chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Consciousness fluctuating, Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638232) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. The patient had no concurrent illness, other medications and medical history. The patients concomitant therapies and prior vaccinations were not reported. On 06-JUN-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L044475 (dose, frequency and lot expiration date were not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies which were given on the same day included VARIVAX (dose number: 3, subcutaneously in the left arm, lot# L046887; dose and expiration date was unknown) and HAVRIX (dose number: 3, intramuscularly in the left arm, lot# Z5DM2; dose and expiration date was unknown). On 06-JUN-2016, immediately after  the injection shots, the patient had nausea, fainting, slumping down and totally lost consciousness for 10 seconds and was in and out of consciousness for 5 minutes. 911 was called. The patient was given oxygen and vital signs were taken. Blood pressure was 120/60 (units not provided) pulse rate 74 (units not provided), respiratory rate 20 (units not provided) and Oxygen saturation (reported as pulse oximeter) 100%. The patient was kept under close observation until the paramedic arrived. The patient had visited the emergency room. The outcome of consciousness fluctuating, syncope, posture abnormal, nausea, loss of consciousness and immediate post-injection reaction 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: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
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 # 638232) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. The patient had no concurrent illness, other medications and medical history. The patients concomitant therapies and prior vaccinations were not reported. On 06-JUN-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L044475 (dose, frequency and lot expiration date were not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies which were given on the same day included VARIVAX (dose number: 3, subcutaneously in the left arm, lot# L046887; dose and expiration date was unknown) and HAVRIX (dose number: 3, intramuscularly in the left arm, lot# Z5DM2; dose and expiration date was unknown). On 06-JUN-2016, immediately after  the injection shots, the patient had nausea, fainting, slumping down and totally lost consciousness for 10 seconds and was in and out of consciousness for 5 minutes. 911 was called. The patient was given oxygen and vital signs were taken. Blood pressure was 120/60 (units not provided) pulse rate 74 (units not provided), respiratory rate 20 (units not provided) and Oxygen saturation (reported as pulse oximeter) 100%. The patient was kept under close observation until the paramedic arrived. The patient had visited the emergency room. The outcome of consciousness fluctuating, syncope, posture abnormal, nausea, loss of consciousness and immediate post-injection reaction was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Dyskinesia, Glare, Glassy eyes, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638406) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 19 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. Other medications included Ibuprofen 200mg. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 dose number 1 (dose, lot number and expiration date unknown) via unknown route in the right arm for prophylaxis. Other suspect therapies included BEXSERO (Manufacturer: Novartis, Vaccinated date: 07-JUN-2016, dose number 1 (dose, lot number and expiration date unknown) via unknown route in the left arm) and meningococcal vaccine (unspecified) ((Manufacturer: Unknown, Vaccinated date: 07-JUN-2016, dose number 1 (dose, lot number and expiration date unknown) via unknown route in the left arm) for prophylaxis. On the same day, the patient slumped over, lost his consciousness, went stiff, began shaking arms and legs and uncontrollable throwing of arms and legs. Eyes were glaring and glassed over - then came out of it. The outcome of 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: 19.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Posture abnormal, 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 # 638406) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 19 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. Other medications included Ibuprofen 200mg. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 dose number 1 (dose, lot number and expiration date unknown) via unknown route in the right arm for prophylaxis. Other suspect therapies included BEXSERO (Manufacturer: Novartis, Vaccinated date: 07-JUN-2016, dose number 1 (dose, lot number and expiration date unknown) via unknown route in the left arm) and meningococcal vaccine (unspecified) ((Manufacturer: Unknown, Vaccinated date: 07-JUN-2016, dose number 1 (dose, lot number and expiration date unknown) via unknown route in the left arm) for prophylaxis. On the same day, the patient slumped over, lost his consciousness, went stiff, began shaking arms and legs and uncontrollable throwing of arms and legs. Eyes were glaring and glassed over - then came out of it. The outcome of 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.