chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 577015). This spontaneous report refers to a 13 year old male patient. The patient's concurrent conditions and concomitant medications were not reported. On 30-APR-2015 the patient was vaccinated with GARDASIL 9 lot # K026246 in the right arm. On the same day, the patient experienced mild rash at injection site. The outcome of injection site rash was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 579691). This spontaneous report was received from a regulatory authority refers to a 20 year old female patient. Patient's other medications and concurrent therapies were not reported. Patient had no current illness and medical history was reported as none. On 26-MAY-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K026246 (dose, frequency and expiration date were not provided) intramuscularly in the left arm for prophylaxis. On 26-MAY-2015, 10 minutes following vaccine administration and during venous blood draw, patient became pale and fainted. Patient was laid on exam bed and had been in the sitting position. Patient lost consciousness for 30 seconds and when came to resting phase, the blood pressure was 110/58 and heart rate was reported as 56 @ 1330. Patient was alert and oriented. The outcome of loss of consciousness, syncope and pallor was reported as recovered. Causality assessment for the events loss of consciousness, syncope and pallor 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: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Grunting, Hypotonia, Loss of consciousness, Respiratory arrest
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 # 579965). This spontaneous report refers to a 18 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. Patient was receiving immunizations at outreach clinic. On 27-MAY-2015, patient was seated on exam table and first received MENACTRA lot # U5049AA, dose 2, intramuscularly in left deltoid and then received GARDASIL 9 lot # L001312, dose 1, intramuscularly in the right deltoid for prophylaxis. Patient went limp, lost consciousness and nurse was able to lay her back on exam table. She began to have a seizure: grunting, pulling legs and moving head back and forth. Patient stopped breathing for a period of time, nurse and patient's mother stayed at her side ensuring safety. 911 was called to respond. Patient came out of seizure, regained consciousness on her own and was oriented to person and place. Lab data: emergency medical services (EMS) arrived and evaluated patient, vitals and blood sugar were stable. Patient refused transport, but was taken to the hospital by her mother. Patient reports having passed out before after giving blood and says that some of her friends said she was shaking. Mother of patient had never witnessed her having a seizure before. The outcome of all the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 579965). This spontaneous report refers to a 18 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. Patient was receiving immunizations at outreach clinic. On 27-MAY-2015, patient was seated on exam table and first received MENACTRA lot # U5049AA, dose 2, intramuscularly in left deltoid and then received GARDASIL 9 lot # L001312, dose 1, intramuscularly in the right deltoid for prophylaxis. Patient went limp, lost consciousness and nurse was able to lay her back on exam table. She began to have a seizure: grunting, pulling legs and moving head back and forth. Patient stopped breathing for a period of time, nurse and patient's mother stayed at her side ensuring safety. 911 was called to respond. Patient came out of seizure, regained consciousness on her own and was oriented to person and place. Lab data: emergency medical services (EMS) arrived and evaluated patient, vitals and blood sugar were stable. Patient refused transport, but was taken to the hospital by her mother. Patient reports having passed out before after giving blood and says that some of her friends said she was shaking. Mother of patient had never witnessed her having a seizure before. The outcome of all the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: headache; oropharyngeal pain; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 580061). This spontaneous report refers to a 12 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 26-MAY-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, intramuscularly for prophylaxis. On 26-MAY-2015, 3 hours post vaccination, the patient experienced headache and oropharyngeal pain (sore throat). The outcome of the events headache and oropharyngeal pain was unknown. The causality assessment for the events headache and oropharyngeal pain 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: HEPA, HPV9
Symptoms: Dizziness, Eye movement disorder, Head injury, Pallor, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 581309) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. Patient had no pertinent medical history. The current illnesses included cold sx/green nasal drainage. Other medications and prior vaccinations were not reported. On 08-JUN-2015, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # K026247, dose number 1 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VAQTA intramuscularly in the left arm, lot # K018181, dose number 1 (dose, frequency and lot expiration date were not reported) for prophylaxis. It was reported that on the same day after vaccination patient felt like fainted while seated and his mother reported that his eyes rolled back and he slid off the chair to the side (dizziness), hitting his right side and head (head injury). His mother called for help and the medical assistant (MA) went in and both moved patient to a supine position on the table with close observation. Patient was talking/appropriate during that time and his color came back. The patient had no HA or dizziness. Patient remained supine for 10-15 min and was doing very well and his mother watched for any signs of concussion i.e. HA and dizziness/fogginess. The outcome of dizziness and head injury 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: FLU3, HEPAB, HPV9
