chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Headache, Nausea, Neurological examination, 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 # 633103) on 18-APR-2017. This spontaneous report refers to a 14 year old male patient. The patient's medical history included eczema, back pain and unspecified tachycardia. The patient's other medications included Allegra, Nasonex and triamcinolone acetate (all were on the patient's medicine list but uncertain if the patient was taking them at the time of the incident). Information about the patient's concurrent illnesses was not reported. On 26-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L037339 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient fainted for 5-10 minutes following vaccine administration, while checking out at the clinic. The patient also experienced a head injury after hitting the head during the fainting spell and then complained of visual disturbance, headache and nausea, because of which he was sent to the emergency department. The patient's vital signs were taken and brief neurological examination was performed following the incident. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: 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 # 633103) on 18-APR-2017. This spontaneous report refers to a 14 year old male patient. The patient's medical history included eczema, back pain and unspecified tachycardia. The patient's other medications included Allegra, Nasonex and triamcinolone acetate (all were on the patient's medicine list but uncertain if the patient was taking them at the time of the incident). Information about the patient's concurrent illnesses was not reported. On 26-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L037339 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient fainted for 5-10 minutes following vaccine administration, while checking out at the clinic. The patient also experienced a head injury after hitting the head during the fainting spell and then complained of visual disturbance, headache and nausea, because of which he was sent to the emergency department. The patient's vital signs were taken and brief neurological examination was performed following the incident. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Diarrhoea, Dizziness, Headache, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 633366) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included anxiety. The patient's other medications included gildess; zoloft and tretinoin. The patient's concurrent illnesses and prior vaccinations were not reported. On 25-APR-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L037339 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 25-APR-2016, 30 min after administration of suspect the patient experienced shaky, dizzy, clammy, vomiting, diarrhea and headache for about 3-4 hrs. The outcome of cold sweat, vomiting, tremor, headache, dizziness and diarrhoea was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 633366) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included anxiety. The patient's other medications included gildess; zoloft and tretinoin. The patient's concurrent illnesses and prior vaccinations were not reported. On 25-APR-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L037339 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 25-APR-2016, 30 min after administration of suspect the patient experienced shaky, dizzy, clammy, vomiting, diarrhea and headache for about 3-4 hrs. The outcome of cold sweat, vomiting, tremor, headache, dizziness and diarrhoea 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: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site 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 # 633379) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 22 year old female patient. The patient's medical history included tetanus toxoid immunization allergy. Information on current illnesses, concomitant medications, lab data and prior vaccinations were not reported. On 10-DEC-2015, the patient was inserted with Prenatal meds Paragard Intra uterine device (IUD). On the same day, the patient was vaccinated with GARDASIL 9 injection, lot # K026247, Expiry date: 29-JAN-2017, dose 1, intramuscularly in the right arm for prophylaxis. On 11-DEC-2015, the patient experienced itching and redness at the injection site. The outcome of both the events were reported as recovered/resolved. The Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Lymph node pain, Lymphadenopathy, Nausea, 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 # 633437) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old female patient. The patient's medical history included food allergy. Information on current illnesses, concomitant medications, lab data and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 dose number 2 (dose, lot number, expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 24-APR-2016, the patient developed itching and rashes on bilateral proximal upper extremities, nausea and vomiting for 2 days with severe generalized abdominal pain, left single mobile posterior cervical lymphadenopathy with tenderness upon palpating. The outcome of the events were not reported. However, it was reported that all the symptoms were improved by day 4 with some lingering abdominal pain and lymphadenopathy. The Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, 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 # 633437) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old female patient. The patient's medical history included food allergy. Information on current illnesses, concomitant medications, lab data and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 dose number 2 (dose, lot number, expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 24-APR-2016, the patient developed itching and rashes on bilateral proximal upper extremities, nausea and vomiting for 2 days with severe generalized abdominal pain, left single mobile posterior cervical lymphadenopathy with tenderness upon palpating. The outcome of the events were not reported. However, it was reported that all the symptoms were improved by day 4 with some lingering abdominal pain and lymphadenopathy. The 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
