chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthroscopy, Cartilage injury, Nuclear magnetic resonance imaging abnormal, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Event: R shoulder SLAP tear, R Subacromial impingement. Treatment: 3/24/17 surgery (R shoulder arthroscopy, Subacromial decompression with acromioplasty, open subpectoral biceps tenodesis).
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder arthroplasty, Tenodesis
Clinical narrative: Event: R shoulder SLAP tear, R Subacromial impingement. Treatment: 3/24/17 surgery (R shoulder arthroscopy, Subacromial decompression with acromioplasty, open subpectoral biceps tenodesis).
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 16-year-old male patient who received BEXSERO. Concomitant products included MENVEO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO on an unknown arm and experienced arm soreness for 2 weeks. The patient required emergency room visit. Sales rep did not have any other information.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Urinary incontinence
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a 16-year-old female patient who received BEXSERO. In January 2017, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced syncope and urinary incontinence. On an unknown date, the outcome of the syncope and urinary incontinence were unknown. It was unknown if the reporter considered the syncope and urinary incontinence to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practical nurse. The age at vaccination was not reported. The nurse told GlaxoSmithKline employee that one of their patients received BEXSERO and experienced an episode of syncope and urinary incontinence during the syncope episode. The patient did not fall nor had any head injuries. The patient lied down with her feet up and recovered and went home.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Inflammation, Scratch
Clinical narrative: Patient got a PNEUMOVAX 23 immunization on 4/19/17 has inflammation and heat in elbow on the same arm. It looks like it could be the result of the vaccine or the scratch on her arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Received the shingles vaccine on Thursday 4/20/2017 about 4:30 pm. On Friday evening 7:30 pm I was itching at the injection site. I looked in the mirror, and there is a 2 inch ling, 1 inch wide red raised rash. There is also a small 1/2 inch circle rash along side the larger rash. They are both itchy hot areas.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Blood test
Clinical narrative: My daughter received a GARDASIL 9 vaccine on September 12, 2016 and has not had her period since that time. She was 15 at the time the vaccine was administered and had been having regular menses since she began at the age of 11.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: My son had his 4-year-old vaccines and within 2 days, his arm swelled, was red, tender, hot to touch and hard around the injection site. He also had a fever for 2 days. The dr confirmed his reaction was related to the PRO-QUAD (MMRV) vaccine.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: My son had his 4-year-old vaccines and within 2 days, his arm swelled, was red, tender, hot to touch and hard around the injection site. He also had a fever for 2 days. The dr confirmed his reaction was related to the PRO-QUAD (MMRV) vaccine.
Age: 35.0
Sex: U
Vaccine: TDAP
Symptoms: Pruritus, Rash, Tongue ulceration
Clinical narrative: I took TDAP (Tetanus vaccine) from doctor and severe rash, itching, ulcers happened on my tongue. It has been persisted since I have taken this vaccine. And, I told the doctor's nurse and they said the expiry of this vaccine is in 2019 and cannot cause side effects.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Bone densitometry, Scan brain
Clinical narrative: Diagnosed with prolonged amenorrhea. Has had one period on her own.  Patient is 22 yrs old.
Age: 2.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Approximately 1.5cm. Red, Heat and tender to the touch.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blindness unilateral, Blood test, Multiple sclerosis, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Blindness Right Eye, Diagnosis of Multiple Sclerosis, IV Steroids, and oral steroids. Use of Rebif and now Capaxon.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Bone densitometry, Scan
Clinical narrative: Diagnosed with prolonged amenorrhea. Has had only one period on her own. She is 22 yrs old and now seeing fertility doctor.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Left arm swelling, redness, warmth from elbow to shoulder.  Mild lethargy.
Age: 1.33
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Pt developed 2 swollen lymph nodes in right inguinal area, 1 cm and 1.5 cm in size.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13
Symptoms: Extra dose administered
Clinical narrative: ADVISED PARENT OF DOUBLE ANTIGEN GIVEN. PARENT STATED COULD NOT COME IN FOR OFFICE VISIT UNTIL 2/15/17.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Swelling
Clinical narrative: Fatigue, swelling,
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Anal fissure, Anal incontinence, Anal pruritus, Diarrhoea, Irritable bowel syndrome
Clinical narrative: Diarrhea, uncontrollable with medication.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Swelling
Clinical narrative: Fatigue, swelling, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Burning sensation, Crying, Pruritus, Rash generalised, Vomiting
Clinical narrative: After leaving office, pt. started crying with feet burning and itching. Proceeded to break out in rash all over with severe itching, vomited x 2.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swollen, painful.
