chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash macular, Rash macular
Clinical narrative: Information has been received from a nurse concerning a female who on 10-APR-2007 was vaccinated with a 0.65 ml dose of Zostavax (Lot # 656609/0015U). On 10-APR-2007 the patient developed a blotchy, red rash at the injection site that "spread down the arm to the hand within 15 minutes after vaccination". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. Information has been received from a nurse concenring a female with no medical history or allergies who on 10-APR-2007 at 11:00 AM was vaccinated with 0.65 ml dose of ZOSTAVAX (Oka/Merck) )lot # 656609/0015U). At the time of vaccination, the patient did not have any illnsses. On 10-APR-2007 the patient developed a blotchy, red rash at the injection site that "spread down the arm tothe hand within 15 minutes after vaccination". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from nurse who reported that patient developed nausea and a mild rash on the injection site 20 minutes after vaccination. The patient was seen in urgent care on the same day. At the time of report, the patient had recovered.  No futher information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 17-APR-2007 was vaccinated SC with a dose of Zostavax. On approximately 21-APR-2007 the patient developed an itchy rash that started around her waist. It was reported that the patient had an doctor visit on 23-APR-2007 and was diagnosed with shingles. The physician reported that patient had a "vesicular rash on the left-side of her upper abdomen". The patient was treated with Neurotin 300 mg BID twice daily and "Sanvir" 500 mg, 2 tablets BID for 7 days. The physician had instructed the patient to call the office back if symptoms did not improve. The physician had not heard back from the patient. A product quality complaint was not involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a consumer concerning his 24 month old grandson whose grandmother was vaccinated with a dose of Zostavax. The reporter noted that his wife received the vaccination and then "transmitted it to her grandson who then developed chickenpox." The child developed chickenpox four to five days after his grandmother received Zostavax. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. No further information is available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Crying, Herpes zoster, Inappropriate schedule of drug administration, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 58 year old female with no allergies and a history of a previous case of shingles  05-JAN-2006 and a history of chicken pox who on 02-MAR-2007 (also reported as January 2007) was vaccinated in the left arm with a 0.65 mL dose of ZOSTAVAX (Merck) y(lot # 656609/0015U). There was no concomitant medication or illness at the time of vaccination. "Shortly after" vaccination, in approximately March 2007, the patient experienced herpes zoster. It was noted that the patient had a lesion the size of a quarter on her left cheek. The physician described the lesion as weeping, crusted, and similar to a chickenpox lesion. It was also described as a herpes zoster vesicular rash on the left face on the C1 or C2 dermatome. The lesion was still present on the patient's face on 20-APR-2007, seven weeks after vaccination. A rash did not occur at the site of injection post-vaccination. The patient's temperature was noted to be normal. Unspecified medical attention was sought. At the time of the report, the patient was on unspecified therapy and was recovering. A product quality complaint was not involved. Additional information has been requested. Additional information indicated that on approximately 05-MAR-2007 the patient developed a rash on her cheek that looked like chickenpox: weeping blister then crusted and at the one point looked like pimples. Entire outbreak was never larger than a quarter. It was slightly irritating, not painful and she never had systemic illness. Subsequently on 02-MAY-2007 the patient recovered. No laboratory tests were performed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 58 year old female with no allergies and a history of a previous case of shingles  05-JAN-2006 and a history of chicken pox who on 02-MAR-2007 (also reported as January 2007) was vaccinated in the left arm with a 0.65 mL dose of ZOSTAVAX (Merck) y(lot # 656609/0015U). There was no concomitant medication or illness at the time of vaccination. "Shortly after" vaccination, in approximately March 2007, the patient experienced herpes zoster. It was noted that the patient had a lesion the size of a quarter on her left cheek. The physician described the lesion as weeping, crusted, and similar to a chickenpox lesion. It was also described as a herpes zoster vesicular rash on the left face on the C1 or C2 dermatome. The lesion was still present on the patient's face on 20-APR-2007, seven weeks after vaccination. A rash did not occur at the site of injection