chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Amnesia, Fall, Malaise, 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 # 641723) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's other medication included over the counter (OTC) multivitamins. The patient had no medical history and concurrent illnesses. On 27-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048459 (Expiration date: 22-FEB-2018) dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 4R3MJ dose 1 (unspecified dosage) and MENVEO lot # A15078 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 27-JUN-2016, few minutes after the vaccines were given in the exam room, the patient was sitting on the exam table, while the patient's mother had gone to another exam room, where the patient's sister was being seen. The nursing staff, then heard a loud noise and saw the patient slumping on the floor, in the hallway. The patient also looked pale and said that she felt sick after the shots. She had become stable after a few minutes and was able to drink water. The patient doesn't recall what had happened, she could only remember getting the shot but doesn't remember going out of the room. 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: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Blood lactic acid, Full blood count, Hypoaesthesia, Injection site erythema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641725) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included CLINDAGEL 0.1%. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiration date: 17-OCT-2017) (dose and frequency were not reported), dose 1, intramuscularly in the left arm for prophylaxis.  Other suspect therapies included BOOSTRIX batch/lot # 92N9B, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5216AA, dose 1, intramuscularly in the left arm for prophylaxis. On 24-JUN-2016, the patient complained of redness, swelling in the left arm, pain to the site and the patient also underwent shoulder ultrasound, CBC, CMP (metabolic function test), UA (urine analysis), lactate level test (blood lactic acid). On 25-JUN-2016, the patient complained of pain to the site with continuous redness and swelling, (R) shin pain, (R) wrist pain and numbness to (R) top on the foot. The patient was seen at the ER. Follow-up visit was scheduled on 27-JUN-2016. The patient also had a possible bug bite and possible puncture site on (R) foot. The outcome of vaccination site swelling, urine analysis, ultrasound joint, pain in extremity, metabolic function test, injection site pain, injection site erythema, hypoaesthesia, blood lactic acid and arthralgia was reported as recovered. The 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 pain, Metabolic function test, Pain in extremity, Peripheral 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 (VAERS # 641725) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included CLINDAGEL 0.1%. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiration date: 17-OCT-2017) (dose and frequency were not reported), dose 1, intramuscularly in the left arm for prophylaxis.  Other suspect therapies included BOOSTRIX batch/lot # 92N9B, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5216AA, dose 1, intramuscularly in the left arm for prophylaxis. On 24-JUN-2016, the patient complained of redness, swelling in the left arm, pain to the site and the patient also underwent shoulder ultrasound, CBC, CMP (metabolic function test), UA (urine analysis), lactate level test (blood lactic acid). On 25-JUN-2016, the patient complained of pain to the site with continuous redness and swelling, (R) shin pain, (R) wrist pain and numbness to (R) top on the foot. The patient was seen at the ER. Follow-up visit was scheduled on 27-JUN-2016. The patient also had a possible bug bite and possible puncture site on (R) foot. The outcome of vaccination site swelling, urine analysis, ultrasound joint, pain in extremity, metabolic function test, injection site pain, injection site erythema, hypoaesthesia, blood lactic acid and arthralgia was reported as recovered. The 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: 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 # 641725) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included CLINDAGEL 0.1%. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiration date: 17-OCT-2017) (dose and frequency were not reported), dose 1, intramuscularly in the left arm for prophylaxis.  Other suspect therapies included BOOSTRIX batch/lot # 92N9B, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5216AA, dose 1, intramuscularly in the left arm for prophylaxis. On 24-JUN-2016, the patient complained of redness, swelling in the left arm, pain to the site and the patient also underwent shoulder ultrasound, CBC, CMP (metabolic function test), UA (urine analysis), lactate level test (blood lactic acid). On 25-JUN-2016, the patient complained of pain to the site with continuous redness and swelling, (R) shin pain, (R) wrist pain and numbness to (R) top on the foot. The patient was seen at the ER. Follow-up visit was scheduled on 27-JUN-2016. The patient also had a possible bug bite and possible puncture site on (R) foot. The outcome of vaccination site swelling, urine analysis, ultrasound joint, pain in extremity, metabolic function test, injection site pain, injection site erythema, hypoaesthesia, blood lactic acid and arthralgia was reported as recovered. The 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: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no current illnesses and medical history and the patient's prior