chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Vaccine given on 6/02/2013 in left deltoid, no redness or skin irregularities noted on discharge at 1415.  On 6/4/13 patient to lab, arm warm, swollen and tender.  Patient send to Dr's office.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, hot to touch (R) deltoid. 85 X 90 mm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Photophobia, Rhinorrhoea
Clinical narrative: 12:45 pm vaccine given on June 28, 2013 1:45 pm symptoms began: itchy eyes, runny nose, photophobia (sens. to bright light) 4:15 symptoms decreased by 70% 6:00 pm symptoms resolved w/o Tx - no hist of UR allergies.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction, Erythema, Local swelling, Skin warm
Clinical narrative: Pt called 6/27/13 to be seen for adverse reaction to Tdap given 6/21/13. Left arm red, warm to touch, swollen.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt developed redness around the injection site in the evining after administration.  Over the next day, it was warm and hardened slightly.  Mother drew a line around the area, by the next day, it had spread past that marking so she brought him in to be seen.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given an adult dose of hepatitis A vaccine (Havrix) instead of pediatric dose.
Age: 6.0
Sex: M
Vaccine: DTOX, PPV
Symptoms: Abasia, Antibody test negative, Influenza virus test negative, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Day following immunizations, the patient woke up with left foot pain so severe he was unable to walk. The foot pain lasted for a day and resolved in teh evening. The following day, 2 days after immunization, the patient woke up with right thigh pain which resolved without intervention.
Age: 6.0
Sex: M
Vaccine: DTOX, PPV
Symptoms: Pain in extremity, Rubella antibody negative
Clinical narrative: Day following immunizations, the patient woke up with left foot pain so severe he was unable to walk. The foot pain lasted for a day and resolved in teh evening. The following day, 2 days after immunization, the patient woke up with right thigh pain which resolved without intervention.
Age: 63.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Asthenia, Brachial plexopathy, Electromyogram, Musculoskeletal pain, Nerve conduction studies
Clinical narrative: Right shoulder pain noted a few days after the immunization, then weakness.  A neurologist diagnosed right brachial plexopathy.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at vaccine site, swelling as day went on, bruising, severe swelling and warmth at site.  Eventually about 4-5" in diameter, hard to the touch, painful and warm.  Muscle aches, nausea, slight fever.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Redness at vaccine site, swelling as day went on, bruising, severe swelling and warmth at site.  Eventually about 4-5" in diameter, hard to the touch, painful and warm.  Muscle aches, nausea, slight fever.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, warmth, swelling and pain 3 inches below injections site. Started as two circles the size of dimes and progressed to the size of almost a dollar bill, rectanglish in shape. Lasted for over 1 week.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Diet refusal, Irritability, Lethargy, Poor quality sleep
Clinical narrative: On 7/2/13 developed fever to 101-102, lethargy then became fussy and difficult to console refusing solids but taking liquids, did not sleep well. Saw doctor 7/5/13 symptoms had resolved, normal exam.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: On 7/2/13 developed fever to 101-102, lethargy then became fussy and difficult to console refusing solids but taking liquids, did not sleep well. Saw doctor 7/5/13 symptoms had resolved, normal exam.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Herpes zoster, Myalgia
Clinical narrative: 1-22-13 received influenza vaccine. 2-11-13 patient developed myalgias, cough, diarrhea. 5-13-13 diagnosed facial shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site mass, Local reaction, Upper respiratory tract infection
Clinical narrative: 4/30 received vaccine in office - pt tolerated well. Mom called office 5/3 reddened area only - ? ethyl chloride used but to office for eval. determined normal local reaction. Mom already hesitant about vaccines - reassured. 5/9 pt to office for acute URI - no mention of vaccine reaction by mom. 5/25 Mom still concerned about local reaction - into office for MD eval. Mom reassured no sign of dangerous reaction w/ lump at site.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Received Tdap on Wed. 6/26/13, Thurs. started with generalized pain, fever, chills, HA went home early on Thurs. 6/27 and off from work on Friday 6/28. Also had a lot of pain at injection site but that was expected. By Sat. 6/29 pain and other symptoms resolved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that (Merck) VARIVAX that had been transported for the past six months to a sister clinic that was about 15 minutes down the road. The healthcare worker was unable to provide the temperature that the VARIVAX were exposed to or exact time frame. Two boxes of (Merck) VARIVAX were transported an unspecified amount of times. She was able to report the lot # and expiration date for one of the (Merck) VARIVAX which was H011417 and expiration: 07-JUN-2014. She reported that the (Merck) VARIVAX had been administered but she was unable to provide the dates of administration for the vaccine. She did not have patient details or the amount of patients that the (Merck) VARIVAX were administered too at the time of the call. She did not have physician demographics at the time of the call either. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a physician who reported that the patient (unspecified) of the patient called into the physician's office refers to the 17 year old female daughter patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL intramuscular for prevention of HPV virus (dose and lot# unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an unspecified reaction to GARDASIL after the first dose. The parent reported that her daughter would not be administered the next dose of GARDASIL due to the adverse experience and not reintroduced. The outcome was reported as recovered/resolved on an unknown date. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chest X-ray normal, Chills, Drug screen negative, Headache
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 year old female patient. The patient has chronic syncope and headache which started in April 2009. The patient had no drug reactions or allergies. On 22-APR-2009, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was unknown, route was intramuscular). On 01-JUL-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL (lot number was H021346, expiry date was 01-oct-2015 and the route was intramuscular). Concomitant therapies included adapalene, EPIDUO. Since 2009, the patient has been suffering from recurrent headaches and syncopal episodes. Treatment was unspecified. After the second dose the patient experienced headache, weakness, her ears were ringing, chills and nausea. On morning of 02-JUL-2013, the patient fainted and was seen in the emergency room but she was not admitted to hospital. All the lab work was within normal limits. The patient was given intravenous bolus 0.9 percent. Urinalysis drug screen, chest x ray and beta group a streptococcal screen all were in within normal limits. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Streptococcus test negative, Syncope, Tinnitus, Urine analysis normal
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 year old female patient. The patient has chronic syncope and headache which started in April 2009. The patient had no drug reactions or allergies. On 22-APR-2009, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was unknown, route was intramuscular). On 01-JUL-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL (lot number was H021346, expiry date was 01-oct-2015 and the route was intramuscular). Concomitant therapies included adapalene, EPIDUO. Since 2009, the patient has been suffering from recurrent headaches and syncopal episodes. Treatment was unspecified. After the second dose the patient experienced headache, weakness, her ears were ringing, chills and nausea. On morning of 02-JUL-2013, the patient fainted and was seen in the emergency room but she was not admitted to hospital. All the lab work was within normal limits. The patient was given intravenous bolus 0.9 percent. Urinalysis drug screen, chest x ray and beta group a streptococcal screen all were in within normal limits. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H020910 and 18-JUN-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degress Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H016238 and 11-APR-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Clonus, Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old male patient. On an unspecified date in MAY 2013, the patient was vaccinated with his first dose of GARDASIL intramuscularly, 0.5 ml (lot# unspecified). The patient fainted immediately and went into clonic movements for an unspecified amount of time after receiving GARDASIL. The patient sat in the physician's office for an hour after experiencing those symptoms. It was also reported that the patient's mom called the physician's office when they returned home from the physician's office and she reported that the patient was "okay". The patient did not seek medical attention and no treatment was given for the patient. The outcome of patient was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H02002 and 08-AUG-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 38 year old female patient. On an unknown date, when the patient was pregnant she was vaccinated with a dose of GARDASIL (lot # H021346, expiry: 01-OCT-2015) 0.5 ml, intramuscularly. The LMP and EDD was not known. The pregnancy outcome was pending. There was no adverse effects to the patient. Patient sought medical attention was reported as no. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 22 year old (also reported as 38 year old) female patient. On an unknown date, when the patient was pregnant she was vaccinated with a dose of GARDASIL (lot # H021346, expiry: 01-OCT-2015) 0.5 ml, intramuscularly. The LMP and EDD was not known. The pregnancy outcome was pending. There was no adverse effects to the patient. Patient sought medical attention was reported as no. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Convulsion, Laboratory test
