chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, VARCEL
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 # 638876) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 25 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 23-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L045711 via unknown route in the right arm for prophylaxis. On same day the patient was vaccinated with the first dose of VARIVAX lot # L028275 via unknown route in the right arm for prophylaxis. On 26-MAY-2016, the patient developed rash (L) forearm. No previous treatment was given and the patient was referred to PCP for follow-up. 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.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 638884) and refers to a 14 year old female patient. Patient's current illness and medical history was reported as none. On 01-JUN-2016 the patient was vaccinated with GARDASIL 9, lot # M004116, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 01-JUN-2016, the patient began to lose color in her face and fainted after receiving vaccine. The outcome of pallor and syncope 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: F
Vaccine: HPV9
Symptoms: Menstruation delayed
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 # 638912) 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 medical history, other medications, lab data and prior vaccinations were not reported. Information on patient's concurrent illness was reported as none. On 31-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L026602, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On an unknown date the patient had missed menstrual period by more than one week. The outcome of menstruation delayed was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Erythema, Induration, Oedema peripheral, 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 # 639224) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. The patient's medical history included (+) Scoliosis/asthma- No known allergies (NKA). Information on current illnesses, concomitant medications, lab data and prior vaccinations were not reported. On 10-JUN-2016, the patient was vaccinated with recommended dose of GARDASIL 9 injection, lot # M005714, dose number 3 (dose and lot expiration date unknown) via intramuscular route in the left arm at WCE in office for prophylaxis. On 11-JUN-2016, the patient experienced stomach cramps, redness with edema and induration with warmth to left arm. The patient was treated at home with BENADRYL. The patient required an emergency room visit. On 13-JUN-2016, the patient was seen for followup in office. The signs/symptoms were nearly resolved and returned to normal limits (WNL). 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: Ear injury, Fall, 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 # 639240) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. Information on patient's pertinent medical history, concomitant medications, current illness and prior vaccinations were not reported. The patient's lab data was normal. On 09-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, Expiration date: 17-OCT-2017, dose number 1 (dose and units, frequency unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (Manufacturer: Glaxosmithkline, vaccinated date: 09-JUN-2016, dose number 1 (dose and units, frequency unknown), lot # GS5BR via intramuscular route in the left arm) and meningococcal conj vaccine (unspecified) (Manufacturer: Sanofi Pasteur, vaccinated date: 09-JUN-2016, dose number 1 (dose and units, frequency unknown), lot # U5259AA via intramuscular route in the left arm) for prophylaxis. On the same day, the patient got up to walk out of the room several minutes post vaccination. The patient lost his consciousness and fell forward onto carpeted floor striking his right ear (ear injury). He awoke within 10 seconds and was lead into room to lay down for about 15minutes. The outcome of the events was 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: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639263) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history included anxiety. The patient had no concurrent illnesses. Information on the patient's other medications and prior vaccinations was not reported. On 09-MAY-2016, the patient was vaccinated with GARDASIL 9 in the left arm, route: unknown, lot # L016429 (dose number: 3, expiration date: 09-AUG-2017 and frequency unknown), VAQTA (dose number: 2, site: left arm, route: unknown, lot# L015460; expiration date: 20-JUL-2017, frequency unknown), TRUMENBA (dose number: 1, manufacturer: Pfizer/Wyeth, site: right arm, route: unknown, lot# J29203; frequency and lot expiration date unknown) and MENACTRA (dose number:2, manufacturer: Sanofi Pasteur, site:right arm, route: unknown, lot# U5179AA; frequency and lot expiration date unknown) for prophylaxis. On 10-MAY-2016 in the afternoon/evening, the patient developed fever for which Tylenol was given. He later woke up with fever of 103.5 (units not reported), nausea and vomiting. The patient was taken to Emergency Room (ER) where his temperature was recorded and given ibuprofen and Zofran. The outcome for the events nausea, vomiting and fever were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9, TYP
