chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain, Chills, Headache, Injection site pain, 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 # 648634) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's other medications included Allegra and she had no concurrent illnesses. Information about the patient's medical history and prior vaccinations were not reported. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (Expiration date: 12-OCT-2017) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M37316 dose 1 (unspecified dosage), and MENACTRA lot # U5228BB dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 22-JUN-2016, less than 1 minute after receiving immunizations, the patient experienced syncope and she collapsed. The patient was pale, nauseous and had a blood pressure of 100/62. 1 hour after the immunizations, the patient started complaining of severe pain at the injection site (right shoulder). After the onset of the symptoms, the patient was laid supine for an hour and a half in the office, until she felt well enough to leave the office. On 23-JUN-2016, the patient had called to report about abdominal pain (4/10), chills, body aches and severe headache. The symptoms did not resolve until 24-JUN-2016. 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: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648634) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's other medications included Allegra and she had no concurrent illnesses. Information about the patient's medical history and prior vaccinations were not reported. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (Expiration date: 12-OCT-2017) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M37316 dose 1 (unspecified dosage), and MENACTRA lot # U5228BB dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 22-JUN-2016, less than 1 minute after receiving immunizations, the patient experienced syncope and she collapsed. The patient was pale, nauseous and had a blood pressure of 100/62. 1 hour after the immunizations, the patient started complaining of severe pain at the injection site (right shoulder). After the onset of the symptoms, the patient was laid supine for an hour and a half in the office, until she felt well enough to leave the office. On 23-JUN-2016, the patient had called to report about abdominal pain (4/10), chills, body aches and severe headache. The symptoms did not resolve until 24-JUN-2016. 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, MENB, MNQ, VARCEL
Symptoms: Dizziness, Hypotonic-hyporesponsive episode
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 # 648638) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient had no concurrent illnesses or medical history. On 19-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M007764, expiration date: 30-JAN-2018, dose 1, intramuscularly in the right arm, VARIVAX lot # M012992, dose 2, subcutaneously in the left arm, MENACTRA  (manufacturer: Sanofi Pasteur) lot # U5392AA, dose 1, intramuscularly in the left arm and BEXSERO (manufacturer: Novartis) lot # 156701, dose 1, intramuscularly in the right arm for prophylaxis. On the same day post immunizations, the patient stated feeling lightheaded and while the other nurse was bringing a cot and juice, the patient had hypotonic-hyporesponsive reaction that lasted about 30 seconds to 1 minute. He became alert, drank juice, and sat in chair for about 15 minutes with no other signs and symptoms. The patient stated he felt better and was advised to eat after leaving the appointment. The outcome of hypotonic-hyporesponsive episode and dizziness was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness, 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 # 648902) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient other medications, concurrent illnesses and medical history were reported as none. Information on the patient's prior vaccinations was not reported. On 11-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L018351 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-AUG-2016, the patient was at an outdoor event, standing in line waiting to purchase lemon aid in hot afternoon. The patient fainted, she then attempted to get up and fainted again hitting her head on the lemon aid stand. The patient had no further problems after those two episodes of loss of consciousness. On 16-AUG-2016 the mother of patient called and informed above information. The outcome of head injury, syncope and loss of consciousness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, 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 # 649016) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illnesses, medical history or other medications. The patient had no known drug allergies (NKDA). On 22-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L024993, expiration date: 17-OCT-2017, dose 4, route: unknown in the right arm for prophylaxis. On 17-AUG-2016, the patient was seen in the MD's office for bump and bruise on the right upper arm at injection site. The patient stated that they appeared 2 weeks after vaccination with GARDASIL 9 and was still there. The outcome of injection site bruising and injection site swelling was unknown. The events required an emergency room visit. 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, HPV9
Symptoms: Injection site bruising, Injection site nodule, 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 # 649016) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illnesses, medical history or other medications. The patient had no known drug allergies (NKDA). On 22-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L024993, expiration date: 17-OCT-2017, dose 4, route: unknown in the right arm for prophylaxis. On 17-AUG-2016, the patient was seen in the MD's office for bump and bruise on the right upper arm at injection site. The patient stated that they appeared 2 weeks after vaccination with GARDASIL 9 and was still there. The outcome of injection site bruising and injection site swelling was unknown. The events required an emergency room visit. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, 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 # 649019) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD), acne, eczema, depression and use of amoxicillin and radish. The patient's other medications included ABILIFY, VYVANSE and RETIN-A cream. On 20-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L024993, expiration date: 17-OCT-2017, dose 1, route: unknown in the left arm for prophylaxis. On 17-AUG-2016, during the patient's office visit it was stated that there was a knot that appeared a couple of weeks after injection at the injection site. Also, there was a bruise at injection site and was warm to touch. The outcome of all the events was unknown. The events required an emergency room visit. