chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle rigidity, Unresponsive to stimuli, 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 # 647636) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history, other medications and concurrent illnesses were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 12-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # K026247, lot expiration date 29-JAN-2017 (dose: not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of BOOSTRIX (intramuscularly in the left arm, lot# 5XP4D; dose and expiration date were not reported), first dose of MENVEO (intramuscularly in the left arm, lot# M15148; dose and expiration date were not reported) and first dose of HAVRIX (intramuscularly in the right arm, lot# LN749; dose and expiration date were not reported) for prophylaxis. On the same day immediately after the completion of vaccine administration, the patient became rigid and unresponsive for approximately 2-3 minutes as per the licensed practical nurse (administering) and the patient's mother. Immediately following rigidity, the patient vomited. After vomiting, the patient became alert and oriented (reported as x 3). The outcome of immediate post-injection reaction, vomiting, unresponsive to stimuli and muscle rigidity was reported as recovered. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: 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 # 647639) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses.  Other medications included Adapalene gel, Clindamycin phosphate and Pro air inhaler. On 09-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (dose number: 1, vaccinated date: 09-AUG-2016, intramuscularly in the right arm, lot# M77282; dose and expiration date unknown). On the same day, the patient experienced pain in extremity (severe pain in right arm). The outcome of pain in extremity was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Dizziness, Feeling hot, Flushing, 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 # 648263) 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. The patient's medical history included TAMIFLU, allergy and anxiety. Other medications included PROZAC 40mg once a day (qd) and omeprazole 40mg as needed. The patient's mother stated that patient had adverse event after last immunization in 2010. On 15-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L004014, expiration date: 04-MAR-2017 (dose and frequency were not reported) and vaccinated with the second dose of VARIVAX subcutaneous in the left arm, lot # L049536 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 15-AUG-2016, after immunization the patient became dizzy, lightheaded and flushed/hot. The patient became pale and laid down, ammonia inhalant used along with cool compress and water was given. The patient was observed for 25 minutes and found there were no further issues. The outcome of dizziness, flushing and feeling hot 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, TDAP
Symptoms: Confusional state, Immediate post-injection reaction, Seizure
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 # 648425) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history was reported as none. The patient had no known concurrent illnesses. Information on the patient's other medications, lab data and prior vaccinations were not reported. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L037554 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number 1, intramuscularly in the right arm, lot # 7B222, manufacturer: GlaxoSmithKline; lot expiration date was not reported) and MENACTRA (dose number 1, intramuscularly in the right arm, lot # U5244AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On the same day immediately post vaccinations, the patient had seizure for approximately 5-6 seconds. The patient was held and the patient's father was asked to get the doctor. The seizure had stopped when the doctor arrived but the patient was a little confused. No vomiting or irritation was noticed. The patient was laid down in bed on applied cold compress to the head. 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: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye burns, Eye irritation, Myalgia, 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 # 648547) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old female patient. Information on pertinent medical history and current illnesses were not reported. Other medications included AVIANE and multivitamins. The patient was prior vaccinated with one dose of HPV (manufacturer unknown). On 18-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M007764, Expiry date: 30-JAN-2018, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On the same day, the patient experienced dizziness, vomiting, photophobia, nausea, myalgia, eye irritation and eye burns persisted for 48 hours. The outcome of all the events were 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: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Photophobia, 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 # 648547) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old female patient. Information on pertinent medical history and current illnesses were not reported. Other medications included AVIANE and multivitamins. The patient was prior vaccinated with one dose of HPV (manufacturer unknown). On 18-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M007764, Expiry date: 30-JAN-2018, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On the same day, the patient experienced dizziness, vomiting, photophobia, nausea, myalgia, eye irritation and eye burns persisted for 48 hours. The outcome of all the events were 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: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Pyrexia, 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 # 648827) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. Information on