chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Mucosal dryness, Pallor, Rotavirus infection
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Rotavirus test positive, Vomiting projectile, White blood cell count increased
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 9 month old male with no medical history or allergy who on 18-JUN-2008 was vaccinated with the first dose of ROTATEQ 2ml, orally (lot# 660427/0280X). On 22-AUG-2008 and on 24-OCT-2008 the patient received the second (lot# 660846/0413X) and the third dose of ROTATEQ (lot# 661427/0897). There was no concomitant medication. On 27-JAN-2009 the patient started experiencing symptoms of rotavirus. The patient presented with dehydration. Stool samples were positive for rotavirus antigen as well as norovirus. On 27-JAN-2009 the patient was hospitalized and was there overnight, being discharged on 28-JAN-2009. In follow-up, the nurse reported the patient made a return visit to the emergency room on 02-FEB-2009 for rehydration, but wasn't admitted. The nurse reported that they haven't heard anything back since 02-FEB-2009 so she was assuming the patient was recovering. Follow-up information received from the registered nurse with medical records. It was reported the 9 month old male patient was a full term infant as per parents. He was on a formula. Concomitant therapy included three doses of Hib conj vaccine (manufacturer unspecified), PEDIARIX and pneumococcal vaccine (manufacturer unspecified) on 18-JUN-2009, 22-AUG-2008 and 24-OCT-2008 respectively and a dose of influenza virus vaccine (manufacturer unspecified) on 24-OCT-2008. According to hospital records, in the evening of 27-JAN-2008 the patient began having episodes of projectile vomiting, three or four episodes. It was noted the patient was exposed to a cousin who may have had the stomach flu a couple of days before. He was fatigued appearing and was brought to the Emergency Room. Initial attempts to give the baby PEDIALYTE SOLUTION were unsuccessful with recurrent vomiting. An IV was placed. On examination, the patient was afebrile at 37.1, fatigued appearing, pale with dry mucous membranes and tympanic membranes looked clear. The patient had some hypoactive bowel sounds. The patient was given some ZOFRAN in the Emergency Room which seemed to help his vomiting. The patient laboratory blood work revealed a white blood cell count of 21.9, hemoglobin of 13.8, hematocrit of 38, serum sodium of 139, potassium 4.4, BUN 14, and creatinine of 0.6. The patient had not urinated in the Emergency Room so he was catheterized and approximately 10 cc of clear yellow urine was obtained and sent to the lab (results not provided). The physician admitted the patient to the hospital for intravenous fluids. The physician noted he would give the patient some TYLENOL. Stool specimens were tested and the rotavirus antigen was detected and was positive for norovirus genotype 2. The patient was hospitalized for one day. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected. Medical records available upon request.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Gaze palsy
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 13-FEB-2009 was vaccinated with the first dose of GARDASIL, within five minutes post vaccination the patient had a seizure. The nurse reported that the patient was taken and admitted to the hospital. The nurse reported that the patient had been released from the hospital but did not know how long time the patient was in the hospital, and the physician wanted to run some tests to make sure that nothing else was going on with the patient. At the time of the report the patient was recovering. Upon internal review seizures was considered to be as an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 13-FEB-2009 was vaccinated with the first dose of GARDASIL, within five minutes post vaccination the patient had a seizure. The nurse reported that the patient was taken and admitted to the hospital. The nurse reported that the patient had been released from the hospital but did not know how long time the patient was in the hospital, and the physician wanted to run some tests to make sure that nothing else was going on with the patient. At the time of the report the patient was recovering. Upon internal review seizures was considered to be as an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Drug exposure during pregnancy, Eclampsia, Hypertension
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient with attention deficit/hyperactivity disorder and penicillin allergy who on 27-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 659437/1266U) 0.5 ml intramuscularly. On 31-JAN-2008, the patient received the second dose of GARDASIL (lot# 659055/1522U) 0.5 ml intramuscularly. The patient received the third dose of GARDASIL (lot# 659182/1757U) 0.5 ml intramuscularly on 12-MAY-2008. Concomitant therapy included methylphenidate hydrochloride. The patient was pregnant after receiving the three doses of GARDASIL. No adverse effect was reported. The patient sought unspecified medical attention. Estimated last menstrual period: 19-MAY-2008, Estimated delivery date: 23-FEB-2008. Follow up information has been received from the physician, who reported that on 26-JAN-2009, the female patient delivered a normal and healthy male baby weighing 3062g and apgar score 7/9. There were no congenital anomalies and complications or abnormalities. No complications during the labor/delivery and diagnostic tests during pregnancy were not performed. No infections or illnesses during the pregnancy. The patient had hypertension, eclampsia and seizure during her pregnancy. The patient did not have prenatal care. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Arthralgia, Back pain, Convulsion
