chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: The case was reported by a healthcare professional and described the occurrence of fever in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline), PNEUMOVAX, (Merck) and Tetanus diphtheria vaccine (Sanofi Pasteur).  On an unspecified date in September 2008, the subject received an unspecified dose of FLULAVAL (.5 unknown), an unspecified dose of PNEUMOVAX (unknown), and and unspecified dose of Tetanus diphtheria vaccine (unknown).  At and unspecified time after vaccination with FLULAVAL, PNEUMOVAX and Tetanus diphtheria vaccine, the subject experienced fevers of over 102 degrees Fahrenheit during the next five days.  The subject treated her symptoms at home, but was seen in the physician's office for a follow-up.  At the time of reporting, the event was improved.  Follow-up information received on 07 October 2008 indicated that the subject was 51 years old at the time of event.  She had never had flu or Pneumovax.  The subject's fever went up to 104 degrees F for 1 to 2 days starting on 12 September 2008 and then resolved.  In  the reporter's opinion, the event was possibly related to treatment with FLULAVAL.  All vaccines were administered intramuscularly at a dose of 0.5 ml each.  FLULAVAL and Pneumovax were administered in the same unknown arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a female subject aged between 40 and 49 year old who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 08 September 2008, the subject received unspecified dose of FLULAVAL (.5 unknown, unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced severe arm pain and presented to the emergency room for treatment, where she was prescribed prednisone at 40 mg for five days, vicodin and antibiotics.  The subject was seen for follow-up at the physician's office on 15 September 2008, when she informed the reporting nurse of the event.  The subject told the nurse that she did not know why she was prescribed the antibiotics.  At the time of reporting, the event was improved.  The healthcare professional considered the event was probably related to vaccination with FLULAVAL.  Follow-up information received on 07 October 2008 indicated that the subject was 40 year old at the time of events.  FLULAVAL was administered in an unknown arm.  On 12 September 2008, the subject experience arm pain and had swelling.  She was treated with Prednisone, Vicodin and Keflex.  The events resolved. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was  reported that 20 flu shots were given and three subjects got sick.  Linked cases include A0749130A and A0749131A.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was reported that 20 flu shots were given and three subjects got sick.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 18-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included unknown allergies. Concurrent medications included Allergy injection.  On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 14 November 2008, via pharmacist, who reported the subject was given FLULAVAL intradermally in the right forearm. The site was swollen and red for three days. The events resolved on 19 September 2008. The pharmacist considered the events possibly related to vaccination with FLULAVAL. The events were also associated with erroneous administration.
Age: 15.0
Sex: M
Vaccine: DTAP, FLU3, UNK
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 15-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent vaccinations included TDAP vaccine (unknown manufacturer) and an unknown vaccine (unknown manufacturer) both given on 16 September 2008. On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  This was also considered to be a medication error as FLULAVAL is not indicated for use in subjects under the age of 18.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced right shoulder pain, pain in side of neck and swollen neck.  At the time of reporting the outcome of the events was unspecified.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of upper arm pain in a 57-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced upper arm pain and pain in lower arm.  At the time of reporting the outcome of the events was unspecified.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 38-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain, neck pain and was unable to move arm at the shoulder.  At the time of reporting the outcome of the events was unspecified.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 25-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL, (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain, pain going down the left arm and it was painful to move the arm.  At the time of reporting the outcome of the events was unspecified.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 59-year-old female subject who was vaccinated with (FLULAXAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain and was unable to lift the arm.  At the time of reporting the outcome of the events was unspecified.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of upper arm pain in a 40-year-old male subject who was vaccinated with influenza vaccine trivalent (FLULAVAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL, the subject experienced right upper arm pain.  At the time of reporting the outcome of the event was unspecified.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications.  On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm.  On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness.  The drug was also administered via the incorrect route.  FLULAVAL should have been given intramuscularly.  At the time of reporting the events were unresolved.  This event occurred in three subject.  Linked cases include A0745549A and A0746650A.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Immediate post-injection reaction, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This case was initially reported by a healthcare professional (also subject's grandmother), via a GSK sales representative, that described the occurrence of swollen thigh (injection site) in a female subject aged between 4 and 6 years old who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date in the last week of September 2008, the subject received an unspecified dose of KINRIX (.5 ml, unknown, left thigh).  Immediately after vaccination with KINRIX, the subject experienced swollen thigh (injection site) described as entire thigh swelling, injection site pain and injection site burning.  At the time of initial reporting, the outcome of the events was unspecified.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up was received by the healthcare professional (also the subject's grandmother).  The subject, a 4-year-old female, received the "primary" dose of KINRIX on 25 September 2008.  Immediately after vaccination with KINRIX, on 25 September 2008, the subject experienced swollen thigh (injection site) described as entire thigh swelling, infection site pain and injection site burning.  The events resolved on 07 October 2008.  The healthcare professional identified KINRIX as the suspect product.