the patient's medical history, lab data and prior vaccinations were not reported. The patient's other medication was reported as none. The patient had no known concurrent illnesses. On 19-AUG-2016 at approximately 11:00, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with MENVEO (dose number: 2, intramuscularly in the left arm, lot # M15124, manufacturer: Novartis; lot expiration date was not reported) and BEXSERO (dose number: 1, intramuscularly in the right arm, lot # 156801, manufacturer: Novartis; lot expiration date was not reported) for prophylaxis. On 19-AUG-2016 at 13:00, the patient started with temperature and shaking. At 14:30, the patient was given TYLENOL at home. The patient's mother brought the patient back to the clinic at approximately 14:45. Doctor saw the patient and documented the note: Patient returned to clinic with fever up to 102.8 recorded as well as shaking and shivering. The patient was monitored for roughly about 2-2.5 hours and was given TYLENOL and MOTRIN (600 milligrams). His fever remained high but that should have been stopped. During the entire time, neurologically he remained intact. There was no evidence of airway compromise such as wheezing, shortness of breath or tongue fullness. The patient had no swallowing issues. Ultimately the patient was sent home and was instructed to continue using TYLENOL and ibuprofen to keep the fever down. The patient was to be monitored and was advised to seek medical attention if the symptoms worsened over the weekend. The patient's parent was present there who voiced understanding and agreement. The outcome of tremor, pyrexia and chills 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: HEP, HEPA, HPV9, MMRV
Symptoms: Rash, 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 # 649018) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder. The patient had no known drug allergies. The patient's concurrent illness was reported as none. The patient's other medications included CONCERTA CR tablets. The patient's concomitant therapies and prior vaccinations were not reported. On 16-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M020103 (dose and lot expiration date were not reported) (route of administration: unknown) in the right arm and second dose of PROQUAD lot # L050907, lot expiration date 14-JUN-2017 (dose: not reported) (route of administration: unknown) in the right arm for prophylaxis. Other suspect therapies which were given on the same day, included first dose of HAVRIX (in the left arm, lot# 595MR; dose and expiration date were not reported)(route of administration: unknown) and first dose of ENGERIX-B (in the left arm, lot# LL43A; dose and expiration date were not reported) (route of administration: unknown) for prophylaxis. On 16-AUG-2016, the patient had hives all over the body for 24 hour. BENADRYL 50 mg tablet for three times a day was given until rash was gone. The patient had visited the emergency room. The outcome of urticaria 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: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649975) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder. The patient's concurrent illness was reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL 9 lot # L007560, lot expiration date 15-JUN-2017 (dose: not reported) (route of administration: unknown) in the left arm for prophylaxis. Other suspect therapies which were given on the same day included second dose of HAVRIX (in the left arm, lot# C7252; dose, route of administration and expiration date were unknown), first dose of ADACEL (in the right arm, lot# UU875AA; dose, route of administration and expiration date were unknown) and first dose of MENVEO (in the right arm, lot# M16002; dose, route of administration and expiration date were unknown) for prophylaxis. One day after the shot, the child noticed a lump (small) at the injection site in the afternoon. The lump got red and itchy. The patient's grandparent called the health department and the nurse advised to put cold compress and ice and to take Benadryl. The nurse also advised to consult a Doctor and call back if the condition worsened. The child went to the health department. On 26-AUG-2016, the lump was large grapefruit size red, warm, minimal swelling and itchy to right deltoid. The grandparent stated the patient did not had Benadryl that day. The patient did not have difficulty in breathing or rash anywhere else. The grandfather offered ibuprofen and the child declined in the previous day night. The patient was referred to Doctor on 26-AUG-2016 for right deltoid red, warm itchy and inflamed area. 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: HEPA, HPV9, MNQ, TDAP
Symptoms: 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 # 649975) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder. The patient's concurrent illness was reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL 9 lot # L007560, lot expiration date 15-JUN-2017 (dose: not reported) (route of administration: unknown) in the left arm for prophylaxis. Other suspect therapies which were given on the same day included second dose of HAVRIX (in the left arm, lot# C7252; dose, route of administration and expiration date were unknown), first dose of ADACEL (in the right arm, lot# UU875AA; dose, route of administration and expiration date were unknown) and first dose of MENVEO (in the right arm, lot# M16002; dose, route of administration and expiration date were unknown) for prophylaxis. One day after the shot, the child noticed a lump (small) at the injection site in the afternoon. The lump got red and itchy. The patient's grandparent called the health department and the nurse advised to put cold compress and ice and to take Benadryl. The nurse also advised to consult a Doctor and call back if the condition worsened. The child went to the health department. On 26-AUG-2016, the lump was large grapefruit size red, warm, minimal swelling and itchy to right deltoid. The grandparent stated the patient did not had Benadryl that day. The patient did not have difficulty in breathing or rash anywhere else. The grandfather offered ibuprofen and the child declined in the previous day night. The patient was referred to Doctor on 26-AUG-2016 for right deltoid red, warm itchy and inflamed area. 