: Status epilepticus vs complicated febrile seizure. Pt initially presented to PCP in status epilepticus where EMS was called and transported. Temp 100.9 in office. Rectal Diastat x 2.  Seizing ~1hr with lip cyanosis. Seizure resolved on arrival. Temp 101.4. Pt in sinus tach.  PE (+) for being initially unresponsive to touch, later sleepy with decreased tone.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female with mild asthma, cervical dysplasia and migraine and no history of pervious pregnancies who on 10-SEP-2007 was vaccinated with the first dose of GARDASIL (lot# 657868/05230). On 07-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) daily for routine health maintenance. Subsequently, she became pregnant on approximately 20-NOV-2008 (LMP: 06-NOV-2007, estimated delivery date: 12-AUG-2008). On 05-FEB-2008, as routine screening a serum alpha-fetoprotein test (MSAFP) was performed at first trimester and the results showed low risk pregnancy. On 06-MAR-2008, as routine screening a modified serum MSAFP was performed and the result was negative. On 10-Mar-2008, was performed to the patient an ultrasound as routine screening which showed normal anatomy. On 29-JUL-2008, the patient delivered a normal, healthy female baby at 38 weeks from LMP. The baby had a face presentation at time of delivery (mal presentation). The baby's weight was 2977 grams, with a length of 18 inches, apgar score was 9/9 and a head circumference of 34. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 23 year old daughter who on an unknown dates was vaccinated with the three doses of GARDASIL was given in April 2007. There was no concomitant medications. On approximately 23-Sep-2008, the patient had a Papanicolaou test positive. As of 29-Sep-2008, the patient had not recovered. Further testing must be done pertaining to positive PAP test. The patient sought unspecified medical attention. No additional information is expected.
Age: 0.2
Sex: F
Vaccine: HIBV, PPV
Symptoms: Cough, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received via medical records from a physician concerning a 9 week old American Indian Native female baby with diarrhea at the time of vaccination, with abdominal hernia, candidiasis, constipation, dry skin, eczema, jaundice neonatal, nasal congestion and decreased weight (MSD WAES # 0707USA01947). On 12-MAY-2008, the baby was vaccinated with HIB conj vaccine (OMPC) and pneumococcal vaccine (manufacturer unknown). On 27-JUN-2008 the patient developed diarrhea for 2 days. On 29-JUN-2008, the patient had a fever. The baby had vomiting 3 days ago now resolved but still has diarrhea and a slight cough. The baby was treated with acetaminophen and PEDIALYTE. The baby had a well child visit on 28-JUL-2008. The mother stated that the baby is doing well but gets irritated due to teething. Otherwise mother expressed no acute health concerns at this time. The baby was treated with acetaminophen and ENFALYTE. On 28-JUL-2008 the baby was vaccinated with diphtheria-tetanus-pertussis, pneumococcal vaccine (manufacturer unknown), HIB conj vaccine (OMPC) and vaccine for poliomyelitis. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Pt. had long period of unconsolable crying. No fever.
Age: 0.75
Sex: F
Vaccine: FLU3, HEP
Symptoms: Culture throat negative, Irritability, Rash generalised, Sleep disorder, Streptococcal identification test
Clinical narrative: 10/28/08 Mother states rash all over body, whiny and not sleeping x 1 week. 10/28/2008 rapid strep culture neg. 10/30/2008 throat culture obtained 10/28/2008 reported moderate normal flora.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: 15 minutes following the injection, client complained of tingiling lips and feeling "fainty". Client placed in recumbent position. B/P 108/70. Benadryl 25 mgm per os given. 20 minutes following Benadryl administration, client confirmed decrease in feeling "fainty" and decreased tingiling of lips.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Roughly 8 hours later after recieveing the flu vac. Patient stated that he was ill.  Nausea, vomiting, shaking, fever.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Disorientation, Dizziness, Fatigue
Clinical narrative: Approximately 2 hours after receiving vaccine, I experienced an episode of dizziness, to the point that I needed to sit down to avoid falling.  After sitting for about 15-20 minutes I was able to get up and walk back to my office.  For the next few hours though, I continued to feel a little disoriented or "loopy" for the lack of a better word. Went home about 4 hours later and seemed to be fine, just a little more tired than usual.  Doing just fine now.  PS. I am employed at a hospital and received the vaccine as part of being a healthcare worker.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: area of 3x6 cm erythema and induration at site present tow days after injection.  Afebril to apply local compress and take NSAIDs.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: THE ARM THE CHILD RECEIVED FLU SHOT IN WAS SWOLLEN THE SIZE OF A GRAPEFRUIT,WARM AND ITCHED.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain, Rash erythematous
