chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chills, Full blood count, Headache, Injection site induration
Clinical narrative: A 31 year old female patient, no illness at vaccination time, received on 13 July 2007 first dose of Adacel (lot# C2759AA), intramuscular, into the right arm. The next day, on 14 July 2007, she experienced fever of 102 F, stiff neck, neck of neck and head ache, lower back pain, chill and nausea. She had a 7 cm indurated and painful area around vaccine site. Symptoms lasted 3 days before recovering. CBC was done on an unspecified date results were unknown.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: A 31 year old female patient, no illness at vaccination time, received on 13 July 2007 first dose of Adacel (lot# C2759AA), intramuscular, into the right arm. The next day, on 14 July 2007, she experienced fever of 102 F, stiff neck, neck of neck and head ache, lower back pain, chill and nausea. She had a 7 cm indurated and painful area around vaccine site. Symptoms lasted 3 days before recovering. CBC was done on an unspecified date results were unknown.
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Injection site nodule
Clinical narrative: Cluster of 5 adult patients (no individual patient identification provided) had 6-7 cm redness with 2-3 cm "knot" under skin at the injection site after intramuscularly receiving Adacel (lot number and date of administration not reported), received from a nurse on 31 July 2007. The vaccine was given as a 5 year booster. It was reported that a 23 gauge 1 inch needle was used.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 09 August 2007. A 55 year old, female patient (with an allergy to sulfa drugs) developed a large local reaction of redness, swelling and pain at the injection site that has progressed halfway down the left arm, after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid and Tubersol (lot number C2508AA) intradermally in the right forearm on 01 August 2007. She also received Hep B (lot number 0420) in the right deltoid on 25 July 2007 and Hep (lot number 00420) in the left deltoid on 25 June 2007. The patient was treated with Keflex. She reported the adverse event to the physician on 08 August 2007 and is being evaluated a second time on 09 August 2007. After the time of the report, the patient had not recovered.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Initial report received from a health care provider on 16 August 2007. Four patients had received a dose of Adacel, lot number C2771AA, expiration 02/Nov/2009 and developed large local reaction at the site of injection. One patient had been evaluated at an emergency room and was discharged with a diagnosis of cellulitis. The needle size routinely utilized by this facility for vaccine administration had been reported as 25 gauge, 5/8 inch. Patient identifiers and the date of administration, route and site of administration, Latency of adverse event onset, and prior tetanus vaccination histories had not been reported. No additional information had been reported.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: A 14 year old male patient receive don 08 August 2007 a dose of Adacel (lot# C2730AA), intramuscular into the left deltoid. A day later, on 09 August 2007, he experienced severe headache for two days that was not improved with medications (Tylenol and Motrin). The injection site was swollen and red and he could barely move his arm. The patient had no other vaccine at the same time. The patient had no illnesses at vaccination time and had no pre-existing allergies or medical conditions. Concomitant medications included Zyrtec. The patient had no adverse event following prior vaccination. At the time of the report, the patient had not recovered.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Medication error, Pain
Clinical narrative: A patient, who is also a physician, received an intramuscular shoulder injection of Adacel (lot number not reported) on 03 August 2007. According to the reporter, the injection was given "high in the shoulder". On 04 August 2007, the patient began experiencing severe pain and difficulty moving her arm. Treatment included ibuprofen and one dose of Vicodin. The events were slowly improving, but remained ongoing at the time of the report. A corrective version was created on 27 August 2007, (with the LRD of the previous version), in order to amend the main screen of the case to medically confirmed.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse practitioner concerning a few patients who were vaccinated with the second dose of Rotateq between 11 and 13 weeks after the first dose. All of the patient received the third dose by 32 weeks. The reporter did not have the individual patient information. No further information is available. Follow up information indicated that no child had an adverse experience following the Rotateq. No additional information is expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 month old male with a history of respiratory syncytial virus infection and no drug allergies, who on 23-FEB-2007, 27-APR-2007 and 29-JUN-2007 at 13:50 was vaccinated with the first, second and third (Lot# 655317/0980F) 2ml oral does of Rotateq. There was no illness at the time of vaccination. Concomitant therapy included PEDIARIX. On 01-JUL-2007 the patient experienced mild vomiting and diarrhea. Unspecified medical attention was sought. No labs or diagnostic studies were performed. No treatment was required. Subsequently on 02-JUL-2007, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Haematemesis, Occult blood negative
