chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a pediatric patient with no allergies who on 05-Jun-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It was reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experienced to be important medical events. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a pediatric patient with no allergies who on 05-Jun-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It was reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experienced to be important medical events. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a pediatric patient with no allergies, who on 06-Jun-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experience to be important medical events. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a pediatric patient with no allergies, who on 06-Jun-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experience to be important medical events. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction, Medication error, Poor quality drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who on 11-Apr-2007 was vaccinated SC in the right arm with a 0.5 mL dose of Varivax (lot # 656281/1504F). It was noted that the vaccine was exposed to 36 degrees Fahrenheit for four hours. On 13-APR-2007, the patient was diagnosed with cellulitis and was being treated with an unspecified antibiotic. A product quality complaint was not involved. Cellulitis was considered to be an other important medical event by the reporter. Additional information has been received from the registered nurse who reported that the cellulitis was ruled out and the reaction was diagnosed as an "intense local reaction." Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 73 year old female with rheumatoid arthritis and no allergies who on 20-MAR-2007 was vaccinated with a dose of Zostavax. concomitant therapy included prednisone and methotrexate. On 20-MAR-2007 the patient developed a red spot at the injection site (left posterior arm) immediately after vaccination. It was reported that over a short period of time the spot became larger and hard. The patient was prescribed unknown antibiotics by mouth which resulted in no improvement. The spot became "a little" itchy and pressure on the spot resulted in stinging. The spot became an 8mm erythematous, firm papule on patient's left upper posterior arm. On 22-MAY-2007, a biopsy was performed that resulted in diagnosis of necrotizing vasculitis and dermal necrosis. The patient recovered on 04-JUN-2007. A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site pruritus, Pruritus, Skin necrosis, Vasculitis necrotising
Clinical narrative: Information has been received from a physician concerning a 73 year old female with rheumatoid arthritis and no allergies who on 20-MAR-2007 was vaccinated with a dose of Zostavax. concomitant therapy included prednisone and methotrexate. On 20-MAR-2007 the patient developed a red spot at the injection site (left posterior arm) immediately after vaccination. It was reported that over a short period of time the spot became larger and hard. The patient was prescribed unknown antibiotics by mouth which resulted in no improvement. The spot became "a little" itchy and pressure on the spot resulted in stinging. The spot became an 8mm erythematous, firm papule on patient's left upper posterior arm. On 22-MAY-2007, a biopsy was performed that resulted in diagnosis of necrotizing vasculitis and dermal necrosis. The patient recovered on 04-JUN-2007. A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Nausea, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with no allergies who on 05-JUN-2007 was vaccinated SC on right arm with a dose of Zostavax (Oka/Merck) (Lot # 652947/1411F). On 07-JUN-2007 the patient experienced severe pain under the right rib and nausea and was seen by her physician. The physician felt that the patient may be experiencing a "gallbladder attack" and the patient was sent to the hospital. The patient was admitted to the hospital and stayed overnight. A number of unspecified tests were conducted and a gallbladder attack was ruled out. The patient's symptoms resolved and the patient was discharged on 08-JUN-2007. The origin of the pain was unknown. At the time of report the patient had recovered. Unspecified medical attention was sought.  A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Blood pressure increased, Chest discomfort, Cough, Dyspnoea, Hypersensitivity
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Lymphocyte count normal, Neutrophil count normal, Oxygen saturation, Respiratory rate, Tremor
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Wheezing, Wrong drug administered
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Blood pressure, Chest discomfort, Cough, Dyspnoea, Full blood count
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Heart rate increased, Hypersensitivity, Inappropriate schedule of drug administration, Lymphocyte count normal, Neutrophil count normal
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Oxygen saturation, Respiratory rate, Tremor, Wheezing
