chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Hypoaesthesia, Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old white female with no pre-existing allergies, birth defects or medical conditions weighing 33.5 kg and 148.5 cm in height who on 27-JUN-2007 was vaccinated in the right deltoid with the first dose of Gardasil (lot# 658094/0524U) and in the left deltoid with a dose of BOOSTRIX (lot# AC52B018AB). On 27-JUN-2007 the patient felt dizzy and experienced numbness, pain and tingling of right arm and later left arm and both legs, and pale lips. The patient did not pass out. The symptoms started a few minutes after shots were given and lasted for about one hour. On 27-JUN-2007, the patient recovered. There were no illness at the time of vaccination and no laboratory diagnostic tests performed. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pallor, Paraesthesia, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old white female with no pre-existing allergies, birth defects or medical conditions weighing 33.5 kg and 148.5 cm in height who on 27-JUN-2007 was vaccinated in the right deltoid with the first dose of Gardasil (lot# 658094/0524U) and in the left deltoid with a dose of BOOSTRIX (lot# AC52B018AB). On 27-JUN-2007 the patient felt dizzy and experienced numbness, pain and tingling of right arm and later left arm and both legs, and pale lips. The patient did not pass out. The symptoms started a few minutes after shots were given and lasted for about one hour. On 27-JUN-2007, the patient recovered. There were no illness at the time of vaccination and no laboratory diagnostic tests performed. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Hypoaesthesia, Pain in extremity, Pallor, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old white female with no pre-existing allergies, birth defects or medical conditions weighing 33.5 kg and 148.5 cm in height who on 27-JUN-2007 was vaccinated in the right deltoid with the first dose of Gardasil (lot# 658094/0524U) and in the left deltoid with a dose of BOOSTRIX (lot# AC52B018AB). On 27-JUN-2007 the patient felt dizzy and experienced numbness, pain and tingling of right arm and later left arm and both legs, and pale lips. The patient did not pass out. The symptoms started a few minutes after shots were given and lasted for about one hour. On 27-JUN-2007, the patient recovered. There were no illness at the time of vaccination and no laboratory diagnostic tests performed. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Discomfort, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: information has been received from a registered nurse concerning a 20 year old female patient with a soy allergy and hypersensitivity to MIRALX who on 2-JUL-2007 was vaccinated with the first 0.5 ml dose of Gardasil (Lot # 658094/0524U). Concomitant therapy included KARIVA, XANAX, PHENERGAN, COMPAZINE, and FIORICET. On 02-JUL-2007, the patient experienced syncope shortly after receiving the vaccination. She recovered the same day. on 04-JUL-2007, the patient developed a red rash over both arms. The nurse recommended BENADRYL. At the time of the report, the patient's red rash over both arms persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Rash, Syncope
Clinical narrative: information has been received from a registered nurse concerning a 20 year old female patient with a soy allergy and hypersensitivity to MIRALX who on 2-JUL-2007 was vaccinated with the first 0.5 ml dose of Gardasil (Lot # 658094/0524U). Concomitant therapy included KARIVA, XANAX, PHENERGAN, COMPAZINE, and FIORICET. On 02-JUL-2007, the patient experienced syncope shortly after receiving the vaccination. She recovered the same day. on 04-JUL-2007, the patient developed a red rash over both arms. The nurse recommended BENADRYL. At the time of the report, the patient's red rash over both arms persisted. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with no medical history or allergies who on 05-JUL-2007 at 11:00, was vaccinated into the right deltoid with a third dose of Gardasil (Lot# 654510/0962F). On 06-JUL-2007 at 08:00 when the patient awoke, she had urticaria sporadically over her body on both arms, medical aspect of both thighs and her right upper chest area. Treatment for the urticaria included 50 mg of diphenhydramine hydrochloride (BENADRYL) every 6 hours as needed. At the time of this report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Information has been received from a registered nurse and on request from the FDA under the Freedom of Information Act regarding a 13 year old female patient with no medical history or allergies who on 05-JUL-2007 at 11:00 was vaccinated into the right deltoid with a third dose of GARDASIL vaccine (Lot# 654510/0962F). On 06-JUL-2007 at 8:00 when the patient awoke, she had urticaria sporadically over her body, her neck, on both arms, medical aspect of both thighs and her right upper chest area "about 24 hours". Treatment for the urticaria included 50 mg of BENADRYL every 6 hours as needed. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Aphasia, Areflexia, Asthenia, CSF protein increased, Computerised tomogram normal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Epstein-Barr virus test positive, Facial palsy, Facial paresis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Hypoaesthesia, Lumbar puncture, Muscular weakness, Occupational therapy, Physiotherapy
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Protein total abnormal, Speech rehabilitation