Clinical narrative: Information was viewed on the Internet concerning a 19 year old patient who in approximately April 2008 (10 months ago), was vaccinated with the first dose of GARDASIL. Second dose was administered (unspecified date). The mother of the patient reported that prior to first shot, the patient was healthy and active. After the vaccination the patient's back started hurting immediately and about three weeks after the first dose of GARDASIL the patient had her first seizure. After the second dose of GARDASIL the seizures, increased, as did severe stomach pain experienced, fatigue, headache, joint pain, vision problems, hair loss and bleeding gums. The mother reported that the patient has been hospitalized four times, there has been multiple ambulance calls daily seizures, several incidents of cluster seizures where she stopped breathing and turned blue. The mother reported that patient seemed to be improving as time goes by. Therapy with GARDASIL was discontinued. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Fatigue, Gingival bleeding, Headache, Immediate post-injection reaction
Clinical narrative: Information was viewed on the Internet concerning a 19 year old patient who in approximately April 2008 (10 months ago), was vaccinated with the first dose of GARDASIL. Second dose was administered (unspecified date). The mother of the patient reported that prior to first shot, the patient was healthy and active. After the vaccination the patient's back started hurting immediately and about three weeks after the first dose of GARDASIL the patient had her first seizure. After the second dose of GARDASIL the seizures, increased, as did severe stomach pain experienced, fatigue, headache, joint pain, vision problems, hair loss and bleeding gums. The mother reported that the patient has been hospitalized four times, there has been multiple ambulance calls daily seizures, several incidents of cluster seizures where she stopped breathing and turned blue. The mother reported that patient seemed to be improving as time goes by. Therapy with GARDASIL was discontinued. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Respiratory arrest, Visual impairment
Clinical narrative: Information was viewed on the Internet concerning a 19 year old patient who in approximately April 2008 (10 months ago), was vaccinated with the first dose of GARDASIL. Second dose was administered (unspecified date). The mother of the patient reported that prior to first shot, the patient was healthy and active. After the vaccination the patient's back started hurting immediately and about three weeks after the first dose of GARDASIL the patient had her first seizure. After the second dose of GARDASIL the seizures, increased, as did severe stomach pain experienced, fatigue, headache, joint pain, vision problems, hair loss and bleeding gums. The mother reported that the patient has been hospitalized four times, there has been multiple ambulance calls daily seizures, several incidents of cluster seizures where she stopped breathing and turned blue. The mother reported that patient seemed to be improving as time goes by. Therapy with GARDASIL was discontinued. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with on unspecified date with a dose of GARDASIL. Within 1 week of vaccination the patient developed Bell's palsy. The patient sought medical attention by contacted office. Upon internal review Bell's palsy was considered to be as an other important medical event. Additional information has  been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Alopecia, Autonomic nervous system imbalance, Dizziness, Immune system disorder
Clinical narrative: Information has been received from a consumer via the Internet concerning her daughter who in August 2007, was vaccinated with GARDASIL.  Subsequently the patient had been sick ever since.  The patient had several hospital stays, saw a neurologist on a reg basis, and had been diagnosed with dysautonomia with orthostatic intolerance.  The patient experienced blackouts, chronic dizziness and took massive anxiety medicines.  She also experienced loose clumps of her hair, blurred vision, migraine headaches, nausea and panic attacks.  The patient's immune system had been so compromised that she had gotten MRSA (resistant staff) two times and was hospitalized for that.  The patient was also an honor student (straight A's) with a very bright future.  Her grades had dramatically dropped.  The reporter stated that they had to put her on a plan at school so that her attendance can not be held against her, and her teachers had to reduce her work load because she did not know from one day to the next whether she would be able to get out of bed.  At the time of reporting, the outcome was unknown.  Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Migraine, Nausea, Orthostatic intolerance, Panic attack
