chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the right arm.  This was the wrong route of administration and an inappropriate dose of drug administered.  The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given.  Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour.  The reaction consisted of a 2cm by 2cm area of redness and swelling.  The area was also inflamed.  The events were not resolved at the time of reporting and were being monitored and measured.  No treatment was required.  In the reporter's opinion, the local reaction and redness were probably related to treatment with FLULAVAL.  The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route.  The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the right arm.  This was the wrong route of administration and an inappropriate dose of drug administered.  The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given.  Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour.  The reaction consisted of a 2cm by 2cm area of redness and swelling.  The area was also inflamed.  The events were not resolved at the time of reporting and were being monitored and measured.  No treatment was required.  In the reporter's opinion, the local reaction and redness were probably related to treatment with FLULAVAL.  The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route.  The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a consumer and described the occurrence of watery eyes in a 58-year-old male subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject has had flu vaccinations in the past, but is unsure which vaccines they were. The subject did not experience any reactions with previous flu shots. The subject had no adverse events following previous vaccinations. On 14 October 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 16 October 2008, 2 days after vaccination with FLULAVAL, the subject experienced watery eyes. According to the reporter, all diagnostic tests so far have been negative; no glaucoma and no blocked tear ducts. At the time of reporting the event was unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with (FLULAVAL, GlaxoSmithKline). In 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, unknown arm). On an unspecified date in the fall of 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site reaction, pain, small local reaction and nonspecific reaction. At the time of reporting the injection site reactions, pain and small local reaction were improved. The events improved in possibly a week or more. Outcome of nonspecific reaction was unspecified. This facility vaccinates long term care subjects. They stated to sales representative that they have had a lot of reactions this year and were wondering if it was because we had some type of preservative that other companies do not. When we asked if they felt this was a bad lot, the sales representative said no. The healthcare professional considered the injection site reaction, pain and small local reaction was probably related to vaccination with FLULAVAL. Causality was unspecified fro nonspecific reaction.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer and described the occurrence of itchy rash in a 75-year-old male subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included pneumonia. Concurrent medical conditions included high blood pressure and high cholesterol. Concurrent medications included Aspirin (Baby aspirin), Lisinopril, Lovastatin and Doxycycline. On 5 November 2008 at 09:00 the subject received a dose of FLULAVAL left arm. On 7 November 2008, two days following vaccination with FLULAVAL, the subject developed an itchy rash all over his body. The subject was treated with CLOBEX, unknown medication (BENOS), PREDNISONE and methylprednisolone, but none of these treatments helped the rash. The consumer reported that the rash flares up on different parts of his body and becomes worse at times. The subject stated that his looked like GROVERS disease. The subject discontinued possible allergens such as artificial sweetener, but the rash is not improving and remains unresolved.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Ataxia, Dysarthria, Gait disturbance, Hemiparesis, Nausea
Clinical narrative: A serious spontaneous report of ataxia, left sided hemiparesis, slurring speech, tremors, rolling tongue, impairment in walking and talking, nausea/vomiting has been received from a consumer concerning a 24-month-old male, subsequent to FLUMIST.  The patient's past medical history includes egg allergy.  Reporter states no concomitant medications at the time of FLUMIST administration.  Patient is current with childhood immunizations and no immunizations given with FLUMIST.  The patient received FLUMIST 07-Nov-2008 at his two-year-old wellness visit.  Within a few hours after administration, the patient exhibited the above events.  The patient was hospitalized for two days.  The reporter stated that the discharge diagnosis listed ataxia and possible FLUMIST reaction.  FLUMIST was discontinued at this time.  Subsequently, the patient started taking supplements (eg. selenium, acidophilus).  In March 2009, the patient exhibited the same symptoms again and was hospitalized again.  Reporter states last dose of FLUMIST was 07-Nov-2008.  Currently, the child is at home with no symptoms.  A local neurologist at the hospital is following the patient.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Speech disorder, Tongue disorder, Tremor, Vomiting
