chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Hydrocephalus, Nuclear magnetic resonance imaging, Surgery, Ventriculo-peritoneal shunt, Vomiting
Clinical narrative: Initial report was received on 26 September 2011 from another manufacturer, report number WAES1109USA01131. The initial reporter to this manufacturer had been a consumer who is the parent of the patient. Verbatim from the report: "Information has been received from a consumer concerning her 2 month old daughter with no known drug allergies who in approximately OCT-2010 was vaccinated with ROTATEQ (dose, date unspecified) and ACTHIB (dose, date and route unspecified) and dose of DTAP (dose, date, manufacturer unspecified). On 29-DEC-2010 the patient was diagnosed with Dandy Walker Syndrome which caused the patient to experience hydrocephaly and she was hospitalized. While hospitalized the consumer reported her daughter had surgery to place a ventricular-peritoneal shunt. The consumer reported that her daughter was hospitalized a second time to have a new shunt placed because the first shunt malfunctioned. The consumer reported that her daughter was currently recovering and was stable. The primary reporter considered the Dandy Walker Syndrome to be an other important medical event as well as immediately life-threatening. MRI and CAT scan were performed (results not reported). Follow up information has been received from a physician concerned an 18 weeks old female patient who on 14-OCT-2010 was vaccinated with the first dose of ROTATEQ (lot number: 668036/0594Z) (route of administration not reported). On 14-DEC-2010, the patient was vaccinated with the second dose of ROTATEQ (Lot number: 668036/0549Z) (route of administration not reported). On 14-FEB-2011, the patient was vaccinated with the third dose of ROTATEQ (lot number: 668264/0854Z) (route of administration not reported). The patient was not vaccinated with ACTHIB and DAPTACEL (dates not provided). The events were not related to the vaccines; condition was congenital. Symptoms of Dandy Walker Syndrome: increased head circumference, hydrocephalus, vomiting, and sun-setting. On 30-DEC-2010, the first surgery was performed. On unspecified date, approximately one to two months later, after the first shunt failed, patient had another surgery. Events were disabling and life threatening at the time. Other vaccines were given after the adverse event onset. On 01-MAR-2011, the patient was vaccinated with the first dose of ACTHIB (lot number: 666187/1484Y) thimerosal free, (dose and site of administration not reported). On 16-MAY-2011, the patient was vaccinated with the second dose of ACTHIB (lot number: 668635/1520Z) (dose and site of administration not reported). At the time of the report, the patient was indeed recovering and in fact had "advance development for her age." No further information is available." Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2012US010341 is an initial spontaneous report received via a health care professional from the Vaccine Adverse Event Reporting System (VAERS reference number: 444569) website on 07 Feb 2012 with a follow up received from the quality assurance department (reference number: 146632) on 20 Feb 2012 and a follow up received on 02 Mar 2012. This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M10058) into the right arm, along with FLUARIX (other manufacturer, batch number: AFLUA611A) into the left arm, with GARDASIL (other manufacturer, batch number: 0477AA) into the right arm and with BOOSTRIX (other manufacturer, batch number: AC52B048AC) into the left arm on 02 Dec 2011. On the same day after vaccination she developed cellulitis. The final outcome was reported as condition unchanged as on 05 Dec 2011. The quality assurance department opened a complaint for this case with reference number 146632. Based on the documents review, it was stated that the concerned MENVEO batch number M10058 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information was available. Non-significant follow-up received from the quality assurance department (reference number: 146632) on 20 Feb 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 146632) on 02 Mar 2012. Batch review report updated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Erythema, Fatigue, Swelling face, Urticaria
Clinical narrative: Initial report was received from a health care professional on 01 March 2012. The reporter also reported other adverse events involving other patients and vaccines that were captured in case numbers 2012-02457 and 2012-02458. An 11-year-old female patient had received a dose one injection in the right deltoid of MENACTRA, sanofi pasteur Inc. lot number U3904AA and a dose one injection in the left deltoid of GARDASIL, Merck, lot number 1490AA on 27 February 2012 at 9:53AM. The patient waited for 15 minutes in the office after vaccination and had no reaction. On 27 February 2012 at 12:30, when the patient was at home, the patient was very tired and went to sleep, when she awoke her face was red and swollen and her trunk and extremities were covered in hives. She did not have any difficulty breathing. The patient was treated with BENADRYL. No diagnostic tests or laboratory data was performed. The patient had no adverse reactions following prior vaccinations, received no other vaccinations within four weeks of MENACTRA and a medical history of obesity. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Hypotonia, Irritability, Somnolence