Symptoms: Incoherent, 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 # 581541) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 02-JUN-2015 the patient was vaccinated with the first doe of GARDASIL 9 intramuscularly in the right arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLULAVAL and TWINRIX. On 02-JUN-2015 patient was incoherent for about 3-5 minutes after receiving vaccines and did not respond to verbal or painful stimuli. The patient was immediately administered with adult EPI. The patient responded immediately after initial EPI injection while needle was still in leg. The outcome of events incoherent and unresponsive to stimuli 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: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 582071) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 16-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 in the left arm, lot # L001312, unknown route (dose, frequency and lot expiration date were not reported) for prophylaxis. On 16-JUN-2015, several minutes after GARDASIL 9 was administered, patient's father reported a syncopal episode with "loss of consciousness and shaking of arms and legs (tremor)".  The patient also experienced dizziness and hyperhidrosis. The patient was awake and alert when the nurse was arrived. The patient was oriented but "lightheaded" and diaphoretic and was placed in trendelenburg position in the car and transported to the emergency room. The outcome of events dizziness, tremor, syncope, loss of consciousness and hyperhidrosis 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
Symptoms: Asthenia, Eye movement disorder, Fall, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 582458) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. The patient's other medication included LEXAPRO 10 mg. On 18-JUN-2015 the patient was vaccinated with GARDASIL 9 in the left arm for prophylaxis. Other suspect therapies included hepatitis a virus vaccine (unspecified) (manufacturer unknown). On 18-JUN-2015 the patient's eyes rolled back in his head and got fell down and right side of patient's body was shaking as well as his head, also experience asthenia and tremor. The patient yelled for nurse and the nurse came quickly and they made patient to relax. The patient was made to drink Sprite and then he seemed to be ok but he was little weak The outcome of events asthenia, tremor, fall and eye movement disorder 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: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 582538) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 01-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # K026247, intramuscularly in the right arm for prophylaxis. On 16-JUN-2015, the patient experienced injection site erythema, injection site rash, injection site pruritus and injection site pain. The outcome of events injection site erythema, injection site rash, injection site pruritus and injection site pain 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: 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 # 583165). This spontaneous report refers to a 13 year old female patient. The patient's medical history was reported as pine nut allergy. The patient had no concurrent illnesses and other medications. Information on patient's prior vaccinations was not reported. On 15-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1 via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 15-JUN-2015, the patient experienced urticaria. Six hours after administration, the patient developed hives all over the body, worse on the torso. Benadryl was given with some relief. The patient was significantly better after 24 hours, resolved after 48 hours. The outcome of urticaria was reported as recovered. The causality assessment for the event urticaria 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
Symptoms: Abdominal pain, Blood test, Dizziness, 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 # 583651) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history was not reported. Patient's concomitant therapies, and concurrent illnesses were reported as none.  On 26-JUN-2015 the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm batch/lot#: K022647 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 26-JUN-2015, intramuscularly in the left arm, lot# U4846AA; dose and expiration date unknown) for prophylaxis. On the same day, approximately 3-4 minutes after receiving both the vaccinations, patient was sitting up on exam table and experienced nausea, abdominal pain, dizziness and loss of consciousness. The patient blacked out followed by falling onto ground. She then became conscious, blood pressure was stable. The patient was lying down for approximately 10 minutes, wanted to sit up but 5 minutes later, felt dizzy again. The patient underwent a blood test on the same day but the blood work was pending. After lying down again approximately 10-15 minutes, patient recovered and symptoms 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: 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 # 583651) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history was not reported. Patient's concomitant therapies, and concurrent illnesses were reported as none.  On 26-JUN-2015 the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm batch/lot#: K022647 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 26-JUN-2015, intramuscularly in the left arm, lot# U4846AA; dose and expiration date unknown) for prophylaxis. On the same day, approximately 3-4 minutes after receiving both the vaccinations, patient was sitting up on exam table and experienced nausea, abdominal pain, dizziness and loss of consciousness. The patient blacked out followed by falling onto ground. She then became conscious, blood pressure was stable. The patient was lying down for approximately 10 minutes, wanted to sit up but 5 minutes later, felt dizzy again. The patient underwent a blood test on the same day but the blood work was pending. After lying down again approximately 10-15 minutes, patient recovered and symptoms 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: Erythema, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 584185) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included shellfish allergy, hypothyroidism and rhinitis allergic. The patient's concomitant therapies, concurrent illness and other medications were not reported. On 18-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 (route reported as needle and syringe) lot # K026246 