Symptoms: Unevaluable event
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 # 633775) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. The patient had no past medical history and current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 28-APR-2015, the patient was vaccinated with GARDASIL 9 injection, dose 3 (dose and expiration date unknown), lot # L020015 via intramuscular route in the right arm for prophylaxis. Other suspect therapies included HAVRIX (Manufacturer: Glaxosmithkline, Vaccinated date: 28-APR-2015, dose number 2 (dose, frequency and lot expiration date unknown), via intramuscular route in the left arm) and MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 28-APR-2015, (dose number, dose, frequency and lot expiration date unknown), via intramuscular route in the right arm). On an unknown date, it was reported that the patient experienced an unevaluable event (also reported as no adverse event). The outcome of the event was not reported. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Petechiae, Vomiting projectile
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 # 633783) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old female patient. Information on pertinent medical history, concomitant medications, current illnesses, lab data and prior vaccinations were not reported. The patient's prior vaccination included GARDASIL and post vaccination she had vomiting. On 28-APR-2016, the patient was vaccinated with GARDASIL 9, lot/batch # 1045700, dose number 1 (dose and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 29-APR-2016, the patient had forceful and repeated vomiting (projectile vomiting) continued for at least 12 hours, with subsequent facial petechiae. The patient was taken to emergency room. The outcome of the events were not reported. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
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 # 633941). This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 13-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L004741, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5179AA, dose 1, intramuscularly in the left arm for prophylaxis. On 14-JAN-2016, the patient complained to his mother about severe headaches in back of head. He told that it had been going on for "couple of days". Finally headache continued and was so bad that they went to emergency room (ER). Doctor did not come in to see the patient but just said it was chronic headache and patient could take tylenol. Headache finally stopped and he was no longer voicing any complaints at that time. The outcome of the event headache was reported as recovered. The causality assessment of the event headache with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Extra dose administered, No adverse event
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 # 633961) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 17 year old male patient. Information on pertinent medical history, current illnesses, concomitant medications, lab data and prior vaccinations were not reported. On 26-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L048237, dose number 4 (dose and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included VARIVAX (Vaccinated date: 26-APR-2016, lot # L001331, dose number 3 (dose and lot expiration date unknown) via subcutaneous route in the right arm) for prophylaxis. On the same day, the patient was given extra dose. However, no adverse event was experienced. It was reported that "Patient arrived at the Mobile Unit after being called by the school office to come. He identified himself and his identification was confirmed by vaccines administered. It was only after they were administered, that it was discovered there were two students with the same name. The mother in the office was not informed that he was not her son and that her son had not yet arrived. He received two vaccines that he had received previously (VZV and HPV). Both these series had been completed and he didn't need the ones administered. He had no adverse effects and was eager to get back to class. His mother was called and the situation was explained. The school administration was also notified". Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, VARCEL
Symptoms: Drug administered to patient of inappropriate age
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 # 634020). This spontaneous report refers to a 19 year old female patient. Information on patient's concurrent illnesses and medical history were not reported. Patient's other medications included birth control, Celexa and Klonipin. On 11-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L019297 (expiry date: 18-AUG-2017), dose 1, intramuscularly in the left arm; VARIVAX L034366, dose 2, subcutaneously in the right arm and hepatitis a vaccine, inactivated (manufacturer unknown) (lot #, route and site: unknown) for prophylaxis. On the same day, the patient was vaccinated with FLUZONE QUADRIVALENT lot # UI441AB, dose 3, intramuscularly in the right arm, MENVEO lot # A15053, dose 2, intramuscularly in the right arm for prophylaxis. On 11-APR-2016, wrong pediatric dose of hepatitis a vaccine, inactivated (manufacturer unknown) was given to 19 year old patient. Patient was revaccinated on the same day with appropriate dosage of hepatitis a vaccine, inactivated (manufacturer unknown). Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Malaise, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's current conditions included hydrocele. The patient's medical history included allergic to amoxicillin. The patient's concomitant therapy included Zofran and Vicodin. The patient's prior vaccinations was not reported. On 04-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, lot # L048237, intramuscular (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day at 17:00 the patient had throat swollen, malaise and numbness on left side. On an unknown date the patient was seen in emergency room (ER). The patient was given benadryl and steroids. The outcome of hypoaesthesia, pharyngeal oedema and malaise 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: Asthenia, Diarrhoea, Dizziness, Full blood count normal, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 26 year old female patient. The patient's other medications and medical history were reported as unknown. The patient had no current illnesses and the patient's prior vaccinations was not reported.  On 03-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, (route of administration and site unknown) (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis Lab data included: Common blood count (CBC) at emergency room (ER): normal per patient report. On 03-MAY-2016, the patient had sore throat, lightheaded, stuffy headed hours after receiving immunization went to emergency room (ER), diagnose (dx) with reaction to vaccine, sinus congestion and full blood count normal. On 06-MAY-2016 (also reported 03-MAY-2016) that patient woke up with low grade temperature, nausea, diarrhea, generalized weakness, palms and feet sweaty. The outcome of full blood count normal, pyrexia, oropharyngeal pain, nausea, diarrhoea, asthenia, dizziness, vaccination complication, sinus congestion and hyperhidrosis were not reported. 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: Nausea, Oropharyngeal pain, Pyrexia, Sinus congestion, Vaccination complication
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 26 year old female patient. The patient's other medications and medical history were reported as unknown. The patient had no current illnesses and the patient's prior vaccinations was not reported.  On 03-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, (route of administration and site unknown) (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis Lab data included: Common blood count (CBC) at emergency room (ER): normal per patient report. On 03-MAY-2016, the patient had sore throat, lightheaded, stuffy headed hours after receiving immunization went to emergency room (ER), diagnose (dx) with reaction to vaccine, sinus congestion and full blood count normal. On 06-MAY-2016 (also reported 03-MAY-2016) that patient woke up with low grade temperature, nausea, diarrhea, generalized weakness, palms and feet sweaty. The outcome of full blood count normal, pyrexia, oropharyngeal pain, nausea, diarrhoea, asthenia, dizziness, vaccination complication, sinus congestion and hyperhidrosis were not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Ultrasound scan
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #634757) and refers to a 11 year old female patient. Patient had no current illnesses. Medical history and  other medications were reported as none. On 03-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L019297 dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with ADACEL and MENOMUNE-A/C/Y/W-135 administered on 03-MAY-2016, via intramuscular route for prophylaxis. On 03-MAY-2016, the patient experienced right arm with swelling and erythema extending from the injection site down to mid arm. The events required emergency room visit. On 03-MAY-2016, Ultrasound scan of arm was done and result was not known. The outcome of injection site erythema, ultrasound scan and injection site swelling was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Dizziness, Fatigue, Influenza virus test negative, 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 (HA# 635215) and refers to a 11 year old male patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 14-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, dose 3, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 15-MAR-2016, the patient experienced nausea, fever 102-103 (unit unknown), abdominal pain, fatigue, light sensitivity, dizziness. On 15-MAR-2016, influenza virus test and Streptococcus test was negative. The outcome of abdominal pain, streptococcus test negative, pyrexia, photophobia, nausea, influenza virus test negative, fatigue and dizziness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Photophobia, Pyrexia, Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 635215) and refers to a 11 year old male patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 14-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, dose 3, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 15-MAR-2016, the patient experienced nausea, fever 102-103 (unit unknown), abdominal pain, fatigue, light sensitivity, dizziness. On 15-MAR-2016, influenza virus test and Streptococcus test was negative. The outcome of abdominal pain, streptococcus test negative, pyrexia, photophobia, nausea, influenza virus test negative, fatigue and dizziness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HEPA, HPV9, TD