Clinical narrative: Patient had seizure and temp 99F the night after vaccines administered. Patient taken from home to ER by paramedics.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting projectile
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ, lot #, dose, route and frequency unspecified. The patient experienced projectile vomiting in the office immediately after administration of ROTATEQ. The outcome of the patient was unknown. This one of several reports received from the same reporter. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: FLUX, TTOX, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 33 years old female patient. The patient had no medical history or drug allergies. On 27-DEC-2012, the patient was vaccinated at another health care providers office with a dose of VARIVAX (Merck) (lot number, expiry date, route and dose were not reported), Influenza Virus Vaccine (manufacturer unknown) and tetanus toxoid. No concomitant medications were reported. Subsequently, the patient became pregnant with last menstrual period (LMP) of 07-DEC-2012 and an Estimated date of delivery (EDD) of 13-SEP-2013. The patient was exposed to VARIVAX (Merck), Influenza Virus Vaccine (manufacturer unknown) and tetanus toxoid during trimester 1. The nurse reported that the patient's gestation was 7 weeks 6 days as of 31-JAN-2013. No adverse effects reported. The outcome of pregnancy was unknown (outcome pending). Follow-up information has been received from a physician refers to a 33 year old female patient. Last menstrual period (LMP) was on 07-DEC-2012 and estimated date of delivery (EDD) was on 13-SEP-2013. The patient had 3 previous pregnancies and had 2 full-term delivers. No birth defect occurred in any previous pregnancy. A stillbirth or miscarriage occurred in previous pregnancy. Pre-term births were SAB. On 12-FEB-2013 an ultrasound was performed showing 9 week 4 day intrauterine pregnancy (IUP), + cardiac activity. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), as unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as 0555AE and 14-DEC-2014 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, patients may have vaccinated with a dose of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which was improperly stored at minus 1 degree Celsius (C) for approximately 13 hours. No concomitant medications were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Eye pruritus, Eye swelling, Migraine, Oedema mouth
Clinical narrative: Given injection on 7/5/2013 pt returned home after injection began to feel hives, pt states she felt swelling itching of eyes, swelling of mouth. Pt states she had trouble breathing. Pt also states migraines rash past 3 days. Pt called 7/6/2013 advised to cont BENADRYL. Pt states she went to ER left at time and tried BENADRYL.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Given injection on 7/5/2013 pt returned home after injection began to feel hives, pt states she felt swelling itching of eyes, swelling of mouth. Pt states she had trouble breathing. Pt also states migraines rash past 3 days. Pt called 7/6/2013 advised to cont BENADRYL. Pt states she went to ER left at time and tried BENADRYL.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a two year-old patient, on an unknown date, was vaccinated with a dose of (Merck) PROQUAD (dose and route not provided, lot # j00040, expiry date 04-JUL-2014) and a dose of (Merck) VARIVAX (dose and route unknown, lot # reported as h020248, expiry date 08-NOV-2014) at the same visit. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Anxiety, Dizziness
Clinical narrative: Faintness 10 minutes after administration. No treatment. Patient very anxious about vaccines.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: About 1 minute after giving vaccines patient fainted. Did not lose consciousness. Patient's vitals were taken and patient rested on exam table. Was given a glass of water and assessed by doctor.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain
Clinical narrative: Patient came in 2 days after vaccination presenting with redness and soreness below site of injection. On that morning pt went to see doctor and got 2 rx's (antibiotic and antihistamine) diagnosed w/possible skin infection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: Within several days of shingles vaccine, developed poison ivy type rash on left rear shoulder blade. This was followed by severe sunburn like pain on skin (no visible rash) on left side from armpit to just below waist. After 5 weeks mostly gone.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope, Vomiting
Clinical narrative: In car leaving site pt vomiting, fainted and had movements of arms. Sent by mothers car after EMT evaluation to ER then left.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash macular
Clinical narrative: Macular rash covering most of body - fever x 1 day; fussy.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Gave IM, not SC
