chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Crying, Face injury, Fall, Grunting, Loss of consciousness
Clinical narrative: 11:25 AM pt. received MENACTRA and BEXSERO, then PPD was placed at 11:30. Child walked to seats about 10 steps sat down and fell flat on her face, had seizure like symptom, was rigid all extrem. - making grunting like noise - lasted about 3 min - she woke up and started crying. Provider in attendance. O2 - 98% - HR 115 FS 122.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Muscle rigidity, Seizure like phenomena
Clinical narrative: 11:25 AM pt. received MENACTRA and BEXSERO, then PPD was placed at 11:30. Child walked to seats about 10 steps sat down and fell flat on her face, had seizure like symptom, was rigid all extrem. - making grunting like noise - lasted about 3 min - she woke up and started crying. Provider in attendance. O2 - 98% - HR 115 FS 122.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on arm, chest, neck, face.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Localized macular rash left upper arm, at site of injection of MMR given on 4/5/17. Complaint of tenderness and itching at site of rash. Advised to take TYLENOL or ibuprofen OTC for pain and BENADRYL for itching. Patient state will take TYLENOL P.M. Give cold pack to apply to rash.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, PNC13
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Pyrexia, Rhinorrhoea
Clinical narrative: Pt called with C/O joint aching, runny nose, fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Reaction to ZOSTAVAX - at injection site - red, raised silver dollar sized. Not sore, but itching.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure
Clinical narrative: Patient (my son) had a tonic-clonic seizure 2 days after shots. No fever, no other symptoms. Seizure lasted close to 1 min; slept 4 hours afterwards. 2 seizures 3-23-17. 1 seizure 4-13-17.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Redness and soreness on the arm -rash
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. mother came to clinic on 4/12/17 stating Pt. had a reaction to vaccines given on right thigh, on the second day of vaccination. Pt. right thigh had 6 x 5.5 cm erythema, warmth, and tenderness.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 4x7 by 5.0 cm erythema 5.6 x 5 cm induration. Mild warmth.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Induration, Lymph node palpable, Oedema peripheral
Clinical narrative: 4/12/2017 at approximately 3:34 PM received ADACEL IM left deltoid. That night he developed pain, redness, warmth, swelling that increased in size and redness and induration. Pain, redness, induration swelling continued to increase. He has pain with raising his left arm. Seen on 4/14/17. Mom states the pain and redness is the worst today. Also appreciated is left axillae swelling with 2 cm axillary lymph node palpable.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: 4/12/2017 at approximately 3:34 PM received ADACEL IM left deltoid. That night he developed pain, redness, warmth, swelling that increased in size and redness and induration. Pain, redness, induration swelling continued to increase. He has pain with raising his left arm. Seen on 4/14/17. Mom states the pain and redness is the worst today. Also appreciated is left axillae swelling with 2 cm axillary lymph node palpable.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: None known, immunization was outdated by 3 weeks, parent notified. Manufacturer advised re-immunization.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Rash
Clinical narrative: Angioedema and skin rash.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Patient received PEDIARIX on the right thigh, PEDVAXHIB and PREVENAR on the left thigh. After about 5 minutes of vaccine administration, the whole right leg turned cherry red and also few red blotches developed on the left leg. No further redness/rashes observed in any other parts of the body, no difficulty breathing or shortness of breath as well, child was under observation for about an hour and the redness on both legs disappeared. Mom also remembered and stated that the last time the child received her vaccine last 1/12/2017, she also observed child developed some red blotches only on both legs that night. No fever or any other symptoms.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Extra doses, of PEDRIX Hib and Prev 13 were given mistakenly due o non entry of dates in cir.