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 (HA # 635372) and refers to a 20 year old male patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 11-MAY-2016 the patient was vaccinated with GARDASIL 9, lot # L027282, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with TENIVAC and HAVRIX. On 11-MAY-2016, the patient experienced syncopal episode for less than 60 seconds after receiving 3 vaccines. Patient remained on exam table, did not hit his head. Patient was assisted to supine position, legs elevated. Vital signs were monitored. Patient was given a Pedialyte pop, remained supine for 10 minutes, then sat up and stood up gradually. He was discharged home when vital signs remained stable and symptoms resolved. The outcome of syncope was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 635507). This spontaneous report refers to a 14 year old female patient. The patient had no current illnesses and information on other medications was not reported. The patient's medical history included chronic headaches. On 12-MAY-2016 at 10:20, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the right arm and VAQTA lot # L046953, dose 1, intramuscularly in the left arm for prophylaxis. On 12-MAY-2016, 10 seconds after injections, patient became pale and lightheaded. Patient was helped in to lying position with feet elevated and she reported headache. Patient was observed in the clinic for 90 minutes before she left the clinic with her mother. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 and VAQTA was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Chills, Dehydration, Diarrhoea, 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 # 635582) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 25 year old female patient. Information on the patient's concurrent illnesses, other medications, lab data and prior vaccinations were not reported. The patient's medical history included lactose intolerance allergic to penicillin, ibuprofen and Z-PAK. On 24-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 via intramuscular route, in the left arm for prophylaxis (dosage, lot number and expiry date unspecified). On 24-MAR-2016 at 5:00PM, the patient had pain at the injection site, at 9:00PM had nausea. On 25-MAR-2016, at 4:00AM patient had nausea, chills, weakness, at 6:00AM patient had severe weakness (difficult to stand up), extreme nausea. From 8:00AM-9:00AM on the same day, patient had diarrhea thrice, severe weakness and also felt faint. At 10:00 AM patient had vomiting, diarrhea, hives, fever, at 11:00 AM-8:00PM patient had nausea, diarrhea (10 times). As treatment ice chips was given to the patient throughout day. Patient could not tolerate food and tried jello at 5 PM but had nausea and diarrhea again. On 26-MAR-2016 patient had nausea but it was tolerable, ate food (rice, banana), patient was extremely weak and dehydrated from vomiting and diarrhea from 25-MAR-2016 to 29-MAR-2016. Nausea persists but able to tolerate food and patient was on BRAT diet. The outcome of asthenia, vomiting, urticaria, pyrexia, nausea, injection site pain, food intolerance, dysstasia, dizziness, diarrhoea, dehydration, condition aggravated and chills was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dysstasia, Food intolerance, Injection site pain, Nausea, 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 # 635582) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 25 year old female patient. Information on the patient's concurrent illnesses, other medications, lab data and prior vaccinations were not reported. The patient's medical history included lactose intolerance allergic to penicillin, ibuprofen and Z-PAK. On 24-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 via intramuscular route, in the left arm for prophylaxis (dosage, lot number and expiry date unspecified). On 24-MAR-2016 at 5:00PM, the patient had pain at the injection site, at 9:00PM had nausea. On 25-MAR-2016, at 4:00AM patient had nausea, chills, weakness, at 6:00AM patient had severe weakness (difficult to stand up), extreme nausea. From 8:00AM-9:00AM on the same day, patient had diarrhea thrice, severe weakness and also felt faint. At 10:00 AM patient had vomiting, diarrhea, hives, fever, at 11:00 AM-8:00PM patient had nausea, diarrhea (10 times). As treatment ice chips was given to the patient throughout day. Patient could not tolerate food and tried jello at 5 PM but had nausea and diarrhea again. On 26-MAR-2016 patient had nausea but it was tolerable, ate food (rice, banana), patient was extremely weak and dehydrated from vomiting and diarrhea from 25-MAR-2016 to 29-MAR-2016. Nausea persists but able to tolerate food and patient was on BRAT diet. The outcome of asthenia, vomiting, urticaria, pyrexia, nausea, injection site pain, food intolerance, dysstasia, dizziness, diarrhoea, dehydration, condition aggravated and chills was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria, 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 # 635582) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 25 year old female patient. Information on the patient's concurrent illnesses, other medications, lab data and prior vaccinations were not reported. The patient's medical history included lactose intolerance allergic to penicillin, ibuprofen and Z-PAK. On 24-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 via intramuscular route, in the left arm for prophylaxis (dosage, lot number and expiry date unspecified). On 24-MAR-2016 at 5:00PM, the patient had pain at the injection site, at 9:00PM had nausea. On 25-MAR-2016, at 4:00AM patient had nausea, chills, weakness, at 6:00AM patient had severe weakness (difficult to stand up), extreme nausea. From 8:00AM-9:00AM on the same day, patient had diarrhea thrice, severe weakness and also felt faint. At 10:00 AM patient had vomiting, diarrhea, hives, fever, at 11:00 AM-8:00PM patient had nausea, diarrhea (10 times). As treatment ice chips was given to the patient throughout day. Patient could not tolerate food and tried jello at 5 PM but had nausea and diarrhea again. On 26-MAR-2016 patient had nausea but it was tolerable, ate food (rice, banana), patient was extremely weak and dehydrated from vomiting and diarrhea from 25-MAR-2016 to 29-MAR-2016. Nausea persists but able to tolerate food and patient was on BRAT diet. The outcome of asthenia, vomiting, urticaria, pyrexia, nausea, injection site pain, food intolerance, dysstasia, dizziness, diarrhoea, dehydration, condition aggravated and chills 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, MENB