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure, Erythema, Oxygen saturation, Throat tightness, Urticaria
Clinical narrative: Developed wheezing: "tight throat" - "closing up," hives and redness to face and chest approximately 30 minutes post vaccine administration while in car, mom gave Tylenol and Albuterol inhaler, and returned to clinic. Here in clinic: Room air O2 sat 100%, B/P q 5" WNL, (1515 gave Benadryl 50mg PO: 1525 Epi 1:1000 0.3cc x 1; 1540 Epi repeated; some improvement with redness to upper torso noted so (1555 Epi repeated. Released (1700 to home). 6/21/07-records submitted with VAERS form: 6/14/07-12 year old with moderate persistant asthma who does not usally take control medication was treated for an acute exacerbation about 3 months ago and more recently had a second course of steroid for acute wheezing episode. Seen in clinic for complaint of cough/congestion with fever times 5 days. Allergy to soy protein producte, allergy to milk. Impression:asthma moderate persistent with couple of recent exacerbations of symptoms, currently under treated.  6/21/07-received additional med rec. At 1530 developed itching and wheezing after vaccines administered at 1400. treated with epi 1:1000 and benadryl. recovered in clinic.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Wheezing
Clinical narrative: Developed wheezing: "tight throat" - "closing up," hives and redness to face and chest approximately 30 minutes post vaccine administration while in car, mom gave Tylenol and Albuterol inhaler, and returned to clinic. Here in clinic: Room air O2 sat 100%, B/P q 5" WNL, (1515 gave Benadryl 50mg PO: 1525 Epi 1:1000 0.3cc x 1; 1540 Epi repeated; some improvement with redness to upper torso noted so (1555 Epi repeated. Released (1700 to home). 6/21/07-records submitted with VAERS form: 6/14/07-12 year old with moderate persistant asthma who does not usally take control medication was treated for an acute exacerbation about 3 months ago and more recently had a second course of steroid for acute wheezing episode. Seen in clinic for complaint of cough/congestion with fever times 5 days. Allergy to soy protein producte, allergy to milk. Impression:asthma moderate persistent with couple of recent exacerbations of symptoms, currently under treated.  6/21/07-received additional med rec. At 1530 developed itching and wheezing after vaccines administered at 1400. treated with epi 1:1000 and benadryl. recovered in clinic.
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Asthenia, Blood pressure increased, Chills, Diarrhoea
Clinical narrative: First and second Hep B vaccines during 2003. No reactions after first two vaccines. Third Hep B vaccine was given on 6/14/07. Employee reacted within one hour after vaccine was given and had the following: Elevated BP. Up to 196/70 - Normal is 120/70- 136/80-. 2 Hrs. Later - BP 178/90. C/O nausea, lightheadedness, dizziness, loose stools, weakness, listlessness, and chills. Recommend that she should ho home and/or seek medical attention. Employee refused stating, "I have no medical insurance." Employee came into work the next day at 3:00 p.m. and c/o still experiencing the same s/s of the day before. Spoke to director of nursing and was told that if she didn't feel well enough to work, she should go home or to a medical facility for evaluation. Again, employee refused due to " no medical insurance." At this time, employee BP 148/92. On Friday, June 15, 2007, employee decided to leave work early on her own  and seek medical attention for above s/s. According to her, the attending physician told her she had an adverse reaction to the Hep B vaccine. IV fluids and antibiotics were given. She was not admitted to the hospital. Telephone call on June 18, 2007, to Staff Development Nurse, employee reported that she was now feeling fine.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Listless, Nausea, No reaction on previous exposure to drug, Vaccination complication
Clinical narrative: First and second Hep B vaccines during 2003. No reactions after first two vaccines. Third Hep B vaccine was given on 6/14/07. Employee reacted within one hour after vaccine was given and had the following: Elevated BP. Up to 196/70 - Normal is 120/70- 136/80-. 2 Hrs. Later - BP 178/90. C/O nausea, lightheadedness, dizziness, loose stools, weakness, listlessness, and chills. Recommend that she should ho home and/or seek medical attention. Employee refused stating, "I have no medical insurance." Employee came into work the next day at 3:00 p.m. and c/o still experiencing the same s/s of the day before. Spoke to director of nursing and was told that if she didn't feel well enough to work, she should go home or to a medical facility for evaluation. Again, employee refused due to " no medical insurance." At this time, employee BP 148/92. On Friday, June 15, 2007, employee decided to leave work early on her own  and seek medical attention for above s/s. According to her, the attending physician told her she had an adverse reaction to the Hep B vaccine. IV fluids and antibiotics were given. She was not admitted to the hospital. Telephone call on June 18, 2007, to Staff Development Nurse, employee reported that she was now feeling fine.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: About 5 mins after vaccines were administered pt felt dizzy and stated that his leg "felt numb". He was clammy and nauseated. No LOC BP was 105/62 after 15 mins was feeling better.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Fever, edema erythema tenderness at injection site, RX Ibuprofen 800mg, Medrol Dose Pak
