chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: (R) upper extremity redness and swelling, low grade fever. Was seen at Urgent care. Pt was given an injection - possibly ceftriaxone (no records available. Pt will start BACTRIM today 4/17/17.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful, swollen, warm at injection site (LD).
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Palm-sized, raised red area - pt described as "non-severe" mildly itchy, treated with hydrocortisone 1% cream appeared night of vaccination disappeared in 2 days - reaction occurred several inches below injection site (pharmacist verified).
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Seizure
Clinical narrative: Vaccines were administered at approximately 8:40 AM. Patient's temperature was 100 around 11:00 AM at home. Shortly after 11:00 AM patient had seizure. Patient's mother called 911, patient was taken to ER by ambulance.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Agitation, Decreased appetite, Dyspnoea, Erythema, Fatigue
Clinical narrative: A few hours after the shot, patient started to feel horrible. He was having trouble breathing, skin and eyes were red. He was very sweaty. He was antsy and jittery. His arm was in major pain also. He had no appetite and was tired but restless. He was very on edge. Patient said he didn't know why he felt so bad when he felt fine in the morning.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling abnormal, Feeling jittery, Hyperhidrosis, Ocular hyperaemia, Pain in extremity
Clinical narrative: A few hours after the shot, patient started to feel horrible. He was having trouble breathing, skin and eyes were red. He was very sweaty. He was antsy and jittery. His arm was in major pain also. He had no appetite and was tired but restless. He was very on edge. Patient said he didn't know why he felt so bad when he felt fine in the morning.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Restlessness
Clinical narrative: A few hours after the shot, patient started to feel horrible. He was having trouble breathing, skin and eyes were red. He was very sweaty. He was antsy and jittery. His arm was in major pain also. He had no appetite and was tired but restless. He was very on edge. Patient said he didn't know why he felt so bad when he felt fine in the morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal pain, Oedema peripheral, Pain
Clinical narrative: Left arm and arm pit swollen, red, severe pain, could not move arm. Pain also in shoulder.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Left arm and arm pit swollen, red, severe pain, could not move arm. Pain also in shoulder.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Pyrexia, Rash, Vomiting
Clinical narrative: Vomiting, Fever, Local rash, and itching.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Crying
Clinical narrative: Child had inconsolable crying for 12 hours (intermittent).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Oedema, Pain
Clinical narrative: Pt. given vaccine 5/4/2017 - Had prolonged localized reaction, painful, edematous, erythemic x 5 days.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Became lightheaded after administration. No loss of consciousness. Developed a headache. Has history of headaches. Lightheadedness resolved in 1-2 minutes after started. Given food, fan and drink. Head between legs. Lightheadedness resolved.
Age: 60.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site paraesthesia, Pain, Pain in extremity
Clinical narrative: (L) arm intermittent numbness/tingling down arm from shoulder, when (L) arm stretched behind back-sharp pain occurs and he drops any item in hand. Pt. states started after receiving pneumo 23 and MENACTRA vaccine.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Severe swelling at injection site, travelling all the way down to left elbow, very Red and inflamed.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness. Swelling. Tenderness to touch. Lasted 3 days.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: Redness, tenderness to touch. Unknown how longs signs/symptoms lasted.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain
Clinical narrative: Redness. Painful. Unknown how long signs/symptoms lasted.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient called to report back muscle pain and spasms as she left the store and got in her car that lasted 15-20 minutes, but is fine now. She also reported severe soreness along her entire arm and shoulder this evening. No redness or swelling is reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Flushing, Full blood count, Tachycardia, Ultrasound scan
Clinical narrative: Five mins. after injection - patient was tachycardic; then another 5 mins. started to have flushed face, then on the chest and back and extremities - given BENADRYL 25 mg I.M. Brought to ER - given steroid.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Abdominal pain, Infantile spitting up, Screaming
Clinical narrative: After initial ROTARIX, screaming with belly pain x 7 days. Spitting up profusely x 7 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swollen, erythematous left arm, induration at left shoulder tx'd with Abx for cellulitis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised warm area at injection site (about the size of a quarter per Mother) noted early AM 5/10/17.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Pruritus, Rash generalised
Clinical narrative: Pt. called health dept. on 5/11/2017 reported breaking out in head/toe rash night after receiving Td Imm; severe itching. Took BENADRYL 50 mg, slept all night and all the day after. Rash now resolved.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: Syncope within a few minutes of vaccine administration.
