chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Healthcare worker stated that the patient received the first dose of GARDASIL few years ago (date unspecified) and received the second dose on 13-MAY-2013. Concomitant medications were not reported. Healthcare worker stated that the patient received the first dose of GARDASIL few years ago (date unspecified) and received the second dose on 13-MAY-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient (age and gender not reported) who on 05-MAR-2013 was vaccinated with a dose of ZOSTAVAX, 0.65 ml, (route and lot number not reported). It was reported that the patient only received 0.5 ml dose of the product instead of 0.65 ml dose due to a PQC issue with ZOSTAVAX. No adverse experiences were reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a 3 month old female patient. On 08-MAY-2013 the patient was vaccinated with VAQTA (lot # was not reported). The reporter reported that patient received VAQTA and should have received an unspecified hepatitis b vaccination. No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Whole thigh red, hot and swollen for more than a week with hard nodule at injection site.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. On an unknown date, the patients was vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscularly. On an unknown date, the patients experienced syncope. The healthcare professional present also agreed with the nurse who works for the same practice. It was not stated as to where in the dosing schedule the event syncope had occurred. The outcome of syncope was unknown. This is one of several reports from the same reporter MARRS# 1304USA016449. Follow up information has been received from the registered nurse reporting that she was unable to remember the patient. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner, regarding several patients of unknown age and gender, with no pertinent medical history reported. The Nurse practitioner stated that several patients, throughout the year (2013) had come in late (vaccination dates not reported) for their third dose of GARDASIL vaccination, (lot number and expiration date not reported) (dose and route not specified). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Blood test normal, Computerised tomogram head normal, Dizziness, Urine analysis normal
Clinical narrative: I had a shingles vaccine on 5/4/13 in the afternoon. On 5/6/2013 at 4 AM, I awoke with vertigo which I had never had in my life. It required a trip to the ER where blood work, urinalysis, and head CT revealed no problems. This has required me to miss 3 days of work in addition to the hospital expenses. The vertigo has eased and now it is more dizziness at times. I really feel that this was related to the vaccine and would like to know if anyone else has reported this reaction. If it is part of the posted side effects, I possibly would not have incurred all of the ER expenses and stress.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: I had a shingles vaccine on 5/4/13 in the afternoon. On 5/6/2013 at 4 AM, I awoke with vertigo which I had never had in my life. It required a trip to the ER where blood work, urinalysis, and head CT revealed no problems. This has required me to miss 3 days of work in addition to the hospital expenses. The vertigo has eased and now it is more dizziness at times. I really feel that this was related to the vaccine and would like to know if anyone else has reported this reaction. If it is part of the posted side effects, I possibly would not have incurred all of the ER expenses and stress.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Injection site oedema, Injection site warmth, Nasal congestion
Clinical narrative: Case number PHHY2012US099175, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 463547) web site on 01 Nov 2012, with a follow-up received from Quality Assurance department (QA reference number: 209184) on 17 May 2013: This report refers to 11 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10130), intramuscularly into the right arm and BOOSTRIX (batch number: AC52B085BA), intramuscularly into left arm on 23 Aug 2012 and VARIVAX (batch number: H006535) subcutaneous into left arm on an unspecified date. On an unspecified date the patient experienced warmth at both upper arms that night with large area of edema noted approximately 3 inches and began to experience smaller raised areas with blister like appearance on bilateral arms and legs, upper back and chest. Clear fluid noted at blister centers. The patient's mother gave BENADRYL 2 mg, Q6H and AVENO. No fever but complained of nasal congestion only. The outcome of the event, seriousness and causality assessment was not reported. The quality assurance department stated that, based on the review performed, MENVEO batch number: A10130, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the quality assurance department (QA reference number: 209184) on 17 May 2013: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Dyspnoea, Flushing, Petechiae, Wheezing
Clinical narrative: Case number PHHY2012US111763, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469463) website on 04 Dec 2012 with a follow up information received from the quality assurance department (reference number: 209970) on 17 May 2013. This report refers to an 11-years-old male patient. His medical history included peanut allergy, asthma and tree/mold allergy and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M11076) intramuscularly, and PNEUMOVAX (other manufacturer, batch number: 1853AA) intramuscularly and BOOSTRIX vaccine (other manufacturer, batch number AC52B081BA) intramuscularly on 10 Oct 2012. Within minutes after vaccination, he experienced shortness of breath, wheezing and flushing. He was treated with EPIPEN, Prednisone, Albuterol and BENADRYL. He was transported by ambulance to the emergency department. He also developed petechiae on upper body. The outcome of the events was reported as completely recovered as of 12 Oct 2012. The reporter assessed the seriousness of the case as life-threatening. The causality of the events was not reported. Based on the documents review performed, it was stated that the MENVEO batch M11076 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 17 May 2013: Batch summary and reference number were updated.