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain upper, Hypoaesthesia, Muscular weakness, Nausea, Pain
Clinical narrative: Aches, stomach cramps and nausea. Occasional numb feeling in left hand. Parasthesias and weakness in extremity. Transient, recovered in 3 days.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Paraesthesia
Clinical narrative: Aches, stomach cramps and nausea. Occasional numb feeling in left hand. Parasthesias and weakness in extremity. Transient, recovered in 3 days.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site warmth
Clinical narrative: 4" erythema - Oval shape - warm to touch R arm - Tricep area
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: Presents with angioedema, urticaria and pruritis four hours after vaccination in R arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Well demarcated firm redness on thigh 10 x 9cm (left thigh)
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, White blood cell count increased
Clinical narrative: L upper arm swollen, red x 6x6 1/2 cm, very tender, WBC 12.8, T 98.8F,  placed on Keflex
Age: 7.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Fever and cellulitis of left thigh, beginning 1 day after Pneumovax.  7/6/07 Received hospital medical records which reveal patient experienced redness & warmth over anterior surface of left thigh w/fever 104.8 & diffuse abdominal pain.  Seen in ER & released 5/31 to PCP office who then direct admitted patient 5/31-6/2/07 for IV antibiotics.  Improved slowly.  Abdominal pain attributed to mesenteric adenitis.  D/C to home when afebrile x 24 hrs, cellulitis improved & able to ambulate.  Continued on oral antibiotics & was to have outpatient w/o for possible immuno deficiency. FINAL DX: cellulitis left thigh; recurrent & chronic sinusitis & otitis media; possible immunocomprise.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Nausea, Syncope vasovagal, Vomiting
Clinical narrative: Pt was given injection and immediately had a vagal reaction. Followed by nausea with vomiting 15 minutes post injection.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Reaction to previous exposure to any vaccine, Similar reaction on previous exposure to drug, Syncope vasovagal
Clinical narrative: Pt was given injection and immediately had a vagal reaction. Followed by nausea with vomiting 15 minutes post injection.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient felt nauseated after HPV, Menactra and Varivax were administered. Patient then passed out of approx 5-10 seconds. HPV isn't listed below in #13. Lot# 0523U, administered IM in right deltoid
Age: 27.0
Sex: F
Vaccine: ANTH, FLUX, HEPA
Symptoms: Pruritus, Rash generalised
Clinical narrative: 27 y/o female develops a skin rash 2 days after the receipt of multiple vaccinations (AVA #1, Hep B, and Influenza IM). Pt is about to be deployed. SRC physician wants to known whether or not the SM should be exempted from further anthrax series. Symptom: Rash, diffuse Start: 02/17/2007 End: 03/19/2007 Comment: Rash started on the forearms but than rapidly spread to the torso, back, neck, and legs. Symptoms: Pruritis Start: 02/17/2007 End 03/19/2007 Comment: skin rash was initially pruritic. Pruritis slowly resolved with TAC creme than prednisone rx.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness
Clinical narrative: Woke up day after immunization with chills and dizziness. Went to doctor who told him, these were not unexpected symptoms after receiving vaccine, and he should be fine.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: 5 minutes after vaccination with Dtap/Varivax developed redness swelling and hives on R upper arm where had received Dtap. Bp0102/68 given epinephrine 1:1000 0.15 ml SQ and Benadryl 18.75 mg PO. Observed x 1 hr, hives redness resolved. BP nl HR 100 playing in waiting room. Sent home on steroids x 48 hrs, Benadryl x 24 Hrs. Disc signs of allergic rx.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient developed fever evening after vaccines were administered (6/14/07). By 6/15/07 fever was nearly 104 deg F. Patient taken to local emergency room.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pt developed rash, especially on upper body, less on legs.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion, Electroencephalogram normal, Postictal state
Clinical narrative: Focal seizure lasting about 15-30 sec with post-ictal period lasting about one minute. Occurred 6 days after Varivax given.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Diet refusal, Pyrexia
