chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Blindness transient, Hyperhidrosis, Hypotension, Nausea, Pallor
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 (HA #628133) and refers to a 18 year old female patient. The patient's medical history included cold urticaria and had no current illnesses. Lab data was reported as none, but just repeat BP check. On 19-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L017407, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 19-MAR-2016, the patient experienced Nausea, Vomiting, Hypotension (Blood Pressure was 96/60 (unit unknown)), pre syncope, ringing in the ears, transient vision loss, diaphoresis, pallor. Symptoms lasted approximately 45 minutes. Symptoms started to improve after laying down, cool compresses and drinking water. The outcome of blindness transient, vomiting, tinnitus, presyncope, pallor, nausea, hypotension and hyperhidrosis was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Tinnitus, 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 (HA #628133) and refers to a 18 year old female patient. The patient's medical history included cold urticaria and had no current illnesses. Lab data was reported as none, but just repeat BP check. On 19-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L017407, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 19-MAR-2016, the patient experienced Nausea, Vomiting, Hypotension (Blood Pressure was 96/60 (unit unknown)), pre syncope, ringing in the ears, transient vision loss, diaphoresis, pallor. Symptoms lasted approximately 45 minutes. Symptoms started to improve after laying down, cool compresses and drinking water. The outcome of blindness transient, vomiting, tinnitus, presyncope, pallor, nausea, hypotension and hyperhidrosis was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
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 ID-628184). This spontaneous report refers to a 17 year old female patient. The patient had no current illnesses. The patient's historical conditions and other medications were not reported. On 08-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L016429 dose 2, intramuscular in the right arm for prophylaxis. On 09-MAR-2016, the patient experienced injection site oedema, injection site warmth and injection site pain in the right deltoid. The outcome of injection site oedema, injection site warmth and injection site pain was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site warmth
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 (HA #628395) and refers to a 12 year old female patient. Patient's current illnesses and medical history was reported as none known. On 31-DEC-2015 the patient was vaccinated with GARDASIL 9, dose 3, via an unknown route in the left arm for prophylaxis. Since 17-FEB-2016, patient is experiencing intermittent lump at injection site which comes and goes. Sometimes the lump will be warm to touch and painful. The outcome of injection site mass, injection site warmth and injection site pain was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: M
Vaccine: HPV9, MMRV
Symptoms: Cheilitis, Lymphadenopathy, Oral mucosal eruption, Rash
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 (HA #629012) and refers to a 12 year old male patient. No details about current illnesses, medical history, lab data and prior vaccination was provided. Other medication was none. On 08-MAR-2016 the patient was vaccinated with GARDASIL 9, lot # L018351, dose 2, intramuscular for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with PROQUAD (administered on 08-MAR-2016, lot# L040411, intramuscular for prophylaxis). On 08-MAR-2016, Patient developed a rash on mouth/ears/lips/face. On 18-MAR-2016, his mother said rash was still present. Physician examined and recommended BENADRYL PRN. Patient also developed lymph node enlargement on right posterior neck on 17-MAR-2017. Patient came for follow up in a 1 week to reassess. Rash was resolved according to the physician's exam and lymph node reevaluation pending. Thus the outcome of rash was recovered and outcome of lymphadenopathy was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea
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 # 629101) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient had no concurrent illnesses. Information on the patient's medical history, other medications and prior vaccination details was not reported. On 23-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 in the right arm (unknown route), lot # L017407 (frequency and lot expiration date unknown) for prophylaxis. On the same day, post vaccination, the patient experienced headache and nausea that lasted for 5-10 minutes. The patient was then given BENADRYL 25 mg in office. The patient's blood pressure (BP) was normal. The outcome for the events headache and nausea 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: Full blood count, Metabolic function test, Pruritus generalised
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 (HA #629205) and refers to a 20 year old female patient. patient's current illnesses and medical history was reported as none. Her other medication included ethinyl estradiol norgestimate(ORTHO TRI CYLEN). On 21-JAN-2016 the patient was vaccinated with GARDASIL 9, lot # L016429, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 27-JAN-2016, the patient experienced widespread itching with no actual skin rash. On 27-JAN-2016, the patient underwent Blood work- CBC (complete blood count) and CMP (comprehensive metabolic panel) and results were not reported. The patient was treated with prednisone and antihistamine. The outcome of full blood count, pruritus and metabolic function test was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dysarthria, Loss of consciousness, Miosis, Muscle rigidity, Musculoskeletal stiffness
