chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown gender and age. On 10-JUL-2013 the patient was vaccinated with a second dose of VARIVAX (Merck) (Lot # unknown) 1350 U vial, 0.5 ml, subcutaneous. On approximately 11-JUL-2013, the patient experienced fever (102 degrees F), achiness and sore throat. It was reported that the patient's first dose of VARICELLA (Merck) was given unspecified number of years ago. The patient's outcome was reported as not recovered/not resolved. The relationship between therapy with VARIVAX (Merck) and the event was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-SEP-2008 the patient was vaccinated with VAQTA dose 1 (route, dosage and lot number unknown). The medical assistant reported that the patient was seen on 16-JUL-2013, seeking the 2nd dose of VAQTA. The patient was not administered the 2nd dose of VAQTA because the medical assistant was unsure if 2 doses were necessary. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. Information regarding the patient's pertinent medical history was not provided. On an unknown date the patient was vaccinated with a single dose of ZOSTAVAX (lot number not provided), subcutaneous. Information regarding concomitant medications was not  reported. The ZOSTAVAX was administered in the subcutaneous tissue of the waist line. The patient did not have enough fatty tissue in the deltoid region of the body. No further information was provided. additional informations is not expected.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Confusional state, Dyskinesia, Headache, Influenza like illness, Single photon emission computerised tomogram abnormal
Clinical narrative: Cognitive fragmentation (confusion). Flu-like symptoms. Intolerance to cold and heat. Vocalizes tics-verbal and jerking movements, headaches.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Speech disorder, Streptococcus test, Temperature intolerance, Tic
Clinical narrative: Cognitive fragmentation (confusion). Flu-like symptoms. Intolerance to cold and heat. Vocalizes tics-verbal and jerking movements, headaches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Pruritus
Clinical narrative: Redness, itching, heat, inflamed.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Severe hives.  Went to Urgent Care.  Prescribed Benadryl, Zyrtec, Prednisone.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever 3 days after leading into a febrile seizure.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Abasia, Balance disorder, Blood test, Computerised tomogram, Cytogenetic analysis
Clinical narrative: Immediate: high fever, lethergy, crankiness. Two days later: unable to stand for several hours. Within weeks: loss of balance, loss of ability to stand, loss of ability to walk, gross motor regression, inablity to hold head up, difficulty breathing.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Dysstasia, Electroencephalogram, Endoscopy, Gross motor delay
Clinical narrative: Immediate: high fever, lethergy, crankiness. Two days later: unable to stand for several hours. Within weeks: loss of balance, loss of ability to stand, loss of ability to walk, gross motor regression, inablity to hold head up, difficulty breathing.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Irritability, Lethargy, Lumbar puncture, Nasoendoscopy
Clinical narrative: Immediate: high fever, lethergy, crankiness. Two days later: unable to stand for several hours. Within weeks: loss of balance, loss of ability to stand, loss of ability to walk, gross motor regression, inablity to hold head up, difficulty breathing.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging, Posture abnormal, Pyrexia, X-ray
Clinical narrative: Immediate: high fever, lethergy, crankiness. Two days later: unable to stand for several hours. Within weeks: loss of balance, loss of ability to stand, loss of ability to walk, gross motor regression, inablity to hold head up, difficulty breathing.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Large swelling and redness of left upper thigh at injection site. Mildly tender with 100 degree temp.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: Nose bleed- left nostril. After compression with tissue, blood stopped within seconds. On 07/21/2013, the right nostril began to spontaneously bleed. Again, it stopped almost immediately after compression was started.
