chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.92
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an 11 months-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot# M042322 and expiration date of 21-FEB-2019 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccine was stored at a temperature of 1 degree Celsius for a time frame of 9 hours. No prior temperature excursion or adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of M-M-R II for prophylaxis (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). It was reported that, on multiple unknown dates, the patients "had low titers when tested" M-M-R II (mumps antibody test negative and measles antibody negative) tested byan unspecified titer test. The primary reporter reported that an unspecified amount of the patients were treated by re-vaccinating with a dose of M-M-R II (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). The outcome of mumps antibody test negative and measles antibody negative was not reported. The causality between mumps antibody test negative and measles antibodynegative with M-M-R II was not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003918:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 17-DEC-2010 as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 26-OCT-2011, patient was treated for ongoing painful rash and persistent nerve pain which was then diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness to right outer thigh. size is approx 6-7 cm area of erythema right outer thigh with warmth/hyperemia, mild tenderness; indurated in center. itching present.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Swelling and redness to right outer thigh. size is approx 6-7 cm area of erythema right outer thigh with warmth/hyperemia, mild tenderness; indurated in center. itching present.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received a PPSV23 vaccine in her right upper extremity yesterday, 4/19/2017, around 0830. At about noon, she started to develop redness, swelling, warmth, itching, and pain at the injection site. These symptoms progressed and she was evaluated by her provider today. She has been using ice and Benadryl to help manage her symptoms.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Mobility decreased, Neonatal disorder, Pain
Clinical narrative: I was vaccinated at 27 weeks pregnant. I could not fully lift my arm again for 15 months because there was severe pain when I tried to lift my arm above my head. There is still pain in my arm three years later. My unborn child did not move for three weeks after I was vaccinated. He is now 2.5 years old and he is developmentally delayed and showing signs of autism.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: I was vaccinated at 27 weeks pregnant. I could not fully lift my arm again for 15 months because there was severe pain when I tried to lift my arm above my head. There is still pain in my arm three years later. My unborn child did not move for three weeks after I was vaccinated. He is now 2.5 years old and he is developmentally delayed and showing signs of autism.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial soreness at injection site after injection. Then, about 1 day later, he developed redness and swelling that was very hot to touch roughly 4 inches away from injection site. Patient's doctor prescribed an antibiotic in case of secondary infection.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M034780, expiration date 15-APR-2019; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccine data logger measured a temperature range from 0°C to 1°C for a total time frame of 22 minutes. Previous temperature excursions temperature ranges from 0°C to 1°C and 9°C to 25°C for a total time frame of 1 hour 30 minutes. No adverse effects were reported, and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001657:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M038226, expiration date 07-SEP-2018; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccine data logger measured a temperature range from minus 9°C to 8°C for a total time frame of 4 hours and 50 minutes. There was no previous temperature excursion. No adverse effects were reported, and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011300.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Varicella
Clinical narrative: This is a spontaneous report received from a field representative who received a report from a physician regarding a 65-year-old female consumer who received a dose of ZOSTAVAX injection subcutaneously for prevention of shingles (lot # and expiration not reported). The physician reported that about 4 weeks ago on an unspecified date, a female consumer came into the office to receive her ZOSTAVAX injection. The physician stated that the consumer came back to their office about 2 weeks later on an unspecified date with complaints of a 'rash' at the injection site and on their other arm (did not specify which arm was the injection site arm). The physician stated that it was concluded that the consumer 'developed chicken pox' as a result of the ZOSTAVAX injection. The physician stated they instructed the consumer to take diphenhydramine (BENADRYL) and use calamine lotion. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) at a pharmacy on or about 26-JAN-2012 as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAY-2014, the patient was treated by her physician at a medical center for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed valacyclovir (VALTREX) to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009595: US-009507513-1704USA009664: US-009507513-1704USA009812:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Follow-up information had been received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 21-JAN-2011 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about 12-DEC-2015, patient was treated by physician at a community hospital for a painful rash that was diagnosed as shingles. On or about 13-DEC-2015, patient was evaluated for severe shingles and was diagnosed to have profound post herpetic neuralgia, a painful and chronic condition caused by the residual nerve damage after contracting shingles. While shingles and post herpetic neuralgia are chronic and incurable conditions, patient had been prescribed antivirals and morphine, as needed, to manage his symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169079 Same product/event/reporter, different patient;US-PFIZER INC-2017169080 Same product/event/reporter, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169045 Same product/event/reporter, different patient;US-PFIZER INC-2017169080 Same product/event/reporter, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169079 Same product/event/reporter, different patient;US-PFIZER INC-2017169045 Same product/event/reporter, different patient.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Drooling, Electrocardiogram normal, Eye movement disorder, Hypotonia
Clinical narrative: Mother stated that 30 minutes after visit, was in drive thru and patient began to drool, shook for about 12 seconds then blacked out and went limp for about 8-10 seconds, hand curled up towards her chest, eyes rolled. ER provided IV fluids, no medication.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Loss of consciousness, Muscle contractions involuntary, Tremor
Clinical narrative: Mother stated that 30 minutes after visit, was in drive thru and patient began to drool, shook for about 12 seconds then blacked out and went limp for about 8-10 seconds, hand curled up towards her chest, eyes rolled. ER provided IV fluids, no medication.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Rash, Swelling
Clinical narrative: Started achy feeling, rash (golf ball size), red, swelling, warm sensation, but more pain now.
