chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Immunology test, Intubation, Pallor, Rotavirus test positive, Shock
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Acidosis, Blood gases, Blood pH, Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Hypotension, Hypovolaemia, Immunology test, Intensive care, Intubation
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Mechanical ventilation, Pallor, Red blood cell count normal, Respiratory failure, Resuscitation
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Autism, Diagnostic procedure, Diarrhoea, Facial palsy, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her 5 year old son with no pertinent medical history and no drug reactions/allergies, who on 07-MAR-2003 and 28-JAN-2004 was vaccinated with a first, second and third doses of RECOMBIVAX HB (lot numbers: "1218M", "1100M" and 646602/0751N). Concomitant therapy on 07-APR-2004 included MMR (lot number: 646898/0950N) and VARIVAX (lot number: 646135/0848N); and on 07-MAR-2003 and 07-MAY-2003 and DTP VACCINE ABSORBED USP, INFANRIX-IPV and PNU-IMUNE. After her son's first birthday, he presented with symptoms (unspecified). After his "first vaccinations", (approximately March 2003) he visited the doctor's office due to high fever, diarrhea and vomiting. On 15-MAY-2003 his "face was droopy". In approximately October 2005 the patient was diagnosed with autism. No further information was available. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. The events were considered to be disabling by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 5 year old son with no pertinent medical history and no drug reactions/allergies, who on 07-MAR-2003 and 28-JAN-2004 was vaccinated with a first, second and third doses of RECOMBIVAX HB (lot numbers: "1218M", "1100M" and 646602/0751N). Concomitant therapy on 07-APR-2004 included MMR (lot number: 646898/0950N) and VARIVAX (lot number: 646135/0848N); and on 07-MAR-2003 and 07-MAY-2003 and DTP VACCINE ABSORBED USP, INFANRIX-IPV and PNU-IMUNE. After her son's first birthday, he presented with symptoms (unspecified). After his "first vaccinations", (approximately March 2003) he visited the doctor's office due to high fever, diarrhea and vomiting. On 15-MAY-2003 his "face was droopy". In approximately October 2005 the patient was diagnosed with autism. No further information was available. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. The events were considered to be disabling by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a consumer concerning her 11 year old granddaughter who on 09-AUG-2007 was vaccinated with Varivax (Oka/Merck) (lot# 657619/0605U). Concomitant vaccinations included HAVRIX and ADACEL. Ten days after the vaccination, in 19-AUG-2007 she developed her first seizure. The reported indicated that on, 30-AUG-2007 (also reported as 28-AUG-2007), and 26-SEP-2007, the patient experienced tonic clonic seizure. It was indicated that the seizure on 26-SEP-2007, resolved after two minutes. The patient was seen by a neurologist. The first week of September 2007, therapy with LAMICTAL was begun. The dose of LAMICTAL was titrated to 2 tablets a day. The reporter indicated that at that time, no definitive diagnosis had been provided and the seizures were considered to be unresolved. Current patient status was not reported. Seizures were determined to be an other important medical event. Follow up information is not expected.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness bilateral, Dysphonia, Ear disorder
Clinical narrative: Information has been received from a physician's assistant concerning a 66 year old female with high cholesterol and no drug allergies who on 17-DEC-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). On approximately 18-DEC-2007 24 to 48 hours after vaccination, the patient experienced mild hoarseness in her voice and mild itching on her chest. Both symptoms resolved within a day or two on approximately 20-DEC-2007. On 27-DEC-2007 the patient woke up with severe bilateral ear pain. Upon examination at the physician's office she was found to have "red" ear drums. The patient was treated with an antibiotic for a suspected ear infection. The patient's ear pain continued and her hearing became worse. On approximately 31-DEC-2007 2 weeks after vaccination, the patient went to a specialist for a hearing test which showed moderate to severe nerve damage. The physician thought the event was due to a viral infection and treated the patient with FAMVIR and a steroid. On 28-JAN-2008 the patient had a repeat hearing test which showed mild improvements even though the patient still had trouble hearing other people. The patient was noted to be recovering. There was no product quality complaint. Hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Ear infection, Ear pain, Erythema, Nerve injury, Pruritus