Age: 21.0
Sex: M
Vaccine: JEV1
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out and had a brief (5-10 seconds) loss of consciousness twice within 10 minutes of receiving vaccination. Pt was evaluated by EMTs and cleared to go home after 20 minutes sitting in waiting area. Pt encouraged to contact the pharmacy and his primary care doctor if any further issues or loss of consciousness.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swollen, red, itchy, sore.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint injury
Clinical narrative: Immediately upon injection I had a painful burning sensation that went completely down to my fingertips. The shot administer told me to rub my arm throughout the day but the pain intensified on through the day and night to a point where I had limited mobility.  I then had to seek help from my family doctor. I was sent to an orthopedic doctor who then sent me to a neurologist who is sending me back to the orthopedic doctor.  I am still under doctor's care at this time.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Immediately upon injection I had a painful burning sensation that went completely down to my fingertips. The shot administer told me to rub my arm throughout the day but the pain intensified on through the day and night to a point where I had limited mobility.  I then had to seek help from my family doctor. I was sent to an orthopedic doctor who then sent me to a neurologist who is sending me back to the orthopedic doctor.  I am still under doctor's care at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site mass, Pruritus, Rash, Swelling
Clinical narrative: Rash, lump at injection site, itching, swelling.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 10-JUL-2013 the patient was vaccinated with MMR II (lot number reported as H017927, expiry date 14-SEP-2014) that reporter could not support with their temperature stability. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry unspecified), subcutaneously. No concomitant medications were reported. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention (doctor visit). It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Flushing, Injection site erythema, Pain
Clinical narrative: Patient got Pneumovax 7/12. That evening she said her arm got very sore in upper arm and had flushing quite pink upper arm moved around arm to inner arm not just area of vaccine. Had chills and felt feverish: did not take temp. By 7/15 some redness and sore. 7/16 back to normal.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient got Pneumovax 7/12. That evening she said her arm got very sore in upper arm and had flushing quite pink upper arm moved around arm to inner arm not just area of vaccine. Had chills and felt feverish: did not take temp. By 7/15 some redness and sore. 7/16 back to normal.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. The patients might have been administered M-M-R II (lot number not provided) that reporter could not support with their temperature stability. No adverse effects reporter. It was unspecified if the patients had sought medical attention. This is one of several reports from same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea. Pt. had several episodes of vomiting and diarrhea which last 3-4 hours after vaccine given. Pt. did not have a reaction to 1st dose. Pt dis well over the weekend.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Chest discomfort, Fatigue, Pharyngeal oedema, Pyrexia
Clinical narrative: 3-4 hrs post vaccine: fever 100 degrees severe fatigue over next 3 days chest heaviness - feeling of swelling "thyroid" area - developed 1 pock. Combo of symptoms lasted 7 days. All resolved.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test negative
Clinical narrative: 3-4 hrs post vaccine: fever 100 degrees severe fatigue over next 3 days chest heaviness - feeling of swelling "thyroid" area - developed 1 pock. Combo of symptoms lasted 7 days. All resolved.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Blister, Pruritus, Rash generalised, Skin lesion
Clinical narrative: Patient developed rash on 6/28/13 that spread to entire body. Pimple fluid filled itchy lesions. Advised ER for assessment diagnosed by ER on 7/1/13. Family called to inform us. Note: All Varivax vaccines given at prior pediatricians offices.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Patient experienced dizziness/lightheadedness 15 min post injection = she remained supine until sx resolved.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Syncope
Clinical narrative: 10 minutes after having vaccine, pt had syncope. Patient was monitored in office x 1 hour after incident and pt was stable and discharged home.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and pain on left anterior thigh. Pt. had immunizations on 7/19/14. Left thigh displays redness and hot with touch.