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red bump on site of immunization feels warm to the touch and swollen, tender to touch.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Rash macular
Clinical narrative: After inj legs started to turn red, got red blotches all over body.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt noticed welps on the bilateral medial aspects of upper arms. Noted to be hives during office visit. No fevers or other reactions such as pain, dryness, eczematous inflammation, local warmth, weeping, exudate, red streaks, nasal stuffiness, wheezing, nor shortness of breath. Spoke with pt and she states no new symptoms except a couple of new welps.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose, Syncope
Clinical narrative: Syncopal episode several minutes after shots. Pt did not eat breakfast that morning, had little to drink that morning. Had previous stress over getting shots. Pt monitored x 1 hour, VSS, recovered completely. Phone plus 2-3 hrs later within normal.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient experienced a serious reaction to the ZOSTAVAX.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Hives upper chest and neck, redness at site of MCV vaccine (upper right arm). No respiratory problems. Gave 50 mg of BENADRYL/at 1615, rash subsided.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Developed a rash on his back after 1st pill.
Age: 33.0
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, TDAP
Symptoms: Rash erythematous
Clinical narrative: Client reports that 4 days after receiving vaccines, May 23, 2013, he noticed small red bumps across forehead (he thought it could be a heat rash). He did not go to a doctor. He also thought rash could be related to vaccines being given the same day. He received antibiotics for two different sexually transmitted infections.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood urine present, C-reactive protein increased, Haematocrit decreased, Metabolic function test
Clinical narrative: Jt pain (R) and (L) shoulder (L) elbow and knee (R) wrist and ROM bilat arms afebrile, rest of ROS (-).
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate increased, Urine analysis
Clinical narrative: Jt pain (R) and (L) shoulder (L) elbow and knee (R) wrist and ROM bilat arms afebrile, rest of ROS (-).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient came into pharmacy the day after she received the vaccine. With redness and a lump at injection site I called manufacturer and was told this was a typical injection site reaction and patient was referred to the prescriber.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a licensed practical nurse, regarding a current 19 year old patient (gender not provided). Pertinent medical history, drug reactions/allergies were not provided. On an unspecified date, the patient received series of RECOMBIVAX HB, (number of doses, lot number, expiration date, and route of administration were not provided). On an unspecified date, when the patient was a child, the patient was tested for titers and had found to be not immune. The patient was given a booster dose of pediatric RECOMBIVAX HB on an unknown date, and tested again and found to be not immune. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness of the event with RECOMBIVAX HB was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old female patient. On 10-OCT-2011, 30-JUL-2012 and 09-JAN-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (lot# not reported) 0.5 ml, intramuscular in the left arm. On 02-JUL-2013, the patient was advertently vaccinated with extra fourth dose of GARDASIL. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX. No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist reported that (Merck) VARIVAX, stored at an overall average temperature of minus 14.5C for five months, may had been administered to unspecified patients. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from licensed practical nurse, regarding an unknown number of patients (number, age, and gender were not provided). On an unknown date, unknown number of patients might have received doses of GARDASIL; RECOMBIVAX; and VAQTA, for prophylaxis purposes. (Lot number, expiration date, and route were not provided). The reporter stated that the doses were exposed to consistent temperatures of 33.5 degrees F, every day for 4 months. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from the director of a health department via a company representative refers to an unspecified male patients (reported as four other female and male) of unknown age. On an unknown date the patients experienced fainting after receiving vaccination with a dose of GARDASIL (route, lot number and expiration date not reported) for prophylaxis and others unspecified shots (unspecified dose/frequency and unspecified manufacturer). The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Received vaccines on 6/24/2013. Client states on 6/30/2013 after work, he had a swollen and painful area above rt. wrist. He had worn a reader, scanner wrist band at work. States didn't have injury to area. Client states wrist band at work was to tight and he moved it higher on arm. Area remains slightly swollen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US044455, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484048) website on 06 May 2013, with a follow up received from the quality assurance department (QA reference number: 227037) on 05 Jul 2013. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M12013) and BOOSTRIX (batch number: AC52B090AA, other manufacturer) on 06 Feb 2013 both in the left arm. On 07 Feb 2013, one day after vaccination he experienced erythema, heat and tenderness at left deltoid region. He also experienced mild erythema at the injection site. On the same date, he also experienced cellulitis and received treatment with cephalexin. The symptoms worsened on day 2 after immunization. The patient visited the emergency room. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Based on the batch review received from the quality assurance department on 05 Jul 2013, it was concluded that the concerned MENVEO batch number M12013 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department on 05 Jul 2013: Updated batch review report.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Follow up information has been received from a physician assistant. The reporter stated that a male patient and a female patient experienced syncope after receiving GARDASIL (not two female patients experienced syncope as was previously reported). Follow up information has been received from a licensed nurse practitioner. It was reported that a 15 year old male patient (student) with no illness and no pre-existing allergies/medical conditions on 24-MAY-2013 at 3:45 P.M. the patient was administered a second dose of GARDASIL (lot number H021346) intramuscularly into the left arm. There was no concomitant therapy. There was no adverse event following prior vaccination. Patient became lightheaded and had a few second period of loss of consciousness immediately after the shot. Patient regained consciousness in a few seconds. Patient was seated and safe the whole time. Patient was monitored with observed for 1/2 hour. Patient was well at that point to walk out to car with mother. There was no laboratory test performed. Patient was recovered from the event on 24-MAY-2013. Upon internal review, loss of consciousness was determined to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Follow up information has been received from a physician assistant. The reporter stated that a male patient and a female patient experienced syncope after receiving GARDASIL (not two female patients experienced syncope as was previously reported). Follow up information has been received from a licensed nurse practitioner. It was reported that a 15 year old male patient (student) with no illness and no pre-existing allergies/medical conditions on 24-MAY-2013 at 3:45 P.M. the patient was administered a second dose of GARDASIL (lot number H021346) intramuscularly into the left arm. There was no concomitant therapy. There was no adverse event following prior vaccination. Patient became lightheaded and had a few second period of loss of consciousness immediately after the shot. Patient regained consciousness in a few seconds. Patient was seated and safe the whole time. Patient was monitored with observed for 1/2 hour. Patient was well at that point to walk out to car with mother. There was no laboratory test performed. Patient was recovered from the event on 24-MAY-2013. Upon internal review, loss of consciousness was determined to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA003568 via same reporter link. Follow up information has been received from a physician assistant. The reporter stated that a male patient and a female patient experienced syncope after receiving GARDASIL (not two female patients experienced syncope as was previously reported). Follow up information has been received from a licensed nurse practitioner. It was reported that a 15 year old male patient (student) with no illness and no pre-existing allergies/medical conditions on 24-MAY-2013 at 3:45 P.M. the patient was administered a second dose of GARDASIL (lot number H021346) intramuscularly into the left arm. There was no concomitant therapy. There was no adverse event following prior vaccination. Patient became lightheaded and had a few second period of loss of consciousness immediately after the shot. Patient regained consciousness in a few seconds. Patient was seated and safe the whole time. Patient was monitored with observed for 1/2 hour. Patient was well at that point to walk out to car with mother. There was no laboratory test performed. Patient was recovered from the event on 24-MAY-2013. Upon internal review, loss of consciousness was determined to be an other important medical event. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Laboratory test abnormal, Petechiae, Platelet count decreased
Clinical narrative: Multiple bruises noted on patient in the morning. By the evening, bruises increasing in number and severity.  Noted petechia on lower extremities and trunk.  Notified MD via telephone.  Pt assessed by pediatrician and hematologist next day.  Admitted to hospital for abnormal labs, low platelets and WBCs.  Platelet count critical low value.  Monitored and discharged following day with diagnosis of idiopathic thrombocytopenia purpura (ITP).