vaccinations was not reported. The patient's other medications included Ibuprofen and Tylenol taken after shot given but didn't help. On 23-JUN-2016, the patient was vaccinated with of GARDASIL 9, lot # M005714 and expiration date: 03-OCT-2017, intramuscularly in the right arm (dose number, dose and frequency unknown) for prophylaxis. And the same day, patient experienced deep aching pain in right deltoid and had difficulty moving arm in full ROM. The outcome of injected limb mobility decreased and injection site pain 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: Back pain, Body temperature increased, Headache, Malaise, Neck pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's other medications included Vyvanse 40 mg one cap PO (orally) daily, Trazodone 50 mg one tablet PO (orally) QHS (every night at bed time), Intuniv 3 mg one tab PO (orally) QHS (every night at bed time). The patient's medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis, severe insomnia and mood swings. On 07-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L013429 and expiration date: 21-JUL-2017, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number 1; vaccinated date: 07-JUL-2016, intramuscularly in the left arm, lot # GS58R, (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 07-JUL-2016, intramuscularly in the left arm, lot # U5228BA, (dose, frequency and lot expiration date unknown). On 07-JUL-2016, the patient had elevated temperature (body temperature increased), headache, neck pain, back pain, vomiting, and general malaise. On 08-JUL-2016, the patient was evaluated in the clinic and her temperature was 101.4 F (Fahrenheit). The patient was having mild headache, but neck pain and back pain were gone. Physical examination of the patient was negative for acute infection, then she received Benadryl 25 mg injection and oral Tylenol. The patient was discharged home with a prescription of oral Prednisone 10 mg to take for five days and instructions to continue Benadryl 25 mg every 8 hours for 3 days. The outcome of back pain, vomiting, malaise, headache, body temperature increased and neck pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's other medications included Vyvanse 40 mg one cap PO (orally) daily, Trazodone 50 mg one tablet PO (orally) QHS (every night at bed time), Intuniv 3 mg one tab PO (orally) QHS (every night at bed time). The patient's medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis, severe insomnia and mood swings. On 07-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L013429 and expiration date: 21-JUL-2017, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number 1; vaccinated date: 07-JUL-2016, intramuscularly in the left arm, lot # GS58R, (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 07-JUL-2016, intramuscularly in the left arm, lot # U5228BA, (dose, frequency and lot expiration date unknown). On 07-JUL-2016, the patient had elevated temperature (body temperature increased), headache, neck pain, back pain, vomiting, and general malaise. On 08-JUL-2016, the patient was evaluated in the clinic and her temperature was 101.4 F (Fahrenheit). The patient was having mild headache, but neck pain and back pain were gone. Physical examination of the patient was negative for acute infection, then she received Benadryl 25 mg injection and oral Tylenol. The patient was discharged home with a prescription of oral Prednisone 10 mg to take for five days and instructions to continue Benadryl 25 mg every 8 hours for 3 days. The outcome of back pain, vomiting, malaise, headache, body temperature increased and neck pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Deafness, Dizziness, Dyskinesia, Haemoglobin normal
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no other medications, current illnesses and medical history. The patient's, prior vaccinations was not reported. On 13-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L044475 and expiration date: 12-MAY-2017, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number 1; vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # Z9Z4Y, (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # U5228BA, (dose, frequency and lot expiration date unknown). On 13-JUL-2016, the patient stated she could not hear, felt faint, pale in color, patient had slight jerk of movement and had to be laid down. Laboratory tests were normal. The patient had random blood sugar and hemoglobin tests. The outcome of blood glucose, dizziness, pallor, laboratory test normal, haemoglobin, dyskinesia and deafness 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: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no other medications, current illnesses and medical history. The patient's, prior vaccinations was not reported. On 13-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L044475 and expiration date: 12-MAY-2017, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number 1; vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # Z9Z4Y, (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # U5228BA, (dose, frequency and lot expiration date unknown). On 13-JUL-2016, the patient stated she could not hear, felt faint, pale in color, patient had slight jerk of movement and had to be laid down. Laboratory tests were normal. The patient had random blood sugar and hemoglobin tests. The outcome of blood glucose, dizziness, pallor, laboratory test normal, haemoglobin, dyskinesia and deafness 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: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Electrocardiogram normal, Immediate post-injection