chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cerebral small vessel ischaemic disease, Computerised tomogram head, Computerised tomogram normal, Convulsion, Cyanosis
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram normal, Eosinophil percentage, Grunting, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intensive care, Lymphocyte percentage increased, Mean cell volume normal, Monocyte percentage, Musculoskeletal stiffness
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Neutrophil percentage decreased, Nuclear magnetic resonance imaging brain abnormal, Platelet count increased, Platelet morphology normal, Posture abnormal
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Red blood cell count decreased, Red blood cell morphology normal, Red cell distribution width normal, Scan with contrast abnormal, White blood cell count normal
Clinical narrative: This male subject was enrolled in the prophylactic study 112957 (HIB-097).  On 28 March 2011, he received the 1st dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 11 April 2011, 14 days after the 1st dose of PEDIARIX, 14 days after the 1st dose of ROTARIX, 14 days after the 1st dose of HIBERIX, 14 days after the 1st dose of PREVNAR 13, this two-month-old subject developed seizure.  The subject was hospitalised.  The subject was treated with lorazepam and phenobarbitone.  The event resolved on 11 April 2011.  The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13.  Investigator Comments : CT head w/o contrast=grossly normal with no acute intracraneal pathology.  Electroencephalogram=normal for stated age.  MRI Brain without and with contrast = Very subtile periventricular white matter T2 hyperintensity is noted.  This likely related to patients age and related to phase of myelination.  No midline shift, mass effect or abnormal enhancement is identified.  11APR2011-MRSA culture- No methicillin resistant staph aureus isolated.  19APR2011-He was doing well at home until after feeding he turned blue around mouth and started grunting, head turned to left side and left arm and leg noted to be stiff.  Taken to Emergency Department where he had one afrebile seizure lasting 20-30 min with left sided stiffness.  He received 3 doses Lorazepam, 1 fluid bolus and 1 loading dose of Phenobarbital, which broke his seizure.  Transferred to PICU for further management and observation.  No further seizure activity.
Age: 10.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain, Syncope, Vomiting
Clinical narrative: Vasovagal syncope/ fainting 2x outside of patient's car 2x vomits between fainting events Complained of extreme pain of MMR shot in R arm, had dTAP& IPV in Left arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 9 x 8 cm redness with induration on Left arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear pain, Headache, Hypoaesthesia facial, Rhinorrhoea
Clinical narrative: HA x 3 days, right side of face feels numb x2 days. Cough, runny nose, & left ear ache
Age: 1.18
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotateq vaccine given to infant (1 yr 2 mo) which was above manufacturer recommended age limit.  No other complications.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Otorrhoea, Scab
Clinical narrative: Numbness of right side of face x3 days (started 12/1/10), draining ear with crusting in right ear canal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Facial paresis, Headache, Hypoaesthesia facial, Movement disorder
Clinical narrative: Facial weakness & numbness x 3days. Difficulty speaking and controlling mouth and eyes. C/o headache and left earache.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Facial weakness & numbness x 3days. Difficulty speaking and controlling mouth and eyes. C/o headache and left earache.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Local swelling
Clinical narrative: LOCALIZED SWELLING, REDNESS ON LEFT THIGH AND NON-STOP CRYING AND FUSSINESS. THIS OCCURED TO ANOTHER PATIENT SEEN THE SAME DAY. NEW LOT OF VACCINE GIVEN TO BOTH.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Emotional distress, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: LOCALIZED SWELLING, REDNESS ON RIGHT THIGH AND NON-STOP CRYING AND FUSSINESS. MOTHER ALSO REPORT CHILD WILL SLEEP 1-2 MINUTES AND THEN WAKES UP SCREAMING AND FALLS ASLEEP AGAIN.  THIS OCCURED TO ANOTHER PATIENT SEEN THE SAME DAY. NEW LOT OF VACCINE GIVEN TO BOTH. PROGRESS NOTE AS DICTATED BY MD: "He had a swollen right thigh, was very fussy, and upset. When I saw him last night he was afebrile, but was very fussy and difficult to console. His thigh at about 2.5 x 4 cm of erythema, 1.5 cm of induration, and mild warmth. It appeared as if he had a fairly significant reaction to the immunization, likely the hepatitis B given its location and that it was the only repeat immunization he had received. There is another child of the same age to receive the same immunization and had a similar, but less severe reaction yesterday. We spoke to the parents last night and this morning and that infant was doing okay, but was fussy and had some significant swelling.  He has had no difficulty breathing, wheezing, high fevers, or other symptoms of concern. Last night. He went home, slept for quite a while, woke up, slept some more, and then has been alert and acting appropriately, and feeding well since then."