Age: 26.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site streaking
Clinical narrative: Redness, swelling, tenderness extending from upper right shoulder to elbow, red streak extending from right shoulder diagonally across right chest to mid-breast, onset approximately 48 hrs following receipt of SPV, right arm, and typhoid vaccine, no systemic symptoms.  Evaluated in hospital ER & diagnosed with "allergic reaction to smallpox vaccine";  treated with oral antibiotics and BENADRYL with full recovery 2 days later.  No medical record documentation available at this time.  Unknown if prior VAERS filed.    Erythema, Edema @ injection site > 120 mm not beyond elbow, Tenderness.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Bowel movement irregularity, Small intestinal obstruction, Urinary system X-ray, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 week old male with a medical history of hydrocele-small, who on 26-JUN-2008 was vaccinated with ROTATEQ (Lot #660684/0301X) by mouth, ACT HIB (Sanofi Pasteur, Lot #UF262AA) intramuscular in the left leg, DAPTACEL (Sanofi Pasteur, Lot #C2934AA) intramuscular in the left leg, RECOMBIVAX HB (Lot #1884U) intramuscular in the right leg, PREVNAR (Wyeth Pharmaceutical, Lot #C49271) and IPOL (Sanofi Pasteur, Lot #A0492) subcutaneously in the left leg. On 01-JUL-2008, the 11 week old infant was taken to the office after beginning to vomit "green emesis" in the night with no fever. The patient had no stools during the day at daycare but although he usually had several stools daily. KUB was performed and showed a small bowel obstruction with dilated small bowel. The doctor transferred the patient to the hospital for surgery because of the possibility of malrotation of the bowel. Between 2-3-JUL-2008 and 3-7-JUL-2008, the patient was diagnosed with intussusception and recurrent intussusception. The patient initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool. A physical exam later was positive for an abdominal mass. Barium enema was unable to reduce the intussusception, so the patient was taken to the operating room for exploratory laparotomy, reduction of ileocolic intussusception and inversion appendectomy. The patient was discharge at 03-JUL-2008 but returned on the same day with bilious projectile vomiting and lethargy. The patient had mucously stool in ER. The barium enema was repeated and did not showed IS but an abdominal computed axial tomography confirmed IS. The patient returned to the operating room for reduction. Nasogastric tube was placed post operation, which was removed and post operative advanced. The patient was discharged at the second day post operative. On 15-SEP-2008, the patient's medical record was received for the date of service (DOS). The adverse events were reported as serious and life threatening. A lot check has been requested. The original reporting was not provided. The VAERS ID # 323331-1. A standard lot check investigation was performed for lot numbers 0660684/0301X and 0659666/1884U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Appendicectomy, Barium enema abnormal, Bowel movement irregularity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 week old male with a medical history of hydrocele-small, who on 26-JUN-2008 was vaccinated with ROTATEQ (Lot #660684/0301X) by mouth, ACT HIB (Sanofi Pasteur, Lot #UF262AA) intramuscular in the left leg, DAPTACEL (Sanofi Pasteur, Lot #C2934AA) intramuscular in the left leg, RECOMBIVAX HB (Lot #1884U) intramuscular in the right leg, PREVNAR (Wyeth Pharmaceutical, Lot #C49271) and IPOL (Sanofi Pasteur, Lot #A0492) subcutaneously in the left leg. On 01-JUL-2008, the 11 week old infant was taken to the office after beginning to vomit "green emesis" in the night with no fever. The patient had no stools during the day at daycare but although he usually had several stools daily. KUB was performed and showed a small bowel obstruction with dilated small bowel. The doctor transferred the patient to the hospital for surgery because of the possibility of malrotation of the bowel. Between 2-3-JUL-2008 and 3-7-JUL-2008, the patient was diagnosed with intussusception and recurrent intussusception. The patient initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool. A physical exam later was positive for an abdominal mass. Barium enema was unable to reduce the intussusception, so the patient was taken to the operating room for exploratory laparotomy, reduction of ileocolic intussusception and inversion appendectomy. The patient was discharge at 03-JUL-2008 but returned on the same day with bilious projectile vomiting and lethargy. The patient had mucously stool in ER. The barium enema was repeated and did not showed IS but an abdominal computed axial tomography confirmed IS. The patient returned to the operating room for reduction. Nasogastric tube was placed post operation, which was removed and post operative advanced. The patient was discharged at the second day post operative. On 15-SEP-2008, the patient's medical record was received for the date of service (DOS). The adverse events were reported as serious and life threatening. A lot check