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient has chicken pox after receiving varicella vaccine on 9/20/16.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, DTAP, FLU4
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site oedema, Vaccination site pruritus
Clinical narrative: Erythema and edema at vaccine site posterior deltoid, pruritus; appeared day following vaccination. Allergic.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, DTAP, FLU4
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Erythema and edema at vaccine site posterior deltoid, pruritus; appeared day following vaccination. Allergic.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal discomfort, Peripheral swelling, Skin warm, Swelling, Tenderness
Clinical narrative: Tender to touch under the arm vaccinated. Swollen and warm to touch. Some discomfort in muscle, but swelling happened on the inside of the upper arm.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Headache, Influenza virus test negative, Injection site erythema
Clinical narrative: Swelling and redness at injection site, fever, dizziness, fatigue, headache, body aches. Treated with ADVIL and ice pack. Worse following day.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Swelling and redness at injection site, fever, dizziness, fatigue, headache, body aches. Treated with ADVIL and ice pack. Worse following day.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dehydration, Gastroenteritis, Gastrointestinal infection, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Admitted to hospital for vomiting/AGE. Small bowel intussusception noted on ultrasound (2.7cm in length). Self resolved but required long 14 day hospital stay for vomiting/post infectious enteropathy/dehydration.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Admitted to hospital for vomiting/AGE. Small bowel intussusception noted on ultrasound (2.7cm in length). Self resolved but required long 14 day hospital stay for vomiting/post infectious enteropathy/dehydration.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site induration, Peripheral swelling
Clinical narrative: Patient states arm very red and swollen since injection. The site was hard but that has since decreased and area of redness appears larger. Patient used compresses and was going to take Benadryl in case she is having an allergic reaction.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash over upper back/shoulder rt.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Difficulty moving arm, very painful.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Started out sore, but then became difficult to move arm. Describes extreme pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Tic, Vomiting
Clinical narrative: Patient developed severe motor tics 2 hours post-vaccination, followed by a fever and vomiting. Her motor tics have yet to subside. She was completely fine prior to receiving the vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin irritation, Skin warm, Swelling, Viral test negative
Clinical narrative: Patient received vaccine 4/12/17. Over 2 days, patient developed swelling, irritation to pain greater than silver dollar size swelling w/warmth to touch and pain.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Skin on inside of arm (opposite side from ZOSTAVAX injection site) became red, swollen, warm, and painful to touch. Attempts to follow up lot pt were unsuccessful. No treatments done that we are aware of.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Injection site (right outer thigh) is swollen, red, has a huge knot in it and is hot to the touch. It is about the size of her fist, maybe 3 inches in diameter.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal
Clinical narrative: Miscarriage noted on 20 week ultrasound.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Bedridden, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, painful, red, hot site, pt bedridden x 48 hours.
Age: 34.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Peripheral swelling, Skin tightness, Urticaria
Clinical narrative: A half hour after nursing my child, who received the PCV 13 and hib vaccines, I developed hives on my left breast. They spread to my torso and extremities. I have tightness and swelling in my hands and feet. The hives and swelling dissipate during the day, but reappear before every feeding and are present throughout the night. The swelling in my hands and feet is becoming more intense as the days have passed.
Sex: F
Vaccine: 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 # 581354). This spontaneous report refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 08-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, in the right arm for prophylaxis (dosage and route unspecified). On the same day, patient was also vaccinated with MENACTRA lot/batch # U4846AA, dose 1, in the left arm for prophylaxis (dosage and route unspecified). On 08-JUN-2015, the patient experienced dizziness after vaccine administration. The outcome of dizziness was unknown. 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: F
Vaccine: HPV9
Symptoms: Asthenia, Blood test normal, Fatigue, Headache, Hypersomnia