Clinical narrative: Information has been received from a physician's assistant concerning a 66 year old female with high cholesterol and no drug allergies who on 17-DEC-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). On approximately 18-DEC-2007 24 to 48 hours after vaccination, the patient experienced mild hoarseness in her voice and mild itching on her chest. Both symptoms resolved within a day or two on approximately 20-DEC-2007. On 27-DEC-2007 the patient woke up with severe bilateral ear pain. Upon examination at the physician's office she was found to have "red" ear drums. The patient was treated with an antibiotic for a suspected ear infection. The patient's ear pain continued and her hearing became worse. On approximately 31-DEC-2007 2 weeks after vaccination, the patient went to a specialist for a hearing test which showed moderate to severe nerve damage. The physician thought the event was due to a viral infection and treated the patient with FAMVIR and a steroid. On 28-JAN-2008 the patient had a repeat hearing test which showed mild improvements even though the patient still had trouble hearing other people. The patient was noted to be recovering. There was no product quality complaint. Hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician's assistant concerning a 66 year old female with high cholesterol and no drug allergies who on 17-DEC-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). On approximately 18-DEC-2007 24 to 48 hours after vaccination, the patient experienced mild hoarseness in her voice and mild itching on her chest. Both symptoms resolved within a day or two on approximately 20-DEC-2007. On 27-DEC-2007 the patient woke up with severe bilateral ear pain. Upon examination at the physician's office she was found to have "red" ear drums. The patient was treated with an antibiotic for a suspected ear infection. The patient's ear pain continued and her hearing became worse. On approximately 31-DEC-2007 2 weeks after vaccination, the patient went to a specialist for a hearing test which showed moderate to severe nerve damage. The physician thought the event was due to a viral infection and treated the patient with FAMVIR and a steroid. On 28-JAN-2008 the patient had a repeat hearing test which showed mild improvements even though the patient still had trouble hearing other people. The patient was noted to be recovering. There was no product quality complaint. Hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever, Death  2/12/08 Received vax record from reporter/provider & confirms as reported.  4/11/08Reviewed autopsy report which states COD as SIDS. Autopsy also states patient was 32 wk preemie & developed fever 104 next day tx w/antipyretic & seen in ER.  Patient found cold, breathing arrested & unresponsive on 1/31/08 while co-sleeping w/parents.  EMS coded & taken to ER in cardiopulomonary arrest where resuscitation unsuccessful.  Accidental overlay could not be completely ruled out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5, TD
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Patient inadvertently given Td vaccine instead of Prevnar.  Contacted CDC for protocol.  Stated that local reaction would be increased but no long term or serious side effects.  Error noticed when entering data in computer.  2-5-08 contact with mom via telephone.  She reports no pain, irritability, fever or local reaction.
Age: 8.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of swelling and redness surrounding and extending injection site.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood creatinine normal, Blood urea normal, Full blood count normal, Henoch-Schonlein purpura, Laboratory test normal
Clinical narrative: Pt developed lower extremity rash which at 1st looked urticarial to 1st provider but clearly evolved into Henoch Schonlein purpura over lower extremities.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Platelet count normal, Red blood cell sedimentation rate normal, Streptococcal identification test, Urticaria
Clinical narrative: Pt developed lower extremity rash which at 1st looked urticarial to 1st provider but clearly evolved into Henoch Schonlein purpura over lower extremities.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Left arm erythema 11 cm x 14 cm at site of vaccine decreased with Benadryl.  Also had central area of darker erythema at site injection.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site haemorrhage, Injection site vesicles
Clinical narrative: Cellulitis of left upper arm at vaccine site, centered darker erythema, + vesicles, + ecchymotic areas.  2-2-08 per mother, area fading and getting better.  Improving without medication.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Oedema peripheral, Pruritus, Tenderness
Clinical narrative: R arm increased swelling/tender touch & itching after received MCV4 & varicella.
Sex: U
Vaccine: HEPA
Symptoms: Oedema peripheral
Clinical narrative: Swelling left arm.