Clinical narrative: Information has been received from a consumer via the Internet concerning her daughter who in August 2007, was vaccinated with GARDASIL.  Subsequently the patient had been sick ever since.  The patient had several hospital stays, saw a neurologist on a reg basis, and had been diagnosed with dysautonomia with orthostatic intolerance.  The patient experienced blackouts, chronic dizziness and took massive anxiety medicines.  She also experienced loose clumps of her hair, blurred vision, migraine headaches, nausea and panic attacks.  The patient's immune system had been so compromised that she had gotten MRSA (resistant staff) two times and was hospitalized for that.  The patient was also an honor student (straight A's) with a very bright future.  Her grades had dramatically dropped.  The reporter stated that they had to put her on a plan at school so that her attendance can not be held against her, and her teachers had to reduce her work load because she did not know from one day to the next whether she would be able to get out of bed.  At the time of reporting, the outcome was unknown.  Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Staphylococcal infection, Vision blurred
Clinical narrative: Information has been received from a consumer via the Internet concerning her daughter who in August 2007, was vaccinated with GARDASIL.  Subsequently the patient had been sick ever since.  The patient had several hospital stays, saw a neurologist on a reg basis, and had been diagnosed with dysautonomia with orthostatic intolerance.  The patient experienced blackouts, chronic dizziness and took massive anxiety medicines.  She also experienced loose clumps of her hair, blurred vision, migraine headaches, nausea and panic attacks.  The patient's immune system had been so compromised that she had gotten MRSA (resistant staff) two times and was hospitalized for that.  The patient was also an honor student (straight A's) with a very bright future.  Her grades had dramatically dropped.  The reporter stated that they had to put her on a plan at school so that her attendance can not be held against her, and her teachers had to reduce her work load because she did not know from one day to the next whether she would be able to get out of bed.  At the time of reporting, the outcome was unknown.  Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a 58 year old female with allergy to VICODIN and MINOCIN who on 21-JAN-2009 was vaccinated IM with the first dose of PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). Concomitant therapy included influenza virus vaccine (manufacturer unspecified), ZANTAC, VENTOLIN, SYMBICORT, RESTORIL, PREMARIN, NASONEX, CENTRUM, and ACIDOPHILUS. On 21-Jan-2009 the patient developed arm pain, swelling and redness at the injection site. Subsequently, the patient recovered from arm pain, swelling at the injection site and redness at the injection site. The patient sought medical attention in the office. The reporter considered arm pain, swelling and redness at the injection site to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a 38 year old female with no medical history or drug reactions/allergies who on 16-FEB-2009 was vaccinated with PNEUMOVAX 23 (lot number 659922/1667U) IM with no concomitant therapy. On 16-FEB-2009 the patient experienced arm pain, swelling and redness at the injection site. The adverse events were considered to be disabling. The patient had made a phone call for medical attention. No lab diagnostics were performed. The outcome of the patient's adverse events was not reported. This is one of the several patients from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 38 year old female with no medical history or drug reactions/allergies who on 16-FEB-2009 was vaccinated with PNEUMOVAX 23 (lot number 659922/1667U) IM with no concomitant therapy. On 16-FEB-2009 the patient experienced arm pain, swelling and redness at the injection site. The adverse events were considered to be disabling. The patient had made a phone call for medical attention. No lab diagnostics were performed. The outcome of the patient's adverse events was not reported. This is one of the several patients from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE, NOT ABLE TO MOVE ARM, FEVER
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE, NOT ABLE TO MOVE ARM, FEVER
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Ear pain, Hyperacusis, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with diabetes, hypertension and dyslipidaemia who on the morning of 01-DEC-2008 was vaccinated with a first dose of ZOSTAVAX (lot # 663197/1418X) in his left arm. Concomitant therapy included AVAPRO, CALAN SR, LIPITOR and cyclobenzaprine HCl (MSD). The physician reported that the patient woke up 48 hours after vaccination with hearing loss, developed severe earache, slight sore throat with fever, moderate earache. The patient saw an ear, nose and throat (ENT) specialist, then developed hyperacusis. Saw ENT in follow up. Hearing bad to non existent. The physician stated that she didn't have any correspondence from ENT. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Anorexia, Depression, Dyskinesia