Age: 13.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt requested meningococcal and Varicella vaccines. Provider gave MMR. There were no adverse reactions from this. No treatment nec.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pain, Rash
Clinical narrative: Zostavax 0.65 ml SQ was administered on 7/12/13. Patient developed a painful/sore rash that spread up arm to shoulder on 7/14/13. Rash subsided to small welt localized to shot site on 7/15/13.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Patient noticed asmall red knot on the back of his left arm.  Said was painless to touch.  Says throughout the course of the dat the knot enlarged and at 4:00 p.m the knot was the size of an egg so he decided to notify the Health Department.  Heatlh Department referred to private medical doctor.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Information was received from a claims examiner referring to a male patient, age unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # H021710. On 23-JUN-2013, the patient experienced an adverse reaction (not further specified) to the ZOSTAVAX vaccine. The outcome of the adverse reaction is unknown. No additional information is expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information was received from a claims examiner referring to a male patient, age unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # H021710. On 23-JUN-2013, the patient experienced an adverse reaction (not further specified) to the ZOSTAVAX vaccine. The outcome of the adverse reaction is unknown. No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 74 year old female patient with hyperlipidemia, kidney stones, hypothyroidism, allergic to penicillin, VIOXX (MARRS# 1307USA012935) and LAMISIL, diverticulosis and osteoarthritis. The patient's medical history included melanoma resect in 2012. On 18-DEC-2007 the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot # not reported). On 09-JUL-2013 the patient was vaccinated with the second 0.5 ml dose of PNEUMOVAX23 (lot # J004058, EXP date 22-JUN-2014) intramuscular in the left deltoid. Concomitant therapy included SYNTHROID. Later on 09-JUL_2013 the patient became sleepy and her injection site became red, swollen and "hot to touch". Patient sought medical attention by noticing practice. The patient was going to be seen by her attending physician. There were no labs performed. The outcome of sleepy , injection site become hot to touch, injection site become swollen and injection site became red was reported as not recovered/not resolved. The nurse was asking for a lot check. Follow up information has been received indicated that this case has been for a routine QIR. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 74 year old female patient with hyperlipidemia, kidney stones, hypothyroidism, allergic to penicillin, VIOXX (MARRS# 1307USA012935) and LAMISIL, diverticulosis and osteoarthritis. The patient's medical history included melanoma resect in 2012. On 18-DEC-2007 the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot # not reported). On 09-JUL-2013 the patient was vaccinated with the second 0.5 ml dose of PNEUMOVAX23 (lot # J004058, EXP date 22-JUN-2014) intramuscular in the left deltoid. Concomitant therapy included SYNTHROID. Later on 09-JUL_2013 the patient became sleepy and her injection site became red, swollen and "hot to touch". Patient sought medical attention by noticing practice. The patient was going to be seen by her attending physician. There were no labs performed. The outcome of sleepy , injection site become hot to touch, injection site become swollen and injection site became red was reported as not recovered/not resolved. The nurse was asking for a lot check. Follow up information has been received indicated that this case has been for a routine QIR. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Rash generalised
Clinical narrative: Family states at 10:30 AM on 7/13/13 the right leg at the site of injection was swollen. Went to ER for Benadryl. 7/14/13 1 A.M. went back to ER for swollen leg & rash on body. Received steroid shot and Benadryl and new Rx for steroids.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 5-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# not reported), 0.5 ml, intramuscular. On 05-JUL-2013, the patient had a red spot, swelling and pain at the area. The patient sought medical attention via office visit. No treatment was given for the adverse events. At the time of the report, the outcome of the events were reported as not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Eye irritation, Eye pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old female healthcare worker with drug allergy, no pertinent medical history. The patient had following drug allergies: BACTRIM-hives; doxycycline- vomiting; DEMEROL- nausea/hallucination; CIPRO-hives. No concomitant therapy involved. On 12-JUL-2013, a dose of VARIVAX (Merck) (lot# was reported as H018788, EXP date: 15-OC-2014), after reconstitution, sprayed out of the back end of the syring needle from the vial and went into the right eye of a healthcare worker who was preparing the VARIVAX (Merck) dose for administration to a patient. Healthcare worker reported to the nurse of experiencing stinging and burning in the right eye after this occurred. PQC filed because of excess pressure from VARIVAX (Merck) vial. The patient had eye staining test from eye kit. The patient was flushed eyes out with eye solution and applied patch to affected eye and sent home for rest. The patient had sought medical attentions as the event occurred at the provider office. At time of reporting, the patient was recovering from the events. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age (gender not provided). On 18-JUN-2013 the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (lot # and route were not provided). And after more than two months later, on 18-DEC-2012 the patient was administered with the second dose of LIQUID PEDVASHIB (lot # and route were not provided). Other suspect therapies included a dose of ACTHIB (lot # and route were not provided) on an unspecified date in March of 2013. No adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Flatulence, Full blood count, Rectal examination
Clinical narrative: This spontaneous report as received from a nurse refers to a 72 year old male patient with high blood pressure and high cholesterol. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number was not reported), 0.65 ml, subcutaneous, suggested by physician. Concomitant medications included unspecified high blood pressure medication and an unspecified high cholesterol medication. On 13-JUL-2013, the patient experienced diarrhea and gas. The patient sought medical attention (office visit). No treatment was given for the adverse event. A complete blood count and rectal examination (results not reported) were performed. The outcome of diarrhea and gas was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient with no pertinent medical history. Current conditions of the patient included Nitrofurantoin allergy and lodine allergy. On 11-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000447 and 11-APR-2014 respectively), subcutaneously. Concomitant medication included an antidepressant (unspecified). On 16-JUL-2013, the patient experienced tingling and itching sensation after receiving ZOSTAVAX. The patient sought medical attention (called the pharmacist). She took 4 tablets of valacyclovir to prevent the cold sores. The patient did not have cold sores at the time of report (reported as currently). No lab tests were performed. The patient was not recovered from tingling and itching sensation. The relatedness for tingling and itching sensation was unknown for ZOSTAVAX. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a 35 year old female pregnancy patient regarding herself. The patients medical history included thyroidectomy in 1987. The patient had no drug allergies or reactions. On 15-JUL-2013, the pregnant patient was by mistake vaccinated wtih a dose of GARDASIL, (lot number, expiry date was not reported) instead of pertussis by the nurse. Concomitant therapies included SYNTHROID. On an unknown date, the patient was found to be pregnant with LMP of 04-JAN-2013 and EDD of 11-OCT-2013 and was due on 05-OCT-2013. There were no symptoms from having received the GARDASIL injection. Blood work for pregnancy was performed. There was no treatment rendered for the events. The patient sought medical attention(doctors visit). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 15 year old daughter. The consumer reported her daughter was administered the GARDASIL (Lot #, dose and route not reported) shot and found out "about" two weeks later that she was pregnant. LMP and EDD were unspecified. It was not known if the patient sought medical attention. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Nerve stimulation test, Nuclear magnetic resonance imaging, Ophthalmological examination, Optic neuritis
Clinical narrative: Woke up and could not see out of right eye went to ophthalmologist, neurologist. No treatments prescribed - Optic nerve inflamed.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound Doppler
Clinical narrative: Woke up and could not see out of right eye went to ophthalmologist, neurologist. No treatments prescribed - Optic nerve inflamed.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a  5 year old patient. On 06-DEC-2012, the patient was vaccinated with first dose of MMR II. On 15-JAN-2013, the patient was vaccinated with second dose of MMR II. Other suspect therapies included PROQUAD which was administered on 19-JUL-2013. No adverse effect was reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Dehydration, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Patient had vomiting for a day with every feed, decreased urine output, severe dehydration. Started on 7/20, for about 10 episodes before - hospitalization. U/S abd - Intussusception. Got enema reduction and f/u x-ray showed no intussusception. He recovered after enema.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine output decreased, Vomiting, X-ray normal
Clinical narrative: Patient had vomiting for a day with every feed, decreased urine output, severe dehydration. Started on 7/20, for about 10 episodes before - hospitalization. U/S abd - Intussusception. Got enema reduction and f/u x-ray showed no intussusception. He recovered after enema.
Age: 0.8
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 9 months old patient. On 01-APR-2013 the patient was vaccinated with an unspecified hepatitis a vaccine, either HAVRIX or VAQTA (lot # not reported) 0.5 ml, route not reported. No adverse effect reported.  Additional information has been requested.
