chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site 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 ID-646407) This spontaneous report refers to a 21 year old male patient. Information on patient's historical conditions, concurrent conditions and other medications was not reported. On 01-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M007764 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis.  On the same day, the patient was vaccinated with BEXSERO dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On an unknown date the patient had hives around the injection site (urticarial). The outcome of injection site urticaria was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Presyncope, 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 # 646441) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included allergic to penicillin. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 04-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # K026247, expiration date: 29-JAN-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included HAVRIX and MENVEO. On 04-AUG-2016, post vaccine administration the patient was moved from exam table to chair. While sitting in chair, the patient began shaking for approximately 2 seconds as reported by administering LPN (Licensed practical nurse) and patient's mother. The patient experienced near syncopal episode for approximately 20 minutes post administration. The patient was assisted to supine position and provided with ice packs and water. LPN remained with the patient until she was well enough to walk safely. The outcome of presyncope and tremor 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
Symptoms: Pruritus generalised, Rash 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 (VAERS # 646450) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's concurrent conditions included sore throat, reactive airway disease that was not asthma and other seasonal allergic rhinitis. The patient's medical history included dust allergy and allergy to horses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 03-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L038503 (dose number, dose, frequency and lot expiration date were not reported) via intramuscular route in the left arm and VAQTA lot # M003011, Expiration date: 15-NOV-2017 (dose number, dose, frequency were not reported) via intramuscular route in the right arm for prophylaxis . On the same day, the patient developed rash and itchiness all over the body. The outcome of pruritus generalised and rash were reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Exfoliative rash, Rash, Skin exfoliation
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-646477). This spontaneous report refers to a 12 year old male patient. The patient's historical conditions included asthma. Other medications included Proair. The patient had no current illnesses. On 01-AUG-2016 the patient was vaccinated with GARDASIL 9 (lot # PM005714) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 02-AUG-2016, the patient experienced rash and skin exfoliation. Flat scaly rash on trunk was first noted in the evening. It was not painful, itchy and worsening. The patient was otherwise feeling fine. The outcome of rash and skin exfoliation was reported as 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, TDAP
Symptoms: Dizziness, Face injury, Fall, Mouth injury, Nervousness
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 # 646491) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 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 04-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the right arm, lot # L037554 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. On 04-AUG-2016, around 8:50 am in the morning the patient had fell when laying down on exam table. The patient had Injury chin and braces injury mouth. Also complained about dizzy and body feeling shaky inside. Doctor assessed the situation of patient and gave fluids, crackers and checked blood pressure. The outcome of dizziness, nervousness, mouth injury, fall and face injury 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, MNQ
Symptoms: Asthenia, Headache, Insomnia, Lethargy, 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 # 646582) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. The patient's medical history included Attention deficit disorder/Attention deficit hyperactivity disorder. The patient's concurrent illness was reported as none. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications included ZOLOFT and INTUNIV. On 02-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L043214 (dose, frequency and lot expiration date were not reported) via intramuscular route in the left arm for prophylaxis. Other suspect therapies which were given on the same day included second dose of MENACTRA (intramuscularly in the right arm, lot# U5390AA; dose and expiration date unknown) and first dose of HAVRIX (intramuscularly in the right arm, lot# Z5DM2; dose and expiration date unknown) for prophylaxis. On 02-AUG-2016, the patient experienced insomnia, weakness and lethargy which was very marked. The patient had fever of 102. The patient also had headache and neck stiffness. The outcome of the events were 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: M
Vaccine: HEPA, HPV9, MNQ
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 (VAERS # 646582) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. The patient's medical history included Attention deficit disorder/Attention deficit hyperactivity disorder. The patient's concurrent illness was reported as none. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications included ZOLOFT and INTUNIV. On 02-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L043214 (dose, frequency and lot expiration date were not reported) via intramuscular route in the left arm for prophylaxis. Other suspect therapies which were given on the same day included second dose of MENACTRA (intramuscularly in the right arm, lot# U5390AA; dose and expiration date unknown) and first dose of HAVRIX (intramuscularly in the right arm, lot# Z5DM2; dose and expiration date unknown) for prophylaxis. On 02-AUG-2016, the patient experienced insomnia, weakness and lethargy which was very marked. The patient had fever of 102. The patient also had headache and neck stiffness. The outcome of the events were 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: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, 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 # 646591) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. Patient's current illnesses were reported as vaginal yeast infection.  