chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, 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 # 649495). This spontaneous report refers to a 16 year old male patient. The patient's concurrent illnesses, medical history and other medications were reported as none. On 19-AUG-2016 the patient was vaccinated with GARDASIL 9, dose 3 (lot# M021407), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced syncope, seizure and the patient's blood glucose was normal (109). Patient fainted and had seizure activity lasting approximately 5 seconds (approximately 5 minutes after administration). Patient never had side effects with previous HPV-9 administration. No previous history of seizures. Only HPV-9 given at this appointment. The outcome of blood glucose normal, syncope and seizure were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, 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 # 649498). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses was reported as none. The patient's medical history and other medications were not reported. On 15-AUG-2016 the patient was vaccinated with GARDASIL 9 dose 1 (lot# M011840), intramuscularly in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included ADACEL (lot# US476AA, intramuscularly in the left arm) and MENACTRA (dose 1, lot# US416AA, intramuscularly in the left arm). On 16-AUG-2016, the patient experienced cellulitis, peripheral swelling and pain in extremity. Patient complained of excessive pain, swelling left arm (TDAP and MENACTRA) after immunization. Called medical doctor on call, sent to urgent care and diagnosed with cellulitis. Parents concerned wrong needle used for small stature child. The outcome of cellulitis, peripheral swelling and pain in extremity were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, 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 # 649515) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on patient's medical history was reported as none. Patient had no current illness. Patient's blood pressure was 96/62. On 24-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 1, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENACTRA lot/batch # US259AA, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On 24-AUG-2016, after receiving the two vaccines, patient became pale. Patient stated that he was feeling funny and his eyes rolled back in his head. Patient was immediately layed down and he felt fine within seconds or one minute of the incident. Patient was given a cold cloth and water to drink. The outcome of eye movement disorder, pallor and feeling abnormal 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: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Lip 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 # 649575) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male. Information on the patient's prior vaccinations were not reported. Patient's medical history included Amoxicillin allergy. Patient's current illness included asthma with mild cough. Patient's other medication included Albuterol HFA. On 24-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M013636, dose 2, intramuscularly in the left arm for prophylaxis (dosage unspecified). The day after the vaccination, patient's  upper lip started swelling. Patient had cough without throat closing or dyspnea. Patient had lip swelling after the first vaccination with HPV also but it was attributed to Amoxicillin prescribed on the same day. The outcome of lip swelling and cough was unknown. Patient was sent to allergist. The causality assessment for the events lip swelling and cough with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Chest X-ray normal, Lymphadenopathy, Urinary system x-ray normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649969) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's medical history and concurrent illnesses included autistic spectrum disorder. There were no known drug allergies or other medications. On 20-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L013429, expiration date: 21-JUL-2017,dose 1, intramuscularly in the left arm for prophylaxis. On 25-JUL-2016, the patient experienced left supraclavicular lymphadenopathy which occurred shortly after vaccination and underwent chest x-ray, urinary system (kidney urinary bladder) x-ray which were normal/negative. The workup for the lymph node was negative and clinical evaluation was performed. The outcome of all the events was reported as recovered/resolved. The events required an emergency room visit. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Culture throat, Myalgia, Pharyngeal erythema, Pyrexia, Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 650035). This spontaneous report refers to a 13 year old male patient. The patient's concurrent illnesses and medical history were reported as none. On 25-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M020103, dose 2, via unknown route in the left arm for prophylaxis. On the same day, patient had fever and muscle pain (diffuse). No swelling or redness at vaccination site. Throat erythema today, rapid streptococcus test was negative, throat culture was sent. The outcome of myalgia, streptococcus test negative, pyrexia, pharyngeal erythema and culture throat were reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-650362). This spontaneous report refers to a 13 year old male patient. The patient had no current illnesses, historical conditions and other medications. On 22-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M009378 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. A few hours later, the patient developed a rash which became generalized, erythematous and urticaric. The patient was taken to an emergency room. The patient's condition improved after taking Benadryl the following day and was seen by the provider. The outcome of rash erythematous, urticaria and rash generalised was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness, Malaise, 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 # 650579) on 02-MAY-2017. This spontaneous report refers to a 18 year old female patient. The patient's other medications included LO/OVRAL-28 and albuterol inhaler. The patient had no concurrent illnesses and medical history. On 25-AUG-2016 at 10:00, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018)  dose 2 (unspecified dosage) via route: needle and syringe (not specified), in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO lot # 151301 (unspecified dose and dosage) via route: needle and syringe (not specified), in the right arm for prophylaxis. On the same day at 10:02, the patient reported not feeling well and at 10:03, the patient fainted and was lowered into a chair. A cold cloth was applied to her forehead. The patient was unconscious, but was breathing and had a pulse for 3 minutes. The patient responded verbally after 3 minutes. At 10:10, the patient walked to an exam room and at 10:45, she left the room after having recovered. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 650581) on 02-MAY-2017. This spontaneous report refers to a 19 year old male patient. The patient had no concurrent illnesses and other medications. The patient's medical history included robitussin. On 17-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M009116 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 20-AUG-2016, 3 days after the vaccine was administered, the patient developed hives after swimming. The patient experienced them again after swimming on 21-AUG-2016. No further symptoms reported since that time. The outcome of urticaria was reported as recovered. The causality assessment for urticaria was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Pruritus, Rash generalised, 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 # 650829) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were reported as none. Information on patient's prior vaccination and lab data were not provided. On 17-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L011846, dose 1, intramuscularly, in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # M15078, dose 2, intramuscularly, in the left arm and VARIVAX lot # M009767, dose 2, intramuscularly, in the left arm for prophylaxis (dosage and expiry date unspecified). On 25-AUG-2016, when patient was working out, he broke out with rashes all over his body and also developed hives on top of the hives. Patient felt very itchy. The outcome of pruritus, urticaria and rash generalised was reported as not recovered. The patient required emergency room visit. 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: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Muscle twitching, Nuclear magnetic resonance imaging, Petit mal epilepsy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-651210). This spontaneous report refers to a 12 year old female patient. The patient's historical conditions included Attention deficit hyperactivity disorder (ADHD) and peanut allergy. She had no history of seizures. On 01-JUL-2016 the patient was vaccinated with GARDASIL 9 (unspecified lot # and dosage regimen) for prophylaxis. On 05-JUL-2016, the patient experienced petit mal epilepsy and muscle twitching. The patient also underwent computerised tomogram and magnetic resonance imaging. The patient was taken to emergency room. Petit mal epilepsy and muscle twitching lasted for about 20 minutes and continued for 2 months decreasing in frequency. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Vulvovaginal erythema, Vulvovaginal pain, Vulvovaginal rash, Vulvovaginal swelling, Vulvovaginal warts
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 # 651228). This spontaneous report refers to a 42 year old female patient. The patient had no current illnesses and information on patient's medical history was not reported. Patient's other medications included wellbutrin, fentanyl and ativan. On 02-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose, lot # and route not reported) for prophylaxis. Patient stated that, she never had HPV vaccine or genital warts. Prior to the injection, patient had a full examination and pap and everything came back clear. On 03-SEP-2016, within 24 hours of taking the first vaccine patient had some bumps. By 06-SEP-2016, patient's entire vulva/vagina was covered in warts and it's painful, swollen, bright red and had bumps everywhere leading towards the anus. The patient said that she would return to doctor for a further examination. Patient did some research and there were proven cases where that shot had given warts and she was devastated. Patient stated that it was uncomfortable to wear panties and she was not sexually active currently and asked if it could be fixed. The outcome of all the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, 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 # 651442) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 30-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENVEO (dose number: 1, vaccinated date: 30-AUG-2016 , intramuscularly in the right arm, lot# A15149; dose and expiration date unknown) and BOOSTRIX (dose number: 1, vaccinated date: 30-AUG-2016 , intramuscularly in the right arm, lot# H5299; dose and expiration date unknown). On 31-AUG-2016, the patient experienced injection site erythema, injection site swelling and injection site pruritus. Patient's mother called the office and stated that the patient had some redness, swelling and itchiness at right deltoid site from 2 shots. Patient was advised to take benadryl and apply cold compress to the site and was asked to mark a circle around the reaction area. If the redness did not improve or was increased, the patient was asked to call the office back. The outcome of injection site erythema, injection site swelling and injection site pruritus 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
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651452) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a female patient of unknown age. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 lot # M017983 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENVEO lot/batch # M15149, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On an unknown date, the patient experienced injection site swelling and injection site warmth at left deltoid. Patient was given benadryl and ibuprofen. The outcome of injection site swelling and injection site warmth was reported as recovered/resolved. Causality assessment was not reported.        Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651793) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient with prophylaxis. The patient's medical history included elevated blood pressure without the history of hypertension. Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 08-SEP-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L043214, via unknown route in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 08-SEP-2016, via unknown route in the left arm, lot# US390AA; dose and expiration date unknown). On 09-SEP-2016, the patient experienced hypersensitivity, injection site warmth and injection site swelling. Patient had swelling (no redness) and warmth in the right deltoid area and this was reported to the school nurse. Patient was instructed to take ibuprofen and placed with ice pack on that area. Patient's mother later reported the same. Patient was given an appointment in the afternoon and patient's mother was unsure if she could take her daughter. She was instructed to see if there was no improvement and/or show signs and symptoms of infection. Patient's mother took her to ER (emergency room) that evening and was told that the patient had allergic reaction. The outcome of hypersensitivity, injection site warmth and injection site swelling was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Head injury, Laceration, 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 ID-651804). This spontaneous report refers to a 14 year old male patient. The patient had no current illnesses and historical conditions. Information on patient's other medications and prior vaccinations was not reported. On 07-SEP-2016 the patient was vaccinated with GARDASIL 9 (lot # M023169) dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX Quadrivalent (lot # 37PK4), dose 1 (unspecified dose), intramuscularly in the left arm for prophylaxis. The patient had syncope - fainted shortly after leaving the office in the hall way of the building. He hit his head and had laceration. It was cleared and the patient was able to go home. The outcome of head injury, syncope and laceration 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: Sleep apnoea syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651827) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 09-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M021407 (dose, frequency, and lot expiration dates were not reported) route: unknown, in the left arm for prophylaxis. On 09-SEP-2016, the patient experienced sleep apnoea syndrome (SAS). The outcome of sleep apnoea syndrome was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dyskinesia, Fall, Immediate post-injection reaction, Lethargy, 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 # 652012) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on medical history, other medications and prior vaccinations were not reported. Patient had a family history of seizures. The patient had no concurrent illnesses. On 22-JUL-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M007728, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA (dose number: 1, vaccinated date: 22-JUL-2016, intramuscularly in the right arm, lot# M011116; dose and expiration date unknown). On the same day, the patient experienced dyskinesia, vomiting, syncope, pallor, lethargy, immediate post-injection reaction and fall. Patient had fainting episode immediately after shots were given. Patient fell on the floor and jerked for a few seconds. Patient was taken to Emergency room by her mother. The outcome of dyskinesia, vomiting, syncope, pallor, lethargy, immediate post-injection reaction and fall 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: HEPA, HPV9
Symptoms: Syncope, 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 # 652012) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on medical history, other medications and prior vaccinations were not reported. Patient had a family history of seizures. The patient had no concurrent illnesses. On 22-JUL-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M007728, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA (dose number: 1, vaccinated date: 22-JUL-2016, intramuscularly in the right arm, lot# M011116; dose and expiration date unknown). On the same day, the patient experienced dyskinesia, vomiting, syncope, pallor, lethargy, immediate post-injection reaction and fall. Patient had fainting episode immediately after shots were given. Patient fell on the floor and jerked for a few seconds. Patient was taken to Emergency room by her mother. The outcome of dyskinesia, vomiting, syncope, pallor, lethargy, immediate post-injection reaction and fall 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, VARCEL
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
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 # 653078) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's medical history included allergy to bees. Information on prior vaccinations were not reported. The patient had no concurrent illnesses. Patient's other medications included multivitamin at time of vaccination. On 30-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot/batch # M021407) (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included VARIVAX (lot # M009766) (dose, frequency and lot expiration date were not reported) subcutaneously in the left arm. On the same day, the patient experienced dizziness, loss of consciousness, head injury (hit head on metal garbage can) and fall. The outcome of dizziness, loss of consciousness, head injury and fall was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Induration, Skin warm
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 # 653216) 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 17-AUG-2016 the patient was vaccinated with the second 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 MENACTRA. On 19-AUG-2016, mother called and informed that patient's left arm was hot, red and induration to about 3-4 inches. The patient had no cardiorespiratory compromises. The outcome of erythema, skin warm and induration was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653362) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included Miralax. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 (expiration date: 01-FEB-2018) (dose, dose number and frequency were not reported) route: unknown, in the right arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5390AA, route: unknown, in the right arm and BOOSTRIX batch/lot # 7RJ9B, route: unknown, in the left arm for prophylaxis. On 30-AUG-2016, patient experienced cellulitis of right and left upper limb. The patient visited emergency room. He was treated with Cephalexin, Benadryl and Ibuprofen. Rocephin Inj. was also given. The outcome of cellulitis was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Poor quality sleep, Vaccination site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653521) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 06-SEP-2016 the patient was vaccinated with the third dose of GARDASIL 9 via unknown route in the left arm, lot # L036301 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 06-SEP-2016, the patient felt little dizzy, had very restless night sleep and had a fall in the morning (am) due to dizziness. The patient had some tenderness at vaccination site later that day, no loss of conscious and no vomiting. The outcome of dizziness, vaccination site pain, restlessness, poor quality sleep and fall was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, 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 # 654143) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 25 year old female patient. The patient's medical history included bipolar disorder, grave's disease, hypertension, cervical intraepithelial neoplasia II and drug abuse. The patient was allergic to Depakote and Seroquel. The patient's other medications included metoprolol, methimazole and multivitamin. The patient had no current illnesses. The patient's concomitant therapies and prior vaccinations were not reported. On 14-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot #, lot expiration date, dose, frequency and site of administration were not reported) via intramuscular route for prophylaxis. On 18-SEP-2016, the patient experienced eye swelling and rash on the arms, legs, chest and back. The patient took Benadryl and fell asleep. The rash was minimally improved and eye swelling also improved. The patient was advised to seek emergent medical attention as the symptoms worsened. The outcomes of eye swelling and rash were 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
Symptoms: Fall, Feeling abnormal, Injection site 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 # 654147) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L043213, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient had a fall and  experienced injection site discomfort. Patient complained about the arm where he received the injection and reported feeling "funny" and then slowly fell forward from seated position on exam table and fell on the ground. Patient was assisted by his mother and registered nurse (RN). The outcome of fall and injection site discomfort was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: 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 # 654169) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 13-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L040054,(dose, frequency and lot expiration date were not reported)  intramuscularly in the right arm for prophylaxis. On 14-SEP-2016, the patient experienced rash. Patient also experienced rash on feet and scalp 24 hours after receiving vaccine. No other symptoms were reported. The outcome of rash was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Immediate post-injection reaction, Tinnitus
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 # 654322) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included possible concussion on 03-SEP-2016, for which he was referred to the neurological department. Information about the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 06-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M020103 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # EC9A9 dose 1 (unspecified dosage) and MENACTRA lot # U5410AA dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, immediately after vaccination, the patient experienced a post-injection reaction, intermittent ringing in both the ears (tinnitus) and headache. The patient also stated that he had the headache from hitting his head on 03-SEP-2016 (prior to vaccines), but denies the occurrence of ringing in ears prior to vaccination, specifically GARDASIL 9. The outcome of the events was unknown. The causality assessment for the events was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discolouration, Injection site induration, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654380) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Patient had no current illness. Information on the patient's other medications and medical history were reported as none. Information on patient's prior vaccination was not reported. On 10-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L038503, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). After the first HPV vaccination patient got injection site induration and that lasted for 2 to 3 weeks. On 10-MAY-2016, after the second HPV vaccination he again got injection site induration in blue color and was persisted for 4 months. Patient's mother was also a physician, she wanted to report this, in case others were also experiencing any similar occurrences. The outcome of induration, skin discolouration and pain were unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Injection site erythema, Pain, Vaccination site pain, Vaccination 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 # 654441).This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses, other medications and medical history were reported as none. On 17-SEP-2016, the patient was vaccinated with GARDASIL 9 dose 3, lot# M011840, intramuscularly in the left arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included FLUZONE (dose 10, lot# UI678AE, intramuscularly in the left arm) and TRUMENBA (dose 1, lot# M77282, intramuscularly in the right arm). On 20-SEP-2016, the patient experienced pain, vaccination site swelling, vaccination site pain and injection site erythema. Patient was accompanied by mom, visit for reaction to TRUMENBA shot right arm with redness, swelling and pain. Since then the vaccinations, sites on both arms have been tender, swollen and red, right side greater than left side. No fever, nausea, dizziness. Mother gave her BENADRYL before bed last night. Patient was using TYLENOL for pain and cool compresses to sites. Redness is less today but pain persists right side greater than left side with use of the arm. The outcome of injection site erythema, vaccination site swelling, vaccination site pain and pain was unknown. 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: 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 # 654561). This spontaneous report refers to a 13 year old female patient. The patient had no current illnesses. The patient's medical history included allergy to cefdinir; obsessive-compulsive disorder, seasonal allergic rhinitis, anxiety and acid reflux. Patient's other medications included fluoxetine, omeprazole, allegra and hydroxyzine prn. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (expiry date: 24-APR-2018), dose 2, intramuscularly in the left arm for prophylaxis. On 16-SEP-2016 in the morning, the patient developed hives on legs while at school. By the end of day, legs were covered in hives and some were itching. Patient had some relief with benadryl after she came home from school. On 18-SEP-2016, hives spread to knuckles and face. Patient was evaluated at an urgent care clinic and was administered 16 mg dexamethasone and was also given steroid dose pack. Patient returned to office reporting that hives had improved until that day but new hives erupted on legs again. Patient was in the office for recheck of recurrent hives and was considering allergy/Immunology referral now as antihistamines and steroids have not resolved the issue. The outcome of the events was reported as not recovered. The causality assessment for 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: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood pressure systolic decreased, Dizziness, Eye movement disorder, Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654699) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's medical history and prior vaccinations were not reported. Patient's other medication included Miralax (prn: when necessary) for constipation. Patient's current illness included left ear pain. Patient's lab data included blood sugar level 76 (units not provided). On 27-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 27-JUN-2016, the patient felt dizzy after the vaccination. Blood pressure cuff was placed on him (also reported as her) to obtain blood pressure and then the patient had a hand twitching and his eyes went up. These lasted for few seconds. Blood pressure was checked twice and was normal. He was pale around the lips. Few minutes later systolic blood pressure was dropped to 87. Patient then ate and drank and was monitored for another 30 minutes and he returned to normal. Patient's blood pressure prior to leaving was normal. The outcome of blood glucose normal, pallor, muscle twitching, eye movement disorder and dizziness 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: 11.0
Sex: M
Vaccine: HPV9
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 # 654699) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's medical history and prior vaccinations were not reported. Patient's other medication included Miralax (prn: when necessary) for constipation. Patient's current illness included left ear pain. Patient's lab data included blood sugar level 76 (units not provided). On 27-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 27-JUN-2016, the patient felt dizzy after the vaccination. Blood pressure cuff was placed on him (also reported as her) to obtain blood pressure and then the patient had a hand twitching and his eyes went up. These lasted for few seconds. Blood pressure was checked twice and was normal. He was pale around the lips. Few minutes later systolic blood pressure was dropped to 87. Patient then ate and drank and was monitored for another 30 minutes and he returned to normal. Patient's blood pressure prior to leaving was normal. The outcome of blood glucose normal, pallor, muscle twitching, eye movement disorder and dizziness 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, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Rash, Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655585) on 02-MAY-2017. This spontaneous refers to a 14 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the patient was not taking any other medications. On 16-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M011840 (expiration date: 01-FEB-2018) (dose, dose number and frequency were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included M-M-R II lot # M000768 (dose, dose number, frequency and lot expiration dates were not reported), subcutaneously in the right arm, VARIVAX lot # M025864 (dose, dose number, frequency and lot expiration dates were not reported), subcutaneously in the left arm, BOOSTRIX batch/lot # 7RJ9B, intramuscularly in the left arm, FLULAVAL batch/lot # U1657A, intramuscularly in the left arm, POLIOVAX batch/lot # M122311M, subcutaneously in the left arm, MENACTRA batch/lot # U5392AC, intramuscularly in the right arm, HAVRIX batch/lot # GP75A, intramuscularly in the left arm and ENGERIX-B batch/lot # D344L, intramuscularly in the right arm for prophylaxis. On 16-SEP-2016 at 12:30, medical assistant reported that the patient's left arm turned red immediately after POLIOVAX (immediate post-injection reaction), at 12:50 the patient complained of rash, itching, and throat felt tight. The patient was given Benadryl and Epipen at 13:06 and transported to ER via ambulance. The outcome of erythema, throat tightness, rash, pruritus and immediate post-injection reaction 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: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Skin abrasion, 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 # 655585) on 02-MAY-2017. This spontaneous refers to a 14 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the patient was not taking any other medications. On 16-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M011840 (expiration date: 01-FEB-2018) (dose, dose number and frequency were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included M-M-R II lot # M000768 (dose, dose number, frequency and lot expiration dates were not reported), subcutaneously in the right arm, VARIVAX lot # M025864 (dose, dose number, frequency and lot expiration dates were not reported), subcutaneously in the left arm, BOOSTRIX batch/lot # 7RJ9B, intramuscularly in the left arm, FLULAVAL batch/lot # U1657A, intramuscularly in the left arm, POLIOVAX batch/lot # M122311M, subcutaneously in the left arm, MENACTRA batch/lot # U5392AC, intramuscularly in the right arm, HAVRIX batch/lot # GP75A, intramuscularly in the left arm and ENGERIX-B batch/lot # D344L, intramuscularly in the right arm for prophylaxis. On 16-SEP-2016 at 12:30, medical assistant reported that the patient's left arm turned red immediately after POLIOVAX (immediate post-injection reaction), at 12:50 the patient complained of rash, itching, and throat felt tight. The patient was given Benadryl and Epipen at 13:06 and transported to ER via ambulance. The outcome of erythema, throat tightness, rash, pruritus and immediate post-injection reaction 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.