Sex: M
Vaccine: PER
Symptoms: Detoxification, Dyspepsia, Irritability, Metal poisoning, Toxicologic test abnormal
Clinical narrative: Initial report was received on 12 July 2013 from a consumer, who is also the patient's parent. A male patient had received a pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, (verbatim from the report) "had toxic levels of heavy metal in his brain and irritable, digestive issues and after he was five months old and he had a metal detox he got better a month after the first pertussis vaccinations his major outbreak was after his second vaccination." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient, who, on 01-JUL-2013 was vaccinated with a dose of ZOSTAVAX, 0.65 ml, intramuscularly (lot # not reported). No adverse effect was reported. Additional information has been requested. Follow-up received from a pharmacist. The patient's demographics were updated. The patient is a 81 year old male patient with diabetes and hypertension. On 01-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000853 dose 2, .65 ml, intramuscular. On 01-JUL-2013, number of previous doses 1. The outcome of number of previous doses 1 is unknown. The reporter considered a number of previous doses 1 to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a clinical assistant (healthcare worker) refers to a patient of unknown age. On 18-JUL-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0363AE, exp date as 16-MAR-2013) for prophylaxis. No symptoms reported. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood culture negative, Full blood count normal, Lymph node pain, Lymphadenopathy, Serology normal
Clinical narrative: Pt received MCV4 7-8-13; Next day developed swollen, tender lymph node (axillary) same side as vaccine. Resolved by 7-12-13.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Fontanelle bulging, Irritability, Laboratory test normal, Lumbar puncture normal, Pyrexia
Clinical narrative: Fever, bulging fontanelle and fussiness - full inpatient work up (including an LP) was negative and symptoms gradually resolved.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: 11cm by 13cm local reaction. Site was red, swollen and itchy.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. On 15-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot # was not reported) by injection route for prevention of HPV. It was reported that after patient received vaccination, she then sat in the physician's office for 10 to 15 minutes afterward before being released. On 15-JUL-2013 she fainted at the front of the physician's office as she was leaving. As a result of the fainting, the patient was treated by being kept in the office for an additional 30 minutes, and then her "vitals were taken" before he was released. The taking of the patient's vitals was the only testing performed and no result provided. The patient did not seek medical attention. The outcome of fainted was reported as recovered on 15-JUL-2013. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an 11 year old male patient who on an unknown date was vaccinated with dose 1 of GARDASIL, 0.5 ml, intramuscular for prevention of HPV. It was reported that the patient had received his vaccination, felt faint, fell to the floor and "hit his head on the way down". The office staff assisted the patient to the exam table and laid him down, the patient was examined and found to have no injuries. After a short period of time the patient felt better and was sent home. At the time of the report the patient was recovering from the events. Relationship between felt faint, fell to the floor and "hit his head on the way down" and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever onset 4 days post vaccination lasting several days.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist concerning a patient of unknown age and gender. ON 18-JUL-2013 (reported as yesterday), the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date reported as 669579/0595AA and 30-AUG-2012 respectively, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at site, hot to touch, redness and swelling to site.  Taking Advil and ice to site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope. Treatment: juice box.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 103; pain at injection site on day of admin. Fever 100-102, mild pain and swelling at injec site on day 2. Treated with ibuprofen and ice pack.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Fall, Nausea