Clinical narrative: Initial report was received from a health care professional on 29 February 2012 with additional information received on 01 March 2012. This reporter also reported another adverse event that was captured in case number 2012-02458. A 2-month-old male patient had received a dose one intramuscular injection in the right thigh of PENTACEL, sanofi pasteur, Ltd. lot number C4143AA, a dose one intramuscular injection in the left thigh of PREVNAR, Wyeth, lot number F56177 and a dose one of oral dose of ROTATEQ, Merck, lot number 0922AA on 20 February 2012 at 2:00PM. On 20 February 2012 at 3:00PM the patient slept more than normal for three days and seemed to have less muscle tone when picked up. When the sleepiness resolved, the muscle tone improved and the patient developed high pitched screaming, inconsolable crying and irritability. The patient had no illness at the time of vaccination, no medical history and took no concomitant medications. The patient also received an intramuscular injection in the left thigh of HepB, Merck, lot number 0231AA on 19 January 2012. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Hypersomnia, Hypotonia, Irritability, Screaming
Clinical narrative: Initial report was received from a health care professional on 29 February 2012 with additional information received on 01 March 2012. This reporter also reported another adverse event that was captured in case number 2012-02458. A 2-month-old male patient had received a dose one intramuscular injection in the right thigh of PENTACEL, sanofi pasteur, Ltd. lot number C4143AA, a dose one intramuscular injection in the left thigh of PREVNAR, Wyeth, lot number F56177 and a dose one of oral dose of ROTATEQ, Merck, lot number 0922AA on 20 February 2012 at 2:00PM. On 20 February 2012 at 3:00PM the patient slept more than normal for three days and seemed to have less muscle tone when picked up. When the sleepiness resolved, the muscle tone improved and the patient developed high pitched screaming, inconsolable crying and irritability. The patient had no illness at the time of vaccination, no medical history and took no concomitant medications. The patient also received an intramuscular injection in the left thigh of HepB, Merck, lot number 0231AA on 19 January 2012. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Confusional state, Diarrhoea, Disorientation, Hallucination, visual, Headache
Clinical narrative: Confused, disoriented, complained of seeing maps when he closed his eyes. Mother notified primary care giver who referred her to HD to report adverse reaction.  These symptoms lasted four hours.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Confused, disoriented, complained of seeing maps when he closed his eyes. Mother notified primary care giver who referred her to HD to report adverse reaction.  These symptoms lasted four hours.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Confusional state, Disorientation, Hallucination, visual
Clinical narrative: Confused, disoriented, complained of seeing maps when he closed his eyes. Mother notified primary care giver who referred her to HD to report adverse reaction.  These symptoms lasted four hours.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal, Lumbar puncture, Nerve conduction studies
Clinical narrative: A few weeks after receiving vaccine, patient reports of loss of sensation in arms and legs, bilaterally. Patient followed up with neurologist who believes it to be Guillain-Barre syndrome.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia
Clinical narrative: A few weeks after receiving vaccine, patient reports of loss of sensation in arms and legs, bilaterally. Patient followed up with neurologist who believes it to be Guillain-Barre syndrome.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome, Nerve conduction studies abnormal, Sensory loss
Clinical narrative: A few weeks after receiving vaccine, patient reports of loss of sensation in arms and legs, bilaterally. Patient followed up with neurologist who believes it to be Guillain-Barre syndrome.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea at 7:30, two bouts of emesis at 07:55 AM.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Crying, Decreased appetite, Emotional distress, Screaming
Clinical narrative: BABY STARTED CRYING AT 1300, SCREAMING AT HIGH PITCH, FLAILING ARMS, INCONSOLABLE FOR 7 HOURS. GAVE TYLENOL BY WEIGHT, EVERY 4 HOURS. CONSTANT COMFORTING- ROCKING, ETC. BABY DID NOT EAT WELL UNTIL NEXT 12 HOURS AFTER IMMUNIZATIONS. DIDN'T REPORT TO DR. READ TODAY THAT CRYING MORE THAN 3 HOURS SHOULD BE REPORTED.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diplegia, Electromyogram, Hypoaesthesia, Immediate post-injection reaction, Lumbar puncture