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site nodule, 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 # 649019) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD), acne, eczema, depression and use of amoxicillin and radish. The patient's other medications included ABILIFY, VYVANSE and RETIN-A cream. On 20-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L024993, expiration date: 17-OCT-2017, dose 1, route: unknown in the left arm for prophylaxis. On 17-AUG-2016, during the patient's office visit it was stated that there was a knot that appeared a couple of weeks after injection at the injection site. Also, there was a bruise at injection site and was warm to touch. The outcome of all the events was unknown. The events required an emergency room visit. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot, Heart rate increased, Pallor, Skin abrasion
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 # 649188) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). Information on the patient's prior vaccinations and the other medications were not reported. On 18-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # m009378 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included VAQTA lot # m018644 (expiration date: 20-SEP-2017), dose 1, intramuscularly in the right arm, BOOSTRIX batch/lot # ec9a9, dose 1, intramuscularly in the right arm and MENVEO batch/lot # m16004, dose 1, intramuscularly in the left arm for prophylaxis. On 18-AUG-2016, the patient did well with immunizations initially but as he stood with his mom at the scheduling desk he became lightheaded and fainted. The patient sustained a mild abrasion to the chin and both the knees but his mom was able to partially hold him as he went down. The patient's legs were elevated and he was immediately aware of his surroundings. He felt dizzy and hot but resolved quickly. The patient looked pale, his heart rate increased up to 100s but slowed to 80s within couple of minutes and his color also returned. The patient then sat up on floor and had no pain in the head, neck or elsewhere. He was able to get up into the chair and sat for 5 minutes and drank some water. The patient denied any further dizziness. The outcome of dizziness, syncope, skin abrasion, pallor, heart rate increased and feeling hot was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
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 # 649188) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). Information on the patient's prior vaccinations and the other medications were not reported. On 18-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # m009378 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included VAQTA lot # m018644 (expiration date: 20-SEP-2017), dose 1, intramuscularly in the right arm, BOOSTRIX batch/lot # ec9a9, dose 1, intramuscularly in the right arm and MENVEO batch/lot # m16004, dose 1, intramuscularly in the left arm for prophylaxis. On 18-AUG-2016, the patient did well with immunizations initially but as he stood with his mom at the scheduling desk he became lightheaded and fainted. The patient sustained a mild abrasion to the chin and both the knees but his mom was able to partially hold him as he went down. The patient's legs were elevated and he was immediately aware of his surroundings. He felt dizzy and hot but resolved quickly. The patient looked pale, his heart rate increased up to 100s but slowed to 80s within couple of minutes and his color also returned. The patient then sat up on floor and had no pain in the head, neck or elsewhere. He was able to get up into the chair and sat for 5 minutes and drank some water. The patient denied any further dizziness. The outcome of dizziness, syncope, skin abrasion, pallor, heart rate increased and feeling hot was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649271). This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history. On 23-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (expiry date: 30-JAN-2018), dose 1, intramuscularly in the left arm for prophylaxis. On 23-AUG-2016, as soon as child got home, had slight headache, then spiked a fever of 101 processed by generalized body aches on evening and body aches continued next day. Patient kept home from school. On 25-AUG-2016, slight body aches remain, fever resolved, patient back to school today. The outcome of headache and 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.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, 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 # 649993). This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history includes allergy to penicillin. On 24-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 1, intramuscularly in the left arm for prophylaxis. On the same day the patient was vaccinated with other suspect therapies included MENACTRA (lot # X15078, dose 1, intramuscularly in the left arm) and BOOSTRIX (lot # 7C73A, dose 1, intramuscularly in the right arm). On 29-AUG-2016, the patient experienced injection site swelling and injection site redness. On the same day, patient was in emergency room and was diagnosed with cellulitis. The patient was treated with BACTRIM, twice in a day (BID) for 10 days. The outcome of cellulitis, injection site swelling and injection site erythema were 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: Injection site erythema, Injection site swelling, Nodule