Age: 12.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Hypotonia, Syncope
Clinical narrative: 12 YO MALE BECAME LIMP AND FAINTED AFTER VACCINE. PER MOM PATIENT HAS NOT HAD BREAKFAST OR LUNCH, NO SEIZURE ACTIVITY REPORTED. 12 YO W VASOVAGAL SYNCOPE. PT OBSERVED FOR 20 MINS, ER WARNINGS GIVEN.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Rash
Clinical narrative: Pt reports sunburn last week during trip. But this redness, rash initially around neck, clavicle area. Burning, itching, has spread down to chest and now rib cage symetrically. yesterday, became blistered after working outdoors in the afternoon.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Sunburn
Clinical narrative: Pt reports sunburn last week during trip. But this redness, rash initially around neck, clavicle area. Burning, itching, has spread down to chest and now rib cage symetrically. yesterday, became blistered after working outdoors in the afternoon.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Skin discolouration
Clinical narrative: DOLLAR SIZE REDNESS/ITCHINESS AFTER 12 HOURS FROM SHINGLES VACCINE GIVEN SUBCUT LT ARM SITE BECAME INCREASINGLY RED, ENLARGING, HARDENED SKIN + ITCHINESS AT SITE MEASURED 5X4CM INDURATION, 11 1/2 X 7 1/2 CM PINK DISCOLORATION OF SKIN, ITCHINESS, NO SOB.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle rigidity, Pyrexia, Respiratory arrest, Unresponsive to stimuli, Vomiting
Clinical narrative: My child vomited, became unresponsive, rigid and stopped breathing after a few minutes became conscious again and was rushed to the ER where she was found to have a high temperature 103.7 degrees F.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site nodule
Clinical narrative: History of left thigh nodule after vaccines. Non-tender, should self-resolve Rx: supportive care.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In 2013, the patient was vaccinated with the first and the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient now would like to receive a third dose of RECOMBIVAX HB. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the infectious disease division director at the Health Department and other unspecified reporters, referring to a 2 year old unspecified children of unknown gender (reported as "only 42 percent of 2-year old children"). This information had been collected in the article. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with the first dose of M-M-R II (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the latest estimates showed that only 42 percent of 2-year old children had received their first M-M-R II shot (on unknown dates), which most health experts recommend at age 1 year old. Also reported that the second shot was administered when a child enters kindergarten, and produces highly effective immunity. However, on the statewide the vaccination rate was 88.5 percent.  The reporter stated that "whenever you had an outbreak in unvaccinated kids, measles just had a field day." Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose was not reported) (lot number: M041212; expiration date: 21-JUN-2019) administered intramuscularly, for prophylaxis. According to the reporter, when she was administering the dose using a pre-filled syringe, most of GARDASIL 9 dose leaked out from the base of the needle, where it attached to the lower portion of the pre-filled syringe. The reporter believed that the patient received very little amount of GARDASIL 9 (accidental underdose). No adverse effects were reported. A product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 25-OCT-2013, the patient received an expired dose of PNEUMOVAX lot number 0217AE, expiration date 22-AUG-2013 (dose, and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX lot number M035687, expiration date 10-AUG-2018 (dose and route were not reported) for prophylaxis, reconstituted with properly stored of sterile diluent (STERILE DILUENT) (dose, route, lot number and expiration date were not reported). The temperatures involved were from 6°F to 14°F for 15 minutes; from 15°F to 46°F  for 9 hours. It was not previous temperature excursion, and a data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase MB increased, Blood creatinine increased
Clinical narrative: Pain in legs/upper extremities, Rhabdomyolysis, acute kidney injury.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urea increased, Pain in extremity, Rhabdomyolysis
Clinical narrative: Pain in legs/upper extremities, Rhabdomyolysis, acute kidney injury.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: ZOSTAVAX shot admin. 4/23, 3 days later pt. still had redness, swelling in area of admin., pt states day 4, diagnosis with cellulitis, receiving abx.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: Patient called the pharmacy to report she was having a lot of itching after receiving the BOOSTRIX on Tuesday April 25. She said she had no rash or any redness, or swelling, just itching all over. Reported that 04/26 it was pretty severe itching, and on 04/27 when I talked to her it was not as bad (yet).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Per patient grandmother round red circle on later right thigh.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Nurse (myself) grabbed combination vaccine PENTACEL instead of PEDIARIX.  Also administered PEDVAX (Hib vaccine), so child received a double dose of Hib.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Insomnia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Called patient left detailed message. Please call patient and tell him that he can take 25mg Benadryl and that should help if its an allergic reaction.  Tell them to avoid heat and that ice may be better to reduce inflammation. Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Noted. Treated with Keflex for suspected soft tissue infection at PNEUMOVAX injection site.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Called patient left detailed message. Please call patient and tell him that he can take 25mg Benadryl and that should help if its an allergic reaction.  Tell them to avoid heat and that ice may be better to reduce inflammation. Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Noted. Treated with Keflex for suspected soft tissue infection at PNEUMOVAX injection site.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Soft tissue infection