in the left arm for prophylaxis. On 23-JUN-2015, the patient experienced erythema and injection site pain. The outcome of erythema and injection site pain was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site 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 # 584217) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. The patients other medication included Nasonex. On 30-JUN-2015 the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENVEO. Lab data: child was given Benadryl. On 30-JUN-2015 approximately 7 minutes after vaccine was administered the patient developed hives in a 3" diameter around the vaccine site. The outcome of injection site urticaria 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: Head injury, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 584227) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included rhinitis allergic and vasovagal fainting spells. The patient's concomitant therapies, concurrent illness and other medications were not reported. On 12-JUN-2015 the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. On 12-JUN-2015 within few minutes after receiving vaccines, the patient experienced a spell of whole-body stiffening, which lasted a few seconds and he banged his head on a window. The outcome of head injury and musculoskeletal stiffness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Pruritus
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 # 584405) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 30-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENVEO. On 01-JUL-2015, the patient experienced redness, irritation, swelling, pain around injection site on left deltoid where vaccination was given. Also had rash on left side of face with itching. The outcome of events injection site erythema, rash pruritic, rash, injection site swelling, injection site pain and injection site irritation was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 584405) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 30-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENVEO. On 01-JUL-2015, the patient experienced redness, irritation, swelling, pain around injection site on left deltoid where vaccination was given. Also had rash on left side of face with itching. The outcome of events injection site erythema, rash pruritic, rash, injection site swelling, injection site pain and injection site irritation 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: Dizziness, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 585232) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient has no current illness and medical history. The patient's concomitant therapies and prior vaccinations were not reported. On 07-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # K006960 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 07-JUL-2015, intramuscularly in the left arm, lot # C4714AA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 07-JUL-2015, intramuscularly in the left arm, lot # U5026AA; dose and expiration date unknown). On 08-JUL-2015, the patient experienced dizzy, fever, arm swollen, and red. On an unknown date, the patient underwent emergency room (ER) visit. The outcome of dizziness, peripheral swelling, pyrexia and erythema was reported as recovered. Lot number K006960 was an invalid lot number for GARDASIL 9. Additional information is not expected from the Agency as follow up information cannot be obtained
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 585774) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illnesses, medical history, other medications and prior vaccinations were not reported. On 13-JUL-2015, the patient was vaccinated with GARDASIL 9 (route of administration unknown) in the left arm, lot # L004741 (dose number, dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX vaccinated date: 13-JUL-2015 in the right arm, lot # 3N53A; dose number, dose, route of administration, and expiration date unknown) and MENACTRA vaccinated date: 13-JUL-2015 in the right arm, lot# U4986AA; dose number, dose, route of administration, and expiration date unknown). On 13-JUL-2015, the patient experienced moderate redness, swelling on the right upper arm at the site of BOOSTRIX vaccine and the patient had mildly tender to palpation which was noticed on 14-JUL-2015. On an unknown date, the patient had an emergency room (ER) visit. The outcome of injection site pain, injection site swelling and injection site erythema was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Erythema of eyelid, 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 # 585920) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no pertinent medical history and concurrent illnesses. The concomitant therapies were not reported. On 15-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L004741, dose 2 (prior vaccinations information was not reported), intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day the patient experienced erythema and rash on face with redness around the eyes. Patient was treated with BENADRYL and was observed for 30 minutes. No rash was noticed and patient was sent home later. The outcome of erythema and rash was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586329). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 14-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1 via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day, the patient was also vaccinated with ADACEL batch # U5214AA, dose 1 via intramuscular route in the right arm and MENACTRA batch # U4847AA, dose 1 via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 16-JUL-2015, the patient experienced injection site cellulitis. The patient required emergency room visit. The patient was treated with AUGMENTIN for 10 days. The outcome of injection site cellulitis was unknown. The causality assessment for the event injection site cellulitis 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: Dermatitis contact, Rash generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586340) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 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 06-JUL-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, dose number 1, intramuscularly in the left arm for prophylaxis. On 07-JUL-2015, the patient experienced dermatitis contact and rash