chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patient were vaccinated with a dose of PROQUAD, (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one of three reports received from the same reporter. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Metabolic function test normal, Polymorphic eruption of pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a Medical Assistant, for GARDASIL and SINGULAIR, a Pregnancy Registry product, concerning an 18 years old female patient with no known medical allergies. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 2 of GARDASIL on 13-JUN-2012 (lot number, date, dose and route not reported0. Secondary suspect therapies included SINGULAIR (dose and indication not reported). Concomitant medications included prenatal vitamins, ZOLOFT, fluticasone propionate, ADVAIR, albuterol (manufacturer unknown) and ALLEGRA. Subsequently, the patient became pregnant with an estimated LMP of 27-APR-2012 and an EDD of 01-FEB-13. Initial exposure to GARDASIL was at 6 week(s). The patient was exposed to GARDASIL and SINGULAIR during the first trimester. An ultrasound was conducted on 05-JUL-2012 to confirm pregnancy. The patient had not been hospitalized during the pregnancy. No treatment information was reported. Follow up pregnancy questionnaire has been received from the nurse practitioner concerning the patient with anxiety disorder and asthma. The patient's medical history included anemia, syncope and collapse and no previous pregnancies. The patient was vaccinated with (lot # 0026AE) dose 2 of GARDASIL (dose and route not provided) on 13-JUN-2012. Additional concomitant medications included iron (unspecified). An ultrasound was performed on 05-JUL-2012 due to amenorrhea and to confirm dates. The patient's last menstrual period was on 16-MAY-2012 and the EDD was of 01-FEB-2013 versus 20-FEB-2013. Follow-up information has been received from a nurse practitioner concerning an 18 year old female patient with a history of backache and dipped tobacco. The patient had no obstetric history of previous pregnancies. Other suspect therapies included SINGULAIR. Concomitant therapies included iron (unspecified), prenatal vitamins (unspecified), ZOLOFT, fluticasone propionate, ADVAIR, ALBUTEROL and ALLEGRA. The patient became pregnant with LMP of 16-MAY-2012 and EDD of 01-FEB-2013. Initial exposure to GARDASIL was at 4 week(s). Laboratory tests included MSAFP (alpha-fetoprotein test) done on 21-AUG-2012 (negative), nuchal translucency (20-JUL-2012 - negative) and PNL - metabolic panel (20-JUL-2012 - "WNL"). It was reported that, on an unknown date the patient experienced pruritic urticarial papules and plaques of pregnancy (PUPPS). On 24-JAN-13, at 39 weeks gestation, the patient delivered a normal male infant weighing 4166.53 gms (9 lbs 3 oz) (no complication during labor/delivery was reported). There was no congenital anomalies and other complications or abnormalities. The pregnancy outcome was live birth. Action taken regarding montelukast sodium was not reported. The outcome of PUPPS was unknown. The relatedness for PUPPS was unknown for GARDASIL and SINGULAIR. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a Medical Assistant, for GARDASIL and SINGULAIR, a Pregnancy Registry product, concerning an 18 years old female patient with no known medical allergies. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 2 of GARDASIL on 13-JUN-2012 (lot number, date, dose and route not reported0. Secondary suspect therapies included SINGULAIR (dose and indication not reported). Concomitant medications included prenatal vitamins, ZOLOFT, fluticasone propionate, ADVAIR, albuterol (manufacturer unknown) and ALLEGRA. Subsequently, the patient became pregnant with an estimated LMP of 27-APR-2012 and an EDD of 01-FEB-13. Initial exposure to GARDASIL was at 6 week(s). The patient was exposed to GARDASIL and SINGULAIR during the first trimester. An ultrasound was conducted on 05-JUL-2012 to confirm pregnancy. The patient had not been hospitalized during the pregnancy. No treatment information was reported. Follow up pregnancy questionnaire has been received from the nurse practitioner concerning the patient with anxiety disorder and asthma. The patient's medical history included anemia, syncope and collapse and no previous pregnancies. The patient was vaccinated with (lot # 0026AE) dose 2 of GARDASIL (dose and route not provided) on 13-JUN-2012. Additional concomitant medications included iron (unspecified). An ultrasound was performed on 05-JUL-2012 due to amenorrhea and to confirm dates. The patient's last menstrual period was on 16-MAY-2012 and the EDD was of 01-FEB-2013 versus 20-FEB-2013. Follow-up information has been received from a nurse