Sex: U
Vaccine: HEPA
Symptoms: Oedema peripheral
Clinical narrative: Swelling L arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Left arm 5 cm x 6 cm erythematous, warm plaque.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pharyngeal oedema
Clinical narrative: Reported by client less than 15 minutes after administration.  Client left before observation time expired.  Client called saying she felt throat was swelling.  Denied any problem breathing.  Advised to go to nearest ER.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired drug administered, No adverse reaction
Clinical narrative: Client given an expired dose of Twinrix on 1-11-08; Client contacted and advised of situation. No adverse effects reported. Twinrix #1 will be repeated 2-12-08
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Blood immunoglobulin E, Blood immunoglobulin M decreased, Dizziness, Full blood count normal, Laboratory test normal
Clinical narrative: Within about 30 minutes of 1st dose, he felt mild nausea & lightheadedness.  The next morning the left side of his face was swollen without rash, itching.  Called our office on 1/21 & was seen the next day.  Use of ice, ibuprofen, demone.  Sx resolved by 1/28/08.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Mumps antibody test, Nausea, Red blood cell sedimentation rate normal, Swelling face
Clinical narrative: Within about 30 minutes of 1st dose, he felt mild nausea & lightheadedness.  The next morning the left side of his face was swollen without rash, itching.  Called our office on 1/21 & was seen the next day.  Use of ice, ibuprofen, demone.  Sx resolved by 1/28/08.
Age: 2.5
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient with varicella form rash on trunk appearing 3 4 days after varicella vaccine. No fever, No pruritis
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging, Oedema, Tendon disorder
Clinical narrative: A small subdeltoid fluid collection is present.  There is also minimal edema within the anterior aspect of the deltoid muscle itself.  The adjacent subscapularis portion of the cuff has mild tendinosis.  A rotator cuff tear is not seen.  The labrum has a normal appearance.  There is no tendon dislocation.  There is no bone marrow edema.  A type I acromion is present with a small subacromial spur is present.  Mild AC joint hypertrophy is present.  A small amount of fluid is present within the subdeltoid bursa.  The adjacent deltoid muscle has minimal edema ant the adjacent subscapularis portion of the cuff has mild tendinosis.  While the findings could represent an infection, it is less likely.  An infection usually has a more exuberant inflammatory response.  There is no other significant abnormality.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: 50 mm diameter round swelling on arm.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Computerised tomogram normal, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: L arm SQ area above elbow from pneumonia shot on Wednesday afternoon- by Thursday morning area became sore - swollen to the size of a quarter -reddened - had violent shivering episodes - Friday at dinnertime noticed it was getting bigger-shivering continued - had trouble moving her arm due to the pain - took Motrin and Darvocet but did not take away pain.  Saturday morning awoke and went directly to the ER approx. 11am - the hospital completed blood work - Pt stated she was told she had an infection - a CT scan was completed and IV pain medication was started - CT scan showed no abscess - started on IV antibiotics - was not admitted - Given Vicodin and a PO antibiotic - Was unable to sleep because of pain. Sunday she called her family physician and stated it was worse - PCP told her to go to hospital for admission immediately. Pt was in hospital for 4 days on IV antibiotics and pain medications - diagnosed with cellulitis.  Released to home on Wednesday evening with Vicodin and Bactrim BID. Swelling has decreased - pain has decreased "a little" - Will follow up with physician tomorrow. 2/8/08-records received for DOS 2/3-2/06/08-Presented to ED with C/O left arm pain and swelling, pain in left hand. PE: left upper extremity erythema and duration located in triceps region, minimal fluctuance with discomfort on palpation. DX: Left upper extremity cellulitis.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: L arm SQ area above elbow from pneumonia shot on Wednesday afternoon- by Thursday morning area became sore - swollen to the size of a quarter -reddened - had violent shivering episodes - Friday at dinnertime noticed it was getting bigger-shivering continued - had trouble moving her arm due to the pain - took Motrin and Darvocet but did not take away pain.  Saturday morning awoke and went directly to the ER approx. 11am - the hospital completed blood work - Pt stated she was told she had an infection - a CT scan was completed and IV pain medication was started - CT scan showed no abscess - started on IV antibiotics - was not admitted - Given Vicodin and a PO antibiotic - Was unable to sleep because of pain. Sunday she called her family physician and stated it was worse - PCP told her to go to hospital for admission immediately. Pt was in hospital for 4 days on IV antibiotics and pain medications - diagnosed with cellulitis.  Released to home on Wednesday evening with Vicodin and Bactrim BID. Swelling has decreased - pain has decreased "a little" - Will follow up with physician tomorrow. 2/8/08-records received for DOS 2/3-2/06/08-Presented to ED with C/O left arm pain and swelling, pain in left hand. PE: left upper extremity erythema and duration located in triceps region, minimal fluctuance with discomfort on palpation. DX: Left upper extremity cellulitis.