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Irritability, Local swelling, Poor quality sleep, Screaming
Clinical narrative: LOCALIZED SWELLING, REDNESS ON RIGHT THIGH AND NON-STOP CRYING AND FUSSINESS. MOTHER ALSO REPORT CHILD WILL SLEEP 1-2 MINUTES AND THEN WAKES UP SCREAMING AND FALLS ASLEEP AGAIN.  THIS OCCURED TO ANOTHER PATIENT SEEN THE SAME DAY. NEW LOT OF VACCINE GIVEN TO BOTH. PROGRESS NOTE AS DICTATED BY MD: "He had a swollen right thigh, was very fussy, and upset. When I saw him last night he was afebrile, but was very fussy and difficult to console. His thigh at about 2.5 x 4 cm of erythema, 1.5 cm of induration, and mild warmth. It appeared as if he had a fairly significant reaction to the immunization, likely the hepatitis B given its location and that it was the only repeat immunization he had received. There is another child of the same age to receive the same immunization and had a similar, but less severe reaction yesterday. We spoke to the parents last night and this morning and that infant was doing okay, but was fussy and had some significant swelling.  He has had no difficulty breathing, wheezing, high fevers, or other symptoms of concern. Last night. He went home, slept for quite a while, woke up, slept some more, and then has been alert and acting appropriately, and feeding well since then."
Age: 42.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Hypotension, Nausea, Syncope, Vomiting
Clinical narrative: Fainted, followed by low blood pressure and vomiting.  Severe nausea lasted for 3 hours following the event.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash, Rash vesicular
Clinical narrative: Pt presents with redness, blistery rash. Varicella -like rash
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Pallor
Clinical narrative: Patient stated that he did not feel well - that he felt dizzy & lightheaded. Patient became pale after - 15-20 minutes of being vaccinated. Emergency Medical Service contacted and transport patient to hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Warmth, swelling & pruritis at injection site. Hives - generalized.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medication error - given TDaP rather then DTaP. No AE reported to date 5/5/11.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypoaesthesia, Muscle spasms
Clinical narrative: Client reports that she went to emergency 4 hours after receiving immunization on 12/8/10 with symptoms of leg numbness and severe muscle cramping in legs. She also was SOB & reports receiving an inhaler.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Local reaction
Clinical narrative: #1 vaccine Td given on 5-2-2011. #2 vaccine MENACTRA given on 4-25-11.
Age: 1.08
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash on body, (+) HCV.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Cough 24 hours prior to vaccine. Approx. 6 hours after vaccine, started with 102 fever & increasing redness & swelling at injection site. Seen in office 5/4 - redness extended entire (L) arm wrapping around to sides over to shoulder & to midline of chest . Treated with KEFLEX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Swollen extending through the whole Rt arm upper arm, lower arm to 2 cm above wrist red sl swollen.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within several hours after receiving PNEUMOVAX developed pain & swelling in arm around injection site. By next day, redness surrounded upper arm circumference & swelling worse. Seen 3 days later & red swollen area 4 inches x 2 inches in diameter. Warm to touch.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Child has hives to both lower extremities and left arm, no respiratory distress.