Symptoms: Nausea, Pain, 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 # 639347) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient's medical history, concurrent illnesses and other medications were not reported. Information on the patient's prior vaccinations was not reported. On 08-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M007728 (frequency and lot expiration date unknown) and TYPHIM VI (dose number: 1, intramuscularly in the left arm, lot# M0083; manufacturer: Sanofi Pasteur; frequency and lot expiration date unknown) for prophylaxis. On the same day post vaccination, the patient experienced vomiting, felt achy and nauseous. The event required emergency room (ER) visit. The outcome for the events pain, vomiting and nausea was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #639510) and refers to a 13 year old male patient. The patient's medical history and current condition included seasonal allergy. Other medication included cetirizine. Lab data was reported as none. On 27-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # M003659, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with VAQTA (administered on 27-MAY-2016, lot #L023936, intramuscular in the right arm for prophylaxis). On 27-MAY-2016, patient experienced syncope episode following administration of the vaccines. The Patient recovered within 5 min after episode. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dyskinesia, Feeling abnormal, Feeling hot, Loss of consciousness, Muscle 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 # 640076) on 18-APR-2017. This spontaneous report refers to an 18 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 20-JUN-2016 the patient was seated and vaccinated with the second dose of GARDASIL 9 lot # L048459, intramuscularly in the right arm for prophylaxis. Other suspect therapies included BEXSERO lot # 151501, intramuscularly in the right arm for prophylaxis. On 20-JUN-2016, after vaccination the patient reported that he felt something coming on. The nurse started talking to the patient while he had leaned back and passed out and she called for another nurse meanwhile. The patient had a few jerks to his arm but then he opened his eyes and sat up. He was orient to where he was and knew his name. He was able to talk to the nurses and said he just felt hot (feeling hot). He also complained that he bit his tongue and had some tightening in the left arm. The entire episode lasted for less than a minute. A cool towel was placed on the patient's neck and he sat for another 15 minutes. The patient drank a bottle of water and stated that he had pop-tart for breakfast. The patient was able to walk out of the office and was discharged. He was not given any treatment but was advised to be monitored, eat and stay hydrated. The outcome of dyskinesia, tongue biting, muscle tightness, loss of consciousness and feeling hot was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Tongue biting
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 # 640076) on 18-APR-2017. This spontaneous report refers to an 18 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 20-JUN-2016 the patient was seated and vaccinated with the second dose of GARDASIL 9 lot # L048459, intramuscularly in the right arm for prophylaxis. Other suspect therapies included BEXSERO lot # 151501, intramuscularly in the right arm for prophylaxis. On 20-JUN-2016, after vaccination the patient reported that he felt something coming on. The nurse started talking to the patient while he had leaned back and passed out and she called for another nurse meanwhile. The patient had a few jerks to his arm but then he opened his eyes and sat up. He was orient to where he was and knew his name. He was able to talk to the nurses and said he just felt hot (feeling hot). He also complained that he bit his tongue and had some tightening in the left arm. The entire episode lasted for less than a minute. A cool towel was placed on the patient's neck and he sat for another 15 minutes. The patient drank a bottle of water and stated that he had pop-tart for breakfast. The patient was able to walk out of the office and was discharged. He was not given any treatment but was advised to be monitored, eat and stay hydrated. The outcome of dyskinesia, tongue biting, muscle tightness, loss of consciousness and feeling hot was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Eye movement disorder, Fear, Malaise, 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 (HA #640219) and refers to a 15 year old female patient. Patient had no current illnesses and history. Patient informed she did not eat anything. Other medication was reported as none. On 20-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L048459, dose 2, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 20-JUN-2016, after injection was given patient became pale. She had a blank stare and her eyes rolled back. Patients body then started to stiffen up and her arms started to jerk. Patient did come through quickly. She began to yell and say that she was scared and did not feel well. She immediately knew who she was and where she was. She was also aware of time and date. A full set of vital signs on patient during the event, and after the event was noted. Patient was examined by a physician. The outcome of dyskinesia, staring, pallor, musculoskeletal stiffness, malaise, fear and eye movement disorder 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Staring