practitioner concerning an 18 year old female patient with a history of backache and dipped tobacco. The patient had no obstetric history of previous pregnancies. Other suspect therapies included SINGULAIR. Concomitant therapies included iron (unspecified), prenatal vitamins (unspecified), ZOLOFT, fluticasone propionate, ADVAIR, ALBUTEROL and ALLEGRA. The patient became pregnant with LMP of 16-MAY-2012 and EDD of 01-FEB-2013. Initial exposure to GARDASIL was at 4 week(s). Laboratory tests included MSAFP (alpha-fetoprotein test) done on 21-AUG-2012 (negative), nuchal translucency (20-JUL-2012 - negative) and PNL - metabolic panel (20-JUL-2012 - "WNL"). It was reported that, on an unknown date the patient experienced pruritic urticarial papules and plaques of pregnancy (PUPPS). On 24-JAN-13, at 39 weeks gestation, the patient delivered a normal male infant weighing 4166.53 gms (9 lbs 3 oz) (no complication during labor/delivery was reported). There was no congenital anomalies and other complications or abnormalities. The pregnancy outcome was live birth. Action taken regarding montelukast sodium was not reported. The outcome of PUPPS was unknown. The relatedness for PUPPS was unknown for GARDASIL and SINGULAIR. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood bilirubin increased, Hepatic enzyme increased, Rash
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 57 years old female patient with hypothyroidism, allergy to penicillin and allergy to NASONEX. The patients medical history included mitral valve disorder, bilateral cataracts and hypotension. On 02-FEB-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671139/1265AA, expiry date 05-NOV-2012 and dose was not reported) subcutaneously. Concomitant therapies included verapamil, triamterene, hydrochlorothiazide, levothyroxine sodium, calcium (unspecified) vitamin d and vitamins (unspecified) (reported as multivitamin). Approximately on 16-FEB-2012 (reported as 2 weeks after vaccination) the patient experienced rash all over the face. Following vaccination approximately on an unknown date in July 2012, the patient developed elevated hepatic enzymes (ast and alt) and elevated bilirubin levels. The nurse reported that the patient went to an unspecified eye doctor for the treatment of the rash (treatment details were unspecified). The duration and the type of the rash was not specified. The patient had reported about the rash on 07-MAR-2013 during the routine office visit. On an unknown date, unspecified blood test was performed. On an unknown date, the patient recovered from rash all over the face. on an unknown date in September 2012, the event elevated hepatic enzymes (ast and alt) was reported as recovered/resolved. The outcome of elevated bilirubin levels was reported as not recovered/not resolved at the time of this report. Additional information has been requested.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On 06-MAR-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported), 0.5 ml, intramuscularly. Concomitant therapies included PREVNAR 13 on 06-MAR-2013. On an unknown date in March 203, the patient experienced pain in the injection site where the PNEUMOVAX 23 was administered. The injection site was still hurting 2 days later and the patient could not lift her arm above her head. She had applied ice but has not seen her physician. No laboratory tests were performed. The outcome of pain in the injection site was unknown. This is one of 2 reports received from the same source. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism spectrum disorder, Sensory integrative dysfunction
Clinical narrative: Developed behavioral problems in Sept '12 shortly after beginning daycare for the first time. Behaviors are most suspicion for sensory integration problem, though an autistic spectrum disorder has not been ruled out yet.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: 15x7 cm area of erythema over (L) deltoid. Hot to touch. Treated with antibiotic & Ibuprofen.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Per mom "Pt passed out" after vaccines. No LOC, responded to verbal stimuli Pt had not eaten prior to vaccines. Sugar & water & peanut crackers given to PT.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is also a pharmacist regarding herself. On an unknown date in December 2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose, route not reported). No concomitant medications were reported. On an unknown date in December 2012, the patient experienced pain in the injection site but the pain subsided in a few days. The outcome of pain in the injection site was recovered. This is one of 2 reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Mild abdominal cramping after 1st pill.
