chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis
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 # 653417) on 02-MAY-2017. This spontaneous report refers to a 15 year old female patient. The patient had no concurrent illnesses. The patient's medical history included headaches and recurrent cold sores. Information on the patient's prior vaccinations was not reported. The patient's other medications included Topical Acyclovir, Valacyclovir, Loratadine, Tylenol, Ibuprofen, Necon 1/35. On 31-AUG-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M021407 (expiration date: 30-APR-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. On 31-AUG-2016 the patient developed body aches. On 01-SEP-2016, the patient had back pain (right sided) which was occasional, brief and had occurred a few times. The patient's urine had a dark appearance and this continued till 03-SEP-2016, when she was evaluated in urgent care. The patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine was observed. The patient also had metabolic function test, full blood count, complement factor C4, complement factor C3, and blood albumin. The patient's lab data included urinalysis, CBC, BMP, C-3, C-4, albumin, urinary tract ultrasound. The outcome of back pain, urine analysis, ultrasound urinary system, pain, metabolic function test, full blood count, complement factor C4, complement factor C3, chromaturia, blood urine present and blood albumin was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Blepharospasm, Chest X-ray normal, Drooling, Dysphagia, Facial paralysis
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 # 653474) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses. The patient's medical history included Hodgkin's lymphoma at 12 years of age, positive T-spot (25-JUL-2016) and negative chest x-ray (25-AUG-2016)-latent tuberculosis infection. Information on the patient's prior vaccinations and the other medications were not reported. On 10-AUG-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # M011117 (expiration date: 07-DEC-2017) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5272AB, dose 2, intramuscularly in the right arm and BEXSERO batch/lot # 157501, dose 1, intramuscularly in the right arm for prophylaxis. On 13-SEP-2016, the patient reported left sided facial numbness/paralysis/droop, diminished taste, drooling, left eye twitch and difficulty in swallowing. The patient was seen in PCP (primary care physician) office on 14-SEP-2016. The physician advised to get a CT of head and referred him to ED for evaluation. The patient visited the health department on 15-SEP-2016, symptoms remained same. The patient was alert and oriented *3, tongue was at the center without deviation, gaze/vision was normal, no weakness in the extremities/no motor loss was noted. Skin was normal without rash/hives, respiration was normal, normal vital signs/afebrile. The patient's mother stated that no CT of head has been completed, the physician advised the patient to be seen in ER for evaluation. The patient and his mother went to the ED. The outcome of blepharospasm, hypogeusia, hypoaesthesia, facial paralysis, dysphagia and drooling was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Hypoaesthesia, Hypogeusia, Latent tuberculosis
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 # 653474) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses. The patient's medical history included Hodgkin's lymphoma at 12 years of age, positive T-spot (25-JUL-2016) and negative chest x-ray (25-AUG-2016)-latent tuberculosis infection. Information on the patient's prior vaccinations and the other medications were not reported. On 10-AUG-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # M011117 (expiration date: 07-DEC-2017) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5272AB, dose 2, intramuscularly in the right arm and BEXSERO batch/lot # 157501, dose 1, intramuscularly in the right arm for prophylaxis. On 13-SEP-2016, the patient reported left sided facial numbness/paralysis/droop, diminished taste, drooling, left eye twitch and difficulty in swallowing. The patient was seen in PCP (primary care physician) office on 14-SEP-2016. The physician advised to get a CT of head and referred him to ED for evaluation. The patient visited the health department on 15-SEP-2016, symptoms remained same. The patient was alert and oriented *3, tongue was at the center without deviation, gaze/vision was normal, no weakness in the extremities/no motor loss was noted. Skin was normal without rash/hives, respiration was normal, normal vital signs/afebrile. The patient's mother stated that no CT of head has been completed, the physician advised the patient to be seen in ER for evaluation. The patient and his mother went to the ED. The outcome of blepharospasm, hypogeusia, hypoaesthesia, facial paralysis, dysphagia and drooling was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