Age: 57.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Paraesthesia, Rash erythematous
Clinical narrative: Patient received ZOSTAVAX inj. on Friday 4/28/2017. Returned to pharmacy on Tuesday 5/2/2017 with red half circle rash and tingling sensation.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Redness, warmth, pain left upper arm approximately 2hr after injection of PNEUMOVAX. Then had severe pain in area, chills, syncope approximately 5hr after injection. Recurrent emesis for 4-6 hr Nausea x 24 hr.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Syncope, Vomiting
Clinical narrative: Redness, warmth, pain left upper arm approximately 2hr after injection of PNEUMOVAX. Then had severe pain in area, chills, syncope approximately 5hr after injection. Recurrent emesis for 4-6 hr Nausea x 24 hr.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: Severe pain reported in muscle and shoulder joint, no redness or swelling. Patient was unable to use arm for several hours.
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: Moderate problems. Headache, nausea, vomiting, diarrhea, stomach ache, pain where shot was given. Symptoms lasted for a week.
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Moderate problems. Headache, nausea, vomiting, diarrhea, stomach ache, pain where shot was given. Symptoms lasted for a week.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Decreased appetite, Erythema, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: Fever 102.5 hot stomach and thighs. Fri. nite arm swelled 2x normal size - Red and hot. Lost appetite for food or drink. Fever went down Sat. morning. Arm immobile from pain. Fever started again-went to Em. Rm. Got steroids and antibiotics. Took 5 days to recover.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Fever 102.5 hot stomach and thighs. Fri. nite arm swelled 2x normal size - Red and hot. Lost appetite for food or drink. Fever went down Sat. morning. Arm immobile from pain. Fever started again-went to Em. Rm. Got steroids and antibiotics. Took 5 days to recover.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm, White blood cell count normal
Clinical narrative: Fever 102.5 hot stomach and thighs. Fri. nite arm swelled 2x normal size - Red and hot. Lost appetite for food or drink. Fever went down Sat. morning. Arm immobile from pain. Fever started again-went to Em. Rm. Got steroids and antibiotics. Took 5 days to recover.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Ear pain, Headache, Hypophagia, Influenza virus test negative
Clinical narrative: Fever 102.9 approximately 14 hours after vaccine, nausea, severe all over body pain and headache, ear pain, throat pain, developed wet cough, back pain. Poor PO - saltines, applesauce, ice chips.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain, Productive cough, Pyrexia
Clinical narrative: Fever 102.9 approximately 14 hours after vaccine, nausea, severe all over body pain and headache, ear pain, throat pain, developed wet cough, back pain. Poor PO - saltines, applesauce, ice chips.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Fever 102.9 approximately 14 hours after vaccine, nausea, severe all over body pain and headache, ear pain, throat pain, developed wet cough, back pain. Poor PO - saltines, applesauce, ice chips.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: At injection site - started itchy and red then progressed to swelling and increased redness, this spread down pt's arm. Pt was seen at walk in on May 6th and prescribed prednisone. As of 5/8/17 condition has not resolved. Pain has subsided though.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuropathy peripheral, Protein urine present
Clinical narrative: Left neck into face numbness/leg and foot numbness. Peripheral neuropathy after flu shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction with redness, pain swelling.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor
Clinical narrative: Temporary loss of consciousness occurred immediately after receiving Tdap MCV4 and HPV. Slight body twitching, jerking and pale coloring. Pt was sitting, no harm or injury occurred. Incident lasted 30 sec and consciousness was regained. Recovery occurred in a few minutes following. No medical intervention other than observation was needed. Child left the building ambulatory.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion, Musculoskeletal stiffness, Tremor
Clinical narrative: Febrile seizure. Per report patient's legs went straight and stiff, and started shaking for approx. 2 min.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Presyncope
Clinical narrative: Vasovagal. Intense arm pain 18 hrs later.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient due for TDaP vaccine, but was given DTaP. Dr. notified immediately. Doesn't expect there to be any adverse reaction other than a more vigorous response at the site of injection with perhaps a more sore muscle. Parent notified before. Patient Rx'd and given info on expected outcome.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Blood lead, Blood mercury, C-reactive protein, Chest pain
Clinical narrative: Patient has recurrent headaches, abdominal pain, and chest pain since completing HPV series 10/14/2013. She has been worked up by cardiology, neurology, and has had many screening labs. Concern for possible adverse reaction to the HPV vaccine as symptoms began shortly after series completed.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Full blood count, Headache, Metabolic function test, Nuclear magnetic resonance imaging brain, Thyroid function test
Clinical narrative: Patient has recurrent headaches, abdominal pain, and chest pain since completing HPV series 10/14/2013. She has been worked up by cardiology, neurology, and has had many screening labs. Concern for possible adverse reaction to the HPV vaccine as symptoms began shortly after series completed.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Ultrasound scan, Vitamin D
Clinical narrative: Patient has recurrent headaches, abdominal pain, and chest pain since completing HPV series 10/14/2013. She has been worked up by cardiology, neurology, and has had many screening labs. Concern for possible adverse reaction to the HPV vaccine as symptoms began shortly after series completed.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash and redness with induration around site of injection.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis/redness to right upper posterior arm.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site joint pain
Clinical narrative: Arthralgia of left arm/shoulder. Seen by PCP 5/15/17.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Pain, Vomiting
Clinical narrative: Body joint aches over a week. Took the shingles vaccine have felt deathly ill since. Body aches feels like a fever without a temp. Vomiting.