Age: 1.53
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site swelling
Clinical narrative: Parent reported that patient had swelling in (R) leg. Parent reported that patient has no fever, rash, respiratory problems, and is playing appropriately. RN advised parent to use cool moist compresses to area.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Haematochezia, Intestinal operation, Intussusception, Ultrasound scan normal
Clinical narrative: 3/7/13 - developed bloody stool, U/S negative, bloody stool increased, air enema diagnosis of intussusception but not successfully reduced. 3/8/13 - Brought to OR for reduction.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood test normal, Depressed level of consciousness, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Pt was fed a bottle of formula before being put to bed. When Mom laid her down she noticed she didn't move like normal. Tried to wake her up but couldn't. Father had to give CPR to get baby to breathe. Called 911. Baby was seen in ER put in hospital x2 days.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Resuscitation, Urine analysis normal
Clinical narrative: Pt was fed a bottle of formula before being put to bed. When Mom laid her down she noticed she didn't move like normal. Tried to wake her up but couldn't. Father had to give CPR to get baby to breathe. Called 911. Baby was seen in ER put in hospital x2 days.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Human chorionic gonadotropin, Unevaluable event, Urine analysis
Clinical narrative: 38 year old female possible allergic reaction to TDAP vaccine.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle atrophy, Nuclear magnetic resonance imaging normal, Pain in extremity, X-ray normal
Clinical narrative: Severe pain in upper-right arm.  Sought medical help and was given several rounds of oral steroids. Severe pain lasted several months and then led to muscle atrophy.  Began physical therapy to regain use of right arm.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, CSF test, Deafness, Decreased appetite, Headache
Clinical narrative: Patient had headaches, nausea, decreased appetite, muscle soreness,  malaise and anorexia. Patient can hardly get up from his bed for 6 days. The next week, patient still felt very weak and has lost 15 pounds. Within 3 weeks of the flu shot, patient complained of hearing loss mostly on the right side.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased, Myalgia, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient had headaches, nausea, decreased appetite, muscle soreness,  malaise and anorexia. Patient can hardly get up from his bed for 6 days. The next week, patient still felt very weak and has lost 15 pounds. Within 3 weeks of the flu shot, patient complained of hearing loss mostly on the right side.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Weight decreased
Clinical narrative: Patient had headaches, nausea, decreased appetite, muscle soreness,  malaise and anorexia. Patient can hardly get up from his bed for 6 days. The next week, patient still felt very weak and has lost 15 pounds. Within 3 weeks of the flu shot, patient complained of hearing loss mostly on the right side.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Arm starting hurting more.  Arm red around injection site with burning sensation.  Starting to swell more.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Arm starting hurting more.  Arm red around injection site with burning sensation.  Starting to swell more.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Employee states, "On 02/07/2013, I received a MMR vaccination from Employee Health. I did not have any side effects that I noticed from then to before Friday. But on 03/01/2013, when I came home and tried to lay down on the bed and rest, I noticed a golf ball-size lump at the site of injection at my right upper arm. It was hot and painful and it has not gone away. I tried ice, heat, and Benadryl and Motrin. The size became a little smaller and there is just little heat."
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: CSF culture negative, CSF white blood cell count negative, Convulsion, Culture urine negative, Full blood count normal
Clinical narrative: 4 days after receving vaccinations DTAP, IPV, MMR AND VARICELLA, patient had a seizure episode at day care on 03/08/13 at 10:00am. She also had 2 seizure episodes after being admitted in the PICU on 03/08/13 at 7:00 PM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Intensive care
Clinical narrative: 4 days after receving vaccinations DTAP, IPV, MMR AND VARICELLA, patient had a seizure episode at day care on 03/08/13 at 10:00am. She also had 2 seizure episodes after being admitted in the PICU on 03/08/13 at 7:00 PM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Pt has hypopigmention at vaccine site in shape of circle.