generalised. On the same day, rash was noted on the face and neck of the patient around 3:00 PM and the patient was taken for an urgent care visit and it was diagnosed as dermatitis. Rash faded and patient had no other symptoms. The outcome of dermatitis contact and rash generalised was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 587075) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's concomitant therapies, concurrent illnesses and pertinent medical history were not reported. On 23-JUL-2015 the patient who was a student was vaccinated with GARDASIL 9 lot # L006547 dose 2 (dose, frequency, lot expiration date and prior vaccination information were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 23-JUL-2015, intramuscularly in the right arm, batch/lot# U5037AA; dose, expiration date and prior vaccination information were unknown) and BOOSTRIX (dose number: 2, vaccinated date: 23-JUL-2015, intramuscularly in the left arm, batch/lot# 74NT9; dose, prior vaccination information and expiration date were unknown) for prophylaxis. The GARDASIL 9 was the last to be administered. On the same day post vaccination, patient experienced hyperhidrosis, musculoskeletal stiffness and loss of consciousness. His whole body became stiff/clamped and he lost consciousness for less than a minute (about 40 seconds). The patient was a little diaphoretic after the episode. The outcome of all the events was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Deafness, Feeling cold, Hyperhidrosis, Loss of consciousness, Nasopharyngitis
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 # 588437) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 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 03-AUG-2015, the patient was vaccinated with GARDASIL 9, intramuscularly in the right arm, lot# L007531, dose number 1 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VARIVAX subcutaneously in the right arm, lot # K016127, (dose number 2, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported), MENACTRA intramuscularly in the left arm, lot # U5037AA, (dose number 1, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported), and BOOSTRIX intramuscularly in the left arm, lot # 5TN9R, (dose number 1, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported). On 03-AUG-2015, the patient experienced deafness, loss of consciousness, pallor, nasopharyngitis and hyperhidrosis. Patient also experienced blackout, sweating, hearing loss and began to feel cold/pale. Symptoms lasted for a few minutes and there was no treatment required. The outcome of deafness, loss of consciousness, pallor, nasopharyngitis and hyperhidrosis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 588437) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 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 03-AUG-2015, the patient was vaccinated with GARDASIL 9, intramuscularly in the right arm, lot# L007531, dose number 1 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VARIVAX subcutaneously in the right arm, lot # K016127, (dose number 2, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported), MENACTRA intramuscularly in the left arm, lot # U5037AA, (dose number 1, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported), and BOOSTRIX intramuscularly in the left arm, lot # 5TN9R, (dose number 1, vaccination date: 03-AUG-2015, dose, frequency and lot expiration date were not reported). On 03-AUG-2015, the patient experienced deafness, loss of consciousness, pallor, nasopharyngitis and hyperhidrosis. Patient also experienced blackout, sweating, hearing loss and began to feel cold/pale. Symptoms lasted for a few minutes and there was no treatment required. The outcome of deafness, loss of consciousness, pallor, nasopharyngitis and hyperhidrosis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 588476). This spontaneous report refers to a 11 year old female patient. The patient's historical conditions included allergy and asthma. The patient had no current illness. The patient's concomitant medications included zyrtec and albuterol. On 28-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026246 dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA dose 1 given intramuscularly in the right arm. On the same day, the patient experienced urticaria. She had hives on arms, legs and abdomen 5-6. No SOB or wheezing. The outcome of urticaria was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus, 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 # 588842). This spontaneous report refers to a 11 year old female patient. The patient had no known drug allergies (NKDA). The patient's concurrent conditions and concomitant medications were not reported.  On 22-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L004741 dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA, given intramuscularly in the right arm. On the same day, the patient experienced injection site erythema, rash maculopapular, rash erythematous, pruritus, injection site rash and injection site pruritus. Both arms developed itching and a bright red maculopapular lacy rash from shoulder to hands. No hives no respiratory or systemic sx. No laboratory tests were performed. The outcome of injection site erythema, rash maculopapular, rash erythematous, pruritus, injection site rash and injection site pruritus was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash erythematous, Rash maculo-papular