Clinical narrative: A serious spontaneous report of ataxia, left sided hemiparesis, slurring speech, tremors, rolling tongue, impairment in walking and talking, nausea/vomiting has been received from a consumer concerning a 24-month-old male, subsequent to FLUMIST.  The patient's past medical history includes egg allergy.  Reporter states no concomitant medications at the time of FLUMIST administration.  Patient is current with childhood immunizations and no immunizations given with FLUMIST.  The patient received FLUMIST 07-Nov-2008 at his two-year-old wellness visit.  Within a few hours after administration, the patient exhibited the above events.  The patient was hospitalized for two days.  The reporter stated that the discharge diagnosis listed ataxia and possible FLUMIST reaction.  FLUMIST was discontinued at this time.  Subsequently, the patient started taking supplements (eg. selenium, acidophilus).  In March 2009, the patient exhibited the same symptoms again and was hospitalized again.  Reporter states last dose of FLUMIST was 07-Nov-2008.  Currently, the child is at home with no symptoms.  A local neurologist at the hospital is following the patient.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 35 year old female patient with no previous medical history and allergies reported, who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB IM. On 23-FEB-2009, the patient was vaccinated with the second dose of RECOMBIVAX HB (Lot number 662114/0866X) IM. Concomitant therapy included AUGMENTIN and clindamycin since 16-FEB-2009 for a facial abscess. On 23-FEB-2009, about 5-6 hours later the patient complained of itching. The next morning, on 24-FEB-2009, the patient woke up with a rash that covered her entire body except for her face. The nurse also mentioned that the patient had developed a vaginal yeast infection during this time. The patient had seen her physician regarding the rash. He discontinued to the antibiotics and prescribed a topical cream for the itching. As of 26-FEB-2009, the patient's adverse events persisted. Follow up information has been received from the licensed practical nurse who stated that the patient was taking AUGMENTIN and clindamycin for the abscess. The patient experienced hives all over body, except for face. RECOMBIVAX HB was also received before reaction occurred, although the licensed practical nurse stated that their office thought the reaction was not due to RECOMBIVAX HB, but rather due to the concomitant antibiotics. The patient was being referred back to their regular physician. Follow up information has been received from the licensed practical nurse concerning the patient records, who on 23-JAN-2009 at 10:00 am was vaccinated IM into the left upper arm with a first dose of RECOMBIVAX HB (lot #662115/1263X). On 24-FEB-2009 at 5-6 p.m. itching and hives over entire body except face - patient stated hives lasted until 02-MAR-2009. She saw her primary care physician, who stopped the AUGMENTIN and clindamycin she was taking at the time of the vaccine. The PCP gave her topical ointment. The LPN noted that the patient had been hospitalized in February of 2009 for facial abscess and stated she had a yeast infection. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Rash generalised, Subcutaneous abscess, Urticaria, Vulvovaginal mycotic infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 35 year old female patient with no previous medical history and allergies reported, who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB IM. On 23-FEB-2009, the patient was vaccinated with the second dose of RECOMBIVAX HB (Lot number 662114/0866X) IM. Concomitant therapy included AUGMENTIN and clindamycin since 16-FEB-2009 for a facial abscess. On 23-FEB-2009, about 5-6 hours later the patient complained of itching. The next morning, on 24-FEB-2009, the patient woke up with a rash that covered her entire body except for her face. The nurse also mentioned that the patient had developed a vaginal yeast infection during this time. The patient had seen her physician regarding the rash. He discontinued to the antibiotics and prescribed a topical cream for the itching. As of 26-FEB-2009, the patient's adverse events persisted. Follow up information has been received from the licensed practical nurse who stated that the patient was taking AUGMENTIN and clindamycin for the abscess. The patient experienced hives all over body, except for face. RECOMBIVAX HB was also received before reaction occurred, although