chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia, Sleep disorder
Clinical narrative: I received the pneumonia vaccination at about 2:35 p.m. on 13 Nov 07 at the Health Department.  I was asked to wait 10 minutes in the lobby after receiving the shot.  I started to feel a little light headed and nauseaous but did not think it was that serious.  There was no pain when the vaccine was administered.  By 14 Nov 07 at 8 a.m. the site where the injection was given was extremely sore and felt very hot.  The injection site was about the size of a quarter.  By the evening of 14 Nov 07 I could barely move my left arm and there was tingling going down into my fingers on my left hand.  I took 800 mg. of ibuprofen that evening.  Had a difficult time sleeping because my arm was so painful.  I also started itching from head to toe.  On the morning of 15 Nov 07 I contacted my doctor's office because my arm hurt so badly.  I was also suffering with a headache, eye pain and my knees were hurting.  The nurse at my doctor's office said I was having a localized reaction and did not need to be seen by the doctor.  By the late afternoon of 15 Nov 07 I was absolutely exhausted, was running a fever, had a headache and body aches.  I had a difficult time sleeping on the night of 15 Nov 07 because of the body aches, itching and severe pain in my arm.  The fever broke during the early hours of 16 Nov 07.  I contacted my doctor's office again because the injection site had more than tripled in size from the size of a quarter.  It was very red, very itchy and had an extremely hard and painful lump under the skin.  I saw my doctor on 16 Nov 07 and he examined the injection site.  The affected area had spread to 6 cm.  It did not appear to be infected so I was instructed to continue watching the area to make sure it did not grow larger.  In addition to taking 800 mg. of ibuprofen every 6 hours, I was also taking 25 mg. of benadryl every 4 hours to help control the itching.  The affected area grew larger than 6 cm. by 17 Nov 07 but I was not having any more fever or body aches.  It has stopped getting larger however, I continue to have an extremely hard and painful lump under the skin where the injection was given.  I will follow up with my doctor on 21 Nov 07 because I was advised I could get cellulitis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Developed enlarged inguinal Lymph nodes after first series of HPV vaccine.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood creatinine increased, Diarrhoea, Diet refusal, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: Information has been received from a physician concerning a 19 week old male with a history of reflux and no drug reactions/allergies, who on 29-AUG-2007 was vaccinated po with a first dose of Rotateq (lot number: 657511/0553U). On 09-NOV-2007 the patient was vaccinated with a second dose of Rotateq (lot number: 657667/1392U). Concomitant vaccinations that day included PEDIARIX, Hib conj vaccine, PREVNAR. Concomitant therapy included ZANTAC. On 11-NOV-2007 the patient experienced vomiting, diarrhea and refused to eat. On 12-NOV-2007 the physician examined the patient. The child was eating but his other symptoms had not resolved. On 13-NOV-2007 the patient was examined in the emergency room and diagnosed with hemolytic anemia. The patient was admitted and transferred to the Intensive Care Unit. Lab diagnostics studies were performed and included: hemoglobin 6 g/L and creatinine 3 mg/dL: 13-NOV-2007. The outcome was reported as not recovered. No further information was available. There was no product quality complaint. The adverse events were considered to be an other medical event, disabling and immediately life-threatening by the reporter. Additional information has been requested.  11/26/2007 MR received. Child presented to local ER with 3 day hx of vomiting and diarrhea.  Decreased oral intake x 3 days.  No urine output since prior pm. Puffiness of hands and feet beginning day before admission, and maked pallor.  Child was transfered directly to PICU of local Hospital for eval.  Pt noted to have dry mucus membranes, delayed cap refill, hypertension 160's/100's, and a faint erytematous macular rash. Admission PE (+) for moderate respiratory distress, tachypnea and grunting respirations, marked pallor, edema of hands and feet, scrotal edema, abdominal distention, tachycardia, irritability and tea-colored urine.  Admitted with Hemolytic Uremic Syndrome requiring dialysis.  Peritoneal dialysis catheter inserted on 11/13/07 and returned to OR x2 for catheter malfunctions.  PICU note on day #14 shows current problem list:  Acute renal failure 2' hemolytic uremic syndrome.  Hypertension. Serratia marcescens bacteremia.  Acute upper GI bleeding. Nutritional deficiencies on TPN. Electrolyte abnormalities.  Anemia requiring intermittant transfusion. Thrombocytopenia requiring platelet transfusions.  Hypogammaglobulinemia.  Narcotic Abstinance syndrome.  Wolff-Parkinson-White pre-excitation syndrome.  Acute respiratory failure requiring mechanical ventilation-now resolved. Massive anasarca-now resolved.  Hypoalbuminemia and hypo proteinemia now resolved.  12/27/2007 D/C Summary received for DOS 11/13-12/18/2007 with Final DX:  Acute Renal Failure.  Probable hemolytic uremic syndrome.  Hypertension.  Anemai.  GI bleeding 2' to irritation from NG tube. Pt on dialysis 11/14-12/07/2007 with reduction in creatinine. Pt remained somewhat hypertensive during admission. D/C on Enalapril and Norvasc. otherwise as above.