Clinical narrative: TINGLING AND NUMBNESS VACCINATED ARM IMMEDIATELY RIGHT ARM; TINGLING AND NUMBNESS AND WEAKENING OF RIGHT HAND AND OVER 6 MONTHS TO LEFT ARM AND HAND EVENTUALLY CAUSING PARALYSIS OF BOTH ARMS AND HANDS; EVOLVING MYOPATHY/NEUROPATHY BOTH LEGS.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Myopathy, Neuropathy peripheral, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: TINGLING AND NUMBNESS VACCINATED ARM IMMEDIATELY RIGHT ARM; TINGLING AND NUMBNESS AND WEAKENING OF RIGHT HAND AND OVER 6 MONTHS TO LEFT ARM AND HAND EVENTUALLY CAUSING PARALYSIS OF BOTH ARMS AND HANDS; EVOLVING MYOPATHY/NEUROPATHY BOTH LEGS.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: TINGLING AND NUMBNESS VACCINATED ARM IMMEDIATELY RIGHT ARM; TINGLING AND NUMBNESS AND WEAKENING OF RIGHT HAND AND OVER 6 MONTHS TO LEFT ARM AND HAND EVENTUALLY CAUSING PARALYSIS OF BOTH ARMS AND HANDS; EVOLVING MYOPATHY/NEUROPATHY BOTH LEGS.
Age: 1.09
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Pyrexia, Rash pustular
Clinical narrative: My son presented with a fever of around 103-104 approximately 2 weeks after receiving his 12 month vaccines which included the MMR, VARIVAX, and influenza vaccines.  Shortly after the onset of his fever he developed a large (quarter size) welt on his leg.  The welt was hot to the touch and painful.  He then developed approximately 24 pox like marks on his body.  I called his pediatrician who advised me to administer Benadryl and Tylenol until his reaction resolved.  It took him about 5 days to recover.  I was unable to visit the pediatrician since we moved cross country between the administration of the vaccine and the adverse reaction.
Age: 1.09
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: My son presented with a fever of around 103-104 approximately 2 weeks after receiving his 12 month vaccines which included the MMR, VARIVAX, and influenza vaccines.  Shortly after the onset of his fever he developed a large (quarter size) welt on his leg.  The welt was hot to the touch and painful.  He then developed approximately 24 pox like marks on his body.  I called his pediatrician who advised me to administer Benadryl and Tylenol until his reaction resolved.  It took him about 5 days to recover.  I was unable to visit the pediatrician since we moved cross country between the administration of the vaccine and the adverse reaction.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Headache, Pruritus, Rash, Rhinorrhoea
Clinical narrative: Runny Nose, headache, joint pain, itching (skin rash in back, chest, face and arms). Every six hours used  two Benadryl for the allergy and  once a day Advil for the pain.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at site & redness - was given BENADRYL 25 mg by mouth - pt felt fine was told to take BENADRYL at home also - kept pt in clinic for 45 min and checked on her the next day & swelling had started to go down.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Nodule
Clinical narrative: Very mild erythema localized to (L) upper arm/deltoid at site of injection given on 2/27/12. Patient noticed day after injection & a small node under (L) arm - which resolved at time of exam on 3-1-12.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Rash, Streptococcal infection
Clinical narrative: Information has been received from a Registered nurse (certified) concerning her 18 year old daughter who on an unspecified date as a young child, was vaccinated with a dose of VARIVAX (Merck) (lot number, dose and route not reported). The Mother reported that on an unspecified date, her daughter had a rash caused by "strep" and confirmed that her daughter did not have chickenpox. It was reported that the patient had to drop out of college and was unable to work as an after school supervisor. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Rash caused by "strep" was considered to be disabling by the reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cholecystectomy, Cholecystitis, Death, Herpes zoster, Rash
Clinical narrative: Information has been received from a Doctor of microbiology and a licensed practical nurse (LPN) concerning a 45 year old female with end stage renal disease (ESRD), lupus, a history of renal transplant that was failing so patient was being considered for another one; who on an unspecified date, may have been vaccinated or exposed to someone who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, dose and route not reported). The LPN reported that after much investigation it could not be determined if the patient had ever received a VARIVAX (Merck) (manufacturer unknown) or if she was exposed to chicken pox, and stated that the office would not have authorized or administered a live vaccine to a immunosuppressed patient. The Doctor of Microbiology reported that on 10-FEB-2012, the patient was admitted to the hospital with a diagnosis of cholecystitis. On 11-FEB-2012 a cholecystectomy was performed. On 15-FEB-2012, rash and skin lesions appeared. On an unspecified date, strain identification for samples was found to be varicella zoster virus (VZV) positive in the lab. The patient experienced respiratory failure on 19-FEB-2012 and died at 11:28 hours. The doctor of microbiology reported that there was "disseminated varicella" at time of death. The cause of death was respiratory failure secondary to herpes zoster viremia. It was unknown if an autopsy was performed (death certificate showed No for autopsy). Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Respiratory failure, Skin lesion, Varicella, Varicella virus test positive, Viraemia