Clinical narrative: Information has been received from a physician concerning a 4-month-old male who on 23-JUL-2007 was vaccinated with the second dose of ROTATEQ (Lot #657514/0667U). The physician reported that on 31-JUL-2007, the patient developed bloody emesis, loose stools and intermittent crying bouts. The patient's stool was tested and no blood was seen. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6-month-old male who in July 2007, was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot #654794/0776F). The physician reported that on 24-JUL-2007, the patient experienced diarrhea. Unspecified medical attention was sought. After almost two weeks of diarrhea, the patient recovered. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 15-month-old female who on 07-AUG-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq (Lot #656393/0240U). Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Secondary transmission, Vomiting
Clinical narrative: Information has been received from a physician concerning a mother who developed severe vomiting, diarrhea and fever after her daughter was vaccinated PO with the first dose of Rotateq. Unspecified medical attention was sought. Three days after onset, the mother's events resolved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6-month-old male who in August 2007, was vaccinated PO with a dose of Rotateq. The RN reported that in August 2007, the patient vomited after being vaccinated and the dose was re-administered. Unspecified medical attention was sought. No other adverse events were reported. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated on an unspecified date with a dose of Rotateq. Subsequently the patient developed a fever. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Echocardiogram abnormal
Clinical narrative: Information has been received from consumer concerning his 20 week old son with supraventricular tachycardia and no known allergies who on 22-MAY-2007 and 26-JUL-2007 was vaccinated with a first and second dose of Rotateq, respectively. The consumer reported that his son had an abnormal echocardiogram on 07-AUG-2007 after the second dose of Rotateq. The patient had no symptoms. The patient has been treated by a pediatric cardiologist since he was born because of a high neonatal heart rate. The patient has had two echocardiograms within normal parameters prior to the 09-AUG-2007 abnormal echocardiogram. The cardiologist will repeat the echocardiogram in one month. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with the first dose of Rotateq. The physician reported that the patient subsequently developed diarrhea. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. It was noted that the patient was discontinued from the series. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a mother concerning her approximately 44-week-old son who was vaccinated with the first (at 44-46 weeks of age) and second doses (at 55 weeks of age) of Rotateq. It was unknown if medical attention was sought. No symptoms were reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Hypersensitivity
Clinical narrative: Information ahs been received from a physician concerning a "few" month old female who was vaccinated with a dose of Rotateq (lot number not provided). It was reported that the patient had an allergic reaction. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a health professional concerning an 8 week old male with a history of gastroschisis repaired shortly after birth and no allergies, who on 16-JUL-2007 was vaccinated with an oral one tube dose of Rotateq (Lot# "0240U"). Concomitant vaccines included a dose of COMVAX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IPOL and a dose of PREVNAR. The patient's mother informed the reporter that the patient had loose stools, up to 6 or 7 daily since the date of vaccination, on 16-JUL-2007. A stool culture was positive for rotavirus. No other symptoms were noted. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 11-APR-2007 was vaccinated with the first oral dose of Rotateq. On 09-AUG-2007 the patient was vaccinated with the second oral dose of Rotateq, 17 weeks after the first dose. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HIBV, RV5
Symptoms: Body temperature increased, Diarrhoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician's assistant concerning her 2 month old daughter with no pertinent medical history or drug allergies, who in February 2007 was vaccinated with her first oral dose of Rotateq. Concomitant therapy included Hib conj vaccine. In February 2007, within 24 hours of vaccination the patient developed severe diarrhea and fever of at least 102 f. Unspecified medical attention was sought. No other labs or diagnostic studies were performed. Subsequently the symptoms persisted for 48 hours and then the patient recovered while on therapy (unspecified). In 2007, the patient received her second oral dose of Rotateq and only developed a little diarrhea. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, UNK
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 month old male who in August 2007, was vaccinated with his first oral dose of Rotateq (No lot number was given). In August 2007, the patient developed urticaria a day or so after vaccination. Concomitant unspecified vaccinations were administered within the same visit. Unspecified medical attention was sought. It was noted that the physician was planning on discontinuing Rotateq. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from a physician concerning an 2 month old patient who was vaccinated with the first dose of Rotateq. The patient developed nasopharyngitis. The patient sought medical attention via ER visit and was treated with a dose of penicillin (unspecified). Subsequently, the patient recovered and was noted to be fine. There was no product quality complaint. Additional information has been requested.