Sex: M
Vaccine: HEP, HPV9, TDAP
Symptoms: Abdominal pain, Dysstasia, Groin pain, Headache, Moaning
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 # 617987). This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient's medical history included sickle cell disease, last crisis was in November 2015. Patient's other medication included measles virus vaccine live M-M-R and poliovirus vaccine inactivated (unspecified) (IPV) on 10-DEC-2015. On 06-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5243AA, dose 7, intramuscularly in the left arm and ENGERIX-B lot # 5DE7C, dose 2, intramuscularly in the right arm for prophylaxis. Patient's mother reported that, she thought patient had a fever and was given a fever reducing medicine. Patient woke up in middle of the night with headache and blurry vision and went back to sleep. On 08-JAN-2016, in the morning patient woke up with fever, abdominal pain and patient's mother brought patient back to the health department where he received his vaccines. Patient doubled over holding abdomen, had fever of 103.1 (units not reported) and complained of headache and right groin pain. Due to patient's history of sickle cell disease, patient's mother was encouraged to bring the patient to urgent care or emergency room for medical treatment. Patient's mother had no transportation and stated that she can have family member take them. Declined 911 service and patient continued to moan and hold abdomen. He could not stand up without support and had severe abdominal pain. Patient was assisted to vehicle via wheelchair by a family member and patient's mother reported that patient was taken to ER at 11:25 on 08-JAN-2016. Patient's mother was advised to call the nurse with update as soon as she was able to later that day. The outcome of all the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEP, HPV9, TDAP
Symptoms: Pyrexia, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 617987). This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient's medical history included sickle cell disease, last crisis was in November 2015. Patient's other medication included measles virus vaccine live M-M-R and poliovirus vaccine inactivated (unspecified) (IPV) on 10-DEC-2015. On 06-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5243AA, dose 7, intramuscularly in the left arm and ENGERIX-B lot # 5DE7C, dose 2, intramuscularly in the right arm for prophylaxis. Patient's mother reported that, she thought patient had a fever and was given a fever reducing medicine. Patient woke up in middle of the night with headache and blurry vision and went back to sleep. On 08-JAN-2016, in the morning patient woke up with fever, abdominal pain and patient's mother brought patient back to the health department where he received his vaccines. Patient doubled over holding abdomen, had fever of 103.1 (units not reported) and complained of headache and right groin pain. Due to patient's history of sickle cell disease, patient's mother was encouraged to bring the patient to urgent care or emergency room for medical treatment. Patient's mother had no transportation and stated that she can have family member take them. Declined 911 service and patient continued to moan and hold abdomen. He could not stand up without support and had severe abdominal pain. Patient was assisted to vehicle via wheelchair by a family member and patient's mother reported that patient was taken to ER at 11:25 on 08-JAN-2016. Patient's mother was advised to call the nurse with update as soon as she was able to later that day. The outcome of all the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 618572) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on patient's other medication was reported as none. Information on the patient's concurrent illnesses and medical history were reported as not applicable. Information on patient's prior vaccination was not reported. On 04-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L020015, via intramuscular route, in the right arm for prophylaxis (dosage unspecified). On the same day the patient was vaccinated with BOOSTRIX lot/batch # 2224P, via intramuscular route, in the left arm and MENACTRA lot/batch # U5068AA, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On 05-JAN-2016, patient had sore upper right arm, it was warm to touch and slightly swollen. No fever was there. TYLENOL and MOTRIN was not given by the mother. The outcome of injection site pain, injection site warmth and injection 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.
