chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV9
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, 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 # 657488) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9  (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) Manufacturer: unknown (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On the same day post vaccination the patient experienced severe headache immediately, nausea, vision issue, sore throat and fatigue. The outcome of fatigue, headache, immediate post-injection reaction, nausea, oropharyngeal pain and visual impairment was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Incorrect dose administered
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 # 657788) on 02-MAY-2016. This spontaneous report as received from a regulatory authority refers to a 20 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 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included second dose of HAVRIX intramuscularly in the left arm, lot # C7392, Manufacturer: GlaxoSmithKline, first dose of BEXSERO intramuscularly in the left arm, lot # 157101A, Manufacturer: Novartis and the second dose of MENACTRA intramuscularly in the right arm, lot # U5260AA, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day the adult patient was vaccinated with the pediatric dose of HAVRIX. The outcome of drug administered to patient of inappropriate age was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyspnoea, Pallor, Rash, Rash erythematous, Skin discolouration
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 # 657819) on 02-MAY-2017. This spontaneous report 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 the other medications were not reported. On 16-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 batch/lot # L400054 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # 7RJ9B, intramuscularly in the left arm and MENACTRA batch/lot # U5392AA, intramuscularly in the right arm for prophylaxis. On 16-SEP-2016, the patient became pale with red speckles on and all around his face. His periorbital area became dark purple. The patient also complained of mild shortness of breath within minutes of vaccine. The patient was immediately given oral allergy medication/CLARITIN. The care provider chose not to give IM BENADRYL on hand to see how patient responded instead of upsetting him with another injection. After 20 minutes, the patient's color and breathing difficulty had returned to normal. His breathing never became labored anymore. The outcome of skin discolouration, pallor, erythema and dyspnoea 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, MEN, TDAP
Symptoms: Dizziness, Fatigue, 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 # 657900) 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 on the patient's prior vaccinations and the other medications were not reported. On 03-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L036301 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # E735A, intramuscularly in the right arm and MENOMUNE-A/C/Y/W-135 batch/lot # U5228BB, intramuscularly in the right arm for prophylaxis. On 04-OCT-2016, the patient woke up feeling very fatigue, dizzy and vomiting. The outcome of vomiting, fatigue and dizziness was unknown. 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: Antinuclear antibody negative, Blood creatine phosphokinase normal, Culture throat negative, Haematocrit normal, Haemoglobin 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 # 658226) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's concurrent illness included subacute impetigo. The patient's medical history included obesity. Information on the patient's prior vaccinations was not reported. The patient's other medications included Sulfamethoxazole. On 08-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L036301 (dose, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. On 08-SEP-2016, the patient went for a wellness checkup. GARDASIL 9 was given as routine vaccine. The patient had some subacute impetigo on groin but no fever, no illness and no visible problems were observed. On an unknown date the patient began to have pain in arm and lowered on 12-SEP-2016. Pain with movement was observed on 15-SEP-2016, 17-SEP-2016 and 19-SEP-2016 and the patient also experienced white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative. The patient went to the ER. Her symptoms were resolved. The lab data of the patient included Sed rate, 18; nl CPK, WBC 3000, x-rays nl, Streptozyme, neg; CPK, 125; ANA, neg; Rapid strep, neg; Throat culture, neg; CBC-WBC, 3,900; Hgb, 13; Hct, 36.5; Pit, 220,000. The outcome of white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, pain in extremity, pain, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative 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: Pain, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate increased, Streptococcus 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 # 658226) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's concurrent illness included subacute impetigo. The patient's medical history included obesity. Information on the patient's prior vaccinations was not reported. The patient's other medications included Sulfamethoxazole. On 08-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L036301 (dose, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. On 08-SEP-2016, the patient went for a wellness checkup. GARDASIL 9 was given as routine vaccine. The patient had some subacute impetigo on groin but no fever, no illness and no visible problems were observed. On an unknown date the patient began to have pain in arm and lowered on 12-SEP-2016. Pain with movement was observed on 15-SEP-2016, 17-SEP-2016 and 19-SEP-2016 and the patient also experienced white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative. The patient went to the ER. Her symptoms were resolved. The lab data of the patient included Sed rate, 18; nl CPK, WBC 3000, x-rays nl, Streptozyme, neg; CPK, 125; ANA, neg; Rapid strep, neg; Throat culture, neg; CBC-WBC, 3,900; Hgb, 13; Hct, 36.5; Pit, 220,000. The outcome of white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, pain in extremity, pain, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative 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: White blood cell count decreased, X-ray 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 # 658226) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's