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 #640219) and refers to a 15 year old female patient. Patient had no current illnesses and history. Patient informed she did not eat anything. Other medication was reported as none. On 20-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L048459, dose 2, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 20-JUN-2016, after injection was given patient became pale. She had a blank stare and her eyes rolled back. Patients body then started to stiffen up and her arms started to jerk. Patient did come through quickly. She began to yell and say that she was scared and did not feel well. She immediately knew who she was and where she was. She was also aware of time and date. A full set of vital signs on patient during the event, and after the event was noted. Patient was examined by a physician. The outcome of dyskinesia, staring, pallor, musculoskeletal stiffness, malaise, fear and eye movement disorder 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: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Injection site induration, Injection site nodule, Injection site swelling, 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 # 640297) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. Information on the patient's lab data and prior vaccinations were not reported. Patient's other medication included Albuterol MDI. Information on patient's current illness was reported as none. The patient's medical history included asthma, NKA prior. On 18-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 via intramuscular route, in the left arm for prophylaxis (dosage, lot and expiry date unspecified). On 19-MAY-2016, day after vaccination, patient had approximately 1.5 inch area of induration and swelling at site of injection. Also nauseated and vomited twice. On 20-MAY-2016, patient was tired but no more vomiting. Area of induration still present. Patient also developed a firm knot under the site of injection and some swelling. He was nauseated and vomited once on the same day. He felt better after vomiting. Patient had no fever. Rx ondansetron was advised. Patient's mother will be followed up on patient in the next morning. The outcome of fatigue, vomiting, nausea, injection site swelling, injection site nodule and injection site induration 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: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640297) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. Information on the patient's lab data and prior vaccinations were not reported. Patient's other medication included Albuterol MDI. Information on patient's current illness was reported as none. The patient's medical history included asthma, NKA prior. On 18-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 via intramuscular route, in the left arm for prophylaxis (dosage, lot and expiry date unspecified). On 19-MAY-2016, day after vaccination, patient had approximately 1.5 inch area of induration and swelling at site of injection. Also nauseated and vomited twice. On 20-MAY-2016, patient was tired but no more vomiting. Area of induration still present. Patient also developed a firm knot under the site of injection and some swelling. He was nauseated and vomited once on the same day. He felt better after vomiting. Patient had no fever. Rx ondansetron was advised. Patient's mother will be followed up on patient in the next morning. The outcome of fatigue, vomiting, nausea, injection site swelling, injection site nodule and injection site induration 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, MNQ, TDAP
Symptoms: Abdominal pain upper, Mydriasis, Pallor, Tremor, 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 # 640386) 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 to penicillin. The patient's concomitant therapies and concurrent illness were not reported. On 16-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L037554 (dose, frequency and lot expiration date were not reported), via intramuscular route in the right arm for prophylaxis. Other suspect therapies, which were vaccinated on the same day, included BOOSTRIX (dose number: 1, via intramuscular route in the left arm, lot# B4SD9; dose and expiration date unknown) and meningococcal conj vaccine (unspecified) (manufacturer: Novartis) (dose number: 1, via intramuscular route in the left arm, lot# A15078; dose and expiration date unknown) for prophylaxis. On 16-JUN-2016, post vaccination, as the patient was walking out of clinic the patient's mother stated that the patient was pale, requested to sit down and while sitting up he began to shake uncontrollably (not violently) and his pupils were dilated. The patient was unresponsive to mother when she called his name. The episode lasted for about 30 seconds. The nurse was called afterwards. The patient also had complained of stomach hurting which felt fine later. The patient was given juice/granola bar. Vital signs were found to be within the normal limits. The patient's color returned to normal, he was aware of the surroundings and was able to verbalize needs. Usual care/emergency room precautions were given to the patient. The outcome of abdominal pain upper, unresponsive to stimuli, tremor, pallor and mydriasis were reported as recovered. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Erythema, Fatigue, Injected limb mobility decreased, Lymph node 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 # 640545) on 18-APR-2017. This spontaneous report refers to a 17 year old female patient with chronic abdominal pain and anxiety-depression. The patient's medical history included augmentin allergy, rib deformity, lactose intolerance, undiagnosed cardiac murmurs, generalized abdominal pain, intermittent exotropia monocular and anxiety/depression. Information about the patient's other medications was unknown. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. On the same day, patient was also vaccinated with BEXSERO lot # 151401, dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis and MENACTRA lot # U5390AA dose 2 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. On 08-JUN-2016, the patient experienced dyspnoea, tender lump in the left clavicle, pyrexia (fever of 100.5), worse pain in the arms (pain in extremity), mobility decreased (the patient could not lift right arm), mass, lymph node pain, red marks on the arm near the injection site, fatigue and erythema. The patient required an emergency room visit, three days after the vaccine was administered and had seen the primary care physician (PCP), for complaints about arms hurting the day after the injection was administered. Patient had difficulty breathing through throat. The symptoms were reported to have persisted the following day and was somewhat better on the third day. The red marks persisted and the area of redness was neither itching nor spreading. No other associated symptoms were reported. The physical findings included, tender to palpation above left clavicle with small palpable lymph nodes in supraclavicular area, erythematous skin on bilateral upper arms that are tender to palpation, not warm or fluctuant and no hives/welts were noted. The outcome of the events was reported as recovered. The causality assessment for the events with 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: Mass, Pain in extremity, Pyrexia, Tenderness
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 # 640545) on 18-APR-2017. This spontaneous report refers to a 17 year old female patient with chronic abdominal pain and anxiety-depression. The patient's medical history included augmentin allergy, rib deformity, lactose intolerance, undiagnosed cardiac murmurs, generalized abdominal pain, intermittent exotropia monocular and anxiety/depression. Information about the patient's other medications was unknown. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. On the same day, patient was also vaccinated with BEXSERO lot # 151401, dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis and MENACTRA lot # U5390AA dose 2 (unspecified dose and units), intramuscularly in the left arm for prophylaxis. On 08-JUN-2016, the patient experienced dyspnoea, tender lump in the left clavicle, pyrexia (fever of 100.5), worse pain in the arms (pain in extremity), mobility decreased (the patient could not lift right arm), mass, lymph node pain, red marks on the arm near the injection site, fatigue and erythema. The patient required an emergency room visit, three days after the vaccine was administered and had seen the primary care physician (PCP), for complaints about arms hurting the day after the injection was administered. Patient had difficulty breathing through throat. The symptoms were reported to have persisted the following day and was somewhat better on the third day. The red marks persisted and the area of redness was neither itching nor spreading. No other associated symptoms were reported. The physical findings included, tender to palpation above left clavicle with small palpable lymph nodes in supraclavicular area, erythematous skin on bilateral upper arms that are tender to palpation, not warm or fluctuant and no hives/welts were noted. The outcome of the events was reported as recovered. The causality assessment for the events with GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Haematoma, Head injury
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640615) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and allergic rhinitis. The patient's current conditions were reported as upper respiratory tract infection (URI) and allergic rhinitis. Information on lab data and prior vaccinations were not reported. Other medications were reported as Vyvanse and Singulair. On 26-MAY-2016, the patient was vaccinated with GARDASIL 9 injection, lot/batch # L035105, dose number 1 (dose, frequency and lot expiration date unknown) via unknown route in the left arm for prophylaxis. On the same day, the patient felt dizzy and fell to the ground few minutes after standing. Hit head left-side of occiput (head injury). After examination patient was diagnosed with scalp hematoma. The patient recovered quickly. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Eye movement disorder, Nausea, Postictal state, 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 # 640626) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included mild intermittent stable asthma. The patient's current illnesses were reported as none and concurrent therapies were not reported. On 14-JUN-2016 the patient was vaccinated with first 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 therapies included MENACTRA (dose number: 1, vaccinated date: 14-JUN-2016, via unknown route, in the right arm, lot# U5415AA; dose and expiration date unknown). On 14-JUN-2016, the patient felt fainted and nausea approximately one minute after the vaccine administration. Two registered nurses witnessed patient eyes rolling back in and patient was postictal. The outcome of dizziness, postictal state, nausea and eye movement disorder 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.
Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9
Symptoms: Anaemia, Dizziness, Epistaxis, Haematemesis, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640717) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included constipation, fatigue, heterozygous thalassemia and leg pain. The patient's current illness was reported as none and concomitant medication was not reported. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L045700 (dose, frequency, dose number and lot expiration date were not reported), via intramuscular route (injection site reported as unknown) for prophylaxis. Other suspect therapies which were vaccinated on the same day, included influenza FLUZONE (lot# UI1506AB, intramuscular route, dose number, dose, site of injection and expiration date were unknown) and FLUMIST Quadrivalent (dose number: 2, intranasal route, lot, dose and expiration date were unknown). The patient received half dose of FLUMIST spray in error (perhaps expired medication), immediately followed by FLUZONE injection. On 15-JUN-2016, the patient experienced nosebleed and hematemesis. On the same day, the patient also had dizziness which continued for 2 weeks perhaps due to anemia (undiagnosed) or poor sleeping habits. The patient had visited emergency room. The outcome of dizziness, vaccination error, haematemesis and epistaxis were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9
Symptoms: Poor quality sleep, Vaccination error
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 # 640717) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included constipation, fatigue, heterozygous thalassemia and leg pain. The patient's current illness was reported as none and concomitant medication was not reported. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L045700 (dose, frequency, dose number and lot expiration date were not reported), via intramuscular route (injection site reported as unknown) for prophylaxis. Other suspect therapies which were vaccinated on the same day, included influenza FLUZONE (lot# UI1506AB, intramuscular route, dose number, dose, site of injection and expiration date were unknown) and FLUMIST Quadrivalent (dose number: 2, intranasal route, lot, dose and expiration date were unknown). The patient received half dose of FLUMIST spray in error (perhaps expired medication), immediately followed by FLUZONE injection. On 15-JUN-2016, the patient experienced nosebleed and hematemesis. On the same day, the patient also had dizziness which continued for 2 weeks perhaps due to anemia (undiagnosed) or poor sleeping habits. The patient had visited emergency room. The outcome of dizziness, vaccination error, haematemesis and epistaxis 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: Cellulitis, Erythema, Local reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640759) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 13-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L026602 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-JUN-2016, the patient experience local reaction within 12 hours redness and increased for one and half days. Also experienced secondary cellulitis which was treated with KEFLEX 500 mg 1 tablet twice a day (bid) for about 7 days. The patient had visited emergency room. The outcome of cellulitis, local reaction and erythema was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Deafness, Dizziness, Loss of consciousness, 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 (HA #640789) and refers to a 11 year old male patient. He had no current illnesses and history was reported as none. On 27-JUN-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 27-JUN-2016, after vaccination patient felt dizzy and could not hear for about 10 minutes. He then lost consciousness for about 60 seconds. Woke up and lost consciousness again with twitching in arms and legs. Smell salts were used to help bring him to consciousness. The patient was brought home with periods of dizziness but no loss of consciousness. The patients parent felt it was important to report this because according to them the events direct correlation to the vaccine was indisputable. The patient has never had any reaction from any shots or blood draw. No lab tests were performed. The patient still has two more doses in the GARDASIL 9 vaccine series and his parents were unsure of any long term damage at this time. This was more than a vasovagal response. The outcome of deafness, muscle twitching, loss of consciousness and dizziness was unknown. 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: M
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: 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 # 640812) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 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 27-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L038917 (dose, frequency and lot expiration date were not reported) for prophylaxis. On same day the patient was vaccinated with the second dose of VARIVAX subcutaneous route in the left arm, lot # L045956 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA and BEXSERO. On 27-JUN-2016 the patient was passed out after receiving the second vaccine. The patient was supported by nurse and his dad to lay on a cot and ice packs were applied on his neck and juice was given at that time. After 20 minutes of monitoring the patient stated that he was feeling much better and walked to car with his dad. The outcome of loss of consciousness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site reaction, Soft tissue 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 (HA #640852) and refers to a 14 year old male patient. Patient's current illness and medical history was reported as none. On 13-JUN-2016, the patient was vaccinated with GARDASIL 9, lot # L026602, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with VAQTA and MENACTRA, on 13-JUN-2016, via intramuscular route for prophylaxis. On 13-JUN-2016, the patient experienced soft tissue swelling in the right upper arm. The outcome of injection site swelling was unknown. 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 # 640998) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. Information on current illnesses, concomitant medications, pertinent medical history, lab data and prior vaccinations were not reported. On 28-JUN-2016, the patient was vaccinated with GARDASIL 9 injection, lot # M009116, dose number 2 (dose and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day, post vaccination the patient experienced syncope and also loss of consciousness for few seconds. 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: U