Clinical narrative: My daughter started to get restless in the legs and had many headaches. She was twitching and couldn't stop from jerking movements in head and legs. We thought maybe she got a hold of some kind of drug. The doctors said she has rheumatic fever. This is triggered by strep throat. The only problem she tested negative for that. Now she can't even walk. She has no hunger and is very depressed. 10 years old and making drugs that take healthy kids and turn them into this. I didn't like the idea of my child taking this drug and my wife only did because the doctor said he highly recommended it. Well now that this has happened I have found out that they have had 21 deaths in 2 years. Thanks for telling us that in the side effects. I don't see anything mentioned about this. My daughter got only one dose and was set to get her second when this happened. This drug needs to be taking off the market. I don't want to see another family go through what we are going through. She has missed 3 weeks of school and I don't see her recovering anytime soon. 1 death is too many and I know that there are many out there that will be permanently disabled over this drug. PLEASE TAKE THIS DRUG OFF THE MARKET. I will continue to spread the word out to Family & Friends in hope that they won't put their child in the hands of this drug maker. GARDASIL needs to be stopped.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscle twitching, Restless legs syndrome, Rheumatic fever, Streptococcal identification test negative
Clinical narrative: My daughter started to get restless in the legs and had many headaches. She was twitching and couldn't stop from jerking movements in head and legs. We thought maybe she got a hold of some kind of drug. The doctors said she has rheumatic fever. This is triggered by strep throat. The only problem she tested negative for that. Now she can't even walk. She has no hunger and is very depressed. 10 years old and making drugs that take healthy kids and turn them into this. I didn't like the idea of my child taking this drug and my wife only did because the doctor said he highly recommended it. Well now that this has happened I have found out that they have had 21 deaths in 2 years. Thanks for telling us that in the side effects. I don't see anything mentioned about this. My daughter got only one dose and was set to get her second when this happened. This drug needs to be taking off the market. I don't want to see another family go through what we are going through. She has missed 3 weeks of school and I don't see her recovering anytime soon. 1 death is too many and I know that there are many out there that will be permanently disabled over this drug. PLEASE TAKE THIS DRUG OFF THE MARKET. I will continue to spread the word out to Family & Friends in hope that they won't put their child in the hands of this drug maker. GARDASIL needs to be stopped.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Bronchitis, Electrocardiogram normal, Influenza like illness, Loss of consciousness
Clinical narrative: Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns.  3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Mydriasis, Pain, Pallor, Pyrexia
Clinical narrative: Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns.  3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tooth injury
Clinical narrative: Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns.  3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Rash, Rash pruritic
Clinical narrative: I was given the GARDASIL shot. A week after being injected I had a serious allergic reaction and broke out in a very itchy rash all over my fingers and between fingers, and also spots on my face. The rash consisted of little bumps, and was spreadable.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Hypoaesthesia
Clinical narrative: My daughter had the vaccine GARDASIL and now her arm is bruising up looks really nasty and she saying she's got numbness of the arm and Dr. don't think it's the GARDASIL I'm very worried, she does allergies but Dr. did say shot was ok for her.  3/18/09 Received vac records & PCP medical records of  FINAL DX: purpuric rash LUE; allergies; urticaria Records reveal patient experienced good health on day of #1 & #2 HPV vaccines.  RTC 1/15/09 w/rash, redness, itching & bruising LUE which had started in wrist area & moved up arm.   Dx w/insect bite (spider) LUE.  Tx w/IV antibiotic & antihistamine.  RTC 2/2/09 w/URI & pain left arm.  Dx w/strep throat & URI.  Tx w/antibiotics.  Seen in ER 2/3/09 for probable insect bite LUE & enlarged bilateral axillary lymph nodes.  Tx w/continued antibiotics & antihistamines.  RTC 2/19 w/purpuric rash left arm & 2/24 w/bruising & tenderness of both arms, chest pain & taste alteration.  Dx w/allergies & urticaria.  Tx w/antihistamines.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Pt developed trunkle red micropapule rash 2 wks post MMR
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Feeling abnormal, Immediate post-injection reaction, Mydriasis
Clinical narrative: pt c/o "fuzziness".  Slumped in chair post immz given pupil dilated.  Assisted to cot when appropriate.  Applied cool rag.  Given snack & juice when recovered.  Total time 10 minutes.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Blanchable nonspecific rash. Described as hives by parents.