Clinical narrative: Patient received Pneumovax vaccine on Friday, Oct 17, 2008 at approximately 4:00 pm in her right arm. The pt insisted on receiving the vaccine.  On Sat, Oct 18, the patient presented to the emergency room with symptoms of generalized body aches and a 9x9 erythematous area in the right deltoid muscle area.  The redness stretched from the pt's shoulder to her elbow.  The cellulitis-type rash was "swollen, red-hot, and tender to the touch."  The pt was started on cephalexin and Bactrim for treatment of cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Patient received Pneumovax vaccine on Friday, Oct 17, 2008 at approximately 4:00 pm in her right arm. The pt insisted on receiving the vaccine.  On Sat, Oct 18, the patient presented to the emergency room with symptoms of generalized body aches and a 9x9 erythematous area in the right deltoid muscle area.  The redness stretched from the pt's shoulder to her elbow.  The cellulitis-type rash was "swollen, red-hot, and tender to the touch."  The pt was started on cephalexin and Bactrim for treatment of cellulitis.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Hyperalgesia/Paresthesia to the to the arms and legs developed 4 months after the vaccine.  No motor changes.  Area of the vaccination became sore 4 months later as well (in October).  Symptoms are now resolving on their own.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: I RECEIVED THE VACCINATION AT 3:00PM. AT 8:00PM I BEGIN TO FEEL FUNNY. AT 9:00PM I STARTED TO GET SEVERE CHILLS AND A VERY SEVERE HEADACHE. IT PROGRESSIVELY GOT WORSE SO I WENT TO BED COVERING WITH MANY COVERS, FINALLY WAS ABLE TO STOP SHAKING AROUND 1:00AM.  FROM 1:00AM TO 5:00AM I EXPERIENCED, RAPID HEARTBEAT, SHALLOW BREATHING AND JUST ABOUT THE WORST "PRESSURE" HEADACHE I HAVE EVER EXPERIENCED. I WAS FINALLY ABLE TO "FALL" ASLEEP AT THAT TIME AND AWOKE AT 9:00AM FEELING MUCH BETTER. SPENT THE DAY IN BED AS I FELT EXHAUSTED! THE NEXT DAY I FELT PRETTY GOOD.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoventilation, Tremor
Clinical narrative: I RECEIVED THE VACCINATION AT 3:00PM. AT 8:00PM I BEGIN TO FEEL FUNNY. AT 9:00PM I STARTED TO GET SEVERE CHILLS AND A VERY SEVERE HEADACHE. IT PROGRESSIVELY GOT WORSE SO I WENT TO BED COVERING WITH MANY COVERS, FINALLY WAS ABLE TO STOP SHAKING AROUND 1:00AM.  FROM 1:00AM TO 5:00AM I EXPERIENCED, RAPID HEARTBEAT, SHALLOW BREATHING AND JUST ABOUT THE WORST "PRESSURE" HEADACHE I HAVE EVER EXPERIENCED. I WAS FINALLY ABLE TO "FALL" ASLEEP AT THAT TIME AND AWOKE AT 9:00AM FEELING MUCH BETTER. SPENT THE DAY IN BED AS I FELT EXHAUSTED! THE NEXT DAY I FELT PRETTY GOOD.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Approx 30 minutes after receiveing the vaccine, the patient developed intense itching, hives and sensation of throat swelling. Received Benadryl IM initially, required a repeat dose which was given Intravenously. No subsequent episodes of symptoms after that time.  Follow-up: Pt hospitalized at time of vaccination but reaction so severe that would have required hospitalization any way.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Rash erythematous, Urticaria
Clinical narrative: erythematous edematous hive type rash on left arm
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations, Tachycardia
Clinical narrative: Tachycardia, pounding of heart
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oral pain, Swollen tongue, Urticaria
Clinical narrative: 2 DAYS POST SHOT PATIENT DEVELOPED TONGUE SWELLING, SWOLLEN LYMPH NODES AND WELTS ON THE BACK OF TONGUE THAT CAUSED PAIN IN THE MOUTH
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Flushing
Clinical narrative: Patient reported that approximately one hour after receiving the Flu Mist that her face became very red and flushed. She had no itching, no facial edema, no SOB, no other s/s at all.  She reports that this lasted approximately one hour and then disappeared.  She also reports that she is taking Accutane and wonders if there is some reaction with this medication and Flu Mist.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Burning sensation, Pyrexia
Clinical narrative: For 3 days I had a fever and my bones felt like they were on fire and hurt                         Moltrin