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 # 588842). This spontaneous report refers to a 11 year old female patient. The patient had no known drug allergies (NKDA). The patient's concurrent conditions and concomitant medications were not reported.  On 22-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L004741 dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA, given intramuscularly in the right arm. On the same day, the patient experienced injection site erythema, rash maculopapular, rash erythematous, pruritus, injection site rash and injection site pruritus. Both arms developed itching and a bright red maculopapular lacy rash from shoulder to hands. No hives no respiratory or systemic sx. No laboratory tests were performed. The outcome of injection site erythema, rash maculopapular, rash erythematous, pruritus, injection site rash and injection site pruritus was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Head injury, Nasal injury, Nausea, 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 # 588844). This spontaneous report refers to a 16 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 31-JUL-2015, at 11:05 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 2 via unknown route in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day, at 11:05 the patient was also vaccinated with MENACTRA lot/batch # U5026AA, dose 2 via unknown route in the left arm for prophylaxis (dosage and expiry date unspecified). On 31-JUL-2015, the patient experienced fall, swelling, nausea and head injury. Post vaccination, the patient stood up and walked towards her mother and fell forward hitting her head on chairs. The patient was rolled onto her back and the patient responded immediately and asked "what happened?". The patient's feet were elevated and cool pack was applied to her injuries where swelling showed up on the bridge of the nose and forehead. The patient's blood pressure was 107/82, pulse was 100 at 11:15, the registered nurse (RN) checked pupils and they were equal/reactive. The patient's mother gave the patient two puffs of her personal inhaler at 11:20 am and at 11:24 am pulse was 96, respiratory rate 20. The patient was advised to seek medical attention at that time for the nose injury. The patient had complaints of nausea and received a "coke" to drink, no vomiting at that time. At 11:33, the patient was sitting up and talking to her mother, cool rag to neck, drinking a "coke". At 11:40 am, the patient was able to ambulate to vehicle with assistance from her mother and RN, kept cool packs to apply as needed. A copy of nursing notes involving incident was sent with the patient's mother. The patient's mother stated during the episode that "she has never passed out before." The outcome of fall, swelling, nausea and head injury was reported as recovered. The causality assessment for the events fall, swelling, nausea and head injury 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, VARCEL
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 # 588866). This spontaneous report refers to a 10 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # L004741, dose 1, intramuscularly in the left arm for prophylaxis and on the same day she was also vaccinated with VARIVAX lot # K020758, dose 2, subcutaneously in the left arm for prophylaxis. On 18-JUL-2015, the patient had symptoms of erythema, skin warm and induration (red, hot, firm to touch 10cm x 7cm in diameter) which worsened daily (area got bigger). On 20-JUL-2015, the patient returned to clinic. The outcome of the events erythema, skin warm and induration was unknown. The causality assessment for all the events with respect to the suspect therapies was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Nausea, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589038). This spontaneous report refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 07-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # AG7KY, dose 1, intramuscularly in the right arm and HAVRIX lot # 3RB2G, dose 1, intramuscularly in the left arm for prophylaxis. On 07-AUG-2015, within one minute of administering the vaccine, patient got very lightheaded and turned white. He was given a bottle of water. Patient was sweaty, cold and his dad was there to help. Patient took deep breaths and he felt like he was going to throw up, and he did. Once he threw up, he felt much better. He stayed seated for about 10 minutes and color returned to his face. He waited in the office for about another 20 minutes, stated that he felt fine and left with his father. Of note: a very similar incident happened with his older brother when he received a vaccine about 2 years ago. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, TDAP
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 # 589038). This spontaneous report refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 07-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # AG7KY, dose 1, intramuscularly in the right arm and HAVRIX lot # 3RB2G, dose 1, intramuscularly in the left arm for prophylaxis. On 07-AUG-2015, within one minute of administering the vaccine, patient got very lightheaded and turned white. He was given a bottle of water. Patient was sweaty, cold and his dad was there to help. Patient took deep breaths and he felt like he was going to throw up, and he did. Once he threw up, he felt much better. He stayed seated for about 10 minutes and color returned to his face. He waited in the office for about another 20 minutes, stated that he felt fine and left with his father. Of note: a very similar incident happened with his older brother when he received a vaccine about 2 years ago. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Laboratory test, Lymphadenopathy, Muscular weakness, Myalgia
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 # 589340). This spontaneous report refers to a 17 year old female patient. The patient's medical history included rhinitis allergic and chronic headache. Other medications included Singulair and Claritin. On 21-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1 (unspecified route) in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose 2) vaccinated in the right arm. On the same day, the patient experienced headache, pyrexia, myalgia, muscular weakness, apparent lymphadenopathy and also had a laboratory test performed. The outcome of headache, laboratory test, pyrexia, myalgia, muscular weakness and lymphadenopathy was reported as unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589340). This spontaneous report refers to a 17 year old female patient. The patient's medical history included rhinitis allergic and chronic headache. Other medications included Singulair and Claritin. On 21-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1 (unspecified route) in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose 2) vaccinated in the right arm. On the same day, the patient experienced headache, pyrexia, myalgia, muscular weakness, apparent lymphadenopathy and also had a laboratory test performed. The outcome of headache, laboratory test, pyrexia, myalgia, muscular weakness and lymphadenopathy was reported as unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.