Age: 1.0
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Blanchable non-specific rash described as hives by parents.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Crying, Pyrexia
Clinical narrative: Fever, crying non stop x 1-2 hr. 2/18/09 - temp 101 this mother has cystic fibrosis - not breastfeeding.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Pt. began to have stiff neck on (L) shoulder - progressed to stiffness bilaterally in her trapezius muscle and base of skull. Feb. 10 - symptoms intensified to headache - extreme pain through Feb. 11. Subsiding today 2/12/209 with assist of 4 Ibuprofen every 6 hours, also experienced pain in biceps/triceps bilat 2/6 -2/8
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after receiving shots RT leg, sore, red, warm and swollen about the size of mom's palm of hand. Went to see Dr on 2/10. Told was an allergic reaction. Gave BENADRYL and IBP about 4 days. Leg better since 2/12. Still a little bruised.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain in extremity
Clinical narrative: 2 days after receiving shots RT leg, sore, red, warm and swollen about the size of mom's palm of hand. Went to see Dr on 2/10. Told was an allergic reaction. Gave BENADRYL and IBP about 4 days. Leg better since 2/12. Still a little bruised.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Injection site erythema, Injection site inflammation, Injection site pruritus, Sinusitis
Clinical narrative: 2 days after shot injection site itched, became red and raised. Eventually the itching moved down arm and red rash went away. On 11/2007 she went to doctor for general exam and mentioned itch. Was given steroid cream which relieved itching. Itch continues now. Because of severe sinus infection after 08' flu shot she is undergoing allergy elimination testing. Arm continues to itch about 2" below vacc. Site.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood thyroid stimulating hormone, Cellulitis, Chills, Dizziness, Erythema
Clinical narrative: L arm sore and client dizzy evening after shot.  Next morning left arm swollen and client began to shiver and low grade fever 100 degrees F.  Very reddened spots underneath the band aid.  Dx. 1/29/09 @ MD othce with cellulitis.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: L arm sore and client dizzy evening after shot.  Next morning left arm swollen and client began to shiver and low grade fever 100 degrees F.  Very reddened spots underneath the band aid.  Dx. 1/29/09 @ MD othce with cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Eye pain, Headache, Hypoaesthesia, Injection site atrophy
Clinical narrative: Acute onset of excruciating right shoulder and upper arm pain following flu virus immunization. Pain intensity very high (9+/10) and maximal at onset. Pain is sharp and throbbing and constant since injection. Deep aching and muscle weakness and atrophy in upper right arm. Also, sharp/shooting pain affecting eyes and head. Numbness and muscle weakness continuing chronic right upper arm and shoulder pain, significant muscle weakness continuing with physicians for diagnostic work up. 4/3/09-records received-office visit 1/21/09-C/O 3 months of right upper arm lateral aspect being painful with decreased strength. 4/16/09 neurology consult received for DOS 12/16/08-C/O headaches with black spots in front of eyes. Anxiety worsenes tension type headaches.  Impression: chronic daily headaches both migraine and tension type and analgesic rebound headache. Daytime somnolence snoring and gasping respiration and weight gain. Lancinating headaches. 2/2/09-C/O right upper arm pain since receiving flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Musculoskeletal pain, Myalgia, Nerve conduction studies abnormal
Clinical narrative: Acute onset of excruciating right shoulder and upper arm pain following flu virus immunization. Pain intensity very high (9+/10) and maximal at onset. Pain is sharp and throbbing and constant since injection. Deep aching and muscle weakness and atrophy in upper right arm. Also, sharp/shooting pain affecting eyes and head. Numbness and muscle weakness continuing chronic right upper arm and shoulder pain, significant muscle weakness continuing with physicians for diagnostic work up. 4/3/09-records received-office visit 1/21/09-C/O 3 months of right upper arm lateral aspect being painful with decreased strength. 4/16/09 neurology consult received for DOS 12/16/08-C/O headaches with black spots in front of eyes. Anxiety worsenes tension type headaches.  Impression: chronic daily headaches both migraine and tension type and analgesic rebound headache. Daytime somnolence snoring and gasping respiration and weight gain. Lancinating headaches. 2/2/09-C/O right upper arm pain since receiving flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pain