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 # 653890) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 22 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 14-SEP-2016 at 08:38 am, the patient was vaccinated with GARDASIL 9 (also reported as v15-APR-2015) intramuscularly in the left arm (reported as left deltoid), Dose: 0.5 ml, lot # M009116 with expiry date: 13-JUN-2018, (frequency were not reported) for prophylaxis. On 15-SEP-2016, the patient was experienced headache. The patient was diagnosed with encounter for immunization Z23. The outcome of headache was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653955) on 02-MAY-2017. This spontaneous report refers to a 18 year old male patient. The patient had no concurrent illnesses and other medications. The patient's medical history included anaphylactic reaction to an unknown agent, 8 years ago, as reported by a medical officer on call (MOC). On an unknown date at 18:00, the patient was vaccinated with the first dose of GARDASIL 9 and TRUMENBA. On 20-JUN-2016, the patient had a reaction, which was similar to the events associated with the second dose of the vaccines, but it was less severe. On 22-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M009116, in the right arm and TRUMENBA lot # N11902, in the left arm via intramuscular route, for prophylaxis. On the same day, the patient had soreness on both the arms and was unable to move them. The patient also experienced general fatigue, swelling and erythema, at both the injection sites. The outcome of the events was reported as recovered. The causality assessment for the events 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, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654001) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # M16002 dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 14-SEP-2016, the patient experienced injection site cellulitis. The outcome of injection site cellulitis was reported as recovered. The causality assessment for injection site cellulitis was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site vesicles
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 # 654253). This spontaneous report refers to a 14 year old male patient. The patient's concurrent illnesses was reported as none and medical history included mild CP (cerebral palsy). On 09-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M016193 (expiry date: 24-APR-2018), dose 2 (route reported as needle and syringe-not specified), in the right arm for prophylaxis. On the same day of vaccination, the patient experienced blisters at injection site. The outcome of injection site vesicles 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: 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 # 654309). This spontaneous report refers to a 9 year old male patient. The patient's concurrent illnesses and medical history were not reported. Other medications included Albuterol and ADDERALL. On 08-SEP-2016 (also reported as 08-AUG-2016), the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017), dose 2, via unknown route in the left arm for prophylaxis. On 10-SEP-2016 (also reported as following day of vaccination), the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site pain. On 12-SEP-2016, warmth and swelling were extended distally to injection site. The patient had an emergency room visit. The outcome of injection site erythema, injection site warmth, injection site swelling and injection site pain were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular
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 # 654350). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses and other medications were reported as none. The patient historical conditions includes asthma, allergy to ibuprofen and allergy to Tamiflu. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (expiry date: 03-OCT-2017), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included ADACEL (lot # US378AA, dose 1, intramuscularly in the right arm) and MENACTRA (lot # US410AA, dose 1, intramuscularly in the right arm). On 14-JUL-2016, the patient experienced rash, macular rash on right arm, left arm and buttock area. The outcome of rash and rash macular was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Abasia, Arthralgia, Injection site pain, Injection site swelling, Musculoskeletal 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 # 654385). This spontaneous report refers to a 7 year old female patient. The patient had no concurrent illnesses and medical history includes amoxicillin allergy. Patient's other medications included Ibuprofen OTC, when necessary (prn). On 23-JUN-2011, the patient was vaccinated with GARDASIL 9 lot # M007728, dose 1, intramuscularly in the leg for prophylaxis. On the same day of vaccination, within 10 mins after injection, the site was swollen and painful. On 23-JUN-2016, the patient was unable to walk for 30 mins, experienced pain in extremity, neuralgia, musculoskeletal pain and arthralgia. Legs were painful for more than 2 days. On 23-JUN-2016 (also reported as 15-JUL-2003) sudden onset of intense 'stabbing" nerve-like pain in face, neck and head for 45 seconds. One week later, same pain in shoulder area. Multiple episodes of this same pain in shoulder, upper arm, hands and wrist since this time, sometimes multiple times a day, not experienced every day. The patient had an emergency visit. The outcome of abasia, pain in extremity, neuralgia, musculoskeletal pain, injection site swelling, injection site pain and arthralgia were reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Neuralgia, 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 # 654385). This spontaneous report refers to a 7 year old female patient. The patient had no concurrent illnesses and medical history includes amoxicillin allergy. Patient's other medications included Ibuprofen OTC, when necessary (prn). On 23-JUN-2011, the patient was vaccinated with GARDASIL 9 lot # M007728, dose 1, intramuscularly in the leg for prophylaxis. On the same day of vaccination, within 