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypertension, Injection site erythema, Injection site swelling
Clinical narrative: Client noted reddness & swelling (about 4"x5")at injection site mid-morning 10/26/08. No tenderness at site. Went to ER On 10/26/08 at 2pm. BP 198/71; Dx:Cellulitis & HTN. Client saw her primary care physician, on 10/27/08. Redness/swelling still remained.  Given Medrol dose pack. Client states redness/swelling gone by 10/29/08.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Informed by client's mother that the injection site has erythema, edema, and is "hard and hot."  There is no rash present.  Client has been afebrile.  Per client's mom, client was seen at an immediate care clinic and told that the site was infected and was prescribed antibiotics.  On 10/29/08 the physician marked the location and told the client that if the redness spread at all to return immediately.  As of 10/30/08, there have been changes to the site.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Patient received flu (lt) and pneumonia (rt) vaccinations 10/23/08 at VA, and within 24 hrs had swelling of right arm and pain at injection site.  VS wnl.  Moderate edema and redness rt f/a; no pain or tenderness c/o.  MD recommended patient use diphenhydramine as needed.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Patient received flu (lt) and pneumonia (rt) vaccinations 10/23/08 at VA, and within 24 hrs had swelling of right arm and pain at injection site.  VS wnl.  Moderate edema and redness rt f/a; no pain or tenderness c/o.  MD recommended patient use diphenhydramine as needed.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Nausea
Clinical narrative: Soreness to right deltoid, injection site of pneumovax vaccination. Mild nausea starting 6pm of 10/28/08. Chills starting 4pm 10/29/08. 8:45am 10/30/08 only injection site soreness remains.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Lip oedema, Rash macular, Rash pruritic
Clinical narrative: Patient presented 2 days after vaccine was given with new onset of symptoms that began yesterday.  They included swelling and puritis around both eyes, slight edema of lower lip, and a flat puretic rash on her neck.  She denies any c/o sob.  She was instructed to begin Claritin now and then tonight at bedtime to take 25mg of bendryl.  She was instruced to go directly to the ER if any difficulty in breathing occurs.  She did not identify any risk factors prior to the vaccine and she has had the flu vaccine in the past and did not have any problems.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Pt received the flu shot and pneumococcal vaccine in the left deltoid and had a cellulitis within 24 hours.  Alcohol was used to prep the skin.  Bandaids were applied.  Pt's PMH pertinent for long time smoker, copd
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: Acute onset fever, tremors, leukocytosis, vomiting,  marked swelling at injection site 3 hours post injection 11/4/08-records received for DOS 10/29-10/30/08-DC DX: Allergic reaction to pneumovax vaccine. Leukocytosis. Presented to ED with rigors, fever, swelling of arm and shoulder. Feeling cold. Requested that he be discharged.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Tremor, Vomiting, White blood cell count increased
Clinical narrative: Acute onset fever, tremors, leukocytosis, vomiting,  marked swelling at injection site 3 hours post injection 11/4/08-records received for DOS 10/29-10/30/08-DC DX: Allergic reaction to pneumovax vaccine. Leukocytosis. Presented to ED with rigors, fever, swelling of arm and shoulder. Feeling cold. Requested that he be discharged.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Inflammation, Vaccination complication
Clinical narrative: CHEST PAINS STARTED WITHIN 18 HOURS ER ADMISSION 24 HOURS AFTER ADMINISTRTION DX WITH INFLAMMATORY REACTION TO FLU SHOT
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2 hours after receiving vaccine client c/o itching, swelling, redness around site.  Had extreme sweeling from shoulder to elbow.  Saw PCP who ordered "antibiotic" and ice to area.  48 hours after vaccine still had some redness and swelling but much improved.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash macular
Clinical narrative: Upon administration of HPV(Gardasil) #3, pt developed lacey, red, flat rash on upper arm at site and extending across upper neck and involving opposite upper arm. Occurred within seconds of injection. Benedryl 25 mg given po. Redness/rash improved after approx. 20 minutes with no further complaints.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: c/o redness and induration at site of immunization - developed about 12 hrs after vaccine  Arm red, about 3 " X 3" induration and redness over deltoid area LASTED 48 HRS