the licensed practical nurse stated that their office thought the reaction was not due to RECOMBIVAX HB, but rather due to the concomitant antibiotics. The patient was being referred back to their regular physician. Follow up information has been received from the licensed practical nurse concerning the patient records, who on 23-JAN-2009 at 10:00 am was vaccinated IM into the left upper arm with a first dose of RECOMBIVAX HB (lot #662115/1263X). On 24-FEB-2009 at 5-6 p.m. itching and hives over entire body except face - patient stated hives lasted until 02-MAR-2009. She saw her primary care physician, who stopped the AUGMENTIN and clindamycin she was taking at the time of the vaccine. The PCP gave her topical ointment. The LPN noted that the patient had been hospitalized in February of 2009 for facial abscess and stated she had a yeast infection. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Headache, Intensive care, Intraventricular haemorrhage, Vomiting
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. An 18 year old female with no pertinent medical history who on 18-MAR-2009 was vaccinated with a second dose of GARDASIL (Lot # 661846/1312X) intramuscularly into the left arm. Concomitant therapy included TDAP. On 19-MAR-2009 approximately 36 hours after vaccination she experienced headache and vomiting. On 21-MAR-2009 she was admitted to surgical intensive care unit for observation and close monitoring for intraventricular hemorrhage. Magnetic resonance imaging, magnetic resonance angiography of brain, computed axial tomography were performed. Headache, intensive care, intraventricular haemorrhage and vomiting were considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot # 661846/1312X 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 and was released. This was originally reported by a consumer. The VAERS # ID is 342730.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Computerised tomogram, Headache, Intensive care, Intraventricular haemorrhage, Nuclear magnetic resonance imaging
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. An 18 year old female with no pertinent medical history who on 18-MAR-2009 was vaccinated with a second dose of GARDASIL (Lot # 661846/1312X) intramuscularly into the left arm. Concomitant therapy included TDAP. On 19-MAR-2009 approximately 36 hours after vaccination she experienced headache and vomiting. On 21-MAR-2009 she was admitted to surgical intensive care unit for observation and close monitoring for intraventricular hemorrhage. Magnetic resonance imaging, magnetic resonance angiography of brain, computed axial tomography were performed. Headache, intensive care, intraventricular haemorrhage and vomiting were considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot # 661846/1312X 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 and was released. This was originally reported by a consumer. The VAERS # ID is 342730.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Vomiting
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. An 18 year old female with no pertinent medical history who on 18-MAR-2009 was vaccinated with a second dose of GARDASIL (Lot # 661846/1312X) intramuscularly into the left arm. Concomitant therapy included TDAP. On 19-MAR-2009 approximately 36 hours after vaccination she experienced headache and vomiting. On 21-MAR-2009 she was admitted to surgical intensive care unit for observation and close monitoring for intraventricular hemorrhage. Magnetic resonance imaging, magnetic resonance angiography of brain, computed axial tomography were performed. Headache, intensive care, intraventricular haemorrhage and vomiting were considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot # 661846/1312X 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 and was released. This was originally reported by a consumer. The VAERS # ID is 342730.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, unknown route, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were unspecified.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, unknown route, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were unspecified.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site swelling, Local reaction, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, unknown route, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were unspecified.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Pt received ZOSTAVAX vaccine on 4/3/2009. About 2 days after the injection she noticed a big, red, and swollen area on her upper arm. She reported it being about 5 inches in size. She also noted that there was a hard spot and it looked similar to a bee sting. She stated she experienced minimal itching and it was not painful. It lasted for about a week before it disappeared, and during this time she did not do anything to treat this.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus