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 week old male with a history of reflux and no drug reactions/allergies, who on 29-AUG-2007 was vaccinated po with a first dose of Rotateq (lot number: 657511/0553U). On 09-NOV-2007 the patient was vaccinated with a second dose of Rotateq (lot number: 657667/1392U). Concomitant vaccinations that day included PEDIARIX, Hib conj vaccine, PREVNAR. Concomitant therapy included ZANTAC. On 11-NOV-2007 the patient experienced vomiting, diarrhea and refused to eat. On 12-NOV-2007 the physician examined the patient. The child was eating but his other symptoms had not resolved. On 13-NOV-2007 the patient was examined in the emergency room and diagnosed with hemolytic anemia. The patient was admitted and transferred to the Intensive Care Unit. Lab diagnostics studies were performed and included: hemoglobin 6 g/L and creatinine 3 mg/dL: 13-NOV-2007. The outcome was reported as not recovered. No further information was available. There was no product quality complaint. The adverse events were considered to be an other medical event, disabling and immediately life-threatening by the reporter. Additional information has been requested.  11/26/2007 MR received. Child presented to local ER with 3 day hx of vomiting and diarrhea.  Decreased oral intake x 3 days.  No urine output since prior pm. Puffiness of hands and feet beginning day before admission, and maked pallor.  Child was transfered directly to PICU of local Hospital for eval.  Pt noted to have dry mucus membranes, delayed cap refill, hypertension 160's/100's, and a faint erytematous macular rash. Admission PE (+) for moderate respiratory distress, tachypnea and grunting respirations, marked pallor, edema of hands and feet, scrotal edema, abdominal distention, tachycardia, irritability and tea-colored urine.  Admitted with Hemolytic Uremic Syndrome requiring dialysis.  Peritoneal dialysis catheter inserted on 11/13/07 and returned to OR x2 for catheter malfunctions.  PICU note on day #14 shows current problem list:  Acute renal failure 2' hemolytic uremic syndrome.  Hypertension. Serratia marcescens bacteremia.  Acute upper GI bleeding. Nutritional deficiencies on TPN. Electrolyte abnormalities.  Anemia requiring intermittant transfusion. Thrombocytopenia requiring platelet transfusions.  Hypogammaglobulinemia.  Narcotic Abstinance syndrome.  Wolff-Parkinson-White pre-excitation syndrome.  Acute respiratory failure requiring mechanical ventilation-now resolved. Massive anasarca-now resolved.  Hypoalbuminemia and hypo proteinemia now resolved.  12/27/2007 D/C Summary received for DOS 11/13-12/18/2007 with Final DX:  Acute Renal Failure.  Probable hemolytic uremic syndrome.  Hypertension.  Anemai.  GI bleeding 2' to irritation from NG tube. Pt on dialysis 11/14-12/07/2007 with reduction in creatinine. Pt remained somewhat hypertensive during admission. D/C on Enalapril and Norvasc. otherwise as above.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Dialysis, Diarrhoea, Haemolytic uraemic syndrome, Renal failure, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 week old male with a history of reflux and no drug reactions/allergies, who on 29-AUG-2007 was vaccinated po with a first dose of Rotateq (lot number: 657511/0553U). On 09-NOV-2007 the patient was vaccinated with a second dose of Rotateq (lot number: 657667/1392U). Concomitant vaccinations that day included PEDIARIX, Hib conj vaccine, PREVNAR. Concomitant therapy included ZANTAC. On 11-NOV-2007 the patient experienced vomiting, diarrhea and refused to eat. On 12-NOV-2007 the physician examined the patient. The child was eating but his other symptoms had not resolved. On 13-NOV-2007 the patient was examined in the emergency room and diagnosed with hemolytic anemia. The patient was admitted and transferred to the Intensive Care Unit. Lab diagnostics studies were performed and included: hemoglobin 6 g/L and creatinine 3 mg/dL: 13-NOV-2007. The outcome was reported as not recovered. No further information was available. There was no product quality complaint. The adverse events were considered to be an other medical event, disabling and immediately life-threatening by the reporter. Additional information has been requested.  11/26/2007 MR received. Child presented to local ER with 3 day hx of vomiting and diarrhea.  Decreased oral intake x 3 days.  No urine output since prior pm. Puffiness of hands and feet beginning day before admission, and maked pallor.  Child was transfered directly to PICU of local Hospital for eval.  Pt noted to have dry mucus membranes, delayed cap refill, hypertension 160's/100's, and a faint erytematous macular rash. Admission PE (+) for moderate respiratory distress, tachypnea and grunting respirations, marked pallor, edema of hands and feet, scrotal edema, abdominal distention, tachycardia, irritability and tea-colored urine.  Admitted with Hemolytic Uremic Syndrome requiring dialysis.  Peritoneal dialysis catheter inserted on 11/13/07 and returned to OR x2 for catheter malfunctions.  PICU note on day #14 shows current problem list:  Acute renal failure 2' hemolytic uremic syndrome.  Hypertension. Serratia marcescens bacteremia.  Acute upper GI bleeding. Nutritional deficiencies on TPN. Electrolyte abnormalities.  Anemia requiring intermittant transfusion. Thrombocytopenia requiring platelet transfusions.  Hypogammaglobulinemia.  Narcotic Abstinance syndrome.  Wolff-Parkinson-White pre-excitation syndrome.  Acute respiratory failure requiring mechanical ventilation-now resolved. Massive anasarca-now resolved.  Hypoalbuminemia and hypo proteinemia now resolved.  12/27/2007 D/C Summary received for DOS 11/13-12/18/2007 with Final DX:  Acute Renal Failure.  Probable hemolytic uremic syndrome.  Hypertension.  Anemai.  GI bleeding 2' to irritation from NG tube. Pt on dialysis 11/14-12/07/2007 with reduction in creatinine. Pt remained somewhat hypertensive during admission. D/C on Enalapril and Norvasc. otherwise as above.