Clinical narrative: Client fell on the floor. He stated he did not lose consciousness but suddenly felt very weak. Father said that he did not eat breakfast or lunch. Apple juice was given and client stated that he felt nauseated. Offered a chair to sit on until he felt better. He left with the father at 2:05 PM with a steady gait.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Guillain-Barre syndrome, Headache, Hypoaesthesia, Lethargy
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Blood test, Guillain-Barre syndrome
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Immune system disorder, Impaired work ability
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Intensive care, Motor dysfunction, Muscle atrophy, Nerve degeneration, Plasmapheresis
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Tremor
Clinical narrative: Numbness & tingling of hands and feet, muscle aches, lethargic, headache, backache.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Full blood count, Immediate post-injection reaction, Injection site pain, Metabolic function test
Clinical narrative: IMMEDIATELY FELT PAIN AT INJECTION SITE, LEFT DELTOID. THEN FELT HEAVINESS IN LEFT ARM SECONDS AFTER. WITHIN ONE MINUTE (LESS THAN A MINUTE) PATIENT WAS NEAR SYNCOPE, STARTED TO FALL OVER, PALE WHITE TO THE FACE, EYES CLOSED, HAD A COUPLE JERKY MOVEMENTS, LAID PATIENT DOWN, LENGTH OF TIME WAS 10-15 SECONDS. PATIENT OPENED EYES AND ASKED WHAT HAPPENED. PATIENT WAS UNAWARE OF WHAT HAPPENED. DOCTOR INFORMED AND PATIENT EXAMINED AGAIN. BLOOD SUGAR 80, BLOOD PRESSURE 110/64 LEFT ARM LAYING DOWN WITH HEAD ELEVATED 45 DEGREES. BLOOD PRESSURE STANDING 118/70. LATE BREAKFAST AT 10:00 AM, NO LUNCH. GAVE DR. PEPPER TO DRINK, WAITED 30 MINUTES OR MORE BEFORE LEAVING. COLOR CAME BACK IN FACE WITHIN A FEW MINUTES. LABS ORDERED CBC, CMP. RESULTS PENDING.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pallor, Presyncope, Sensation of heaviness
Clinical narrative: IMMEDIATELY FELT PAIN AT INJECTION SITE, LEFT DELTOID. THEN FELT HEAVINESS IN LEFT ARM SECONDS AFTER. WITHIN ONE MINUTE (LESS THAN A MINUTE) PATIENT WAS NEAR SYNCOPE, STARTED TO FALL OVER, PALE WHITE TO THE FACE, EYES CLOSED, HAD A COUPLE JERKY MOVEMENTS, LAID PATIENT DOWN, LENGTH OF TIME WAS 10-15 SECONDS. PATIENT OPENED EYES AND ASKED WHAT HAPPENED. PATIENT WAS UNAWARE OF WHAT HAPPENED. DOCTOR INFORMED AND PATIENT EXAMINED AGAIN. BLOOD SUGAR 80, BLOOD PRESSURE 110/64 LEFT ARM LAYING DOWN WITH HEAD ELEVATED 45 DEGREES. BLOOD PRESSURE STANDING 118/70. LATE BREAKFAST AT 10:00 AM, NO LUNCH. GAVE DR. PEPPER TO DRINK, WAITED 30 MINUTES OR MORE BEFORE LEAVING. COLOR CAME BACK IN FACE WITHIN A FEW MINUTES. LABS ORDERED CBC, CMP. RESULTS PENDING.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Cold sweat, Confusional state, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: DIZZINESS, NAUSEA, DIARRHEA, CLAMMY SKIN, SWEATING, MILD CONFUSION, LOW GRADE FEVER THREE HOURS AFTER SHOT. 24 HOURS LATER INJECTION SITE WAS RED AND HOT TO THE TOUCH, BECAME CELLULITIS. 7 DAYS LATER, ON ANTIBIOTICS FOR INFECTIONS, SYMPTOMS CONTINUE.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Nausea, Pyrexia
Clinical narrative: DIZZINESS, NAUSEA, DIARRHEA, CLAMMY SKIN, SWEATING, MILD CONFUSION, LOW GRADE FEVER THREE HOURS AFTER SHOT. 24 HOURS LATER INJECTION SITE WAS RED AND HOT TO THE TOUCH, BECAME CELLULITIS. 7 DAYS LATER, ON ANTIBIOTICS FOR INFECTIONS, SYMPTOMS CONTINUE.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (103.8); Chills; Bodyaches relieved with over the counter pain/fever reducer medication.