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 # 584832). This spontaneous report refers to a 15 year old female patient. Information on the patient's concurrent illnesses and medical history were not reported. The patient's other medications included Methylphenidate 36 mg. On 19-JUN-2015, the patient was vaccinated with GARDASIL 9 dose 1 in the left arm for prophylaxis (dosage, route and lot# unspecified). On 19-JUN-2015, the patient experienced asthenia, pyrexia, malaise, hypersomnia, headache, fatigue and the patient's urine analysis and blood test were normal. The patient had headache and was feeling unwell the first 24 hours, followed by very high fever that lasted for 2 weeks. The patient had to use Tylenol and Motrin together to keep the fever down, which never reached below 100. The patient had visited pediatrician 3 times during the two week period, having blood drawn twice and urine tested. Nothing abnormal was found. At the pediatrician's office, the patient's temperature was high and an Emergency Room (ER) visit was recommended. The patient went to the ER and temperature was 105.6 when the patient was admitted. The patient had her blood drawn and urine tested again. Nothing abnormal was found for any of the tests. While in the ER the patient was given IV fluids before being sent home. The patient was tired and she couldn't keep her eyes open, the patient slept for all but 3 hours during a 24 hour period. This lasted for 3 days. After 14 days, the patient's fever finally broke but the patient continued to have a hard time staying awake and was extremely weak for another 3 days. The outcome of all the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pyrexia, Urine analysis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 584832). This spontaneous report refers to a 15 year old female patient. Information on the patient's concurrent illnesses and medical history were not reported. The patient's other medications included Methylphenidate 36 mg. On 19-JUN-2015, the patient was vaccinated with GARDASIL 9 dose 1 in the left arm for prophylaxis (dosage, route and lot# unspecified). On 19-JUN-2015, the patient experienced asthenia, pyrexia, malaise, hypersomnia, headache, fatigue and the patient's urine analysis and blood test were normal. The patient had headache and was feeling unwell the first 24 hours, followed by very high fever that lasted for 2 weeks. The patient had to use Tylenol and Motrin together to keep the fever down, which never reached below 100. The patient had visited pediatrician 3 times during the two week period, having blood drawn twice and urine tested. Nothing abnormal was found. At the pediatrician's office, the patient's temperature was high and an Emergency Room (ER) visit was recommended. The patient went to the ER and temperature was 105.6 when the patient was admitted. The patient had her blood drawn and urine tested again. Nothing abnormal was found for any of the tests. While in the ER the patient was given IV fluids before being sent home. The patient was tired and she couldn't keep her eyes open, the patient slept for all but 3 hours during a 24 hour period. This lasted for 3 days. After 14 days, the patient's fever finally broke but the patient continued to have a hard time staying awake and was extremely weak for another 3 days. The outcome of all the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: DTAPIPV, HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586265) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's medical history included allergic to milk and penicillin (PCN). The patient's concurrent illnesses was reported as none and prior vaccinations were not reported. On 15-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, (dose number, dose, frequency, lot expiration date unknown) intramuscularly in the left arm for prophylaxis. Other suspect therapies included KINRIX (vaccinated date: 15-JUL-2015, lot # DR294, intramuscularly in the left arm, dose number, dose, frequency, lot expiration date unknown), MENVEO (vaccinated date: 15-JUL-2015, lot # A14055, intramuscularly in the left arm, dose number, dose, frequency, lot expiration date unknown) and HAVRIX (vaccinated date: 15-JUL-2015, lot # X22P4, intramuscularly in the left arm, dose number, dose, frequency, lot expiration date unknown) for prophylaxis. On 17-JUL-2015, the patient's mother reported injection site erythema, vaccination site warmth, vaccination site swelling and vaccination site pain on the left upper arm where the vaccines were administered. The outcome of injection site erythema, vaccination site warmth, vaccination site swelling and vaccination site pain were unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
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 # 586660). This spontaneous report refers to a 11 year old male patient. The patient's medical history included allergies. The patient had no concurrent illnesses. Information on the patient's prior vaccinations were not reported. The patient's other medications included singulair, zyrtec and nasonex. On 20-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, intradermal route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated MENACTRA lot/batch# U5068AA, dose 1 via intramuscular route in the right arm and BOOSTRIX lot/batch# D9X9Z, dose 1 via intramuscular route in the right arm for prophylaxis (dosage unspecified). On 21-JUL-2015, the patient experienced injection site erythema. The redness at the injection site (left arm) was noted by the patient's parent after the patient got out of the shower. The