Clinical narrative: Pt received ZOSTAVAX vaccine on 4/3/2009. About 2 days after the injection she noticed a big, red, and swollen area on her upper arm. She reported it being about 5 inches in size. She also noted that there was a hard spot and it looked similar to a bee sting. She stated she experienced minimal itching and it was not painful. It lasted for about a week before it disappeared, and during this time she did not do anything to treat this.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Musculoskeletal stiffness
Clinical narrative: Patient's father reports elevated temp at home 4/23/09, for which he administered Tylenol. States child woke up with a scream in 5am 4/24/09 child woke up with a scream ~ 5am 4/24/09 and "stiff"  X 30 sec. Lips noted to be  "blue" briefly. Was diagnosed with febrile seizure in ER + was given Motrin in ER.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Screaming
Clinical narrative: Patient's father reports elevated temp at home 4/23/09, for which he administered Tylenol. States child woke up with a scream in 5am 4/24/09 child woke up with a scream ~ 5am 4/24/09 and "stiff"  X 30 sec. Lips noted to be  "blue" briefly. Was diagnosed with febrile seizure in ER + was given Motrin in ER.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 4/17/2009: SM contacted VHC reporting receipt AVA #2 on 4/8/2009 (lot# unknown). The next day he had numbness to right 4th/5th digits. 4/10/09 this numbness had progressed to his 3rd/middle finger with pain in his right forearm. He stated his palm tingles after lifting/moving boxes and his wrist aches. His AVA site is sore w/o redness or swelling.  He reported past history of right shoulder/neck problems with normal x-rays. Prior to vaccination and after he helped load-packed gear in preparation for deployment, continued training, and was wearing 50 lb ''IBA'' packs. He advised moving his right arm/shoulder caused the forearm to hurt. He was given Ibuprofen 400mg every 6 hr by medical with minimal relief.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia
Clinical narrative: 4/17/2009: SM contacted VHC reporting receipt AVA #2 on 4/8/2009 (lot# unknown). The next day he had numbness to right 4th/5th digits. 4/10/09 this numbness had progressed to his 3rd/middle finger with pain in his right forearm. He stated his palm tingles after lifting/moving boxes and his wrist aches. His AVA site is sore w/o redness or swelling.  He reported past history of right shoulder/neck problems with normal x-rays. Prior to vaccination and after he helped load-packed gear in preparation for deployment, continued training, and was wearing 50 lb ''IBA'' packs. He advised moving his right arm/shoulder caused the forearm to hurt. He was given Ibuprofen 400mg every 6 hr by medical with minimal relief.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Nuclear magnetic resonance imaging
Clinical narrative: My daughter was given all three doses of Gardasil on 8/28/08, then on 11/1/08, and the last on 3/7/09. On April 11, 2009 my daughter suffered with two seizures on this day and was hospitalized for five days. There is no history of seizures in my family. She was then put on Keppra. A week and a half later she suffered with three more seizures. Patient was again hospitalized. Keppra was then increased to 1500 mg twice a day. Now we are going to the neurologist to try to pinpoint the cause. I did research and found the side affects of Gardasil and one of them were seizures.  6/17/09 Hospital ED records received DOS 4/23/09. Assessment: Seizure.  Patient presents actively seizing with a history of having a tonic-clonic seizure. Sleepy, disoriented, lethargic (decreased awareness), responds to verbal stimuli, responsive to painful stimuli, postictal state, unable to speak.  7/14/09 Hospital records received 4/11/09 to 4/15/09   Assessment: New onset seizures. Patient presents with seizure for 3 hours. Suddenly became quite, uprolling of eyes, foaming from mouth, generalized 'tonicoclonic' seizure with 10-15 minute postictal phase. 3 episodes of vomiting. Headache. Morbid obesity.  7/14/09 Hospital records received 4/23/09 to 4/25/09 Assessment: Seizure disorder, breakthrough convulsion. Patient presents with Seizure (Tonic-Clonic) generalized for 5 minutes. Foaming at mouth, rolling of eyes. Three episodes. Post-ictal phase. Vomiting, feels tired. Hurt left side of head. Neurological follow-up suggested.  ICD-9 Codes: 780.39, 278.00, 345.11 \ksk
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Intensive care, Nuclear magnetic resonance imaging