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: CSF culture negative, CSF protein increased, CSF test normal, Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccination with a dose of Gardasil. Concomitant therapy included Menactra. The physician reported that the patient developed "Guillain Barre Syndrome" after receiving a dose of Gardasil over at the hospital and had to be hospitalized. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received form a physician concerning a 10 year old patient who on 21-Jun-2007 was vaccinated IM in to right deltoid with a first dose of GARDASIL lot # 657868/0523U. Concomitant therapy included MENACTRA.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, concerning a 17 year old female patient, who on 27-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # 655205/1426F). On 27-JUN-2007, 5 to 10 minutes after receiving the vaccination, she fainted, while still in the physician's office. The nurse reported that the patient recovered on the same day, 27-JUN-2007. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Hypersensitivity, Hypotonia, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a24 year old female, who on 23-JUL-2007 was vaccinated in the left arm with a0.5mL second dose of Gardasil. Within a "minutes" after receiving the vaccination the patient felt "tingling  in her left arm, hand, and fingers." She also felt "dizzy." The patient was administered 50mL of BENADRYL for her symptoms. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual disturbance
Clinical narrative: Information has been received from a registered nurse concerning a24 year old female, who on 23-JUL-2007 was vaccinated in the left arm with a0.5mL second dose of Gardasil. Within a "minutes" after receiving the vaccination the patient felt "tingling  in her left arm, hand, and fingers." She also felt "dizzy." The patient was administered 50mL of BENADRYL for her symptoms. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a24 year old female, who on 23-JUL-2007 was vaccinated in the left arm with a0.5mL second dose of Gardasil. Within a "minutes" after receiving the vaccination the patient felt "tingling  in her left arm, hand, and fingers." She also felt "dizzy." The patient was administered 50mL of BENADRYL for her symptoms. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 4 months old patient who on 15-MAY-2007 was vaccinated with the first dose of oral Rotateq. The patient was not experiencing any known symptoms. Unspecified medical attention was sought. The infant's mother refused the second dose. No product quality complaint reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 4 months old patient who on 15-MAY-2007 was vaccinated with the first dose of oral Rotateq. The patient was not experiencing any known symptoms. Unspecified medical attention was sought. The infant's mother refused the second dose. No product quality complaint reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Head injury, Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female who on 17-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # 657621/0387U). After the vaccination, the patient experienced syncope. The patient fainted and hit her head. An ambulance was called but she refused to be taken to the emergency room. Medical attention was sought. The patient recovered on the same day. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a registered nurse concerning a 16 year old female with MOTRIN allergy. Prior to being administered the vaccination the patient verbalized her fear of needles. On 17-JUL-2007 at 4:44 pm, the patient was vaccinated with the first dose of GARDASIL (Lot #657621/0387U), IM in the left deltoid. Concomitant medication was not reported. No illness was reported at the time of vaccination. On 17-JUL-2007 at 5:00 pm, approximately 15 minutes after the vaccination, the patient experienced a syncope episode. The patient had the syncope episode while on her way out to the waiting room and hit her head on the edge of the door. There was no visible injury. The patient was upset and crying after the injection and the nurse sat in the room until the patient was calmed which was about 10 minutes. An ambulance was called and the patient was taken to the hospital. The patient's guardian met her at the hospital where it was decided that the patient did not need to be seen. The guardian then took the patient home. Unspecified medical attention was sought. The patient recovered on the same day. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female who on 17-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # 657621/0387U). After the vaccination, the patient experienced syncope. The patient fainted and hit her head. An ambulance was called but she refused to be taken to the emergency room. Medical attention was sought. The patient recovered on the same day. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a registered nurse concerning a 16 year old female with MOTRIN allergy. Prior to being administered the vaccination the patient verbalized her fear of needles. On 17-JUL-2007 at 4:44 pm, the patient was vaccinated with the first dose of GARDASIL (Lot #657621/0387U), IM in the left deltoid. Concomitant medication was not reported. No illness was reported at the time of vaccination. On 17-JUL-2007 at 5:00 pm, approximately 15 minutes after the vaccination, the patient experienced a syncope episode. The patient had the syncope episode while on her way out to the waiting room and hit her head on the edge of the door. There was no visible injury. The patient was upset and crying after the injection and the nurse sat in the room until the patient was calmed which was about 10 minutes. An ambulance was called and the patient was taken to the hospital. The patient's guardian met her at the hospital where it was decided that the patient did not need to be seen. The guardian then took the patient home. Unspecified medical attention was sought. The patient recovered on the same day. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a health care professional concerning a 16 year old female patient who on 19-JUL-2007 at 4:30 pm, was vaccinated in the left arm, with the first dose of GARDASIL (lot# 658094/0524U). On 19-JUL-2007 at 4:35 pm, 5 minutes after the vaccination, the patient experienced an episode of syncope. Again at 10 minutes after the vaccination the patient experienced an episode of syncope. On 19-JUL-2007, the patient had recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle strain, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 24-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) and ethinyl estradiol (+) etonogestrel (NUVARING). on 24-JUL-2007 the patient developed neck and muscle pain. The patient also had a hard time walking during the night. On 25-JUN-2005 the patient was taken to the hospital. At the time of the report it was unknown if the patient was admitted to the hospital. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 24-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) and ethinyl estradiol (+) etonogestrel (NUVARING). on 24-JUL-2007 the patient developed neck and muscle pain. The patient also had a hard time walking during the night. On 25-JUN-2005 the patient was taken to the hospital. At the time of the report it was unknown if the patient was admitted to the hospital. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Myalgia, Neck pain
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 24-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) and ethinyl estradiol (+) etonogestrel (NUVARING). on 24-JUL-2007 the patient developed neck and muscle pain. The patient also had a hard time walking during the night. On 25-JUN-2005 the patient was taken to the hospital. At the time of the report it was unknown if the patient was admitted to the hospital. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dyspnoea, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a physician concerning an 11 or 12 year old female, who on 09-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant vaccination included a dose of DTaP. On 11-MAY-2007 the patient developed urticaria and was hospitalized. On 20-JUL-2007, the physician found out about the patient's experience and is not sure if he will give the patient a second dose of Gardasil. The physician considered the urticaria to be an other important medical event. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician concerning a 17 year old female with no drug allergies, HPV (no date provided), alcohol and marijuana abuse, cervical adenitis, dysmenorrheal, and Obsessive Compulsive Disorder, who on 09-MAY-2007 was vaccinated with intramuscularly in the right arm with a first dose of GARDASIL "11844C". Concomitant vaccination given in the left arm included a dose of DTaP (unspecified). On 13-MAY-2007 the patient developed a temporal, generalized, diffuse, itching rash that was diagnosed as urticaria. The patient went to the emergency room only (previously reported that the patient was hospitalized). The patient was treated with dexamethasone, BENADRYL, and an unspecified antacid. No laboratory diagnostics were performed. On 14-MAY-2007, the patient recovered. The physician stated that he event of urticaria in regards to therapy with GARDASIL was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 11 or 12 year old female, who on 09-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant vaccination included a dose of DTaP. On 11-MAY-2007 the patient developed urticaria and was hospitalized. On 20-JUL-2007, the physician found out about the patient's experience and is not sure if he will give the patient a second dose of Gardasil. The physician considered the urticaria to be an other important medical event. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician concerning a 17 year old female with no drug allergies, HPV (no date provided), alcohol and marijuana abuse, cervical adenitis, dysmenorrheal, and Obsessive Compulsive Disorder, who on 09-MAY-2007 was vaccinated with intramuscularly in the right arm with a first dose of GARDASIL "11844C". Concomitant vaccination given in the left arm included a dose of DTaP (unspecified). On 13-MAY-2007 the patient developed a temporal, generalized, diffuse, itching rash that was diagnosed as urticaria. The patient went to the emergency room only (previously reported that the patient was hospitalized). The patient was treated with dexamethasone, BENADRYL, and an unspecified antacid. No laboratory diagnostics were performed. On 14-MAY-2007, the patient recovered. The physician stated that he event of urticaria in regards to therapy with GARDASIL was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Crying, Malaise, Muscle rigidity, Syncope, Tremor