post-vaccination. The patient's temperature was noted to be normal. Unspecified medical attention was sought. At the time of the report, the patient was on unspecified therapy and was recovering. A product quality complaint was not involved. Additional information has been requested. Additional information indicated that on approximately 05-MAR-2007 the patient developed a rash on her cheek that looked like chickenpox: weeping blister then crusted and at the one point looked like pimples. Entire outbreak was never larger than a quarter. It was slightly irritating, not painful and she never had systemic illness. Subsequently on 02-MAY-2007 the patient recovered. No laboratory tests were performed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Laboratory test, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old patient who was seronegative for Varivax who on 27-APR-2007 was vaccinated with a dose of Zostavax instead of a second dose of Varivax. It was noted that the patient received their first dose of Varivax on 30-MAR-2007. No symptoms have been reported. The event was a result of human error, not product confusion. No further information is available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning an 82 year old female with osteoporosis, hypertension and gastrooesophageal reflux disease who on 09-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium, Benicar, Celebrex and Ambien. On 13-APR-2007 the patient experienced itching of the skin and hives over the body. No previous allergic reactions were known. She returned to the physician's office and the physician immediately treated her with steroids IM and oral steroids for one week. No further information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood cholesterol, Blood glucose increased, Cardiac stress test
Clinical narrative: Information has been received from a pharmacist concerning his 66 year old wife with diabetes, high cholesterol, hot flashes and a penicillin allergy who on Friday 27-APR-2007 at 10:00 was vaccinated SC with a dose of Zostavax (Oka/Merck). Concomitant therapy included insulin lispro (HUMALOG), estradiol (ESTRACE), atorvastatin calcium (LIPITOR), ezetimibe (MSD), quinapril HCl (ACCUPRIL), aspirin, calcium (unspecified), docusate Na (COLACE), vitamins (unspecified) and lorazepam (ATIVAN). From the middle of the night on 27-APR-2007 until late Sunday night (29-APR-2007) her glucose increased to 300-400 mg/dL. From late Sunday night (29-APR-2007) to Monday morning (30-APR-2007) her glucose had gone down to 109 mg/dL. It was reported that medical attention was not sought though lab studies performed included protein, A1c, ALT, AST, cholesterol (results not reported) and a nuclear stress test (results not reported). On 30-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin, Protein albumin ratio, Protein total
Clinical narrative: Information has been received from a pharmacist concerning his 66 year old wife with diabetes, high cholesterol, hot flashes and a penicillin allergy who on Friday 27-APR-2007 at 10:00 was vaccinated SC with a dose of Zostavax (Oka/Merck). Concomitant therapy included insulin lispro (HUMALOG), estradiol (ESTRACE), atorvastatin calcium (LIPITOR), ezetimibe (MSD), quinapril HCl (ACCUPRIL), aspirin, calcium (unspecified), docusate Na (COLACE), vitamins (unspecified) and lorazepam (ATIVAN). From the middle of the night on 27-APR-2007 until late Sunday night (29-APR-2007) her glucose increased to 300-400 mg/dL. From late Sunday night (29-APR-2007) to Monday morning (30-APR-2007) her glucose had gone down to 109 mg/dL. It was reported that medical attention was not sought though lab studies performed included protein, A1c, ALT, AST, cholesterol (results not reported) and a nuclear stress test (results not reported). On 30-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 25-APR-2007 was vaccinated SC with a dose of Zostavax instead of Varivax. It was reported that this was due to a nursing error. The vaccines and been stored together in the freezer. The reporter stated that the vaccines are now stored in separate bins which are marked pediatric and adult. As of 04-MAY-2007 the patient was "still fine with no problems". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Information has been received from a 69 year old female with no history of drug reactions/allergies who on 09-APR-2007 was vaccinated in the "left deltoid" with Zostavax. Concomitant therapy included Actonel, alendronate sodium, diazepam and Ambien. Starting on 12-APR-2007, the patient experienced periodic aching and tenderness at injection site. The patient also reported periodic headaches. The patient reported the pain would come and go at short intervals for both the injection site tenderness and headaches. The patient sought medical attention. No lab testing was performed. The patient was still experiencing the "adverse experience". Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 73 year old female with asthma and a history of poliomyelitis and colitis ulcerative who in March 2007, was vaccinated with a dose of Zostavax. Concomitant therapy included montelukast sodium. In April 2007, "about three weeks after vaccination", the patient experienced aches and pains in her neck, shoulders, arms and hands. At the time of report, patient's symptoms were "greatly improved". Patient was treated with Percogesic. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomach discomfort, Vaccination failure