Age: 0.3
Sex: M
Vaccine: DTAP, DTAPH, IPV, PNC, RV5
Symptoms: Abdominal rigidity, Bowel movement irregularity, Constipation, Crying
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 weeks old male who was a premature baby with no drug reactions/allergies, who on 31-AUG-2007 was vaccinated with a first dose of Rotateq and on 26-OCT-2007 was vaccinated po with a second dose of Rotateq (lot number: 657661/0973U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and PREVENAR and poliovirus vaccine inactivated (unspecified). On 31-OCT-2007 the patient experienced a rigid abdominal constipation, 17 hours of straight crying, and no bowel movement for 2 days and was hospitalized. On 05-NOV-2007 the patient was discharged from the hospital. No lab diagnostics studies were performed. Mirilax  was given. No further information was provided. There was no product quality complaint. The adverse event was thought to be an other medical event. Additional information has been requested. 12/26/07-records received for DOS 10/31-11/01/07-DC DX: Constiption. Mild dehyrdration. Presented with abdominal pain and fussiness. Decreased feeds for 1-2days. No vomiting. At PCP office no bowel sounds heard.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Barium enema, Intussusception, X-ray
Clinical narrative: Information has been received from a physician concerning a 7 month old male who on 15-MAY-2007 received a first oral 2 ml, and a second dose on 21-SEP-2007 of Rotateq. On 31-OCT-2007, he developed intussusception. It was reported he was seen in the physician's office, was hospitalized, and underwent emergency surgical correction after he failed to respond to an enema. The patient was discharged and was to have a follow up visit on 09-NOV-2007 with his physician. No other symptoms or treatment was reported. A product quality complaint was not reported. No further information was available. The patient's intussusception was determined to be an other important medical event, and life threatening by the reporter. Additional information has been requested. 12/10/07-records received-for DOS 10/31-11/03/07-DC DX: Idiopathic ileocolic intussusception. Presented with vomiting and bloody diarrhea times 1 day. Abdominal ultrasound showed instussusception. Exploratory laparotomy mandual reduction of intussusception and incidental appendectomy.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Haematochezia
Clinical narrative: Information has been received from a consumer concerning her 8 week old granddaughter who on 05-NOV-2007 received her first dose orally of Rotateq. It was reported that one day after administration of the dose (06-NOV-2007), she was examined by her physician after she developed blood in her stool. It was reported that on 06-NOV-2007 a stool culture was taken (results not reported). It was reported that the patient was referred to an unspecified specialist for evaluation. As of this report it was reported that the patient had not recovered. No product quality complaint was involved. Additional information was not available. Upon internal review, the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypoaesthesia, Tachycardia
Clinical narrative: Information has been received from a physician concerning a female who on 09-NOV-2007 was vaccinated with Gardasil. On 09-NOV-2007 the patient's arm was red and her arm went numb. The physician sent the patient to the emergency room where she remained for 6 hours. While in the emergency room, the patient developed tachycardia. She was treated with diazepam (Valium) to calm her down. The patient recovered on 10-NOV-2007; however, it was also reported that the patient's arm was numb for 3 days before the feeling came back. The physician considered the patient's red arm, numb arm and tachycardia to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with her second dose of Gardasil (Date not provided). Subsequently the patient experienced a seizure. The seizure did not happen in the physician's office. It was reported that the patient was to have an MRI. She did not experience a seizure after her first dose. 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: Contusion, Fall, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from two nurses concerning a 19 year old female who was vaccinated with the first dose of Gardasil (lot# not reported), 0.5mL injection. After receiving Gardasil, the patient experienced syncope and fell and hit her head. The patient was taken to the emergency room because she hit her head, but it was unknown if she was admitted (also reported as hospitalized because she hit her head). During the week of 12-NOV-2007 the patient reported that she had a bump on her head and a bruise on her bottom from the fall, but that she was now doing fine. The patient recovered, date not reported. Followup information received from the nurse, via the company representative, confirmed that it was unknown if the patient was hopitalised for any of the events. Additional information received from a healthcare professional (HCP), provided the lot # for the dose of Gardisil (lot # 658563/1063U), and confirmed that the patient was seen in the emergency room (ER), but was not hospitalized for any of the events. She added that the patient had recovered as previously reported, and was still doing well. Additional information is not expected. Follow up information received from a physician's