Age: 32.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Case number PHHY2013US012202, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 476628) website on 08 Feb 2013: This report refers to a 32-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11051) intramuscularly to right arm, GARDASIL (other manufacturer, batch number: H010649) intramuscularly to right arm and BOOSTRIX (other manufacturer, batch number: AC52B093BA) intramuscularly to left arm on 05 Dec 2012. It was reported she received GARDASIL at first and on the same day, post vaccination she experienced dizziness and reported to her mother. The patient passed out and was unresponsive for two to three minutes. The patient was examined by the physician and was sent to hospital for outpatient observation. The outcome of the events was reported as not recovered as of 05 Dec 2012. The event seriousness and causality were not reported.
Age: 20.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Chest discomfort, Confusional state, Cough, Crying
Clinical narrative: Patient presented to office 3 days after vaccine c/o anxiety since receiving the vaccine. Patient ultimately spiraled from sever anxiety to a psychotic episode 6 days s/p vaccine. Patient had no history of this problem prior to vaccination.
Age: 20.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Disturbance in attention, Dysphonia, Dyspnoea, Insomnia, Logorrhoea
Clinical narrative: Patient presented to office 3 days after vaccine c/o anxiety since receiving the vaccine. Patient ultimately spiraled from sever anxiety to a psychotic episode 6 days s/p vaccine. Patient had no history of this problem prior to vaccination.
Age: 20.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Nervousness, Staring
Clinical narrative: Patient presented to office 3 days after vaccine c/o anxiety since receiving the vaccine. Patient ultimately spiraled from sever anxiety to a psychotic episode 6 days s/p vaccine. Patient had no history of this problem prior to vaccination.
Age: 20.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Anxiety, Psychotic disorder
Clinical narrative: Patient presented to office 3 days after vaccine c/o anxiety since receiving the vaccine. Patient ultimately spiraled from sever anxiety to a psychotic episode 6 days s/p vaccine. Patient had no history of this problem prior to vaccination.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever 102, body aches, fatigue x 48 hrs.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Immediate swelling and redness of arm and pain that gradually worsened. She went to the ER and was admitted overnight.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: Pt got vaccine on 5/13 and came back in on 5/14 to show us a reaction at the injection site. Area is red and had small blisters. Area is about 5 inch by 3 inch. Told her to keep covered and not let anyone come in contact of area till it scabs over.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Pt got vaccine on 5/13 and came back in on 5/14 to show us a reaction at the injection site. Area is red and had small blisters. Area is about 5 inch by 3 inch. Told her to keep covered and not let anyone come in contact of area till it scabs over.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC13, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: I gave the patient a varicella zoster by mistake instead of varicella on 5-17-13 at 3:30 pm no treatment patients mom was notified of the error and was told of signs and symptoms to watch for.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Needle issue
Clinical narrative: Gave VARIVAX vaccine IM in (L) thigh with 5/8 inch needle.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Redness, swelling, tightness, bruising not feeling - all to skin around injection site - used ice pack and TYLENOL.
Age: 0.33
Sex: F
Vaccine: DTAP, DTAPIPVHIB, RV5
Symptoms: Wrong drug administered
Clinical narrative: None. PENTACEL, PREVNAR, ROTATEQ ordered but PENTACEL, DTaP, ROTATEQ given.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness of injection site 9 days after vaccine of chicken pox.
