chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Computerised tomogram head, Endotracheal intubation, Fall, Head injury, Intensive care
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Skull fracture, Subdural haematoma, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Bladder catheterisation, Blood potassium abnormal, Brain midline shift, Bruxism, Computerised tomogram abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Computerised tomogram head, Convulsion, Endotracheal intubation, Fall, Gaze palsy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Head injury, Hypokalaemia, Intensive care, Skull fracture, Subdural haematoma
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female with hypothyroidism and a history of using LEXAPRO for anxiety with no previous illness, was vaccinated on 14-FEB-2011 with a first IM dose of GARDASIL (lot# 666595/0992Z) into her left arm. Concomitant vaccination administered on the same day included a first IM dose of TRIPEDIA (lot# U3487AA) into her left arm. Concomitant therapy included SYNTHROID. The patient experienced a syncopal episode, 5 to 10 minutes after vaccine administration. She fell to the ground from standing position and hit her head. Skull fracture and subdural hematoma. The patient required intubation and was admitted to ICU (intensive care unit). The following information was obtained from ER (emergency room) record received for DOS. Impression: subdural hemorrhage. Patient w/C-collar received on stretcher from rapid response team. The patient was reported to have received tetanus and HPV vaccines in family practice office. Subsequently, the patient was standing in waiting room and experienced syncope. The patient fell while standing and hit her head. Patient had a witnessed seizure. Upon arrival in ER, she was unresponsive and actively seizing. The patient was intubated, an IV was started and a Foley catheter placed. The patient underwent head CT scan and was treated with ATIVAN, mannitol, DILANTIN and propofol. The patient was transferred to a higher facility with known subdural hemorrhage with midline shift. Upon ER presentation, intubated patient was noted to have fine tonic-clonic activity, was not responding to pain, had roving eyes, eyes were not tracking and clenched teeth. Laboratory testing revealed mild hypokalemia and mild elevated WBC (white blood cell). The patient was admitted to neurosurgical ICU in critical condition. CT (computed tomography) head/brain WO cont.: abnormal (nondisplaced FX of left occip). At the time of the report, the outcome of the patient was unknown. The agency considered the events to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 416885-1.  This report is related to VAERS ID # 416885-2. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Blood test, Blood urine present, Immunoglobulin therapy, Platelet count decreased, Rash
Clinical narrative: 39 yo m with h/o HTN presents to the ER with c/o blood in his urine which started this morning. Says that he started taking lisinopril and hydrochlorothiazide about 1 week ago. Also says that he has noted a rash on his legs and chest for the past 4 days. Dexamethasone mg every day, globulin, immune 90 gm every day.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 102F x 2 days, Vomiting x 1, Headache, body aches, chills, arm pain when lifting overhead.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fever 102F x 2 days, Vomiting x 1, Headache, body aches, chills, arm pain when lifting overhead.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abasia, Activities of daily living impaired, Amnesia, Asthenia, Cognitive disorder
Clinical narrative: Ongoing Condition getting progressively worse. Body weakness, lethargic, severe muscle spasms and tightening, severe pain in extremities, slurred speech, loss of cognitive skills and short term memory, unable to walk at times and care for self or my children.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Computerised tomogram, Condition aggravated, Dysarthria, Electroencephalogram, Lethargy
Clinical narrative: Ongoing Condition getting progressively worse. Body weakness, lethargic, severe muscle spasms and tightening, severe pain in extremities, slurred speech, loss of cognitive skills and short term memory, unable to walk at times and care for self or my children.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Lumbar puncture abnormal, Muscle spasms, Muscle tightness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Ongoing Condition getting progressively worse. Body weakness, lethargic, severe muscle spasms and tightening, severe pain in extremities, slurred speech, loss of cognitive skills and short term memory, unable to walk at times and care for self or my children.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Joint range of motion decreased, Oedema, Pain
Clinical narrative: 13x13 indurated warm fluctuant area w/ assoc. erythema, warmth, tenderness, decreased ROM secondary to edema & pain. 3 visits to clinic. Tx 1 gm ROCEPHIN IM then BACTRIM 875/105 BID x 10 d.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: 13x13 indurated warm fluctuant area w/ assoc. erythema, warmth, tenderness, decreased ROM secondary to edema & pain. 3 visits to clinic. Tx 1 gm ROCEPHIN IM then BACTRIM 875/105 BID x 10 d.