concurrent illness included subacute impetigo. The patient's medical history included obesity. Information on the patient's prior vaccinations was not reported. The patient's other medications included Sulfamethoxazole. On 08-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L036301 (dose, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. On 08-SEP-2016, the patient went for a wellness checkup. GARDASIL 9 was given as routine vaccine. The patient had some subacute impetigo on groin but no fever, no illness and no visible problems were observed. On an unknown date the patient began to have pain in arm and lowered on 12-SEP-2016. Pain with movement was observed on 15-SEP-2016, 17-SEP-2016 and 19-SEP-2016 and the patient also experienced white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative. The patient went to the ER. Her symptoms were resolved. The lab data of the patient included Sed rate, 18; nl CPK, WBC 3000, x-rays nl, Streptozyme, neg; CPK, 125; ANA, neg; Rapid strep, neg; Throat culture, neg; CBC-WBC, 3,900; Hgb, 13; Hct, 36.5; Pit, 220,000. The outcome of white blood cell count decreased, haemoglobin normal, streptococcus test negative, red blood cell sedimentation rate increased, platelet count normal, pain in extremity, pain, x-ray normal, haematocrit normal, culture throat negative, blood creatine phosphokinase normal and antinuclear antibody negative 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: Decreased appetite, Dizziness, Dyspnoea, Full blood count normal, 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 # 657985) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on the patient's prior vaccinations, current illnesses and other medications were not reported. The patient's medical histories included copperhead bite on 15-JUL-2016 and received CROFAB, on 25-AUG-2016 dizziness and fatigue and tested positive for recent Epstein-Barr virus (EBV) infection. On 26-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M018644 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient's lab data included chemistries. On 28-SEP-2016, the patient experienced shaking, dry heaving, nausea, feeling short of breath at times, dizzy, loss of appetite and sore throat. The outcome of decreased appetite, dizziness, dyspnoea, full blood count normal, laboratory test normal, nausea, oropharyngeal pain, retching, streptococcus test negative and tremor was reported as not recovered/not 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: Nausea, Oropharyngeal pain, Retching, Streptococcus test negative, 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 # 657985) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on the patient's prior vaccinations, current illnesses and other medications were not reported. The patient's medical histories included copperhead bite on 15-JUL-2016 and received CROFAB, on 25-AUG-2016 dizziness and fatigue and tested positive for recent Epstein-Barr virus (EBV) infection. On 26-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M018644 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient's lab data included chemistries. On 28-SEP-2016, the patient experienced shaking, dry heaving, nausea, feeling short of breath at times, dizzy, loss of appetite and sore throat. The outcome of decreased appetite, dizziness, dyspnoea, full blood count normal, laboratory test normal, nausea, oropharyngeal pain, retching, streptococcus test negative and tremor was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Cold sweat, Heart rate increased, Loss of consciousness, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658148) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 07-OCT-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M007764 (expiration date: 30-JAN-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT batch/lot # 9D325, dose 7, intramuscularly in the right arm for prophylaxis. On 07-OCT-2016, the patient began to lean against the door with her left shoulder and sat down on nursing student's knee. The patient was clammy and had pounding rapid pulse. She then passed out but quickly gained her consciousness after being laid on the exam table with her feet elevated. The outcome of loss of consciousness, heart rate increased and cold sweat 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: FLU4, HPV9, MNQ
Symptoms: Body temperature increased, Erythema, Pain, Skin warm, 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 # 658229) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. Information on patient's medical history and other medications were not reported. The patient had no concurrent illnesses. Information on patient's prior vaccination was reported as same vaccine not specified with no brand name. On 06-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M016193, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLULAVAL (vaccinated date: 06-OCT-2016, intramuscularly in the right arm, lot# AE735; dose and expiration date unknown) and MENVEO (dose number: 1, vaccinated date: 06-OCT-2016, intramuscularly in the right arm, lot# M16010; dose and expiration date unknown). On 07-OCT-2016, the patient's body temperature increased, white blood cell count normal and also experienced swelling, skin warm, pain and erythema. Redness below the elbow was moderately painful. Patient's body temperature was 99 (units unspecified) and WBC (white blood cell) count was 6.1 (units unspecified). The outcome of body temperature increased, white blood cell count normal, swelling, skin warm, pain and erythema were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: White blood cell count 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 # 658229) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. Information on patient's medical history and other medications were not reported. The patient had no concurrent illnesses. Information on patient's prior vaccination was reported as same vaccine not specified with no brand name. On 06-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M016193, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLULAVAL (vaccinated date: 06-OCT-2016, intramuscularly in the right arm, lot# AE735; dose and expiration date unknown) and MENVEO (dose number: 1, vaccinated date: 06-OCT-2016, intramuscularly in the right arm, lot# M16010; dose and expiration date unknown). On 07-OCT-2016, the patient's body temperature increased, white blood cell count normal and also experienced swelling, skin warm, pain and erythema. Redness below the elbow was moderately painful. Patient's body temperature was 99 (units unspecified) and WBC (white blood cell) count was 6.1 (units unspecified). The outcome of body temperature increased, white blood cell count normal, swelling, skin warm, pain and erythema were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Influenza like illness, 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 # 658230) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and anxiety with depression. Patient's other medications included VYVANSE 30 mg, Melatonin 5 mg and CLARITIN 10 mg. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 04-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L026602, via unknown route in the right arm for prophylaxis. On the same day, the patient experienced dizziness, nausea and influenza like illness. Patient felt nauseated for about 20 minutes after getting home and this feeling continued for at least a week. Lab data revealed that nothing was notified until 22-SEP-2016. The outcome of dizziness, nausea and influenza like illness were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: 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 # 658472) 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 was reported as none. The patient had no concurrent illnesses. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 17-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L026602, lot expiration date 19-OCT-2017 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. On 17-AUG-2016, post vaccination the patient's deltoid remained sore for 5 weeks. The patient's deltoid hurts with movement. The outcome of pain 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.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Gaze palsy, Tension, 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 # 658895) on 02-MAY-2017. This spontaneous report refers to a 15 year old female patient. The patient had no concurrent illnesses. The patient's medical history included allergic rhinitis, gastro-oesophageal reflux disease (GERD), tetracycline intolerance and rash. Information on the patient's prior vaccinations and the other medications were not reported. On 04-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # L040164 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. On 04-OCT-2016, the patient did not sit after GARDASIL 9 injection. She fell to the floor, her eyes rolled back, patient was unresponsive and her legs and arms were tensed for 3-5 minutes approximately. The patient was recovered 2 minutes later. The outcome of fall, unresponsive to stimuli, tension and gaze palsy 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: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, 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 # 659150) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's had no concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 03-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M009378 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included first dose of ADACEL lot # U5459AC and MENACTRA lot # U5415AA, via intramuscularly in the left arm, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day the patient experienced redness, swelling on the left arm from the deltoid muscle and down 120 millimeter, area was warm to touch, slightly hard and raised. The affected area measured approximately 120 x 85 millimeter. The patient's mother did not give TYLENOL or apply ice to area and she stated that the patient had scratched the area. The outcome of injection site erythema, injection site induration, 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, MENB, MNQ
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's current illnesses and medical history was not reported. The patient's other medications and prior vaccinations were not reported. On 27-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L040054, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included MENACTRA dose number 2; vaccinated date: 27-SEP-2016, intramuscularly in the left arm, lot # U5513AA; (dose, frequency and lot expiration date unknown) and TRUMENBA dose number 1; vaccinated date: 27-SEP-2016, intramuscularly in the right arm, lot # N11903; (dose, frequency and lot expiration date unknown). On 29-SEP-2016 two days after vaccines administered, the patient had left arm redness, swelling of 50 mm x 30 mm and was painful. The patient took cold compresses, HYTONE and MOTRIN. The patient had a follow up for 2 days. The outcome of erythema, pain and local swelling was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, 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 # 661411) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's other medications, concurrent illnesses and pertinent lab data were not reported. On an unspecified date at 11:00, the patient had fever after vaccination with GARDASIL 9 (dose:1 ) previously. The patient had no medical history. On 19-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # L036301, (route, dose  number: unknown), in the left arm and FLUZONE QUADRIVALENT (manufacturer: Sanofi Pasteur) lot # U5596DA, (route, dose  number: unknown), in the right arm  for prophylaxis. On 20-OCT-2016, at 12:20, the patient's mother called in and reported that the patient had a fever of 104 at 4 am that day and wanted her child to be checked. It was later reported by the patient's mother that the fever came down to 99.8 at 3:00 pm the next day, with no signs and symptoms of infection. The outcome of fever 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: 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 # 661647) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient's medical history included penicillin allergy (PCN), asthma, allergy to dogs and  tree pollens. The patient had no concurrent illnesses and other medications. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M009362 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On an unknown date, the patient experienced urticaria and required an emergency room visit. The outcome of urticaria was reported as recovered. The causality assessment for urticaria was not reported.       Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Induration