outcome of injection site erythema was unknown. The causality assessment for the event injection site erythema 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: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Chills, Decreased appetite, Fatigue, 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 # 589825) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old male patient. The patient's concurrent illnesses and pertinent medical history were reported as none. Other medications included vitamins. On 06-AUG-2015, at approximately 11 AM the patient was vaccinated with GARDASIL 9 dose number 3, lot # K026247, (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included HAVRIX, vaccinated approximately at 11 AM, (dose number 2, vaccinated date: 06-AUG-2015, left arm, lot# 3RB2G, dose and expiration date unknown). On the same day, at 04:30 PM the patient's mother reported with concerns of chills, fatigue, decreased appetite and patient also had severe vomiting for several hours and went to Emergency room. The outcome of chills, vomiting, fatigue and decreased appetite were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Axillary pain, Oedema peripheral, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590793) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient with prophylaxis. The patient's current illness, medical history and prior vaccination was not reported. The patient's other medications included loratadine 10 mg capsule, VYVANSE 60 mg capsule, dextroamphetamine sulfate 5 mg tablet and guanfacine 1 mg tablet. On 17-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX (dose number: 2, vaccinated date: 17-AUG-2015, intramuscularly in the right arm, lot # 9CJ5Y; dose and expiration date unknown). On 18-AUG-2015, the patient experienced axillary pain, peripheral swelling, and pain in extremity and oedema peripheral. The patient had pain and swelling of axilla and entire arm (same side as vaccination). The outcome of axillary pain, peripheral swelling, pain in extremity and oedema peripheral was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Vaccination site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590793) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient with prophylaxis. The patient's current illness, medical history and prior vaccination was not reported. The patient's other medications included loratadine 10 mg capsule, VYVANSE 60 mg capsule, dextroamphetamine sulfate 5 mg tablet and guanfacine 1 mg tablet. On 17-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX (dose number: 2, vaccinated date: 17-AUG-2015, intramuscularly in the right arm, lot # 9CJ5Y; dose and expiration date unknown). On 18-AUG-2015, the patient experienced axillary pain, peripheral swelling, and pain in extremity and oedema peripheral. The patient had pain and swelling of axilla and entire arm (same side as vaccination). The outcome of axillary pain, peripheral swelling, pain in extremity and oedema peripheral was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590836) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 10-AUG-2015, the patient was vaccinated with GARDASIL 9, lot # L001312, (dose number, dose, frequency, lot expiration date unknown) intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 10-AUG-2015, lot # XE2DJ, intramuscularly in the right arm, dose number, dose, lot expiration date unknown) and MENACTRA (vaccinated date: 10-AUG-2015, lot # U5026AA, intramuscularly in the right arm, dose number, dose, lot expiration date unknown). On 12-AUG-2015, the patient's right arm (upper deltoid area) was swollen (injection site swelling) and hard (injection site induration), also developed redness (injection site erythema) and hot to touch (injection site warmth) and diagnosed with local reaction. The patient was taken to Emergency room. On 14-AUG-2015, the symptoms subsided. The outcome of injection site erythema, local reaction, injection site warmth, injection site swelling and injection site induration was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Erythema, Injection site pain, Pain in extremity, 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 # 590913). This spontaneous report refers to a 14 year old female patient. The patient's concurrent illnesses was reported as none and medical history was not reported. On 13-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L011846, dose 1, intramuscularly in the left arm for prophylaxis. At 4:00 am on 14-AUG-2015, patient was awaken with pain at site of injection, no redness, no swelling and bilateral hands burning and itching. On 14-AUG-2015, the patient experienced erythema, pruritus, pain in extremity, injection site pain and burning sensation. Patient was seen in clinic at 9:00 AM and had an emergency room visit. Bilateral hands still burn and itch-red pain side 6/10 treated with BENADRYL and prednisone. Symptoms worse. Instructed to return to clinic if not resolving. Other medications includes DEPO-PROVERA and ADDERALL. The outcome of erythema, pruritus, pain in extremity, injection site pain and burning sensation 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: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 592206). This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history included seasonal allergies. On 14-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, intramuscularly in the left arm for