has been requested. The original reporting was not provided. The VAERS ID # 323331-1. A standard lot check investigation was performed for lot numbers 0660684/0301X and 0659666/1884U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram abnormal, Crying, Enema administration, Gastrointestinal tube insertion, Haematochezia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 week old male with a medical history of hydrocele-small, who on 26-JUN-2008 was vaccinated with ROTATEQ (Lot #660684/0301X) by mouth, ACT HIB (Sanofi Pasteur, Lot #UF262AA) intramuscular in the left leg, DAPTACEL (Sanofi Pasteur, Lot #C2934AA) intramuscular in the left leg, RECOMBIVAX HB (Lot #1884U) intramuscular in the right leg, PREVNAR (Wyeth Pharmaceutical, Lot #C49271) and IPOL (Sanofi Pasteur, Lot #A0492) subcutaneously in the left leg. On 01-JUL-2008, the 11 week old infant was taken to the office after beginning to vomit "green emesis" in the night with no fever. The patient had no stools during the day at daycare but although he usually had several stools daily. KUB was performed and showed a small bowel obstruction with dilated small bowel. The doctor transferred the patient to the hospital for surgery because of the possibility of malrotation of the bowel. Between 2-3-JUL-2008 and 3-7-JUL-2008, the patient was diagnosed with intussusception and recurrent intussusception. The patient initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool. A physical exam later was positive for an abdominal mass. Barium enema was unable to reduce the intussusception, so the patient was taken to the operating room for exploratory laparotomy, reduction of ileocolic intussusception and inversion appendectomy. The patient was discharge at 03-JUL-2008 but returned on the same day with bilious projectile vomiting and lethargy. The patient had mucously stool in ER. The barium enema was repeated and did not showed IS but an abdominal computed axial tomography confirmed IS. The patient returned to the operating room for reduction. Nasogastric tube was placed post operation, which was removed and post operative advanced. The patient was discharged at the second day post operative. On 15-SEP-2008, the patient's medical record was received for the date of service (DOS). The adverse events were reported as serious and life threatening. A lot check has been requested. The original reporting was not provided. The VAERS ID # 323331-1. A standard lot check investigation was performed for lot numbers 0660684/0301X and 0659666/1884U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Laparotomy, Lethargy, Mucous stools, Small intestinal obstruction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 week old male with a medical history of hydrocele-small, who on 26-JUN-2008 was vaccinated with ROTATEQ (Lot #660684/0301X) by mouth, ACT HIB (Sanofi Pasteur, Lot #UF262AA) intramuscular in the left leg, DAPTACEL (Sanofi Pasteur, Lot #C2934AA) intramuscular in the left leg, RECOMBIVAX HB (Lot #1884U) intramuscular in the right leg, PREVNAR (Wyeth Pharmaceutical, Lot #C49271) and IPOL (Sanofi Pasteur, Lot #A0492) subcutaneously in the left leg. On 01-JUL-2008, the 11 week old infant was taken to the office after beginning to vomit "green emesis" in the night with no fever. The patient had no stools during the day at daycare but although he usually had several stools daily. KUB was performed and showed a small bowel obstruction with dilated small bowel. The doctor transferred the patient to the hospital for surgery because of the possibility of malrotation of the bowel. Between 2-3-JUL-2008 and 3-7-JUL-2008, the patient was diagnosed with intussusception and recurrent intussusception. The patient initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool. A physical exam later was positive for an abdominal mass. Barium enema was unable to reduce the intussusception, so the patient was taken to the operating room for exploratory laparotomy, reduction of ileocolic intussusception and inversion appendectomy. The patient was discharge at 03-JUL-2008 but returned on the same day with bilious projectile vomiting and lethargy. The patient had mucously stool in ER. The barium enema was repeated and did not showed IS but an abdominal computed axial tomography confirmed IS. The patient returned to the operating room for reduction. Nasogastric tube was placed post operation, which was removed and post operative advanced. The patient was discharged at the second day post operative. On 15-SEP-2008, the patient's medical record was received for the date of service (DOS). The adverse events were reported as serious and life threatening. A lot check has been requested. The original reporting was not provided. The VAERS ID # 323331-1. A standard lot check investigation was performed for lot numbers 0660684/0301X and 0659666/1884U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, Vomiting projectile, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 week old male with a medical history of hydrocele-small, who on 26-JUN-2008 was vaccinated with ROTATEQ (Lot #660684/0301X) by mouth, ACT HIB (Sanofi Pasteur, Lot #UF262AA) intramuscular