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history who on 31-JUL-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 31-JUL-2007 the patient fainted 2-3 minutes after receiving the Gardasil and became rigid during the episode. The fainting episode lasted 90 seconds. At the end of the fainting episode the patient screamed and vomited. On 31-JUL-2007 the patient's pulse oximetry reading was 98 percent. Unspecified medical attention was sought. Subsequently, the patient recovered from the episode. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history who on 31-JUL-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 31-JUL-2007 the patient fainted 2-3 minutes after receiving the Gardasil and became rigid during the episode. The fainting episode lasted 90 seconds. At the end of the fainting episode the patient screamed and vomited. On 31-JUL-2007 the patient's pulse oximetry reading was 98 percent. Unspecified medical attention was sought. Subsequently, the patient recovered from the episode. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Cold sweat, Pain in extremity, Pallor, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history who on 31-JUL-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 31-JUL-2007 the patient fainted 2-3 minutes after receiving the Gardasil and became rigid during the episode. The fainting episode lasted 90 seconds. At the end of the fainting episode the patient screamed and vomited. On 31-JUL-2007 the patient's pulse oximetry reading was 98 percent. Unspecified medical attention was sought. Subsequently, the patient recovered from the episode. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Immediate post-injection reaction, Muscle rigidity, Oxygen saturation, Screaming, Syncope
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history who on 31-JUL-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 31-JUL-2007 the patient fainted 2-3 minutes after receiving the Gardasil and became rigid during the episode. The fainting episode lasted 90 seconds. At the end of the fainting episode the patient screamed and vomited. On 31-JUL-2007 the patient's pulse oximetry reading was 98 percent. Unspecified medical attention was sought. Subsequently, the patient recovered from the episode. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history who on 31-JUL-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 31-JUL-2007 the patient fainted 2-3 minutes after receiving the Gardasil and became rigid during the episode. The fainting episode lasted 90 seconds. At the end of the fainting episode the patient screamed and vomited. On 31-JUL-2007 the patient's pulse oximetry reading was 98 percent. Unspecified medical attention was sought. Subsequently, the patient recovered from the episode. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Symptoms: Large, Red, Itchy Bumps, Rashes all over Body within 12 hours. Slight fever. Usually during the day. During the night when cooler, the bumps go away. Day time, when the weather is hotter, bumps return and goes away again at night. THis is the 2nd day in a row. Doctor recommended Benadryl for children & Tylenol for fever. This happened after the 12 Month lot of vaccinations consisting of:1. HIB, 2. Hepatitis B, 3. MMR, 4. Chicken pox, 5. TB Skin test. I suspect the MMR. It is documented that after MMR, 7-10 days after might have adverse reactions.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Pyrexia, Rash, Skin warm, Urticaria
Clinical narrative: An immediate red welt and red rash formed just below the MMR Chickenpox vaccine site.  She has a low grade fever 99.7 degrees.  We have given her benadryl, but it doesn't seem to be doing anything.  The rash is no better and it is no worse.  It is warm to the touch and slightly raised.  I drew around the rash so I would know it is got any better or worse and it hasn't changed in 3 days.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anorexia, Lethargy, Pyrexia
Clinical narrative: Fever around 101 degrees F, general lethargy, loss of appetite.  Fever onset about 20 hours after injection. Treated with 2 tsp of Children's Motrin, administerd 2 tinesd at 6 hour interval. Fever broke and other symptoms abated about 12 hours after onset.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Dyskinesia, Dysstasia, Electroencephalogram normal, Eye disorder, Irritability
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 03-MAY-2006 was vaccinated with MMR. Suspect vaccine administered on the same day included a third dose of PEDIARIX in the left arm and concomitant vaccine included Hib conj vaccine. Previous vaccinations included two doses of PEDIARIX administered on 04-JAN-2006 and 03-MAR-2006 respectively. On 03-MAY-2006, 5 hours after vaccination with PEDIARIX, the patient experienced twitching on his left side which the physician described as "drawing up head toward left". The event lasted for 10-15 minutes and then completely resolved. The patient was seen in the physician's office and was advised to take BENADRYL. The healthcare professional considered the events were a congenital anomaly. The following day, on 04-MAY-2007, the physician who didn't think this was seizure activity ordered an electroencephalogram (EEG) to rule out the possibility of seizure activity. The EEG result was normal. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. The reporter noted that when the patient received his MMR vaccine at 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of PEDIARIX.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Lacrimation increased, Muscle twitching