Clinical narrative: 3 mo, 1-2 days after Hib vaccine, Fever. P PO intake dropped from 5-6 oz Q8 to 1-2oz Q2-4 hours with turning face away when offered bottle. Pt still requires significant coaxing to eat 3 months later. Pt taken still only 2-4 ox Q 3-4 and some days only 1oz Q3hrs, Now on Axid Prevacid, but with GERD sx prior to vaccine.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Bowel movement irregularity, Diarrhoea
Clinical narrative: 1-2 days s/p vaccines administered, loose stools 6/8 x day and have persisted through present. Used to have BM Q6 x BID.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold compress therapy, Injection site discolouration, Injection site erythema, Local reaction, Pruritus
Clinical narrative: Pt called this am stating she had localized reaction to Zostavax administration.  Pt states that her left arm is red and has a brown spot in the center of it, as of this am.  Pt denies any heat, swelling, or pain to arm at this time.  Pt received vaccine on 06/11/2007, arm has been red since administration.  Pt states she has taken Benadryl for itching and redness, without relief.  Instructed pt to try cool compress for 15 minute intervals.  Pt to come by Health Department for me to visualize arm.  Pt going out of town for 2 months, leaving tomorrow.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Neck pain, Pyrexia, Urticaria
Clinical narrative: 6/13 P.M. Fever 99-101 began. 6/14 Headache/Neck pain began. 6/19 Hives on legs moving up back to arms and abdomen. Seen by Dr. (PCP). Rx Benadryl and Tylenol. Taking oatmeal baths. 6/20 Whelps are worse. Mother called Health Clinic. Mother advised to notify client's PCP if symptoms become worse.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Varicella
Clinical narrative: Patients father states "child had one bumplike area on mid right cheek on the evening of 6/19/07 did not complain about anything, woke up this morning with several red itchy bumplike areas on forehead and cheeks, only on face nowhere else." Patient and her father came to clinic on 6/20/07 to be seen. Dr. examined patient and determined that patient had mild case of chicken pox, and talked with patient and her father medication was ordered for the patient.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Cold compress therapy, Injection site swelling
Clinical narrative: Grandmother brought child to clinic 6/19/07.  Child has a red swollen left arm.  Grandmother was instructed to use cool wash cloth on the swollen area, tylenol or motrin prn for discomfort, monitor for fever and if patient has increased symptoms to bring child to urgent care. "After the Shots" form also given with instructions.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Blindness, Cold compress therapy, Cold sweat, Dizziness, Feeling abnormal
Clinical narrative: At approximately 11:15 A.M., The patient was admistered the Menactra vaccine intramuscularly in the left deltoid and the Varivax vaccine subcutaneously in the left tricep area.  The patient complained of temporary loss of vision, "seeing all white", blurred vision, lightheadedness, tightness in his throat and he "felt like his head was going to explode."  The patient became pale and clammy. The patient was given orange juice and was instructed to take small sips. He an ice pack was placed on the back of his neck and a damp cloth on his head. An alcohol wipe was passed under his nose several times for him to smell. After approximately ten minutes, the patient's color was back to normal and he said he felt a lot better. He stated he no longer felt pressure in his head and his vision was clear.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pallor, Throat tightness, Vision blurred
Clinical narrative: At approximately 11:15 A.M., The patient was admistered the Menactra vaccine intramuscularly in the left deltoid and the Varivax vaccine subcutaneously in the left tricep area.  The patient complained of temporary loss of vision, "seeing all white", blurred vision, lightheadedness, tightness in his throat and he "felt like his head was going to explode."  The patient became pale and clammy. The patient was given orange juice and was instructed to take small sips. He an ice pack was placed on the back of his neck and a damp cloth on his head. An alcohol wipe was passed under his nose several times for him to smell. After approximately ten minutes, the patient's color was back to normal and he said he felt a lot better. He stated he no longer felt pressure in his head and his vision was clear.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Client had live vaccine on April 24.  Patient returned for second dose of vaccine on June 19.  Reported to nurse that discovered she was pregnant right after received first vaccination, but was unaware of pregnacny at time of vaccination.  Patient reports spontaneous abortion at apporoximately 6 weeks gestation on June 13.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Coordination abnormal, Dizziness, Rash generalised, Urticaria