Age: 0.61
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 44 month old male patient with asthma and no known drug allergy who on 23-AUG-2007, 19-NOV-2007 and 30-JAN-2008 were vaccinated with the first, second and third dose of ROTATEQ (lot number 656188/1238F for the first dose). Concomitant medications included: PULMICORT and albuterol (manufacturer unknown). On 14-MAR-2011 patient had symptoms of diarrhea and vomiting so was presented to emergency room and was admitted as an inpatient to the hospital. Laboratory test was positive for Rotavirus. Patient was treated with IV fluids and released on 15-MAR-2011. The patient fully recovered on an unspecified date. No further information is available.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Multiple sclerosis relapse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received 15 April 2011 from a consumer, who is also the patient. This case involved an inappropriate schedule of vaccine administered. A 47-year-old female patient who had a history of MS (multiple sclerosis), had received a third dose injection of TDAP vaccine during November 2010 (manufacturer, lot number, route, site and exact date of administration unknown). During January 2011 (exact date not reported) the patient experienced an exacerbation of her MS. According to the patient, her neurologist stated that her MS was exacerbated based upon MRI results from January 2011. The patient had received two prior doses of TDAP vaccine (manufacturer and lot numbers unknown) during June 2009 and April 2010 respectively. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Oedema peripheral, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 19 April 2011. A 21-year-old female patient whose medical history was not reported, had received the morning of 18 April 2011 a first intramuscular left deltoid injection of MENACTRA (lot number U3510AA), an intramuscular right deltoid injection of a TDAP vaccine (trade name and manufacturer unknown, lot number, route and site of administration not reported) and a TB (tuberculin) test (trade name, manufacturer name, lot number, route and site of administration not reported). The same day, the patient called the health department to report that she had blacked out for 1 minute, and that her left arm was sore and swollen up to her shoulder. The patient required a doctor visit, however the results of that visit were not provided. The reported did not have the patient's record at time of reporting, but will provide further information in follow-up. At the time of this report, the patient had not recovered. Additional information has been requested. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 19 April 2011. A 21-year-old female patient whose medical history was not reported, had received the morning of 18 April 2011 a first intramuscular left deltoid injection of MENACTRA (lot number U3510AA), an intramuscular right deltoid injection of a TDAP vaccine (trade name and manufacturer unknown, lot number, route and site of administration not reported) and a TB (tuberculin) test (trade name, manufacturer name, lot number, route and site of administration not reported). The same day, the patient called the health department to report that she had blacked out for 1 minute, and that her left arm was sore and swollen up to her shoulder. The patient required a doctor visit, however the results of that visit were not provided. The reported did not have the patient's record at time of reporting, but will provide further information in follow-up. At the time of this report, the patient had not recovered. Additional information has been requested. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Local reaction, Loss of consciousness, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 19 April 2011. A 21-year-old female patient whose medical history was not reported, had received the morning of 18 April 2011 a first intramuscular left deltoid injection of MENACTRA (lot number U3510AA), an intramuscular right deltoid injection of a TDAP vaccine (trade name and manufacturer unknown, lot number, route and site of administration not reported) and a TB (tuberculin) test (trade name, manufacturer name, lot number, route and site of administration not reported). The same day, the patient called the health department to report that she had blacked out for 1 minute, and that her left arm was sore and swollen up to her shoulder. The patient required a doctor visit, however the results of that visit were not provided. The reported did not have the patient's record at time of reporting, but will provide further information in follow-up. At the time of this report, the patient had not recovered. Additional information has been requested. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site vesicles, Vaccination site rash
Clinical narrative: Patient developed rash (04/12/11) that spread to approximate 4 inch width with blister in center at vaccination site. It is painful to the touch but does not hurt.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt. developed erythematous & indurated area (at site of injection) painful/measuring 5cm x 3.5cm developed evening of vaccine.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Pain in extremity
Clinical narrative: He also reports that the pneumonia vaccine he received yesterday has caused a local reaction, his arm and shoulder are swollen at and above site and warmth to touch and aching in arm. He was instructed to take Ibuprofen 400mg four times daily prn and to use ice to the site and he agrees. -- per medical record.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Weight decreased
Clinical narrative: States that after last flu shot, got sick x 4 weeks and lost about 30 lbs.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Just nausea/vomiting and diaphoresis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Blood test, Computerised tomogram, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Delivered healthy baby girl on 4/1. Dischared from hospital on 4/2. On 4/5 experienced a sudden rise in blood pressure to 210/106, severe headache, taken by ambulance to the hospital.  Received magnesium sulfate via IV to prevent seizures and treated as if pre-eclampsia had occurred postpartum.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Dysstasia, Injection site pain
Clinical narrative: Child complained of soreness in the right leg. Parent stated that the child could not walk or stand.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Generalized rash.
Age: 32.0
Sex: F
Vaccine: RUB
Symptoms: Rheumatoid arthritis
Clinical narrative: Arthritis.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Screaming
Clinical narrative: Child jerked about 40 times and had high-pitched screaming on and off for 4 - 4.5 hours.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain, Swelling
Clinical narrative: Swelling and pain from shoulder, deltoid & collar bone. Advised TYLENOL, ice packs & antihistamines. RTC if no improvement.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Hepatomegaly, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of abdominal swelling in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included blood transfusion. On 13 April 2011 the subject received 1st dose of ENGERIX B (.5 ml, intramuscular, left arm). On 13 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced abdominal swelling, injection site redness, injection site tenderness, intermittent fever, swollen liver and vaccine underdose (adult dose of ENGERIX B is 1 ml). The reason for the vaccine underdose was not reported. A healthcare professional visit on 13 April 2011 noted swelling around the liver. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting, the injection site redness and injection site tenderness were improved, the intermittent fever was unresolved, and the outcome of the abdominal swelling and swollen liver was unspecified. The vaccination course with ENGERIX B was discontinued. The healthcare professional considered the injection site redness and injection site tenderness were probably related to vaccination with ENGERIX B, the abdominal  swelling was possibly related to vaccination with ENGERIX B, and the relationship of the intermittent fever and swollen liver was unspecified.