assistant, confirmed that the patient was caucasian with no known drug allergies and no illness at the time of vaccination, and on 31-OCT-2007 at 11:30 am, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658563/1063U). She confirmed that immediately after the vaccination, at 11:30 am, the patient had a vasovagal episode and hit her head on a metal door frame. She had no lacerations, no bleeding and no hematoma, though she did complain of a headache. She was taken to the ER via an ambulance. The patient's exam was normal, an electrocardiogram (EKG) was normal, and her vital signs were normal. No additional labs or studies were obtained. Additional information is not expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Eye disorder, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an approximately 9-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax. At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Eye injury, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an approximately 5-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax (Oka/Merck). At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Eye injury, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an approximate 3-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax (Oka/Merck). At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Immunisation reaction, Pruritus, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of systemic shot reaction in a 30-year-old male subject who was vaccinated with Flulaval for prophylaxis. The subject had no relevant medical history. There were no concurrent medications. No other vaccinations were administered on the date of receipt of Flulaval. The subject had not previously received a flu shot. On 12 November 2007 at 2:00 p.m., the subject received 1st dose of Flulaval (.5 ml, unknown, left arm). On 14 November 2007, 2 days after vaccination with Flulaval, the subject experienced a systemic reaction which included hives, redness and itching. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Benadryl and Claritin. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician and described the occurrence of aphasia in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline). The subject's medical history, concurrent medications were not reported. Information regarding previous immunization with influenza virus vaccine was not provided. The reporting physician did not have the subject's chart with him at the time of the call. On 15 November 2007 at 8:00 a.m., the subject received unspecified dose of Flulaval (.5 ml, unknown). On 15 November 2007, within a few minutes of receipt of Flulaval, the subject became "unresponsive." The physician reported that the subject's eyes were open but she was no longer able to speak. The physician described the subject was "unresponsiveness or aphaisiac". The subject's vital signs were stable and the subject did not pass out. Emergency medical services was called and the subject was taken to the hospital. The reporting physician has spoken with the emergency room physician and was told the subject was still in this "state" and they plan to admit her to the hospital. The reporting physician also considered the events to be disabling. At the time of reporting the events were unresolved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest pain, Dizziness, Dyspnoea, Erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of a burning sensation over the body in a 43-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 12 October 2007 at 15:10 the subject received unspecified dose of Flulaval in the left arm. On 12 October 2007, 10 minutes after vaccination with Flulaval, the subject experienced a burning sensation over her body. Other events reported with unspecified time to onset included dizziness, headache (described as sections of her head hurting), fatigue, tingling over the body, glands hurt, breaking out, itching, nausea, internal burning sensation (such that when she exhales she feels that heat is coming out), difficulty breathing, muscle pain, chest pain, cloudy vision and redness and burning of the eyes. The consumer reported that her opthamologist said her corneas were irritated and inflamed. The subject also reported having a stiff neck. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified with the exception of the burning sensation over the body which was unresolved. Reportedly, the subject's physician spoke to an infectious physician and it was noted that gentomycin is in "the drug" and that the subject could be reacting to that.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Fatigue, Headache, Keratitis, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer and described the occurrence of a burning sensation over the body in a 43-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 12 October 2007 at 15:10 the subject received unspecified dose of Flulaval in the left arm. On 12 October 2007, 10 minutes after vaccination with Flulaval, the subject experienced a burning sensation over her body. Other events reported with unspecified time to onset included dizziness, headache (described as sections of her head hurting), fatigue, tingling over the body, glands hurt, breaking out, itching, nausea, internal burning sensation (such that when she exhales she feels that heat is coming out), difficulty breathing, muscle pain, chest pain, cloudy vision and redness and burning of the eyes. The consumer reported that her opthamologist said her corneas were irritated and inflamed. The subject also reported having a stiff neck. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified with the exception of the burning sensation over the body which was unresolved. Reportedly, the subject's physician spoke to an infectious physician and it was noted that gentomycin is in "the drug" and that the subject could be reacting to that.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Ocular hyperaemia, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of a burning sensation over the body in a 43-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 12 October 2007 at 15:10 the subject received unspecified dose of Flulaval in the left arm. On 12 October 2007, 10 minutes after vaccination with Flulaval, the subject experienced a burning sensation over her body. Other events reported with unspecified time to onset included dizziness, headache (described as sections of her head hurting), fatigue, tingling over the body, glands hurt, breaking out, itching, nausea, internal burning sensation (such that when she exhales she feels that heat is coming out), difficulty breathing, muscle pain, chest pain, cloudy vision and redness and burning of the eyes. The consumer reported that her opthamologist said her corneas were irritated and inflamed. The subject also reported having a stiff neck. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified with the exception of the burning sensation over the body which was unresolved. Reportedly, the subject's physician spoke to an infectious physician and it was noted that gentomycin is in "the drug" and that the subject could be reacting to that.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Vision blurred
Clinical narrative: This case was reported by a consumer and described the occurrence of a burning sensation over the body in a 43-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 12 October 2007 at 15:10 the subject received unspecified dose of Flulaval in the left arm. On 12 October 2007, 10 minutes after vaccination with Flulaval, the subject experienced a burning sensation over her body. Other events reported with unspecified time to onset included dizziness, headache (described as sections of her head hurting), fatigue, tingling over the body, glands hurt, breaking out, itching, nausea, internal burning sensation (such that when she exhales she feels that heat is coming out), difficulty breathing, muscle pain, chest pain, cloudy vision and redness and burning of the eyes. The consumer reported that her opthamologist said her corneas were irritated and inflamed. The subject also reported having a stiff neck. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified with the exception of the burning sensation over the body which was unresolved. Reportedly, the subject's physician spoke to an infectious physician and it was noted that gentomycin is in "the drug" and that the subject could be reacting to that.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Intensive care, Myalgia, Nausea, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of supraventricular tachycardia in a 64-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to ibuprofen, allergy to vicodin, aspirin allergy, asthma, chronic obstructive pulmonary disease and sulf allergy. Concurrent medications included Salbutamol sulphate (Albuterol), Fluticasone propionate+salmeterol xinafoate (Advair) and Tiotropium (Spiriva). On 13 October 2007 at 13:15 the subject received 1st dose of Fluarix (.5 ml, left arm). On 13 October 2007, less than one day after vaccination with Fluarix, the subject experienced shivering, chills, body aches and muscle aches. On 14 October 2007, the subject experienced nausea. On 16 October 2007, the subject experienced supraventricular tachycardia and wheezing. The subject presented to the emergency room on 16 October 2007, 17October 2007 and 18October 2007. She was taken by ambulance to the hospital on 19 October 2007 and hospitalized in the intensive care unit. Treatment was not specified. She was discharged home on 24 October 2007. The subject considered that the events were jeopardizing or required intervention to prevent a serious outcome. At the time of reporting the outcome of the wheezing, supraventricular tachycardia, shivering and chills had resolved. The outcome of the other events were unspecified.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Supraventricular tachycardia, Wheezing
Clinical narrative: This case was reported by a consumer and described the occurrence of supraventricular tachycardia in a 64-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to ibuprofen, allergy to vicodin, aspirin allergy, asthma, chronic obstructive pulmonary disease and sulf allergy. Concurrent medications included Salbutamol sulphate (Albuterol), Fluticasone propionate+salmeterol xinafoate (Advair) and Tiotropium (Spiriva). On 13 October 2007 at 13:15 the subject received 1st dose of Fluarix (.5 ml, left arm). On 13 October 2007, less than one day after vaccination with Fluarix, the subject experienced shivering, chills, body aches and muscle aches. On 14 October 2007, the subject experienced nausea. On 16 October 2007, the subject experienced supraventricular tachycardia and wheezing. The subject presented to the emergency room on 16 October 2007, 17October 2007 and 18October 2007. She was taken by ambulance to the hospital on 19 October 2007 and hospitalized in the intensive care unit. Treatment was not specified. She was discharged home on 24 October 2007. The subject considered that the events were jeopardizing or required intervention to prevent a serious outcome. At the time of reporting the outcome of the wheezing, supraventricular tachycardia, shivering and chills had resolved. The outcome of the other events were unspecified.