Clinical narrative: Acute onset of excruciating right shoulder and upper arm pain following flu virus immunization. Pain intensity very high (9+/10) and maximal at onset. Pain is sharp and throbbing and constant since injection. Deep aching and muscle weakness and atrophy in upper right arm. Also, sharp/shooting pain affecting eyes and head. Numbness and muscle weakness continuing chronic right upper arm and shoulder pain, significant muscle weakness continuing with physicians for diagnostic work up. 4/3/09-records received-office visit 1/21/09-C/O 3 months of right upper arm lateral aspect being painful with decreased strength. 4/16/09 neurology consult received for DOS 12/16/08-C/O headaches with black spots in front of eyes. Anxiety worsenes tension type headaches.  Impression: chronic daily headaches both migraine and tension type and analgesic rebound headache. Daytime somnolence snoring and gasping respiration and weight gain. Lancinating headaches. 2/2/09-C/O right upper arm pain since receiving flu shot.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Ran fever after imm Fever 101.1
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Cyanosis, Lip swelling
Clinical narrative: Mother called Health Dept @ 3:45pm reporting that child's lips were turning blue and swelling, she also reported child to E.R. because they were still in car in route near hospital. Child was seen in E.R. @ approx 3:50pm. He was given Benadryl and released home. At 4:30pm father reported child up and playing as normal. 7/17/09
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Diarrhoea, Nausea
Clinical narrative: Patient was given vaccines on 2/13/2009. Patient came into office on 2/17/09 c/o nausea, diarrhea, wt loss, fever, chills, stomach bloating and stomach cramps x 3 days.
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Patient was given vaccines on 2/13/2009. Patient came into office on 2/17/09 c/o nausea, diarrhea, wt loss, fever, chills, stomach bloating and stomach cramps x 3 days.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Urticaria
Clinical narrative: Hives started 2 days after flu vaccine ? allergy to eggs.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received varicella vaccine RA SQ on 2-4-09 and returned to office 2-16-09 with red/swollen (15 mm) in area around injection site and reported area itches instructions given per VIS and to return if area worsens or gets larger.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Pt learned she was pregnant 2 months after receiving GARDASIL vaccine. Pt miscarried at 2 1/2- 3 mos pregnant.
Age: 0.19
Sex: M
Vaccine: HIBV, IPV, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient received Tdap instead of DTap. No adverse reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Gave 3 immunizations, about 3-4 min later fell to the right off chair, hit head on floor.  I helped her up.  She was twitching.  Felt dizzy, blacked out.  Layed her on table, took blood pressure (normal) gave juice. Felt fine afterwards (time 5 min)
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Muscle twitching
Clinical narrative: Gave 3 immunizations, about 3-4 min later fell to the right off chair, hit head on floor.  I helped her up.  She was twitching.  Felt dizzy, blacked out.  Layed her on table, took blood pressure (normal) gave juice. Felt fine afterwards (time 5 min)
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever (low grade) starting five days after administration, following by rash to face/neck/torso on ninth day after shots.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Palpitations, Rash erythematous, Tenderness, Type III immune complex mediated reaction
Clinical narrative: Mom states erythema in shot area started day of injection, worsened through weekend. Presented to Clinic 2/16 with large (about 10 x 11 cm) erythematous area on left upper arm, mildly tender to palpation, no fevers, no induration. Diagnosed with arthus reaction.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Retching, Vomiting, Vomiting projectile
Clinical narrative: Pt administered 2nd dose of ROTATEQ. Rec'd this dose prior to administration of IM vaccines due today. Pt had projectile vomiting immediately after swallowing  Emesis came through nostrils and mouth, struggling + gagging. Airway remained clear. After vomiting no other symptoms presented.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: Pt administered 1st dose ROTATEQ, had projectile vomiting with copious emesis from mouth +nostrils. No other vaccine had been given. Pt observed and no other S/S presented + vomiting stopped
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Headache
Clinical narrative: Headache - post immunization evening - continuing at time/date of call on 02/12/09. Given MOTRIN by mother - Mother related - Some relief - but once MOTRIN dose wore off - teen c/o headache again.