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of abdominal swelling in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included blood transfusion. On 13 April 2011 the subject received 1st dose of ENGERIX B (.5 ml, intramuscular, left arm). On 13 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced abdominal swelling, injection site redness, injection site tenderness, intermittent fever, swollen liver and vaccine underdose (adult dose of ENGERIX B is 1 ml). The reason for the vaccine underdose was not reported. A healthcare professional visit on 13 April 2011 noted swelling around the liver. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting, the injection site redness and injection site tenderness were improved, the intermittent fever was unresolved, and the outcome of the abdominal swelling and swollen liver was unspecified. The vaccination course with ENGERIX B was discontinued. The healthcare professional considered the injection site redness and injection site tenderness were probably related to vaccination with ENGERIX B, the abdominal  swelling was possibly related to vaccination with ENGERIX B, and the relationship of the intermittent fever and swollen liver was unspecified.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient reports receiving a flu shot that was a regular flu shot plus protection from H1N1 (approximately November 2010). Woke up the next morning and had full body red rash and itching. Went to outside clinic and received Z-PACK, cimetidine, and diphenhydramine.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This patient received PNEUMOVAX on 10/9/2009 and 6/2004. No details of the reaction are available for review. Complained of arm swelling after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm swelling - redness starting evening of 4/25/11 - date pt received vaccine, temp. 98.8. No tx.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Acute widespread urticaria. Tx: Antihistamines < ZYRTEC, BENADRYL.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Seen by MD in office 4/27/11 with 3 day history of rash on trunk and spread to his neck and arms. No fevers or other concerns. Had received MMR vaccine two weeks ago. MD. ASSESSMENT: Rash, likely a reaction to the MMR vaccine.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Seen by Md for history of rash for 3 days, started on trunk and spread to neck and arms. Non fevers or other concerns noted. Patient recieved MMR vaccine two weeks ago. Md assessment rash most likely a reaction to MMR vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, PPV
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Hypersensitivity, Injection site rash
Clinical narrative: AT 8:45 NOTICED RASH ON R ARM FROM SHOULDER DOWN TO ELBOW. FELT WARM AND WAS GIVEN TYLENOL BY PARENT. CHILD WAS CRYING AND DIFFICULT TO CONSOLE. ACTIONS SEEMED UNUSUAL TO PARENT. CHILD SAYS HE HURTS ALL OVER. DOESN'T WANT TO MOVE AROUND IN HIS NORMAL FASHION.  PARENTS TOOK HIM TO PMD TODAY AND TEMP THERE WAS 101.5. MD SAID HE HAD AN ALLERGIC REACTION TO THE PNEUMOVAX 23. CHILD WAS PRESCRIBED PREDNISONE LIQUID STARTING AT 14 ML AND DECREASING BY 2 ML EVERY DAY UNTIL GONE. BENADRYL TWICE A DAY, 1 3/4 TSP.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, PPV
Symptoms: Mobility decreased, Pain, Skin warm
Clinical narrative: AT 8:45 NOTICED RASH ON R ARM FROM SHOULDER DOWN TO ELBOW. FELT WARM AND WAS GIVEN TYLENOL BY PARENT. CHILD WAS CRYING AND DIFFICULT TO CONSOLE. ACTIONS SEEMED UNUSUAL TO PARENT. CHILD SAYS HE HURTS ALL OVER. DOESN'T WANT TO MOVE AROUND IN HIS NORMAL FASHION.  PARENTS TOOK HIM TO PMD TODAY AND TEMP THERE WAS 101.5. MD SAID HE HAD AN ALLERGIC REACTION TO THE PNEUMOVAX 23. CHILD WAS PRESCRIBED PREDNISONE LIQUID STARTING AT 14 ML AND DECREASING BY 2 ML EVERY DAY UNTIL GONE. BENADRYL TWICE A DAY, 1 3/4 TSP.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Developed chills, sweats, shortness of breath later in the evening. Did not seek medical care and felt fine in the a.m.  Since then has gradually developed marked stiffness in fingers of both hands. Has not sought medical care yet, but will have insurance next week and will do this.