Clinical narrative: Patient in clinic today with concerns for redness pain and swelling at area of PNEUMOVAX injection yesterday. Concerns for superficial skin and soft tissue infection. Prescribing doxycycline monohydrate 100 mg by mouth twice a day for 5 days. TYLENOL for pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling around the injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vaccination error
Clinical narrative: Patient received on Dilute of ROTARIX.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Acupuncture, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient says her arm was red/swollen and painful the day after receiving 2 vaccines in her left arm. Says pain never really went away but has worsened over the last few months. Says she has received acupuncture treatments.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: LARGE RED AREA ABOUT 4 X 6 INCH AROUND THE INJECTION SITE. SHE DID STATE THAT SHE HAD A SLIGHT FEVER YESTERDAY AS WELL.
Age: 0.25
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Acute respiratory failure, Blood gases, Chest X-ray, Endotracheal intubation, Hypothermia
Clinical narrative: Congestion and lethargy one day post vaccine administration. ER evaluation-hypothermia, acute respiratory failure. Required intubation from 4/5/17-4/15/17 secondary viral pneumonia.
Age: 0.25
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lethargy, Pneumonia viral, Respiratory tract congestion, Respiratory viral panel
Clinical narrative: Congestion and lethargy one day post vaccine administration. ER evaluation-hypothermia, acute respiratory failure. Required intubation from 4/5/17-4/15/17 secondary viral pneumonia.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Pt waited 15 min pt had a 7x5 cm erythema blotchy, decreased to 3.5x 3.5 cm, 5ml of BENADRYL given and ice applied pt. waited 15 min pt had a 7x5 cm erythema blotchy, decreased to 3.5x 3.5 cm on left thigh, 5ml of BENADRYL given and ice applied.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and heat at injection site.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site rash
Clinical narrative: Pt has rash and soreness on injection after 1 week of injection.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis, Herpes zoster, Pain in jaw
Clinical narrative: Pt given (L) arm GARDASIL shot Developed severe Jaw pain, shingles then Bell's Palsy.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Loss of personal independence in daily activities, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Very painful arm, back and neck (unable to work). Fever.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 2.5cm x 3cm raise, circular induration on (R) deltoid. Red and purple in color. Antibiotics Rx per provider, home care instructions given: warm soaks 3 times per day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt. waited 10-15 min no reaction.VIS was given. Pt. had a welt 2 2/4 on left deltoid that began 4-27-17.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Nausea, Pallor, Presyncope, Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-505298). This spontaneous refers to a 11 year old male patient. The patient had no medical history, concurrent conditions and concomitant medications. On 02-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L007560, (unspecified dosage regimen) intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA given on the same day, with unspecified dosage regimen, intramuscularly in the right arm. 5 minutes after immunizations administered patient became pale and nauseous, eyes closed with jerking motion of arm, ringing in ears. Per MD "near syncope and brief episode of jerking". "Mom observed pallor. Patient always awake". Observed- symptoms improved. The patient recovered from the events and discharged with no appreciable disease at 17:30. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HPV9, IPV, TD, VARCEL
Symptoms: Dizziness, 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 # 591874) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 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 28-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L000610, dose 2, intramuscularly in the right arm for prophylaxis. Other suspect therapies included VARIVAX (vaccination date: 28-SEP-2015, subcutaneously in the left arm, dose, frequency and lot expiration date were not reported) lot # L019125, IPOL (vaccination date: 28-SEP-2015, intramuscularly in the right arm, dose, frequency and lot expiration date were not reported) lot# L1001, TENIVAC (vaccination date: 28-SEP-2015, intramuscularly in the left arm, dose, frequency and lot expiration date were not reported) lot# U4852AA, ENGERIX-B (vaccination date: 28-SEP-2015, intramuscularly in the left arm, dose, frequency and lot expiration date were not reported) lot# A94X7 and FLUARIX (vaccination