Age: 17.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MEN
Symptoms: Asthenia, Dizziness, Heart rate decreased, Loss of consciousness, Pallor
Clinical narrative: Pale (White), weakness, LOW heart rate, Dizziness, Passed out, was out for about 90 sec. Put water on face, after came to gave her orange juice.  Patient was also given at the same time 3 other shots. Tetanus, Hepatitis A, Meningococcal Vaccine. I had asked before she was given all of the shots if it would be to much for her. They told me that it would be fine.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, PNC
Symptoms: Pyrexia, Rash generalised
Clinical narrative: PATIENT WAS ADMINISTED HEP A VACCINE ON 8/1/2006. ON 08/06/2007 PRESENTED IN OUR OFFICE WITH ALMOST HIVE-LIKE RASH SCATTERED THROUGHOUT HER ENTIRE BODY.  FEVER STARTED THE DAY AFTER THE ABOVE INJECTION OF 101-102 BUT ONLY LASTING 24 HOURS.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Lymphadenopathy, Nausea
Clinical narrative: Reddened hard knot to injection site, Lymph nodes under left arm swollen, fever 2nd day after injection, nausea & vomiting 1st day after injection.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Reddened hard knot to injection site, Lymph nodes under left arm swollen, fever 2nd day after injection, nausea & vomiting 1st day after injection.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Somnolence, Swelling face
Clinical narrative: AFTER RECEIVED VACCINE, TOOK 5 HR. NAP. WHEN HE AWOKE, MOM NOTICED HIS FACE WAS SWOLLEN, 8-9 HRS. AFTER RECEIVING VACCINE. NEXT MORNING SHE NOTICED HE STILL WAS SWOLLEN. SHE GAVE BENADRYL. NURSE SPOKE WITH MOM ON 2/6/08. SHE STATES SWELLING IS GONE AND PATIENT IS ACTING FINE.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: C/O feeling dizzy and nauseated 30 min after injection.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Rash at site of Varicella vaccine in Left upper arm, then few days later, at injection site in right upper arm. Consistent with varicella.
Age: 13.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MEN, MMR, PPV
Symptoms: Convulsion, Wrong drug administered
Clinical narrative: Notified by patient's mother that shortly after receiving vaccine, patient had "a short episode of seizure outside the clinic".  Mother notified health center 9 days after this occurred.  No notificiation to VAERS at that time.  In December 2007, while researching patient's file for a billing question, documentation showed that patient had received either a DTaP vaccine, or a Pediarix, at the age of 13 years.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Injection site induration, Injection site pain, Lip swelling, Muscle spasms
Clinical narrative: Pt developed pain at injection site approx. 36 hours after administration - hardened area without redness.  Also had muscle spasms at site of injection.  The next night she developed itching on her chest and trunk area, woke the morning after that with red rash on trunk and hives around her neck.  Her throat was itchy, chest was tight, lips were swollen.  Came to ER.  Took a Clarinex, symptoms improved minimally but then got worse again.  Later took a Zyrtec, went to bed.  Woke feeling better.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: Pt developed pain at injection site approx. 36 hours after administration - hardened area without redness.  Also had muscle spasms at site of injection.  The next night she developed itching on her chest and trunk area, woke the morning after that with red rash on trunk and hives around her neck.  Her throat was itchy, chest was tight, lips were swollen.  Came to ER.  Took a Clarinex, symptoms improved minimally but then got worse again.  Later took a Zyrtec, went to bed.  Woke feeling better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Skin lesion
Clinical narrative: Lesions on upper right arm, under arm, and on breast and pain across the back. Vaccine was given on 1-23-08 about 2pm.  Complete case of zoster by 7pm. Called the dr on the 25th he said take Benadryl.  On the 1st still in pain. Went to the dr and he diagnosed as such. Gave me Famvir.  Today is the 7th of Feb and still in pain.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Nausea, Neck pain
Clinical narrative: WITHIN HOURS AFTER RECEIVING VACCINE, PATIENT DEVELOPED POSTERIOR NECK PAIN, HEADACHE, NAUSEA, AND SINCE HAS BEEN DIZZY AND LIGHTHEADED (2 DAYS POST VACCINATION).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Client received Zostavax vaccination and developed a rash on upper torso, bilateral arms and neck.  Client presented to medical Center, no treatment was received.  Client complained that rash is "itchy" and "working its way up his neck".