Vaccine: HPV9
Symptoms: Urticaria, Wheezing
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 # 641149). This spontaneous report refers to a 14 year old patient of unknown gender. Information on patient's concurrent illnesses and other medications were not reported. The patient's medical history included asthma and selective IgA deficiency. On 13-JUN-2016 in the morning, the patient was vaccinated with GARDASIL 9 lot # M007728, dose 3, intramuscularly in the left arm for prophylaxis. On 13-JUN-2016 (also reported as 14-JUN-2016) in the evening, the patient woke with hives to chest and wheezing. Patient was given 25 mg BENADRYL and albuterol. Patient went to emergency department (ED), symptoms resolved and was monitored in ED. The outcome of the events 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, MNQ
Symptoms: Vaccination site nodule, Vaccination site swelling, Vaccination 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 ID-641206). This spontaneous report refers to a 16 year old male patient. The patient's historical conditions included amoxicillin allergy. The patient had no current illness and other medications. On 20-JUN-2016 the patient was vaccinated with GARDASIL 9 (lot # L042213) dose 1 (unspecified dose and units), via unspecified route in the left arm for prophylaxis. Other suspect therapies included BEXSERO (lot # 151301C), dose 1, via unspecified route in the right arm for prophylaxis and MENACTRA (lot # U5179AA), dose 1, via unspecified route in the left arm for prophylaxis. One day after vaccination, on 21-JUN-2016, the patient experienced vaccination site nodule, vaccination site warmth and vaccination site swelling (area around vaccine puncture in the size of base ball, warm to touch and knot felt). The outcome of vaccination site nodule, vaccination site warmth and vaccination site swelling was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness postural, Fall, Head injury
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641428) on 18-APR-2017. This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses and prior vaccinations were not reported. The patient's medical history included penicillin allergy. Other medications included Vyvanse and melatonin. On 29-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M007728, intramuscularly in the right arm (dose, frequency and lot expiration dates were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX batch/Lot # KJ4MS, intramuscularly in the left arm and MENVEO batch/Lot # M15122, intramuscularly in the left arm for prophylaxis. On 29-JUN-2016, after vaccination the patient stood up and became dizzy (dizziness postural), fell (fall) and bumped his left temple on the wall in exam room (head injury). The outcome of fall, dizziness postural and head injury 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: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Nausea, Syncope, Vertigo, 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 # 641593) on 18-APR-2017. This spontaneous report refers to an 18 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 29-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M09362, intramuscularly in the right arm for prophylaxis. Other suspect therapies included second dose of VAQTA lot # M022531, intramuscularly in the left arm, MENVEO lot # M15122, intramuscularly in the left arm, and BEXSERO lot # 15101, intramuscularly in the right arm for prophylaxis. On 29-JUN-2016, the patient fainted for 1-2 minutes approximately, afterwards he vomited and later he complained of nausea and vertigo. The outcome of nausea, vomiting, vertigo and syncope was reported as recovered. The causality assessment was not reported. Lot number M09362 is an invalid lot for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
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 an 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder, cerebral palsy, asthma, epilepsy; he was premature and had seizures.  On 19-DEC-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Other suspect therapies included BOOSTRIX and MENVEO. The patient's mom stated that on 20-DEC-2016, the patient experienced muscle twitching and was taken to the emergency room in which he was kept for a few hours for observation and then discharged on the same day in afternoon. The outcome of the event was not mentioned. The causality relationship between the event 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.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus generalised, Urticaria
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 an 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder, cerebral palsy, asthma, epilepsy; he was premature and had seizures.  On 19-DEC-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Other suspect therapies included BOOSTRIX and MENVEO. The patient's mom stated that on 20-DEC-2016, the patient experienced muscle twitching and was taken to the emergency room in which he was kept for a few hours for observation and then discharged on the same day in afternoon. The outcome of the event was not mentioned. The causality relationship between the event 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.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 675163). This spontaneous report refers to a 11 year old male patient. The patient's concurrent conditions included allergy to melons, walnuts and peanuts. On 20-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M034195, intramuscularly (strength and expiration date were not provided) for prophylaxis. Other suspect therapies included BOOSTRIX, FLUARIX and MENVEO. On 21-DEC-2016, the patient experienced arm swelling upper around injection site bilateral arm sore-bilateral for 24 hours. It was reported that other medications included EPIPEN and CLARITIN. At the time of the report, the outcome of pain in extremity and injection site swelling was reported as recovered on an unspecified date. The reporter did not assess the relatedness between the pain in extremity and injection site swelling and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.