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, 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 # 638454) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 14 year old female patient. The patient's medical history, and concurrent illness were reported as none. Information on the patient's prior vaccinations was not reported. On 03-JUN-2016 the patient was vaccinated with the first dose of  GARDASIL 9 intramuscularly in the right arm, lot # L048237 (lot expiration date was not reported) for prophylaxis. On the same day, 10-15 minutes post vaccination, the patient developed hives on her back and started to have erythema in a discrete patch on her face. The patient's other medications included Benadryl (50 mg, orally) and Zyrtec which were given after the hives. The patient was then monitored for more than 30 minutes. The patient had no hypoxia, no wheezing, and the hives improved. The outcome for the events erythema and 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: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638940) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 31-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # M003659 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included first dose of VAQTA lot# L036300 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On the same day of vaccination, the patient experienced lightheadedness. The outcome of dizziness was reported as recovered. Causality assessment of the event was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639244) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included seasonal allergy. The patient's concomitant therapies and concurrent illness were not reported. Other medications included CLARITIN and nasal spray. On 25-MAY-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # M003659 (dose, frequency and lot expiration date were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 25-MAY-2016, intramuscularly in the right arm, lot# C4990AA; dose and expiration date unknown). and MENACTRA (dose number: 1, vaccinated date: 25-MAY-2016, intramuscularly in the left arm, lot# U5185BA; dose and expiration date unknown) for prophylaxis. On 26-MAY-2016, patient experienced dizziness and elevated blood pressure. The patient had an emergency visit. Patient had a follow up visit on 31-MAY-2016. The outcome of blood pressure increased and dizziness were reported as recovered. Causality assessment of 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, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #639408) and refers to a 11 year old female patient. No details about medical history, lab data, prior vaccination were provided and current illnesses was reported as none. Other medications included VENTOLIN HFA. On an unknown date the patient was vaccinated with GARDASIL 9, lot # L026602, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with ADACEL, TRUMENBA and MENACTRA. On an unknown date, 48 hours after vaccination, the patient experienced full body hives for 4 days. The outcome of urticaria was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site 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 # 639415) on 18-APR-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included double aortic arch post repair and attention deficit/hyperactivity disorder (ADHD). The patient's other medication included VYVANSE (10mg, once daily). The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 09-JUN-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L044475 (dose number: 3, lot expiration date was not reported) for prophylaxis. On 12-JUN-2016, the patient experienced non pruritic rash surrounding the injection site. The patient had no swelling, no pain, the injected site was stable and the symptoms did not progress. The outcome for the event injection site 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, MNQ
Symptoms: 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 # 639437) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old male patient. The patient's medical history included allergic rhinitis. The patient did not have any other illnesses at the time of vaccination. Information on the patient's other medications and prior vaccinations were not reported. On 09-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M005714 (lot expiration date was not reported) and MENACTRA (dose number: 1, intramuscularly in the right arm, lot # U5392AA, manufacturer: Sanofi Pasteur; lot expiration date unknown) for prophylaxis. On 10-JUN-2016, the patient's mother noticed the injection site of the patient to be red and puffy. 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, MENB
Symptoms: Anticonvulsant drug level below therapeutic, Condition aggravated, Generalised tonic-clonic 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 # 639531) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. Information on the patient's concurrent illnesses was reported to be none. Patient's other medication included Levetiracetam. Patient medical history included seizure disorder and arachnoid cyst. Patient's prior vaccination included TRUMENBA On 07-JUN-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L026602 (expiration date: 19-OCT-2017), via intramuscular route, in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with TRUMENBA lot/batch # M37314, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 10-JUN-2016, the patient had anticonvulsant drug level below therapeutic and had grand mal seizure after 3 days of vaccination. However seizure disorder was well controlled with Levetiracetam. Patient had levetiracetam subtherapeutic level 4, range was given as (12-46). The outcome of anticonvulsant drug level below therapeutic and generalised tonic-clonic seizure was reported as recovered. The patient required emergency room visit. 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