10 mins after injection, the site was swollen and painful. On 23-JUN-2016, the patient was unable to walk for 30 mins, experienced pain in extremity, neuralgia, musculoskeletal pain and arthralgia. Legs were painful for more than 2 days. On 23-JUN-2016 (also reported as 15-JUL-2003) sudden onset of intense 'stabbing" nerve-like pain in face, neck and head for 45 seconds. One week later, same pain in shoulder area. Multiple episodes of this same pain in shoulder, upper arm, hands and wrist since this time, sometimes multiple times a day, not experienced every day. The patient had an emergency visit. The outcome of abasia, pain in extremity, neuralgia, musculoskeletal pain, injection site swelling, injection site pain and arthralgia were reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Fall, Head injury, Hyperhidrosis, 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 # 654490) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and other medications. The patient's medical history included Penicillin. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose 1 (unspecified dosage) and influenza FLUARIX QUADRIVALENT lot # CD3TF dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, 3-5 minutes after receiving the vaccinations, the patient fainted at the check out desk. The patient hit the left side of the forehead on the wall and slid to the ground, which was not witnessed. The patient was taken to the exam room by doctors and placed in supine position for 10 minutes. Ice was applied to the patient's forehead and she was given apple juice. The patient's blood pressure was obtained. The patient felt fine and left the office accompanied by her mother and sister. The patient then experienced syncope, at the front desk. She was lying prone, rousing with eyes opening and nodding yes when her name was called. The patient also experienced silent ischemic (SI) diaphoresis, with strong radial pulse of 88. She was kept lying supine for several minutes, followed by sitting and then was standing with support. She walked to an exam room, where she had her blood pressure and heart rate checked, while supine. The patient then sat and drank 24 oz cans juice. With the patient's second blood pressure (BP) being stable, she was released to leave the office with her mother and sister, without any difficulty. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: 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 # 654610) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no known concurrent illnesses, medical history or other medications. On 15-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M023169 dose 1, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced hives all over. The outcome of urticaria was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Muscular weakness, 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 # 654628). This spontaneous report refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history includes mold allergy. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9, dose 1, intramuscularly in the left arm for prophylaxis. On 21-SEP-2016, he developed hives on his entire body and was given Benadryl. Hives subsided with Benadryl but reoccurred again the next morning. Unsure of whether this is temporary or chronic at this point. Patient will not proceed with other shots in the series, as this is definitely an allergic reaction. Patient also says that, he was experiencing weakness in his legs. The outcome of hypersensitivity, urticaria, muscular weakness and incomplete course of vaccination was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654689). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 16-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # M018810 (expiry date: 28-MAY-2018), dose 1, via unknown route in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included MENVEO, lot # M15167, dose 3, via unknown route in the left arm. On 17-SEP-2016, the patient experienced injection site erythema, injection site swelling, injection site pruritus and injection site pain. The patient had redness raised on upper arm area, burning and itching. The patient had an emergency room visit. The outcome of injection site erythema, injection site swelling, injection site pruritus and injection site pain were reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Contusion, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654718) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. The patient's concurrent illness and medical history were reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 20-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M020103 (dose and lot expiration date were not reported) via intramuscular route, in the right arm and first dose of VAQTA lot # M002268 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of ADACEL (intramuscularly in the left arm, lot# U5468AA; dose and expiration date were not reported) and first dose of MENACTRA (intramuscularly in the left arm, lot# U5390AA; dose and expiration date were not reported) for prophylaxis. On 21-SEP-2016, the patient woke up with swelling of the left arm which increased over the course of the day. The patient also developed redness and a bruised area. The patient's injection site and swelling on the arm distal to the site were very red, warm and tender to palpitation. The patient had visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site warmth, Peripheral 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 # 654718) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. The patient's concurrent illness and medical history were reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 20-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M020103 (dose and lot expiration date were not reported) via intramuscular route, in the right arm and first dose of VAQTA lot # M002268 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of ADACEL (intramuscularly in the left arm, lot# U5468AA; dose and expiration date were not reported) and first dose of MENACTRA (intramuscularly in the left arm, lot# U5390AA; dose and expiration date were not reported) for prophylaxis. On 21-SEP-2016, the patient woke up with swelling of the left arm which increased over the course of the day. The patient also developed redness and a bruised area. The patient's injection site and swelling on the arm distal to the site were very red, warm and tender to palpitation. The patient had visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654766). This spontaneous report refers to a 11 year old male patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M013636 (expiry date: 15-FEB-2018), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 324Z7, dose 1, intramuscularly in the right arm; MENVEO lot # M15167, dose 1, intramuscularly in the right arm and VARIVAX # L026412, dose 2, via subcutaneous route in the right arm. On 21-SEP-2016, the patient experienced cellulitis at the injection site (4 inch by 3.5 inch). The patient started amoxicillin-pot clavulanate and had follow up after 4 days. The outcome of the event injection site cellulitis was reported as unknown. The causality assessment of the event injection site cellulitis 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: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Vaccination site induration, 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 # 654778) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illness and medical history. The patient's other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 19-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M021407, lot expiration date 30-APR-2018 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day included first dose of MENVEO (intramuscularly in the right arm, lot# M16004; dose and expiration date were not reported) for prophylaxis. On 20-SEP-2016, the patient had redness on her arm below the vaccine site which spread downward on arm. On 21-SEP-2016, the patient had 6 x 4.5 inch warm hard red swollen area. The top border of the area was approximately 1 inch below the vaccination site. The patient was treated with cephalexin. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Erythema, Nodule, Pain, 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 # 655999) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illness and medical history. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications were reported as none. On 19-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M016193, lot expiration date 24-APR-2018 (dose: not reported) via intramuscular route, in the left arm and third dose of VARIVAX lot # M023379 (dose and lot expiration date were not reported) via subcutaneous route, in the left arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of HAVRIX (intramuscularly in the left arm, lot# GP75A; dose and expiration date were not reported) and first dose of MENACTRA (intramuscularly in the right arm, lot# U5462AA; dose and expiration date were not reported) for prophylaxis. The patient's mother called and informed that on 21-SEP-2016, the patient had red raised very sore knots which were bigger than the size of a quarter. The patient slept with ice packs on. The doctor told her to take Benadryl. The patient had visited the emergency room. The outcome of erythema and nodule were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656161) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder and was taking Adderall and Trileptal. The patient's concurrent illness was reported as none. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 12-SEP-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L036301 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of ADACEL (intramuscularly in the left arm, lot# CA990AA; dose and expiration date were not reported) and MENACTRA (intramuscularly in the right arm, lot# U5392AA; dose and expiration date were not reported) for prophylaxis. On 12-SEP-2016, 6 hours post vaccination the patient had redness and tenderness in the area of vaccination (right deltoid). After 24 hours post vaccination, the symptoms got worsened - fever with 102 degree Fahrenheit (F), spreading of redness and pain to the entire right limb. He had weakness to the right limb 36 hours after vaccination. The patient visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 656161) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder and was taking Adderall and Trileptal. The patient's concurrent illness was reported as none. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 12-SEP-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L036301 (dose and lot expiration date were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included first dose of ADACEL (intramuscularly in the left arm, lot# CA990AA; dose and expiration date were not reported) and MENACTRA (intramuscularly in the right arm, lot# U5392AA; dose and expiration date were not reported) for prophylaxis. On 12-SEP-2016, 6 hours post vaccination the patient had redness and tenderness in the area of vaccination (right deltoid). After 24 hours post vaccination, the symptoms got worsened - fever with 102 degree Fahrenheit (F), spreading of redness and pain to the entire right limb. He had weakness to the right limb 36 hours after vaccination. The patient visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Blood insulin, Dizziness, Electrocardiogram normal, Fatigue