Clinical narrative: Vaccines administered evening of 4/17/07, client did not have any adverse effect until next day. States while in school started feeling weak and dizzy, this progressivly became worse, but did not require leaving school. That night symptoms still occuring and worsening. "almost drunk -like" Mother callled ER at Hospital. Instruced to give Benadryl. Client Slept through night. Remained "dizzy and uncoordinated: the next morning, received more Benadryl. Symptoms resolved that day. No rash during initial episode, but did C/O rash over majority of body, possibly hives, about 2 weeks after immunizations. Benadryl given about TID during this episode and rash lasted about 3 days.No further symptoms. Informed of these events on 6/19/07 when client came in for HPV #2, incident reviewed by Medical director and order obtained to give HPV #2, request that family call Health Department for any problems.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TD
Symptoms: Asthenia, Dizziness, Full blood count, Granulocyte count increased, Headache
Clinical narrative: 102 fever, headache, dizziness, weak, body aches. Given Motin 200mg(1) for fever & aches.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TD
Symptoms: Monocyte count increased, Pain, Pyrexia, White blood cell count
Clinical narrative: 102 fever, headache, dizziness, weak, body aches. Given Motin 200mg(1) for fever & aches.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia, Contusion, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: severe pain in arm and shoulder. Lack of mobility, weakness and numb/tingling fingers. Internal bruising on underside of arm.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Paraesthesia
Clinical narrative: severe pain in arm and shoulder. Lack of mobility, weakness and numb/tingling fingers. Internal bruising on underside of arm.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysphonia, Dyspnoea, Panic reaction, Pharyngeal oedema
Clinical narrative: Hoarseness, swelling of throat, diff breathing, panicky reaction, all lasting approx 2 hours until arrival in ER, treated with nebulizer and benadryl and zantac through iv saline drip.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysphagia, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Hoarseness, swelling of throat, diff breathing, panicky reaction, all lasting approx 2 hours until arrival in ER, treated with nebulizer and benadryl and zantac through iv saline drip.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in a 82-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis. On 2 January 2007 the subject received primary course of Flulaval (.5 ml, unknown). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. The consumer considered that the events were disabling and life-threatening. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Grand mal convulsion, Oxygen supplementation, Urinary incontinence
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized tonic clonic seizures in a 15-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Gardasil (non-gsk) for prophylaxis. The subject's medical history included neurocardiogenic syncope and hives after Septra. On 15 June 2007, the subject received 1st dose of Havrix (unknown, left arm), and unspecified dose of Gardasil (unknown). On 15 June 2007, less than one day after vaccination with Gardasil and Havrix, the subject experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The subject experienced a seizure while sitting in the waiting room after her vaccinations were administered. This case was assessed as medically serious by GSK. The subject was treated with oxygen and went to the emergency room and was later released. At the time of reporting, her vital signs were stable and the events were resolved.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Grand mal convulsion, Urinary incontinence
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized tonic clonic seizures in a 15-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Gardasil (non-gsk) for prophylaxis. The subject's medical history included neurocardiogenic syncope and hives after Septra. On 15 June 2007, the subject received 1st dose of Havrix (unknown, left arm), and unspecified dose of Gardasil (unknown). On 15 June 2007, less than one day after vaccination with Gardasil and Havrix, the subject experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The subject experienced a seizure while sitting in the waiting room after her vaccinations were administered. This case was assessed as medically serious by GSK. The subject was treated with oxygen and went to the emergency room and was later released. At the time of reporting, her vital signs were stable and the events were resolved.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in a 84-year-old male subject who was vaccinated with Flulaval GlaxoSmithKline for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's wife. Concurrent medical conditions included arthritis and heart condition. Concurrent medications included Cardiovascular medication. On 2 January 2007 the subject received primary course of Flulaval (0.5 ml, unknown, unknown arm). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. This case was assessed as medically serious by GSK. The reporter considered that the events were disabling and life-threatening. At the time of reporting the event was resolved.