Age: 0.62
Sex: M
Vaccine: HEP, HIBV, IPV, PPV, RV5, TDAP
Symptoms: Rash papular, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 month old male who in June 2007, was vaccinated with a 2ml oral dose of ROTATEQ (Lot# not provided). In June 2007, the patient developed fine papules a few days after the second dose. Unspecified medical attention was sought. There was no information when the first dose of ROTATEQ was given. Subsequently the patient was noted to be recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 7 month old male who on 12-JUL-2007 (previously reported as June 2007) was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 656705/0241U). Concomitant vaccinations administered that day included an IM dose of poliovirus vaccine inactivated (unspecified) (lot# 205482), an IM dose of hepatitis B virus vaccine (unspecified) (Lot# "AHB40206"), an IM dose of Tdap (lot# U19858A), an IM dose of Hib conj vaccine (unspecified carrier) (lot# UF104A) and an IM dose of PNEUMOVAX 23 (lot# 808692B). On the same day, the patient developed a fever lasting " a few days." On 16-JUL-2007 the patient also developed fine papules described as a generalized rash. The patient was seen in the clinic on 18-JUL-2007 for the rash. No medication was given, observation and follow-up phone call were made. Patient returned to clinic two weeks later for daycare forms. Subsequently, the patient recovered. There was no information when the first dose of ROTATEQ given. There was no product quality complaint. Additional information is not expected.
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a mother concerning her daughter who on 14-AUG-2007 was vaccinated with a first 2 ml oral dose of Rotateq. It was reported that the patient spit out the vaccine at the physician's office. The patient's mother then asked the office for a replacement dose to give to the patient again when she got home. The patient's mother gave the patient another dose, and it was spit out again. It was reported that the patient had no ill effects from the event. No product quality complaint was involved. Additional information is not expected.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Full blood count, Gastroenteritis rotavirus, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning an 8 month old 18.5 pound, 25 inch female, with no medical history and no allergies, who was vaccinated with a first, second, and third 2 ml oral dose of Rotateq on 29-JAN-2007 (Lot# 656101/1231F), 29-MAR-2007 (Lot# 656388/0506U), and 30-MAY-2007 (lot# 656388/0506U), respectively. There was no concomitant medication. There was no reported illness at the time of vaccination. On 06-AUG-2007 (previously reported as 02-AUG-2007), the patient experienced nausea, vomiting, and diarrhea that was diagnosed as rotavirus infection. Follow up information from the physician's office reported that she was seen in the in the office by her physician. On 06-AUG-2007, diagnostic studies obtained were positive for rotavirus (source unspecified), and stool specimens that were negative for leukocytes, ova and parasites, and enteric pathogens. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Nausea, Rotavirus infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 8 month old 18.5 pound, 25 inch female, with no medical history and no allergies, who was vaccinated with a first, second, and third 2 ml oral dose of Rotateq on 29-JAN-2007 (Lot# 656101/1231F), 29-MAR-2007 (Lot# 656388/0506U), and 30-MAY-2007 (lot# 656388/0506U), respectively. There was no concomitant medication. There was no reported illness at the time of vaccination. On 06-AUG-2007 (previously reported as 02-AUG-2007), the patient experienced nausea, vomiting, and diarrhea that was diagnosed as rotavirus infection. Follow up information from the physician's office reported that she was seen in the in the office by her physician. On 06-AUG-2007, diagnostic studies obtained were positive for rotavirus (source unspecified), and stool specimens that were negative for leukocytes, ova and parasites, and enteric pathogens. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 22 week old female who on 10-MAY-2007 and 15-AUG-2007 was vaccinated with the first and second dose of Rotateq. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 17-week-old male who in January 2007, was vaccinated PO with a second 2mL dose of Rotateq (Lot # "1116S"). Concomitant therapy that day included a dose of PEDIARIX, a dose of PREVNAR, and a dose of Hib conj vaccine. On 20-MAR-2007 the patient experienced diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from diarrhea. Therapy with Rotateq was discontinued. No additional information was provided. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of Rotateq at four months of age but did not receive the vaccine at two months. It was reported that the patient's mother did not want the child to be vaccinated but the nurse accidentally gave the patient the dose at four months "assuming it was part of routine vaccination". There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician and a healthcare office worker concerning a patient who on 14-AUG-2007 and 16-AUG-2007 was vaccinated with the first and second oral dose of Rotateq (Lot# 656705/0241U). The patient was not experiencing any known symptoms. Medical attention was sought via physician's office by phone. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25.4 week old female who on 17-AUG-2007 was vaccinated with her first oral dose of Rotateq. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 week old female who on 21-JUN-2007 was vaccinated with the first dose of Rotateq (656195/0025U) and developed diarrhea for two weeks. The patient's mother refused to continue with the doses. The patient's formula was changed. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: IPV, RV5