Clinical narrative: Information has been received from a Doctor of microbiology and a licensed practical nurse (LPN) concerning a 45 year old female with end stage renal disease (ESRD), lupus, a history of renal transplant that was failing so patient was being considered for another one; who on an unspecified date, may have been vaccinated or exposed to someone who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, dose and route not reported). The LPN reported that after much investigation it could not be determined if the patient had ever received a VARIVAX (Merck) (manufacturer unknown) or if she was exposed to chicken pox, and stated that the office would not have authorized or administered a live vaccine to a immunosuppressed patient. The Doctor of Microbiology reported that on 10-FEB-2012, the patient was admitted to the hospital with a diagnosis of cholecystitis. On 11-FEB-2012 a cholecystectomy was performed. On 15-FEB-2012, rash and skin lesions appeared. On an unspecified date, strain identification for samples was found to be varicella zoster virus (VZV) positive in the lab. The patient experienced respiratory failure on 19-FEB-2012 and died at 11:28 hours. The doctor of microbiology reported that there was "disseminated varicella" at time of death. The cause of death was respiratory failure secondary to herpes zoster viremia. It was unknown if an autopsy was performed (death certificate showed No for autopsy). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on an unknown date was vaccinated with three 0.5 ml doses of GARDASIL, (route and Lot number unknown). On an unknown date the patient developed cervical cancer. Patient sought unspecified medical attention. At the time of the report the patient's status was unknown. Upon internal review cervical cancer was determined to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Caesarean section, Maternal exposure during pregnancy, No adverse event, Prolonged labour
Clinical narrative: Information has been received from a Registered nurse, for GARDASIL, a pregnancy registry product, concerning a 23 year old female patient, with no pertinent medical history, drug reactions or allergies reported, who on 11-JAN-2011 was vaccinated intramuscularly, with her first dose of 0.5 ml, GARDASIL (Lot #: 666597/0768Z, Exp: 17-OCT-2012). Concomitant therapy included prenatal vitamins. Registered nurse reported that patient found out she was pregnant "soon after" she received the GARDASIL. The patient's last menstrual period was on 30-JAN-2011. No adverse effects were reported. A prenatal exam, a blood work and an ultrasound were performed (results not provided). Follow up information has been received via telephone call concerning the patient, who on 04-NOV-2011 at 39 weeks 5 days of gestation delivered a healthy baby boy. The baby was delivered via C-section due to (labor) failing to progress. The baby weighed 9 lbs 11 oz and had no reported congenital anomalies. There were no reported complications with delivery or the pregnancy. Upon internal review the baby was delivered via C-section was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen
Clinical narrative: Information has been received from a Registered nurse, for GARDASIL, a pregnancy registry product, concerning a 23 year old female patient, with no pertinent medical history, drug reactions or allergies reported, who on 11-JAN-2011 was vaccinated intramuscularly, with her first dose of 0.5 ml, GARDASIL (Lot #: 666597/0768Z, Exp: 17-OCT-2012). Concomitant therapy included prenatal vitamins. Registered nurse reported that patient found out she was pregnant "soon after" she received the GARDASIL. The patient's last menstrual period was on 30-JAN-2011. No adverse effects were reported. A prenatal exam, a blood work and an ultrasound were performed (results not provided). Follow up information has been received via telephone call concerning the patient, who on 04-NOV-2011 at 39 weeks 5 days of gestation delivered a healthy baby boy. The baby was delivered via C-section due to (labor) failing to progress. The baby weighed 9 lbs 11 oz and had no reported congenital anomalies. There were no reported complications with delivery or the pregnancy. Upon internal review the baby was delivered via C-section was considered to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient who on 05-JAN-2012, was vaccinated with the first 0.5 ml dose of GARDASIL (lot number and route not reported). Secondary suspect vaccine included a dose of AFLURIA (manufacturer unknown) (lot number, dose and route not reported) on 05-JAN-2012. Concomitant vaccines included MENACTRA on 05-JAN-2012 and DTAP on 05-JAN-2012. The physician reported that on 29-JAN-2012, the patient was evaluated by a physician for complaints of weakness and paresthesia in the patient's legs. The patient was referred to another physician and the patient was diagnosed with acute transverse myelitis. The patient was admitted to the hospital. The patient was attending physical therapy. At the time of the report the patient was improving. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Psoriasis