Age: 61.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Chills, Nasopharyngitis, Tremor
Clinical narrative: Woke up feeling cold and chills and violent shakes lasting about 45 minutes. Client went to emergency room.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Adverse event, Measles, Measles antibody positive, Pyrexia, Rash
Clinical narrative: Pt developed fever to 103 & rash which progressed 4/12 & persisted x 5-6 days. Unable to differentiate wild type measle, infection from adverse vaccine event.
Age: 1.69
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature, Rash erythematous
Clinical narrative: Small red flat rash, temps.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Eye irritation, Headache
Clinical narrative: Ongoing dizziness, whole body aches & pains, headache, sore throat, irritation in eyes from thimerosal, overall weakness, cough & nausea. No treatment.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain, Reaction to preservatives
Clinical narrative: Ongoing dizziness, whole body aches & pains, headache, sore throat, irritation in eyes from thimerosal, overall weakness, cough & nausea. No treatment.
Age: 47.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site swelling, Paraesthesia
Clinical narrative: Initial report received from a physician on 07 April 2011. A 47 year-old male patient who had no concurrent illnesses and no known allergies had received a first intramuscular left arm injection of MENACTRA (lot number U3517AA) on 05 April 2011, and 24 hours (reported also as next day) after vaccination had a temperature of 101.0 degrees Fahrenheit, tingling in the left arm, and swelling at the injection site. It was not reported whether the patient required medical evaluation or treatment. It was noted the patient had received a dose of MENOMUNE in the past with no reported adverse event. He also had no reported adverse events with any other prior vaccinations. Recovery status was reported as "not recovered". Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 11.0
Sex: F
Vaccine: HEPA, JEV, RAB, TDAP, VARCEL
Symptoms: Body temperature increased, Headache, Lethargy, Nasal congestion, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 28 June 2010. A 11-year-old female patient, with no medical history, no other medications and no illness at the time of vaccination, received on 27/May/2010 the following vaccines: an intramuscular (IM) injection of ADACEL, lot number C3448AA, an IM injection (dose 1) of IMOVAX, lot number D0792-1, a subcutaneous (SC) injection (dose 1) of JE-VAX, lot number EJN234A, an injection of Hepatitis A vaccine, lot number AHAVB362BA, and an injection of Varicella vaccine, lot number 0996K. On 03 June 2010, the patient received a SC injection (dose 2) to the left arm of JE-VAX, lot number EJN234A, and a IM injection (dose 2) to the right arm of IMOVAX, lot number D0792-1. On 06 Jun 2010, which was 10 days after the first vaccines and 3 days after the second vaccines, the patient developed a temperature of 100-101 (units not provided), headache, sore throat, lethargy, and nasal stuffiness. The patient was seen by the primary care physician (PCP) and was diagnosed with a virus. The patient's Streptococcus test was negative. The outcome was reported as recovered. Follow-up information received on 07 July 2010 from Biken, the manufacturer of JE-VAX. The only information provided was the manufacturer's reference number for this case which is F0897. Follow-up information was received 23 July 2010 from a health care professional. The patient was confirmed to have been a female and she had no illness at the time of vaccination. According to the reporter, they reviewed the case information and had no additional information to provide. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HEPA, JEV, RAB, TDAP, VARCEL
Symptoms: Streptococcus test negative, Viral infection
Clinical narrative: Initial report received from a health care professional on 28 June 2010. A 11-year-old female patient, with no medical history, no other medications and no illness at the time of vaccination, received on 27/May/2010 the following vaccines: an intramuscular (IM) injection of ADACEL, lot number C3448AA, an IM injection (dose 1) of IMOVAX, lot number D0792-1, a subcutaneous (SC) injection (dose 1) of JE-VAX, lot number EJN234A, an injection of Hepatitis A vaccine, lot number AHAVB362BA, and an injection of Varicella vaccine, lot number 0996K. On 03 June 2010, the patient received a SC injection (dose 2) to the left arm of JE-VAX, lot number EJN234A, and a IM