Age: 0.17
Sex: M
Vaccine: DTPIHI, IPV, MEN, TD
Symptoms: Decreased appetite, Diarrhoea, Insomnia, Screaming
Clinical narrative: Inconsolable screaming, insomnia, diarrhea, anorexia, 6 DAYS STRAIGHT.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Crying, Death, Irritability, Malaise
Clinical narrative: Patient was put to bed by his parents the previous night. His Mother discovered him deceased in his bed the next morning.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder developmental, Staring
Clinical narrative: Patient was put to bed by his parents the previous night. His Mother discovered him deceased in his bed the next morning.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Head discomfort
Clinical narrative: Onset of dizziness and fullness in head. I drank water and rested in bed. When I kept my head still, I felt ok. When I moved my head, the dizziness returned. I fell asleep after a hour. When I woke up, the dizziness was less but was still driven by head movement. Dizziness lessened over the course of time and went away 04/20/2017 7:00 PM.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Electroencephalogram, Respiration abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: Call from parent to office phone triage RN reported possible seizure child non responsive, breathing funny. Instructed to call 911, transported to ER. Dr notified child with 2 subsequent seizures in ER. Admitted for observation and evaluation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness. Warm to the touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's father states pt started to C/O pain in her right arm the day after vaccines administered, on 4/18/17. Pt's father noted some redness and swelling to pt's right arm and took her to Urgent Care. Urgent Care staff informed father to monitor arm. Pt treated today, 4/20/17 for cellulitis (R) arm - antibiotic and steroid therapy.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Immediately after given GARDASIL, patient became pale, lightheaded, C/O dizziness, blurred vision, she was given water, laid down on exam table - BP 90/60. After 5 min. her color returned, felt nauseous. BP 100/70, she was observed another 20 minutes. No problems. I contacted Mom the next day - 4/18/17. She called office back on 4/19/17 - doing well on 4/19/17. Patient had a headache 4/18/17.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Immediately after given GARDASIL, patient became pale, lightheaded, C/O dizziness, blurred vision, she was given water, laid down on exam table - BP 90/60. After 5 min. her color returned, felt nauseous. BP 100/70, she was observed another 20 minutes. No problems. I contacted Mom the next day - 4/18/17. She called office back on 4/19/17 - doing well on 4/19/17. Patient had a headache 4/18/17.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Product packaging confusion, Wrong drug administered
Clinical narrative: We have had 2 errors one involving giving influenza versus Tdap and the other was giving Tdap when influenza was ordered. Reportedly the two packages look alike. Is this happening elsewhere?