Sex: M
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in an adult male subject who was vaccinated with influenza virus vaccine (unknown manufacturer) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in a male subject of unspecified age who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in an adult female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (ml, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 25.0
Sex: F
Vaccine: DT, MMR, VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pregnant female was given MMR, Varicella, DT by above name facility despite informing them that she was pregnant.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Anorexia, Gastrointestinal disorder, Headache, Nausea, Pyrexia
Clinical narrative: Headache 8pm 6-15-07; Fever min 104 F. Treat with Tylenol/Motrin; gastrointestinal upset; loss appetite over days 0-4 and nausea and vomiting. No injection site reaction.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Headache 8pm 6-15-07; Fever min 104 F. Treat with Tylenol/Motrin; gastrointestinal upset; loss appetite over days 0-4 and nausea and vomiting. No injection site reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Skin tightness, Urine analysis normal
Clinical narrative: Shots given 6-18-07. Yesterday evening mom noticed Right thigh red inflamed 6-20-07. Size 9cm x 10cm red, tight, hot to touch area anterior Right thigh.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Dtap when he should have had Td per someone at the health dept. Patient did not have any reaction.
Age: 7.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Dtap when she should have been given Td per someone at health department. Patient did not have any reaction.
Age: 52.0
Sex: U
Vaccine: TD
Symptoms: Cold compress therapy, Erythema, Pain, Skin warm
Clinical narrative: 3 inch area of redness. hot to touch-painful observed by doctor. Advised ice and Tylenol as needed
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Blood pressure, Chest X-ray, Febrile convulsion, Full blood count, Pyrexia
Clinical narrative: Fever increased 105 within 24 hours and febrile seizure x 2 within 24 hours.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Urine analysis
Clinical narrative: Fever increased 105 within 24 hours and febrile seizure x 2 within 24 hours.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fevers 103-104 within 6 hours of vaccine
Sex: M
Vaccine: HEP, PNC
Symptoms: Cold compress therapy
Clinical narrative: Given right thigh Prevnar #4 and Hep A #1 on 6/18/2007. Prescribed cool compress Right thigh and Benadryl every 6 hours, seen 0n 6/20/2007.
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter who on 27-JUN-2007 was vaccinated with a first dose of Gardasil and on 22-AUG-2007 was vaccinated with a second dose of Gardasil.  The reporter reported that after each dose her daughter experienced dizziness and disorientation.  She mentioned that after the 1st injection her daughter experienced dizziness and disorientation for "a while."  She indicated that after she received her second dose of Gardasil the dizziness and disorientation returned and was worse than the first time.  She was not sure if her daughter should receive her last injection or not.  It was unknown if patient sought medical attention.  As of this report day the patient had not recovered.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV, PPV
Symptoms: Agitation, Diet refusal, Lethargy, Pyrexia, Rash erythematous
Clinical narrative: fever started 6/13/07, spots started 6/14/07, lethargic, agitated, refusal of food, symtoms peaked 6/16/07, aproxamately 4-6 spots per sq. inch over entire body. red 2-3 mm raised spots no open blisters or crusting. spots are fading but not yet gone as of 6/20/07
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Asthenia, Erythema, Hypotonia, Injection site anaesthesia, Neurological examination
Clinical narrative: Patient is complaining of numbess in his Right Arm following ANT, TYV, and TPP immunizations on 14 Jun 2007; 5 days following immunizations.  Pt recieved Typhoid vaccine in Right Deltoid with IM injection, Anthrax in left deltoid with Sub-Q injection and PPD on right forearm.  The numbess is localized from his R Shoulder to his R Elbow with associated weakness upon a neuro exam.  Skin Color is Pink, Skin is Warm and Moist with Cap Refill < 3 Sec.  Individual has decreased muscle strength at shoulder with Full strength at Elbow.  At this time, Individual is being considered for Referral to Neurology evaluation.