injection (dose 2) to the right arm of IMOVAX, lot number D0792-1. On 06 Jun 2010, which was 10 days after the first vaccines and 3 days after the second vaccines, the patient developed a temperature of 100-101 (units not provided), headache, sore throat, lethargy, and nasal stuffiness. The patient was seen by the primary care physician (PCP) and was diagnosed with a virus. The patient's Streptococcus test was negative. The outcome was reported as recovered. Follow-up information received on 07 July 2010 from Biken, the manufacturer of JE-VAX. The only information provided was the manufacturer's reference number for this case which is F0897. Follow-up information was received 23 July 2010 from a health care professional. The patient was confirmed to have been a female and she had no illness at the time of vaccination. According to the reporter, they reviewed the case information and had no additional information to provide. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pruritus, Lethargy, Rash pustular, Rash vesicular, Somnolence
Clinical narrative: Initial report received from a consumer on 22 September 2010. A 55-year-old female patient, with a history of hypertension and seasonal allergies, received (dose 5) on 16 August 2010 an intramuscular (IM) injection (site not reported) of IMOVAX Rabies, lot number not reported, for post exposure. The previous dates of the doses of IMOVAX Rabies were not reported. She had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the IMOVAX. On 16 August 2010, she began itching at the injection site and developed pustules on her lower back. The patient complained of feeling lethargic and possibly depressed. She felt like she had no get and go and sleepier than usual. The pustules have cleared up. The outcome was reported as not recovered. Documents held by sender: None. Follow-up information received from a nurse on 18 October 2010: The patient had been bitten by a dog in another country on July 22, 2010. She had received rabies immune globulin and her first and second dose of rabies vaccine on 02 August 2010 and 05 August 2010. The patient received her fourth dose of rabies vaccine (batch number D0792, expiration date 04 September 2011) in the right deltoid on 09 August 2010. She received her fifth dose of rabies vaccine (batch number D0792, expiration date 04 September 2011) in the right deltoid on 16 August 2010. On 11 August 2010, the patient called the nurse reporting that she had a rash on her back. She did not report rash elsewhere and stated that she had not had any other symptoms such as wheezing or shortness of breath. On 16 August 2010, when she was seen for her final dose, she was examined. The rash was located in the middle of her back and had a vesicular appearance which is not characteristic of hives. Follow-up information was received 06 December 2010 from a health care professional who reported that only four doses had been administered to the patient in accordance with the MMWR March 19, 2010 / 59(02);1-9. An update in the patient's recovery status was not provided at the time of the report. Outcome remained not recovered. Follow-up information was received 14 January 2011 from a health care professional. Vaccination dose numbers were amended by the reporter. The patient received IMOVAX Rabies dose three (previously reported as dose four) on 09 August 2010, and dose four (previously reported as dose five) on 16 August 2010. The reporter amended the patient's recovery status from not recovered to unknown and they had no additional information at the time of the report. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial report received from a health care professional on 07 February 2011. A 33-year-old female patient with a medical history of psoriasis and allergies to penicillin, bee stings, eggplant and butternut squash, received on 31 January 2011 an intramuscular injection (site not reported) of IMOVAX Rabies. She had no illness at the time of vaccination and took no concomitant medications. On 31 January 2011 in the evening of the vaccination the patient developed extremely sore muscles which felt as if they were frozen and painful and also felt exhausted. The outcome was reported as recovered. Follow-up information received from a nurse on 11 March 2011. Contact information for the patient's primary care physician was provided. IMOVAX (lot number D1177-1) that was administered on 31 January 2011 was reported as being the first dose the patient had received, and was administered in the left deltoid. It was confirmed the patient was not taking any other medications at time of vaccination. Per the reporter, the patient was not seen by a physician for her symptoms and did not require any treatment; her symptoms resolved (date not reported) without further complaint. The reporter had written in section 14 of the VAERS form that the patient had received an oral Typhoid, Hep A (dose 1), HEP B (dose 1), and questionably polio vaccine from her primary care physician on unidentified dates. It was not reported whether the patient had experienced any adverse events after those vaccinations, and additional information has been requested regarding those vaccines. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Diarrhoea, Headache
Clinical narrative: Initial report received from a health care professional on 18 February 2011. A -year old female patient received on 15 February 2011 at 11:10 AM a left deltoid intramuscular injection (dose 2) of IMOVAX, sanofi pasteur lot number D1177-1. The patient had no medical history, no allergies, no concomitant medications, no illness at the time of vaccination, no other vaccinations within 4 weeks prior and had no adverse event following prior vaccination. On 15 February 2011 at night, the patient developed a bad headache, chills and diarrhea. The outcome was reported as not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Body temperature decreased, Headache, Pain in extremity
Clinical narrative: Initial report was received 28 February 2011 from a health care professional. A 46-year-old female patient with no past medical history and no concurrent illness, had received an intramuscular right deltoid booster dose of IMOVAX Rabies, lot number E-0393-1 on 23 February 2011 during the AM, and four days later on 27 February 2011 during the AM, she developed leg and back aches, and a headache. Her temperature was 96 degrees. At the time of the report, the event did not require a doctor's visit and no corrective treatments were reported. Diagnostic and laboratory testing was not performed. Concomitant medications consisted of diet medications (not specified). The patient had previously received IMOVAX rabies vaccines in the past (number of doses not reported). Outcome was reported as unknown. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Neck pain, Pain
Clinical narrative: Initial report was received from a health care professional on 01 March 2011. A 22 year-old female patient with no reported past medical history had received an intramuscular left deltoid injection of IMOVAX Rabies, lot number D1177-2 on 22 January 2011. Five days after the first vaccination on 27 January 2011, she developed neck pain. According to the reporter the patient was able to move her head forward without discomfort but it hurt to bend her neck back and from side to side. Diagnostic tests and laboratory data were reported as none. Treatments were not reported. Concomitant medications included birth control. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Headache, Immunoglobulin therapy, Rash
Clinical narrative: Initial report received on 24 March 2010 from a consumer. A 38 year-old male patient with a medical history significant for gout and allergy to hydrocodone received 5 doses of vaccine and immune globulin. At the time of vaccination the patient denied illness but reported being bitten by a bat. A questionable amount of vaccine was given, some doses of vaccine were given into gluteal. The reported date of vaccination was 15 August 2009 with IMOVAX (lot # not reported) and immunoglobulin human antirabies (manufacturer and lot # not reported). It is not known whether this date was the first date for the IMOVAX series. The patient complained of joint pain in hip for a day or so after each injection. He also developed a rash in axillary and groin area a few weeks following receipt of the series. Additionally, the patient developed a severe headache on 12-13 October 2009 that persisted. The patient reported receiving influenza vaccine (manufacturer and lot # unknown) a few weeks prior to the onset of the headache. The patient did not recover from the adverse events at the time of the report. No other information was provided. List of documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Diarrhoea, Immediate post-injection reaction, Immunoglobulin therapy, Muscle rigidity, Nausea