Symptoms: Seizure like phenomena, 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 # 639713) on 18-APR-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and the patient's prior vaccination included HPV (unspecified brand name). Information on other medication was not reported. On 16-JUN-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M004116 (dose, frequency and lot expiration date were not reported), intramuscularly in the left arm for prophylaxis. On 16-JUN-2016, after the vaccine was administered, within a minute the patient experienced a brief period of unresponsiveness with seizure like activity which lasted for about 10 seconds. The patient was monitored for about 30 minutes. The outcome of seizure like phenomena and unresponsive to stimuli was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Limb mass, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639934) on 18-APR-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 16-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L037554 (dose number, dose, frequency, lot expiration date and vaccination site were not reported), intramuscularly for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # 943Z5 and MENACTRA batch/lot # U5187AA intramuscularly for prophylaxis. On 16-JUN-2016, the patient experienced redness, swelling and hard lump on left arm. The outcome of erythema, peripheral swelling, mass and induration was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Exposure during pregnancy
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 # 640081) on 18-APR-2017. This spontaneous prospective pregnancy report was received from a regulatory authority refers to a 23 year old female patient. Patient had no medical history. Information on the patient's concurrent illnesses and other medications were reported as none. Information on patient's prior vaccination and lab data was not reported. On 09-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L016428, via unknown route, in the right arm for prophylaxis (dosage unspecified). She was screened as usual and denied being pregnant. On the same day the patient was also vaccinated with ADACEL dose 1, lot/batch # U1565AA, via unknown route, in the right arm, MENACTRA dose 1, lot/batch # U5185BA, via unknown route, in the left arm, FLUVIRIN dose 1, lot/batch # 1516601, via unknown route, in the left arm, hepatitis a vaccine, inactivated dose 1, lot/batch # L016428, via unknown route, in unknown site and hepatitis b vaccine (recombinant) dose 1, lot/batch # L016428, via unknown route, in the unknown site for prophylaxis (dosage and expiry date unspecified). On 16-JUN-2016, patient came to PHC and informed that she was pregnant. The LMP and EDD were not known. The pregnancy outcome was unknown. The outcome of exposure during pregnancy was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Abdominal pain upper, Crying, Injection site reaction, Malaise, Middle insomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #640240) and refers to a 17 year old female patient. Patient had no current illness and medical history. Other medications included VYVANSE (reported as hadn't taken that day) and an unspecified birth control pill. On 16-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapy included vaccination with BEXSERO, administered on 16-JUN-2016, intramuscular for prophylaxis. On 17-JUN-2016, the patient woke up during night crying with stomach pain, nausea and was unable to touch area where she had vaccine. The patient felt ill for 3-4 days. The outcome of abdominal pain upper, vaccination site pain, nausea, middle insomnia, malaise and crying was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #640240) and refers to a 17 year old female patient. Patient had no current illness and medical history. Other medications included VYVANSE (reported as hadn't taken that day) and an unspecified birth control pill. On 16-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapy included vaccination with BEXSERO, administered on 16-JUN-2016, intramuscular for prophylaxis. On 17-JUN-2016, the patient woke up during night crying with stomach pain, nausea and was unable to touch area where she had vaccine. The patient felt ill for 3-4 days. The outcome of abdominal pain upper, vaccination site pain, nausea, middle insomnia, malaise and crying was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9
Symptoms: 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 # 640281) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old male patient. The patient's medical history included prolonged QT syndrome. The patient had no current illnesses. Other medications included purified protein derivative (PPD) vaccine and Nadolol. Information on concomitant medications, lab data and prior vaccinations were not reported. On 23-MAY-2016, the patient was vaccinated with GARDASIL 9 injection, lot # M003659, dose number 1 (dose and lot expiration date unknown) via unspecified route in the left arm for prophylaxis. On the same day, post vaccination the patient experienced brief syncope for a minute and lost his consciousness for less than a minute. The outcome of the events were reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Blood glucose decreased, Bradycardia, Conjunctival pallor, Dizziness, Hunger
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 # 640343) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 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 21-JUN-2016 the patient was vaccinated with second dose of GARDASIL 9 intramuscularly, lot # M003659, (injection site, dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VARIVAX subcutaneously, lot # L049533 (injection site, dose, frequency and lot expiration date were not reported) for prophylaxis. On 21-JUN-2016 after receiving second dose intramuscularly, the patient felt dizzy and became pale saying that she was hungry and made her to laid down on the exam table, pale lips  & conjunctiva were observed. Heart rate was 52/min regular strong. After rest and intake of food at 12:10 PMPT heart rate was improved to 70/min strong. The patient claimed that she felt better blood pressure was 94/60, less pallor, neg dizzy(negative dizziness), she was able to stand and walked out of the office for the ride. The outcome of blood glucose decreased, bradycardia, conjunctival pallor, dizziness, hunger 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: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640343) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 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 