prophylaxis. On 21-AUG-2015, the patient experienced injection site erythema, injection site pain and injection site nodule. One week after GARDASIL 9 was administered patient was still c/o pain, redness and knot to injection site. Other medications included AUGMENTIN. The outcome of injection site erythema, injection site pain and injection site nodule were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595330) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 12 year old female patient with prophylaxis. The patient's current illnesses, medical history, other medications and prior vaccinations were not reported. On 26-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L007560 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: not reported, vaccinated date: 26-AUG-2015, intramuscularly in the left arm, lot # C4775AA; dose and expiration date unknown). On 27-AUG-2015, the patient experienced welts/rash that itched and broke out on patient's skin, beginning on both arms and progressing to rest of body (generalized rah, urticarial and pruritic rash). On an unknown date, the patient underwent emergency room (ER) visit. The outcome of rash generalised, urticaria and rash pruritic 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: HEPA, HPV9, MNQ, TDAP
Symptoms: Syncope, Tonic clonic movements
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 # 595449) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's medical history included anxiety. The patient had no current illnesses, other medication and prior vaccinations. On 03-SEP-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 03-SEP-2015, intramuscularly in the left arm, lot # 43MP2; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 03-SEP-2015, intramuscularly in the right arm, lot# U5058AC; dose and expiration date unknown), HAVRIX (dose number: 1, vaccinated date: 03-SEP-2015, intramuscularly in the right arm, lot # 9CJ5Y; dose and expiration date unknown).  On 03-SEP-2015, the patient was fainted (syncope) with tonic-clonic activity of extremities, lasted for less than 10 seconds. The patient recovered after he laid down and rested for 20-30 minutes. The outcome of the events syncope and tonic-clonic movements were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Antinuclear antibody positive, Arthralgia, Borrelia test negative, C-reactive protein increased, Full blood count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595604) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient with prophylaxis. The patient's medical history included allergic to amoxicillin. The patient's current illnesses included ankle Achilles tendonitis. The patient's other medications and prior vaccinations was not reported. On 31-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO (dose number: 1, vaccinated date: 31-AUG-2015, intramuscularly in the right arm, lot # A14120; dose and expiration date unknown). On 31-AUG-2015, several hours after vaccine administration the patient developed rash on feet and swelling of feet with mild ankle pain, patient's red blood cell sedimentation rate was normal, rheumatoid factor was negative, full blood count was normal, C-reactive protein was normal, Borrelia test was negative, antinuclear antibody was positive and laboratory test was normal. The outcome of antinuclear antibody positive, arthralgia, rheumatoid factor negative, red blood cell sedimentation rate normal, rash, peripheral swelling, laboratory test normal, full blood count normal, c-reactive protein normal and Borrelia test negative was reported as recovered. Lab data: Lyme: negative (-), complete blood count/chemistry screen: normal, erythrocyte sedimentation rate (ESR): 13, C-reactive protein (CRP): 1.8, rheumatoid factor negative (RF): negative (-) and antinuclear antibody (ANA): positive (+). Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Laboratory test normal, Peripheral swelling, Rash, Red blood cell sedimentation rate increased, Rheumatoid factor 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 # 595604) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient with prophylaxis. The patient's medical history included allergic to amoxicillin. The patient's current illnesses included ankle Achilles tendonitis. The patient's other medications and prior vaccinations was not reported. On 31-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO (dose number: 1, vaccinated date: 31-AUG-2015, intramuscularly in the right arm, lot # A14120; dose and expiration date unknown). On 31-AUG-2015, several hours after vaccine administration the patient developed rash on feet and swelling of feet with mild ankle pain, patient's red blood cell sedimentation rate was normal, rheumatoid factor was negative, full blood count was normal, C-reactive protein was normal, Borrelia test was negative, antinuclear antibody was positive and laboratory test was normal. The outcome of antinuclear antibody positive, arthralgia, rheumatoid factor negative, red blood cell sedimentation rate normal, rash, peripheral swelling, laboratory test normal, full blood count normal, c-reactive protein normal and Borrelia test negative was reported as recovered. Lab data: Lyme: negative (-), complete blood count/chemistry screen: normal, erythrocyte sedimentation rate (ESR): 13, C-reactive protein (CRP): 1.8, rheumatoid factor negative (RF): negative (-) and antinuclear antibody (ANA): positive (+). Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