Age: 18.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient received DTaP instead of Tdap.
Age: 1.21
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Erythema, Swelling face
Clinical narrative: 10 to 15 min after receipt of vaccines, mother noticed pt's face red and swollen, mother called health dept @ 12:02, advised to take child to ER.  Seen @ local ER treated with Benadryl, facial swelling decreased, discharged to home with order for Benadryl every 6 hrs.  Child in no distress @ 2:30 PM.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Mild swelling and rash around injection site.  Persisting 1 week after administration.  Continued swelling and spreading of rash after 1 week.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Fatigue, Headache, Hypotension
Clinical narrative: Per patient: On Friday evening, my left arm (where I got the tetanus/pertussis shot) started aching.  I woke up in the middle of the night in extreme pain, unable to move that arm, feeling very nauseous and dizzy.  My arm was very swollen, hot, hard and red.  I felt awful on Saturday and paged your doctor on call, who advised me to go to the ER.  I had made it up to my parents house and planned on going to the ER there, but I took my temperature and it was normal, and I just felt like I wanted to sleep, so I took some Advil and slept for 14 hours at their house.  Sunday I still felt awful, no change in my arm, but I drove home.  Monday I continued to have flu-like symptoms -- dizzy, nauseous, achy, and my arm remained swollen, tender, hot and red.  I did not go to work, and insisted on taking me to the ER.  My temp was still normal, but my BP was very low (90/66), and the PA I saw thought I had a systemic infection going on from the vaccine, and put me on antibiotics.  I missed work again on Tuesday. I started feeling a little better on Weds. and went back to work.  My arm has started to feel better, but I still have flu-like symptoms.  Today I have taken 9 Advil since this morning and still have a splitting head and neck-ache and my arm is aching.  I am having a hard time getting comfortable enough to sleep feeling this achy and am not sleeping well.  I feel really run down and exhausted.  I don't think I simply caught the flu because of the onset of the symptoms in conjunction with the vaccine, and also b/c I am not vomiting or congested... just in pain and exhausted.  I am also still quite dizzy.  I am toughing out work b/c I have a lot going on right now and couldn't stay out any longer, but am feeling just lousy.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Influenza like illness, Injected limb mobility decreased, Malaise, Nausea
Clinical narrative: Per patient: On Friday evening, my left arm (where I got the tetanus/pertussis shot) started aching.  I woke up in the middle of the night in extreme pain, unable to move that arm, feeling very nauseous and dizzy.  My arm was very swollen, hot, hard and red.  I felt awful on Saturday and paged your doctor on call, who advised me to go to the ER.  I had made it up to my parents house and planned on going to the ER there, but I took my temperature and it was normal, and I just felt like I wanted to sleep, so I took some Advil and slept for 14 hours at their house.  Sunday I still felt awful, no change in my arm, but I drove home.  Monday I continued to have flu-like symptoms -- dizzy, nauseous, achy, and my arm remained swollen, tender, hot and red.  I did not go to work, and insisted on taking me to the ER.  My temp was still normal, but my BP was very low (90/66), and the PA I saw thought I had a systemic infection going on from the vaccine, and put me on antibiotics.  I missed work again on Tuesday. I started feeling a little better on Weds. and went back to work.  My arm has started to feel better, but I still have flu-like symptoms.  Today I have taken 9 Advil since this morning and still have a splitting head and neck-ache and my arm is aching.  I am having a hard time getting comfortable enough to sleep feeling this achy and am not sleeping well.  I feel really run down and exhausted.  I don't think I simply caught the flu because of the onset of the symptoms in conjunction with the vaccine, and also b/c I am not vomiting or congested... just in pain and exhausted.  I am also still quite dizzy.  I am toughing out work b/c I have a lot going on right now and couldn't stay out any longer, but am feeling just lousy.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Oedema peripheral, Pain in extremity, Skin warm, Sleep disorder