date: 28-SEP-2015, intramuscularly in the right arm, dose, frequency and lot expiration date were not reported) lot# 9525T. On 28-SEP-2015, the patient experienced dizziness and tremor. Patient was on exam table and complained of dizziness. Patient remained responsive, had no injuries or fall observed. Patient was applied with ice pack. Patient said he did not eat needles or was afraid of needles. Vital signs at 10:50 showed 99 F, 60, 16, 134/76. No pain was observed. Patient was pink, not diaphoretic, but shaking. BP (blood pressure) was 140/90 at 11 AM. Patient had warm water at 11:05 AM. Vital signs at 11:15 AM 140/80, 60,18, temperature 98.6, and patient still complained of shaking. Emergency unit (911) was called and patient was directed to go to ER (emergency room). Patient stated that he began feeling better and denied of having dizziness and shakiness while leaving the clinic, ambulatory without difficulties. On 28-SEP-2015, the patient experienced dizziness and tremor. The outcome of dizziness and tremor 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: Injection site nodule
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 # 595782). This spontaneous report refers to a 12 year old male patient. Patient's concurrent illnesses included keratosis pilaris. Information on patient's medical history and other medications were not reported. On 26-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L004014, dose 1, intramuscularly in the left arm for prophylaxis. On 31-AUG-2015, 5 days after vaccination, grape-sized deep nodule formed at the injection site. The outcome of the event injection site nodule was unknown. The causality assessment of the event injection site nodule 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: Body temperature increased, Hyperhidrosis
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 # 595864). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses and medical history was reported as none. On 14-SEP-2015 the patient was vaccinated with GARDASIL 9 lot# L004014, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5068AA, dose 1, intramuscularly in the left arm. On 15-SEP-2015, the patient experienced body temperature increased and hyperhidrosis. Patient started bad at school, when she came home she had gotten in bed. Temperature was 101. Later that night 103. Given Tylenol. At 2 AM temperature was 102. This morning she was soaked, but fever has not returned. The outcome of body temperature increased and hyperhidrosis 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: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Pruritus, Rash, Rash erythematous, Throat irritation
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 # 596129) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications included Trazadone, Wellbutrin, Lamictal, Lantus novalog and levothyroxine. On 16-SEP-2015, the patient was vaccinated with GARDASIL 9 (lot/batch# K023432) (dose, frequency and lot expiration date were not reported) dose 2, intramuscularly in the left arm for prophylaxis. On 18-SEP-2015, the patient experienced hypersensitivity, vaccination complication, throat irritation and pruritus which required ER (emergency room) visit. When patient woke up at 5 AM, he noticed red rash covering the abdomen and upper legs, extreme itchiness, and complained of itchy throat but denied respiratory difficulty. Patient went to medical facility and was advised of allergic reaction to vaccination recently received, no other new allergens in patient's environment were reported. Patient took ibuprofen, Benadryl, and prednisone and was advised to return to health care provider if conditions worsened. The outcome of hypersensitivity hypersensitivity, vaccination complication, throat irritation and pruritus was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Vaccination complication
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 # 596129) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications included Trazadone, Wellbutrin, Lamictal, Lantus novalog and levothyroxine. On 16-SEP-2015, the patient was vaccinated with GARDASIL 9 (lot/batch# K023432) (dose, frequency and lot expiration date were not reported) dose 2, intramuscularly in the left arm for prophylaxis. On 18-SEP-2015, the patient experienced hypersensitivity, vaccination complication, throat irritation and pruritus which required ER (emergency room) visit. When patient woke up at 5 AM, he noticed red rash covering the abdomen and upper legs, extreme itchiness, and complained of itchy throat but denied respiratory difficulty. Patient went to medical facility and was advised of allergic reaction to vaccination recently received, no other new allergens in patient's environment were reported. Patient took ibuprofen, Benadryl, and prednisone and was advised to return to health care provider if conditions worsened. The outcome of hypersensitivity hypersensitivity, vaccination complication, throat irritation and pruritus was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Malaise, Nausea, Oropharyngeal 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 # 596144) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 02-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L014415, dose 1, via unknown route in the left arm for prophylaxis. The patient received the vaccine approximately at 10 am at school based health center without any incident. After finishing school, the patient played volleyball that afternoon. Patient's mother reported that the patient came home tired and was not feeling well. Patient attended school the next day but that night had