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 # 596579) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's medical history included bradycardia. The patient had no current illnesses and other medications. On 21-SEP-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L027282 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 21-SEP-2015, intramuscularly in the right arm, lot # U5247AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 21-SEP-2015, intramuscularly in the right arm, lot# U5187AA; dose and expiration date unknown). After administration of 1st vaccine GARDASIL 9 patient stated that he felt lightheaded on the same day. He was then laid down and the rest of the vaccines were given. After 10 minutes the patient's (Blood pressure) B/P was 110/60 and felt ok to leave after the full 15 minutes of waiting. Juice and Granola bar were given prior to vaccines being given. The outcome of dizziness was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising
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 # 600737). This spontaneous report refers to a 14 year old female patient. Patient had no concurrent illnesses and medical history. Information on other medications was unknown. On 08-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L00610, dose 3, intramuscular in the left arm for prophylaxis. Patient had no side effects from the vaccination initially. On 05-OCT-2015 (approximately two weeks after vaccine was administered), patient complained of a bruised feeling at site. No discoloration of skin, swelling or lump noted at the site. The outcome of injection site bruising was reported as recovered. The causality assessment for the event injection site bruising 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: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Crying, Dizziness, Fear
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 # 600862). This spontaneous report refers to a 12 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 22-SEP-2015 at 12:00 after eating lunch, the patient was vaccinated with GARDASIL 9 (lot # L007560, dose 1, intramuscularly, site: unknown); VARIVAX (lot # L001084, dose 2, subcutaneously, site: unknown); HAVRIX (lot # 77D7L, dose 2, intramuscularly, site: unknown); MENVEO (lot # M15008, dose 1, intramuscularly, site: unknown); BOOSTRIX lot # T4N79, dose 1, intramuscularly, site: unknown for prophylaxis. Immediately after receiving immunizations, the patient complained of dizziness and nausea. Patient's feet was elevated and a ice pack was applied to the back of his neck. Patient started feeling sleepy with sinking episodes and he was placed in a supine trendelenburg position. At 12:25, vitals: 124/76, pulse: 85, temperature: 98.1, respiratory rate: 16. Patient was alert, orientated to name, place and time. Patient's skin was dry and warm to touch. Respiration was even and unlabored. Denies shortness of breath (SOB), chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints like everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eye. Patient was not recovering after 30 minutes and had symptoms of anxiety/panic attack, doctor was notified and agreed to call "911". Patient's mother agreed with the plan of care. At 12:30, blood pressure (BP): 150/107, heart rate (HR) 82, Respiratory rate: 16 and Temperature: 98.0. Attempted to distract the patient with phone and he dropped the phone stating " my arms are weak". At 12:35, emergency medical services (EMS) were at the bedside of patient, transported to stretcher and sent to ER with his mother. Vitals: 114/42, heart rate (HR): 65, Respiratory rate: 16, Temperature: 98.0. Patient's symptoms remain the same but his vision was clear. Patient was alert, oriented (OX3) and stable at the time of transfer. Patient's mother was instructed by the ER to follow-up with EMS, she verbalized good understanding and agreed with the plan of care. Report was given to EMS using SBAR. The outcome of the events was unknown. 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.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Feeling abnormal, Immediate post-injection reaction, Lacrimation increased, Muscular weakness, 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 # 600862). This spontaneous report refers to a 12 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 22-SEP-2015 at 12:00 after eating lunch, the patient was vaccinated with GARDASIL 9 (lot # L007560, dose 1, intramuscularly, site: unknown); VARIVAX (lot # L001084, dose 2, subcutaneously, site: unknown); HAVRIX (lot # 77D7L, dose 2, intramuscularly, site: unknown); MENVEO (lot # M15008, dose 1, intramuscularly, site: unknown); BOOSTRIX lot # T4N79, dose 1, intramuscularly, site: unknown for prophylaxis. Immediately after receiving immunizations, the patient complained of dizziness and nausea. Patient's feet was elevated and a ice pack was applied to the back of his neck. Patient started feeling sleepy with sinking episodes and he was placed in a supine trendelenburg position. At 12:25, vitals: 124/76, pulse: 85, temperature: 98.1, respiratory rate: 16. Patient was alert, orientated to name, place and time. Patient's skin was dry and warm to touch. Respiration was even and unlabored. Denies shortness of breath (SOB), chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints like everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eye. Patient was not recovering after 30 minutes and had symptoms of anxiety/panic attack, doctor was notified and agreed to call "911". Patient's mother agreed with the plan of care. At 12:30, blood pressure (BP): 150/107, heart rate (HR) 82, Respiratory rate: 16 and Temperature: 98.0. Attempted to distract the patient with phone and he dropped the phone stating " my arms are weak". At 12:35, emergency medical services (EMS) were at the bedside of patient, transported to stretcher and sent to ER with his mother. Vitals: 114/42, heart rate (HR): 65, Respiratory rate: 16, Temperature: 98.0. Patient's symptoms remain the same but his vision was clear. Patient was alert, oriented (OX3) and stable at the time of transfer. Patient's mother was instructed by the ER to follow-up with EMS, she verbalized good understanding and agreed with the plan of care. Report was given to EMS using SBAR. The outcome of the events was unknown. 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.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Panic attack, Somnolence, Visual impairment
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 # 600862). This spontaneous report refers to a 12 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 22-SEP-2015 at 12:00 after eating lunch, the patient was vaccinated with GARDASIL 9 (lot # L007560, dose 1, intramuscularly, site: unknown); VARIVAX (lot # L001084, dose 2, subcutaneously, site: unknown); HAVRIX (lot # 77D7L, dose 2, intramuscularly, site: unknown); MENVEO (lot # M15008, dose 1, intramuscularly, site: unknown); BOOSTRIX lot # T4N79, dose 1, intramuscularly, site: unknown for prophylaxis. Immediately after receiving immunizations, the patient complained of dizziness and nausea. Patient's feet was elevated and a ice pack was applied to the back of his neck. Patient started feeling sleepy with sinking episodes and he was placed in a supine trendelenburg position. At 12:25, vitals: 124/76, pulse: 85, temperature: 98.1, respiratory rate: 16. Patient was alert, orientated to name, place and time. Patient's skin was dry and warm to touch. Respiration was even and unlabored. Denies shortness of breath (SOB), chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints like everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eye. Patient was not recovering after 30 minutes and had symptoms of anxiety/panic attack, doctor was notified and agreed to call "911". Patient's mother agreed with the plan of care. At 12:30, blood pressure (BP): 150/107, heart rate (HR) 82, Respiratory rate: 16 and Temperature: 98.0. Attempted to distract the patient with phone and he dropped the phone stating " my arms are weak". At 12:35, emergency medical services (EMS) were at the bedside of patient, transported to stretcher and sent to ER with his mother. Vitals: 114/42, heart rate (HR): 65, Respiratory rate: 16, Temperature: 98.0. Patient's symptoms remain the same but his vision was clear. Patient was alert, oriented (OX3) and stable at the time of transfer. Patient's mother was instructed by the ER to follow-up with EMS, she verbalized good understanding and agreed with the plan of care. Report was given to EMS using SBAR. The outcome of the events was unknown. 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, TDAP
Symptoms: Paraesthesia
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 # 602626) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. There patient had no concurrent illness, medical history and other medications. There was no lab data. On 14-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L014198 dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 14-OCT-2015, intramuscularly in the left arm, lot# H5299; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 14-OCT-2015, intramuscularly in the right arm, lot# U5178AA; dose and expiration date unknown) for prophylaxis. On the same day post vaccination, patient experienced paraesthesia. He felt tingly after the vaccines. The event resolved within few minutes. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 603377) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 27 year old female patient. The patient's pertinent medical history was not reported. There was no pertinent lab data. The patient had no concurrent illness and other medications included MARLISSA. On 12-OCT-2015 the patient was vaccinated with GARDASIL 9 dose number 2, (prior vaccination details, dose, frequency and lot# and expiration date were not reported) intramuscularly in the right arm for prophylaxis. On 16-OCT-2015, the patient experienced urticaria and rash pruritic. There was itchy rash/hives that first appeared on elbows/forearms. The hives continued to spread in following order: entire forearm, knees, calves, thighs, back, upper chest/neck area. Each individual hive/cluster of hives lasted approximately 24 hrs. The patient also experienced peripheral swelling with swollen fingers and toes on 2nd & 3rd day i.e. on 17-OCT-2015 and 18-OCT-2015 (onset also reported as 16-OCT-2015). The patient was treated with BENADRYL at maximum recommended dosage. The hives spread over the course of 3 days until 19-OCT-2015, most hives disappeared by that day. There were some lingering breakouts of individual hives on arms & legs. The outcome of peripheral swelling, urticaria and rash pruritic 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.