Age: 10.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Vomiting
Clinical narrative: Multiple episodes of vomiting, headache. Temp of 99.
Age: 35.0
Sex: F
Vaccine: ANTH, IPV
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: PPD was placed on 08 March 13, and that evening the site was flat.  Patient took a shower the next morning and put lotion on her skin, by that night on the same day as lotion was applied, the site started to itch.  On Sunday morning, wheals (blistering) formed over the site, it continued to itch profusely.  On Monday 11 March 2013, patient followed up at immunization clinic and was sent to Flight Medicine. Topical medication was prescribed and used.  Problem soon resolved.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cyst, Injection site discolouration, Nodule
Clinical narrative: Vaccine received 1/8. Pt called with injection site discoloration 7-14 days later. This was thought to be a normal rxn. Pt noticed a knot in her arm and saw MD on 3/12/13. Now has a cyst at the injection site. MD says only way to get rid of is to remove.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: Patient received shots on 3/1/13. (R) thigh, Varicella, HIB, and Hepatitis A. Noticed reaction, inflammation at injection sites on 3/9/13, area hard to the touch. Evaluated in clinic by provider on 3/11/13.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Soreness, redness 5" x 5" redness - cellulitis. Rx: KEFLEX 500 mg QID x 10d.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse reaction.
Age: 1.48
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had allergic reaction to right thigh DTap & PREVNAR given on right thigh. Turned red & swollen 3-4 hrs later. Red, feverish, hard & swelling 1/2 dollar size.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Scab
Clinical narrative: This spontaneous report as received from a 79 year old male consumer referring on himself with hypertension, cholesterol, enlarged prostate. On 22-JAN-2013, 6 week ago, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # H011426 expiration date, 12-SEP-2013), injected in the left arm. The patient's drug reactions/allergies include allergy to VICODIN and mercury. The patient did not want to provide concomitant medications. On 22-JAN-2013 (also reported as a week after injection), the patient noticed that he had a dime sized patch that had crusted over and had not gone away. The patient also stated that the patch was very itchy and was asking for medication he can take for the itching. No treatment was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical nurse (LPN) refers to a patient (unknown age and gender). On 25-JAN-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB 2 doses of pediatric (0.5 ml doses) equal an adult dose but the doses had expired (lot # 666806/0732Z and exp date 10-NOV-2012) (route not reported) and on 25-FEB-2013 vaccinated with the second dose of RECOMBIVAX HB 2 doses of pediatric (0.5 ml doses) equal an adult dose but the doses had expired (lot # 666806/0732Z and exp date 10-NOV-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medication was reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Psoriasis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with psoriasis flare ups. On 19-SEP-2012, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) and on 07-MAR-2013, the patient received the second dose of GARDASIL (Lot # not reported). The nurse reported that the patient received the second dose of GARDASIL until 07-MAR-2013 because her psoriasis flare-up occurred several months after receiving the first dose of GARDASIL. The outcome of psoriasis flare-up was unknown. The nurse did not think that psoriasis flare-up to were related to GARDASIL. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate decreased, Loss of consciousness, Nasopharyngitis, Nausea
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 18 year old male patient. On 22-FEB-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H011350, expiration date 21-FEB-2015) intramuscularly. The nurse reported that on 22-FEB-2013, after administration of the vaccine, the patient passed out. The patient's blood pressure dropped to 86/40. The patient was shaking, cold and had nausea. The patient's pulse dropped to 62 bmp and the tongue turned grey. The patient did not eat or drink in the morning of the shot. The patient received water and juice as treatment for the adverse events. At the time of the report, the patient was recovering. Additional has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Tongue discolouration, Tremor