Age: 70.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Dysuria, Syncope
Clinical narrative: Information has been received from a physician concerning a male approximately in his "early 70's" who at 08:00 (date unspecified) was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day at 08:00 included a dose of influenza virus vaccine (unspecified). Subsequently the patient experienced trouble urinating from about 12:00 until 04:00 and then fainted. The patient went to the emergency room and was subsequently admitted to the hospital for an overnight stay. The patient was able to urinate around 04:00 and was noted to be recovering. Medical treatment in the hospital was not specified. There was no product quality complaint. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchiolitis, Inappropriate schedule of drug administration
Clinical narrative: We received on 09 NOV 2007 via MedCom US from a nurse the following information: A 3-year-11month-old male patient, born on 06 DEC 2003, was vaccinated i.m. with 0.5 ml Fluvirin, batch no. 80956, on 02 NOV 2007. The patient experienced bronchiolitis and was hospitalised from 05 NOV 2007 to an unknown date. The outcome is unknown. Company assessment: Serious criterion: hospitalisation. Causality: not related. Expectedness assessment according to product information and regulatory agency. Administration to a child under 4 years and bronchiolitis are unexpected after vaccination with Fluvirin. MedCom US no.: NA07-006282
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Possible seizure admitted to hospital for workup. 12/3/07-records received for DOS 115/15-11/16/07-Overnight observation-Assessment:choking episode. Family member observed child foaming at mouth, gasping for air. Suctioned his nose as it appeaded he was not catching his breath and strangling on saliva. Seemed to have some loss of muscle tone. No color changes no shaking or eye deviation.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, Chest pain, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Weakness of lower extremities, pain in back and chest, paresthesias, hospitalized 5 days for Guillain-Barre Syndrome. Rx plasmapheresis.  01/04/2008 MR received for DOS 10/27-11/01/2007 with D/C Dx: Guillain-Barre Syndrome.  Pt presented to ER with c/o progressive weakness and pain in the back x 9-10 days with paresthesias. Pt recently lost bladder and bowel control and was admitted. Txd with plasmapheresis with improvement of sx.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plasmapheresis
Clinical narrative: Weakness of lower extremities, pain in back and chest, paresthesias, hospitalized 5 days for Guillain-Barre Syndrome. Rx plasmapheresis.  01/04/2008 MR received for DOS 10/27-11/01/2007 with D/C Dx: Guillain-Barre Syndrome.  Pt presented to ER with c/o progressive weakness and pain in the back x 9-10 days with paresthesias. Pt recently lost bladder and bowel control and was admitted. Txd with plasmapheresis with improvement of sx.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Per hospital admission note - admitted on 11/17/07 for acute loss of consciousness. 6/23/08-records received for DOS 11/15-11/24/07-DC DX: seizure disorder. Presented with nonconvulsive status epilepticus demonstrated on EEG.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Per hospital admission notice - admitted 11/15/07 for seizures. 6/27/08-records received for DOS 11/17-11/25/07-DC DX: Global developmental delay.  Presented with status epilepticus with some desaturation at home, generalized tonic-clonic seizures and decreased responsiveness per parent. Cough and nasal congestion noted. Known seizure disorder.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Convulsion
Clinical narrative: Probable seizure - 12 hours after Pediarix, Rotateq, Prevnar, Flu.  01/09/2008 MR received for DOS 11/20-21/2007 with D/C DX:  Febrile Seizure/UTI. Child presented to ER after seizure episode.  Child had initially woken with T=100.1, given Tylenol but vomited.  Later parent noted staring, tonic-clinic movements,  gasping breaths, and drooling.  Child was unresponsive, later sleepy with decreased activity. D/Cd on abx for UTI. 1/15/2010 The patient continues to be on seizure medication. The neurologist felt not related to vaccinest (thought febrile seizure) but patient continues to have seizures and is on seizure medication.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Woke up during night w/ chills fever. Next morning was achy; tired; headache - stayed on sofa under cover until 11:00 AM; tried to move around; noticed a red spot on arm that shots were given in Thurs afternoon. Applied ice; arm is extremely sore; did not feel like eating; slept a little better Thurs night; moved around some on Fri, still had a few chills; Sat 2:00 PM noticed another large area on arm; applied ice; Sunday AM had a nurse tried look at red spot - she said it was still warm and I should apply heat. Sunday night arm is moving better.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up during night w/ chills fever. Next morning was achy; tired; headache - stayed on sofa under cover until 11:00 AM; tried to move around; noticed a red spot on arm that shots were given in Thurs afternoon. Applied ice; arm is extremely sore; did not feel like eating; slept a little better Thurs night; moved around some on Fri, still had a few chills; Sat 2:00 PM noticed another large area on arm; applied ice; Sunday AM had a nurse tried look at red spot - she said it was still warm and I should apply heat. Sunday night arm is moving better.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Rash erythematous, Skin warm, Swelling