Clinical narrative: Initial report received on 29 March 2010 by a consumer. A 60 year-old female with medical history significant for hypertension and hyperlipidemia who was bitten by a cat subsequently received IMOVAX (lot number not reported) intramuscular to right thigh on 08 March 2010. She also received immunoglobulin (unknown manufacturer and lot number) half the dose to the right deltoid and the other half to the site of cat scratches and tetanus vaccine (unknown manufacturer and lot number) to the left deltoid the same day. The patient received IMOVAX Dose 2 to the left hip on 11 March 2010 and IMOVAX Dose 3 to the left arm on 15 March 2010. Immediately after first vaccinations on 08 March 2010 the patient reported her legs "freezing up" and remaining that way. The patient also reported nausea, vomiting, fever (continuing at the time of report) and diarrhea which started in the first two weeks after the first vaccine. Her legs continue to feel heavy and she can't bend them at the time of this report. The patient was given doxycycline on 08 March 2010 and then put on AUGMENTIN (unspecified date). The concomitant medications reported by the patient were FLEXERIL for sleep and blood pressure medication (not specified). List of documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Pyrexia, Sensation of heaviness, Vomiting
Clinical narrative: Initial report received on 29 March 2010 by a consumer. A 60 year-old female with medical history significant for hypertension and hyperlipidemia who was bitten by a cat subsequently received IMOVAX (lot number not reported) intramuscular to right thigh on 08 March 2010. She also received immunoglobulin (unknown manufacturer and lot number) half the dose to the right deltoid and the other half to the site of cat scratches and tetanus vaccine (unknown manufacturer and lot number) to the left deltoid the same day. The patient received IMOVAX Dose 2 to the left hip on 11 March 2010 and IMOVAX Dose 3 to the left arm on 15 March 2010. Immediately after first vaccinations on 08 March 2010 the patient reported her legs "freezing up" and remaining that way. The patient also reported nausea, vomiting, fever (continuing at the time of report) and diarrhea which started in the first two weeks after the first vaccine. Her legs continue to feel heavy and she can't bend them at the time of this report. The patient was given doxycycline on 08 March 2010 and then put on AUGMENTIN (unspecified date). The concomitant medications reported by the patient were FLEXERIL for sleep and blood pressure medication (not specified). List of documents held by sender: None.
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal, Arthralgia, Back pain, Diarrhoea, Eye irritation
Clinical narrative: Initial report received from a consumer on 18 August 2010. A female patient, age reported as less than 60-years, completed a post exposure series of Imogam Rabies-HT and IMOVAX Rabies (lot numbers, doses, site and route not reported). Her medical history included thyroid problem, allergy to penicillin, allergy to dust and no illness at time of vaccination. The patient had no adverse event following prior vaccinations. A few days after completing a post exposure series, the patient began having joint pain in her ankles, hips, thighs, fingers and hands. Her eyes feel like they are burning and are watery. She complained of back pain which comes and goes, feeling exhausted and has been having diarrhea. She wakes in the morning feeling tired. The patient required a doctor's visit. The patient had a titer done 2-3 weeks after the IMOVAX series and the level was borderline. The patient was scheduled to have a repeat titer done in 2-3 weeks. Treatment was not reported. The patient did not want to give personal information. The outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Lacrimation increased
Clinical narrative: Initial report received from a consumer on 18 August 2010. A female patient, age reported as less than 60-years, completed a post exposure series of Imogam Rabies-HT and IMOVAX Rabies (lot numbers, doses, site and route not reported). Her medical history included thyroid problem, allergy to penicillin, allergy to dust and no illness at time of vaccination. The patient had no adverse event following prior vaccinations. A few days after completing a post exposure series, the patient began having joint pain in her ankles, hips, thighs, fingers and hands. Her eyes feel like they are burning and are watery. She complained of back pain which comes and goes, feeling exhausted and has been having diarrhea. She wakes in the morning feeling tired. The patient required a doctor's visit. The patient had a titer done 2-3 weeks after the IMOVAX series and the level was borderline. The patient was scheduled to have a repeat titer done in 2-3 weeks. Treatment was not reported. The patient did not want to give personal information. The outcome was reported as not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Musculoskeletal stiffness