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 03-MAY-2006 was vaccinated with MMR. Suspect vaccine administered on the same day included a third dose of PEDIARIX in the left arm and concomitant vaccine included Hib conj vaccine. Previous vaccinations included two doses of PEDIARIX administered on 04-JAN-2006 and 03-MAR-2006 respectively. On 03-MAY-2006, 5 hours after vaccination with PEDIARIX, the patient experienced twitching on his left side which the physician described as "drawing up head toward left". The event lasted for 10-15 minutes and then completely resolved. The patient was seen in the physician's office and was advised to take BENADRYL. The healthcare professional considered the events were a congenital anomaly. The following day, on 04-MAY-2007, the physician who didn't think this was seizure activity ordered an electroencephalogram (EEG) to rule out the possibility of seizure activity. The EEG result was normal. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. The reporter noted that when the patient received his MMR vaccine at 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of PEDIARIX.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Head injury, Syncope
Clinical narrative: Information has been received from a Physician's Assistant concerning a female patient who on 08-AUG-2007 was vaccinated with her first dose of Gardasil. A couple of minutes later, the patient became dizzy, fainted and hit her head against something in the office, and had seizures. The office then had paramedics come and take the patient to the hospital. The amount of time the patient stayed at the hospital was unknown. Her outcome was  unknown. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin, Blood bilirubin, Gamma-glutamyltransferase
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who on 30-JUL-2007 was vaccinated with a 2 ml oral first dose of Rotateq. Concomitant vaccines included a dose of DTaP, a dose of IPOL, a dose of Prevnar and a dose of Comvax (MSD). Approximately 12 to 24 hours after vaccination, the patient developed several episodes of vomiting, once or twice a day since the day of vaccination. The patient was seen by a health care professional on 31-JUL-2007 for vomiting, no diarrhea was reported. The patient continued with approximately 1 vomiting episode per day. On 08-AUG-2007 the patient vomited bright red blood following a feeding with breastmilk. The patient was hospitalized for evaluation and observation. It was reported that vomiting had since resolved. Laboratory studies during the events an alanine aminotransferase test and an aspartate aminotransferase test, which increased in the "300's." It was noted that the tests had since decreased. There was no noted increased in bilirubin, GGT, or albumin levels. Pyloric stenosis was ruled out. There was no evidence of neonatal hepatitis, and results from a newborn screen and "congenital disorder screen" were not significant. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematemesis, Hepatic enzyme increased, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who on 30-JUL-2007 was vaccinated with a 2 ml oral first dose of Rotateq. Concomitant vaccines included a dose of DTaP, a dose of IPOL, a dose of Prevnar and a dose of Comvax (MSD). Approximately 12 to 24 hours after vaccination, the patient developed several episodes of vomiting, once or twice a day since the day of vaccination. The patient was seen by a health care professional on 31-JUL-2007 for vomiting, no diarrhea was reported. The patient continued with approximately 1 vomiting episode per day. On 08-AUG-2007 the patient vomited bright red blood following a feeding with breastmilk. The patient was hospitalized for evaluation and observation. It was reported that vomiting had since resolved. Laboratory studies during the events an alanine aminotransferase test and an aspartate aminotransferase test, which increased in the "300's." It was noted that the tests had since decreased. There was no noted increased in bilirubin, GGT, or albumin levels. Pyloric stenosis was ruled out. There was no evidence of neonatal hepatitis, and results from a newborn screen and "congenital disorder screen" were not significant. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report received from another company (no reference number provided) on 07 August 2007. The case was reported to the other company by a health care professional. A female patient had received an injection of Tetanus Toxoid vaccine, manufacturer and lot number not reported, and experienced an anaphylactic reaction on an unspecified date. The reporter stated that this event "happened a while ago" and that the patient "sought medical attention". No additional information relating to the patient, the event, or the vaccine was provided at the time of this report. The patient's recovery status is unknown.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient fell to floor and hit her head, developed LOC and tonic-clonic movements of arms for about 30 secs and recovered with full orientation for a few minutes then fell again and had a second similar episode. She was taken to the hospital ER when she had a 3rd episode hours later. Recovered without any further problems. 8/28/2007 MR received for ER visit following fainting episode with questionable seizure activity.  When pt fell at health dept pt hit head, but pain has resolved. Pt passed out x1 in the ED BR. Clinical Impression Syncope, Vasovagal.  Heart Murmurs NOS.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Tonic clonic movements
Clinical narrative: Patient fell to floor and hit her head, developed LOC and tonic-clonic movements of arms for about 30 secs and recovered with full orientation for a few minutes then fell again and had a second similar episode. She was taken to the hospital ER when she had a 3rd episode hours later. Recovered without any further problems. 8/28/2007 MR received for ER visit following fainting episode with questionable seizure activity.  When pt fell at health dept pt hit head, but pain has resolved. Pt passed out x1 in the ED BR. Clinical Impression Syncope, Vasovagal.  Heart Murmurs NOS.