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 ID-629406) This spontaneous report refers to a 18 year old female patient. The patient's other medications included Celexa. The patient's historical conditions included anxiety for celexa. The patient had no current illnesses.  On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot # A15066) dose 1 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. While receiving GARDASIL 9, the patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck. Patient remained unconscious approximately 3 minutes. Once awake, speech remained slow and slurred for approximately 5 minutes. The patient had dysarthria and nuchal rigidity. The patient complained of continued muscle stiffness. Pupils were constricted and unreactive to light accommodation for approximately 5 minutes after regaining consciousness. The patient was taken to emergency room. The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Nuchal rigidity, Posturing, Pupillary reflex impaired, Seizure like phenomena, Slow speech
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 ID-629406) This spontaneous report refers to a 18 year old female patient. The patient's other medications included Celexa. The patient's historical conditions included anxiety for celexa. The patient had no current illnesses.  On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot # A15066) dose 1 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. While receiving GARDASIL 9, the patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck. Patient remained unconscious approximately 3 minutes. Once awake, speech remained slow and slurred for approximately 5 minutes. The patient had dysarthria and nuchal rigidity. The patient complained of continued muscle stiffness. Pupils were constricted and unreactive to light accommodation for approximately 5 minutes after regaining consciousness. The patient was taken to emergency room. The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Tremor
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 ID-629406) This spontaneous report refers to a 18 year old female patient. The patient's other medications included Celexa. The patient's historical conditions included anxiety for celexa. The patient had no current illnesses.  On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot # A15066) dose 1 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. While receiving GARDASIL 9, the patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck. Patient remained unconscious approximately 3 minutes. Once awake, speech remained slow and slurred for approximately 5 minutes. The patient had dysarthria and nuchal rigidity. The patient complained of continued muscle stiffness. Pupils were constricted and unreactive to light accommodation for approximately 5 minutes after regaining consciousness. The patient was taken to emergency room. The outcome of the events 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: HPV9, MNQ
Symptoms: Decreased appetite, Diarrhoea, Headache, Muscular weakness, Pain
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 # 630037) on 18-APR-2017. This spontaneous report refers to a 17 year old male patient. Information about the patient's medical history, prior vaccinations and other medications were not reported. The patient's concurrent illness included ear pain. On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 1 (unspecified dosage), intramuscularly in the arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5228BA, dose 1 (unspecified dosage), intramuscularly in the arm for prophylaxis. On 29-MAR-2016, the day after the vaccine was administered, the patient started vomiting and required an emergency room visit. Two days after the administration, the patient experienced pyrexia, body aches, muscular weakness, headache, diarrhea and decreased appetite. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pyrexia, 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 # 630037) on 18-APR-2017. This spontaneous report refers to a 17 year old male patient. Information about the patient's medical history, prior vaccinations and other medications were not reported. The patient's concurrent illness included ear pain. On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 1 (unspecified dosage), intramuscularly in the arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5228BA, dose 1 (unspecified dosage), intramuscularly in the arm for prophylaxis. On 29-MAR-2016, the day after the vaccine was administered, the patient started vomiting and required an emergency room visit. Two days after the administration, the patient experienced pyrexia, body aches, muscular weakness, headache, diarrhea and decreased appetite. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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 # 630076). This spontaneous report refers to a 12 year old female patient. The patient had no current illnesses and information on other medications was not reported. The patient's medical history included drug amoxicillin allergy, asthma and migraines. On 30-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L019286 (expiry date: 14-SEP-2017), dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VARIVAX lot # L037559, dose 2, intramuscularly in the left arm and HAVRIX lot # C9DA2, dose 2, intramuscularly in the right arm for prophylaxis. On 31-MAR-2016 in the morning, the patient's mother noticed immunization site red and swollen before sending the patient to school. After returning from school ice was applied, swelling increased in left arm, pain and warmth to site was noted. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 and VARIVAX 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, MNQ, TDAP