Age: 28.0
Sex: M
Vaccine: DTAP, HEPAB, MMR
Symptoms: Chills, Fatigue, Injection site erythema, Vaccination site swelling
Clinical narrative: Cold chills, fatigue, redness and swelling at vaccination site.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area around injection site was Red, tender and warm to the touch. The size of the affected area was 10cm X 7cm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area with warm at injection site.  Advised to use cold pack and Benadryl and follow up with Dr. if not resolving.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at injection site. Advised to use cold pack and Benadryl and follow up with doctor if not resolving.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood culture, Full blood count, Headache, Pyrexia
Clinical narrative: Fever to Tmax 105, headaches
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Acupuncture, Headache, Herpes zoster, Pain
Clinical narrative: Severe headache which resulted in shingles. Pain after shingles continues to date.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pain in upper arm, radiating to top of shoulder, collar bone, and just below neck. Vaccine was administered in left deltoid. Pain is on the left side.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site nodule
Clinical narrative: Knots in legs at injection sight, no pain noted when spot is touched, waiting to see if knots will disappear, been rubbing and applying warm compress
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red around the vaccine area, in where it was administered. BENADRYL was given at office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Patient received KINRIX IM (L) AT about 1610. About 5-10 mins later (while still in office) mom noticed that pt had redness/hives of cheeks & upper (L) arm along with itching, doctor did note a rash on trunk during exam prior to vaccine administration. Gave 12.5 mg of BENADRYL and observed pt. x 40 mins with resolution of sx's no difficulty breathing or swelling of mouth/tongue/lips.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Noted (L) upper arm pain x about 18h, red this a.m./(L) arm feels "tingly" x about 6 h.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Incisional drainage
Clinical narrative: 4-22-11 Vaccine received. 4-24-11 Seen in ER - placed on BACTRIM. 4-26-11 Return to HCP - I & D. 4-28-11 Is better - referred to HCP/Requested by employee.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Fluid intake reduced, Rotavirus test positive, Vomiting
Clinical narrative: Approximately 10 hours after receiving ROTATEQ, PENTACEL, and PREVNAR the pt. had vomiting and copious diarrhea that resulted in the office the next day with dehydration and inability to take PO fluids. The pt. was then admitted to the hospital for IV fluids.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Anxiety, Crying, Fear of needles, Hyperhidrosis, Insomnia
Clinical narrative: Client found on floor with head against door. Client noted to be unconscious. Security notified. Client repositioned & placed flat on back with feet slightly elevated. Client noted to be diaphoretic & crying with eyes closed. Client asked if she knew where she was, did not remember. BP 122/72, HR 80, RR 30. Client asked to slow breathing. Client completed. RR 16. Client calmed & got up & sat in chair. Client orientated x 4. PA examine client. Client given juice, had nothing to eat or drink this AM & is afraid of shots. Client stated she was up most of night worrying about shots this AM. 0951 Client dc'd home awake/alert & oriented x 4 with Mom.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Client found on floor with head against door. Client noted to be unconscious. Security notified. Client repositioned & placed flat on back with feet slightly elevated. Client noted to be diaphoretic & crying with eyes closed. Client asked if she knew where she was, did not remember. BP 122/72, HR 80, RR 30. Client asked to slow breathing. Client completed. RR 16. Client calmed & got up & sat in chair. Client orientated x 4. PA examine client. Client given juice, had nothing to eat or drink this AM & is afraid of shots. Client stated she was up most of night worrying about shots this AM. 0951 Client dc'd home awake/alert & oriented x 4 with Mom.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Erythema, Pain in extremity
Clinical narrative: Pain in axilla, breast, & arm starting about 24 hr after vaccination & lasting 3 days. Also red streak on arm lasting a few days.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area - erythematous, slightly swollen, warmth & slightly tender to touch.