Clinical narrative: Initial report received from a consumer on 23 August 2010. A 60-year-old female patient, with a history of osteoporosis and on hormone replacement therapy, received on 22 August 2010 the 4th dose of intramuscular (IM) deltoid IMOVAX Rabies (lot number unknown). The patient had a cold and cough at the time of vaccination. One hour after receiving the 4th dose, she experienced neck stiffness and pain in the lower back, knees and both hips. She received IMOVAX Rabies (dose 0) and Immune globulin in the Emergency Room (ER) on 08 August 2010, IMOVAX Rabies (dose 1) on 11 August 2010 and IMOVAX Rabies (dose 3) on 15 August 2010. The outcome was reported as unknown. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: RAB
Symptoms: Gait disturbance, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Initial case received on 30 August 2010 from a consumer who is also the mother of the patient. A 6 year old male patient received a first dose of IMOGAM (lot not reported) and a first dose injection of IMOVAX (lot not reported) on 21 August 2010 as part of post exposure rabies series. He also received a second dose injection of IMOVAX (lot not reported) on 24 August 2010. He experienced soreness at the injection sites post vaccinations, on 21 August 2010 and 24 August 2010. On 28 August 2010 the patient received a second dose right thigh injection of RABAVERT (lot not reported, manufacturer Novartis). On 29 August 2010, he experienced a fever (101.0-102.0), soreness of both legs and limping on right side. The patient had no illness at the time of the vaccinations. He had no pre-existing medical history and no known allergies. Concomitant medications included vitamin supplements. At the time of this report it was unknown if he had recovered from the soreness at the injection sites, fever, soreness of both legs and limping in right side. The outcome of the adverse events was not reported. This case is linked to 2010-04616 and 2010-04618. Documents held by sender: None.
Age: 51.0
Sex: M
Vaccine: RAB
Symptoms: Oral herpes, Pain in extremity
Clinical narrative: Case received from a non-healthcare professional (patient himself) on 13 October 2010 under the agency local reference number 10-0715. A 51-year-old male patient, who denied illness at time of vaccination and other medications, had received his 3rd intramuscular dose of IMOVAX Rabies, batch number unknown, in the left deltoid, on 11 October 2010. He had no known allergies but a history of high blood pressure (diet controlled at the time of the report). He had had no adverse event following prior vaccination. Following a bat exposure, the patient had received his 1st dose of IMOVAX Rabies, batch number unknown, in the gluteal region, on 04 October 2010 and his 2nd dose of IMOVAX Rabies, batch number unknown, in the deltoid, on 07 October 2010. On 11 October 2010, in the night post-vaccination, the patient experienced sore arm. On the following day, he woke up with a cold sore on the right upper lip and then also developed another cold sore on his left lower lip. The patient's symptoms were not resolved at the time of the report. Documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site swelling, Rash, Skin warm, Tenderness
Clinical narrative: Patient presented to Preventive Medicine with localized rash on right arm.  Tender and warm to the touch.  Swelling is present with rash spreading from shoulder down to elbow.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Rash
Clinical narrative: MENACTRA given 5/4/11. Rash 5/5/11. Temp 99.8 5/6/11. Info gathered by TPC.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: (R) arm blistered area erythema - raised edema - tender to palpation. Improved with ibuprofen. Symptoms developed about 48 hours after vaccine administration.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Conjunctival hyperaemia, Flushing, Headache, Pyrexia
Clinical narrative: About 12 hrs after injection, fever, chills, HA, flushed, conjunctival infection.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Febrile, with max. temp 102, stiff neck, HA, back pain, joint pain, arm pain.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Febrile, with max. temp 102, stiff neck, HA, back pain, joint pain, arm pain.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Marked thigh swelling, erythema, entire thigh.