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 # 650222) 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. The patient's medical history included allergy to amoxicillin. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 23-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # L036301 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 24-AUG-2016, the patient experienced significant redness, swelling and knot/swelling at the site of injection. The outcome of injection site erythema, injection site swelling and nodule was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, 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 # 650263) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 17 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 16-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M016193, Expiry date: 24-APR-2018, (dose, frequency unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included HAVRIX (Manufacturer: GlaxosmithKline, Vaccinated date: 16-AUG-2016, lot # 2PC5H (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm) and MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 16-AUG-2016, lot # U5272AA (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm) for prophylaxis. On the same day, 5 minutes after vaccination, patient became diaphoretic, complained of light headedness and his skin color appeared grey. The patient stated that he had not eaten since breakfast (now 2:30pm) and had just been doing hard work outdoors in the heat. He then took water, raisins & crackers for relief. Blood pressure was 130/80 after snack and monitored for 20 minutes. At 5PM pateint's mother reported that patient was feeling fine. The outcome of dizziness, skin discolouration and hyperhidrosis was reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, 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 # 650272) on 02-MAY-2017. This spontaneous report refers to a 42 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 22-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, lot and lot expiration dates were not reported) route: not specified, in the left arm for prophylaxis. The patient experienced slight soreness and swelling at the site of injection on the day she received the first shot of the GARDASIL 9 vaccine (22-AUG-2016). The symptoms subsided on the same day, but the patient developed a significant pain and swelling (about 5 cm in length) at the injection site on 28-AUG-2016. The swelling and soreness were still present as of 31-AUG-2016 albeit less than on 28-AUG-2016. The patient visited the ER. The outcome of injection site pain and injection site swelling was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain, Rotator cuff syndrome
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 # 650495). This spontaneous report refers to a 22 year old female patient. The patient's concurrent illnesses was reported as none and medical history included car accident 1 year ago and was treated with physical therapy. Other medications included Vyvanse and birth control medication. On 08-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L014198 (expiry date: 05-SEP-2017), dose 2, intramuscularly in the right arm for prophylaxis. On 12-AUG-2016, the patient experienced injection site pain, rotator cuff syndrome and pain. Patient had sharp pain when abducting or rotation or lifting of the injected arm. Injection site still painful to touch. Rotator cuff feels to be messed up. The patient had an emergency room visit. The outcome of injection site pain, rotator cuff syndrome and pain 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: U
Vaccine: HPV9, MENB, MNQ
Symptoms: 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 # 650578). This spontaneous report refers to an 18 year old patient of unknown gender. The patient had no concurrent illnesses and medical history. On 22-AUG-2016, the patient was vaccinated with GARDASIL 9, lot# M021407, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included TRUMENBA (lot# M37314, dose 1, intramuscularly in the right arm) and MENACTRA (lot# U5272AA, dose 2, intramuscularly in the left arm). Patient's mother reported that, 4 hours after vaccination, the patient experienced generalized rash from head to toe. The outcome of rash generalised 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: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypertension, 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 # 650964) on 02-MAY-2017. This spontaneous report refers to a 22 year old female patient. The patient's medical history included self reported tetanus toxoid and the patient had no other medications. Information about the patient's concurrent illnesses and prior vaccinations were not reported. On 19-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L044475 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On the same day, the patient experienced dizziness, nervousness and hypertension. The patient required an emergency room visit and was treated there around midnight. The patient was discharged around 2 am. The patient's laboratory data included blood pressure (BP), measured between 9 pm-12 am: 159/114 and 156/112. 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: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, 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 # 651146) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. On 02-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M007764, expiration date: 30-JAN-2018, dose 2, route: unknown, in the right arm, BOOSTRIX lot # 7XR47, dose 1, route: unknown in the left arm, MENACTRA (manufacturer: Sanofi Pasteur) lot # U5462AB, dose 1, route: unknown in the left arm and HAVRIX lot # C7252, dose 2, route: unknown in the right arm for prophylaxis. On the same day at 02:33 pm, the mother reported that the patient was feeling faint, nauseous, perspiring and vomited on the floor. The patient was assisted to room, helped to lay down with feet elevated and a cold wash cloth was placed on forehead. The patient was given cold water to sip and at 02:40 he felt better and left clinic. The outcome of dizziness, vomiting and nausea was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 0.25
Sex: F
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 # 651212) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 3 month 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 07-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left thigh (left leg), lot # L016429 with expiration date: 09-AUG-2017 (dose and frequency were not reported) for prophylaxis. The patient was administered with GARDASIL 9 instead of Pentacel vaccine. The outcome of wrong drug administered was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury
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-651213). This spontaneous report refers to a 14 year old female patient. The patient had no current illnesses and historical conditions. Information on patient's other medications was not reported. On 06-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L038503 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with BOOSTRIX lot # EC9AE, dose 1 (unspecified dosage) and MENACTRA lot # U5415AA, dose 1 (unspecified dosage) both given intramuscularly in the left arm for prophylaxis. After vaccination, the patient was checking out at the front desk and fell backwards, hit head on floor and had head injury. Cool compresses were applied to back of head and the patient was given juice. The patient's vital signs were recorded (Blood pressure: 139/83 (units unspecified) and Heart rate: 97 (units unspecified)) and her mental status was assessed. The outcome of fall and head injury 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: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site cellulitis