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 18 year old male patient. On 22-FEB-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H011350, expiration date 21-FEB-2015) intramuscularly. The nurse reported that on 22-FEB-2013, after administration of the vaccine, the patient passed out. The patient's blood pressure dropped to 86/40. The patient was shaking, cold and had nausea. The patient's pulse dropped to 62 bmp and the tongue turned grey. The patient did not eat or drink in the morning of the shot. The patient received water and juice as treatment for the adverse events. At the time of the report, the patient was recovering. Additional has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Localized-at site of injection-red, swollen, warm to touch. 4 inch oval-hard, not sore. Headache-excruciating, back of neck up to crown - sporadic nausea. Lasted 8 days. Neck muscle tenderness. External ear  pain - jaw pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pain in jaw
Clinical narrative: Localized-at site of injection-red, swollen, warm to touch. 4 inch oval-hard, not sore. Headache-excruciating, back of neck up to crown - sporadic nausea. Lasted 8 days. Neck muscle tenderness. External ear  pain - jaw pain.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: Information has been received from a line listing obtained on request by the company from the FDA under the Freedom of Information Act concerning a 26 year old female with no previous illnesses or drug reactions/allergies who on 30-JUL-2007 was vaccinated with a second dose of GARDASIL (lot# 0530U) in the left arm IM. There was no concomitant medication. On 30-JUL-2007 the patient felt lightheaded, nausea, dizzy, tingling face down arms and legs. The approximate time till patient could safely sit up was 25 minutes. The heart rate (HR) was 60 to 80. The patient had shortness of breath (SOB), patient was scared and had difficult breathing. No further information is available. No further information is available. The VAERS ID number is 286459. It has been determined that case # 0801USA02040 is a duplicate of case # 0712USA02400. Therefore, case # 0801USA02040 is being deleted from our files and the cases consolidated into case # 0712USA02400.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Fear, Nausea, Paraesthesia
Clinical narrative: Information has been received from a line listing obtained on request by the company from the FDA under the Freedom of Information Act concerning a 26 year old female with no previous illnesses or drug reactions/allergies who on 30-JUL-2007 was vaccinated with a second dose of GARDASIL (lot# 0530U) in the left arm IM. There was no concomitant medication. On 30-JUL-2007 the patient felt lightheaded, nausea, dizzy, tingling face down arms and legs. The approximate time till patient could safely sit up was 25 minutes. The heart rate (HR) was 60 to 80. The patient had shortness of breath (SOB), patient was scared and had difficult breathing. No further information is available. No further information is available. The VAERS ID number is 286459. It has been determined that case # 0801USA02040 is a duplicate of case # 0712USA02400. Therefore, case # 0801USA02040 is being deleted from our files and the cases consolidated into case # 0712USA02400.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 26 year old female with no known drug allergies and no pre-existing illness who on 30-JUL-2007 was vaccinated with a second dose of GARDASIL (lot# reported as 05304) intramuscularly into the left arm. On 30-JUL-2007 the patient experienced lightheadedness, nausea, dizzy, tingling face, tingling down arms and legs, short of breath, difficulty breathing and patient was scared. It took approximately time 25 minutes till the patient could safely sit up. Heart rate was 60-80. None laboratory tests were performed. The outcome of the events was unknown. The original reporting source was not provided. Additional information is not expected. It has been determined that case # 0801USA02040 is a duplicate of case # 0712USA02400. Therefore, case # 0801USA02040 is being deleted from our files and the cases consolidated into case # 0712USA02400.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Fear, Nausea, Paraesthesia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 26 year old female with no known drug allergies and no pre-existing illness who on 30-JUL-2007 was vaccinated with a second dose of GARDASIL (lot# reported as 05304) intramuscularly into the left arm. On 30-JUL-2007 the patient experienced lightheadedness, nausea, dizzy, tingling face, tingling down arms and legs, short of breath, difficulty breathing and patient was scared. It took approximately time 25 minutes till the patient could safely sit up. Heart rate was 60-80. None laboratory tests were performed. The outcome of the events was unknown. The original reporting source was not provided. Additional information is not expected. It has been determined that case # 0801USA02040 is a duplicate of case # 0712USA02400. Therefore, case # 0801USA02040 is being deleted from our files and the cases consolidated into case # 0712USA02400.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Biopsy, Electroencephalogram normal, Headache, Herpes zoster