Symptoms: Convulsion, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 8 month old male with congenital adrenal hyperplasia, "AGI", and a history of sepsis victoriana who on 22-AUG-2007 was vaccinated with his third oral dose of Rotateq (Lot# 656379/0505U). Concomitant vaccinations included poliovirus vaccine inactivated (Lot# Z0547) and other multiple medications (specifics unknown). On that same day, the patient developed a high fever and a seizure a few hours after vaccination and was hospitalized. The patient's lab diagnostic studies included bloodwork taken regularly. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first 2.0 mL dose of Rotateq (lot number not provided). The physician reported that the patient subsequently developed vomiting and diarrhea. Unspecified medical attention was sought and the patient was subsequently hospitalized. At the time of this report, the outcome was unknown. Additional information has been requested. Follow-up information was received from a nurse in the physician's office indicating that the patient was not a patient of the physician. The physician had read an article about the patient's experience. No further information is availble.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 17-week female who on 20-APR-2007 and 21-JUN-2007 was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (Lot #656384/0237U). The physician reported that on 24-JUN-2007, the patient developed severe diarrhea. Unspecified medical attention was sought. On 28-JUN-2007, the patient was hospitalized. On 10-JUL-2007, the patient was discharged from the hospital. The patient subsequently recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of Rotateq at 4 months of age. No symptoms were noted. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 week old male who on approximately 13-JUN-2007 (reported as 10 weeks ago) was vaccinated with the first dose of Rotateq, which was reported as older than the recommended age. It was reported that the patient was to receive the second dose on 22-AUG-2007. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infantile spitting up, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 22-FEB-2007 was vaccinated with his first oral dose of Rotateq. on 23-FEB-2007 the patient was splitting up and vomiting, followed by an increased mark of emesis on 25-FEB-2007. No medical attention was sought. Subsequently, the patient recovered. The patient was not given the other two doses of Rotateq. There was no product quality complaint. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 32 week old patient who was vaccinated with a third dose of Rotateq at 32.5 weeks instead of at 32 weeks. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a person working in a physician's office concerning a child who was vaccinated with the first and second oral dose of Rotateq. Subsequently the patient developed persistent diarrhea for six weeks after the first dose. Medical attention was sought through a pediatric gastroenterologist and the diarrhea "had resolved". Subsequently, the patient recovered. There was no adverse experience with the second dose. There was no product quality complaint.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Vomiting
Clinical narrative: Information has been received from the patient's mother concerning an 8 week old white female (weight 18lbs, 15 oz., height 23 1/2 ") who on 24-APR-2007 was vaccinated with the first dose of Rotateq (lot # 656383/0235U). Concomitant vaccines administered the same day included PEDIARIX, intramuscularly in the left thigh (LOT# AC21B132BA), PEDVAXHIB, intramuscularly in the right thigh (LOT# 654679/1126F) and PREVNAR, intramuscularly in the right thigh (LOT# B08646C). The patient had no illness a time of vaccination. On 26-APR-2007, two days after receiving Rotateq, the patient experienced vomiting and diarrhea. On 03-MAY-2007, the patient was seen in the doctor's office with vomiting and diarrhea. A stool culture was performed which showed no enteric pathogens; negative for ROTAVIRUS, GIARDIA AG, and CRYPTOSPORIDIUM. The patient's outcome was not reported. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Infantile spitting up