Clinical narrative: Per patient: On Friday evening, my left arm (where I got the tetanus/pertussis shot) started aching.  I woke up in the middle of the night in extreme pain, unable to move that arm, feeling very nauseous and dizzy.  My arm was very swollen, hot, hard and red.  I felt awful on Saturday and paged your doctor on call, who advised me to go to the ER.  I had made it up to my parents house and planned on going to the ER there, but I took my temperature and it was normal, and I just felt like I wanted to sleep, so I took some Advil and slept for 14 hours at their house.  Sunday I still felt awful, no change in my arm, but I drove home.  Monday I continued to have flu-like symptoms -- dizzy, nauseous, achy, and my arm remained swollen, tender, hot and red.  I did not go to work, and insisted on taking me to the ER.  My temp was still normal, but my BP was very low (90/66), and the PA I saw thought I had a systemic infection going on from the vaccine, and put me on antibiotics.  I missed work again on Tuesday. I started feeling a little better on Weds. and went back to work.  My arm has started to feel better, but I still have flu-like symptoms.  Today I have taken 9 Advil since this morning and still have a splitting head and neck-ache and my arm is aching.  I am having a hard time getting comfortable enough to sleep feeling this achy and am not sleeping well.  I feel really run down and exhausted.  I don't think I simply caught the flu because of the onset of the symptoms in conjunction with the vaccine, and also b/c I am not vomiting or congested... just in pain and exhausted.  I am also still quite dizzy.  I am toughing out work b/c I have a lot going on right now and couldn't stay out any longer, but am feeling just lousy.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Somnolence, Tenderness
Clinical narrative: Per patient: On Friday evening, my left arm (where I got the tetanus/pertussis shot) started aching.  I woke up in the middle of the night in extreme pain, unable to move that arm, feeling very nauseous and dizzy.  My arm was very swollen, hot, hard and red.  I felt awful on Saturday and paged your doctor on call, who advised me to go to the ER.  I had made it up to my parents house and planned on going to the ER there, but I took my temperature and it was normal, and I just felt like I wanted to sleep, so I took some Advil and slept for 14 hours at their house.  Sunday I still felt awful, no change in my arm, but I drove home.  Monday I continued to have flu-like symptoms -- dizzy, nauseous, achy, and my arm remained swollen, tender, hot and red.  I did not go to work, and insisted on taking me to the ER.  My temp was still normal, but my BP was very low (90/66), and the PA I saw thought I had a systemic infection going on from the vaccine, and put me on antibiotics.  I missed work again on Tuesday. I started feeling a little better on Weds. and went back to work.  My arm has started to feel better, but I still have flu-like symptoms.  Today I have taken 9 Advil since this morning and still have a splitting head and neck-ache and my arm is aching.  I am having a hard time getting comfortable enough to sleep feeling this achy and am not sleeping well.  I feel really run down and exhausted.  I don't think I simply caught the flu because of the onset of the symptoms in conjunction with the vaccine, and also b/c I am not vomiting or congested... just in pain and exhausted.  I am also still quite dizzy.  I am toughing out work b/c I have a lot going on right now and couldn't stay out any longer, but am feeling just lousy.
Age: 6.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Oedema peripheral, Swelling face, Urticaria
Clinical narrative: Developed swelling of face, hands and feet the following morning, along with hives all over the body. Was taken to the emergency room and given a prescription for 5 days of prednisone and Benadryl to use as needed for swelling.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was inadvertently given Tdap.  Patient is 2 Years old.