Clinical narrative: My daughter was given all three doses of Gardasil on 8/28/08, then on 11/1/08, and the last on 3/7/09. On April 11, 2009 my daughter suffered with two seizures on this day and was hospitalized for five days. There is no history of seizures in my family. She was then put on Keppra. A week and a half later she suffered with three more seizures. Patient was again hospitalized. Keppra was then increased to 1500 mg twice a day. Now we are going to the neurologist to try to pinpoint the cause. I did research and found the side affects of Gardasil and one of them were seizures.  6/17/09 Hospital ED records received DOS 4/23/09. Assessment: Seizure.  Patient presents actively seizing with a history of having a tonic-clonic seizure. Sleepy, disoriented, lethargic (decreased awareness), responds to verbal stimuli, responsive to painful stimuli, postictal state, unable to speak.  7/14/09 Hospital records received 4/11/09 to 4/15/09   Assessment: New onset seizures. Patient presents with seizure for 3 hours. Suddenly became quite, uprolling of eyes, foaming from mouth, generalized 'tonicoclonic' seizure with 10-15 minute postictal phase. 3 episodes of vomiting. Headache. Morbid obesity.  7/14/09 Hospital records received 4/23/09 to 4/25/09 Assessment: Seizure disorder, breakthrough convulsion. Patient presents with Seizure (Tonic-Clonic) generalized for 5 minutes. Foaming at mouth, rolling of eyes. Three episodes. Post-ictal phase. Vomiting, feels tired. Hurt left side of head. Neurological follow-up suggested.  ICD-9 Codes: 780.39, 278.00, 345.11 \ksk
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Furuncle, Hypokinesia, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: A GOLF BALL SIZE NODE IN ARMPIT OF SAME ARE ARM AS INJECTION SITE. MADE SLEEPING DIFFICULT AND ARE MOVEMENT PAINFUL. ALSO 2 BOILS APPEARED ON FACE, ONE AROUND LEFT EYE AND ANOTHER ON LEFT SIDE OF JAW. INJECTION SITE, EXTREMELY RED SWOLLEN AND DISGUSTING. I HATED GETTING THIS SHOT AND WILL NOT GET IT AGAIN.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nodule, Pain
Clinical narrative: A GOLF BALL SIZE NODE IN ARMPIT OF SAME ARE ARM AS INJECTION SITE. MADE SLEEPING DIFFICULT AND ARE MOVEMENT PAINFUL. ALSO 2 BOILS APPEARED ON FACE, ONE AROUND LEFT EYE AND ANOTHER ON LEFT SIDE OF JAW. INJECTION SITE, EXTREMELY RED SWOLLEN AND DISGUSTING. I HATED GETTING THIS SHOT AND WILL NOT GET IT AGAIN.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Furuncle, Injection site erythema, Injection site swelling, Insomnia, Lymphadenopathy
Clinical narrative: A GOLF BALL SIZE NODE IN ARMPIT OF SAME ARE ARM AS INJECTION SITE. MADE SLEEPING DIFFICULT AND ARE MOVEMENT PAINFUL. ALSO 2 BOILS APPEARED ON FACE, ONE AROUND LEFT EYE AND ANOTHER ON LEFT SIDE OF JAW. INJECTION SITE, EXTREMELY RED SWOLLEN AND DISGUSTING. I HATED GETTING THIS SHOT AND WILL NOT GET IT AGAIN.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pain
Clinical narrative: A GOLF BALL SIZE NODE IN ARMPIT OF SAME ARE ARM AS INJECTION SITE. MADE SLEEPING DIFFICULT AND ARE MOVEMENT PAINFUL. ALSO 2 BOILS APPEARED ON FACE, ONE AROUND LEFT EYE AND ANOTHER ON LEFT SIDE OF JAW. INJECTION SITE, EXTREMELY RED SWOLLEN AND DISGUSTING. I HATED GETTING THIS SHOT AND WILL NOT GET IT AGAIN.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fatigue, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: fever of 100.7F, body aches, HA, sore throat, fatigue, dizziness, sore arm
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: fever of 100.7F, body aches, HA, sore throat, fatigue, dizziness, sore arm
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL
Symptoms: Abdominal pain, Anorexia, Blood test, Dizziness, Dyspepsia
Clinical narrative: Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea.  This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon.  She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found.  She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS:  Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL
Symptoms: Endoscopy, Listless, Nausea, Pyrexia, Stool analysis
Clinical narrative: Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea.  This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon.  She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found.  She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS:  Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL
Symptoms: Syncope, Ultrasound scan, Vomiting, Weight decreased
Clinical narrative: Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea.  This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon.  She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found.  She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS:  Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Localized erythema Left shoulder and axillary area.  Lymphadenopathy.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Asthenia, Chills, Injection site rash, Nausea, Pain
Clinical narrative: Localized erythema Left shoulder and axillary area.  Lymphadenopathy.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Localized erythema Left shoulder and axillary area.  Lymphadenopathy.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Rash over chest, back, and arms.   ITCHING, NO DRAINAGE.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Body temperature increased, Pneumonia