Age: 1.17
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reactions noted presently. Patient received ZOSTAVAX instead of PROQUAD.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Otitis media acute, Pyrexia, Streptococcus test negative, Tonsillitis, Viral infection
Clinical narrative: Patient developed fever to 103. Seen in ED dx'd with virus. Seen in office approximately 12 hr later. Dx'd with LAOM. Acute Tonsillitis.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine administration site.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Frequent bowel movements, Irritability
Clinical narrative: Fussy, increased frequency stool, abnormal odor to looser stool, green, some sloughing outer anus and brown flecks in stool (? sloughed mucosa), (-) blood.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Skin exfoliation
Clinical narrative: Fussy, increased frequency stool, abnormal odor to looser stool, green, some sloughing outer anus and brown flecks in stool (? sloughed mucosa), (-) blood.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid, red, swollen and hot, radiated to (L) shoulder.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590947) on 04-APR-2017. This spontaneous report was received from a regulatory authority and refers to a 13 year old male patient. The patient's concomitant therapies, other medications, concurrent illness and pertinent medical history were not reported. The patient's father called and reported that on 12-AUG-2015, the patient, his child who was healthy, was vaccinated with GARDASIL 9 dose number 1, lot # L000610, (dose, lot expiration date not reported) intramuscularly in the left arm and HAVRIX (dose number 1, intramuscularly in the right arm, lot # X22P4, dose and lot expiration date not reported) for prophylaxis. On 14-AUG-2015, which was a Friday, the patient experienced urticaria, injection site erythema, injection site swelling and injection site urticaria. The patient had a break out from head to toe with hives, his arms at the injection sides were very red, swollen like with some white lump like hives. The patient's father stated that they gave him BENADRYL and CLARITIN but they did not seem to help him, he also stated that it was a fest and was outside in heat as well. The patient was taken to emergency room on Saturday where he was given a steroid shot, and medications as well. It was told by the doctors and nurses that those two vaccinations really should not be given together because they can cause reactions together. Patient's father reported about his son's allergic reaction and wanted to be called back to know if this allergic reaction was true on these two vaccinations. The father was told that he would be called after calling the health department to see what their thoughts were on this reaction. The outcome of injection site erythema, urticaria, injection site urticaria and injection site swelling was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Phlebitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 593924) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient had no current illnesses and medical history. The patient's other medications and prior medications were not reported. On 10-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L013429 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapy included ADACEL (dose number: 1, vaccinated date: 10-SEP-2015, intramuscularly in the right arm, lot # C4456AA; dose and expiration date unknown). On the same day, the patient had phlebitis in the ventral wrist ipsilateral to the shoulder that the GARDASIL 9 and ADACEL vaccines were administered earlier on that day. The outcome of phlebitis was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594264) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 25 year old female patient with prophylaxis. The patient had no medical history, current illnesses. The patient's other medications included doxycycline. On 08-SEP-2015, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # 001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 09-SEP-2015, the patient experienced headache, fever and body aches. The outcome of pain, pyrexia and headache was reported as recovered. Causality assessment was not reported. Lot number 001312 is an invalid lot number for GARDASIL 9. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Culture urine negative, Full blood count normal, Haematuria, Metabolic function test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595387) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient with prophylaxis. The patient had no current illnesses, medical history and other medications. On 10-SEP-2015, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L011846 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included, MENACTRA (dose number 2; vaccinated date: 10-SEP-2015, intramuscularly in the right arm, lot # U5058AD; dose and expiration date unknown), TRUMENBA (vaccinated date: 10-SEP-2015, intramuscularly in the left arm, lot # J29203; dose and expiration date unknown). On 12-SEP-2015, the patient experienced nausea, chills 48 hours after vaccines, on the same day morning patient developed hematuria. And on the same day patient's ultrasound pelvis was normal, ultrasound kidney was normal, full blood count was normal, microscopic red blood cells urine was positive (50 +), urine culture was negative, serum pregnancy test was negative and comprehensive metabolic panel (CMP) (reported as metabolic function test) was within normal limits. On an unknown date, the patient had underwent emergency room (ER) visit. The outcome of culture urine negative, nausea, chills, ultrasound pelvis normal, ultrasound kidney normal, red blood cells urine positive, pregnancy test negative, metabolic function test normal, haematuria and full blood count normal was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Nausea, Pregnancy test negative, Red blood cells urine positive, Ultrasound kidney normal, Ultrasound pelvis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595387) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient with prophylaxis. The patient had no current illnesses, medical history and other medications. On 10-SEP-2015, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L011846 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included, MENACTRA (dose number 2; vaccinated date: 10-SEP-2015, intramuscularly in the right arm, lot # U5058AD; dose and expiration date unknown), TRUMENBA (vaccinated date: 10-SEP-2015, intramuscularly in the left arm, lot # J29203; dose and expiration date unknown). On 12-SEP-2015, the patient experienced nausea, chills 48 hours after vaccines, on the same day morning patient developed hematuria. And