On 08-JUN-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot/batch# M11840 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced injection site erythema, vomiting, pyrexia, myalgia, injection site swelling and injection site pain. Patient had fever of 102 (units unspecified). The outcome of injection site erythema, vomiting, pyrexia, myalgia, injection site swelling and injection site pain 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: 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 # 646591) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. Patient's current illnesses were reported as vaginal yeast infection.  On 08-JUN-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot/batch# M11840 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced injection site erythema, vomiting, pyrexia, myalgia, injection site swelling and injection site pain. Patient had fever of 102 (units unspecified). The outcome of injection site erythema, vomiting, pyrexia, myalgia, injection site swelling and injection site pain 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: Appendicitis, Computerised tomogram abdomen abnormal, Surgery
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 # 646678) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history, concurrent illnesses and other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 03-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # M009378 (dose, frequency and lot expiration date were not reported) via intramuscular route, on the arm for prophylaxis. On 04-AUG-2016, the patient was seen in the emergency room for appendicitis and had surgery later in the day. On computerised tomogram, the patient was found to have abnormal appendix. The outcome of appendicitis, surgery and computerised tomogram abdomen abnormal 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, MNQ
Symptoms: Dizziness, Hypoacusis, Paraesthesia, 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 # 647084) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information about the patient's prior vaccinations and other medications were not reported. On 05-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # M15147 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced lightheadedness, blurry vision and decreased hearing. The patient had some tingling in the arms, 24-36 hours later. The patient was then seen, at an urgent care facility. The outcome of the events was reported as recovered. The causality assessment for the events was not reported.     Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
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 # 647120) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient's medical history included Augmentin allergy, seasonal asthma and allergic rhinitis. The patient had no concurrent illnesses. Information on the patient's other medications and prior vaccinations was not reported. On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # M013636 (dose number 4, lot expiration date: 15-FEB-2018) for prophylaxis. The patient had inadvertently received the 4th dose of GARDASIL 9 by mistake. After 12 hours of vaccination, the patient felt feverish, chills, headache, weak, myalgia and fatigue. On 06-AUG-2016, the patient felt better and on 08-AUG-2016, the patient was back to baseline. The patient's lab data was reported as none. The outcome of the events 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: M
Vaccine: HPV9
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 (VAERS # 647120) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient's medical history included Augmentin allergy, seasonal asthma and allergic rhinitis. The patient had no concurrent illnesses. Information on the patient's other medications and prior vaccinations was not reported. On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # M013636 (dose number 4, lot expiration date: 15-FEB-2018) for prophylaxis. The patient had inadvertently received the 4th dose of GARDASIL 9 by mistake. After 12 hours of vaccination, the patient felt feverish, chills, headache, weak, myalgia and fatigue. On 06-AUG-2016, the patient felt better and on 08-AUG-2016, the patient was back to baseline. The patient's lab data was reported as none. The outcome of the events 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, MNQ, TDAP
Symptoms: Crying, Dizziness, 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 # 647152) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history included seasonal allergies. The patient's concurrent illnesses and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 05-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route: unknown, site: left arm, lot # L026602, expiration date: 19-OCT-2017). On the same day, the patient was also vaccinated with MENVEO (dose number: 1, lot # M15143, route: unknown, site: left arm, manufacturer: Novartis; lot expiration date was not reported) and BOOSTRIX (dose number 1, lot # 54L37, route: unknown, site: left arm, manufacturer: GlaxoSmithKline; lot expiration date was not reported) for prophylaxis. On 05-AUG-2016 during vaccination, the patient had cried and thrashed around. After vaccination, the patient was given water which she immediately vomited (water). The patient was a little dizzy but had recovered after lying down. The patient's lab data was reported as none. The outcome for the events crying, vomiting and dizziness were 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: Immediate post-injection reaction, Injection site hypoaesthesia, Pain in extremity, 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 # 647169) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. Other medications included Evoclin and Claritin. On 02-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # L03214 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 02-AUG-2016, the patient had syncope instantly after injection. 24 hours later, the patient complained of numbness at injection site, unable to verbalize or move for several minutes and persistent arm pain. The outcome of immediate post-injection reaction, syncope, pain in extremity and injection site hypoaesthesia was 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, MNQ