Clinical narrative: Initial report was received from a health care professional on 27 February 2012. A female patient (age and date of birth) had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route, site and exact date not reported) in September of 2011 and broke out in psoriasis. At the time of the report, the condition persisted. No further information was available at the time of the report. The patient's outcome was reported as unknown. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Bordetella test positive, Bronchial hyperreactivity, Condition aggravated, Cough, Dyspnoea
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02347, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 10-year-old male patient had received a 0.5 ml dose 5 injection of DTaP, lot number 0151F (manufacturer, route and site not reported) on 14 June 2006. The patient was 5-years-old at the time. On the same date, the patient had received a 0.5 ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR, and a 0.5ml dose 2 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 19 January 2012 with complaints of a cough for a couple of weeks, shortness of breath (SOB), hard to breathe, headache and vomiting once after coughing. Upon examination, the patient's lungs pre-nebulizer treatment had moderate air movement and right sided coarse wheeze while post-nebulizer had good air movement and no wheeze or crackle. The physician's assessment was cough and reactive airways disease (RAD). A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 23 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was seen again on 26 January 2012 with diagnosis of cough, pertussis and RAD. The patient was treated with Albuterol nebulizer, FLOVENT HFA, Albuterol aerosol, azithromycin and prednisone. The patient had an allergy to AUGMENTIN and CEFTIN (stomach upset) and took no concomitant medications. The patient had a past medical history of bloody noses, febrile seizures, reactive airways disease (RAD), non-displaced right tibial fracture, bedwetting, croup, headache, sinusitis, pharyngitis, cholelithiasis, abdominal pain, otalgia, eustachian tube disorder, rhinitis, syncope and collapse, asthma and upper respiratory infection (URI). The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0503AA on 11 July 2001, lot number U0513BA on 14 September 2001, lot number U0536BA on 16 November 2001 and lot number U0582AA on 28 August 2002 (routes and sites not reported). The patient was also up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father passed away from a myocardial infarction (MI) in August 2006, paternal grandfather passed away of an MI and maternal grandfather had an MI. The patient's mother had a history of RAD, allergies, sinus infections and weight problems. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Headache, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Vomiting
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02347, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 10-year-old male patient had received a 0.5 ml dose 5 injection of DTaP, lot number 0151F (manufacturer, route and site not reported) on 14 June 2006. The patient was 5-years-old at the time. On the same date, the patient had received a 0.5 ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR, and a 0.5ml dose 2 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 19 January 2012 with complaints of a cough for a couple of weeks, shortness of breath (SOB), hard to breathe, headache and vomiting once after coughing. Upon examination, the patient's lungs pre-nebulizer treatment had moderate air movement and right sided coarse wheeze while post-nebulizer had good air movement and no wheeze or crackle. The physician's assessment was cough and reactive airways disease (RAD). A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 23 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was seen again on 26 January 2012 with diagnosis of cough, pertussis and RAD. The patient was treated with Albuterol nebulizer, FLOVENT HFA, Albuterol aerosol, azithromycin and prednisone. The patient had an allergy to AUGMENTIN and CEFTIN (stomach upset) and took no concomitant medications. The patient had a past medical history of bloody noses, febrile seizures, reactive airways disease (RAD), non-displaced right tibial fracture, bedwetting, croup, headache, sinusitis, pharyngitis, cholelithiasis, abdominal pain, otalgia, eustachian tube disorder, rhinitis, syncope and collapse, asthma and upper respiratory infection (URI). The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0503AA on 11 July 2001, lot number U0513BA on 14 September 2001, lot number U0536BA on 16 November 2001 and lot number U0582AA on 28 August 2002 (routes and sites not reported). The patient was also up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father passed away from a myocardial infarction (MI) in August 2006, paternal grandfather passed away of an MI and maternal grandfather had an MI. The patient's mother had a history of RAD, allergies, sinus infections and weight problems. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Wheezing