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: Multiple bruises noted on patient in the morning. By the evening, bruises increasing in number and severity.  Noted petechia on lower extremities and trunk.  Notified MD via telephone.  Pt assessed by pediatrician and hematologist next day.  Admitted to hospital for abnormal labs, low platelets and WBCs.  Platelet count critical low value.  Monitored and discharged following day with diagnosis of idiopathic thrombocytopenia purpura (ITP).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 74 year old female patient. The patient's medical history included cholesterol, blood pressure and 'hypthyroidism'. In 2009 the patient was vaccinated with ZOSTAVAX in the arm for prophylaxis (lot number not provided). Concomitant medication was not provided. End May 2013 the patient experienced shingles. The outcome of shingles was not reported. Additional information has been requested.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a female patient of unknown age. The medical history of the patient included allergic reaction described as a rash to penicillin on an unspecified date. On 25-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number and expiry date reported as H020852 and 26-MAY-2014 respectively, dose unspecified), subcutaneously instead of M-M-R II. The patient was also vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) concomitantly on 25-JUN-2013. No adverse effects were reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Arthralgia, Bowel movement irregularity, Decreased appetite, Hypoaesthesia
Clinical narrative: After the vaccine was administered I experience aching joints and nausea. I had to stay in bed 2 days. My appetite has decreased since that time and I have not bad a BM. My cycle came around 7/3/13, and it was backwards in its flow. Last night I experienced numbness in my legs and when I attempt to eat something I get nausea. I contacted the County Registrar.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Menstrual disorder, Nausea
Clinical narrative: After the vaccine was administered I experience aching joints and nausea. I had to stay in bed 2 days. My appetite has decreased since that time and I have not bad a BM. My cycle came around 7/3/13, and it was backwards in its flow. Last night I experienced numbness in my legs and when I attempt to eat something I get nausea. I contacted the County Registrar.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Pt was given MMR, Varicella, and Hep A vaccines.  Eight days later he had a fever for 2 days, then mom noticed a red bumpy rash on his face.  The rash spread to body the following day.  He was seen in clinic on the 3rd day of rash.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Urticaria
Clinical narrative: 2" raised "welt", slight pain, no itch 2 days post injection, reddish in color, the 1 days later irregular rash 1-2 inches away from original, no pain, no itch, pt on 7-10-13 says both rashes are lessening.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dysphemia
Clinical narrative: Child started stuttering.  Over the next week the stutter increased.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient did not have a fever. The area of injection, left leg, was swollen and tender. Treatment given was a cold compress.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Headache, Injection site pain
Clinical narrative: Fever 100.2 F, chills, congestion, headache, ache over whole body, particularly bad in back and knees, soreness at vaccine administration site, and pain in vaccine administration arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever 100.2 F, chills, congestion, headache, ache over whole body, particularly bad in back and knees, soreness at vaccine administration site, and pain in vaccine administration arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Immediate post-injection reaction, Local swelling, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 63 year-old female patient, who, on 20-MAY-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously (lot # J001004, expiry date 24-APR-2014, dose not provided). It was reported that, on 20-MAY-2013, the patient developed an immediate reaction. It was noted that, directly after receiving the vaccine, the patient complained of itching and minor swelling and sensitivity. The adverse symptoms worsened to include "significant swelling" from shoulder to elbow, intensified itching, redness and tenderness to the touch. The patient sought a medical attention by an emergency room visit (was not admitted). Unspecified topical antibiotic was prescribed as a treatment. It was also noted that this dose, along with another reported as an adverse experience, represented the last two doses remaining in this lot. All prior doses from the mentioned batch did not cause a reported reaction. The patient recovered from all the symptoms in June 2013. Relatedness for the reaction to the vaccine was not reported for ZOSTAVAX. Additional information has been requested. This is one of two reports from the same source. The other linked report is MARRS # 1306USA014277.