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 621674). This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses and medical history. Patient's other medications included MOTRIN 200 mg, tablet 1-2 tablets by mouth every 6 hours as needed for pain. On 01-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5186AA, intramuscularly in the right arm and FLUARIX QUADRIVALENT lot # 2SN22, intramuscularly in the right arm for prophylaxis. On 01-FEB-2016, the patient sat and was monitored for the recommended 15 minutes after the immunizations and did not show any symptoms of adverse reactions. As the patient was getting ready to leave, she began to feel lightheaded and was assisted to lie in trendelenburg position, the patient's symptoms began to resolve after about 5 minutes. The patient drank 6 ounces of apple juice and was then able to sit up, without return of lightheadedness or any other symptoms. Vital signs were stable (blood pressure: 136/82 (units not specified), pulse: 73 (units not specified)) and patient's condition returned to the same as it was prior to vaccination. Patient was then discharged to home. Patient was advised to get plenty of rest, drink adequate oral fluids and refrain from over-exertion and strenuous activities for the next several hours. Patient was advised for future vaccination and she should lie down prior to and for 15 minutes after the vaccinations. The outcome of the event dizziness was reported as recovered. The causality assessment for the event dizziness 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: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 621892) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's concomitant therapies and other medications were not reported. On 01-FEB-2016, the patient was vaccinated with third dose of GARDASIL 9 (dose, frequency and lot# were not reported) via intramuscular route, in the left arm for prophylaxis. On 03-FEB-2016, patient experienced redness and swelling on the left arm at the injection site. The patient had no pain or itching and had full movement of the arm. The outcome of injection site erythema and injection site swelling 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: HEPA, HPV9, MNQ, TDAP
Symptoms: Eyelid function disorder, Hypoaesthesia
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 # 622242) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a female patient of unknown age with prophylaxis. Patient's medical history and current illness were reported as none. Information on patient's other medications and prior vaccinations were not reported. On 13-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was vaccinated with ADACEL, lot/batch # L013429, dose 1, via intramuscular route, in the left arm, HAVRIX lot/batch # KP79Z, dose 1, via intramuscular route, in the right arm and MENACTRA lot/batch# U5178AA, dose 1, via intramuscular route, in the right arm for prophylaxis. On 18-OCT-2015, the patient was at hospital at 12:03, with the complaints of right side facial numbness, not able to smile on right side and unable to close right eye completely. The patient required emergency room visit. The outcome of eyelid function disorder and hypoaesthesia was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: 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 # 622248). This spontaneous report refers to a 14 year old female patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications was not known. On 09-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L017407, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with included HAVRIX lot # F4KR5, dose 1, intramuscularly in the left arm for prophylaxis. On 09-FEB-2016, patient experienced systemic rash which was treated with BENADRYL. The outcome of the event was reported as recovered. The causality assessment for the event 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: 21.0
Sex: F
Vaccine: HEPA, HPV9, PPV
Symptoms: Erythema, Limb mass, 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 #622939) and refers to a 21 year old female patient. Patient's current illnesses and medical history was reported as none. No details about lab data, other medications and prior vaccination was provided. On 15-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L0016429, dose 2, intramuscular in the left arm for prophylaxis (strength and dosing details unknown). Other suspect therapies included vaccination with PNEUMOVAX 23 and HAVRIX. On 16-FEB-2016, patient's lower right arm started hurting, states she has a red lump, denies being hot to the touch. Patient was instructed to apply cold pack 20 min on, 20 min off, mark borders of area, take medication for pain. Patient was scheduled to come in the next day for TB reading for assessment. The outcome of erythema, limb mass and pain in extremity was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEP, HPV9, IPV, MNQ, TDAP, 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 ID-623092). This spontaneous report refers to a 17 year old female patient. Information on patient's other medications was unknown. The patient had no current illness and historical conditions. The patient's prior vaccinations were not reported. On 17-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 dose 1 (unspecified dose and units), intramuscularly in the right arm for prophylaxis and VARIVAX (lot # L012038, expiration date: 07-APR-2017) dose 1 (unspecified dose and units), subcutaneously for prophylaxis. Other suspect therapies included, BOOSTRIX (lot # 9NA32), dose 1 (unspecified dose and units), IPOL (lot # L10011), dose 5 (unspecified dose and units), MENACTRA (lot # U5058AC), dose 1 and ENGERIX-B (lot # 475PE), dose 1 given on the same day, intramuscularly for prophylaxis. The patient's mother stated that the patient had rash to upper shoulders after receiving vaccines on 17-AUG-2015 and rash appeared to back, upper shoulders and chest after receiving vaccines on 19-OCT-2015. The outcome of rash was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-623153). This spontaneous report refers to a 16 year old male patient. The patient had no current illness, other medications and historical conditions. On 19-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L018351 dose 3 (unspecified dose and units), intramuscularly in the right arm for prophylaxis. Other suspect therapies included HAVRIX (lot # P3A42), dose 2 and ENGERIX-B (lot # CB544) dose 3 vaccinated on the same day, intramuscularly in the left arm for prophylaxis. After vaccination, on the same day, the patient complained of feeling lightheaded. The patient's vital signs were stable; rested in supine position for 40 minutes with resolution of symptoms after 5-10 minutes; recovered in good condition under care of parent. The outcome of dizziness 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: F