Clinical narrative: Swelled up/red/hot to the touch red rash size of a silver dollar or larger hard in the center
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Contusion, Feeling cold, Headache, Muscle spasms
Clinical narrative: patient had freezing cold, all body muscle spasm, Headache, nausea/vomiting for 2 days after pneumonia and flu shot. Pain in R arm and chest, armpit. Bruise on armpit
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: patient had freezing cold, all body muscle spasm, Headache, nausea/vomiting for 2 days after pneumonia and flu shot. Pain in R arm and chest, armpit. Bruise on armpit
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, High-pitched crying
Clinical narrative: Inconsolable, nonstop very pitched crying for four hours. Onset 2 days past vaccines. She did calm during the drive to the pediatricians office.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of arm in which vaccine was administered (right). Patient went to emergency room as precaution and received Cephalexin.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Wrong drug administered
Clinical narrative: A 11 year old boy was inadvertently given Pediarix vaccine (combination of DTaP, IPV, and Hep B) instead of Tdap.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Faint/syncope within 1 minute of Gardasil vaccination. Patient was sitting and fainted forward-caught by Dr and positioned onto bed. No trauma.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Pallor, Unresponsive to stimuli
Clinical narrative: At 10am pt & mom were in pt. room discussing possible vaccines to receive today; they decided to have Gardasil and Menactra administered today; at 10:15am this nurse injected Gardasil IM into her (L) deltoid muscle; was applying bandaid & mom said "call the doctor!!" & pt closed her eyes and "slumped" forward. Mom saw a color change in face; pt. had jerking movements & was unresponsive for 1 to 2 min. M.D. came into room and Epipen Jr was injected into thigh and Menactra never was injected.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none noted or reported by pt- pt received flu vaccine 11-19-07 stated he had received one 3 wk prior
Age: 1.3
Sex: M
Vaccine: FLU3, MMR
Symptoms: Parotitis
Clinical narrative: Pt developed parotitis approx. 7-10 days after MMR vaccine.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: 11-20-07 13 y/o female was given Fluarix 0.5 ml IM in (R) arm lot AFLUA282DA Exp 6/30/08. This vaccine is not approved for children < 19 yrs old. No adverse event reported from parent
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen deltoid, from shoulder to elbow but decreased a lot in redness and size with Benadryl.
Age: 1.8
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives next day after receiving Fluzone .25 ml. Thimerosol-Free
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Client called on 11/13/07 to report symptoms of urticaria - raised edematous patches of skin with itching noted to (L) upper arm, radiating down back of arm 2 days post-flu vaccination. Did not have fever or other adverse reaction such as: breathing difficulties, wheezing or dizziness. Instructed client to take Benadryl and report to health unit when return to work on 11/14/07. Noted upon assessment, small "red bumps" to (L) upper arm - no swelling noted since using Benadryl within the last 24 hours. Itching resolved as well.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Sensory loss
Clinical narrative: 12:15 pm, client given HPV left deltoid IM, C/O pain after vaccine administered, decreased sensation to left arm (anterior upper arm) and from elbow to finger tips.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Full blood count, Platelet count decreased
Clinical narrative: Platelet count dropped to 57k. Recovering but count is still low.  02/26/2008 MR received from PCP for dates beginning 9/12/2007 to 11/20/2007.  Normal WCC exam on 9/12/07.  Labs 9/15/07 reveal thrombocytopenia.  No bleeding or bruising noted.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states pt's arm became red and warm to touch at injection site on the evening of 11-14-07. Mother states a large red, warm area on his (R) arm was present in the am on 11/15/07, mother also noted and rash around the red area and took pt to the ER-the ER gave the pt Benadryl and sent home Mother states today 11-19-07 that the swelling, redness and heat is gone.