21-JUN-2016 the patient was vaccinated with second dose of GARDASIL 9 intramuscularly, lot # M003659, (injection site, dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VARIVAX subcutaneously, lot # L049533 (injection site, dose, frequency and lot expiration date were not reported) for prophylaxis. On 21-JUN-2016 after receiving second dose intramuscularly, the patient felt dizzy and became pale saying that she was hungry and made her to laid down on the exam table, pale lips  & conjunctiva were observed. Heart rate was 52/min regular strong. After rest and intake of food at 12:10 PMPT heart rate was improved to 70/min strong. The patient claimed that she felt better blood pressure was 94/60, less pallor, neg dizzy(negative dizziness), she was able to stand and walked out of the office for the ride. The outcome of blood glucose decreased, bradycardia, conjunctival pallor, dizziness, hunger 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.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Slow response 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 # 640348) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history and lab data were reported as none. Information on patient's prior vaccination and other medications were not reported. On 22-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M004116, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # A15097, via intramuscular route, in the left arm and BOOSTRIX lot/batch # 54LS7, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 22-JUN-2016, after vaccination with GARDASIL vaccine, Meningococcal and Tdap, patient stood up and told her mother that she felt dizzy, then she fell on the floor. She was placed in supine position. She was first slow to respond but then was oriented to her name, could recognized her mother and where she was located. VS assessment showed 110/80, HR 64 apical, respiration was even and unlabored. After several minutes, she was assisted to sitting position. Patient was feeling less dizzy and was given water to drink. She recovered. She was alert and oriented. She reported dizziness had subsided. Outcome of all the events were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Panic attack, Paraesthesia
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 # 640369) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 injection, lot # M007728, dose number 1 via needle and syringe (unspecified) route in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, Vaccinated date : 20-JUN-2016, Lot # U5316AA, dose number 1 (dose , frequency and lot expiration date unknown) via needle and syringe (unspecified) route in the left arm) and MENVEO (Manufacturer: Novartis, Vaccinated date : 20-JUN-2016, Lot # M15123, dose number 1 (dose, frequency and lot expiration date unknown) via needle and syringe (unspecified) route in the left arm) for prophylaxis. On an unspecified date, the patient developed chest pains, shortness of breath with tingling to her extremities about one hour after injection. The patient was seen at Emergency room, diagnosed with panic attack. The outcome of 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.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, 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 # 640608) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. The patient's had no known drug allergies (NKDA). The patient's concurrent illnesses was reported as none. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications included clindamycin phosphate and benzoyl peroxide. On 03-JUN-2016 the patient was vaccinated with second dose of GARDASIL 9 lot # M003659 (dose, frequency and lot expiration date were not reported), via unknown route, in the left arm for prophylaxis. Other suspect therapy included HAVRIX (dose number: 1, vaccinated date: 03-JUN-2016, via unknown route, in the left arm, lot# C7252; dose and expiration date was unknown). On 03-JUN-2016, patient came with mother for second dose of HPV. The patient was given orange juice before the shot as she did not eat breakfast, but had early lunch at 12:00. The patient was given second dose of HPV in the left deltoid and first dose of Hepatitis A vaccine at 14:40. On the same day at 14:45, the patient stated that, she felt nauseous and laid her head back in chair and closed her eyes. The registered nurse observed head movement and asked the patient how she was feeling. The patient stated that, she was feeling nauseous and dizzy and she responded to the registered nurse appropriately. The patient's blood pressure was checked. The patient was given orange juice again, cold cloth and chair to sit in supine position. The patient did not lose conscious or vomit. The patient was observed for an extended period of 70 minutes with vitals being assessed. The Patient's blood pressure (units not provided) was found to be 97/63 (at 14:45), 99/66(at 14:55), 102/68 (at 15:10) and 110/69 (at 15:40). The patient's heart rate (units not provided) was found to be 77 (at 14:45), 80 (at 14:55), 76 (at 15:10) and 71 (at 15:40). The patient became stable and was discharged with her mother. The outcome of dizziness and nausea were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
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 # 640627) on 18-APR-2017. This spontaneous prospective pregnancy report was received from a regulatory authority concerning a 15 year old female patient. Information on pertinent medical history, current illnesses, concomitant medications and prior vaccinations were not reported. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 injection, lot # M00414116, (dose number, dose, lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On an unknown date, the patient underwent human chorionic gonadotropin test which showed positive results. The patient exposed to the drug during pregnancy. The outcome of 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.