Vaccine: FLU4, 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 # 623154). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications was not reported. On 12-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 9432Z5, dose 2, intramuscularly in the right arm; FLUARIX QUADRIVALENT lot # 45ER7, intramuscularly in the right arm and MENACTRA lot # U5172BA, dose 2, intramuscularly in the left arm for prophylaxis. On 13-FEB-2016, the patient had rash on both arms. The outcome of the event rash was reported as recovered. The causality assessment of the event rash 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: Rash, Rash macular, Rash pruritic
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 # 625038) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history, lab data and prior vaccinations were reported as none. Information on patient's prior vaccination was not reported. On 27-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot/batch# L002560, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). Patient's grandmother reported on 05-FEB-2016 that, two days following vaccination (29-JAN-2016) patient developed pink, itchy blotches, smaller than a dime on both arms and both legs. Approximately 20 blotches were observed. Patient had no other symptoms. The outcome of pruritus and rash macular was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Back pain, Body temperature increased, Peripheral swelling, 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 # 625713). This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses, medical history or other medications. Information on the patient's prior vaccinations was not reported. On 17-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017) dose 1 via intramuscular route in the right arm for prophylaxis (dosage unspecified) and the patient was also vaccinated with TRUMENBA lot/batch # J29757, dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient experienced peripheral swelling, skin warm, increased body temperature and back pain. The patient began with body temperature 100.1-100.2, 8 hours after GARDASIL 9 and TRUMENBA was administered. The patient reported bad back pain, the left arm had swelling and was warm to touch. The outcome of skin warm, peripheral swelling, body temperature increased and back pain was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Gingival swelling, Lymphadenopathy, Oropharyngeal pain, Stomatitis, Streptococcus test positive
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient's concomitant therapies included amlodipine 10 mg. The patient's medical history included depression, hypertension and allergic to adhesive tape. The patient had no current illness and prior vaccinations was not reported. On 17-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L036245 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient's lab data included, patient returned for doctor visit. rapid streptococcus A test performed, result: negative. On 18-FEB-2016, the patient experienced swollen gums (gingival swelling), had streptococcus test negative, stomatitis, oropharyngeal pain, sore throat, irritation to mouth and swelling of Lymph Nodes under left arm and under jaw (lymphadenopathy). On an unknown date the patient had an emergency room (ER) visit. The outcome of gingival swelling, streptococcus test negative, stomatitis, oropharyngeal pain and lymphadenopathy was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 626219). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent conditions or medical history. Information on the patient's prior vaccinations and other medications were not reported. On 23-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017) dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# Z9Z4Y, dose 1, intramuscular route in the right arm and TRUMENBA batch/lot# J29757, dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On 24-FEB-2016,  the patient experienced injection site swelling, injection site warmth and injection site erythema. The patient's left deltoid area post TRUMENBA vaccine was swollen, red and hot. The patient was treated with ice pack and BENADRYL. The outcome of injection site swelling, injection site warmth and injection site erythema was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 626220). This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses or medical history. Information on patient's prior vaccinations and other medications were not reported. On 18-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L028083 dose 3, route reported as: needle and syringe (not specified further) for prophylaxis (dosage and site of administration unknown). On 19-JAN-2016, the patient experienced injection site swelling and injection site pain. It was reported that, the patient had a "dime sized" bump under the skin in the area where shot number 3 was administered and the site was tender to touch. The outcome of injection site pain and injection site swelling was reported as recovered. The causality assessment for the events injection site pain and injection site swelling with respect to GARDASIL 9 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: Blood glucose normal, Blood pressure decreased, Dizziness, 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 # 626223). This spontaneous report refers to a 11 year old female patient. The patient had no medical history or adverse reactions to previous vaccines. The patient had no concurrent illnesses or other medications and was generally in good health. Information on the patient's prior vaccinations was not reported. On 08-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017) dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# AG74KY, dose 1, intramuscular route in the right arm and MENACTRA batch/lot# U5180AA, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On 08-MAR-2016, the patient