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02347, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 10-year-old male patient had received a 0.5 ml dose 5 injection of DTaP, lot number 0151F (manufacturer, route and site not reported) on 14 June 2006. The patient was 5-years-old at the time. On the same date, the patient had received a 0.5 ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR, and a 0.5ml dose 2 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 19 January 2012 with complaints of a cough for a couple of weeks, shortness of breath (SOB), hard to breathe, headache and vomiting once after coughing. Upon examination, the patient's lungs pre-nebulizer treatment had moderate air movement and right sided coarse wheeze while post-nebulizer had good air movement and no wheeze or crackle. The physician's assessment was cough and reactive airways disease (RAD). A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 23 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was seen again on 26 January 2012 with diagnosis of cough, pertussis and RAD. The patient was treated with Albuterol nebulizer, FLOVENT HFA, Albuterol aerosol, azithromycin and prednisone. The patient had an allergy to AUGMENTIN and CEFTIN (stomach upset) and took no concomitant medications. The patient had a past medical history of bloody noses, febrile seizures, reactive airways disease (RAD), non-displaced right tibial fracture, bedwetting, croup, headache, sinusitis, pharyngitis, cholelithiasis, abdominal pain, otalgia, eustachian tube disorder, rhinitis, syncope and collapse, asthma and upper respiratory infection (URI). The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0503AA on 11 July 2001, lot number U0513BA on 14 September 2001, lot number U0536BA on 16 November 2001 and lot number U0582AA on 28 August 2002 (routes and sites not reported). The patient was also up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father passed away from a myocardial infarction (MI) in August 2006, paternal grandfather passed away of an MI and maternal grandfather had an MI. The patient's mother had a history of RAD, allergies, sinus infections and weight problems. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Mar-2012) concerns a 50 year old female patient with no medically history. She was also not taking any concomitant medication. On 11-NOV-2011, the patient received a standard dose of AFLURIA (batch: N55906) by intramuscular injection. On 11-NOV-2011, the same day as vaccination, the patient's arm started hurting bad immediately after the administration and the pain continued. The patient lost mobility of her arm and experienced fairly severe pain in various arm positions. The pain did not resolve over time and the patient is currently undergoing physical therapy to resolve pain in her arm. The patient has not yet recovered.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M increased, Borrelia test, Lyme disease, Muscular weakness
Clinical narrative: Initial report was received on 02 March 2012 from a health care professional. A 43 year-old male patient with no known allergies and no medical conditions had received on an unknown date in October 2011 an intramuscular left deltoid injection of FLUZONE (sanofi pasteur lot number was not reported) and two days later, developed winged scapula on the right side. Damage to the long "thoracic" (thoracic) nerve was confirmed. According to the reporter, the patient was thought to have had Lyme disease and was being treated however the patient does not. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 06 March 2012. The patient has had right arm weakness (without pain) since October that was most noticeable when the patient tried to raise his arm over his head. At that time, the patient's work-up included a serology panel for Lyme disease with results IgM [+], IgG [-]. Consequently, the patient began antibiotic therapy for Lyme disease. The patient has since been seen by four other infectious disease (ID) physicians who have repeated the Lyme serology panel and gotten the same results, leading them to think that the initial positive IgM represents a false-negative result (coupled with the patient no reporting any obvious risk factors for Lyme disease and his review of systems (ROS) being negative except for the right arm weakness). Despite this, the original ID physician has had the patient on at least 4 months of antibiotics therapy since October. The patient had also been evaluated by an orthopedic surgeon; nerve conduction studies confirmed damage to the right long thoracic nerve. An evaluation by a neurologist was unrevealing. A computed tomography (CT) scan with contrast was planned to rule out a compression injury to the nerve. The patient's outcome was not recovered. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Nerve root injury thoracic, Winged scapula