Sex: M
Vaccine: HPV9
Symptoms: Injection site reaction, Paraesthesia, Pyrexia, Rash macular, 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 # 640634) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient had no past medical history and current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 23-JUN-2016, the patient was vaccinated with GARDASIL 9 injection, lot # M009116, dose number 3 (dose and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On the same day (also reported as 23-JUN-2014), patient had a fever of 101.6. On 24-JUN-2016, from 2:30am to 3:30am patient had vomiting. The vomiting was stopped but he still had a fever of 100. The patient's mother described rash macules and a red blotchy rash about a silver dollar size around the injection site. Her son complained that there was pins and needles all over his body. The outcome of the events were not reported. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Seroma
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 # 640724) on 18-APR-2017. This spontaneous report refers to a 21 year old female 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 APRI. On 17-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L026602 (expiration date 19-OCT-2017) (dose number, dose and frequency were not reported), intramuscularly in the right arm for prophylaxis. On 17-JUN-2016, the patient had seroma of size 8 cm. The outcome of seroma was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, 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 # 640900) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's other medications and prior vaccinations were not reported. Patient had no current illness and medical history. Information on patient's lab data was reported as none. On 28-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with VAQTA lot # M009377, via intramuscular route, in the left arm, ADACEL lot/batch # U540688, via intramuscular route, in the right arm and MENACTRA lot/batch # U5282BC, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified) for prophylaxis. On 28-JUN-2016, patient fainted and fell off the exam table. No additional injury noted. Patient had no complaints of pain prior to leaving the office approximately 20 minutes after incident. The outcome of fall and syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640992) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 years 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 21-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M005714 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 21-JUN-2016, following administration of GARDASIL 9 vaccine the patient experienced nausea and appeared pale and the patient was given 6 oz of orange juice, candy and water. Vital signs were monitored, initially blood pressure was 72/39 and pulse 58. Color improved, reported feeling better. Before going home vital signs were improved BP 100/59, pulse 58 and then 94/56, pulse 76. The patient was observed by provider before leaving office. The patient parent was called later in day who reported patient felt much better, nausea resolved, eating well. The outcome of nausea and pallor was reported was recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
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 # 641005). This spontaneous report refers to a 12 year old female patient. The patient had no current illnesses and information on other medications was not reported. The patient's medical history included peanut allergy. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5264AA, dose 6, intramuscularly in the left arm and MENACTRA lot # U5172BA, dose 1, intramuscularly in the right arm for prophylaxis. On 22-JUN-2016, the patient experienced significant pain and swelling in deltoid region which started hours after injection and lasted several days. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Contusion, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641135) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 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-JUN-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # M005714 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included TRUMENBA intramuscularly in the left arm, lot # M37316, manufacturer: Pfizer/Wyeth, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-JUN-2016, patient experienced left arm bruised, swollen, very sore, headache and fatigue. The patient's mom was advised to give Ibuprofen and heat/ice to be used as needed (PRN) at the injection site. The outcome of contusion, peripheral swelling, pain in extremity, headache and fatigue was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Ear pain, Headache, 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 # 641324). This spontaneous report refers to a 17 year old female patient. Information on patient's concurrent illnesses was not reported. Patient had no known drug allergies. Patient's other medications included ADDERALL XR; VENTOLIN HFA. On 23-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M37316, dose 1, intramuscularly in the left arm and MENACTRA lot # U5410AA, dose 2, intramuscularly in the right arm for prophylaxis. On 23-JUN-2016, approximately one and half hours after receiving vaccines, patient started with myalgia, very bad headache, nausea, chills throughout the evening and approximately 12 hours later patient also had ear and jaw pain, fever and arm pain. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain in extremity, Pain in jaw, 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 # 641324). This spontaneous report refers to a 17 year old female patient. Information on patient's concurrent illnesses was not reported. Patient had no known drug allergies. Patient's other medications included ADDERALL XR; VENTOLIN HFA. On 23-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M37316, dose 1, intramuscularly in the left arm and MENACTRA lot # U5410AA, dose 2, intramuscularly in the right arm for prophylaxis. On 23-JUN-2016, approximately one and half hours after receiving vaccines, patient started with myalgia, very bad headache, nausea, chills throughout the evening and approximately 12 hours later patient also had ear and jaw pain, fever and arm pain. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hypersensitivity, Peripheral swelling, 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 # 669558) on 10-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included scoliosis. On 03-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot# M028323) dose 1  and FLUZONE (lot# UI729AA) dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient presented with bilateral swelling of hands, associated with itching and wheals on the arms and back. At the time of visit, the patient was recommended to begin taking ZYRTEC for allergic reaction and follow up in 24-48 hours if reaction persists. There were no other illness at time of visit. The patient was in to see physician for a well visit. At the time of this report, the outcome of hypersensitivity, urticaria, pruritus and peripheral swelling was unknown. The causality of hypersensitivity, urticaria, pruritus and peripheral swelling with respect to GARDASIL 9 and FLUZONE was not reported. Additional information is not expected as follow up information cannot be obtained from the Agency.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Pain, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#672346) under the Freedom of Information Act (FOI) regarding a 12 year old female patient Mom said that her daughter really complained about the GARDASIL 9 lot # M030380 dose 1, intramuscular in the left arm for prophylaxis (dosage and expiration date were not reported), as it was really painful when she got it on 18-NOV-2016. After that, mom stated that she developed a weird rash on her arm where the shot was given. That had resolved and there was no swelling at the time of reporting. Since then, she had experienced pain going down her arm, to the point, mom said that she could not even move it due to pain. She was experiencing shooting pains in her 1-3 fingers. Current illnesses: no. History: malignant neoplasm of bladder neck, age 2. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 11.0
Sex: M
Vaccine: HPV9, MMRV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#673324)  under the Freedom of Information Act (FOI) and regarding a 11 year old male patient.  On 12-DEC-2016, the patient was vaccinated with PROQUAD lot # M03144, dose 2, in the left arm for prophylaxis (route, and expiration date were not reported).  Other suspect therapies given on the same date included GARDASIL 9 lot # M028323, dose 1, in the left arm for prophylaxis (route, and expiration date were not reported); BOOSTRIX  lot # EC9A9, dose 1, in the right arm for prophylaxis (route, and expiration date were not reported); and MENVEO lot # M18166. dose 1, in the right arm for prophylaxis (route, and expiration date were not reported). On 13-DEC-2016,the patient experienced swelling, warmth, redness and 9 x 6 cm induration in left deltoid. Other medications: none Current illnesses: none History: attention-deficit hyperactivity disorder (ADHD). Additional information is not expected as no follow-up can be obtained from the agency.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 673799) under the Freedom of Information Act referring to a 14 year old female patient. The patient's concurrent conditions included an allergic reaction to "carme" (not specified). Pertinent medical history and concomitant medications were not mentioned. On 16-DEC-2016, the patient was vaccinated with a dose of GARDASIL 9) in the left arm, intramuscularly (lot # L040054, expiration date was not provided), for prophylaxis. On 17-DEC-2016, the patient experienced generalized hives (pruritus generalized) and 5 x 5 cm redness (injection site erythema), hot indurated circular area around the injection site (injection site warmth). Additionally, the patient complained of generalized itching (pruritus generalized). At the reporting time, the patient had recovered from the events. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.