Age: 1.91
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Hypersensitivity, Pyrexia, Rash
Clinical narrative: Mother called 6/24/13 to report that on 6/22/2013, the patient developed fever and fine rash.  She took the child to facility then to Dr. Mother stated patient received a prescription for diphendydramine 12.5 mg 1/2 teaspoon TID for allergic reaction then further stated patient had fever spike on 6/25 and 6/26.   After this, no further problems.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Local swelling, Pain
Clinical narrative: Large red, swollen and bruised area on arm, pain.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Erythema, Fatigue, Feeling hot, Urticaria
Clinical narrative: Large baseball sized welt, redness, heat, pt had weakness and fatigue. Skin over vaccine area had area of fluid filled vesicles.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Vaccination site vesicles
Clinical narrative: Large baseball sized welt, redness, heat, pt had weakness and fatigue. Skin over vaccine area had area of fluid filled vesicles.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: The child was given Tdap and Hep A in left deltoid as he is sitting on the exam bed, after vaccines are given he stood up and walked to his mother as he is leaning against a table he starts to turn pale and begins to lean to the left. The nurse grabs him and lays him on the floor the child is very pale and sweaty he is still able to talk while the nurse has him on the floor. The child is moved to the exam bed where he continues to be pale and profusely sweating.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cerebral ventricle dilatation, Computerised tomogram head abnormal, Full blood count normal, Metabolic function test normal, Tremor
Clinical narrative: Within 24 hours of vaccination there were bouts of shaking head which became worse over 48 hours.  He was seen at facility and then sent to hospital for further evaluation.  All vital signs were normal and was afebrile.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching and warmth. Started on Claritin on 7/23/13.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Nausea, Oedema peripheral, Pyrexia, Skin tightness
Clinical narrative: Swollen arm, hot, red and tight. Fever and nausea. Went to ER, treated with rocephin and amox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin warm
Clinical narrative: Swollen arm, hot, red and tight. Fever and nausea. Went to ER, treated with rocephin and amox.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Screaming, Vaccination site pain
Clinical narrative: It started with mild pain on the vaccinated left upper arm (no swollen or redness on the site) in AM. Around 2:00 PM the pain on the left upper arm was so severe to the point spontaneous scream with the position change. The same degree of pain continued until night on 7/22/13. The pain subsided considerably on AM on 7/23/13. At 3:00 PM on 7/23/13 the pain was almost gone. Used Tylenol with a minimal help.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 5.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: ZOSTAVAX vaccine administered instead of Varicella. No adverse symptoms or reaction.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: Localized hive like reaction near site of injection doctor examined and told mom to monitor and given BENADRYL if worsened and call our office. 1:30 pm 7/23/13 - Follow up call to mom - she notes symptoms are resolved.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swelling and redness extending 6-8 inches beyond injection site. Pt self treated with TYLENOL. Advised ice and BENADRYL prn.
Age: 1.02
Sex: F
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Developed chicken pox. No fever no treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at site of shingles vacine inoculation ..2/1/2 inches by 1 1/2 inches; very hot to touch; skin raised and hardness like a lump under skin; itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Redness at site of shingles vacine inoculation ..2/1/2 inches by 1 1/2 inches; very hot to touch; skin raised and hardness like a lump under skin; itching.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Amnesia, Anti-NMDA antibody negative, Antinuclear antibody positive, CSF test normal
Clinical narrative: Child had vomiting, dizziness, that proceeded to headaches, over ensuing weeks, child developed amnesia, dystonia, and lost ability to walk; child had multiple pseudoseizures.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dystonia, Electroencephalogram normal, Headache, Laboratory test normal
Clinical narrative: Child had vomiting, dizziness, that proceeded to headaches, over ensuing weeks, child developed amnesia, dystonia, and lost ability to walk; child had multiple pseudoseizures.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Psychogenic seizure, Vomiting
Clinical narrative: Child had vomiting, dizziness, that proceeded to headaches, over ensuing weeks, child developed amnesia, dystonia, and lost ability to walk; child had multiple pseudoseizures.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, TD
Symptoms: Body temperature increased, Decreased appetite, Dysphagia, Dyspnoea, Streptococcus test negative
Clinical narrative: My son was having a very difficult time breathing and swallowing. He didn't eat or drink anything even water and applesauce was too much for him. He also had a temp of 101.8 later that morning around 4:30 AM.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, TD
Symptoms: X-ray normal
Clinical narrative: My son was having a very difficult time breathing and swallowing. He didn't eat or drink anything even water and applesauce was too much for him. He also had a temp of 101.8 later that morning around 4:30 AM.