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 # 656167) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included sulfa allergies. Patient's current illnesses was reported as irregular menses. Information on prior vaccinations were not reported. On 18-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L043213, intramuscularly in the left arm for prophylaxis. On 21-MAY-2016, the patient's blood glucose decreased, electrocardiogram was normal and also experienced syncope, paraesthesia, fatigue, dizziness and blood insulin. Symptoms began about 8 days after vaccination which included hands and feet tingling. Patient had several episodes of syncope and low blood sugar. Insulin level was found to be 56.9 (units unspecified). The outcome of blood glucose decreased, syncope, paraesthesia, fatigue, dizziness and blood insulin 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, 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 # 656167) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included sulfa allergies. Patient's current illnesses was reported as irregular menses. Information on prior vaccinations were not reported. On 18-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L043213, intramuscularly in the left arm for prophylaxis. On 21-MAY-2016, the patient's blood glucose decreased, electrocardiogram was normal and also experienced syncope, paraesthesia, fatigue, dizziness and blood insulin. Symptoms began about 8 days after vaccination which included hands and feet tingling. Patient had several episodes of syncope and low blood sugar. Insulin level was found to be 56.9 (units unspecified). The outcome of blood glucose decreased, syncope, paraesthesia, fatigue, dizziness and blood insulin 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: M
Vaccine: HPV9
Symptoms: Injection site urticaria, 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 # 656199) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 27-SEP-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # M011840 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. On 28-SEP-2016, hives first appeared in the evening around the injection site. On 29-SEP-2016 morning, the hives spread to the rest of his arm. The patient called the clinic to report the reaction (29-SEP-2016), the patient was advised to take Benadryl or antihistamine. The outcome of injection site urticaria and urticaria was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Feeling hot, Head injury, Headache, Migraine
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 # 656536) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old female patient. The patient's medical history included sulfa allergies. Patient current illnesses included anxiety and went to the doctor for treatment. Other medications were reported as Lexapro 5 mg and Ventolin HFa. Information on patient's prior vaccinations were not reported. On 28-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9, lot/batch # 038917, intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (vaccinated date: 28-SEP-2016, intramuscularly in the right arm, lot# U5416AA; dose and expiration date unknown). On the same day, the patient experienced fall, syncope, migraine, headache and feeling hot. Patient stood up and was standing with her father and she felt hot and fainted, fell on the floor and hit her head and no one witnessed it. When the patient was asked about her head, she said she did not hit and was offered cold packs. Patient reported being fine and sat on the chair for another 15 minutes, felt fine and went home. Next day, patient visited the ER (emergency room) twice for migraines/headaches. The outcome of fall, syncope, migraine, headache and feeling hot is unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: 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 # 656536) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old female patient. The patient's medical history included sulfa allergies. Patient current illnesses included anxiety and went to the doctor for treatment. Other medications were reported as Lexapro 5 mg and Ventolin HFa. Information on patient's prior vaccinations were not reported. On 28-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9, lot/batch # 038917, intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (vaccinated date: 28-SEP-2016, intramuscularly in the right arm, lot# U5416AA; dose and expiration date unknown). On the same day, the patient experienced fall, syncope, migraine, headache and feeling hot. Patient stood up and was standing with her father and she felt hot and fainted, fell on the floor and hit her head and no one witnessed it. When the patient was asked about her head, she said she did not hit and was offered cold packs. Patient reported being fine and sat on the chair for another 15 minutes, felt fine and went home. Next day, patient visited the ER (emergency room) twice for migraines/headaches. The outcome of fall, syncope, migraine, headache and feeling hot is unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Expired product administered