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a 63 year-old female patient, who, on 20-MAY-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously (lot # J001004, expiry date 24-APR-2014, dose not provided). It was reported that, on 20-MAY-2013, the patient developed an immediate reaction. It was noted that, directly after receiving the vaccine, the patient complained of itching and minor swelling and sensitivity. The adverse symptoms worsened to include "significant swelling" from shoulder to elbow, intensified itching, redness and tenderness to the touch. The patient sought a medical attention by an emergency room visit (was not admitted). Unspecified topical antibiotic was prescribed as a treatment. It was also noted that this dose, along with another reported as an adverse experience, represented the last two doses remaining in this lot. All prior doses from the mentioned batch did not cause a reported reaction. The patient recovered from all the symptoms in June 2013. Relatedness for the reaction to the vaccine was not reported for ZOSTAVAX. Additional information has been requested. This is one of two reports from the same source. The other linked report is MARRS # 1306USA014277.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 60 year old female patient. The patients medical history included shingles three months prior to the vaccination. On 03-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot # H019997), expiry date Feb 2014, route was subcutaneous). Concomitant medications were not reported. on 05-JUL-2013, the patients left arm was totally red after receiving ZOSTAVAX which was other than indicated in the prescribing information. The patient was prescribed Prednisone. The outcome of left arm was totally red was unknown. It was unspecified if patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a male patient of unknown age regarding himself. On an unknown date in 2007, the patient was vaccinated with 0.65 ml ZOSTAVAX, (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were not reported. On an unknown date in 2007, the patient experienced serious chicken pox after receiving ZOSTAVAX. The outcome of serious chicken pox was reported as recovered in end of 2008. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Pallor, Paraesthesia, Posture abnormal
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient with no reported medical history. On 24-JUN-2013 the patient was vaccinated with GARDASIL lot # H021861, 0.5 ml, intramuscular. No other suspect therapy or concomitant medication was reported. On 24-JUN-2013, a few minutes after administration, the patient experienced that her head was thrown back and her arms were jerking. "The patient then closed her eyes for a second and opened them and she was alert and coherent". The patient then said "What just happened? That was really weird". The nurse reported that the patient was "extremely pale and dizzy" and was taken to a room in the physician's office to "eat crackers and water and lay down". The patient then stated that "her face and hands were tingling". The nurse reported that the patient's "blood pressure and heart rate were check and they were fine". The patient remained in the office for "about an hour" at which time "she was feeling better and was able to walk out of the office". The nurse reported that the patient "had gone running in the morning and had not eaten before receiving GARDASIL". "The physician had given the patient water and crackers to eat" before GARDASIL was administered. No treatment information was reported. The outcome of after administration the patient's head was thrown back and her arms were jerking, dizzy, her face and hands were tingling and extremely pale was reported as recovered/resolved. The reporters relatedness of after administration the patient's head was thrown back and her arms were jerking, dizzy, her face and hands were tingling and extremely pale to GARDASIL is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: 50mm red area around injection site. Pt denies any other symptoms. Pt instructed to apply warm compresses and observe for any changes.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 months old male patient with no drug reactions or allergies. The patient's medical history included cleft-lip repair. On 10-APR-2013 the patient was vaccinated with the first and only VARIVAX (Merck) (INJ) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. On 01-JUL-2013, the patient was diagnosed with varicella. The patient sought medical attention and he was seen in the office. Calamine and baking soda paste was the treatment given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.