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Local reaction, Pain
Clinical narrative: Local reaction - mild redness, soreness
Age: 29.0
Sex: M
Vaccine: FLU3, MNQ, TD
Symptoms: Deafness, Dizziness, Dry mouth, Dyspnoea, No reaction on previous exposure to drug
Clinical narrative: Soon after receiving the tetanus, influenza and meningococcal vaccines and having blood drawn, service member complains of ringing in his ears, lightheadedness, unable to hear (deafness), dry mouth and difficulty breathing. He was given epinephrine 0.5 cc SQ.
Age: 29.0
Sex: M
Vaccine: FLU3, MNQ, TD
Symptoms: Tinnitus
Clinical narrative: Soon after receiving the tetanus, influenza and meningococcal vaccines and having blood drawn, service member complains of ringing in his ears, lightheadedness, unable to hear (deafness), dry mouth and difficulty breathing. He was given epinephrine 0.5 cc SQ.
Age: 0.7
Sex: M
Vaccine: DTAP, RV5
Symptoms: Wrong drug administered
Clinical narrative: Mistakenly gave DTAP #4 to 8 month old. Received DTAP #3 on 1/21/2009. Mistakenly gave ROTATEQ #4 same time. ROTATEQ #3 on 1/21/09
Age: 1.16
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Crying, Pyrexia, Rash erythematous
Clinical narrative: Parent's report on 2/21/09 at 1 pm pt fever 102 degrees axillary. Gave acetaminophen and "fever went down". Crying most of the time. Temp did not go below 100 degrees with medication every 4 hours until 2/22/09 at 4 pm. Rash developed on2/21/09 at 9pm. Rash began on thighs and arms. Then noticed on trunk area then on face. Stated rash was red and flat. Today 2/23/09 red, raised, corn meal feel rash over face, trunks and extremities. Temp is 97 degrees at 10:00am. Visit, playing and has taken juice and 1/2 bottle this am.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Computerised tomogram normal, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Pt with initial syncope, nausea, lasting several minutes post injection. Was monitored for 20 min and was normal. 1 week later developed chest pain, arm and leg pain with dizziness. Normal exam. Mom concerned RE clot. CT done, NEG for embolus.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity, Syncope
Clinical narrative: Pt with initial syncope, nausea, lasting several minutes post injection. Was monitored for 20 min and was normal. 1 week later developed chest pain, arm and leg pain with dizziness. Normal exam. Mom concerned RE clot. CT done, NEG for embolus.
Sex: U
Vaccine: HEP
Symptoms: Pharmaceutical product complaint
Clinical narrative: Although GSK labels their pre-filled syringes of Hepatitis B Vaccine - ENGERIX-B for adults and children with a yellow and olive band, respectively, to distinguish the products, labeling "except for the strength" 10 mcg/0.5 ml for children and 20 mcg/ml for adults is the only difference. I suggest labeling of the adult product includes: ADULT DOSE I suggest labeling of the pediatric product includes: PEDIATRIC DOSE.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Weight bearing difficulty
Clinical narrative: Temp 103 degrees within hours of injection. C/O severe pain to right leg, nearly intractable pain. Unable to bear weight on leg x 36 hrs. Post injection significant redness et swelling to groin et all of upper right leg. See photos included.