Clinical narrative: Initial report was received on 02 March 2012 from a health care professional. A 43 year-old male patient with no known allergies and no medical conditions had received on an unknown date in October 2011 an intramuscular left deltoid injection of FLUZONE (sanofi pasteur lot number was not reported) and two days later, developed winged scapula on the right side. Damage to the long "thoracic" (thoracic) nerve was confirmed. According to the reporter, the patient was thought to have had Lyme disease and was being treated however the patient does not. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 06 March 2012. The patient has had right arm weakness (without pain) since October that was most noticeable when the patient tried to raise his arm over his head. At that time, the patient's work-up included a serology panel for Lyme disease with results IgM [+], IgG [-]. Consequently, the patient began antibiotic therapy for Lyme disease. The patient has since been seen by four other infectious disease (ID) physicians who have repeated the Lyme serology panel and gotten the same results, leading them to think that the initial positive IgM represents a false-negative result (coupled with the patient no reporting any obvious risk factors for Lyme disease and his review of systems (ROS) being negative except for the right arm weakness). Despite this, the original ID physician has had the patient on at least 4 months of antibiotics therapy since October. The patient had also been evaluated by an orthopedic surgeon; nerve conduction studies confirmed damage to the right long thoracic nerve. An evaluation by a neurologist was unrevealing. A computed tomography (CT) scan with contrast was planned to rule out a compression injury to the nerve. The patient's outcome was not recovered. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PNEUMOVAX given SQ in (R) arm on 3/1/12. Pt went to an urgent care clinic on 3/4/12 for redness, swelling and pain at the injection site. Pt was given an IM injection (pt does not know name) and PO LEVAQUIN for 10 days.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Palpitations, Ventricular extrasystoles
Clinical narrative: Patient reports having "PVC's" a few hours after receiving GARDASIL. States that she was having heart palpitations & was given EKG at her mom's job that showed PVC's. Denies dizziness, headache, shortness of breath, difficulty breathing or local reactions.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram abnormal, Palpitations, Ventricular extrasystoles
Clinical narrative: Patient reports having "PVC's" a few hours after receiving GARDASIL. States that she was having heart palpitations & was given EKG at her mom's job that showed PVC's. Denies dizziness, headache, shortness of breath, difficulty breathing or local reactions.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin decreased, Blood chloride normal
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Blood potassium normal, Blood sodium normal, Carbon dioxide normal, Cellulitis, Confusional state
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Disorientation, Full blood count normal, Haematocrit normal, Haemoglobin normal, Injection site erythema
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test, Mean cell haemoglobin concentration normal
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Mean cell haemoglobin decreased, Mean cell volume decreased, Metabolic function test, Pain in extremity, Platelet count normal
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Sluggishness, White blood cell count, White blood cell count normal
Clinical narrative: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Cough, Dizziness, Malaise, Muscle spasms
Clinical narrative: After (10 min) receiving PNEUMOVAX, pt was seated put her coat on & then stated she did not feel well. C/O feeling sl dizziness. Sl cough, put head down to knees. Once she sat up c/o L back pain ? spasm. B/P 100/70 P - 68 R - 18. Symptoms improved within 10 min pt. then walk out of clinic, pt called about 220p reported she got home OK & felt fine. 3/7/12 states she feels much better.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh swollen, red, warm.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Round flat pink/red circular area at the site of injection. Has enlarged to 2 1/2 cm over 1 wk. Slight warm to touch, but not tender.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: School RN reported that pt. experienced redness, swelling, pain to injection site after varicella vax. Parent iced x24 hrs, administered ADVIL et child's BENADRYL. No c/o fever, SOB, or other systemic response. Pt now recovered, site observed by school RN as per usual.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatinine normal, Rash, Rash vesicular, White blood cell count normal
Clinical narrative: Rash found on 1/24 above right eye, seen in ER on 1/25 with rash in vesicular form across forehead into hairline and across bridge of nose. Treatment: acyclovir 750 mg IV, prn acyclovir 800 mg po 5 x 1 day x 10 d,  Trifluridine ophth solution 2 dotts 5x/day, clindamycin 900 mg IV then d/c due to unable to tolerate, hydrocodone (APAP) prn, cephalexin 500 mg  PO BID x 7 d.