Age: 1.13
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Blood creatinine normal, Convulsion, Echocardiogram normal, Electroencephalogram abnormal
Clinical narrative: Increased seizure frequency 10/08/07-DC summary included with VAERS report for DOS 7/31-8/3/07-DC DX: Infantile Spasms. Increased seizures. EEG demonstrated infantile spasms. Echo normal.  11/1/07-records received for DOS 7/30/8/3/07-DC DX: Infantile spasms. Presented to ER with increased frequency and duration of seizures manifested as extensor posturing.  Follow-up: Pt still has seizures, mother states seizures are no different now than they were prior to vaccine. Pt has epilepsy.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Body temperature increased, Cellulitis, Erythema, Hypersensitivity, Medical device complication
Clinical narrative: needle bent-equipment failure 9/10/07-Friday in day care provided states slight elevated temp-administered ibuprofen. 9/11/07 Sat-erythema & edema of arm noted by mother-size of dollar bill applied ice-no c/o swelling 3 pm resorted to hospital x-ray of deltoid-Dx Cellulitis, allergic reaction Rx Cephalexin 250 mg 3 x day Benadryl, Motrin-1 tsp-swelling diminished @ hospital-left 7 pm 9/14/07 slight redness at site-"different shade" no swelling 9/16/07 skin tissue healed no swelling redness normal child behavior
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Oedema
Clinical narrative: needle bent-equipment failure 9/10/07-Friday in day care provided states slight elevated temp-administered ibuprofen. 9/11/07 Sat-erythema & edema of arm noted by mother-size of dollar bill applied ice-no c/o swelling 3 pm resorted to hospital x-ray of deltoid-Dx Cellulitis, allergic reaction Rx Cephalexin 250 mg 3 x day Benadryl, Motrin-1 tsp-swelling diminished @ hospital-left 7 pm 9/14/07 slight redness at site-"different shade" no swelling 9/16/07 skin tissue healed no swelling redness normal child behavior
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving immunizations-recovered rapidly-pulse 62 BP 100/70 evaluated by physician.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema
Clinical narrative: 4 days after immunization redness and edema noted on (R) shoulder
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pain
Clinical narrative: c/o pain 8-8-07 2 hrs after inj. mom rubbed clear alcohol on shoulder x 2
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Noted redness and swelling left shoulder. 2 day after injec. of DTaP
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Induration, Local reaction, Pyrexia, Tremor
Clinical narrative: woke from sleep with shaking chills, fever to 102 in clinic: large local rxn (8 cm, indurated), pneumococcal vaccine site unaffected. fever to 38.1 in clinic. given 30 mg prednisone daily x 3 days
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Rt. shoulder with redness and swelling a day after inj. lasted approx 2-3 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Pain
Clinical narrative: Joint pains- hands and feet noted 6/11/07. Workup showed (+) ANA of 1:160. Patient read article from "National Vaccine Information Center" and would like this to be reported as a possible adverse event following Gardasil to VAERS
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain radiating from (L) delt IM site, to (L) shoulder, to (L) neck since im on 8/4/07 through today 8/10/07
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Pain radiating from (L) delt IM site, to (L) shoulder, to (L) neck since im on 8/4/07 through today 8/10/07
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope, Throat tightness
Clinical narrative: syncope-recovered quickly when layed down c/o throat tightness-did not progress to allergic reaction
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: syncope-recovered quickly when layed down c/o throat tightness-did not progress to allergic reaction
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Faeces discoloured, Flatulence, Irritability, Screaming