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 71 year old female with a history of stroke (April 2008, records received - PMH on 11-AUG-2008), cerebrovascular accident, rheumatoid arthritis, chronic kidney disease and gastroesophageal reflux disease on 10-JUL-2008 was vaccinated with ZOSTAVAX SC into left arm (lot # 659406/0298X). Concomitant therapy included propranolol HCl, aspirin and PRILOSEC. It was reported "sore head" on 15-JUL-2008. The patient was taken by ambulance for "facial twisting" remained hospitalized from 15-JUl-2008 to 18-JUL-2008. The biopsy was taken with pending results. The patient was treated with shingles. On 11-AUG-2008 records received from DOS 17-JUL-2008 to 18-JUL-2008, the patient was seen for complained of right scalp discomfort beginning 1-2 days prior, neuritic in quality and same distribution as previous bout of herpes zoster several years ago. On 11-AUG-2008 EEG revealed normal. Discharge diagnoses were altered level of consciousness, resolved. Scalp lesions with neuritic pain. The original reporting source was not provided. The VAERS ID is 321390. Follow up information was received on 08-MAR-2013 from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Reporter Information was added. Refers a patient with no illness noted at the time of vaccination. On 10-JUL-2008, the patient was vaccinated with ZOSTAVAX (lot # 659406/0298X; exp. date: 25-JUL-2009). No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Neuralgia, Skin disorder, Skin lesion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 71 year old female with a history of stroke (April 2008, records received - PMH on 11-AUG-2008), cerebrovascular accident, rheumatoid arthritis, chronic kidney disease and gastroesophageal reflux disease on 10-JUL-2008 was vaccinated with ZOSTAVAX SC into left arm (lot # 659406/0298X). Concomitant therapy included propranolol HCl, aspirin and PRILOSEC. It was reported "sore head" on 15-JUL-2008. The patient was taken by ambulance for "facial twisting" remained hospitalized from 15-JUl-2008 to 18-JUL-2008. The biopsy was taken with pending results. The patient was treated with shingles. On 11-AUG-2008 records received from DOS 17-JUL-2008 to 18-JUL-2008, the patient was seen for complained of right scalp discomfort beginning 1-2 days prior, neuritic in quality and same distribution as previous bout of herpes zoster several years ago. On 11-AUG-2008 EEG revealed normal. Discharge diagnoses were altered level of consciousness, resolved. Scalp lesions with neuritic pain. The original reporting source was not provided. The VAERS ID is 321390. Follow up information was received on 08-MAR-2013 from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Reporter Information was added. Refers a patient with no illness noted at the time of vaccination. On 10-JUL-2008, the patient was vaccinated with ZOSTAVAX (lot # 659406/0298X; exp. date: 25-JUL-2009). No further information is available.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Chronic inflammatory demyelinating polyradiculoneuropathy, Drug hypersensitivity, Dysstasia, Food allergy
Clinical narrative: Initial report was received on 04 March 2013 from a consumer who is also the patient. A 45 year-old female patient with a history of a penicillin allergy had received on 15 February 2010, ADACEL, lot number U3298AA (route and site of administration not reported) and "about one week after" begun having problems standing and unsteady gait. The problems worsened and she was unable to feel her feet and then was unable to walk at all. The patient was being followed by a physician and she was hospitalized (dates not reported). The patient continues to be unable to walk and was diagnosed with CIDP. The patient also reported that since vaccination she has numerous medication allergies (including ASA, Ibuprofen, PERCOCET and naproxen), food allergies and latex allergy. No further information was available at the time of the report. The events resulted in permanent disability. The patient's outcome was not recovered. Documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Rubber sensitivity, Sensory loss
Clinical narrative: Initial report was received on 04 March 2013 from a consumer who is also the patient. A 45 year-old female patient with a history of a penicillin allergy had received on 15 February 2010, ADACEL, lot number U3298AA (route and site of administration not reported) and "about one week after" begun having problems standing and unsteady gait. The problems worsened and she was unable to feel her feet and then was unable to walk at all. The patient was being followed by a physician and she was hospitalized (dates not reported). The patient continues to be unable to walk and was diagnosed with CIDP. The patient also reported that since vaccination she has numerous medication allergies (including ASA, Ibuprofen, PERCOCET and naproxen), food allergies and latex allergy. No further information was available at the time of the report. The events resulted in permanent disability. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient noticed large bump/swelling at the injection site with redness radiating distally in a pseudopod fashion. Infection not suspected on exam.
