chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Borrelia test negative, Dysmorphism, Eyelid disorder, Lip disorder, VIIth nerve paralysis
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 24-MAR-2010 was vaccinated with the first dose of GARDASIL (IM, lot # 663454/0672Y, expired on 19-SEP-2011). A few weeks after the first vaccination, in April 2010, the patient experienced Bell's Palsy. On 10-APR-2010 the patient went to the emergency room, but was not hospitalized. The patient was treated with prednisone and acyclovir. At the time of the report, the patient was recovering. Follow up information was received from the registered nurse concerning a female patient with no pertinent medical history or known drug allergies who on 24-MAR-2010 was vaccinated with the first dose of GARDASIL. The patient also received a dose of MENACTRA (lot # U3030AA). There were no other concomitant medications. On 10-APR-2010, the patient presented to ER with right sided facial droop and difficulty closing eyelid. The patient tested for Lyme, result was negative. At the 26-APR-2010 office visit, the patient was recovering, but was referred to a pediatric neurologist. Follow up information has been received from the registered nurse and medical records concerning a 14 year old female patient with no known drug allergies and no illness at time of vaccination who on 24-MAR-2010 at 14:00, was intramuscularly vaccinated with a first dose of GARDASIL (lot # 663454/0672Y) in her right arm. Concomitant therapy included a first dose of MENACTRA (lot # U3030AA) in her left arm at 14:00 on 24-MAR-2010. On 10-APR-2010 the patient presented to ED with right side facial droop and difficulty in opening eyelid. Lyme titer was performed and result was negative. The patient had follow-up visit on 13-APR-2010 and was found to have right facial droop with difference in lip opening while smiling, poor visualization of right nasolabial fold. Had incomplete closure of right eye lid with upturned eye. The patient was to continue prednisone tablet 10 mg orally once a day, acyclovir capsule 200 mg orally once a day and eye care (unspecified). On 26-APR-2010, the patient was seen for follow-up and was reported to being "much better". Right facial droop almost disappeared without any noticeable difference in lip opening while smiling and right nasolabial fold almost equal to left side. The patient still with some difficulty in closing the eye, still using artificial tears (unspecified). The patient's father requested referral to specialist for another opinion in view of persistence of some symptoms, the patient referred to pediatric neurology (results of referral not reported). As of 26-APR-2010, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Information has been received from a nurse on 21-APR-2010 concerning a now 16 year old female who in September 2009 was vaccinated with a dose of GARDASIL (LOT# 661841/0653X, expire date 17-SEP-2009). Concomitant medication included "VEREVAX". On an unspecified date, the patient experienced redness, swelling and soreness on her arm listing two to three days. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse on 21-APR-2010 concerning a now 16 year old female who in September 2009 was vaccinated with a dose of GARDASIL (LOT# 661841/0653X, expire date 17-SEP-2009). Concomitant medication included "VEREVAX". On an unspecified date, the patient experienced redness, swelling and soreness on her arm listing two to three days. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscular weakness, Weight bearing difficulty
Clinical narrative: Information has been received from a consumer concerning a her 14 year old grandson with no pertinent medical history who on 23-APR-2010 was vaccinated with a 0.5 ml dose of GARDASIL at 10:30am. There was no concomitant medication. It was reported that the patient had waited for 15 minutes. When the patient left the office he said, "Wow, I feel weak." the reporter's daughter took him to eat and then to school some time around 11:30am. The patient texted her a message from school saying "I'm becoming really tired. I can hardly open my eyes and I can't help it." The patient went to the nurse's station. It was a struggle to walk to the nurse' station. He got to the nurse and the muscle weakness became increasingly worse to the point where he couldn't bear his own weight. He was driven emergency room but was not admitted. They hooked him to take all his vitals and everything was normal, but he was almost paralyzed. The patient said that his brain was working fine, but he was unable to make his muscle move. The doctor got there almost an hour later, and he started to be able to open his eyes wider and was able to move his legs. He was able to squeeze the consumer's hand. Within that hour he was back to normal. Next day an office manager confirmed absence of any pertinent medical history or drug allergies. The office manager also confirmed that there were no pertinent medicines or vaccines. The manager provided the lot number of GARDASIL as 663452/0671Y. According to the ER note, the manager reported that no shortness of breath, no headaches, no rashes. The patient complained of being weak all over, but upon examination, the patient displayed a full range of motion (no paralysis). No testing was noted. It was also reported that the event was not disabling or lift threatening and no hospitalization was required. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Eye disorder, Fatigue, Gait disturbance, Muscular weakness