chills, nausea and vomiting. On 02-SEP-2015, the patient experienced chills, vomiting, pyrexia, pain, oropharyngeal pain, nausea, malaise and fatigue. It was also reported that on 04-SEP-2015 morning, the patient had fever of 102.4 degree Celsius along with body aches and mild sore throat. On 05-SEP-2015, the patient still had slight fever. On 06-SEP-2015, symptoms were resolved. Patient underwent treatment with TYLENOL and MOTRIN MOC, for all the reactions to the immunization. Patient denied problems with the 2 previous GARDASIL 9 vaccinations. The outcome of chills, vomiting, pyrexia, pain, oropharyngeal pain, nausea, malaise and fatigue were 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: Pain, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596144) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 02-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L014415, dose 1, via unknown route in the left arm for prophylaxis. The patient received the vaccine approximately at 10 am at school based health center without any incident. After finishing school, the patient played volleyball that afternoon. Patient's mother reported that the patient came home tired and was not feeling well. Patient attended school the next day but that night had chills, nausea and vomiting. On 02-SEP-2015, the patient experienced chills, vomiting, pyrexia, pain, oropharyngeal pain, nausea, malaise and fatigue. It was also reported that on 04-SEP-2015 morning, the patient had fever of 102.4 degree Celsius along with body aches and mild sore throat. On 05-SEP-2015, the patient still had slight fever. On 06-SEP-2015, symptoms were resolved. Patient underwent treatment with TYLENOL and MOTRIN MOC, for all the reactions to the immunization. Patient denied problems with the 2 previous GARDASIL 9 vaccinations. The outcome of chills, vomiting, pyrexia, pain, oropharyngeal pain, nausea, malaise and fatigue were 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: 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 (VAERS # 597168). This spontaneous report refers to a 14 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history included seasonal allergy. On 10-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L014198, dose 2, intramuscularly in the left arm for prophylaxis. On 10-SEP-2015, the patient experienced pain in extremity. Arm pain occurred after administration which continues to worsen 8 days out from when vaccine was given. The outcome of pain in extremity was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597196). This spontaneous report refers to a 20 year old female patient. The patient's concurrent illnesses and medical history was not reported. On 12-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L011846, dose 1, (route:unknown) in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapy included ENGERIX-B (lot # ZF2L3, dose 5, route unknown, in the left arm). On 12-SEP-2015, the patient experienced syncope (fainted). The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Head injury, 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 # 597202). This spontaneous report refers to a 27 year old male patient. The patient's concurrent illnesses, medical history and other medications were reported as none. On 11-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L016428, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapy included ADACEL (lot # U5267AA, dose 1, intramuscularly in the right arm). On the same day, the patient experienced head injury and syncope. Syncope approximately 10 minutes after vaccinations. Observed in treatment room for 1 hour. Vital signs, observed for head injury. The patient had an emergency visit. The outcome of head injury and syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Nephrotic syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597630) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 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 15-MAY-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246, dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (vaccination date: 15-MAY-2015, lot # J29203, dose, frequency and lot expiration date were not reported). On an unknown date, the patient experienced nephrotic syndrome. Nephrotic syndrome was diagnosed approximately on 11-JUN-2015 for the symptoms. The outcome of nephrotic syndrome was reported as not recovered/not 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: F
Vaccine: HPV9, MNQ
Symptoms: Suture insertion, 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 # 597942) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 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 23-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L000610, dose 1 (dose, frequency and lot expiration date were not reported) via unknown route in the right arm for prophylaxis. Other suspect therapies included MENACTRA (vaccination date: 23-SEP-2015, lot # U5068AA, route of administration, dose, frequency and lot expiration date were not reported) in the left arm. The patient had syncope and also had three sutures in right chin. Vital signs were within normal limits. On 23-SEP-2015, the patient underwent suture insertion and experienced syncope which required ER (emergency room) visit. The outcome of suture insertion and syncope 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: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, 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 # 601143). This spontaneous report refers to a 15 year old female patient. Patient had no concurrent illnesses and other medications. Information on patient's medical history was not reported. On 14-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, route: unknown in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VARIVAX lot # L011085, dose 2, route: unknown in the left arm; MENVEO lot # A15008, dose 1, route: unknown in the left arm; ADACEL lot # U5095AA, dose 1, route: unknown in the right arm and HAVRIX lot # X22P4, dose 1, route: unknown in the right arm for prophylaxis. On 17-SEP-2015, child complained of localized pain, swelling and redness at the site of VARIVAX injection. Patient's parents gave her benadryl (oral) for several days and had no relief. On 23-SEP-2015, child had increased swelling and warmth and parent instructed to see the physician. Child was instructed to apply topical hydrocortisone to the area and to return if any streaking was noticed. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 and VARIVAX 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
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 601304). This spontaneous report refers to a 12 year old male patient. Patient had no concurrent illnesses, lab data and medical history. Patient's other medication included melatonin. On 22-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L019287, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # M15023, dose 1, intramuscularly in the left arm. In the evening of 22-SEP-2015 (also reported as 24-SEP-2015), patient had redness and his skin was warm to touch. Patient visited the clinic on 25-SEP-2015 with 10cm x 13cm area of warm, erythema, and mildly tender. Patient was treated with KEFLEX 500 mg q12hrs x 10 days. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blister, Erythema, 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 # 601678). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses was reported as none. The patient's medical history included asthma. On 28-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L006547, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapy included MENVEO (lot # M14135, dose 1, intramuscularly in the right arm). On 29-SEP-2015, the patient experienced blister, swelling and erythema. The patient had an emergency visit. The outcome of blister, swelling and erythema was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 602453). This spontaneous report refers to a 16 year old female patient. The patient's concurrent illnesses and medical history was reported as none. On 30-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, (route: unknown) in the left arm for prophylaxis. Approximately 5 mins after vaccine administered, patient complaints of pounding headache, followed by lightheadedness, dizziness, and ringing in ears. Advised patient to remain sitting until she felt she could ambulate. After 15 minutes with patient, she was assisted to private vehicle. Advised mother to take patient to emergency room ASAP or Primary Medical Doctor. The outcome of dizziness, tinnitus and headache 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: FLU3, HPV9
Symptoms: Limb mass
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 # 602620). This spontaneous report refers to a 22 year old female patient. The patient's concurrent illnesses was not reported. The patient had no known drug allergies (NKDA). On 05-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with FLUVIRIN lot # 157003, intramuscularly in the right arm. Patient called on 12-OCT-2015 states she received GARDA51L 9 one week ago and complaints of quarter size lump on left arm (limb mass). The outcome of limb mass 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: HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 602814). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses, medical history and other medications were reported as none. On 15-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included VAQTA (lot # L023936, dose 1, intramuscularly in the left arm) and MENACTRA (lot # U5179AA, dose 1, intramuscularly in the right arm). On the same day of vaccination, the patient experienced syncope episodes. The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, 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 # 604502). This spontaneous report refers to a 14 year old male patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 08-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L016429, dose 1, intramuscular in the left arm for prophylaxis. Patient stated that he was feeling dizzy, nauseous and clammy immediately after the injection, 15 minutes after the injection patient was taken back to the examination room and observed for another 15 minutes. Patient's vitals were all good and he was evaluated by the doctor before being discharged. 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: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain, Chest X-ray, Injection site cyst
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 # 604759). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses and other medications was reported as none. On 26-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L011846, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5068AA, dose 2, intramuscularly in the right arm. The patient had abdominal pain on the date of service. Patient referred to general surgeon and was sent to radiology to get an x-ray of the rib cage left side for abdominal pain. On 26-OCT-2015, the patient experienced abdominal pain, dermal (sebaceous) cyst on left upper arm and underwent chest x-ray. The outcome of abdominal pain, dermal cyst and chest x-ray was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.