Clinical narrative: Information has been received from a medical assistant concerning a 20 week old male patient who on 16-MAR-2007 was vaccinated with first dose of Rotateq. On 13-JUN-2007, 12 weeks after first dose, the patient received the second dose of Rotateq. The patient spit up within 15 minutes of administration of his second dose and also the third dose of Rotateq on 23-AUG-2007. The patient may have received an incomplete second and third dose. The patient did not experience any further problems. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9-month-old white female with no medical history who on 19-DEC-2006 (Lot #654664/0726F), 19-FEB-2007 (Lot #655406/1114F) and 19-APR-2007 (Lot #655485/1033F) was vaccinated PO with the first, second and third doses, respectively, of Rotateq. There was no illness at the time of vaccination. The RN reported that on 26-JUL-2007, the patient developed diarrhea. On 29-JUL-2007, the patient was taken to the Emergency Room (ER). The patient tested positive for rotavirus. A stool leukocyte smear showed no polymorphonuclear cells, a stool culture revealed no Salmonella, Shigella or Campylobacter and a C. diff toxin assay was non-reactive for toxin A or B. The patient was placed on Isomil DF formula and a diarrhea diet. On 01-AUG-2007, the patient's stools were noted to be normal. No further information is available.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 22 week old male who on 17-JUN-2007 was vaccinated with a first dose of Rotateq.  It was reported that, on 30-AUG-2007, the patient was in the office for the second dose.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Decreased appetite, Reaction to previous exposure to any vaccine, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a healthcare professional and a physician concerning a 4 month old patient with no pre-existing medical history or allergies who on 16-AUG-2007 at 09:15 was vaccinated with the second oral dose of ROTATEQ (lot# 657291/0669U). There was no illness at the time of vaccination. No adverse events were following prior vaccination. Concomitant vaccination administered that day included the second dose of COMVAX (lot# 655552/0002U) in the right thigh, a second dose of PREVNAR (lot# B70145E) in the left thigh and the second dose of DAPTACEL (lot# C2650AH) in the left thigh. On that same day (also reported as 17-AUG-2007), the patient experienced forceful vomiting and decreased appetite.  Medical attention was sought through the patient's physician.  The patient had no fever but the vomiting and decreased appetite persisted. The patient experienced vomiting every other day. The emesis had blood tinge in it for 2 episodes only but has since resolved. The patient's bottle nipples were changed which may have contributed. The patient's exam was normal. No other labs or diagnostic studies were performed. On 04-SEP-2007 the patient recovered. There was no weight gain. There was no product quality complaint. No further information is available. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 week old female who on 07-AUG-2007 was vaccinated with the second 2ml oral dose of Rotateq (Lot# 656393/0240U).  Concomitant therapy included PEDIARIX and PREVNAR.  On 13-AUG-2007 the patient experienced a fever of 102.3 after vaccination.  Unspecified medical attention was sought.  The recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on an unspecified date "couple of weeks ago" was vaccinated with Gardasil (lot# unknown) injection.  Concomitant therapy included MENACTRA and Varivax (MSD) (lot# unknown).  The patient experienced syncope "1 or 2 minutes" after receiving the Gardasil vaccination.  Medical attention was sought.  The nurse had given the patient a Popsicle.  The patient had fully recovered and walked out of the office the same day as the vaccination.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 24 year old female with an iodine allergy, a bicornuate uterus, endometriosis and a "partial duplication of the left renal collecting system" who on 17-MAY-2007 was vaccinated with a first dose of Gardasil.  On 18-JUL-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 658094/0524U).  Concomitant therapy included YAZ.  In July 2007 a couple of days after vaccination she developed an erythematous rash on her chest, back and arms.  The patient was treated with BENADRYL.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who in August 2007, "last week" was vaccinated with a first dose of Gardasil (lot # unknown) 0.5mL injection.  Concomitant vaccinations included MENACTRA.  In August 2007, "last week" the patient fainted after receiving her first dose of Gardasil.  Medical attention was sought.  At the time of reporting it is unknown if the patient had recovered.  No additional information was provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil.  Subsequently the next day the patient's lip puffed up.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  The physician reported that the puffed lip may not be related to the Gardasil.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Bursitis, Drug administered at inappropriate site, Hypoaesthesia, Injection site anaesthesia, Joint effusion