on the same day patient's ultrasound pelvis was normal, ultrasound kidney was normal, full blood count was normal, microscopic red blood cells urine was positive (50 +), urine culture was negative, serum pregnancy test was negative and comprehensive metabolic panel (CMP) (reported as metabolic function test) was within normal limits. On an unknown date, the patient had underwent emergency room (ER) visit. The outcome of culture urine negative, nausea, chills, ultrasound pelvis normal, ultrasound kidney normal, red blood cells urine positive, pregnancy test negative, metabolic function test normal, haematuria and full blood count normal was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595646) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient with prophylaxis. The patient's medical history included asthma. The patient's current illnesses and prior vaccinations were not reported. The patient's other medications included albuterol sulfate and VENTOLIN HFA. On 26-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 (route of administration: unknown) in the left arm, lot # L007560 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-AUG-2015, the patient experienced joint pain and tingling fingers. On an unknown date, the patient received Acetaminophen 300 mg and codeine 30 mg/12.5 ml. And on an unknown date, the patient underwent emergency room (ER) visit. The outcome of the events paraesthesia and arthralgia was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Monoplegia, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595798) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient with prophylaxis. The patient had no current illnesses, medical history, other medications and prior vaccinations. On 19-JUN-2015, the patient was vaccinated with GARDASIL 9 (route of administration, batch/lot number, dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-JUL-2015, the patient experienced pain in her elbow and wrist which has progressed to monoplegia on her right side and on the same day the patient had underwent X-ray, nuclear magnetic resonance imaging (MRI) and blood test. On an unknown date, the patient had 10 Doctor's visits including a trip to the emergency room (ER), and had many x-rays, blood work and 3 MRIs. The outcome of arthralgia, x-ray, nuclear magnetic resonance imaging, monoplegia and blood test was not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Electrocardiogram, Loss of consciousness, Pregnancy test urine negative, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596795) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient with prophylaxis. The patient had no current illnesses and the patient's other medications was not reported. The patient's medical history included scoliosis. On 28-AUG-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # K026246 (dose, frequency and lot expiration date were not reported) for prophylaxis and on same day lab data: Urine pregnancy test: negative. On 29-AUG-2015, the patient went to urgent care to obtain x-ray to check progress of her scoliosis and it was there before the procedure was done that she passed out and was sent to the emergency room (ER) and patient's pregnancy test urine showed negative, blood glucose was normal, had electrocardiogram and the patient experienced loss of consciousness. Lab data: On 29-AUG-2015, Urine pregnancy test: negative, point of care (POC) glucose: 87 and electrocardiogram: result unknown. The outcome of blood glucose normal, x-ray, pregnancy test urine negative, loss of consciousness and electrocardiogram was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597365) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's concomitant therapies, other medications, prior vaccination details and lab data were not reported. The patient's historical conditions included environmental allergy (allergen unspecified). The patient had no concurrent illness. On 24-AUG-2015 the patient was vaccinated with GARDASIL 9, route: needle and syringe (not further specified) (dose number, lot#, dose, and site unknown) for prophylaxis. On the same day post vaccination, the patient experienced injection site pain, fever of 102 (units unspecified) and general malaise. The outcome of injection site pain, fever and malaise was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Feeding disorder, Pain in jaw, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 598499). This spontaneous report refers to a 12 year old female patient. Patient had no concurrent illnesses and medical history. Information on patient's other medications was not reported. On 05-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L028664, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient had blurry vision and was almost unable to see. She had extreme jaw pain and was unable to eat. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Face oedema, Orbital oedema, Scan with contrast normal, Urine analysis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 600852). This spontaneous report refers to a 9 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and anxiety in 2013. Patient had no concurrent illness and other medications included DAYTRANA patch, RITALIN and ZOLFT. On 02-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L019287, dose 1, route: unknown in the left arm for prophylaxis. On 07-SEP-2015 at 16:00, the patient developed severe facial edema from jawline into eye socket on the right side. Lab data included: CT scan with contrast (negative) and urine for kidney disease (negative). On the same day, patient's computerized tomogram, urine analysis and scan with contrast was normal. Patient went to urgent care on 07-SEP-2015 and went to emergency room (ER) on 08-SEP-2015. Patient began KEFLEX, steroids and NSAIDS. The outcome of the events was reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 600860). This spontaneous report refers to a 17 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 22-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient told her dad that she was dizzy and had syncopal event for 2 seconds. Patient was pale, sweaty and she lied down with head of the bed elevated. She was given water and vitals were taken. Patient was monitored for 20-25 minutes and was checked by the doctor. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Headache, Swelling, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 601563). This spontaneous report refers to a 23 year old female patient. Patient had no concurrent illnesses and medical history. On 06-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, intramuscularly in the left arm for prophylaxis. The patient experienced headache about an hour after administration and two days after she developed hives, swelling, erythema. Other medications included CELEXA 40 mg; FLAGYL 500 mg; Iron 325 mg. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Migraine