Age: 1.5
Sex: M
Vaccine: MMRV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 18 month old patient of unknown gender. The patient's medical history included pre-existing heart condition. On an unknown date, the patient was vaccinated with a dose of M-M-R II (expiry date, lot number, route and dose were not reported). On an unknown date, the patient experienced swelling behind the left ear. The patient sought medical attention(unspecified). The physician indicated that the patient was hospitalized(date was unspecified) due to the event but had not disclosed if the hospital stay was overnight. On an unknown date, the event of swelling behind the left ear was recovered. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at site.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old female patient. In 1994, the patient was vaccinated with the complete series of hepatitis B vaccine (recombinant) (manufacturer unknown) (Lot # not reported). The nurse reported that, "recently", on an unknown date, the patient had negative titer to hepatitis B. The outcome of negative titer to hepatitis B was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 70 year old female consumer with asthma and allergy to several antibiotics reporting on herself. The consumer's medical history included bronchitis. On approximately 07-MAR-2011, "about 2 years ago", the consumer was vaccinated with a dose of ZOSTAVAX (lot # not reported) in the right arm. The consumer reported that on 15-DEC-2012, she got shingles. The consumer stated that the shingles appeared on the same arm that she received the vaccination in. The patient sought medical attention. The patient received treatment for the adverse event. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with unspecified Non-Steroidal Antiinflammatory Drugs (NSAIDS) allergy and tetracycline allergy. On 17-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified). The pharmacist reported that the patient experienced redness, swelling and pain at the injection site on an unspecified date that last 3 shortly after received ZOSTAVAX in July 2012. The pharmacist also reported the patient stated on 24-FEB-2013 that she now had the same symptoms again at the same site, but it was not as severe. The patient had been treated with unspecified antihistamine. No lab diagnostics studies performed. The patient present status was reported as not recovered. The patient had sought medical attention. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old male patient. On 08-MAR-2013 the patient was vaccinated with a dose of PROQUAD, subcutaneously and the second dose of VARIVAX (merck) inadvertently. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a healthcare professional via field representative referred to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (Lot#, dose/frequency, route and duration were unspecified). It was indicated that patient couldn't move his arm after being administered PNEUMOVAX23. The outcome and causality were unknown. This is one of several report that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician concerns a patient who received the last dose of GARDASIL (lot #, dose and route not reported) in November of 2011 (last dose was reported to be the second dose of GARDASIL (lot #, dose and route not reported) and the first dose a few months prior to the second dose (exact date of first dose was unspecified, but reported to be more than 2 months prior to the second dose). The physician reported that the patient received both prior doses of GARDASIL at another facility (name of the facility was unspecified). The patient was in the physician's office today (06-MAR-2013) to receive the third dose of GARDASIL (lot #, dose and route not reported). No adverse event reported. Additional information is not expected.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 04 March 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three doses of PENTACEL: dose one, (lot number not reported) received on 14 July 2011; dose two, (lot number not reported) received on 29 September 2011; and dose three, lot number C3952AA received on 28 November 2011 (routes and sites of administration not reported). The subject developed a cough on 15 July 2012, approximately seven months after the last dose. The subject developed a paroxysmal cough on 19 July 2012 with a whoop. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (unspecified dates). Laboratory testing included a positive PCR on 22 July 2012. Chest x-ray findings were negative for pneumonia/ Corrective treatments consisted of azithromycin starting on 22 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported as 15 days at that time. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 04 March 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three doses of PENTACEL: dose one, (lot number not reported) received on 14 July 2011; dose two, (lot number not reported) received on 29 September 2011; and dose three, lot number C3952AA received on 28 November 2011 (routes and sites of administration not reported). The subject developed a cough on 15 July 2012, approximately seven months after the last dose. The subject developed a paroxysmal cough on 19 July 2012 with a whoop. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (unspecified dates). Laboratory testing included a positive PCR on 22 July 2012. Chest x-ray findings were negative for pneumonia/ Corrective treatments consisted of azithromycin starting on 22 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported as 15 days at that time. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 04 March 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had four doses of PENTACEL: dose one, lot number C3465AA received on 02 December 2009; dose two, lot number C3287AA received on 25 January 2010; dose three, lot number C3335AA received on 25 March 2010; and dose four, lot number C3603AA (invalid lot number) on 27 December 2010, (routes and sites of administration not reported). The subject developed cold-like symptoms on 24 January 2013 (reported as 24 January 2012), approximately two years after the last dose. On 24 January 2013, the subject developed both cough and paroxysmal cough, without a whoop. The subject also experienced apnea, posttussive vomiting and sleep disturbance (dates not specified). Laboratory testing included a positive PCR on 07 February 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 February 2013 for five days. The subject was not hospitalized. At the time of final contact on 15 February 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 19 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 04 March 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had four doses of PENTACEL: dose one, lot number C3465AA received on 02 December 2009; dose two, lot number C3287AA received on 25 January 2010; dose three, lot number C3335AA received on 25 March 2010; and dose four, lot number C3603AA (invalid lot number) on 27 December 2010, (routes and sites of administration not reported). The subject developed cold-like symptoms on 24 January 2013 (reported as 24 January 2012), approximately two years after the last dose. On 24 January 2013, the subject developed both cough and paroxysmal cough, without a whoop. The subject also experienced apnea, posttussive vomiting and sleep disturbance (dates not specified). Laboratory testing included a positive PCR on 07 February 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 February 2013 for five days. The subject was not hospitalized. At the time of final contact on 15 February 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 19 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare professional via field representative referred to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot#, dose/frequency, route and duration were unspecified). It was indicated that patient ended up with something that looked like cellulitis after being administered PNEUMOVAX23. The outcome and causality were unknown. This is one of several report that received from the same source. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Nasopharyngitis, Vaccination site pain
Clinical narrative: Vaccine site had reddened area radiating to the underside of his arm. Patient stated he is taking 200mg MOTRIN and the redness/pain is being reduced. Patient also has cold like symptoms for one week.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient and father unaware of all 3 GARDASIL imm. given in 0708. Was not on comp. chart, error on giving another GARDASIL vaccine. Pt. stable at 2:30 pm, no temp. No adverse reactions noted. Made pt. aware of error. Calling parents to explain.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Convulsion
Clinical narrative: Initial report was received from a consumer on 05 March 2013. A patient (age, birth date and gender not reported), who was 19-months-old at time of report, past medical history not reported, previously received an injection of PENTACEL, sanofi pasteur Ltd., (lot number, route, site, side and dose in series not reported) on an unspecified date. On an unspecified date (also reported as occurred last year), the patient had a seizure after PENTACEL vaccination. Laboratory or diagnostic tests and treatments were not reported. No additional information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Injection site erythema, Injection site pain
Clinical narrative: Redness, hard swollen area, sore, itching a few hours after injection, headache. Injection site still red, sore & itching a week later.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pain, Pruritus, Swelling
Clinical narrative: Redness, hard swollen area, sore, itching a few hours after injection, headache. Injection site still red, sore & itching a week later.
Sex: U
Vaccine: PER
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial report was received on 27 February 2013 from an electronic lay press article. An unidentified patient received an injection of PERTUSSIS VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later developed whooping cough. The patient tested positive. Outcome was not reported. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received 01 March 2013 from a health care professional. A 45-year-old female patient (medical history not reported), had received an intramuscular left deltoid injection of ADACEL, lot number C4196AA on 22 February 2013 and six days later, she developed cellulitis, redness and swelling at the left deltoid, and an increase in the diameter of the swelling and redness that was warm to touch. She was seen in an urgent care center and prescribed antibiotics (not specified) for 10 days. Laboratory and diagnostic testing was reported as "none". According to the reporter, the patient showed some improvement however outcome was not recovered. Documents held by sender: None.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Pt. presented with a fever starting the night of immunization. The next morning the pt. awoke with a swollen (L) eye. Treatment was encouragement of OTC MOTRIN and TYLENOL.