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Somnolence
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #635640) and refers to a 18 year old male patient. Patient's current illnesses and other medication was reported as none. On 16-MAY-2016 the patient was vaccinated with GARDASIL 9, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with BEXSERO. On 16-MAY-2016, patient fainted, lost consciousness for approximately 20 seconds. He was pale and diaphoretic. He had not eaten and was very nervous about receiving this or any shot. Patient's forehead was wiped with a wet cloth and he was given with chocolate, water, and a lollipop. He was talking and moving. Reported he still felt dizzy. No nausea, no vomiting. His face color returned, but still felt dizzy and sleepy. Patient was sent to home with mother and siblings, advising them to feed patient, let him rest and not to leave him unattended. Also advised that fainting is common side-effect. The outcome of dizziness, loss of consciousness, syncope, somnolence, pallor and hyperhidrosis was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MENB
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 (HA #635640) and refers to a 18 year old male patient. Patient's current illnesses and other medication was reported as none. On 16-MAY-2016 the patient was vaccinated with GARDASIL 9, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with BEXSERO. On 16-MAY-2016, patient fainted, lost consciousness for approximately 20 seconds. He was pale and diaphoretic. He had not eaten and was very nervous about receiving this or any shot. Patient's forehead was wiped with a wet cloth and he was given with chocolate, water, and a lollipop. He was talking and moving. Reported he still felt dizzy. No nausea, no vomiting. His face color returned, but still felt dizzy and sleepy. Patient was sent to home with mother and siblings, advising them to feed patient, let him rest and not to leave him unattended. Also advised that fainting is common side-effect. The outcome of dizziness, loss of consciousness, syncope, somnolence, pallor and hyperhidrosis was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 635963) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Patient had no current illness and medical history. Information on patient's lab data was reported as not applicable. On 17-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L040164, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 17-MAY-2016, the patient had syncopal event. The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, 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 # 636190) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Patient had no known illness and significant medical history or other medical condition at the time of vaccination. Information on the patient's lab data and other medications were reported as not applicable. Information on patient's prior vaccination was not reported.  On 16-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L044475, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with ADACEL lot/batch# U5278AA, via intramuscular route, in the right arm and MENVEO lot/batch# M15077A, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On 18-MAY-2016, it was informed to the office that patient's arm had been swollen and red. Patient had no fever and other symptoms, just arm pain and redness/soreness (event start date: 16-MAY-2016). Patient also visited the clinic on 18-MAY-2016 and diagnosed with cellulitis. He was place on antibiotics Cephalexin for 10 days. The patient required emergency room visit. The outcome of erythema, peripheral swelling and pain in extremity was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Incorrect product formulation 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 # 636650) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 23-MAY-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # 1024993 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO Intramuscularly in the right arm, lot # X15078, manufacturer: Novartis, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 23-MAY-2016, the patient was given the MENVEO "diluent" instead of the mixed concentration. The outcome of incorrect product formulation administered was reported as recovered/resolved. Causality assessment was not reported. Lot number 1024993 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast). Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Diarrhoea, Dizziness, Dyspnoea, 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 # 638152) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. Other medications included THC recreationally daily, according to patient. On 27-APR-2016  the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L045711 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-APR-2016 the patient reported that approximately one and half hour after receiving first GARDASIL 9 vaccine had severe nausea, vomiting, some diarrhea, headache, felt light headed and had difficulty breathing. Two days later the patient went to emergency room after driving himself up to the mountains and was given an IV, IV medication for nausea and vomiting and that "knocked him out". When the patient woke up he felt somewhat better, but still lethargic. The outcome of blood test, vomiting, urine analysis, nausea, lethargy, dyspnoea, dizziness and diarrhoea 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: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Lethargy, Nausea, Urine analysis, 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 # 638152) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. Other medications included THC recreationally daily, according to patient. On 27-APR-2016  