Age: 19.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: On 11-19-07 pt developed itching spots on hands around 5:30 - 6:00 pm. Progressed to (B) lower and upper extremities and waist. Hives started about 8:00pm with hands/feet swelling. Seen at health center 11/20/07 9:15 am - T 97. Given Benadryl 50mg at 945 am and to repeat every 6 hrs for at least 48 hours then decrease as tolerated.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swelling at site injection, kept getting bigger until went to to ED on 10/28. Patient stated no systemic adverse events. Patients stated doctor diagnosed cellulitis and gave Cefdinir 300 and Clindamycin 300. Patient recovered completely. I never saw patient's arm after giving vaccine.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: Client called at 14:45 c/o heart racing and mild shortness of breath 30 min after receiving vaccine. These sx subsided and was c/o of fatigue, body aches and head cold/congestion sx.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Client called at 14:45 c/o heart racing and mild shortness of breath 30 min after receiving vaccine. These sx subsided and was c/o of fatigue, body aches and head cold/congestion sx.
Age: 1.2
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Fluzone administered 0.25 ml I.M. left thigh 11/19/07 9:32 am. 11/20/07 2 PM - Hives noted for the first time on lt. thigh, trunk and extremities, no other respiratory s/s. No breathing difficulties, alert, active, playful, not any distress. Benadryl (12.5 mg) 1 tsp PO tid x 24 hours, then as needed.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure, Dizziness, Hot flush, Nervousness, Paraesthesia
Clinical narrative: Pt c/o arm received vaccine in (L) felt "wobbly-like Jello" and (L) side of face felt "tingly". Pt states she had hot flash and it was already hot inside building and she got nervous. States "I know I'm nervous because I can feel it in my stomach." No rash, no breathing probs, no other symptoms.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Lip swelling, Paraesthesia, Pruritus, Swelling face
Clinical narrative: Administered 11/19/07 at 1500. started itching on arms at 1700. By 2100 had hives whole body even on scalp. Took 25mg Benadryl PO went to bed. 11/21/07 Woke up swollen lt lip and lt cheek. No edema at site lt deltoid, swollen area numb and tingling. No throat or resp problems at all. Lt side of face and lips still swollen at 0930.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Administered 11/19/07 at 1500. started itching on arms at 1700. By 2100 had hives whole body even on scalp. Took 25mg Benadryl PO went to bed. 11/21/07 Woke up swollen lt lip and lt cheek. No edema at site lt deltoid, swollen area numb and tingling. No throat or resp problems at all. Lt side of face and lips still swollen at 0930.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: local rxn to flu vaccine requiring U.C visit 2d after flu shot administered. Tx'd by U.C. doctor & Amoxicllin
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: pt given 1st (L) arm Gardasil  then developed shingles (L) shoulder (L) upper ant chest and trunk approx 4 hours after Gardasil injection.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster
Clinical narrative: pt given 1st (L) arm Gardasil  then developed shingles (L) shoulder (L) upper ant chest and trunk approx 4 hours after Gardasil injection.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Blood culture negative, CSF test normal, Convulsion, Culture urine negative, Full blood count
Clinical narrative: Pt developed a fever the evening after receiving his routine 6 month immunizations and his first influenza vaccine. Then he had a prolonged SZ. ER W/U: negative. Sent home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever the evening after receiving his routine 6 month immunizations and his first influenza vaccine. Then he had a prolonged SZ. ER W/U: negative. Sent home.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Bronchospasm, Cough, Dyspnoea, Hypoaesthesia
Clinical narrative: approx 1/2 hour after injection, pt reports she had (L) raw numbness and twitching for approx 15-20 min. On 11-8-07 pt seen in ER for cough, fever, increased dyspnea. Dx with Bronchitis, pneumonia bronchospasm
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza serology negative, Muscle twitching, Pneumonia, Pyrexia
Clinical narrative: approx 1/2 hour after injection, pt reports she had (L) raw numbness and twitching for approx 15-20 min. On 11-8-07 pt seen in ER for cough, fever, increased dyspnea. Dx with Bronchitis, pneumonia bronchospasm
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Parent called states pt has developed warts on her hand. has had (2) Gardasil vaccines 6-14-07 and 9/28/07. Mom states she has no history of warts-concerned that it maybe related to vaccine
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: 3 days after getting shot, hands and feet turned in and have remained the same. Medicines have not helped and she is in constant pain throughout whole body.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: increased swelling pain given Levaquin 750 11/19/07 better/can use hand slightly/not as red
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: Headache - diarrhea - dizzy - heavy chest - shortness of breath 11-12-07. 9-9:30 AM vaccine given, 10-10:30 AM symptoms started.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pallor, Skin reaction
Clinical narrative: Pt reports skin rxn 20 min after injection, left deltoid w/induration, site was plae, firm, 2x3 cm with area of redness around site. Pt c/o itching.