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.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Groin pain, Headache, 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 # 650481) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient's medical history included preB acute lymphoblastic leukemia (June 2011). The patient other/concomitant medications included Cryselle (also reported as Crysalta-28). The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 17-JUN-2016 (also reported as 17-AUG-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 03-AUG-2016, the patient underwent medical evaluation for symptoms including groin pain, arthralgia and headache. No diagnosis was made and no treatment was prescribed at that time. On 09-AUG-2016, the patient was subsequently seen by her oncologist for evaluation of continuing symptoms and the oncologist did not believe the symptoms were related to the HPV vaccine. The patient's oncologist initiated an evaluation to determine the etiology of the patient's symptoms. On 15-AUG-2016, the patient's symptoms did not improve and she returned to the oncologist for further evaluation, including a work-up to rule out leukemia recurrence. Leukemia recurrence was ruled out and the final report of the additional evaluation were pending at that time. On 25-AUG-2016, the patient's mother contacted the study nurse and reported that the patient had been evaluated by her obstetrics and gynaecology physician for a variety of medical issues including arthralgia and painful nodules on bilateral lower extremities. The patient's mother stated that the patient's medical issues might have been related to HPV vaccine that the patient had received on June, which had prompted the report. The patient's mother also reported that the physician indicated that alternatively the patient's medical issues may be due to a concomitant medication (birth control pills- Crysalta-28 tab, 0.3 mg/0.03 mg, Initiated 18-JUN-2018), which was discontinued. Medical records of the patient had been requested and the report would be updated when there were more information, but what was known at that time was reported. The patient was enrolled in a clinical trial that was evaluating the HPV vaccine on cancer survivors. The outcome of groin pain, headache, arthralgia, nodule and laboratory test 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: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Crying, Dizziness, Enuresis, Full blood 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 # 651125) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included acanthosis nigricans, hypertriglyceridaemia and hypovitaminosis D. The patient's concurrent illness was reported as none. The patient's other medications include cetirizine. The patient's concomitant therapies and prior vaccinations were not reported. On 31-AUG-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L035105 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. On 31-AUG-2016 (also reported as 01-SEP-2016), the patient experienced crying, pain to right arm and headache. The patient couldn't get out of the bed throughout the night, wet the bed, felt pressure in head and eyes, had dizziness and blurred vision. The patient was taken to school, but could not get out of the car because of pain and weakness. The patient was taken to the hospital emergency room. On 01-SEP-2016, in the emergency room, the patient's complete blood count, urine analysis and comprehensive metabolic panel were done and the reports stated complete blood count, urine analysis and comprehensive metabolic panel were within the normal limits. The emergency room physician told the patient's grandmother that patient could be having possible reaction to the HPV vaccine. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Head discomfort, Headache, Metabolic function test normal, Mobility decreased, Ocular discomfort
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 # 651125) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included acanthosis nigricans, hypertriglyceridaemia and hypovitaminosis D. The patient's concurrent illness was reported as none. The patient's other medications include cetirizine. The patient's concomitant therapies and prior vaccinations were not reported. On 31-AUG-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L035105 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. On 31-AUG-2016 (also reported as 01-SEP-2016), the patient experienced crying, pain to right arm and headache. The patient couldn't get out of the bed throughout the night, wet the bed, felt pressure in head and eyes, had dizziness and blurred vision. The patient was taken to school, but could not get out of the car because of pain and weakness. The patient was taken to the hospital emergency room. On 01-SEP-2016, in the emergency room, the patient's complete blood count, urine analysis and comprehensive metabolic panel were done and the reports stated complete blood count, urine analysis and comprehensive metabolic panel were within the normal limits. The emergency room physician told the patient's grandmother that patient could be having possible reaction to the HPV vaccine. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Urine analysis normal, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651125) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included acanthosis nigricans, hypertriglyceridaemia and hypovitaminosis D. The patient's concurrent illness was reported as none. The patient's other medications include cetirizine. The patient's concomitant therapies and prior vaccinations were not reported. On 31-AUG-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L035105 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. On 31-AUG-2016 (also reported as 01-SEP-2016), the patient experienced crying, pain to right arm and headache. The patient couldn't get out of the bed throughout the night, wet the bed, felt pressure in head and eyes, had dizziness and blurred vision. The patient was taken to school, but could not get out of the car because of pain and weakness. The patient was taken to the hospital emergency room. On 01-SEP-2016, in the emergency room, the patient's complete blood count, urine analysis and comprehensive metabolic panel were done and the reports stated complete blood count, urine analysis and comprehensive metabolic panel were within the normal limits. The emergency room physician told the patient's grandmother that patient could be having possible reaction to the HPV vaccine. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction
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 # 651285) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient had no known allergies but had history of asthma and hydronephrosis. The patient had no current illness at the time of report. Other medications included Albuterol HFA, as needed (prn). On 06-SEP-2016 the patient was vaccinated with GARDASIL 9 dose number 2, lot # M011840 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included MENVEO (Manufacturer: Novartis, Vaccinated date: 06-SEP-2016, lot # M15148, dose number 1 (dose, frequency and lot expiration date unknown) for prophylaxis. On the same day, patient was seen for a physical examination and was given MENVEO, left deltoid. The mother stated that patient complained of injection site swelling and injection site pain to left deltoid same evening. On 07-SEP-2016, left deltoid was worse, warm to touch and pain. On 08-SEP-2016, after examination PNP noticed 16x16cm localized reaction and prescribed KEFLEX 250mg/5ml, BENADRYL, as needed (prn). Patient to follow up on 12-SEP-2016. The patient required an emergency room visit. The outcome of the events were not reported. The 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, MNQ, TDAP
Symptoms: Amnesia, Anxiety, Confusional state, Crying, Fall
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 # 651815) 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 10-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L040054, expiration date: 26-DEC-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 10-SEP-2016, the patient went to clinic for WCC and received 3 vaccines (HPV, MCV, Tdap), was stable/normal during exam. Provider left room after exam, MA (medical assistant) administered 3 vaccines. Within 1 (one) minute patient described headache, clutched sides of his head, closed his eyes and became stiff while collapsing. MA called provider who came in from room next door. The patient was tonic in all limbs, neck, jaw and eyes open. Whole tonic state lasted approximately 30-40 seconds. The patient's body relaxed, he appeared confused, then anxious/started crying/ trying to run from room. MA convinced patient to sit, took vitals. The patient remained stable until EMS arrived approximately 2-3 minutes post end of seizure. The patient reported severe headache, no memory then confusion. Denies incontinence during episode. Had mild-moderate headache after episode. Reports fall with no head injury or loss of consciousness. As per mother patient had no previous seizure. The patient transferred to emergency room (ER) for evaluation via ambulance. The outcome of anxiety, syncope, seizure, musculoskeletal stiffness, muscle rigidity, headache, crying and confusional state 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Hypotonia, Musculoskeletal stiffness, Seizure, 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 # 651815) 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 10-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L040054, expiration date: 26-DEC-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 10-SEP-2016, the patient went to clinic for WCC and received 3 vaccines (HPV, MCV, Tdap), was stable/normal during exam. Provider left room after exam, MA (medical assistant) administered 3 vaccines. Within 1 (one) minute patient described headache, clutched sides of his head, closed his eyes and became stiff while collapsing. MA called provider who came in from room next door. The patient was tonic in all limbs, neck, jaw and eyes open. Whole tonic state lasted approximately 30-40 seconds. The patient's body relaxed, he appeared confused, then anxious/started crying/ trying to run from room. MA convinced patient to sit, took vitals. The patient remained stable until EMS arrived approximately 2-3 minutes post end of seizure. The patient reported severe headache, no memory then confusion. Denies incontinence during episode. Had mild-moderate headache after episode. Reports fall with no head injury or loss of consciousness. As per mother patient had no previous seizure. The patient transferred to emergency room (ER) for evaluation via ambulance. The outcome of anxiety, syncope, seizure, musculoskeletal stiffness, muscle rigidity, headache, crying and confusional state 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: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Chest discomfort, Dizziness, Oropharyngeal discomfort, 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 # 653546) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included asthma, gastrooesophageal reflux disease (GERD), adjustment disorder, obstructive sleep apnea (OSA) and obesity. The patient's current illnesses was reported as recovering from pneumonia. Information on the patient's other medications, lab data and prior vaccinations were not reported. On 07-SEP-2016 at 14:00, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L043214 (dose number: 2; lot expiration date was not reported) for prophylaxis. On the same day at 14:05, the patient was also vaccinated with MENACTRA (dose number: 2, intramuscularly in the left arm, lot # U5390AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 07-SEP-2016, the patient complained of dizziness and weakness. The patient was placed in supine position and was applied cold compress. His vitals were taken: blood pressure (BP) was 140/80. The patient proceeded to vomit small amount of mucus. At 02:15, the patient's BP was 150/90, pulse 106 and Oxygen saturation (O2 SAT) was 98. The patient complained of throat and chest discomfort and was examined by the Doctor of Medicine (MD). The patient was monitored for 30 minutes. The patient's vitals at 02:41, BP was 122/86, pulse was 92 and O2 SAT was 97. The patient felt better and was discharged. The patient was contacted at 16:00 and was doing well. Follow-up was to be done the next morning. 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: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, 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 # 653638) on 02-MAY-2017. This spontaneous report as received from a regulatory authority 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 other medications were not reported. On 15-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left thigh (left upper leg), lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENVEO. On 15-SEP-2016, immediately (immediate post-injection reaction) after receiving GARDASIL 9 vaccine, patient fell forward into nurse and father, as if she had passed out (loss of consciousness) but then she had whole body shaking and loss of bladder control which lasted for about several seconds and became pale. The patient was made to lay down and juice was given. The outcome of fall, urinary incontinence, tremor, pallor, loss of consciousness and immediate post-injection reaction 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, TDAP
Symptoms: Urinary incontinence
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653638) on 02-MAY-2017. This spontaneous report as received from a regulatory authority 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 other medications were not reported. On 15-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left thigh (left upper leg), lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENVEO. On 15-SEP-2016, immediately (immediate post-injection reaction) after receiving GARDASIL 9 vaccine, patient fell forward into nurse and father, as if she had passed out (loss of consciousness) but then she had whole body shaking and loss of bladder control which lasted for about several seconds and became pale. The patient was made to lay down and juice was given. The outcome of fall, urinary incontinence, tremor, pallor, loss of consciousness and immediate post-injection reaction 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Aggression, Decreased appetite, Haemoglobin normal, Platelet count normal, Vitamin D decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654318). This spontaneous report refers to an 11 year old male patient. The patient had no concurrent illnesses and medical history included autism spectrum disorder. Other medications included clonidine and clonazepam. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214 (expiry date: 30-AUG-2017), dose 1, intramuscularly in the right leg for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included ADACEL (lot # US378AA, dose 1, intramuscularly in the left leg) and MENACTRA (lot # US282BB, dose 1, intramuscularly in the left leg). On an unknown date, the patient experienced aggression, white blood cell count decreased, vitamin D decreased, platelet count normal, haemoglobin normal and decreased appetite. Poor appetite, aggression beginning from 3-7 days after vaccines and persisting currently as of 20-SEP-2016. The patient lab values included: white blood cells was 3,200 (units not provided), hemoglobin was 15.1 (units not provided), platelets was 280000 (units not provided), 25-OH vitamin D was 21 (units not provided). The patient had an emergency room visit. The outcome of aggression, white blood cell count decreased, vitamin D decreased, platelet count normal, haemoglobin normal and decreased appetite 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.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654318). This spontaneous report refers to an 11 year old male patient. The patient had no concurrent illnesses and medical history included autism spectrum disorder. Other medications included clonidine and clonazepam. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214 (expiry date: 30-AUG-2017), dose 1, intramuscularly in the right leg for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included ADACEL (lot # US378AA, dose 1, intramuscularly in the left leg) and MENACTRA (lot # US282BB, dose 1, intramuscularly in the left leg). On an unknown date, the patient experienced aggression, white blood cell count decreased, vitamin D decreased, platelet count normal, haemoglobin normal and decreased appetite. Poor appetite, aggression beginning from 3-7 days after vaccines and persisting currently as of 20-SEP-2016. The patient lab values included: white blood cells was 3,200 (units not provided), hemoglobin was 15.1 (units not provided), platelets was 280000 (units not provided), 25-OH vitamin D was 21 (units not provided). The patient had an emergency room visit. The outcome of aggression, white blood cell count decreased, vitamin D decreased, platelet count normal, haemoglobin normal and decreased appetite 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.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Headache, Heart rate abnormal, Hypotension, Pallor