Symptoms: Computerised tomogram head, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
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 # 630290) on 18-APR-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and had no known allergies. The patient's other medications included albuterol HFA, amoxicillin, OMNICEF and TYLENOL for cough, ear and eye infection from previous encounter. The patient was clear of infections before vaccine administration. On 02-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (unspecified dose and dosage), intramuscularly for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5263AA, (unspecified dose and dosage), intramuscularly for prophylaxis and MENACTRA lot # U5216AA, (unspecified dose and dosage), intramuscularly for prophylaxis. Seconds after administering the three vaccines, the patient fainted, fell and hit the right side of the head on the floor. The patient lost consciousness for about 30 seconds and also experienced loss of bladder control. There was no vomiting reported. The vital signs of the patient was checked and found to be normal. The patient was observed in the clinic for 45 minutes and then sent to the emergency room (ER) for further monitoring, where she underwent an computerized tomogram head (CT). The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope, Urinary incontinence
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 # 630290) on 18-APR-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and had no known allergies. The patient's other medications included albuterol HFA, amoxicillin, OMNICEF and TYLENOL for cough, ear and eye infection from previous encounter. The patient was clear of infections before vaccine administration. On 02-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (unspecified dose and dosage), intramuscularly for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5263AA, (unspecified dose and dosage), intramuscularly for prophylaxis and MENACTRA lot # U5216AA, (unspecified dose and dosage), intramuscularly for prophylaxis. Seconds after administering the three vaccines, the patient fainted, fell and hit the right side of the head on the floor. The patient lost consciousness for about 30 seconds and also experienced loss of bladder control. There was no vomiting reported. The vital signs of the patient was checked and found to be normal. The patient was observed in the clinic for 45 minutes and then sent to the emergency room (ER) for further monitoring, where she underwent an computerized tomogram head (CT). The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Dizziness, Full blood count, Headache
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 # 630426) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient's medical history included allergic rhinitis. The patient had no concurrent illnesses. The patient's other medication and prior vaccinations were not reported. On 24-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L040164 (dose number: 3, frequency and lot expiration date were not reported) for prophylaxis. On the same day post vaccination, the patient experienced sudden headache, dizziness and the patient's complete blood count with differential white blood cell count (CBC/Diff), thyroxine (T4) and thyroid stimulating hormone (TSH) were tested. The events required emergency room visit. The outcome of all the events was reported as not 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: Thyroxine
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 # 630426) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient's medical history included allergic rhinitis. The patient had no concurrent illnesses. The patient's other medication and prior vaccinations were not reported. On 24-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L040164 (dose number: 3, frequency and lot expiration date were not reported) for prophylaxis. On the same day post vaccination, the patient experienced sudden headache, dizziness and the patient's complete blood count with differential white blood cell count (CBC/Diff), thyroxine (T4) and thyroid stimulating hormone (TSH) were tested. The events required emergency room visit. The outcome of all the events was reported as not 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, MNQ, TDAP
Symptoms: 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 # 630439). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses or medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included multivitamins. On 05-APR-2016, the patient was vaccinated with GARDASIL 9 batch# I045711, dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified) and the patient was also vaccinated with ADACEL batch/lot# UI543AA, dose 1, intramuscular route in the left arm and MENACTRA batch/lot# U5228BA, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On the same day, the patient had hives, which progressed to whole body urticaria. The patient was seen in office on 06-APR-2016 and was treated with Zyrtec and steroids and was referred to allergist. The outcome of urticaria was unknown. The causality assessment for the event urticaria with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blister, Contusion, Rash