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on unspecified dates was vaccinated with a  first and second dose of GARDISIL (lot# unknown).  The physician reported that there was no adverse event with the first and second dose of Gardasil.  On 08-AUG-2007(previousl reported as 08-AUG-2007) the patient was vaccinated with a third dose of Gardasil (lot# unknown) injection in the left deltoid.  On 09-AUG-2007 the patient called the office and reported that her arm was injected became numb from the shoulder to the wrist area.  Medical attention was sought.  On an unspecified date a scan of the patient's arm was performed with results not reported.  The physician believed that the injection was given too high in the patient's arm and that may have been the cause of the patient's arm going numb.  No further adverse event information was given.  Follow up information was received. 07-AUG-2007 the patient developed increasing pain in the left shoulder on motion. On 09-AUG-2007 the patient had an MRI of the left shoulder. The impression was sizable joint effusion with evidence for subacromial/subdeltoid bursitis as well as edema within the infraspinatus muscle near th myotendinous junction. These findings may be related to muscle strain/partial tear involving the infra-articular left shoulder injection. Recommend correlation with history of any attempted therapeutic left shoulder injection. At the time of reporting on 21-SEP-2007 the patient had improved 80-90%. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema, Pain, Scan
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on unspecified dates was vaccinated with a  first and second dose of GARDISIL (lot# unknown).  The physician reported that there was no adverse event with the first and second dose of Gardasil.  On 08-AUG-2007(previousl reported as 08-AUG-2007) the patient was vaccinated with a third dose of Gardasil (lot# unknown) injection in the left deltoid.  On 09-AUG-2007 the patient called the office and reported that her arm was injected became numb from the shoulder to the wrist area.  Medical attention was sought.  On an unspecified date a scan of the patient's arm was performed with results not reported.  The physician believed that the injection was given too high in the patient's arm and that may have been the cause of the patient's arm going numb.  No further adverse event information was given.  Follow up information was received. 07-AUG-2007 the patient developed increasing pain in the left shoulder on motion. On 09-AUG-2007 the patient had an MRI of the left shoulder. The impression was sizable joint effusion with evidence for subacromial/subdeltoid bursitis as well as edema within the infraspinatus muscle near th myotendinous junction. These findings may be related to muscle strain/partial tear involving the infra-articular left shoulder injection. Recommend correlation with history of any attempted therapeutic left shoulder injection. At the time of reporting on 21-SEP-2007 the patient had improved 80-90%. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a female consumer "under 18", who, on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently, the patient's arm was hurting at night.  The patient did not seek medical attention.  At the time of the report, the patient's outcome was unknown.  Additional information is not available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who on 22-MAY-2007 was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 ml IM.  There was no concomitant medication.  On 26-JUL-2007 the patient was vaccinated with a second dose of Gardasil (658094/0524U).  In the same day the patient developed a large number of canker sores all over in her mouth.  Medical attention was sought.  The patient did not have any adverse events after the first dose.  At the time of reporting the patient was still recovering.  Follow up information was received from a physician.  As of 15-AUG-2007 the patient had two sores left in her mouth.  No further information was provided regarding this adverse experience.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  Unspecified medical attention was sought.  The patient was fine after a little while, recovered and went home.  The office manager reported that the office now lays down the patients while administering Gardasil and makes them stay there for at least 30 minutes.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Culture throat negative, Facial palsy, Muscular weakness, Pharyngitis streptococcal, Pharyngolaryngeal pain
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse concerning a 16 year old female student with no drug allergies and reactive airway disease, who on 23-JUL-2007 was vaccinated intramuscularly in the right arm with a 0.5mL dose of Gardasil. Concomitant vaccination administered intramuscularly in the left arm included a dose of MENACTRA.  There were no illnesses at the time of vaccination. On 23-JUL-2007 for a period of "24 to 48 hours the patient experienced muscle weakness and droopiness of the face."  The patient sought unspecified medical attention.  The patient recovered spontaneously within 24-48 hours.  The physician did not know if her experiences were related to the MENACTRA or the Gardasil and was wondering if she should continue with the series.  On 05-AUG-2007 the patient was seen in the office and diagnosed with strep throat.  She was treated with amoxicillin for 10 days.  The patient recovered and it was reported that the sore throat was not related to the vaccination with Gardasil.  On 30-AUG-2007 the patient was seen after office hours at the emergency room for a sore throat.  A strep culture was performed and was negative.  The patient was started on KEFLEX but that was discontinued since the strep test was negative.  This was also unrelated to the vaccinations.  The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Malaise, Nausea, Oxygen supplementation