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no other medications, current illnesses and medical history and the patient's prior vaccinations was not reported. On 26-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9, intramuscularly in the left arm (dose, frequency, lot number and lot expiration date unknown) for prophylaxis. And the same day patient fainted for 3 minutes after receiving vaccine and was out for 60 seconds and upon coming to, the patient was shaking almost seizure-like but stopped on becoming fully alert. Face and lips of patient became extremely pale with very low blood pressure and heart rate which improved in 15 minutes after lying down and drinking water. All these occurred while the patient was in physician's office in front of the nurse. The patient experienced blurred vision and ringing in ears that lasted for 1 hour and headache still persisted 6 hours later, which might be from bumping her head on the cabinet  when she fainted. The outcome of head injury, headache, syncope, vision blurred, tremor, tinnitus, seizure like phenomena, pallor, hypotension and heart rate abnormal 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: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Syncope, Tinnitus, Tremor, Vision blurred
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no other medications, current illnesses and medical history and the patient's prior vaccinations was not reported. On 26-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9, intramuscularly in the left arm (dose, frequency, lot number and lot expiration date unknown) for prophylaxis. And the same day patient fainted for 3 minutes after receiving vaccine and was out for 60 seconds and upon coming to, the patient was shaking almost seizure-like but stopped on becoming fully alert. Face and lips of patient became extremely pale with very low blood pressure and heart rate which improved in 15 minutes after lying down and drinking water. All these occurred while the patient was in physician's office in front of the nurse. The patient experienced blurred vision and ringing in ears that lasted for 1 hour and headache still persisted 6 hours later, which might be from bumping her head on the cabinet  when she fainted. The outcome of head injury, headache, syncope, vision blurred, tremor, tinnitus, seizure like phenomena, pallor, hypotension and heart rate abnormal was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655590) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 36 year old female patient. The patient's concurrent illness was reported as none. The patient's concomitant therapies, prior vaccinations, other medications and medical history were not reported. On 12-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M004116, lot expiration date 12-OCT-2017 (dose: not reported) via intramuscular route, in the right arm, first dose of M-M-R II lot # L029266 (dose and lot expiration date were not reported) via subcutaneous route, in the left arm and first dose of VARIVAX lot # L012038, lot expiration date 07-APR-2017 (dose: not reported) via subcutaneous route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of BOOSTRIX (intramuscularly in the left arm, lot# 54657; dose and expiration date were not reported), first dose of ENGERIX-B (intramuscularly in the left arm, lot# 44DF2; dose and expiration date were not reported), first dose of MENACTRA (intramuscularly in the right arm, lot# U5260AA; dose and expiration date were not reported), first dose of poliovirus vaccine inactivated (vero) (IPOL) (intramuscularly in the right arm, lot# M1205; dose and expiration date were not reported) and first dose of BEXSERO (intramuscularly in the left arm, lot# 153701; dose and expiration date were not reported) for prophylaxis. On 12-AUG-2016 at 10:45, the patient complained about itching all over the body. The patient was given epipen 0.15 mg intramuscularly and called 911. The patient had no wheezing, throat's redness or swelling. The patient did not experience any rash or hives. The patient was alert and oriented (reported as alert and oriented x 3). The patient was sent to the emergency room for monitoring and treatment. The patient was sent home later. The outcome of pruritus generalised 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: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Chills, Fatigue, Pain, 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 # 657545) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses. The patient's medical history included Epicondylar fracture 2 weeks earlier. Information on the patient's prior vaccinations were not reported. The patient's other medications included Zyrtec 10mg/day, Montelukast 10mg/day. On 05-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency, lot and lot expiration dates were not reported), dose 2, route: unspecified, in the left arm for prophylaxis. The patient experienced sore arm following vaccination, tiredness in the evening (05-OCT-2016). On 06-OCT-2016, the patient experienced fever (100.4 degree F) at 4:00, aches, chills, weakness and sore arm. The outcome of pyrexia, pain in extremity, pain, fatigue, chills and asthenia 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: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657545) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses. The patient's medical history included Epicondylar fracture 2 weeks earlier. Information on the patient's prior vaccinations were not reported. The patient's other medications included Zyrtec 10mg/day, Montelukast 10mg/day. On 05-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency, lot and lot expiration dates were not reported), dose 2, route: unspecified, in the left arm for prophylaxis. The patient experienced sore arm following vaccination, tiredness in the evening (05-OCT-2016). On 06-OCT-2016, the patient experienced fever (100.4 degree F) at 4:00, aches, chills, weakness and sore arm. The outcome of pyrexia, pain in extremity, pain, fatigue, chills and asthenia was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.