Age: 1.51
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Local reaction, Skin discolouration
Clinical narrative: 5x8 cm - local reaction erythematous raised border. 2x3 cm purplish central area.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Severe diarrhea causing signs of dehydration. Went to ER. Received IVF bolus, then discharged.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: Initial report received from a healthcare professional on 07 June 2012.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated late with dose 2 or dose 3, GARDASIL (lot# and expiration date not reported) intramuscularly. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting herself. On unknown date the patient was vaccinated with two doses of VARIVAX (Merck) respectively (date, dose, route and lot number not provided). These two doses were administered eight years apart. And the titer results had been "equivocal" after each administration. The outcome the event was unknown. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 65-year-old female patient via a registered pharmacist. Current conditions included asthma, "heart", gout and an unspecified reaction to penicillin. On 14-MAY-2013 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot # J000494, expiration date 14-APR-2014) subcutaneously in the right arm. No concomitant medications were reported. On 15-MAY-2013, the patient experienced a red area on her right upper arm about the size of a quarter below the Band-Aid. The area continually got bigger, described as red, swollen and to the point of redness being coffee-cup size and still swollen. Treatment was ice packs. It was unspecified whether laboratory diagnostic tests were performed. Medical attention was not sought by the patient. The events did not resolve at the time of this report. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) while she was pregnant. No concomitant medications were reported. Last menstrual period (LMP) and estimated Date of Delivery (EDD) were unknown). The pregnancy outcome was pending. No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Death, Varicella
Clinical narrative: This spontaneous report as received from a other health professional (medical student) refers to a currently 15 years old male patient with T cell precursor lymphoblastic leukemia (ALL) undergoing chemotherapy. On an unknown date the patient's brothers were vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) lot # dose not reported, it was not known if the patient had been vaccinated. On an unknown date, the patient experienced disseminated varicella (hospitalization) and died (on an unspecified date). The cause of death was unknown. At the time of the report the outcome for disseminated varicella, patient's brothers were vaccinated with a dose varicella virus vaccine live were unknown. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Rash.
Age: 21.0
Sex: F
Vaccine: IPV
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Began feeling very achy with violent chills in the evening. Took appropriate ibuprofen dose for adult. Took temperature at 11:00 PM (about one hour after ibuprofen) and oral temperature was 101.0 F. Temperature decreased during the night, but was still 99.0 F in the morning and still somewhat achy.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Body temperature increased, Chest X-ray normal, Condition aggravated, Dyskinesia, Eczema
Clinical narrative: Child received MMR #1, DTaP#4, and Hib#4 on 4/23/13. On 4/25/13 child was at daycare and was reported to have been playing and then dropped to the ground and was jerking. Grandma/guardian states she was there within 5 min. and he was still unresponsive and had some slight jerking motions. Temp was 102. He was taken by ambulance to ER where he had CXR that was clear and other infections ruled out. Grandma states his temp went up to 104 that evening while she was alternating Tylenol and Motrin every 3 hours. Grandma states child has bad eczema and had a terrible flare up after vaccine. Also states he had had a cold before the vaccination but was doing ok by the time he got it.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Child received MMR #1, DTaP#4, and Hib#4 on 4/23/13. On 4/25/13 child was at daycare and was reported to have been playing and then dropped to the ground and was jerking. Grandma/guardian states she was there within 5 min. and he was still unresponsive and had some slight jerking motions. Temp was 102. He was taken by ambulance to ER where he had CXR that was clear and other infections ruled out. Grandma states his temp went up to 104 that evening while she was alternating Tylenol and Motrin every 3 hours. Grandma states child has bad eczema and had a terrible flare up after vaccine. Also states he had had a cold before the vaccination but was doing ok by the time he got it.