Clinical narrative: Information has been received from an 84 year old with a history of shingles (3 years ago) who on 16-FEB-2007 was vaccinated with a dose of Zostavax. Subsequently the patient experienced "stomach problems" and believes that she may have "internal shingles". The patient's stomach problems and internal shingles persisted. No medical attention was sought. No product quality complaint. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an approximately 70 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient developed a disseminated rash all over her body. The patient did contact the physician regarding her reaction. There was no product quality complaint involved. No further information was provided. This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse concerning an 84-year-old healthy female who on 30-Apr-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) (lot# 652936/0981F). On 05-Apr-2007, at 1:45 pm, the patient developed a rash starting on her abdomen and BENADRYL and hydrocortisone cream were recommended. On 04-Apr-2007, the patient developed pruritic hives all over her trunk, buttocks, upper extremities and in the hair. She did not have any pain or respiratory symptoms. She was prescribed prednisone 20 milligrams BID for 2 days, 20 milligrams for 3 days and 10 milligrams for 4 days, and to continue with the BENADRYL. No laboratory or diagnostic test were ordered. It is reported that the patient recovered on 10-Apr-2007. There was no product quality complaint involved. No more information is expected. This is one of several reports from the same source.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old white female secretary (weight 260) who on 20-APR-2007 was vaccinated with a dose of Zostavax. SQ in the left arm. Concomitant therapy included Coumadin. On 20-APR-2007 Coumadin was held for one day. On 24-APR-2007 the patient had an elevated INR of 1.5 and prothrombin time (PT) was 41.5 sec.  On 01-MAY-2007 the patient's INR was rechecked and found to be elevated at 3.9 and PT was 46.2 sec.  Therapy with Coumadin was held for one day and decreased to 2.5mg/week.  On 08-MAY-2007, INR was 3.0 ans PT was 15.4 sec. the patient's regular dosing of Coumadin was resumed.  On 22-MAY-2007, INR was 4.6 and PT was 55.4 sec. therapy with Coumadin was held for two days and the dose was decreased to 2.5mg/week.  On 29-MAY-2007. INR was 1.5 and PT was 23.2 the patient resumed dosing of Coumadin.  Unspecified medical attention was sought. There was no product quality complaint involved. At the time of reporting, the outcome of the event was not reported. Additional information is not expected.  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a male child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a male child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 08-Mar-2007 was vaccinated with Zostavax. On approximately 10-MAR-2007, 2 days after getting the Zostavax, the patient experienced a "wheel red mark". This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Deafness, Fatigue, Flushing, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient became light-headed and passed out when she got to the front door. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 17 year old female with a history of having an unknown adverse event when vaccinated with pertussis, and with a history of pertussis, who on 9-MAR-2007 at 10:15AM was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot# 653736/0014U). Approximately fifteen minutes post vaccination the patient became faint. She became lightheaded and passed out when she got to the door. She recovered after lying down for about 5-10 minutes. Later at school she complained of arm numbness and nausea. The patient returned to the clinic the same day for a recheck and was stable. There were no illnesses at the time of the vaccination. No laboratory diagnostic studies were performed. The patient recovered on 9-MAR-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injected limb mobility decreased, Nausea, Pain in extremity, Syncope, Vertigo