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 603081). This spontaneous report refers to a 17 year old male patient. The patient's concurrent illnesses was reported as none. The patient's medical history included mild headaches. On 12-OCT-2015 the patient was vaccinated with GARDASIL 9, lot # K026246, dose 2, intramuscularly in the left arm for prophylaxis. On 13-OCT-2015, the patient experienced severe migraine headache and had an emergency visit, MRI was ordered. The outcome of migraine was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 603272) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's prior vaccination details and lab data were not reported. The patient had no concurrent illnesses and other medications. The patient's medical history included allergy to amoxicillin and sulfa drugs. On 15-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L014415 dose 1, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis.  Other suspect therapies included FLUARIX (dose number: 4, vaccinated date: 15-OCT-2015, intramuscularly in the left arm, lot# 9JX2N; dose and expiration date unknown) for prophylaxis.  On the same day, 5 minutes post vaccinations patient experienced blurred vision. The outcome of event was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Dizziness, Laboratory test, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604757) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient. The patient's medical history included syncope with blood draw. The patient's concurrent illness included morning emesis x 2 weeks. The patient's other medications included ADVIL. On 26-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L028083 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUZONE. On 26-OCT-2015, the patient experienced dizziness, vomiting, syncope and undergone laboratory test. The outcome of dizziness, vomiting, syncope and laboratory test was reported as recovered/resolved.  Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604911). This spontaneous report refers to a 12 year old female patient. The patient's concurrent illnesses and medical history were reported as none. On 26-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L013429, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA (lot# U5172BA, dose 2, intramuscularly in left arm). On 26-OCT-2015, the patient experienced immediate post-injection reaction and loss of consciousness. Immediately following injection of HPV - 9, patient loss consciousness/slumped in chair for approximately 15 seconds. The outcome of immediate post-injection reaction and loss of consciousness were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604923) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's prior vaccination details and lab data were not reported. The patient had no historical conditions, concurrent illnesses and other medications. On 26-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L028083 dose 2, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day post vaccination, after checking out, the patient fainted and fell into the exit door. The patient visited the emergency room and the outcome of fall and syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dyskinesia, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 610997) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 13-NOV-2015  the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L016428 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX. On 15-NOV-2015, the patient experienced dyskinesia and swelling face. The outcome of dyskinesia and swelling face was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616424) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included asthma and seasonal allergic rhinitis. The patient's concomitant therapies, concurrent illness and other medications were not reported. On 16-DEC-2015 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # L014415 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUZONE QUADRIVALENT. On 18-DEC-2015, the patient experienced erythema, skin warm, pain in extremity and had emergency visit. The outcome of erythema, skin warm and pain in extremity was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site rash, Local reaction, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616892). This spontaneous report refers to a 14 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 16-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L016428, dose 1 via intramuscular in the right arm and VARIVAX lot # L024252, dose 1 via subcutaneous route in the left arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX lot batch# PN7GD, dose 1 via intramuscular in the right arm for prophylaxis. On 17-DEC-2015, the patient experienced injection site mass, peripheral swelling, local reaction, injection site rash and injection site pain. The patient's mother stated that, the patient had local reaction to VARIVAX. Left arm was swollen to "baseball" size on day 1, pain and rash at site as well. The symptom was resolving on day 2, the swelling reduced to about 1/3 of the size it was on day 1 and the swelling was more lumpy, not a solid mass like the previous day. The patient's mother stated that, the patient did not take any painkillers or antihistamines. The patient's mother was advised to watch for anaphylaxis (breathing, swallowing difficulties) so that, the patient would be warranted to emergency medical care (ER) and otherwise was advised to use a cold compress (bagged frozen peas or something similar) for short times to ease the swelling and discomfort. Advised VAERS would be filed and the patient's mother may be contacted by CDC. The patient's mother stated that, the patient's older brother was vaccinated at same visit in the office with no reaction other than "a little soreness" but there was no redness or swelling. The lot numbers were checked and VARIVAX vaccine with same lot number was used for both siblings. Nurse who vaccinated both siblings stated that, there was no difference other than the different body built of the siblings -one more muscular and thinner than the other. The patient's mother states the patient had no reaction and no complaint of soreness to the GARDASIL 9 and HAVRIX vaccines which were received on the same day in the right arm. The outcome of local reaction, injection site rash, injection site pain, injection site mass and peripheral swelling was reported as recovered. The causality assessment for the events with respect to VARIVAX and GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.