Age: 1.19
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Varicella and MMR given again.  Father failed to inform us that pt already received shots at Health Department.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever of 102 on 5/17 with rash starting on forehead on 5/19 and progressing down body.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever of 102 on 5/17 with rash starting on forehead on 5/19 and progressing down body.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death, Pyrexia
Clinical narrative: Infant was found expired in her crib on the morning following vaccination.  Mother reports that she had a tactile fever on the evening prior to her death.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and c/o pain to upper L arm after administration of vaccination.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: Pt adm'd exp'd vax.  Discussed with Merck who indicated vax if stored in fridge would maintain potency and pt did not require additional vax.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema multiforme, Rash erythematous, Rash generalised, Skin lesion, Urticaria
Clinical narrative: Red rash initially in inguinal creases, later spread all over body some urticaria and many target lesions, treated with Benadryl; was out of town and seen by another MD prior to returning to our office 05/02/2013 with clear reaction of erythema multiforme.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Crying, Erythema, Hyperacusis, Irritability
Clinical narrative: Fever, crying, fussy, clingy, sensitive to sounds, doesn't want to be set down. Acting completely out of character and this is still on going. Took her to the doctor and was told it was a secondary reaction to the vaccine MMR. Also her arm was red and raised.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Pyrexia, Vaccination complication
Clinical narrative: Fever, crying, fussy, clingy, sensitive to sounds, doesn't want to be set down. Acting completely out of character and this is still on going. Took her to the doctor and was told it was a secondary reaction to the vaccine MMR. Also her arm was red and raised.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Chills, Condition aggravated, Cough
Clinical narrative: Night sweats, frequent awakenings, severe left arm pain extending into the left axilla, with noted erythema to left upper delt region and ventral aspect of the left upper arm.  Subjective chills, temp of 99.0 on Tylenol in clinic, slight nausea and diarrhea, worsening cough.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Middle insomnia, Nausea, Night sweats
Clinical narrative: Night sweats, frequent awakenings, severe left arm pain extending into the left axilla, with noted erythema to left upper delt region and ventral aspect of the left upper arm.  Subjective chills, temp of 99.0 on Tylenol in clinic, slight nausea and diarrhea, worsening cough.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: Night sweats, frequent awakenings, severe left arm pain extending into the left axilla, with noted erythema to left upper delt region and ventral aspect of the left upper arm.  Subjective chills, temp of 99.0 on Tylenol in clinic, slight nausea and diarrhea, worsening cough.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, X-ray limb normal
Clinical narrative: Zostavax Sub-Q administered using a Vanishing Point syringe. Vaccinator pressed release button causing needle to retract into body of syringe. Vaccinator unfamiliar with syringe "wondered where needle went" causing patient to worry that "is needle still in my arm?". Undeterred by vaccinator's advice that needle was "not still your arm", patient & sister went for an xray at hospital ER. X-ray was of course negative.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: 24 hrs after taking first Oral Typhoid capsule c/o waking up to abd cramping and mild nausea lasting until bedtime then stopped. 24 hours after second capsule woke up in AM with abd cramping lasting until 12:00 noon. 24 hours after third capsule woke up with cramping more severe than before and nausea. Talked with patient that day at 10:00 AM. Called Crucell for information.  Phone call back to patient with directions to treat symptoms and may consult physician if worsens and to ask about recommendations for taking 4th capsule. Unable to reach patient by phone later that afternoon or next day.  Left messages asking her to return my call but has not at this time.  No information about whether she took the 4th capsule or if symptoms worsened or resolved.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling, pain, itching, redness at the injection site. Low grade fever of 101. Naprosyn prescribed and cold compresses.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Intensive care, Loss of consciousness, Rash pruritic, Respiratory arrest
Clinical narrative: Patients husband reported finding her unconscious/unresponsive, upon which she underwent respiratory arrest and was admitted into the hospital ICU from 5/11 - 5/16/13. She indicated there was a noticeable blistering rash on her face, along with some on her body/back which itched.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Patients husband reported finding her unconscious/unresponsive, upon which she underwent respiratory arrest and was admitted into the hospital ICU from 5/11 - 5/16/13. She indicated there was a noticeable blistering rash on her face, along with some on her body/back which itched.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Blood grouping, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included Anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, Glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Streptococcus test negative, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included Anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, Glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose increased, Blood group O, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included Anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, Glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Foetal disorder, Streptococcus test negative, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included Anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, Glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Blood grouping, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week 18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during the delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Streptococcus test negative, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week 18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during the delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose increased, Blood group O, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week 18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during the delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Foetal disorder, Streptococcus test negative, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week 18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during the delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Papule
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed shingles two weeks after vaccination. The shingles were described as contained to one dermatome on the torso (front and back), painful, red with many papules. The patient sought medical attention (contacted nurse). The patient was undergoing pain management at the time of reporting. It was unspecified if any lab tests were performed. The outcome of the event was reported as not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Oedema peripheral, Skin warm, Vomiting
Clinical narrative: Started vomited and stomach ache at 1200 AM vomited x3. Right arm swollen and warm. Diarrhea x2 this AM.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of MMR injection became red, swollen and tender, and warm to touch 5/7/13. Afebrile. No lymphangitis. Two arms of deeper induration each size of peanut. Entire area size of orange.