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 # 651443) 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. The patient's medical history included red dye (effects behavior). Information on the patient's prior vaccinations, lab data and other medications were not reported. On 25-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly, lot # M016193 with expiration date: 24-APR-2018 (injection site, dose and frequency were not reported) for prophylaxis. On 26-AUG-2016, the patient experienced cellulitis site at of injection. The patient required an emergency room (ER) visit. The outcome of injection site cellulitis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ
Symptoms: Musculoskeletal stiffness, Mydriasis, 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 # 651927) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female 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-SEP-2016, at 11:30 am the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L038503 (dose, frequency and lot expiration date were not reported) and HAVRIX for prophylaxis. The patient went to get labs drawn, returned to clinic and received MENVEO and IPOL at 13.05 (also reported as 130.5) min. On 09-SEP-2016, after receiving vaccination the patient became very stiff, eyes were dilated and was not responding verbally when asked questions. The patient was not responsive for about 15 seconds. Her blood pressure (BP) was 85/55, heart rate (HR) was 49 and respiratory rate (RR) was 16. The patient was assessed by MD (doctor of medicine), stabilized and discharged home in stable condition. The outcome of musculoskeletal stiffness, unresponsive to stimuli and mydriasis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, 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 # 651987) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient concurrent illnesses and other medications reported as none. The patient's history reported as none (also reported as penicillin). Information on the patient's prior vaccinations was not reported. On 12-SEP-2016 the patient was vaccinated with the second dose of GARDASIL 9 via unknown route in the left arm, lot # L043214 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 12-SEP-2016, approximately 2 hours after receiving vaccine the patient and mother report that teen was broken out in hives and there was very itchy on torso, face, arms and legs. The outcome of pruritus and urticaria 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.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Injection site cellulitis, Metabolic function test
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 # 652008) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient concurrent illnesses included ear abscess and medical history included sulfa drugs. Other medications included mupiroan 2 % ointment to ear abscess. Information on the patient's prior vaccinations was not reported. On 03-SEP-2016 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # M018810, expiration date: 28-MAY-2018 (dose and frequency were not reported) for prophylaxis. On 05-SEP-2016, the patient experienced cellulitis at injection site, underwent full blood count and metabolic function tests. The patient required emergency room visit. The outcome of full blood count, metabolic function test and injection site cellulitis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Axillary pain, Chest pain, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 652038) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illness, prior vaccinations, other medications and medical history were not reported. On 30-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L024993, lot expiration date 17-OCT-2017 (dose not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day, included first dose of MENACTRA (intramuscularly in the left arm, lot# U5187AA; dose and expiration date were not reported) for prophylaxis. On 01-SEP-2016, the patient had soreness in the left arm, mostly pain in the axillary region. There were no bruising or swelling on the arm and no redness around the injection site. She was not feeling well. She also had chest hurting and did not want to go to school. The patient experienced underarm pain, no redness but sore present. She was not using her left arm and had high tolerance to pain. She took some ibuprofen (10 ml each) in the previous two nights. The patient had visited the emergency room. The outcome of the events were 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Genital rash, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653079) 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 07-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M003659, expiration date: 20-SEP-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX intramuscularly in the right arm, lot # B4G4G (dose, frequency and lot expiration date were not reported) and MENACTRA intramuscularly in the left arm, lot # U5416AA (dose, frequency and lot expiration date were not reported) for prophylaxis. On 07-SEP-2016, the patient experienced rash to mostly trunk front and back, with mildly to thighs, hands, breast area up to neck and genitalia. The outcome of rash was unknown. 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: Back pain, Chills, Headache, 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 # 653114) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included Benzoil perozide, Doxycycline hyclate, Clindamycin. On 07-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M021407 (expiration date: 30-APR-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BEXSERO batch/lot # 156801A, dose 1, intramuscularly in the left arm for prophylaxis.The day after immunization (08-SEP-2016) the patient had pain at the injection site, about a baseball diameter the area was reddened, warm and tender  for 3 days. On 12-SEP-2016, the patient experienced chills and fever  and headache and achy arms, legs and back but no join swelling. The patient's left arm was twitchy at the injection site. No redness and swelling was observed at the time of the report  The outcome of chills, tenderness, skin warm, pyrexia, pain, muscle twitching, injection site reaction, injection site pain, headache and erythema 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: HPV9, MENB