Symptoms: Blood thyroid stimulating hormone, Echocardiogram, Electrocardiogram normal, Full blood count, Laboratory 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 # 647201) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. The patient's concomitant therapies, concurrent illness, prior vaccinations and medical history were not reported. The patient's other medications were reported as none. On 19-JUL-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L020015, lot expiration date 16-AUG-2017 (dose and frequency were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapy which were given on the same day included second dose of MENVEO (intramuscularly in the left arm, lot# M15068; dose and expiration date were not reported) for prophylaxis. On 02-AUG-2016, the patient had 2 episodes of syncope (also reported as 1 week after the shot). The patients electrocardiogram and laboratory test were normal. Complete blood count, thyroid stimulating hormone, basic metabolic panel and liver function tests were performed. The result of echocardiogram was pending. The outcome of the events were 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, MNQ
Symptoms: Liver function test, Metabolic function test, 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 # 647201) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. The patient's concomitant therapies, concurrent illness, prior vaccinations and medical history were not reported. The patient's other medications were reported as none. On 19-JUL-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L020015, lot expiration date 16-AUG-2017 (dose and frequency were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapy which were given on the same day included second dose of MENVEO (intramuscularly in the left arm, lot# M15068; dose and expiration date were not reported) for prophylaxis. On 02-AUG-2016, the patient had 2 episodes of syncope (also reported as 1 week after the shot). The patients electrocardiogram and laboratory test were normal. Complete blood count, thyroid stimulating hormone, basic metabolic panel and liver function tests were performed. The result of echocardiogram was pending. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Loss of consciousness, Muscle twitching
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-647213). This spontaneous report refers to a 11 year old female patient. The patient's medical history included amoxicillin allergy, inadequate weight gain and trichotillomania. The patient had no concurrent illnesses and other medications. On 28-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M011840 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, after vaccination, the patient had an episode of brief loss of consciousness with involuntary twitching and involuntary movement of extremities. The patient was under observation for 30 minutes and recovered slowly. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Chromatopsia, Ophthalmological examination normal, Visual impairment
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 # 647277) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. No concurrent illnesses, other medications and medical history of the patient were reported. On 09-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient reported that he had visual disturbances in the left eye, with "orange" appearance. The patient was re-evaluated with a vital check and were all found within normal limits. The provider performed an eye exam on the patient and no abnormalities were reported. The patient was advised to schedule an office visit with the eye doctor, if the symptoms persisted. A follow-up via phone was done, the next afternoon, with the patient's parent. The patient's visual disturbances had resolved within 12 hours and the patient had no other issues. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Cough, Differential white blood cell count normal, Epstein-Barr virus antibody 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 # 647480) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included allergy to amoxicillin, congenital torticollis, acne vulgaris and heart murmur. The patient had no known concurrent illnesses and other medications. On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 (Expiration date: 01-FEB-2018) dose 3 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5508AA dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis and TRUMENBA # M74091 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, a few hours after receiving immunizations, the patient developed a fever and it lasted approximately for 24 hours. During that time, the patient had felt thirsty and had a mild cough. On 06-AUG-2016, the patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All the patient's symptoms had resolved by 08-AUG-2016. On 11-AUG-2016, the patient underwent the following tests: blood bilirubin total test, urine analysis, Group A Strep by nucleic acid amplification, streptococcus test, infectious mononucleosis heterophile test, metabolic function test (CMP), full blood count, differential white blood cell count (complete blood count with differential), Epstein-Barr virus antibody (EBV) and bilirubin direct test. Abnormal results include: bilirubin total-1.8 mg/dL and bilirubin direct-0.7 mg/dL. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fatigue, Full blood count normal, Metabolic function test normal, Mononucleosis heterophile test negative, Ocular icterus