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a yeast hypersensitivity, a history of yeast infections and rashes who on 11-AUG-2007 at 9:15am was vaccinated intramuscularly into the left deltoid with a first dose of Gardasil (658556/1060U).  There was no concomitant medication.  On 11-AUG-2007 at 9:20 am the patient felt dizzy and nauseated within minutes of the vaccination. The patient was placed in a reclining position and treated with 1 liter of oxygen nasal cannula. A cool, wet compress was placed on her forhead. Her blood pressure was 94/57. At 9:30 patient reported she was feeling better. Patient also reported that she had not eaten in the A.M. At 9:50 am patient was talking and feeling better. At 10:20 am patient was discharged to home and stated she was feeling well. Patient was instructed to call the office an Monday to report condition. On 11-AUG-2007 at 2:15 pm a call was placed to the patient. She reported not feeling well the rest of the day of vaccination and that on 12-AUG-2007 she recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a yeast hypersensitivity, a history of yeast infections and rashes who on 11-AUG-2007 at 9:15am was vaccinated intramuscularly into the left deltoid with a first dose of Gardasil (658556/1060U).  There was no concomitant medication.  On 11-AUG-2007 at 9:20 am the patient felt dizzy and nauseated within minutes of the vaccination. The patient was placed in a reclining position and treated with 1 liter of oxygen nasal cannula. A cool, wet compress was placed on her forhead. Her blood pressure was 94/57. At 9:30 patient reported she was feeling better. Patient also reported that she had not eaten in the A.M. At 9:50 am patient was talking and feeling better. At 10:20 am patient was discharged to home and stated she was feeling well. Patient was instructed to call the office an Monday to report condition. On 11-AUG-2007 at 2:15 pm a call was placed to the patient. She reported not feeling well the rest of the day of vaccination and that on 12-AUG-2007 she recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Malaise, Nausea, Oxygen supplementation
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with sensitivity to yeast who on 11-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658556/1060U) IM.  On 11-AUG-2007 the patient developed nausea and dizziness after receiving the first dose.  Medical attention was sought.  The patient requested that she be administered oxygen as this usually made her feel better after her vaccinations.  The patient did not pass out.  Follow-up information was received via telephone from the registered nurse.  The registered nurse reported that immediately following vaccination the patient felt nauseous and dizzy.  The patient recovered within minutes (date recovered 11-AUG-2007).  The events were considered to be non-serious.  No further information was available.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with sensitivity to yeast who on 11-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658556/1060U) IM.  On 11-AUG-2007 the patient developed nausea and dizziness after receiving the first dose.  Medical attention was sought.  The patient requested that she be administered oxygen as this usually made her feel better after her vaccinations.  The patient did not pass out.  Follow-up information was received via telephone from the registered nurse.  The registered nurse reported that immediately following vaccination the patient felt nauseous and dizzy.  The patient recovered within minutes (date recovered 11-AUG-2007).  The events were considered to be non-serious.  No further information was available.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Panic attack
Clinical narrative: Information has been received from a 22 year old female, who, on an unspecified date, was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced a panic attack.  The patient went to the emergency room but was not admitted.  At the time of the report she was still experiencing the panic attacks.  No product quality complaint was involved.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Asthenia, Gaze palsy, Hypotonia, Pallor
Clinical narrative: Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 11-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U).  Concomitant suspect vaccine on 11-AUG-2007 included Varivax (MSD).  Other concomitant vaccine included MENACTRA.  Gardasil was the last of the three vaccines given that day.  On 11-AUG-2007, a second after the vaccines, "the patient got pale, weak, slumped to her side and her eyes went back for a second."  The patient then got up real quick and the physician gave her water.  It was reported that "the patient was fine."  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 13 year old female, who on 13-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil.  Subsequently, within 24 hours post vaccination the patient developed "diffuse hives."  It was reported that the patient did use Nair hair remover the morning she received the vaccine which the physician feels could be the cause.  The patient was treated with two doses of BENADRYL.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.