Symptoms: Injection site reaction, Injection site warmth, Muscle twitching, Pain in extremity, 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 # 653114) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included Benzoil perozide, Doxycycline hyclate, Clindamycin. On 07-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M021407 (expiration date: 30-APR-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BEXSERO batch/lot # 156801A, dose 1, intramuscularly in the left arm for prophylaxis.The day after immunization (08-SEP-2016) the patient had pain at the injection site, about a baseball diameter the area was reddened, warm and tender  for 3 days. On 12-SEP-2016, the patient experienced chills and fever  and headache and achy arms, legs and back but no join swelling. The patient's left arm was twitchy at the injection site. No redness and swelling was observed at the time of the report  The outcome of chills, tenderness, skin warm, pyrexia, pain, muscle twitching, injection site reaction, injection site pain, headache and erythema was unknown. The 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, MNQ, TDAP
Symptoms: Dyskinesia, 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 # 653171) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's concurrent illnesses, medical history and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 25-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 BOOSTRIX intramuscularly in the left arm, lot # 542F3 (dose, frequency and lot expiration date were not reported) and MENVEO intramuscularly in the left arm, lot # M15124 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 25-AUG-2016, after vaccination the patient developed pallor and jerky movements of arms and lower extremities approximately for 1 minute and had no vomiting. The outcome of dyskinesia and pallor was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653375) 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 the patient's prior vaccinations and other medications were not reported. On 13-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L026602, expiration date: 19-OCT-2017 (dose and frequency were not reported) and also vaccinated with the second dose of VARIVAX subcutaneous in the left arm, lot # M009767 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. On 14-SEP-2016, the patient experienced 3"x3" area of redness, warmth, slight swelling and tenderness to left posterior arm at site where VARIVAX was administered. The outcome of injection site erythema, injection site warmth, injection site swelling and injection site pain was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Product use issue
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 # 653386) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient had no concurrent illnesses and medical history. The patient's prior vaccination was not reported. Other medications were unknown. On 08-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L020015, expiration date: 16-AUG-2017 (dose and frequency were not reported) and vaccinated with the second dose of VARIVAX subcutaneous in the left arm, lot # L028275, expiration date: 28-JUL-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included HAVRIX. On an unknown date the patient had product use issue. The outcome of product use issue was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Blood albumin, Blood urine present, Chromaturia, Complement factor C3
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 # 653417) 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 headaches and recurrent cold sores. Information on the patient's prior vaccinations was not reported. The patient's other medications included Topical Acyclovir, Valacyclovir, Loratadine, Tylenol, Ibuprofen, Necon 1/35. On 31-AUG-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M021407 (expiration date: 30-APR-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. On 31-AUG-2016 the patient developed body aches. On 01-SEP-2016, the patient had back pain (right sided) which was occasional, brief and had occurred a few times. The patient's urine had a dark appearance and this continued till 03-SEP-2016, when she was evaluated in urgent care. The patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine was observed. The patient also had metabolic function test, full blood count, complement factor C4, complement factor C3, and blood albumin. The patient's lab data included urinalysis, CBC, BMP, C-3, C-4, albumin, urinary tract ultrasound. The outcome of back pain, urine analysis, ultrasound urinary system, pain, metabolic function test, full blood count, complement factor C4, complement factor C3, chromaturia, blood urine present and blood albumin was unknown. The 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: Complement factor C4, Full blood count, Metabolic function test, Pain, Ultrasound urinary system
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 # 653417) 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 headaches and recurrent cold sores. Information on the patient's prior vaccinations was not reported. The patient's other medications included Topical Acyclovir, Valacyclovir, Loratadine, Tylenol, Ibuprofen, Necon 1/35. On 31-AUG-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M021407 (expiration date: 30-APR-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. On 31-AUG-2016 the patient developed body aches. On 01-SEP-2016, the patient had back pain (right sided) which was occasional, brief and had occurred a few times. The patient's urine had a dark appearance and this continued till 03-SEP-2016, when she was evaluated in urgent care. The patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine was observed. The patient also had metabolic function test, full blood count, complement factor C4, complement factor C3, and blood albumin. The patient's lab data included urinalysis, CBC, BMP, C-3, C-4, albumin, urinary tract ultrasound. The outcome of back pain, urine analysis, ultrasound urinary system, pain, metabolic function test, full blood count, complement factor C4, complement factor C3, chromaturia, blood urine present and blood albumin was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.