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 # 647480) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included allergy to amoxicillin, congenital torticollis, acne vulgaris and heart murmur. The patient had no known concurrent illnesses and other medications. On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 (Expiration date: 01-FEB-2018) dose 3 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5508AA dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis and TRUMENBA # M74091 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, a few hours after receiving immunizations, the patient developed a fever and it lasted approximately for 24 hours. During that time, the patient had felt thirsty and had a mild cough. On 06-AUG-2016, the patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All the patient's symptoms had resolved by 08-AUG-2016. On 11-AUG-2016, the patient underwent the following tests: blood bilirubin total test, urine analysis, Group A Strep by nucleic acid amplification, streptococcus test, infectious mononucleosis heterophile test, metabolic function test (CMP), full blood count, differential white blood cell count (complete blood count with differential), Epstein-Barr virus antibody (EBV) and bilirubin direct test. Abnormal results include: bilirubin total-1.8 mg/dL and bilirubin direct-0.7 mg/dL. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Pyrexia, Streptococcus test negative, Thirst, 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 # 647480) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included allergy to amoxicillin, congenital torticollis, acne vulgaris and heart murmur. The patient had no known concurrent illnesses and other medications. On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 (Expiration date: 01-FEB-2018) dose 3 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5508AA dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis and TRUMENBA # M74091 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, a few hours after receiving immunizations, the patient developed a fever and it lasted approximately for 24 hours. During that time, the patient had felt thirsty and had a mild cough. On 06-AUG-2016, the patient's mother reported that the patient's eyes looked yellow and he was complaining of fatigue. All the patient's symptoms had resolved by 08-AUG-2016. On 11-AUG-2016, the patient underwent the following tests: blood bilirubin total test, urine analysis, Group A Strep by nucleic acid amplification, streptococcus test, infectious mononucleosis heterophile test, metabolic function test (CMP), full blood count, differential white blood cell count (complete blood count with differential), Epstein-Barr virus antibody (EBV) and bilirubin direct test. Abnormal results include: bilirubin total-1.8 mg/dL and bilirubin direct-0.7 mg/dL. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Induration, 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 # 647548) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's concurrent illness included attention deficit/hyperactivity disorder (ADHD). The patient had no medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M011117 (expiration date: 07-DEC-2017) (dose, dose number and frequency were not reported), route: unknown in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # Gs5BR, route: unknown, in the right arm and MENACTRA batch/lot # M15143, route: unknown, in the right arm for prophylaxis. On an unknown date the patient's mom stated that he experienced swelling, hard by phone. The outcome of induration and swelling was unknown. 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, MENB
Symptoms: Nausea, Weight decreased
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-647614). This spontaneous report refers to a 19 year old male patient. The patient had no medical history and concurrent conditions. Information on patient's other medications was not reported. On 05-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L043214 dose 1, intramuscularly in the left arm and VAQTA lot # M011116 (expiration date: 17-JUN-2017), unspecified dose, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with TRUMENBA dose 3, intramuscularly in the right arm for prophylaxis. On 08-AUG-2016,  the patient experienced nausea and weight decreased. The patient was taken to emergency room. No local reaction on arms, no rash and no other significant symptoms were noted. The outcome of nausea and weight decreased was reported as 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, TDAP
Symptoms: Injection site erythema, 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 # 647721) on 02-MAY-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 patient's prior vaccinations was not reported. Other medications included flovent, albuterol, singulair and claritin. On 10-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA intramuscularly in the right arm, lot # US392AB (dose, frequency and lot expiration date were not reported) and BOOSTRIX intramuscularly in the left arm, lot # K2D2T (dose, frequency and lot expiration date were not reported) for prophylaxis. On 11-AUG-2016, the patient had local redness, swelling and site hot to touch. The patient required emergency room visit. The outcome of injection site erythema, injection site warmth and injection site swelling 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: HPV9
Symptoms: Local swelling, Malaise, Pyrexia, Swelling face, Throat tightness
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 # 647749) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 10 year old male patient. The patient's medical history included intermittent asthma. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 16-MAR-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L045711 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 16-MAR-2016, approximately by 8 PM the patient developed high tactile fever and was generally not feeling well. The patient vomited several times and had neck/facial swelling. He also complained of throat lightness. Mom gave BENADRYL to the patient due to the swelling and he fell asleep. The outcome of local swelling, vomiting, throat tightness, swelling face, pyrexia and malaise was reported as recovered/resolved by the next day. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: 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 # 647749) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 10 year old male patient. The patient's medical history included intermittent asthma. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 16-MAR-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L045711 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 16-MAR-2016, approximately by 8 PM the patient developed high tactile fever and was generally not feeling well. The patient vomited several times and had neck/facial swelling. He also complained of throat lightness. Mom gave BENADRYL to the patient due to the swelling and he fell asleep. The outcome of local swelling, vomiting, throat tightness, swelling face, pyrexia and malaise was reported as recovered/resolved by the next day. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