in the left leg, DAPTACEL (Sanofi Pasteur, Lot #C2934AA) intramuscular in the left leg, RECOMBIVAX HB (Lot #1884U) intramuscular in the right leg, PREVNAR (Wyeth Pharmaceutical, Lot #C49271) and IPOL (Sanofi Pasteur, Lot #A0492) subcutaneously in the left leg. On 01-JUL-2008, the 11 week old infant was taken to the office after beginning to vomit "green emesis" in the night with no fever. The patient had no stools during the day at daycare but although he usually had several stools daily. KUB was performed and showed a small bowel obstruction with dilated small bowel. The doctor transferred the patient to the hospital for surgery because of the possibility of malrotation of the bowel. Between 2-3-JUL-2008 and 3-7-JUL-2008, the patient was diagnosed with intussusception and recurrent intussusception. The patient initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool. A physical exam later was positive for an abdominal mass. Barium enema was unable to reduce the intussusception, so the patient was taken to the operating room for exploratory laparotomy, reduction of ileocolic intussusception and inversion appendectomy. The patient was discharge at 03-JUL-2008 but returned on the same day with bilious projectile vomiting and lethargy. The patient had mucously stool in ER. The barium enema was repeated and did not showed IS but an abdominal computed axial tomography confirmed IS. The patient returned to the operating room for reduction. Nasogastric tube was placed post operation, which was removed and post operative advanced. The patient was discharged at the second day post operative. On 15-SEP-2008, the patient's medical record was received for the date of service (DOS). The adverse events were reported as serious and life threatening. A lot check has been requested. The original reporting was not provided. The VAERS ID # 323331-1. A standard lot check investigation was performed for lot numbers 0660684/0301X and 0659666/1884U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Convulsion, Hypoaesthesia, Pain in extremity, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no previous medical history and no illness at time of vaccination reported who on an unknown date was vaccinated with the first dose of GARDASIL IM, 0.5 mL. After the first dose, the patient reported that her arm was numb for about 24 hours and then it resolved. On 06-OCT-2008 at 16:30, the patient was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X) IM in the left deltoid, 0.5 mL, and within 10 minutes after became white (pale) and experienced syncope. The patient felt clammy and her heart rate decreased. She appeared to had seizure, shook for 3 to 5 seconds and her blood pressure decreased for 88/50 to 90/52. When she came to, she said she felt numbness in her arms, a heavy feeling in her feet (dull/numb), a sharp pain in her ribs and was shakey. The patient's blood pressure remained low during an hour of monitoring and her heart rate resolved to within normal limits. The patient also complained that the other arm and feet felt "numb/dull". On 07-OCT-2008, the patient recovered. No treatment was noted. The patient not had any laboratory test done. The patient sought medical attention at the office. Upon internal review, seizure (shook 3-5 seconds) was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensation of heaviness, Shock, Syncope, Tremor, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no previous medical history and no illness at time of vaccination reported who on an unknown date was vaccinated with the first dose of GARDASIL IM, 0.5 mL. After the first dose, the patient reported that her arm was numb for about 24 hours and then it resolved. On 06-OCT-2008 at 16:30, the patient was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X) IM in the left deltoid, 0.5 mL, and within 10 minutes after became white (pale) and experienced syncope. The patient felt clammy and her heart rate decreased. She appeared to had seizure, shook for 3 to 5 seconds and her blood pressure decreased for 88/50 to 90/52. When she came to, she said she felt numbness in her arms, a heavy feeling in her feet (dull/numb), a sharp pain in her ribs and was shakey. The patient's blood pressure remained low during an hour of monitoring and her heart rate resolved to within normal limits. The patient also complained that the other arm and feet felt "numb/dull". On 07-OCT-2008, the patient recovered. No treatment was noted. The patient not had any laboratory test done. The patient sought medical attention at the office. Upon internal review, seizure (shook 3-5 seconds) was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Cold sweat, Convulsion, Heart rate decreased, Hypoaesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no previous medical history and no illness at time of vaccination reported who on an unknown date was vaccinated with the first dose of GARDASIL IM, 0.5 mL. After the first dose, the patient reported that her arm was numb for about 24 hours and then it resolved. On 06-OCT-2008 at 16:30, the patient was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X) IM in the left