Age: 8.0
Sex: F
Vaccine: DT
Symptoms: Dizziness, Erythema, Induration, Swelling, Tenderness
Clinical narrative: Received DTD on 2/7/09.  Mom up pts feet dizzy after leaving clinic & laid down rest of day.  Arm was sore that even. & by next day was red & swollen from shoulder to elbow.  Hurt to move arm.  Was encouraged to move arm.  On children's MOTRIN & alternated warm & cold compresses for 2-3 da.  Saw NP. Friend from church- who said not to do any more tetanus shouts in the future- TC to mom on 2-18-08.  Arm better in past 2-3 days.
Age: 42.0
Sex: M
Vaccine: HEP, TD
Symptoms: Contusion, Erythema, Injection site pain, Swelling
Clinical narrative: Client returned 7 days after immunization with large bruise on right upper arm, extending from deltoid (bottom edge) to elbow, approx 5" in width. States progressed from redness/swelling under injection sight to progressively larger bruise. Complained of moderate pain at site, tingling sensation in right hand, weakness in both arms, declines fever. Client saw healthcare provider on 1/21/09, TX given (per client) 1 week physical therapy and pain medication.
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Received Hepatitis A inoculation on 2/10/09 at approximately 11 am. At 10:30 pm experienced symptoms similar to attack of food poisoning. Vomited and diarrhea for 2-3 hours. Severe stomach pains. Subsided at 1:30am.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Depressed level of consciousness, Fatigue, Headache, Hypotonia
Clinical narrative: Severe headache day of vaccine, through evening. Recurring headaches, constant fatigue, joint pain prominent in left arm where administered. Decreased level of alertness, limp itching.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Severe headache day of vaccine, through evening. Recurring headaches, constant fatigue, joint pain prominent in left arm where administered. Decreased level of alertness, limp itching.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash on skin.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Rash, Skin lesion, Varicella zoster virus serology positive
Clinical narrative: 2/9/09 started with rash, fever and HA. Seen on 2/11/09 counted 44 lesions (papules). Seen 2/12/09 vesicular fluid sample collected. Feels worse.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Induration, Swelling
Clinical narrative: Discomfort started around 2pm. Slight swelling. Hurts to move arm. Ibuprofen and ice the shoulder/arm. 2/13/09 doing much better.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Biopsy skin abnormal, Erythema multiforme, Palmar erythema, Rash erythematous, Rash papular
Clinical narrative: Erythematous, papulovesicular eruption scattered over arms, trunks, and legs, also with palmar lesions, some umbilicated lesion. Rash started 1/30/2009 small pox vaccination site healing well TX: Hydroxyzine 10mg tab qid prn for healing.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Skin lesion
Clinical narrative: Erythematous, papulovesicular eruption scattered over arms, trunks, and legs, also with palmar lesions, some umbilicated lesion. Rash started 1/30/2009 small pox vaccination site healing well TX: Hydroxyzine 10mg tab qid prn for healing.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a certified nurse midwife concerning a 24 year old female patient with asthma, epilepsy and migraine headaches, no drug reactions/allergies, who on 12-DEC-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 661044/0548X). Concomitant therapy included SYNTHROID, TOPAMAX and asthma inhaler (unspecified). On 18-DEC-2008 the patient experienced dizziness and waves of nausea for four days, the patient stated that, was able to continue A.O.L.. Symptoms decreased after 22-DEC-2008, then went away. The patient had recovered. The patient called to the office on 22-DEC-2008. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: PATIENT FAINTED IMMEDIATELY AFTER INJECTION OF GARDASIL. 5 SEC. OF COMPLETE UNCONSCIOUSNESS FOLLOWED BY CONFUSION, DIZZINESS AND NAUSEA UPON AWAKING.  PATIENT MONITORED FOR ADDITIONAL 15MIN AFTER INJECTIONS WITH VITAL SIGNS AND COMFORT MEASURES.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED IMMEDIATELY AFTER INJECTION OF GARDASIL. 5 SEC. OF COMPLETE UNCONSCIOUSNESS FOLLOWED BY CONFUSION, DIZZINESS AND NAUSEA UPON AWAKING.  PATIENT MONITORED FOR ADDITIONAL 15MIN AFTER INJECTIONS WITH VITAL SIGNS AND COMFORT MEASURES.