Clinical narrative: Information has been received from a consumer concerning a her 14 year old grandson with no pertinent medical history who on 23-APR-2010 was vaccinated with a 0.5 ml dose of GARDASIL at 10:30am. There was no concomitant medication. It was reported that the patient had waited for 15 minutes. When the patient left the office he said, "Wow, I feel weak." the reporter's daughter took him to eat and then to school some time around 11:30am. The patient texted her a message from school saying "I'm becoming really tired. I can hardly open my eyes and I can't help it." The patient went to the nurse's station. It was a struggle to walk to the nurse' station. He got to the nurse and the muscle weakness became increasingly worse to the point where he couldn't bear his own weight. He was driven emergency room but was not admitted. They hooked him to take all his vitals and everything was normal, but he was almost paralyzed. The patient said that his brain was working fine, but he was unable to make his muscle move. The doctor got there almost an hour later, and he started to be able to open his eyes wider and was able to move his legs. He was able to squeeze the consumer's hand. Within that hour he was back to normal. Next day an office manager confirmed absence of any pertinent medical history or drug allergies. The office manager also confirmed that there were no pertinent medicines or vaccines. The manager provided the lot number of GARDASIL as 663452/0671Y. According to the ER note, the manager reported that no shortness of breath, no headaches, no rashes. The patient complained of being weak all over, but upon examination, the patient displayed a full range of motion (no paralysis). No testing was noted. It was also reported that the event was not disabling or lift threatening and no hospitalization was required. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Weight bearing difficulty
Clinical narrative: Information has been received from a consumer concerning a her 14 year old grandson with no pertinent medical history who on 23-APR-2010 was vaccinated with a 0.5 ml dose of GARDASIL at 10:30am. There was no concomitant medication. It was reported that the patient had waited for 15 minutes. When the patient left the office he said, "Wow, I feel weak." the reporter's daughter took him to eat and then to school some time around 11:30am. The patient texted her a message from school saying "I'm becoming really tired. I can hardly open my eyes and I can't help it." The patient went to the nurse's station. It was a struggle to walk to the nurse' station. He got to the nurse and the muscle weakness became increasingly worse to the point where he couldn't bear his own weight. He was driven emergency room but was not admitted. They hooked him to take all his vitals and everything was normal, but he was almost paralyzed. The patient said that his brain was working fine, but he was unable to make his muscle move. The doctor got there almost an hour later, and he started to be able to open his eyes wider and was able to move his legs. He was able to squeeze the consumer's hand. Within that hour he was back to normal. Next day an office manager confirmed absence of any pertinent medical history or drug allergies. The office manager also confirmed that there were no pertinent medicines or vaccines. The manager provided the lot number of GARDASIL as 663452/0671Y. According to the ER note, the manager reported that no shortness of breath, no headaches, no rashes. The patient complained of being weak all over, but upon examination, the patient displayed a full range of motion (no paralysis). No testing was noted. It was also reported that the event was not disabling or lift threatening and no hospitalization was required. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy skin, Condition aggravated, Rash pruritic, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 15 year old female with dermatitis atopic and no drug allergies, who in Spring, approximately March 2009, was vaccinated with the first dose of GARDASIL, and developed a rash. The patient's rash worsened after the second dose of GARDASIL, and became even worse after the third vaccination. The rash was mostly on her extremities and resembled eczema with hypopigmentation and discoloration of her skin. She had a biopsy which revealed non-specific inflammation and eczema. She had been treated with ELIDEL and Allicin. The patient had seen in office and had not recovered at the time of the report. Follow up information received from a physician concerning a 14 year old (previously reported as 15 year old) female with a history of dermatitis atopic and no illness at the time of vaccination (lot # 659964/1978U) in the right arm. The patient received the second dose  (lot # 659964/1978U) in the right arm on 23-MAY-2008 and the third dose (lot # 660618/0572X) in the right arm on 03-OCT-2008. On an unspecified date in 2008, the patient developed a diffuse pruritic rash after the first vaccination which worsened after the next 2 vaccinations. The rash had resulted in splotchy hypopigmentation of her skin. She had 2 skin biopsies. The patient had not recovered at the time of the report. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy skin abnormal, Condition aggravated, Dermatitis, Eczema, Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female with dermatitis atopic and no drug allergies, who in Spring, approximately March 2009, was vaccinated with the first dose of GARDASIL, and developed a rash. The patient's rash worsened after the second dose of GARDASIL, and became even worse after the third vaccination. The rash was mostly on her extremities and resembled eczema with hypopigmentation and discoloration of her skin. She had a biopsy which revealed non-specific inflammation and eczema. She had been treated with ELIDEL and Allicin. The patient had seen in office and had not recovered at the time of the report. Follow up information received from a physician concerning a 14 year old (previously reported as 15 year old) female with a history of dermatitis atopic and no illness at the time of vaccination (lot # 659964/1978U) in the right arm. The patient received the second dose  (lot # 659964/1978U) in the right arm on 23-MAY-2008 and the third dose (lot # 660618/0572X) in the right arm on 03-OCT-2008. On an unspecified date in 2008, the patient developed a diffuse pruritic rash after the first vaccination which worsened after the next 2 vaccinations. The rash had resulted in splotchy hypopigmentation of her skin. She had 2 skin biopsies. The patient had not recovered at the time of the report. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Skin discolouration, Skin hypopigmentation
Clinical narrative: Information has been received from a physician concerning a 15 year old female with dermatitis atopic and no drug allergies, who in Spring, approximately March 2009, was vaccinated with the first dose of GARDASIL, and developed a rash. The patient's rash worsened after the second dose of GARDASIL, and became even worse after the third vaccination. The rash was mostly on her extremities and resembled eczema with hypopigmentation and discoloration of her skin. She had a biopsy which revealed non-specific inflammation and eczema. She had been treated with ELIDEL and Allicin. The patient had seen in office and had not recovered at the time of the report. Follow up information received from a physician concerning a 14 year old (previously reported as 15 year old) female with a history of dermatitis atopic and no illness at the time of vaccination (lot # 659964/1978U) in the right arm. The patient received the second dose  (lot # 659964/1978U) in the right arm on 23-MAY-2008 and the third dose (lot # 660618/0572X) in the right arm on 03-OCT-2008. On an unspecified date in 2008, the patient developed a diffuse pruritic rash after the first vaccination which worsened after the next 2 vaccinations. The rash had resulted in splotchy hypopigmentation of her skin. She had 2 skin biopsies. The patient had not recovered at the time of the report. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who was vaccinated with all three doses of GARDASIL (lot # not reported) with schedule: 01-AUG-2007, 19-NOV-2007 and 18-FEB-2008. On 01-AUG-2007 the patient experienced headaches and then on approximately 10-MAY-2010 ("sometime last week") the patient was diagnosed with brain tumor. Unspecified medical attention was sought. The patient's brain tumor persisted. Follow up information has been received concerning the 12 year old female patient with no pre-existing allergies and no other pertinent medical history who 01-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#656051/0244U) IM into the left deltoid. On 19-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. On 18-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. There was no illness at time of vaccination. On 01-AUG-2007, after the first dose of GARDASIL, the patient experienced headaches. Magnetic resonance imaging (MRI) was performed with no results reported. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who was vaccinated with all three doses of GARDASIL (lot # not reported) with schedule: 01-AUG-2007, 19-NOV-2007 and 18-FEB-2008. On 01-AUG-2007 the patient experienced headaches and then on approximately 10-MAY-2010 ("sometime last week") the patient was diagnosed with brain tumor. Unspecified medical attention was sought. The patient's brain tumor persisted. Follow up information has been received concerning the 12 year old female patient with no pre-existing allergies and no other pertinent medical history who 01-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#656051/0244U) IM into the left deltoid. On 19-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. On 18-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. There was no illness at time of vaccination. On 01-AUG-2007, after the first dose of GARDASIL, the patient experienced headaches. Magnetic resonance imaging (MRI) was performed with no results reported. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HPV4