Age: 1.02
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Induration, Rash vesicular
Clinical narrative: Wed. 05-04-11 (+) 4mm x 4mm red, raised, vesicular firm bumps to (L) arm x3 - (R) cheek x1 - (L) ear x1 - Occiput x1 3mm x 3mm circular, pink sl. raised bump on abdm. Rash post varicella vaccination on 4-4-11.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom noted redness, swelling and warmth of (R) upper arm starting 5/4/11 getting worse. 5/5/11 with itching of area also. Tx with BENADRYL 1 tsp QID.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia oral, Muscle twitching
Clinical narrative: Patient called on 4/5/11 wanted to know how long headache last. He got shot on 3/30/11. He had HA for 5 days, also itching & numbness of upper lip. Told patient to check with his MD, to make sure nothing else was going on. I told him I would contact Merck & Co to get more info. Merck called back they reported those symptoms in first trial & post marketing trail. No #'s.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Agitation, Crying, Decreased appetite, Encephalitis, Fatigue
Clinical narrative: Started with a low-grade fever (99.8) and took a longer nap than usual, and diminished appetite was noted.  Fever increased at night to 102.   5/1/11 he woke up with low-grade fever again and seemed to be more agitated during the day.  Fever went away during the day and went up again at night (101).   5/2/11 - low grade fever in the morning only, longer naps again, continued limited appetite, increased agitation, unconsolable crying in the evening.   5/3/11 - very sleepy throughout the day, took him to the doctor who advised he had "mild encephalitis."  Tylenol to be given for headaches.  Increased agitation in the evening (long naps continued). 5/4/11 - Again long naps throughout the day, tired easily, clingy to parents/caregivers, agitation in the evening. 5/5/11 - Again long naps through the day, clingy to caregivers, appetite improved. 5/6/22 - Somewhat less agitated and appetite improved.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Somnolence
Clinical narrative: Started with a low-grade fever (99.8) and took a longer nap than usual, and diminished appetite was noted.  Fever increased at night to 102.   5/1/11 he woke up with low-grade fever again and seemed to be more agitated during the day.  Fever went away during the day and went up again at night (101).   5/2/11 - low grade fever in the morning only, longer naps again, continued limited appetite, increased agitation, unconsolable crying in the evening.   5/3/11 - very sleepy throughout the day, took him to the doctor who advised he had "mild encephalitis."  Tylenol to be given for headaches.  Increased agitation in the evening (long naps continued). 5/4/11 - Again long naps throughout the day, tired easily, clingy to parents/caregivers, agitation in the evening. 5/5/11 - Again long naps through the day, clingy to caregivers, appetite improved. 5/6/22 - Somewhat less agitated and appetite improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Had (R) arm swelling & redness after vaccination. 3 1/2 cm x 2 1/2 cm local rxn area of induration.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Feeling of body temperature change, Mobility decreased, Oedema peripheral
Clinical narrative: Hot and cold flashes, left arm red and swollen 4 x 6 inches. Shoulder joint extremely sore. Difficulty lifting arm. Body aches.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Hot and cold flashes, left arm red and swollen 4 x 6 inches. Shoulder joint extremely sore. Difficulty lifting arm. Body aches.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Erythematous welt on (L) upper arm measurement 20cm long x 11cm wide, redness and warm to touch. Pruritus present.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Arm/shoulder swelling.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Myalgias generalized. Red, hot, swollen arm at injection site with aching - decreased within 24 hours. Fever 101, then less 24 hours - resolved completely.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Myalgias generalized. Red, hot, swollen arm at injection site with aching - decreased within 24 hours. Fever 101, then less 24 hours - resolved completely.
Age: 8.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Vision blurred, Visual impairment
Clinical narrative: Pt started experiencing periods of blurred vision 15 minutes after vaccine was administered. She explains it as if "everything is floating" and she cannot determine how far objects are from her. She had those symptoms 1-2 times per day for about 10 days. Last it happened 4/19/2011.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm area at injection site. Approx 2" x 4 ". Gave BENADRYL 25mg q6 hours. No difficulty breathing, swallowing.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4/27/11 Vaccines received on HD no symptoms noticed. 4/28/11 My mother noticed patient's leg when she was getting ready for school. I noticed it after school being red, swollen, warm & sore.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular, Streptococcus test positive
Clinical narrative: Erythematous maculopapular rash extending from face to feet. Soles & palms spared. No vesicles or scabbing.