deltoid, 0.5 mL, and within 10 minutes after became white (pale) and experienced syncope. The patient felt clammy and her heart rate decreased. She appeared to had seizure, shook for 3 to 5 seconds and her blood pressure decreased for 88/50 to 90/52. When she came to, she said she felt numbness in her arms, a heavy feeling in her feet (dull/numb), a sharp pain in her ribs and was shakey. The patient's blood pressure remained low during an hour of monitoring and her heart rate resolved to within normal limits. The patient also complained that the other arm and feet felt "numb/dull". On 07-OCT-2008, the patient recovered. No treatment was noted. The patient not had any laboratory test done. The patient sought medical attention at the office. Upon internal review, seizure (shook 3-5 seconds) was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal chest pain, Pallor, Sensation of heaviness, Syncope, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no previous medical history and no illness at time of vaccination reported who on an unknown date was vaccinated with the first dose of GARDASIL IM, 0.5 mL. After the first dose, the patient reported that her arm was numb for about 24 hours and then it resolved. On 06-OCT-2008 at 16:30, the patient was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X) IM in the left deltoid, 0.5 mL, and within 10 minutes after became white (pale) and experienced syncope. The patient felt clammy and her heart rate decreased. She appeared to had seizure, shook for 3 to 5 seconds and her blood pressure decreased for 88/50 to 90/52. When she came to, she said she felt numbness in her arms, a heavy feeling in her feet (dull/numb), a sharp pain in her ribs and was shakey. The patient's blood pressure remained low during an hour of monitoring and her heart rate resolved to within normal limits. The patient also complained that the other arm and feet felt "numb/dull". On 07-OCT-2008, the patient recovered. No treatment was noted. The patient not had any laboratory test done. The patient sought medical attention at the office. Upon internal review, seizure (shook 3-5 seconds) was determined to be an other important medical event. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: SM received AVA booster (AVA #10).  Within 24 hrs she developed a large local reaction with erythema, induration & tenderness (7/10) @ and below the injection site.  She reports her arm was painfully down to her elbow.  Systemic symptoms included low-grade fever, headache and generalized achyness.  She states her arm was so painful that she had difficult raising it was unable to sleep on her leftside or through the night.  She self-medicated (alternating TYLENOL and IBUPROFEN) and hot and cold packs with little relief.  She sought medical care on 23 Oct 08.  Edema @ injection site 50-120mm, Joint Pain, isolated.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site oedema, Injection site pain, Local reaction, Pain, Pain in extremity
Clinical narrative: SM received AVA booster (AVA #10).  Within 24 hrs she developed a large local reaction with erythema, induration & tenderness (7/10) @ and below the injection site.  She reports her arm was painfully down to her elbow.  Systemic symptoms included low-grade fever, headache and generalized achyness.  She states her arm was so painful that she had difficult raising it was unable to sleep on her leftside or through the night.  She self-medicated (alternating TYLENOL and IBUPROFEN) and hot and cold packs with little relief.  She sought medical care on 23 Oct 08.  Edema @ injection site 50-120mm, Joint Pain, isolated.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: SM received AVA booster (AVA #10).  Within 24 hrs she developed a large local reaction with erythema, induration & tenderness (7/10) @ and below the injection site.  She reports her arm was painfully down to her elbow.  Systemic symptoms included low-grade fever, headache and generalized achyness.  She states her arm was so painful that she had difficult raising it was unable to sleep on her leftside or through the night.  She self-medicated (alternating TYLENOL and IBUPROFEN) and hot and cold packs with little relief.  She sought medical care on 23 Oct 08.  Edema @ injection site 50-120mm, Joint Pain, isolated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Woke up w/mild hives.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Death
Clinical narrative: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of MMR II (date, dose, route and lot #'s not reported). Concomitant suspect vaccine therapy included a dose of VARIVAX (date, dose, route and lot #'s not reported). It was reported that the patient died within 30 days of receiving the vaccines (date and cause of death not reported). This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: MMRV
Symptoms: Death
Clinical narrative: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of PROQUAD (date, dose, route and lot #'s not reported). It was reported that the patient died within 90 days of receiving the vaccine (date and cause of death not reported). This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: MMRV