Symptoms: Brain neoplasm, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who was vaccinated with all three doses of GARDASIL (lot # not reported) with schedule: 01-AUG-2007, 19-NOV-2007 and 18-FEB-2008. On 01-AUG-2007 the patient experienced headaches and then on approximately 10-MAY-2010 ("sometime last week") the patient was diagnosed with brain tumor. Unspecified medical attention was sought. The patient's brain tumor persisted. Follow up information has been received concerning the 12 year old female patient with no pre-existing allergies and no other pertinent medical history who 01-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#656051/0244U) IM into the left deltoid. On 19-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. On 18-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (lot#657868/0523U) IM into the right deltoid. There was no illness at time of vaccination. On 01-AUG-2007, after the first dose of GARDASIL, the patient experienced headaches. Magnetic resonance imaging (MRI) was performed with no results reported. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Information has been received from an office manager concerning a 9 year old female patient with no known drug allergies or pertinent medical history who on 11-MAY-2010 was vaccinated with a 0.5 ml first dose of GARDASIL IM (lot number 661954/0075Y). There was no concomitant medication. On 11-MAY-2010 after receiving the first dose of GARDASIL, the patient experienced a near-syncopal episode. The patient recovered in about 30-45 minutes. The office manager requested a lot check. No laboratory tests were performed. The patient sought unspecified medical attention. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from an office manager concerning a 9 year old female patient with no known drug allergies or pertinent medical history who on 11-MAY-2010 was vaccinated with a 0.5 ml first dose of GARDASIL IM (lot number 661954/0075Y). There was no concomitant medication. On 11-MAY-2010 after receiving the first dose of GARDASIL, the patient experienced a near-syncopal episode. The patient recovered in about 30-45 minutes. The office manager requested a lot check. No laboratory tests were performed. The patient sought unspecified medical attention. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HPV4
Symptoms: Chest X-ray normal, Electrocardiogram abnormal, Left ventricular hypertrophy, Syncope
Clinical narrative: Information has been received from an office manager concerning a 12 year old female patient with no known drug allergies or pertinent medical history who on 11-MAY-2010 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 661954/0075Y). There was no concomitant medication. On 11-MAY-2010 10 to 15 minutes after receiving GARDASIL the patient experienced a near-syncopal episode. The patient's symptoms improved so she got up to leave. The patient passed out while walking down the hallway. The patient was sent to the emergency room. It was unknown if the patient was admitted or her current status. No laboratory tests were performed. The office manager requested a lot check. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 661954/0075Y 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 Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HPV4
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Information has been received from an office manager concerning a 12 year old female patient with no known drug allergies or pertinent medical history who on 11-MAY-2010 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 661954/0075Y). There was no concomitant medication. On 11-MAY-2010 10 to 15 minutes after receiving GARDASIL the patient experienced a near-syncopal episode. The patient's symptoms improved so she got up to leave. The patient passed out while walking down the hallway. The patient was sent to the emergency room. It was unknown if the patient was admitted or her current status. No laboratory tests were performed. The office manager requested a lot check. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 661954/0075Y 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 Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dyskinesia, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 15 year old female with on pertinent medical history who on 14-AUG-2010 was vaccinated intramuscularly with a dose of GARDASIL. (Lot number is 665547/1318Y). It was part of the adolescent regime, she had gotten other shots that day. On 14-AUG-2010 the patient had a jerky reaction, headache and weakness in her arms after vaccination. The patient was rushed to the emergency room and was hospitalized. The patient had neurological testing done with normal results, she was on medicine but her mom did not know the name of it, she experienced tremors on 30-AUG-2010 and the family physician prescribed gabapentin. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4
Symptoms: Dyskinesia, Headache, Muscular weakness, Neurological examination normal, Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female with on pertinent medical history who on 14-AUG-2010 was vaccinated intramuscularly with a dose of GARDASIL. (Lot number is 665547/1318Y). It was part of the adolescent regime, she had gotten other shots that day. On 14-AUG-2010 the patient had a jerky reaction, headache and weakness in her arms after vaccination. The patient was rushed to the emergency room and was hospitalized. The patient had neurological testing done with normal results, she was on medicine but her mom did not know the name of it, she experienced tremors on 30-AUG-2010 and the family physician prescribed gabapentin. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Rotavirus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 weeks old female with no pertinent medical history and no drug reactions or allergies who on 26-AUG-2010 was vaccinated oral with the first 2 ml dose of ROTATEQ (lot # is 664946/0148Z). Concomitant therapy included PENTACEL, PREVNAR 13 and ENGERIX-B. On 27-AUG-2010, the patient experienced blood in her stool within 24 hours of receiving her first dose of ROTATEQ (lot # is 664946/0148Z), and she had no pain or fever, or other indication of illness. The patient was taken stool culture test, and the result was positive for rotavirus. On an unspecified date in August 2010, the patient sought medical attention via office visit. On 27-AUG-2010, the patient recovered from blood in her stool. Blood in her stool was determined to be an other important medical event. No further information is available.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Culture stool positive, Haematochezia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 weeks old female with no pertinent medical history and no drug reactions or allergies who on 26-AUG-2010 was vaccinated oral with the first 2 ml dose of ROTATEQ (lot # is 664946/0148Z). Concomitant therapy included PENTACEL, PREVNAR 13 and ENGERIX-B. On 27-AUG-2010, the patient experienced blood in her stool within 24 hours of receiving her first dose of ROTATEQ (lot # is 664946/0148Z), and she had no pain or fever, or other indication of illness. The patient was taken stool culture test, and the result was positive for rotavirus. On an unspecified date in August 2010, the patient sought medical attention via office visit. On 27-AUG-2010, the patient recovered from blood in her stool. Blood in her stool was determined to be an other important medical event. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat tightness in a 14-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergies, eczema and exercise induced asthma. Concurrent medications included CLARITIN and Albuterol. On 2 September 2010 at 16:59 the subject received 1st dose of HAVRIX (.5 ml, unknown route, left arm). On 2 September 2010, 12 minutes after vaccination with HAVRIX, the subject experienced throat tightness. On 3 September 2010, the subject experienced headache. The healthcare professional considered the events were life threatening. The subject was treated with BENADRYL and prednisone at the Emergency Room. The healthcare professional reported that the subject "felt loopy" and "out of it" from the BENADRYL. At the time of reporting the throat tightening was resolved, the headache was unresolved and the outcome of the other events was unspecified. The vaccination course with HAVRIX was discontinued. The healthcare professional considered the event of headache was possibly related to vaccination with HAVRIX. The healthcare professional did not provide a causality assessment with HAVRIX for the other events.
Age: 14.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Feeling abnormal, Headache, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat tightness in a 14-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergies, eczema and exercise induced asthma. Concurrent medications included CLARITIN and Albuterol. On 2 September 2010 at 16:59 the subject received 1st dose of HAVRIX (.5 ml, unknown route, left arm). On 2 September 2010, 12 minutes after vaccination with HAVRIX, the subject experienced throat tightness. On 3 September 2010, the subject experienced headache. The healthcare professional considered the events were life threatening. The subject was treated with BENADRYL and prednisone at the Emergency Room. The healthcare professional reported that the subject "felt loopy" and "out of it" from the BENADRYL. At the time of reporting the throat tightening was resolved, the headache was unresolved and the outcome of the other events was unspecified. The vaccination course with HAVRIX was discontinued. The healthcare professional considered the event of headache was possibly related to vaccination with HAVRIX. The healthcare professional did not provide a causality assessment with HAVRIX for the other events.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt insist that she couldn't raise her arm after the shot no local reaction
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Rash
Clinical narrative: Patients lips swelled and developed a rash with itchiness.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain upper, Chest pain, Convulsion, Headache, Immediate post-injection reaction
Clinical narrative: Right away, He had extreme pain in his arm.  He then laid back, fainted and became convulsive.  I screamed and got the doctor down the hall and we sat him up and he started coming back but, didn't know what happened.  He then complained of jaw pain, chest pain, headache and stomach pain.  He then proceeded to vomit about 6 times.  We laid him back down for about 1/2 hour with a cold rag on his forehead.  He still does not feel well, but no symptoms since returning home last night around 5:45 PM.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Malaise, Pain in extremity, Pain in jaw, Syncope, Vomiting
Clinical narrative: Right away, He had extreme pain in his arm.  He then laid back, fainted and became convulsive.  I screamed and got the doctor down the hall and we sat him up and he started coming back but, didn't know what happened.  He then complained of jaw pain, chest pain, headache and stomach pain.  He then proceeded to vomit about 6 times.  We laid him back down for about 1/2 hour with a cold rag on his forehead.  He still does not feel well, but no symptoms since returning home last night around 5:45 PM.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt. developed 2 1/2 cm area erythemic enduration at site of influenza vaccination.