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 # 662403) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient's medical history, concurrent illnesses, other medications and lab data were reported as none. Information on the patient's prior vaccinations was not reported. On 20-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # M023169 (dose number 3; lot expiration date was not reported) for prophylaxis. On 22-OCT-2016, the patient's mother reported that the patient's arm was red and hard. 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: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Headache, Hyperhidrosis, Immediate post-injection reaction, 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 # 663342). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses was reported as none and medical history was not reported. Prior vaccinations included dose 1 HPV (GARDASIL 9) at 12:00 on an unknown date. On 07-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M018810 (expiry date: 28-MAY-2018), dose 2, intramuscularly in the left arm for prophylaxis. On the same day immediately after vaccination, the patient experienced immediate post-injection reaction, sweaty and clammy. On 11-OCT-2016 the patient developed headache, vomiting (x 1) and nausea. The outcome of cold sweat, vomiting, nausea, immediate post-injection reaction, hyperhidrosis and headache 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: 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 # 663342). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses was reported as none and medical history was not reported. Prior vaccinations included dose 1 HPV (GARDASIL 9) at 12:00 on an unknown date. On 07-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M018810 (expiry date: 28-MAY-2018), dose 2, intramuscularly in the left arm for prophylaxis. On the same day immediately after vaccination, the patient experienced immediate post-injection reaction, sweaty and clammy. On 11-OCT-2016 the patient developed headache, vomiting (x 1) and nausea. The outcome of cold sweat, vomiting, nausea, immediate post-injection reaction, hyperhidrosis and headache 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: U
Vaccine: HPV9
Symptoms: Wrong drug administered
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 # 663526) on 02-MAY-2017. This spontaneous report refers to a 6 year old patient (gender unknown). Information on the patient's medical history, concurrent illnesses, other medications, lab data and prior vaccinations were not reported. On 27-JUL-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (route: needle and syringe (not specified further), site: unknown; dose number, lot # and expiration date were not reported). The patient was supposed to receive Hepatitis A vaccine but was wrongly administered with GARDASIL 9 which was being prepared simultaneously for another patient. The outcome of the event was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Gait disturbance, 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 # 663963). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 19-SEP-2016, the patient was vaccinated with GARDASIL 9, lot# L0385D3, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced lightheadedness, dizziness, headache and developed walking issues. The outcome of headache, dizziness and gait disturbance were reported as not 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: Odynophagia, Oropharyngeal pain, Proctalgia, Vaccination complication
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 # 664166). This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history was reported as none. On 28-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), dose 1, intramuscularly in the right arm for prophylaxis. On 29-JUN-2016, the patient experienced odynophagia, vaccination complication, proctalgia and oropharyngeal pain. After HPV-1st dose, patient complaints of severe rectal pain, went to emergency room and no findings were reported. After HPV- 2nd dose patient complaints of severe throat pain and pain with swallowing. The patient went to physician and was told it was reaction to HPV and not to get 3rd dose. The outcome of odynophagia, vaccination complication, proctalgia and oropharyngeal pain were 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: FLUX, HPV9, FLUX, HPV9
Symptoms: Headache, Influenza like illness, Pain, 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 # 664267). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications was not provided. On 04-NOV-2016, the patient was vaccinated with GARDASIL 9 dose 3 and influenza virus vaccine (unspecified) dose 1 for prophylaxis (dosage, lot #, route and site of administration unspecified). On the same day, the patient had high fever, vomiting, headache, body aches and flu-like symptoms which lasted for 3 days. The outcome of headache, vomiting, pyrexia, pain and influenza like illness 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, 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 # 664398). This spontaneous report refers to a 11 year old female patient. The patient had no current illnesses and information on patient's medical history, other medications and prior vaccinations was not reported. On 19-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L040054, dose 1, route: unknown in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5468AA, dose 1, route: unknown in the right arm and MENACTRA lot # U5392AC, dose 1, route: unknown in the left arm. Patient was not ill and hadn't eaten at all on the day of vaccination. Patient's mother was the source of information and on 19-OCT-2016, the patient experienced urticaria. She was given Benadryl 10ml, once daily, at bedtime for urticaria as preventative and was followed by allergist. Patient was ordered to get blood testing done, not skin testing and her mother had not yet gone for labs at the time of report. The outcome of the event urticaria was reported as recovered. The causality assessment of the event urticaria with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