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-647810). This spontaneous report refers to a 15 year old male patient. The patient had no current conditions, medical history and other medications. On 12-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L043214 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. Shortly after vaccination, the patient experienced dizziness, hyperhidrosis and was feeling hot. The patient was diaphoretic and nervous before shot. Cool compress was applied. The patient was observed for 20 minutes with no further issues. He denied issues upon leaving and declined water. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness, 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 # 647814) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and lab data were reported as none. Information on patient's prior vaccination was not reported. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscularly for prophylaxis, in the right arm (dosage and expiry date unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # M15149, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, shortly after the vaccination, patient became pale, diaphoretic and passed out. Ammonia Inhalant used and patient aroused. Patient complained of nausea and felt dizzy and lightheaded. Cool compress was applied on patient, in her mother's presence. Patient was observed for 20 minutes without further issues. while leaving patient did not have any issues. Patient mentioned that she was tired and also drank water. The outcome of all the events were unknown. 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: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: 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 (VAERS # 647814) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and lab data were reported as none. Information on patient's prior vaccination was not reported. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscularly for prophylaxis, in the right arm (dosage and expiry date unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # M15149, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, shortly after the vaccination, patient became pale, diaphoretic and passed out. Ammonia Inhalant used and patient aroused. Patient complained of nausea and felt dizzy and lightheaded. Cool compress was applied on patient, in her mother's presence. Patient was observed for 20 minutes without further issues. while leaving patient did not have any issues. Patient mentioned that she was tired and also drank water. The outcome of all the events were unknown. 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, MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site 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 # 647828) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses, medical history and other medications were reported as none. Information on patient's prior vaccinations was not reported. On 10-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # L024993, expiration date:17-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included MENACTRA via unknown route in the left arm, lot # US178AA, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 11-AUG-2016, the patient's left upper arm became red, swollen, painful, hot to touch, itching, body temperature 99.0 (body temperature increased) and malaise. The patient was treated with Prednisone burst 20 mg thrice a day for 3 days, twice a day for 3 days then daily once for 3 days and Hydroxyzine 25 mg one every 8 hours. The outcome of body temperature increased, malaise, injection site warmth, injection site swelling, injection site pruritus, injection site pain and injection site erythema 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: HPV9, MNQ
Symptoms: Injection site warmth, Malaise
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 # 647828) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses, medical history and other medications were reported as none. Information on patient's prior vaccinations was not reported. On 10-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # L024993, expiration date:17-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included MENACTRA via unknown route in the left arm, lot # US178AA, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 11-AUG-2016, the patient's left upper arm became red, swollen, painful, hot to touch, itching, body temperature 99.0 (body temperature increased) and malaise. The patient was treated with Prednisone burst 20 mg thrice a day for 3 days, twice a day for 3 days then daily once for 3 days and Hydroxyzine 25 mg one every 8 hours. The outcome of body temperature increased, malaise, injection site warmth, injection site swelling, injection site pruritus, injection site pain and injection site erythema 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: HPV9, MENB
Symptoms: Nausea, 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 ID-647836) This spontaneous report refers to a 18 year old male patient. The patient had no current illnesses, historical conditions and other medications. On 20-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # M003659 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M95612, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. After vaccination, the patient had nausea and vomiting for approximately 30 hours. The patient recovered at home. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
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-647838) This spontaneous report refers to a 18 year old female patient. The patient had no current illnesses, historical conditions and other medications. On 05-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L019297 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. One minute post vaccination, the patient had an episode of syncope. Blood pressure (BP) before vaccination was 104/64 (units unspecified) and at the onset of episode, it was 80/40 (units unspecified). The patient was pale, diaphoretic and unresponsive to stimuli for one hour. 2 minutes post incident, patient's BP was 90/60 (units unspecified). The patient became alert and responsive. 5 minutes post incident, patient's blood pressure was 106/60 (units unspecified). The patient rested for 30 minutes. The outcome of events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.