Age: 12.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting x 24 hours after receiving TDAP and MMR.  (Mom requested that we report).
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mass, Pain in extremity, Swelling
Clinical narrative: Arm pain and swelling, which then turned into a lump on arm with a lot of pain. Having pain in shoulder down to injection spot.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Tingling, hands and feet weakness to arms and legs.
Age: 0.14
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever since immunizations - 6 days ago. Tympanic T max 101.6.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Doctor ordered HIB, HEP A & Varicella. An adult dose of HEP A was given by mistake. Spoke to GSK, they said soreness at injection site & malaise would be side effects. Dr spoke to mother of pt. All was documented in EMR - incident report was completed & submitted to our compliance dept.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Local reaction 6x11cm redness.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash on both legs.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: GRANDMOTHER REPORTS EXCESSIVE SWELLING, REDNESS AND PAIN OF LEFT ARM.  SEEN IN ER 9/4.  APPLIED ICE PACKS, TOOK BENADRYL AND TYLENOL AND IBUPROFEN.  RESOLVED SUNDAY NIGHT 9/5-MONDAY MORNING 9/6.  LOCALIZED REACTION ONLY.  DENIES RASH, FACIAL SWELLING, OR DYSPNEA.
Age: 65.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Chromaturia, Injection site pain, Urine viscosity abnormal
Clinical narrative: Patient called pharmacy and reported dark red clumpy urine and sore shoulder near injection site. I referred him to urgent care clinic for evaluation.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Sensation of throat closing up on AM 9/7/2010.  Also with progressively worsening hives and itch starting the same morning.  Has taken Benadryl (help respiratory symptoms but not itch), and OTC hydrocortisone cream.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Skin exfoliation
Clinical narrative: Chronic induration and scaling at site 2 days after injection till now approx 1 mth later - monitor.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Eye irritation, Pain, Pain in extremity, Throat irritation
Clinical narrative: Several pains in back of both legs, escalated to burning pain in both legs. Burning is now in the entire body, back of throating also burning, also the right eyelid feeling burning sensation.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction to PNEUMOVAX swelling, tenderness, heat.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 13 1/2 x 9 cm erythema (L) upper arm superior induration.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Crying, Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Pt received vaccine 9/2/10. On 9/3/10 cried in pain, said it was stinging, swollen, red. Mom called office instructed to give TYLENOL or MOTRIN for pain, warm or cool compresses to site. Later that day, pt developed hives down leg injection was given to. Pt. refused to use leg. Mom started Epsom salt baths. Pt improved to limping x 3 days. Mom followed up on 9/7/10. Pt leg swollen @ injection site has no redness, warmth, or D/C.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site swelling, Injection site urticaria, Weight bearing difficulty
Clinical narrative: Pt received vaccine 9/2/10. On 9/3/10 cried in pain, said it was stinging, swollen, red. Mom called office instructed to give TYLENOL or MOTRIN for pain, warm or cool compresses to site. Later that day, pt developed hives down leg injection was given to. Pt. refused to use leg. Mom started Epsom salt baths. Pt improved to limping x 3 days. Mom followed up on 9/7/10. Pt leg swollen @ injection site has no redness, warmth, or D/C.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Fall, Nausea, Peripheral coldness, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Pt came in Sports PE, was missing, 2nd varicella, per doctor 2nd varicella given, within 2 minutes of injection pt fell back on bed;  became unresponsive, became having tonic-clonic body movements, it lasts 10 seconds. Pt's grandmother awaken him, vitals within normal limits, pt nauseated, cold to touch. Sat pt up, Cheerios & water given. Pt observed for an hour, all vital signs stable. Pt up walking around. Pt. left with informed to go to ER if another seizure or activity happened again.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired vaccine. No adverse event.