Symptoms: Death, Drowning
Clinical narrative: Information has been received from a study concerning a patient (age and gender not reported) who was vaccinated with a dose of PROQUAD (date, dose, route not reported). It was reported that the patient died due to drowning (date not reported). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Autopsy, Body temperature increased, Febrile infection, Pyrexia, Sudden death
Clinical narrative: Information has been received from a study, concerning a patient who was vaccinated with a dose of PROQUAD (Merck) (date, dose, route, lot # not reported). It was reported that 18 days after PROQUAD (Merck) was administered the patient developed a febrile illness. The subject had two days of fever up to 103 and was found dead (twenty days after PROQUAD (Merck) (date not reported) in the crib. The toxicology screen was negative except for amantadine. The chief adjudicator indicated possible viral infection (febrile) as the cause of death. According to the autopsy report, the cause of death was sudden unexpected death in childhood associated with history of febrile illness. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: MMRV
Symptoms: Toxicologic test normal
Clinical narrative: Information has been received from a study, concerning a patient who was vaccinated with a dose of PROQUAD (Merck) (date, dose, route, lot # not reported). It was reported that 18 days after PROQUAD (Merck) was administered the patient developed a febrile illness. The subject had two days of fever up to 103 and was found dead (twenty days after PROQUAD (Merck) (date not reported) in the crib. The toxicology screen was negative except for amantadine. The chief adjudicator indicated possible viral infection (febrile) as the cause of death. According to the autopsy report, the cause of death was sudden unexpected death in childhood associated with history of febrile illness. This is one of several reports from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cerebral disorder
Clinical narrative: Information has been received from a pharmacist concerning a "college age" female who in August 2008 was vaccinated with GARDASIL (dose and duration not reported).  Two months after vaccination, the patient developed cerebralitis and was hospitalized.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning an "approximately 18-20 years old" female who on unspecified date was vaccinated with the first dose of GARDASIL. Immediately after receiving vaccination, the patient had a convulsive seizure for 2 seconds and then fainted. The patient has recovered but the physician does not plan to administer the second or third doses to the patient. The patient sought unspecified medical attention. Upon internal review, convulsive seizure was considered to be an other important event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Convulsion, Hypotonia, Presyncope
Clinical narrative: Information has been received from a consumer concerning her 17 year old grand-daughter with allergy to penicillin and no pertinent medical history reported who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING, flu vaccine (unspecified) (also given on 28-OCT-2008) and unspecified antibiotic.  After receiving her first dose of GARDASIL, on 28-OCT-2008, in the physician's office, the patient almost fainted and her head was flopping around.  The consumer stated that she thought it looked like a seizure.  At the time of reporting, the patient was recovering.  Upon internal review, seizure was considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a health care worker who reported that one of their patient's mother stated that her niece, on an unknown date was vaccinated with the third dose of GARDASIL. The health care worker reported that the patient didn't go to their office. The patient's aunt reported that her niece shortly after received her third dose of GARDASIL  had a seizure. The patient's aunt reported that the seizure happened different times of day and they still happening. She also reported that the patient did see her physician who said that the seizures could be due to GARDASIL. At the time of the report the patient had not recovered. Upon internal review seizure is considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Surgery, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from an office manager concerning a female baby who on an unspecified date in 2007 was vaccinated with the second dose of ROTATEQ.  The office manager reported that in 2007 the patient was seen in the office for severe vomiting and was sent to the emergency room.  An x-ray was taken and the patient was diagnosed with intussusception.  The patient had surgery.  The outcome was reported as recovered (date not reported).  Upon internal review intussusception was considered to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Eye swelling, Headache, Lip swelling, Throat irritation, Urticaria