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 # 656572) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 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 22-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, lot #, route of administration and anatomical site were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 22-SEP-2016, dose, frequency, lot #, route of administration and anatomical site were not reported). On the same day, patient was administered an expired product. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Chills, Dizziness, Feeling cold
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 # 656588) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a patient of unknown age and gender. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, via unknown route in the left arm for prophylaxis. Other suspect therapies FLUZONE Quadrivalent (dose, frequency, lot expiration date and vaccinated date were not reported) lot/batch # UT5636LA via unknown route in the right arm. On unknown dates, the patient experienced dizziness and feeling cold. Patient felt faint and had chills. Patient did not become unconsciousness and was given water, Benadryl syrup, 2 teaspoon, per oral, once, and oxygen via nasal route. Oxygen saturation and BP (blood pressure) was reported to be normal. The outcome of dizziness and feeling cold 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: FLU4, HEPA, HPV9
Symptoms: Crying, Dizziness, Eye movement disorder, Fear, Hypotonia
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 # 656927) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Historical drug included penicillin. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses (patient denies illness). On 03-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M013636, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX (vaccinated date: 03-OCT-2016, intramuscularly in the left arm, lot# 2994A; dose and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 03-OCT-2016, intramuscularly in the right arm, lot# ED72D; dose and expiration date unknown). On the same day, the patient experienced crying, snoring, nausea, musculoskeletal stiffness, hypotonia, fear, eye movement disorder and dizziness. After receiving 3rd injection, patient reported feeling lightheaded and nauseous. Cold towel was applied on patient's neck and the nurse began to fan the patient. Within a couple of minutes, patient's eyes rolled backwards and she went limp and made a snoring noise. Patient's left arm extended straight and her legs stiffened. The nurse and patient's mother assisted patient to the floor and within few minutes, patient opened her eyes and began to cry and stated she was scared. Patient's arm and legs were relaxed. Patient remained on floor for an additional five minutes and then was assisted to chair for an additional period without any further complications. Patient's mother stated that the patient had a doctor's appointment in a few days and she would discuss incident with him. The outcome of crying, snoring, nausea, musculoskeletal stiffness, hypotonia, fear, eye movement disorder and dizziness 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: FLU4, HEPA, HPV9
Symptoms: Musculoskeletal stiffness, Nausea, Snoring
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 # 656927) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Historical drug included penicillin. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses (patient denies illness). On 03-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M013636, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX (vaccinated date: 03-OCT-2016, intramuscularly in the left arm, lot# 2994A; dose and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 03-OCT-2016, intramuscularly in the right arm, lot# ED72D; dose and expiration date unknown). On the same day, the patient experienced crying, snoring, nausea, musculoskeletal stiffness, hypotonia, fear, eye movement disorder and dizziness. After receiving 3rd injection, patient reported feeling lightheaded and nauseous. Cold towel was applied on patient's neck and the nurse began to fan the patient. Within a couple of minutes, patient's eyes rolled backwards and she went limp and made a snoring noise. Patient's left arm extended straight and her legs stiffened. The nurse and patient's mother assisted patient to the floor and within few minutes, patient opened her eyes and began to cry and stated she was scared. Patient's arm and legs were relaxed. Patient remained on floor for an additional five minutes and then was assisted to chair for an additional period without any further complications. Patient's mother stated that the patient had a doctor's appointment in a few days and she would discuss incident with him. The outcome of crying, snoring, nausea, musculoskeletal stiffness, hypotonia, fear, eye movement disorder and dizziness 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: DTAP, HPV9
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 29-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # M009378, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapy included INFANRIX dose number 4; vaccinated date: 29-SEP-2016, intramuscularly in the left arm, lot # HN2R2, (dose, frequency and lot expiration date unknown). The patient was given INFANRIX (DTaP) when patient just needed TD. The outcome of wrong drug administered was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.