Age: 26.0
Sex: M
Vaccine: TD
Symptoms: Cold sweat, Diarrhoea, Impaired work ability, Oedema peripheral, Pain
Clinical narrative: Wife phoned agency reporting husband missed work last night "because of the shot". Reports husbands sx: achy, diarrhea, cold sweats, swelling of left arm "the size of an onion or index finger". Advised to apply ice for 20 minutes every hour x 4 hours and to seek MD assessment if no improvement.
Age: 1.49
Sex: F
Vaccine: PPV, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotavirus was given at over 32 weeks.
Age: 1.44
Sex: F
Vaccine: YF
Symptoms: Auricular swelling, Local swelling, Oedema peripheral, Pyrexia, Rash
Clinical narrative: 9/7/2010 Mother reports to travel nurse, patient seen in ER 9/2/2010 9:30 PM with rash and fever.  9/3/2010 patient taken to another ER with rash, fever and swelling of hands, feet, face neck and ears. Patient seen in clinic by PCP 9/7/2010, symptoms resolved.
Age: 1.44
Sex: F
Vaccine: YF
Symptoms: Swelling face
Clinical narrative: 9/7/2010 Mother reports to travel nurse, patient seen in ER 9/2/2010 9:30 PM with rash and fever.  9/3/2010 patient taken to another ER with rash, fever and swelling of hands, feet, face neck and ears. Patient seen in clinic by PCP 9/7/2010, symptoms resolved.
Age: 74.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Emphysema, Gait disturbance, Nasopharyngitis
Clinical narrative: Initial consumer report received on 26 Aug 2010: This patient was on treatment with FORASEQ with a concentration of 12/400 mcg of capsules for chronic obstructive pulmonary disease for more than 3 years. Initially the posology was one inhalation with each active principle at night. Posteriorly, according medical orientation, she started to perform one inhalation with each active principle twice a day (in the morning and at night). One year ago approximately, following medical recommendation, she started to perform one inhalation with each active principle thrice a day (in the morning, in the afternoon and at night). In Jun 2010, the patient received the H1N1 vaccine (manufacturer and batch no. unknown) and 15 days after that, still in Jun 2010, she experienced pulmonary emphysema episode, shortness of breath, catarrh in the chest and difficulty to walk. These symptoms had already occurred before the treatment with the FORASEQ 12/400 mcg. Every 5 or 6 months, the patient underwent a pulmonary function test and the last test like this was scheduled to Jul 2010, but due to the pulmonary emphysema episode the physician re-scheduled it to Sep 2010. The prescriber physician oriented the patient to continue the treatment with the FORASEQ 12/400 mcg normally. The outcome of the events was reported as completely recovered.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Acute disseminated encephalomyelitis, Central nervous system lesion, Confusional state, Mental disorder, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: PATIENT PRESENTS WITH ALTERED MENTAL STATE, SOMNOLENCE, CONFUSION. DR. DIAGNOSED HER WITH ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM) SECONDARY TO VACCINATION. FOR ANY QUESTIONS OR PATIENT'S HX PLEASE CONTACT DR.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Somnolence, Vaccination complication
Clinical narrative: PATIENT PRESENTS WITH ALTERED MENTAL STATE, SOMNOLENCE, CONFUSION. DR. DIAGNOSED HER WITH ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM) SECONDARY TO VACCINATION. FOR ANY QUESTIONS OR PATIENT'S HX PLEASE CONTACT DR.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, No reaction on previous exposure to drug, Throat tightness
Clinical narrative: Initial report received from a health care professional on 02 September 2010. A female patient (age not reported) received on an unknown date last year, an injection (route and site not provided) of FLUZONE SV, lot number not reported. The patient following vaccination experienced throat constriction and "other anaphylactic reactions". The patient had received several previous FLUZONE vaccines and did not have any reaction. The patient reported that she was not allergic to eggs. Any further information was declined to be provided about the patient or patient's reaction. The information had already been filed with VAERS last year and did not want any further contact for this situation. the outcome was not reported. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Malaise