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 # 630549). This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations was not reported. On 05-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 2, intramuscular route in an unknown site for prophylaxis (dosage unspecified). On 06-APR-2016, the patient developed rash that progressed to bruising and blister on the left arm. The patient required emergency room visit. The outcome of blister, rash and contusion was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HEPA, HPV9, MNQ
Symptoms: Exposure during pregnancy, No adverse event
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 # 630599). This spontaneous prospective pregnancy report refers to a 16 year old female patient. The patient's concurrent illnesses included dysuria and the patient was about 19 weeks pregnant. The patient's other medications included prenatal vitamins. Information on the patient's prior vaccinations was not reported. On 06-APR-2016, the patient was vaccinated with GARDASIL 9 batch/lot# L01297, dose 4, intramuscular route in the left arm for prophylaxis and the patient was also vaccinated with VAQTA lot# L023936 (expiry date: 15-MAR-2017), dose 3, intramuscular route in the right arm, MENACTRA batch/lot# U5228BA, dose 3, intramuscular route in the left arm and FLUZONE lot/batch# UI443AC, dose 9, intramuscular route in the right arm for prophylaxis. On 06-APR-2016, exposure during pregnancy was reported. No adverse event noted, vaccine given was not recommended in pregnant women. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache
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 # 630681). This spontaneous report refers to a 13 year old female patient. The patient's medical history included avascular necrosis of hip, scoliosis deformity at spine and slipped capital femoral epiphysis. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 31-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017), dose 1, unknown route in the left arm for prophylaxis (dosage unspecified). On the same day, within 15 min after immunization the patient developed headache. The patient was brought back into exam room and examined. The patient's neuro was intact. The patient was given TYLENOL and food. The outcome of headache was reported as recovered. The 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, MNQ, TDAP
Symptoms: Anaemia, Haemoglobin decreased, Muscular weakness, Pain in extremity
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 # 630714). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses and historical conditions. Information on the patient's prior vaccinations was not reported. The patient's other medications included seroquel and guanfacine. On 04-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L013429 (expiry date: 21-JUL-2017) dose 1, intramuscular route in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL batch/lot# U5264AA, dose 1, intramuscular route in the left arm, MENVEO batch/lot# M15065, dose 1, intramuscular route in the right arm and HAVRIX batch/lot# 49LH2, dose 1, intramuscular route in the left arm for prophylaxis. On 26-FEB-2016, the patient experienced severe arm pain, muscular weakness, haemoglobin decreased and mild anaemia. The outcome of anaemia, pain in extremity, muscular weakness and haemoglobin decreased was reported as recovered. The 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: Seizure, Syncope, Urinary incontinence
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 # 630931) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 12 year old female patient. The patient's medical history was not reported. The patient's other medications included Adderal and Concerta. The patient had no concurrent illnesses. The patient's prior vaccinations included dose 1 of GARDASIL and post vaccination at 11:00 patient experienced Syncope and 2 doses of GARDASIL 9. On 10-MAR-2016, the patient was vaccinated with the third dose (also reported as dose number 2) of GARDASIL 9 intramuscularly in the left arm, lot # L024993, (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day post vaccination, the patient was sent to the waiting room for 15 minutes. During the waiting period patient was seated on her mother's lap and experienced syncope with seizure and was incontinent of urine. The patient was seen by CRNP VSS after which she rested in office for 30 minutes and was then sent home. The event required an emergency room (ER) visit. The outcome for the events seizure, syncope and urinary incontinence was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Chest X-ray normal, Chest discomfort, Dyspnoea, Nausea
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 (HA # 631126) and refers to a 17 year old female patient. The patient's medical history included rhinitis allergic and dermatitis atopic and current illnesses was reported as none. On 07-APR-2016 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA and BOOSTRIX. On 08-APR-2016, a day after immunizations, the patient awoke feeling weak, nauseated, chest pressure/heaviness, SOB and low-grade fever. Patient was seen in clinic, was stable with normal exam and recommended to rest at home. On 08-APR-2016, the patient had chest X-ray normal and the O2 (Oxygen) sat was 97-98%. The outcome of asthenia, pyrexia, nausea, dyspnoea, chest discomfort and chest x-ray normal was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 (HA # 631126) and refers to a 17 year old female patient. The patient's medical history included rhinitis allergic and dermatitis atopic and current illnesses was reported as none. On 07-APR-2016 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA and BOOSTRIX. On 08-APR-2016, a day after immunizations, the patient awoke feeling weak, nauseated, chest pressure/heaviness, SOB and low-grade fever. Patient was seen in clinic, was stable with normal exam and recommended to rest at home. On 08-APR-2016, the patient had chest X-ray normal and the O2 (Oxygen) sat was 97-98%. The outcome of asthenia, pyrexia, nausea, dyspnoea, chest discomfort and chest x-ray normal was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Altered state of consciousness, Breath holding, Pallor, Presyncope, Tension