Sex: F
Vaccine: HEPAB
Symptoms: Drug exposure during pregnancy, Jaundice neonatal
Clinical narrative: A healthcare professional prospectively reported the occurrence of neonatal jaundice in a newborn female neonate subject who was exposed in utero to Twinrix via the placenta. the subject's mother was vaccinated with Twinrix (GlaxoSmithKline) for prophylaxis. The subject was also exposed in utero to maternal concurrent medications that included prenatal vitamins and Lipil. Maternal history included smoking one-half pack per day of cigarettes. On 06 April 2007 the mother received 3rd dose of Twinrix (1 ml, unknown, left arm). On 17 April 2007, the mother notified the physician's office that she was pregnant and "found out last week." The mother received 3rd dose of Twinrix at approximately 6 weeks of gestation. Prenatal test showed no evidence of birth defects and the conception was normal. It was reported that, the subject delivered a female infant at approximately 41 weeks of gestation by normal vaginal delivery. The infant weighed 6 pounds 1 ounce and was 18 inches long. APGAR score and head circumference were unknown. No birth defects were noted. It was reported that the neonate developed jaundice and was hospitalized for three days after birth. The infant was treated with intravenous fluids and received light treatments. A check-up was done approximately one and one-half weeks and it was reported that the baby "was fine." Details of the mother case can be found in GSK manufacturer number A0648203A.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: hematoma at site shot - started that evening - progressed over a week to the size of a "plate"; no further following by patient
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Headache, Pyrexia
Clinical narrative: Client's mother phoned on 2-6-08 to report child had headache and fever-p.m. of 2-5-08, by 2-6-08 fever 104.2 degrees.  Took client to Emergency Room - there she had IV rxs to reduce the fever and was given Tylenol & treated with ibuprofen and sent home.  Within 30 min.-at ER-fever down to 103.1 then 101.8.  Phoned mother on 2-7-08 she reported child's temp 98.8 today.  Child will see her MD next week.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Bone scan, Erythema, Nuclear magnetic resonance imaging, Staphylococcal infection
Clinical narrative: On 1-19-08 mom noticed red sore place on patient's right thigh approximately 2.5cm.  Red, raised hard.  Was seen on 1-20-08 with diagnosis staph skin infection.  ABx only then seen in office 1-28-08 with limping right leg.  ? immunization adverse effect.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 12/16/07 - PM - injection site left arm became red, increased over next couple days to about 2 inches in diameter.  Seen in doctor's office 12/20/07.  Redness had started to fade by then, and completely resolved by 12/28/07.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient brought into clinic on 2/7/08 with red, swollen, hot to touch LA. LA approx. 12cm x 8cm. 2/7/08
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Pain
Clinical narrative: Reported high fever approximately 24 hours after receiving vaccine "101.9 F", aching.  Took medication to reduce fever.  Approximately 36 hours after vaccine, temperature 98.8 F on 2/7/08 AM.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash
Clinical narrative: Mom states that approximately 24 hours after immunization, patient broke out with an unusual rash on left thigh and lower leg that resembled "bug bites".  Afebrile, alert.  Lasted 24 hours.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Pain in extremity
Clinical narrative: Soreness at injection site. low grade temp 2-3 days after the shot. Gradual radiation of pain down arm into Right elbow over a 4wk period.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Complained of severe headache, dizziness, chills.  Had sore body, body aches and fever 101.8.
Age: 1.2
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Varicella
Clinical narrative: Patient has chickenpox despite 2 doses of Varivax 2/6/08.
Age: 43.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Migraine, Musculoskeletal stiffness, Pain, Pruritus, Rash
Clinical narrative: 1 wk 4 days after inj had body aches with moderate pain & stiffness, next day migraine.  Yesterday 1 wk 6 days small raised rash in limited areas.  Today rash covers 75% of body with pruritus.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm swelling and erythema by patient report; Keflex 500 QID x 7d
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Bursa disorder, Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: 1 day after vaccination, pt developed erythema, edema over L arm at site of injection, with prominent, fluctuant olecranon bursa.  Treated with ibuprofen, ice, elevation also with dicloxacillin with differential dx. of cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: Red rash left arm from shoulder blade to elbow.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Skin discolouration, Skin induration, Skin warm
Clinical narrative: Left Lateral thigh. With Extensive red hot indurated skin, slightly purple in center but NONTENDER. Treatment - cool compress, ibuprophen *Reaction to DTAP
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Induration, Pruritus, Swelling
Clinical narrative: 1/29 Redness, swelling, itchy; mom administered Benadryl - no effect.  1/30 - returned to office.  Area 15% larger, red, indurated, warm area.  *Reaction to DTAP*.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Chronic pain radiating from injection site, starting several days after shot causing discomfort day and night, lasting 3 months plus.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Chronic pain radiating from injection site, starting several days after shot causing discomfort day and night, lasting 3 months plus.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 ml dose of Rotateq (no lot# provided) (dose of series unknown). Subsequently the patient experienced intussusception. The patient sought unspecified medical attention. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Upon internal review, intussusception was determined to be an other important medical event. This is one of two reports from the same source. Additional information has been requested.