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 # 665091) on 02-MAY-2017. This spontaneous report refers to a 15 year old female patient. The patient had no known medical history and concurrent illnesses. Information on the patient's other medications and prior vaccinations were not reported. On 09-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M007764 (lot expiration date: 30-JAN-2018) and FLUZONE QUADRIVALENT (intramuscularly in the right arm, lot # U5691AA, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported) for prophylaxis. On the same day, the patient fainted after receiving the second vaccination which lasted for several seconds. The outcome of the event 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: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 665120) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included allergic to amoxicillin (rash) and cats (rash). Information on the patient's concurrent illnesses, other medications, lab data and prior vaccinations was not reported. On 31-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M009378 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number 1, intramuscularly in the right arm, lot # U5478BA, manufacturer: Sanofi Pasteur; lot expiration date was not reported), MENVEO (dose number 1, intramuscularly in the right arm, lot # M15166, manufacturer: Novartis; lot expiration date was not reported) and FLUARIX QUADRIVALENT (dose number 3, intramuscularly in the left arm, lot # 4GX4F, manufacturer: GlaxoSmithKline; lot expiration date was not reported) for prophylaxis. On 02-NOV-2016, a call was received from the school nurse at 09:00 who reported that the patient was presented with redness and swelling on the left arm. On the same day, the patient was seen at the office with irregular shaped erythema over right deltoid which was warm but not tender (7x4 cm). The patient was diagnosed with cellulitis and treated with ZITHROMAX Z-PAK (250mg, 2 tablets on first day, then 1 tablet daily for 4 days). The patient required emergency room (ER) visit. 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: 21.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Unevaluable 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 ID-665681). This spontaneous report refers to a 21 year old male patient. The patient had no allergies, other historical conditions, current illnesses and other medications. On 11-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M028323 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with HAVRIX lot # 2PC5H, dose 2 (unspecified dosage), intramuscularly in the right arm. On 11-NOV-2016, the patient experienced an unevaluable event (also reported that the patient had no adverse effects). The outcome of unevaluable event 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: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site 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 # 665724) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history and concurrent illnesses were reported as none. The patient had no lab data. Information on the patient's other medications and prior vaccinations were not reported. On 08-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route: unknown, site: left arm, lot # M024261 and expiration date: 30-JUL-2018). On the same day, the patient was also vaccinated with ADACEL (lot # U5478BA, route: unknown, site: right arm, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported), MENACTRA (lot # U5513AA, route: unknown, site: right arm, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported) and FLUZONE QUADRIVALENT (lot # U5630AA, route: unknown, site: left arm, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported) for prophylaxis. On an unknown date, the patient's left deltoid region was red, hyperemic, tender to touch and size 4.5"x3" (margins non elevated). The patient was treated with ice, MOTRIN and BENADRYL (call update (x3 dy)). 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
Symptoms: Dyspnoea
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 # 666491) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history, concurrent illnesses, lab data and other medication were reported as none. Information on the patient's prior vaccinations was not reported. On 14-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L044475 (lot expiration date was not reported) for prophylaxis. On 14-APR-2016 at night, the patient could not breathe well. The patient's mother never presented the patient for the symptom (dyspnoea) because it had resolved quickly. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Hyperhidrosis, Lethargy, Pallor, Presyncope
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 # 666579) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient's medical history included Scheuermann's disease, vitamin D deficiency, adjustment disorder and obesity. The patient's concurrent illnesses included mild bronchitis. The patient's other medication included Sertraline (100mg, daily). The patient's lab data was reported as none. Information on the patient's prior vaccinations was not reported. On 07-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # M028323 (dose number 3; lot expiration date was not reported) and TRUMENBA (dose number 1, intramuscularly in the left arm, manufacturer: Pfizer/Wyeth, lot # M37315; lot expiration date was not reported) for prophylaxis. On 07-NOV-2016, the patient experienced diaphoresis, lethargy and pallor. 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: M
Vaccine: HPV9
Symptoms: Aphthous ulcer
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 # 666652) on 02-MAY-2017. This spontaneous report refers to a 26 year old male patient. The patient's medical history included allergic rhinitis. The patient had no concurrent illnesses. The patient's other medication was reported as none. Information on the patient's prior vaccinations was not reported. On 08-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M030380 (lot expiration date was not reported) for prophylaxis. On 12-NOV-2016, the patient developed aphthous ulcer. The outcome of the event was unknown. 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: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness
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 # 667129) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient has no medical history and concurrent illnesses. Information on the patient's lab data, other medications and prior vaccinations were not reported. On 15-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm (batch/lot# L03601; expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number: 1, intramuscularly in the left arm, lot# U5378AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported), FLUZONE QUADRIVALENT (dose number: 2, intramuscularly in the left arm, lot# UI709AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number: 1, intramuscularly in the right arm, lot# U5392AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On the same day of vaccination, the patient felt dizzy and light headed when she was at the checkout station. The outcome of dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.