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 # 631646) on 18-APR-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 08-APR-2016 the patient was vaccinated with the first dose of with GARDASIL 9 lot # L044475, intramuscularly in the right arm for prophylaxis. Other suspect therapies included second dose of VAQTA Lot # L045713, intramuscularly in the right arm for prophylaxis. On 08-APR-2016, while administering the vaccine, the patient was tensed, shaking and holding his breath that he was about to pass out and the patient was advised to breathe. The mother was advised to sit in the office for few minutes to make sure the patient was not going to pass out. A few minutes later, after the patient left the room his mother called for help. It was observed that the patient was pale and was voiding urine. The patient was laid down and was given water and crackers. Several practitioners went in to check the patient and his mother was explained about the vaso-vagal symptoms that are common with adolescents and the importance of follow up care. The patient was diagnosed with vaso vagal response after vaccines when he was taken to the ER.  The outcome of breath holding, urinary incontinence, tremor, tension, pre-syncope and pallor was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Tremor, Urinary incontinence
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 # 631646) on 18-APR-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 08-APR-2016 the patient was vaccinated with the first dose of with GARDASIL 9 lot # L044475, intramuscularly in the right arm for prophylaxis. Other suspect therapies included second dose of VAQTA Lot # L045713, intramuscularly in the right arm for prophylaxis. On 08-APR-2016, while administering the vaccine, the patient was tensed, shaking and holding his breath that he was about to pass out and the patient was advised to breathe. The mother was advised to sit in the office for few minutes to make sure the patient was not going to pass out. A few minutes later, after the patient left the room his mother called for help. It was observed that the patient was pale and was voiding urine. The patient was laid down and was given water and crackers. Several practitioners went in to check the patient and his mother was explained about the vaso-vagal symptoms that are common with adolescents and the importance of follow up care. The patient was diagnosed with vaso vagal response after vaccines when he was taken to the ER.  The outcome of breath holding, urinary incontinence, tremor, tension, pre-syncope and pallor was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Erythema, Injection site vesicles, Oral mucosal blistering, Pain, Penile blister
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 # 632217) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. The patient's medical history included appendectomy. The patient's current illnesses include headache. Information on concomitant medications, lab data and prior vaccinations were not reported. On 26-OCT-2012, the patient received a dose of HPV4 and Hepatitis A, Peds/Adol and he was fine. On 9-APR-2016, the patient received GARDASIL 9 injection, lot # L043213, dose number 1 (dose and lot expiration date unknown) via intramuscular route in the left arm along with Peds/Adol HAVRIX injection, lot # N2D79, dose number 2 via intramuscular route in the right arm for prophylaxis. On 10-APR-2016, the patient had really bad blisters that were raised located inside and outside of his mouth. They were weeping and red. Patient stated that they are painful. He also had these blisters located on his penis, soles of his feet, injection site of GARDASIL 9 vaccine and on his hands. Patient did go to the Emergency Department because his condition got worse and his mom was very concerned. The outcome of the events were reported as not recovered/not resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Wound secretion
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 # 632217) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. The patient's medical history included appendectomy. The patient's current illnesses include headache. Information on concomitant medications, lab data and prior vaccinations were not reported. On 26-OCT-2012, the patient received a dose of HPV4 and Hepatitis A, Peds/Adol and he was fine. On 9-APR-2016, the patient received GARDASIL 9 injection, lot # L043213, dose number 1 (dose and lot expiration date unknown) via intramuscular route in the left arm along with Peds/Adol HAVRIX injection, lot # N2D79, dose number 2 via intramuscular route in the right arm for prophylaxis. On 10-APR-2016, the patient had really bad blisters that were raised located inside and outside of his mouth. They were weeping and red. Patient stated that they are painful. He also had these blisters located on his penis, soles of his feet, injection site of GARDASIL 9 vaccine and on his hands. Patient did go to the Emergency Department because his condition got worse and his mom was very concerned. The outcome of the events were reported as not recovered/not resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: 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 # 632317) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included syncope. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 13-APR-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L019297 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA intramuscularly in the right arm, lot# U5244AA, manufacturer: Sanofi Pasteur, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-APR-2016 within 5 minutes of GARDASIL 9 and MENACTRA vaccine administration the patient experienced syncope. The patient required emergency room (ER) visit. The patient was examined at office and not referred to emergency department. The patient was recovered from syncope on her own without intervention. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