Clinical narrative: Mother reports client with elevated temperature (average 101) following vaccinations,also reports moderate cough. Temperature continued elevated for four days unable to keep down with acetaminophen. Went to emergency room on 4/28/09.  CXray done, diagnosed with pneumonia and put on Zithromax per parent report.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Painful Hardened red area mid clavicular, left side, pea-sized.  Vaccinatiion site, left deltoid, erythematous.Keflex 500 mg 1 tab 4Xday  X10 dys
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema, Induration, Injection site erythema, Pain
Clinical narrative: Painful Hardened red area mid clavicular, left side, pea-sized.  Vaccinatiion site, left deltoid, erythematous.Keflex 500 mg 1 tab 4Xday  X10 dys
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Patient's mom stated symptoms of redness and swelling at injection site on left upper arm developed on 4/28/09 in the evening.  Arm felt hot to the touch. Pt taken to hospital ER.  Pt started on Orapred for 10 days.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Vertigo
Clinical narrative: Vaccine administered on 04/28/2009. Within 24 hours swelling, fever at injection site, tenderness,and increasing redness appeared. Within 48 hours the redness, fever at site with swelling and pain continue.  On Friday morning 05/01/2009 I woke up with an extreme case of vertigo with nausea.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Pt's mom stated sylmptoms of redness and swelling @ injection site of left deltoid on 4/29/09 in the morning.  Arm felt hot to the touch Dr. prescribed Orapred.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: About 5-6 hrs after DTaP pt had fever with seizure. He had had a febrile seizure the night before with diagnosis of ear infection.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Abdominal pain upper, Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Rednes and Pain at injection site, increasing in size.  Cramping in stomach with meals.    Cellulitis Left Arm.   Keflex EQ 250mg 4 times daily X10 days.
Age: 1.58
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: FEBRILE SEIZURE ON 28APRIL2009, MOTHER OF PATIENT CALLED 911 AND WAS TAKEN TO THE ER BY AMBULANCE
Age: 39.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Discomfort, Erythema multiforme, Pruritus
Clinical narrative: Extensive Erythema Multiforme on back associated with puritis and uncomfortable.  No respiratory distress.  Epinphrine 0.3mg IM, Benadryl 50mg IM.  Triamcinolone Acentonide inj 40mg IM,  Methylprednisolone PO 4mg (654321) on consecutive days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site induration
Clinical narrative: Indurated area at site of each injection.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: APPROXIMATELY 3-5 MINUTES AFTER RECEIVING THE VACCINE THE PATIENT SUDDENLY PASSED OUT - SHE HAD NO WARNING - SHE CAME BACK ARROUND IMMEDIATELY - FEELING A LITTLE DIZZY FOR A FEW MINUTES AND THEN FINE - THERE WAS NO TREATMENT OTHER THAN COLD COMPRESSES TO THE FACE.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Six days after administration of MMR client noticed reddness the size of 50 cent coin. The following day (5/1/09) swelling had increased to 50mm in size, warm to touch with erythema. Client states it itched 4/30 and she scratched it. Ice placed today with improvement per client. T 98.4, P 60, R 18, BP 118/70. Given Cephalexin 500 mg po tid x 7 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Right and Left legs had cellulitis, redness. Did require IV antibiotics for 4 days.  5/22/09 Received hospital medical records of 4/29-4/30/2009. FINAL DX: cellulitis left thigh Records reveal patient experienced progressive erythema w/streaking, induration, &  pain at injection site and fever, x 3 days.  Tx w/IV antibiotics & admitted overnight for observation.  Improved & d/c to home next day on continued oral antibiotics.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received via the internet concerning a 21 year old female who was vaccinated with GARDASIL.  The patient died 4 days after vaccination.  The cause of death was unknown.  No further information is available.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash maculo-papular
Clinical narrative: On 4/29 (the day after receiving the vaccine) the patient returned to the provider's office with-3 spots of maculopapular rash on
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, No reaction on previous exposure to drug, Presyncope
Clinical narrative: On 4/24/09, Pt came in for #2 GARDASIL. Pt had no adverse reaction to #1 dose. Pt had a vasovagal episode immediately after vaccine given. Pt had appropriate recovery time after event.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, FLU3, HEPA
Symptoms: Vomiting
Clinical narrative: Within 12 hours after admin of vaccines began vomiting Q 30 min- was taken to ED- called night clinic X2.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 4x6cm area on right deltoid of erythema and induration, noted about 24-36 hours after vaccine. Ice applied.