Clinical narrative: 28 hrs. after injection: felt like I was getting sick - headache, slight nausea, dizzy and weak. I was awakened at 2 pm w/severe pains in upper hands and wrists. Upon standing, pain in both knees. Pains and feeling sick lasted 1 1/2 days, was taking 3 ADVIL every 4 hrs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: 28 hrs. after injection: felt like I was getting sick - headache, slight nausea, dizzy and weak. I was awakened at 2 pm w/severe pains in upper hands and wrists. Upon standing, pain in both knees. Pains and feeling sick lasted 1 1/2 days, was taking 3 ADVIL every 4 hrs.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: swelling, redness
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Lymphadenopathy, Paraesthesia
Clinical narrative: Tingling down affected arm (LT). Numbness on top of arm and hand. Slight swelling of lymph nodes LT side of neck. Woozy sensation.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8/26/10 call patient's injection site, on her thigh where she received 2 immunizations. The area has been swelling, reddened & painful. Per PA she should put ice on it & give her Ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 8/27/10 call. Patient had immunizations on Wednesday, leg where she had 2 shots is swollen, red & hard. Mom was advised to apply ice & then heat to affected area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Injection site reaction to the Rt. outer V.L. with some erythema on the thigh. Saw Dr. on 8/27/10 & was noted to be a local reaction with erythema without evidence of cellulitis.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Injection given in (R) deltoid - no swelling or redness noted at site - redness and swelling warm to touch a proximal medial upper extremity right arm.
Age: 24.0
Sex: F
Vaccine: HPV2
Symptoms: Chills, Dizziness, Dyspnoea, Myalgia, Nausea
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved.
Age: 24.0
Sex: F
Vaccine: HPV2
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: Muscle feels hard @ injection site- (L) deltoid.  Pt complains of muscle soreness @ & around injection site.  Muscle soreness on back of (L) shoulder blades.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache
Clinical narrative: Woke up with a headache on 8/25/10 that lasted until 8/27/10. Had a headache on 8/28/10 & 8/29/10. Had a red area noticed on 8/26/10 and still there on 9/8/10 starting at 15cm down to 2 cm on 9/8/10.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness, pain, indurated on (R) proximal arm.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Dysphonia, Endoscopy normal, Fatigue, Feeling abnormal
Clinical narrative: Had TDAP 8/25/10- 2 days after started feeling bad, headache, slightly sore arm, hoarseness, fatigued went to PMD- was give antibiotics & a steroid pack for sinus infection. Still felt bad- went back to PMD & ordered a CT scan of sinuses- results- sinus clear. Had light run down throat for c/o hoarseness- vocal cords ok. Client still felt run down low grade temp.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Had TDAP 8/25/10- 2 days after started feeling bad, headache, slightly sore arm, hoarseness, fatigued went to PMD- was give antibiotics & a steroid pack for sinus infection. Still felt bad- went back to PMD & ordered a CT scan of sinuses- results- sinus clear. Had light run down throat for c/o hoarseness- vocal cords ok. Client still felt run down low grade temp.
Age: 30.0
Sex: M
Vaccine: HEPAB, TTOX, TYP, YF
Symptoms: Loss of consciousness
Clinical narrative: PT PASSED OUT AFTER STATING "YEA THAT DID HAVE A LITTLE BITE". HE PASSED OUT AFTER THE LAST SHOT GIVEN WHICH WAS YELLOW FEVER!
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Joint range of motion decreased, Ultrasound scan, X-ray
Clinical narrative: Severe pain in upper left arm into shoulder. Limited range of motion.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Patient received vaccine at 2:00 PM on 6/23/2010. At 3:00 PM, parent reported patient had emesis, fever, headache, and a stiff neck. Parent reported a fever up to 104 degrees F that evening. Symptoms continued through the next day and resolved by 6/25/2010.