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 # 632765) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 19-APR-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L017407 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VAQTA intramuscularly in the right arm, lot# L034381, (dose, frequency and lot expiration date were not reported) and MENACTRA intramuscularly in the left arm, lot# U5185BA, manufacturer: Sanofi Pasteur, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 21-APR-2016 the patient's mother had called after hours service and reported redness, swelling, pain, size of a softball and hot and hard to touch where immunization was given. The patient required emergency room (ER) visit. The outcome of injection site erythema, injection site induration, injection site pain, injection site swelling and Injection site warmth 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: Abdominal pain upper, Lymph node pain, Lymphadenopathy
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 # 632797) on 18-APR-2017. This spontaneous report refers to a 24 year old female patient. The patient's medical history included no allergies, no birth defects and cystic breasts.The patient's concurrent conditions included anxiety and other medications included lamictal, multi vitamin concentrate intravenous infusion (MVI), fish oil and vitamin. On 06-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (Expiration date:19-OCT-2017) dose 1 (unspecified dosage), via an unknown route, in the left arm for prophylaxis. On 07-APR-2016, the patient experienced sharp intermittent upper abdominal pain, lymphadenopathy and lymph node pain. On 08-APR-2016, the patient had swollen left armpit nodes in the size of a kidney bean. The patient stated that it was very tender and was unable to wash the area. The patient required an emergency visit to the physician on 08-APR-2016 and was prescribed claritin and benadryl, as a daily dose. On 19-APR-2016, the patient reported that the area was still swollen and had no stomach pain. The outcome of the events was reported as not recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, Flushing, Headache, Influenza A virus test negative
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 # 632809) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's concurrent illnesses and prior vaccinations were not reported. The patient's medical history included no known drug allergies, no birth defects, menorrhagia and dysmenorrhoea. Other medications included Necon. On 19-APR-2016 at 14:00, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-APR-2016 the patient awoke in the night with headache, dizziness, fever 102.5 (units unknown), body aches, had facial flushing and one episode of diarrhea. The patient was presented to clinic for evaluation where it was determined that influenza swabs - negative for influenza A and B. No local reaction was observed by PA-C. The outcome of diarrhoea, dizziness, flushing, headache, influenza a virus test negative, influenza b virus test, influenza virus test negative, pain and pyrexia was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza B virus test, Influenza virus test negative, Middle insomnia, 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 # 632809) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's concurrent illnesses and prior vaccinations were not reported. The patient's medical history included no known drug allergies, no birth defects, menorrhagia and dysmenorrhoea. Other medications included Necon. On 19-APR-2016 at 14:00, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-APR-2016 the patient awoke in the night with headache, dizziness, fever 102.5 (units unknown), body aches, had facial flushing and one episode of diarrhea. The patient was presented to clinic for evaluation where it was determined that influenza swabs - negative for influenza A and B. No local reaction was observed by PA-C. The outcome of diarrhoea, dizziness, flushing, headache, influenza a virus test negative, influenza b virus test, influenza virus test negative, pain and pyrexia was unknown. 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: Erythema, Pain, 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 # 632850) on 18-APR-2017. This spontaneous report refers to a 13 year old female patient. Information about the patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses and historical conditions. On 23-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L048237, dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced pain and noticed, swelling and redness later on that day. The patient noticed that the condition became worse on 24-APR-2016 (Sunday) and required emergency room visit the next day, 25-APR-2016. The patient was then prescribed cephalexin and Benadryl. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.