Age: 19.0
Sex: M
Vaccine: HEPAB, MNQ, TD
Symptoms: Chills, Dyspnoea, Lacrimation increased, Myalgia, Pharyngeal oedema
Clinical narrative: Fever, chills/shivering, shortness of breath, swollen throat, watery eyes, sniffles, and sore muscles.
Age: 19.0
Sex: M
Vaccine: HEPAB, MNQ, TD
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills/shivering, shortness of breath, swollen throat, watery eyes, sniffles, and sore muscles.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender, with not pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (0.56ml, subcutaneous on the front of the arm, about 2 inches above the fold of the elbow), no other suspect therapies or concomitant medications were reported. The pharmacist reported that on an unknown date (reported as "a few days later") the patient had an injection site reaction which was red and a little swollen and irritated. The outcome for injection site reaction which was red and a little swollen and irritated, was unknown at the time of the report. The pharmacist recommended to the patient BENADRYL and warm compresses. The pharmacist did not assess the causality between ZOSTAVAX and injection site reaction which was red and a little swollen and irritated. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Staring
Clinical narrative: 15 hours later developed fever, staring spell x 2 minutes. Presents with fever 101.2 in office. Otherwise no symptoms. Event reported due to close temporal with vaccinations.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient received Tdap vaccine without problem. After patient left the facility she became lightheaded and vomited. Patient returned to office. We brought her back to a room and she laid down for 20 min. and was given apple jc. When she felt better she was leaving and began to vomit again. Pt. seen by a provider.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Pt received PEDIARIX, Hib, PCV13, ROTARIX in our office on 7/22/13. I spoke with pt's mother on 7/23 and she stated pt continuously cried in a shrill for 6 hours after the vaccines. Pt continued to cry through the night and is currently still crying now. Cry is not as continuous as yesterday.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: (L) upper arm redness and swelling 2.5 inches in diameter.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Crying, Fall, Gait disturbance, Injection site swelling
Clinical narrative: Swollen (R) thigh, abnormal gait told, ambulates freely noticed today by mother. Brother age 4 yo stated pt fell off a chair, crying- mom noticed the leg swelling. NSAIDS given, warm compress continue resolving 7-18-2013.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site pruritus, Local swelling, Skin warm
Clinical narrative: Patient's arm turned red and warm to touch. Began to swell. She said it was also itchy at the site of the ZOSTAVAX injection. Dr gave her KEFLEX and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Arthralgia, Injection site erythema, Pyrexia
Clinical narrative: 4 y/o with 12cm x 14cm surrounding erythema at site of injection. Started today. Also, fever (tmax 101.6) - Started today. Last night, c/o knee pain. No joint swelling/effusion.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient who on 18-JUL-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number 1690AA) that was expired. The vaccine expired on 11-JUL-2013.  No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 23-MAY-2013, the patient was vaccinated with a first dose of GARDASIL (lot number, expiration date, dose and route were not reported). On 16-JUL-2013, the patient was vaccinated with a second dose of GARDASIL (lot number 668260/1570Z, expiration date 06-APR-2013) (dose and route were not reported) for vaccination. Concomitant therapy was not reported. On 16-JUL-2013, a patient received an expired dose of GARDASIL. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse, who reported that an unspecified pharmacist told her that on an unspecified date the pharmacist's child (age and gender not reported) received a dose of VARIVAX (Merck) (lot  # not reported) (dose and route not reported). Concomitant medications were not reported. On an unknown date, the patient developed shingles on his or her hand after receiving VARIVAX (Merck). At the time of the report the patient's outcome was unknown. This case is related with MARRS 1307USA010279 and 1307USA012821. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 31 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 12-JUL-2013 the pregnant patient was vaccinated with GARDASIL (lot # 1291AA, expiry date on 12-APR-2014, 0.5 ml/once, intramuscular) due to a human error. No concomitant medication was reported. The gestation was 29 weeks and 5 days. The Last Menstrual Period (LMP) was 16-DEC-2012 and expected date of delivery (EDD) was 22-SEP-2013. The pregnancy outcome was outcome pending. No adverse effect reported. No lab diagnosis studies performed. Additional information has been requested.