experienced pallor, dizziness and decreased blood pressure. After shots were given, the patient was transferred from examination table to a nearby chair when she started to feel lightheaded. No loss of consciousness (LOC). The patient was observed to be pale. Vitals were taken with blood pressure (BP) dropped from 119/76 to 95/65, pulse from 88 to 64. The patient's blood glucose was 140. The patient had no other associated symptoms including dyspnea, headaches, swelling or rash. The patient was given some water. The patient remained resting in chair and over the course of 15 minutes, regained color to her skin and report of dizziness resolving. The patient was discharged home with the patient's mother with closed monitoring. Emergency room (ER) precautions signs were given to the patient's mother. The outcome of blood pressure decreased, pallor and dizziness was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Paraesthesia, 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 # 626239). This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses or medical history. Information on the patient's prior vaccinations and other medications were not reported. On 23-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017) dose 2, unknown route in the left arm (deltoid) for prophylaxis (dosage unspecified). On the same day, the patient experienced pruritus, paraesthesia and back pain. About 24 hours after vaccination, she developed pins and needles feeling with itching and pain over entire low back area, most noticeable when laying down at bedtime. The outcome of back pain, pruritus and paraesthesia was reported as not recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle spasms
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 # 627366) on 18:APR-2017. This spontaneous report was received from a regulatory authority refers to a 22 year old female patient. Patient's medical history included anxiety. Information on the patient's concurrent illnesses was reported as none. Information on patient's other medications and prior vaccinations were not reported. On 23-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L038917, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 23-FEB-2016, the patient had injected limb mobility decreased and injection site pain which was persisting 16 days afterwards resulting in avoidance of use/spasms. The outcome of injected limb mobility decreased and injection site pain was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 17 year old female patient. The patient did not have medical history or concurrent conditions. Concomitant therapies were not reported. On 07-DEC-2016, the patient was vaccinated in his right arm with the first dose of GARDASIL 9 lot # M030380, administered intramuscularly (strength and expiration date were unknown) for prophylaxis. On 08-DEC-2016, the patient experienced vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue. At the time of the report, the outcome of vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue was reported as not recovered. The reporter did not assess the relatedness between the vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue with the vaccination with GARDASIL 9.  Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 17 year old female patient. The patient did not have medical history or concurrent conditions. Concomitant therapies were not reported. On 07-DEC-2016, the patient was vaccinated in his right arm with the first dose of GARDASIL 9 lot # M030380, administered intramuscularly (strength and expiration date were unknown) for prophylaxis. On 08-DEC-2016, the patient experienced vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue. At the time of the report, the outcome of vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue was reported as not recovered. The reporter did not assess the relatedness between the vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue with the vaccination with GARDASIL 9.  Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 17 year old female patient. The patient did not have medical history or concurrent conditions. Concomitant therapies were not reported. On 07-DEC-2016, the patient was vaccinated in his right arm with the first dose of GARDASIL 9 lot # M030380, administered intramuscularly (strength and expiration date were unknown) for prophylaxis. On 08-DEC-2016, the patient experienced vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue. At the time of the report, the outcome of vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue was reported as not recovered. The reporter did not assess the relatedness between the vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache and fatigue with the vaccination with GARDASIL 9.  Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9
Symptoms: Axillary 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 # 629596) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 21-MAR-2016, the patient was vaccinated with the first dose GARDASIL 9 lot # L020015, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 25-MAR-2016, the patient had armpit pain. Patient had no fever and redness. The outcome of axillary pain was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Cough, Decreased appetite, Dyspnoea, Headache, Influenza A virus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 629937) 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 asthma exercise induced and recurrent urinary tract infection. The patient had no concurrent illnesses. The patient's concomitant therapies were not reported. The patient's other medications included OTC cold preparation (did not get details of specific ingredients). On 18-MAR-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L016428 (expiration date: 30-JUL-2017) (dose and frequency were not reported), via intramuscular route, in the left arm for prophylaxis. On 19-MAR-2016, the patient developed sudden onset of fever and lethargy which last over one week. The patient also had decreased appetite, cough, headache and shortness of breath. The patient's lab data included influenza A and B virus test negative. The patient had visited emergency room. The outcome of cough, pyrexia, lethargy, influenza B virus test, influenza A virus test negative, headache, dyspnoea and decreased appetite were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.