the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L045711 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-APR-2016 the patient reported that approximately one and half hour after receiving first GARDASIL 9 vaccine had severe nausea, vomiting, some diarrhea, headache, felt light headed and had difficulty breathing. Two days later the patient went to emergency room after driving himself up to the mountains and was given an IV, IV medication for nausea and vomiting and that "knocked him out". When the patient woke up he felt somewhat better, but still lethargic. The outcome of blood test, vomiting, urine analysis, nausea, lethargy, dyspnoea, dizziness and diarrhoea was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Cyanosis, Eye movement disorder, Muscle twitching, Mydriasis, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638229). This spontaneous report refers to a 23 year old male patient. The patient had no concurrent illnesses and medical history was not reported. On 27-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L045711, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced cyanosis, unresponsive to stimuli, tremor, pallor, mydriasis, muscle twitching and eye movement disorder. It was reported that the patient's pupils dilated totally (1-2 min), eyes rolled back, tremors/twitches for 1 min then stopped. Patient also diagnosed with pale face, lips somewhat blue, breathing, unresponsive to sound, then patient woke up, conscious and responsive, vital signs stable, patient safety was maintained. The outcome of cyanosis, unresponsive to stimuli, tremor, pallor, mydriasis, muscle twitching and eye movement disorder 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: M
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638229). This spontaneous report refers to a 23 year old male patient. The patient had no concurrent illnesses and medical history was not reported. On 27-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L045711, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced cyanosis, unresponsive to stimuli, tremor, pallor, mydriasis, muscle twitching and eye movement disorder. It was reported that the patient's pupils dilated totally (1-2 min), eyes rolled back, tremors/twitches for 1 min then stopped. Patient also diagnosed with pale face, lips somewhat blue, breathing, unresponsive to sound, then patient woke up, conscious and responsive, vital signs stable, patient safety was maintained. The outcome of cyanosis, unresponsive to stimuli, tremor, pallor, mydriasis, muscle twitching and eye movement disorder 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638265) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and lab data were reported as none. Information on patient's prior vaccination was not reported. On 06-JUN-2016, the patient was vaccinated with the first dose GARDASIL 9 lot # L024993, via intramuscular route, in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with BOOSTRIX lot/batch# L024993, via intramuscular route, in the right arm and MENACTRA lot/batch # U5049AA, via intramuscular route, in the right arm. On 06-JUN-2016, the patient received 3 immunizations in this order: Tdap and MCV 4 into right deltoid and HPV into left deltoid. After the 3rd vaccination was administered patient started to slump in her chair and all color drained from her face. She was assisted to a lying position on the floor. She was breathing but did not respond to questions asked for about 15-20 seconds. Patient then stated that she felt like she had to throw up. She was able to follow the command to breathe deeply and within a few minutes the coloring started to return to her face. She did not throw up. She remained in a supine position for about 15 minutes and then a sitting position for another 15 minutes before she was released. She could not remember anything about the experience except for someone helping her to the floor. She asked her guardian if she had fallen asleep. The outcome of pallor and posture abnormal was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity, Respiratory distress, 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 # 638467) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 12 year old female patient. The patient's medical history included allergy to gum. It was reported that the patient was a healthy (well) child. The patient had no concurrent illnesses and was on no other medications. Information on the patient's prior vaccinations was not reported. On 27-MAY-2016, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L048237 (frequency and lot expiration date unknown) for prophylaxis. On the same day, the patient was also vaccinated with VARIVAX (dose number: 2, subcutaneously in the left arm, lot # L037560; frequency and lot expiration date unknown), BOOSTRIX (dose number: 1, intramuscularly in the right arm, lot # 4G4TE; manufacturer: GlaxoSmithKline, frequency and lot expiration date unknown), MENVEO (dose number: 1, intramuscularly in the left arm, lot # M15071; manufacturer: Novartis, frequency and lot expiration date unknown) and HAVRIX (dose number: 2, intramuscularly in the right arm, lot # A2X9E; manufacturer: GlaxoSmithKline, frequency and lot expiration date unknown) for prophylaxis. On 27-MAY-2016, the patient experienced hypersensitivity and had an anaphylactic reaction for 40 minutes after immunizations were administered. The patient presented with hives all over her body and was in moderate respiratory distress. The patient was immediately given Epi Jr. Shortly after symptoms began to subside, 911 was called and the patient was transported to the emergency department of hospital for further care. The patient's lab data were not available. The outcome for the events respiratory distress, urticaria, hypersensitivity and anaphylactic reaction were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.