Clinical narrative: Multiple red, current stools in diaper. Duration >72 hrs. infant ver fussy, gassy at times, screaming in pain.  8/17/07 Spoke w/pcp who states patient did not have IS.  Everything in ER was WNL.  Continues to have bloody stools but irritability has resolved.  Patient has been referred to pediatric GI.  MD does not feel bloody stools are due to milk allergy.  Will not give further RO vax.  8/17/07 Received medical records from provider which confirm RO dose & lot # as reported.  Office visit 7/6/07 reveals patient well & developing as expected, breastfeeding.  Next visit 8/6/07 on day of vax revealed spitting up & having watery stools over past 5-6 days.Noted to have hydrocele & thrush.  Started on meds & vax given.  8/7 parent called w/child fever 101.1.  8/11/07 parent called to report jelly like stool w/streaks of blood, low grade fever & irritability.  Sent to ER.  IS was ruled out & felt he had milk protein allergy or anal fissure.  Return to office on 8/13/07.  Dx at that time w/probable enterocolitis.  Referred to peds GI consult. 8/31/07 Reviewed hospital ER medical records of 8/11/07 which reveal patient experienced inconsolable crying & screaming spells for several hours, low grade fever, decreased appetite & mucousy blood tinged stools x 2.  Ped Surgery consult done.  D/C from ER to be f/u in Peds GI clinic.  Seen in GI on 8/16 for continued rectal bleeding.  Sigmoidoscopy done revealed lymphonodular hyperplasia in rectum & recto-sigmoid colon.  Biopsy done revealed focal active colitis. FINAL DX: Colitis.  Possible milk protein allergy causing enteropathy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: IPV and MMRV given on 8/7 in right leg. On 8/8 - 8/10 progressive red swelling laterally from vaccine, raised, itchy extending from knee up to within 2-3 inches of up. No trouble swallowing/breathing. No other rashes.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Laceration, Syncope
Clinical narrative: Teen fainted, sustained a laceration that required repair
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt started feeling queasy and nauseous the day after having HPV. Vomited x 1
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Cellulitis, Erythema
Clinical narrative: Rec'd Menactra vaccine 8/1/07 developed tactile temperature and redness (evening) 8/2/07 seen in our office 8/3/07 Diagnosed with cellulitis post reaction to Menactra. Treated with Keflex
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash, redness, swelling, warmth to site. No c/o pain to site voiced. Site location left upper thigh 10 1/2cm x 8cm.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain with 10+ cm swelling at injection site. Local reaction at site of injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 7 cm x 6 cm indurated, erythematous lesion around site of vaccine (R) thigh-warm to touch.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: Local reaction to injection - left deltoid
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Lg cm of erythema and induration to posterior (L) VE-approx 10 cm in diameter tx with Medrol dose pack
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Full blood count normal, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Approx 4 cm round red area at site of DTaP. Skin warm to touch, firm. To use Motrin and cool compresses.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Herpes zoster, Nausea, Rash, Upper respiratory tract infection
Clinical narrative: Varicella zoster, rash reb 10-11 dermatome right.6/27 started with discomfort. 6/28 rash first noted. 6/29 seen in office - increased red rash w/o vesicles. + nausea, mild URI sx before rash.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Varicella zoster, rash reb 10-11 dermatome right.6/27 started with discomfort. 6/28 rash first noted. 6/29 seen in office - increased red rash w/o vesicles. + nausea, mild URI sx before rash.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cellulitis
Clinical narrative: Cellulitis on outer left thigh, post imms < 24 hr. Treated with Keflex 250/5ml .6cc tid for 7 days.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR
Symptoms: Erythema, Feeling cold, Pallor, Rash macular
Clinical narrative: Raised macular lesions, red, cool to touch, blanching. Topicourt LP apply and were a day.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Listless, Oedema peripheral, Pyrexia, Somnolence, Swelling face
Clinical narrative: About 2 hours after receiving vaccine patient became listless, developed swelling of face and feet; threw up once; had fever 101.3. Swelling resolved. Fever was treated with Tylenol or Motrin. She remained sleepy but was doing much better by next day.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: About 2 hours after receiving vaccine patient became listless, developed swelling of face and feet; threw up once; had fever 101.3. Swelling resolved. Fever was treated with Tylenol or Motrin. She remained sleepy but was doing much better by next day.