Age: 70.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Rash erythematous
Clinical narrative: Red spots on my face.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Muscle spasms, Myalgia
Clinical narrative: Joint & muscle pain. Severe muscle cramps in feet & hands. Foot cramps still continue 1 year later.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Cough, Rash, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion
Clinical narrative: 15 mo well exam 2/29. Later that night, pt experienced flat rash spots, (R) facial swelling that eventually resolved. Rash came & went. No hives/itching. (+) congestion, R/N, cough. Seen by PCP 3/2 Dx RSV; No rash/swelling noted. C/O wheeze but none on exam.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Swelling face, Wheezing
Clinical narrative: 15 mo well exam 2/29. Later that night, pt experienced flat rash spots, (R) facial swelling that eventually resolved. Rash came & went. No hives/itching. (+) congestion, R/N, cough. Seen by PCP 3/2 Dx RSV; No rash/swelling noted. C/O wheeze but none on exam.
Age: 86.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm and shoulder swelling with warmth and redness. Tender to touch.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Electrocardiogram, Hypersensitivity, Lip swelling, Migraine, Rash
Clinical narrative: EE states first noticed itchy rash legs on 3/9/12 several hours after Hepatitis B vaccine. Then developed mild lower lip swelling, vomiting up blood, migraine & rash/hives arms, face & legs. Went to ED where diagnosed with allergic reaction & given IV BENADRYL, IV SOLUMEDROL & po BENADRYL.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: EE states first noticed itchy rash legs on 3/9/12 several hours after Hepatitis B vaccine. Then developed mild lower lip swelling, vomiting up blood, migraine & rash/hives arms, face & legs. Went to ED where diagnosed with allergic reaction & given IV BENADRYL, IV SOLUMEDROL & po BENADRYL.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Electrocardiogram, Haematemesis, Lip swelling, Migraine, Rash generalised
Clinical narrative: EE states first noticed itchy rash legs on 3/9/12 several hours after Hepatitis B vaccine. Then developed mild lower lip swelling, vomiting up blood, migraine & rash/hives arms, face & legs. Went to ED where diagnosed with allergic reaction & given IV BENADRYL, IV SOLUMEDROL & po BENADRYL.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Rash pruritic, Throat tightness
Clinical narrative: EE states first noticed itchy rash legs on 3/9/12 several hours after Hepatitis B vaccine. Then developed mild lower lip swelling, vomiting up blood, migraine & rash/hives arms, face & legs. Went to ED where diagnosed with allergic reaction & given IV BENADRYL, IV SOLUMEDROL & po BENADRYL.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Electrocardiogram, Hypersensitivity, Lip swelling, Migraine, Rash
Clinical narrative: Pruritic rash on legs which generalized to arms and face, and mouth migraine headache, slight tightness in throat, vomiting with slight blood in vomit, lip swelling.  Went to ED on 3/11/12 where he received prednisone, IV Benadryl and IV Solumedrol and Pepcid.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pruritic rash on legs which generalized to arms and face, and mouth migraine headache, slight tightness in throat, vomiting with slight blood in vomit, lip swelling.  Went to ED on 3/11/12 where he received prednisone, IV Benadryl and IV Solumedrol and Pepcid.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Electrocardiogram, Haematemesis, Lip swelling, Migraine, Rash generalised
Clinical narrative: Pruritic rash on legs which generalized to arms and face, and mouth migraine headache, slight tightness in throat, vomiting with slight blood in vomit, lip swelling.  Went to ED on 3/11/12 where he received prednisone, IV Benadryl and IV Solumedrol and Pepcid.
Age: 35.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Rash pruritic, Throat tightness
Clinical narrative: Pruritic rash on legs which generalized to arms and face, and mouth migraine headache, slight tightness in throat, vomiting with slight blood in vomit, lip swelling.  Went to ED on 3/11/12 where he received prednisone, IV Benadryl and IV Solumedrol and Pepcid.