Age: 13.0
Sex: M
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling to (L) outer aspect, noticed 24 hrs after vaccines. Tx BENADRYL & ice packs to site.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Blood urine present, Haematuria, Immunoglobulin therapy, Platelet count decreased, Rash
Clinical narrative: 39 yo m with h/o HTN presents to the ER with c/o blood in his urine which started this morning. Says that he started taking lisinopril and hydrochlorothiazide about 1 week ago. Also says that he has noted a rash on his legs and chest for 4 days. Dexamethasone mg every day, globulin, immune 90 mg every day.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Thrombocytopenia
Clinical narrative: 39 yo m with h/o HTN presents to the ER with c/o blood in his urine which started this morning. Says that he started taking lisinopril and hydrochlorothiazide about 1 week ago. Also says that he has noted a rash on his legs and chest for 4 days. Dexamethasone mg every day, globulin, immune 90 mg every day.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain, Skin reaction
Clinical narrative: He called yesterday reporting erythema, pain, and some 3 red streaks, told to take NSAID and apply ice and if not improved to come in today. He is improved with less discomfort though some generalized soreness in (R) shoulder, there is now one localized area of erythema about 3 cm medial to the site of injection, no fever, no adenopathy. Naproxen.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, blister like bumps on (R) lateral upper arm, since noticed 4 days ago has gotten worse.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and minimal pain to the left, upper arm, skin induration.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Myalgia, Paraesthesia, Peripheral coldness, Raynaud's phenomenon, Skin discolouration
Clinical narrative: Initial report received from a consumer, who is also the patient, on 24 May 2010. A 43-year-old female patient, with a history of seasonal allergies, received an intramuscular right deltoid injection of DECAVAC (lot number U2591BA) on 29 December 2009. An unspecified amount of time after vaccination, she began having a tingling sensation in her hands and feet. She also complained of an intermittent sensation of coldness in her hands and feet, during which they would turn white; these symptoms were more evident at night. She had pain in her right and left deltoid muscles. The patient was told that she "may have Reynaud's Disease". As of 10 March 2010, all symptoms had recovered. Follow-up information was received from a health care professional on 14 June 2010 that reported the patient had received no treatment and no diagnostic testing for the events. The patient had a laceration at the time of vaccination. She had no other vaccination within 4 weeks. No additional information available at this time. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: DT
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Radiculitis brachial
Clinical narrative: Initial report received from a health care professional on 10 September 2010.  A 32-year-old female patient had received a dose of DECAVAC (lot number U3008CA) in the left arm on 03 July 2010.  An unspecified amount of time following vaccination the patient experienced pain, numbness and weakness of the left arm and was subsequently diagnosed with brachial neuropathy.  At the time of the report, the patient's symptoms were continuing and she was receiving treatment at the facility where she received the vaccination; however, type of treatment was not provided.  Follow-up information received on 08 October 2010 from a health care professional.  The patient had a history of latex allergy and a medical history of dysfunctional uterine bleeding.  She had a puncture wound at the time of vaccination.  Concomitant medication included Loestrin birth control.  The patient experienced symptoms of pain, numbness, and weakness in her left arm on 03 July 2010 (the same date as vaccination).  She had varied symptoms until she was seen on 10 September 2010 and diagnosed with brachial neuritis.  She was treated at the primary care office with a Medrol dose pack and was to return to the office for follow-up if her symptoms did not improve.  As of 04 October 2010, the patient had not required physical or occupational therapy and had not returned for follow-up.  Her recovery status was reported as pending.  Documents held by sender: None.
Age: 80.0
Sex: M
Vaccine: DT
Symptoms: Encephalitis
Clinical narrative: Initial case received from a pharmacist, via another manufacturer, on 22 November 2010.  An 80-year-old male patient received an intramuscular right deltoid injection of DECAVAC (lot number U1927EA) on 15 March 2007.  The patient was subsequently admitted to the hospital and diagnosed with encephalitis.  No other information was provided.  Follow-up information was received 16 December 2010 from a health care professional who reported that the "patient came in for a shingles shot and told me this reaction happened to him years ago".  The reporter suggested we follow-up with the patient (contact information not provided) and further stated they were unable to provide any additional information.  Outcome was not reported.  Follow-up information was received on 31 January 2011 from a health care professional.  The patient recovered.  Documents held by sender: None.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Convulsion, Diet refusal, Electroencephalogram, Foaming at mouth
Clinical narrative: Ftr stated that child had seizure 2-2 1/2 hrs after vaccine given. Pt was brought by ambulance to Emergency Room. Pt recovered.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Gaze palsy, Musculoskeletal stiffness, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: Ftr stated that child had seizure 2-2 1/2 hrs after vaccine given. Pt was brought by ambulance to Emergency Room. Pt recovered.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urine analysis normal
Clinical narrative: Ftr stated that child had seizure 2-2 1/2 hrs after vaccine given. Pt was brought by ambulance to Emergency Room. Pt recovered.