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 22-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 IM.  Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified).  On 24-OCT-2008 the patient experienced headaches, swelling of the lips and eyes, itchy throat, and hives all over.  The patient went to the ER and was admitted for observations.  The patient was released on 26-OCT-2008 and re-admitted on 27-OCT-2008.  The patient had been there since because of the hives.  She was being treated with MEDROL, BENADRYL and famotidine (MSD).  Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Endotracheal intubation
Clinical narrative: Increase S.O.B. Following flu vaccine. ER -intubated and admitted.  11/12/2008 ER record received for 10/13/2008 with DX:  Respiratory failure/possible anaphylaxis, ? allergic reaction. Pt developed SOB which was progressing quickly despite nebs. En route to ER EMS tx with epi, solumedrol and albuterol nebs. Unable to speak on arrival with labored breathing and minimal air passage. PE (+) for unresponsive to commands, mottling, intercostal retractions, agonal respirations, and lethargic.  Intubated with return of responsiveness and increased alertness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chest pain, Cough, Dysphonia, Lip swelling
Clinical narrative: Flu vaccine given at 1045 at 1400 symptoms of hoarseness, lip swollen, throat tight.  Also had injection to back of neck on same day.  Also c/o chest pain and feet cramps, c/o cough and was anxious.  EPINEPHRINE, SOLUMEDROL, TORADOL, ATIVAN and PREDNISON given in ER.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Throat tightness
Clinical narrative: Flu vaccine given at 1045 at 1400 symptoms of hoarseness, lip swollen, throat tight.  Also had injection to back of neck on same day.  Also c/o chest pain and feet cramps, c/o cough and was anxious.  EPINEPHRINE, SOLUMEDROL, TORADOL, ATIVAN and PREDNISON given in ER.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Paraesthesia, Throat tightness
Clinical narrative: Tight throat, tingly, difficult swallowing.  Benadryl 25mg IM given.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Pain in extremity
Clinical narrative: Flu vaccine given in AM around 1000-around 1300 developed S.O.B. legs aching, dizziness SOLUMEDROL, BENADRYL and PREDNISONE in ER
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a second dose of ROTATEQ (date not specified).  Four days after the patient had received the second dose of ROTATEQ, the patient was hospitalized for intussusception with air reduction.  The dates of hospitalization and patient's outcome were unknown.  No product quality issues were involved.  Additional information has been requested.  1/12/09 Reviewed hospital medical records of 10/13-10/15/2008. FINAL DX: Ileocolic intussusception, enema reduced Records reveal patient experienced irritability, hematemesis, abd distention.  Transferred to PICU from outlying hospital.  Progressed well s/p air enema & d/c to home for PCP f/u.    11/21/08 Reviewed hospital medical records of 10/11-10/13/2008. FINAL DX: abdominal obstruction; sepsis ruled out. Records reveal patient experienced vomiting & change in mental status.  Septic work up neg.  Tx w/IVF & IV antibiotics initially.  Developed persistent vomiting, abdominal pain, hypoactive bowel sounds.  Transferred to higher level of care.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Patient developed chickenpox - documented by MD in office.
Age: 2.0
Sex: M
Vaccine: TD
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: Gave adult Td instead of child flu.  Medication error.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in fingers on (L) arm, tingling to tongue, weakness to (L) arm.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given instead of Pediarix.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood immunoglobulin A increased, Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Lymphadenitis
Clinical narrative: Acute neck lymphadenitis x 1 week after the shot of HPV and FLUVIRIN. Given Augmentin after ENT consult and diagnosis of ? Cat scratch vs ? HPV shot allergy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: 9/5/08 Zostovax administered - 10 days later itchy, vesicular rash appeared on face/chest.  Seen in urgent care clinic 10/14/08.  Rx: doxycycline desonide.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Influenza vaccine administered 10/27/08, Employee called in by phone 10/31/08 to report numbness, tingling in (L) arm on 10/27. By 10/29, c/o numbness in mouth., Called PSP 10/31/08 - PCP recommended for employee to be seen at Urgent Care. 12/1/08-records received-presented on 10/31/08-C/O upper left arm sore with tingling sensation involving area of injection some tingling in radial distribution of left hand, aching of left wrist, slight tingling left side face around mouth and eye. No weakness, sensation okay, neuro negative. Assessment:paresthesia. Doubt vaccine reaction.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 20x14 cm are of swelling.  Area of swelling is warm with mild erythema noted more centrally.  Noted streaking, no induration or fluctuance.  No boils.  No other rash - 3 days after MENACTRA injection.  KEFLEX 500mg capsule 1 capsule oral 3 X daily.  #30 X 10 days prescribed for possible cellulitis.