Age: 17.0
Sex: F
Vaccine: HEPA, IPV, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen like a size of a baseball hot and red.
Age: 46.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Dizziness, Headache, Migraine, Myalgia, Nausea
Clinical narrative: C/o lightheaded with tunnel vision (compared to distorted vision experienced with ocular migraine headaches experienced). Bp 156/90, pulse and resp WNL. Observed X30 min. until symptoms subsided. F/u call 30 minutes later patient states "I'm fine" - Patient notes felt nausea, muscle aches, HA with prior two doses of RABAVERT administered at hospital.
Age: 46.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Tunnel vision, Vaccine positive rechallenge
Clinical narrative: C/o lightheaded with tunnel vision (compared to distorted vision experienced with ocular migraine headaches experienced). Bp 156/90, pulse and resp WNL. Observed X30 min. until symptoms subsided. F/u call 30 minutes later patient states "I'm fine" - Patient notes felt nausea, muscle aches, HA with prior two doses of RABAVERT administered at hospital.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: L arm SQ area red and swollen about half of back arm, hot to touch, hurts to touch and itching.
Age: 70.0
Sex: M
Vaccine: HEPAB, IPV, YF, HEPAB, IPV, YF
Symptoms: Pyrexia, Rash vesicular, Sciatica, Urticaria
Clinical narrative: TC from son (MD): Pt had dried like zoster rash to forehead X 3 days with mild fever only. Now has vesicular (urticaria) rash with sciatica without fever. Now without resp issues. MD starting with VALTREX - Recom. MD eval and eval and tx and symptoms. Initial report received on 01 May 2009 from a health care professional. A 70-year-old male patient had received a right arm subcutaneous booster injection A1229-2), a second subcutaneous left arm injection of YF-VAX  (lot number UF4 left arm injection of TWINRIX (manufacturer GlaxoSmithKline, lot number AHAB. The patient had no concurrent illnesses at the time, but had medical history has not required treatment in the last four years. The patient has been well taking PREVACID and LIPITOR as concomitant medications (indications not reported on 26 April 2009 (time of onset unknown).The patient developed dried like zoster three days with mild fever only. Subsequently (date not reported), the patient reported as urticarial and sciatics. At that time, the patient did not have reported) the patient developed respiratory issues (not described). The patient was recommended to get further medical evaluation and treatment for symptoms the time of this report, this was in process. The recovery status of the patient. Follow up information received on 03 June 2009 from health care professional. The patient did not have a prior history of sciation. The patient has chronic left lower extremity pain as well as foot drop in the left lower extremity with difficulty walking. The patient is being monitored by a neurologist and dermatologist for pain management. The final diagnosis was shingles. No further information was provided. Documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: HEPAB, IPV, YF, HEPAB, IPV, YF
Symptoms: Pyrexia, Rash vesicular, Respiratory disorder, Sciatica, Urticaria
Clinical narrative: TC from son (MD): Pt had dried like zoster rash to forehead X 3 days with mild fever only. Now has vesicular (urticaria) rash with sciatica without fever. Now without resp issues. MD starting with VALTREX - Recom. MD eval and eval and tx and symptoms. Initial report received on 01 May 2009 from a health care professional. A 70-year-old male patient had received a right arm subcutaneous booster injection A1229-2), a second subcutaneous left arm injection of YF-VAX  (lot number UF4 left arm injection of TWINRIX (manufacturer GlaxoSmithKline, lot number AHAB. The patient had no concurrent illnesses at the time, but had medical history has not required treatment in the last four years. The patient has been well taking PREVACID and LIPITOR as concomitant medications (indications not reported on 26 April 2009 (time of onset unknown).The patient developed dried like zoster three days with mild fever only. Subsequently (date not reported), the patient reported as urticarial and sciatics. At that time, the patient did not have reported) the patient developed respiratory issues (not described). The patient was recommended to get further medical evaluation and treatment for symptoms the time of this report, this was in process. The recovery status of the patient. Follow up information received on 03 June 2009 from health care professional. The patient did not have a prior history of sciation. The patient has chronic left lower extremity pain as well as foot drop in the left lower extremity with difficulty walking. The patient is being monitored by a neurologist and dermatologist for pain management. The final diagnosis was shingles. No further information was provided. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Culture positive, Echocardiogram, Electroencephalogram, Encephalopathy, Endotracheal intubation
Clinical narrative: Prev. healthy 4 mo. old admitted to ER status epilepticus and intubated upon arrival. During hosp. had poss. aspiration pneumonia (+) culture Moroxella catarrhalis, treated x 7 days with Cefitime. Had EEG x3, LP x3, MRI head, echocardiogram.   6/1/09 Hospital records received DOS 4/13/09 to 4/20/09. FINAL DIAGNOSIS: 'Probable neonatal seizures' Encephalopathy secondary to unknown etiology. Post vaccination: Admitted in status epilepticus. Not breathing. Vomited. Disconjugate gaze. Aspiration pneumonia. Left corneal epithelial defect secondary to lagophthalmos. Recommended genetics and neurology follow up.  6/17/09 ICD-9 codes received. 78039 Convulsions, 5070 Pneumonitis due to inhaltion of food or vomitus, 51881 Acute respiratory failure, 34830 Encephlalopathy unspecified, 2762 Acidosis, 9181 Superficial injury of cornea, 37420 Lagophthalmos, 26650 Volume depletion unspecified.\
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Status epilepticus
Clinical narrative: Prev. healthy 4 mo. old admitted to ER status epilepticus and intubated upon arrival. During hosp. had poss. aspiration pneumonia (+) culture Moroxella catarrhalis, treated x 7 days with Cefitime. Had EEG x3, LP x3, MRI head, echocardiogram.   6/1/09 Hospital records received DOS 4/13/09 to 4/20/09. FINAL DIAGNOSIS: 'Probable neonatal seizures' Encephalopathy secondary to unknown etiology. Post vaccination: Admitted in status epilepticus. Not breathing. Vomited. Disconjugate gaze. Aspiration pneumonia. Left corneal epithelial defect secondary to lagophthalmos. Recommended genetics and neurology follow up.  6/17/09 ICD-9 codes received. 78039 Convulsions, 5070 Pneumonitis due to inhaltion of food or vomitus, 51881 Acute respiratory failure, 34830 Encephlalopathy unspecified, 2762 Acidosis, 9181 Superficial injury of cornea, 37420 Lagophthalmos, 26650 Volume depletion unspecified.\
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site papule, Skin discolouration, Skin warm, Tenderness
Clinical narrative: Approx 3" area right upper arm warm, pink sl. firm. Symptoms decrease today with papular at injection site. No anaphylaxis sx - no encephalopathy sx. 4-28 reviewed with Dr.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site rash, Rash, Rash generalised, Skin warm
Clinical narrative: 16 X 16 cm Erythemic warm rash on Lt thigh.  Mom putting salve on it.  That is helping.  Pt mom states got whole body rash @ 2 months with vacc.
Sex: U
Vaccine: FLU3
Symptoms: Injection site extravasation, Scab
Clinical narrative: Felts like open cut.  used rubbing alcohol to clean at home.  Has clear liquid at injection site after couple of days, then it scabbed over and got better.  No red or swollen, no fever Sx.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Gastric disorder, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Extreme swelling and redness of whole right upper arm for 3 weeks. Hives and welts everyday for several months, stomach shut down for about 3 weeks 1 time and 2 days another -still have hives and welts every 2-3 days. Seen Dr. for stomach (many test) still seeing Dr. for allergic reactions (Dr. swelling arm, red and fever).
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral
Clinical narrative: Swelling (L) arm
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Patient reported severe injection site soreness.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: R upper arm redness with swelling slight induration 10cm X 8cm.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Pediarix vac. but was supposed to get a DTAP vac.