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient became light-headed and passed out when she got to the front door. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 17 year old female with a history of having an unknown adverse event when vaccinated with pertussis, and with a history of pertussis, who on 9-MAR-2007 at 10:15AM was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot# 653736/0014U). Approximately fifteen minutes post vaccination the patient became faint. She became lightheaded and passed out when she got to the door. She recovered after lying down for about 5-10 minutes. Later at school she complained of arm numbness and nausea. The patient returned to the clinic the same day for a recheck and was stable. There were no illnesses at the time of the vaccination. No laboratory diagnostic studies were performed. The patient recovered on 9-MAR-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Dizziness, Loss of consciousness, Pertussis, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient became light-headed and passed out when she got to the front door. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 17 year old female with a history of having an unknown adverse event when vaccinated with pertussis, and with a history of pertussis, who on 9-MAR-2007 at 10:15AM was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot# 653736/0014U). Approximately fifteen minutes post vaccination the patient became faint. She became lightheaded and passed out when she got to the door. She recovered after lying down for about 5-10 minutes. Later at school she complained of arm numbness and nausea. The patient returned to the clinic the same day for a recheck and was stable. There were no illnesses at the time of the vaccination. No laboratory diagnostic studies were performed. The patient recovered on 9-MAR-2007. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Influenza serology negative
Clinical narrative: Information has been received from a physician concerning a 13 year old female student with no medical history or illness at the time of vaccination who on 13-MAR-2007 was vaccinated at 15:00 with a first dose of GARDISIL (lot # 655619/1427F) (route of administration unknown). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was reported that 24 hours later (also reported as approximately 12 hours later at 03:00) the patient developed fever, chills, headache, dizziness, sore throat, abdominal pain and flu symptoms. It was noted that the patient vomited once. The patient went to the ER but was not hospitalized. On exam the patient was hypotensive and tachycardic. A rapid strep test and influenza A and B tests were negative. On 16-MAR-2007, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Pharyngolaryngeal pain, Pyrexia, Streptococcal identification test negative, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female student with no medical history or illness at the time of vaccination who on 13-MAR-2007 was vaccinated at 15:00 with a first dose of GARDISIL (lot # 655619/1427F) (route of administration unknown). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was reported that 24 hours later (also reported as approximately 12 hours later at 03:00) the patient developed fever, chills, headache, dizziness, sore throat, abdominal pain and flu symptoms. It was noted that the patient vomited once. The patient went to the ER but was not hospitalized. On exam the patient was hypotensive and tachycardic. A rapid strep test and influenza A and B tests were negative. On 16-MAR-2007, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Hypotension
Clinical narrative: Information has been received from a physician concerning a 13 year old female student with no medical history or illness at the time of vaccination who on 13-MAR-2007 was vaccinated at 15:00 with a first dose of GARDISIL (lot # 655619/1427F) (route of administration unknown). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was reported that 24 hours later (also reported as approximately 12 hours later at 03:00) the patient developed fever, chills, headache, dizziness, sore throat, abdominal pain and flu symptoms. It was noted that the patient vomited once. The patient went to the ER but was not hospitalized. On exam the patient was hypotensive and tachycardic. A rapid strep test and influenza A and B tests were negative. On 16-MAR-2007, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Influenza, Influenza serology negative, Oropharyngeal pain, Pyrexia, Streptococcal identification test negative
Clinical narrative: Information has been received from a physician concerning a 13 year old female student with no medical history or illness at the time of vaccination who on 13-MAR-2007 was vaccinated at 15:00 with a first dose of GARDISIL (lot # 655619/1427F) (route of administration unknown). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was reported that 24 hours later (also reported as approximately 12 hours later at 03:00) the patient developed fever, chills, headache, dizziness, sore throat, abdominal pain and flu symptoms. It was noted that the patient vomited once. The patient went to the ER but was not hospitalized. On exam the patient was hypotensive and tachycardic. A rapid strep test and influenza A and B tests were negative. On 16-MAR-2007, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Tachycardia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female student with no medical history or illness at the time of vaccination who on 13-MAR-2007 was vaccinated at 15:00 with a first dose of GARDISIL (lot # 655619/1427F) (route of administration unknown). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was reported that 24 hours later (also reported as approximately 12 hours later at 03:00) the patient developed fever, chills, headache, dizziness, sore throat, abdominal pain and flu symptoms. It was noted that the patient vomited once. The patient went to the ER but was not hospitalized. On exam the patient was hypotensive and tachycardic. A rapid strep test and influenza A and B tests were negative. On 16-MAR-2007, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 15-MAR-2007 was vaccinated with Gardasil (Lot # 656049/0187U). In approximately March 2007, the patient experienced pain at the injection site of the affected arm. On 13-APR-2007, the patient was seen by the physician and still affected arm. On 13-APR-2007, the patient was seen by the physician and still had pain in at the injection site and could not lift her arm. On 16-APR-2007, the patient was reported as recovering from the pain at the injection site. This is one of several patients reported by the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 15-MAR-2007 was vaccinated with Gardasil (Lot # 656049/0187U). In approximately March 2007, the patient experienced pain at the injection site of the affected arm. On 13-APR-2007, the patient was seen by the physician and still affected arm. On 13-APR-2007, the patient was seen by the physician and still had pain in at the injection site and could not lift her arm. On 16-APR-2007, the patient was reported as recovering from the pain at the injection site. This is one of several patients reported by the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 10-FEB-2007 was vaccinated with Gardasil (Lot number 656049/0187U). Subsequently the patient experienced pain at injection site and could not lift that arm. The pain occurred when the patient lifted her arm above her shoulder or if she rotated her arm. The patient sought unspecified medical attention. As of 16-APR-2007, it was unknown if the patient will get second dose. On 17-APR-2007, the patient was recovering from pain at injection site, inability to lift arm and pain when she lifted her arm above her head. This is one of several patients reported from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practioner and a licensed practical nurse concerning a female who on 10-FEB-2007 was vaccinated with Gardasil (Lot number 656049/0187U). Subsequently the patient experienced pain at injection site and could not lift that arm. The pain occurred when the patient lifted her arm above her shoulder or if she rotated her arm. The patient sought unspecified medical attention. As of 16-APR-2007, it was unknown if the patient will get second dose. On 17-APR-2007, the patient was recovering from pain at injection site, inability to lift arm and pain when she lifted her arm above her head. This is one of several patients reported from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Culture throat positive, Guttate psoriasis, Rash macular, Rash maculo-papular, Streptococcal identification test positive
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil (lot #654885/1424F). Concomitant therapy included Vaqta (Merck, Varivax (Merck) and Menactra. Within 24 hours, the patient experienced a rash on the trunk of her body. On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat. The patient subsequently recovered from the strep throat and the rash on the trunk of her body. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil (lot #654885/1424F). Concomitant therapy included Vaqta (Merck, Varivax (Merck) and Menactra. Within 24 hours, the patient experienced a rash on the trunk of her body. On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat. The patient subsequently recovered from the strep throat and the rash on the trunk of her body. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Culture throat positive, Pharyngitis streptococcal, Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil (lot #654885/1424F). Concomitant therapy included Vaqta (Merck, Varivax (Merck) and Menactra. Within 24 hours, the patient experienced a rash on the trunk of her body. On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat. The patient subsequently recovered from the strep throat and the rash on the trunk of her body. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 13-APR-2007 was vaccinated with a third oral dose of Rotateq (Lot# 655483/1116F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left thigh of Pediarix (Lot# AC21B084BA), a third intramuscular dose in the left thigh of PedvaxHib (Lot# 653771/0408F) and a third intramuscular dose in the right thigh of Prevnar (Lot# B08672D). At the time of vaccination the patient had otitis medical which was treated with Biaxin. It was reported that the patient was seen on 16-APR-2007 for diarrhea, vomiting, and dehydration beginning on 14-APR-2007. The patient had a fever to 103.5 on 15-APR-2007. The patient was admitted to the hospital on 16-APR-2007 and was discharged on 17-APR-2007. It was reported that the patient recovered on 27-APR-2007. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood sodium normal, Blood urea increased, Body temperature increased, Dehydration, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 13-APR-2007 was vaccinated with a third oral dose of Rotateq (Lot# 655483/1116F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left thigh of Pediarix (Lot# AC21B084BA), a third intramuscular dose in the left thigh of PedvaxHib (Lot# 653771/0408F) and a third intramuscular dose in the right thigh of Prevnar (Lot# B08672D). At the time of vaccination the patient had otitis medical which was treated with Biaxin. It was reported that the patient was seen on 16-APR-2007 for diarrhea, vomiting, and dehydration beginning on 14-APR-2007. The patient had a fever to 103.5 on 15-APR-2007. The patient was admitted to the hospital on 16-APR-2007 and was discharged on 17-APR-2007. It was reported that the patient recovered on 27-APR-2007. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 13-APR-2007 was vaccinated with a third oral dose of Rotateq (Lot# 655483/1116F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left thigh of Pediarix (Lot# AC21B084BA), a third intramuscular dose in the left thigh of PedvaxHib (Lot# 653771/0408F) and a third intramuscular dose in the right thigh of Prevnar (Lot# B08672D). At the time of vaccination the patient had otitis medical which was treated with Biaxin. It was reported that the patient was seen on 16-APR-2007 for diarrhea, vomiting, and dehydration beginning on 14-APR-2007. The patient had a fever to 103.5 on 15-APR-2007. The patient was admitted to the hospital on 16-APR-2007 and was discharged on 17-APR-2007. It was reported that the patient recovered on 27-APR-2007. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood creatinine normal, Blood urea increased, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 13-APR-2007 was vaccinated with a third oral dose of Rotateq (Lot# 655483/1116F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left thigh of Pediarix (Lot# AC21B084BA), a third intramuscular dose in the left thigh of PedvaxHib (Lot# 653771/0408F) and a third intramuscular dose in the right thigh of Prevnar (Lot# B08672D). At the time of vaccination the patient had otitis medical which was treated with Biaxin. It was reported that the patient was seen on 16-APR-2007 for diarrhea, vomiting, and dehydration beginning on 14-APR-2007. The patient had a fever to 103.5 on 15-APR-2007. The patient was admitted to the hospital on 16-APR-2007 and was discharged on 17-APR-2007. It was reported that the patient recovered on 27-APR-2007. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 13-APR-2007 was vaccinated with a third oral dose of Rotateq (Lot# 655483/1116F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left thigh of Pediarix (Lot# AC21B084BA), a third intramuscular dose in the left thigh of PedvaxHib (Lot# 653771/0408F) and a third intramuscular dose in the right thigh of Prevnar (Lot# B08672D). At the time of vaccination the patient had otitis medical which was treated with Biaxin. It was reported that the patient was seen on 16-APR-2007 for diarrhea, vomiting, and dehydration beginning on 14-APR-2007. The patient had a fever to 103.5 on 15-APR-2007. The patient was admitted to the hospital on 16-APR-2007 and was discharged on 17-APR-2007. It was reported that the patient recovered on 27-APR-2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deafness, Fall, Head injury, Syncope, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no drug reactions/allergies who on 28-MAR-2007 was vaccinated, IM with GARDASIL vaccine (lot # 654885/1424F). On 28-MAR-2007 the patient fainted and hit her head after receiving an immunization with GARDASIL. No lab diagnostics were performed. Subsequently, the patient recovered. Additional information has been requested.  This is in follow-up to  report (s) previously submitted on 5/14/2007.  Additioal information has been obtained on request by the Company and FDA under the Freedom of Information Act. The patient with a history of ingrown toenail was administered her first IM dose of GARDASIl vaccine (lot # 654885/1424F) on 28-MAR-2007 at 12:30 p.m. She was sitting when the vaccine was adminsitered, she got up from the exam table, stood beside the table. Patient fainted, falling on the floor hitting her head to left side. The patient said she stopped hearing and saw everything white. She was helped from the floor and placed on exam table in a lying down position.She was resting for 1 hour. After 1 hour the patient felt better and left the office walking. This report was filed with FDA. The VAERS number is 277187. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deafness, Fall, Head injury, Syncope, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no drug reactions/allergies who on 28-MAR-2007 was vaccinated, IM with GARDASIL vaccine (lot # 654885/1424F). On 28-MAR-2007 the patient fainted and hit her head after receiving an immunization with GARDASIL. No lab diagnostics were performed. Subsequently, the patient recovered. Additional information has been requested.  This is in follow-up to  report (s) previously submitted on 5/14/2007.  Additioal information has been obtained on request by the Company and FDA under the Freedom of Information Act. The patient with a history of ingrown toenail was administered her first IM dose of GARDASIl vaccine (lot # 654885/1424F) on 28-MAR-2007 at 12:30 p.m. She was sitting when the vaccine was adminsitered, she got up from the exam table, stood beside the table. Patient fainted, falling on the floor hitting her head to left side. The patient said she stopped hearing and saw everything white. She was helped from the floor and placed on exam table in a lying down position.She was resting for 1 hour. After 1 hour the patient felt better and left the office walking. This report was filed with FDA. The VAERS number is 277187. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 12 year old female patient with type II diabetes mellitus who on 30-MAR-2007 was vaccinated with 0.5 mL of Gardasil, lot #654885/1424F. Concomitant therapy included sodium fluoride. On 30-MAR-2007 the patient developed headache and dizziness 2-3 minutes after receiving the injection. Unspecified medical attention was sought. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested. Additional information was obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that on 30-MAR-2007, at 10:00 AM patient was vaccinated IM on her left upper arm with a first dose of GARDASIL lot #654885/1424F sitting on an examination table. 2-3 minutes after administering vaccine, patient complained of headache and dizziness. She was placed on examination table in a lying position. The orginal reporting source was not provided. This report was filed with the FDA. The VAERS number is 27718. This is a consoldation of two reports concerning the same patient. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Burning sensation, Haematoma, Injection site swelling, Skin reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced a small red rash at the injection site. The patient outcome was not reported and the patient sought unspecified medical attention. Additional information has been requested.Follow-up received 02/16/2009, 15 year old female with no drug allergies or medical history, who on 15-DEC-2006 was vaccinated with a frist does of GARDASIL vaccine and on 10-APR-2007 was vaccinated in the right arm with a second dose of GARDASIL vaccine (Lot# 656049/0187U). On 17-APR-2007 the patient developed a small red reash at the injection site and crescent shaped scarring. The patient did not have an illness at the time of the vaccination. At the time of the report, the patient had recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site scar
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced a small red rash at the injection site. The patient outcome was not reported and the patient sought unspecified medical attention. Additional information has been requested.Follow-up received 02/16/2009, 15 year old female with no drug allergies or medical history, who on 15-DEC-2006 was vaccinated with a frist does of GARDASIL vaccine and on 10-APR-2007 was vaccinated in the right arm with a second dose of GARDASIL vaccine (Lot# 656049/0187U). On 17-APR-2007 the patient developed a small red reash at the injection site and crescent shaped scarring. The patient did not have an illness at the time of the vaccination. At the time of the report, the patient had recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 13-APR-2007 was vaccinated with the first dose of Gardasil (lot #656049/0187U), 0.5 ml, injection. Concomitant therapy included hepatitis A virus vaccine (unspecified). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75, pulse 85 and one hour later the blood pressure 97/63, pulse 73 and oxygen saturation 99%. No Benadryl was given to the patient. Subsequently the patient recovered from the events that same day. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Blood glucose normal, Blood pressure decreased, Conversion disorder, Nightmare, Oxygen saturation
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 13-APR-2007 was vaccinated with the first dose of Gardasil (lot #656049/0187U), 0.5 ml, injection. Concomitant therapy included hepatitis A virus vaccine (unspecified). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75, pulse 85 and one hour later the blood pressure 97/63, pulse 73 and oxygen saturation 99%. No Benadryl was given to the patient. Subsequently the patient recovered from the events that same day. Additional information has been requested.