reaction, Pregnancy test negative, 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 # 643631) on 02-MAY-2017. This spontaneous report refers to an 18 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included TRINESSA triphasic 35mcg daily. On 11-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 (expiration date: 28-AUG-2017) (dose and frequency were not reported), dose 2, intramuscularly in the right thigh (reported as right leg) for prophylaxis. Other suspect therapies included VAQTA lot # M009377 (expiration date: 17-JUN-2017), dose 2, intramuscularly in the left thigh (reported as left leg) and MENACTRA batch/lot # U5187AA, dose 2, intramuscularly in the right thigh (reported as right leg) for prophylaxis. On 11-JUL-2016, the patient became dizzy immediately after she received the vaccines. She laid in supine position for 30 minutes and drank fluids. The patient then felt better and left the office in a stable condition. As she was leaving the building she became syncopal and was seen in ER. The patient underwent urine analysis, electrocardiogram which were normal and also underwent a pregnancy test which was negative. The outcome of urine analysis normal, presyncope, pregnancy test negative, immediate post-injection reaction, electrocardiogram normal and dizziness was reported as recovered. 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: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Urine analysis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643631) on 02-MAY-2017. This spontaneous report refers to an 18 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included TRINESSA triphasic 35mcg daily. On 11-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 (expiration date: 28-AUG-2017) (dose and frequency were not reported), dose 2, intramuscularly in the right thigh (reported as right leg) for prophylaxis. Other suspect therapies included VAQTA lot # M009377 (expiration date: 17-JUN-2017), dose 2, intramuscularly in the left thigh (reported as left leg) and MENACTRA batch/lot # U5187AA, dose 2, intramuscularly in the right thigh (reported as right leg) for prophylaxis. On 11-JUL-2016, the patient became dizzy immediately after she received the vaccines. She laid in supine position for 30 minutes and drank fluids. The patient then felt better and left the office in a stable condition. As she was leaving the building she became syncopal and was seen in ER. The patient underwent urine analysis, electrocardiogram which were normal and also underwent a pregnancy test which was negative. The outcome of urine analysis normal, presyncope, pregnancy test negative, immediate post-injection reaction, electrocardiogram normal and dizziness was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, 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 # 643664) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, Expiry date: 03-OCT-2017, dose number 2 (dose frequency were not reported) via intramuscular route for prophylaxis. On the same day, the patient experienced syncopal seizures lasted for 10 seconds. The patient was fully recovered. The 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: Erythema, Pain, Skin warm, 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 # 643669) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's medical history and lab data were reported as not applicable. Patient had no concurrent illness. Information on patient's prior vaccination was not reported. Patient's other medication included PRILOSEC 20mg, nightly. On 14-JUL-2016, the patient was vaccinated with GARDASIL 9 lot/batch# M01117, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with BOOSTRIX lot/batch# 7RJ9B, dose 1, intramuscularly in the right arm and MENACTRA lot/batch# U5272AA, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On 15-JUL-2016, the patient had swelling, redness, warm to touch, felt painful. The outcome of the events were reported as recovered. The patient required emergency room visit. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood test, Cough, Diarrhoea, Lymph node pain, Lymphadenopathy
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 # 644317) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included allergies to AUGMENTIN and CEFZIL. The patient had no concurrent illnesses and other medications. On 20-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (Expiration date: 19-OCT-2017) dose 1 (unspecified dosage) via needle and syringe (not specified), in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5180AA dose 2 (unspecified dosage) via needle and syringe (not specified), in the right arm for prophylaxis. On 07-JUN-2016, the patient experienced intermittent cough, swollen lymph nodes in the groin, pain in the testicles, nausea, diarrhoea and painful lymph nodes in the groin. The patient required an emergency room visit and he also underwent blood test and 2 ultrasound scans. The patient had consulted three different specialists and a pediatrician. The patient's mother enquired on who would be reimbursing her, for the costs incurred due to the forced toxic immunization and also stated that the toxic vaccine, was making the patient sick. The outcome of the events was reported as not 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: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nausea, Specialist consultation, Testicular pain, 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 (VAERS # 644317) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's medical history included allergies to AUGMENTIN and CEFZIL. The patient had no concurrent illnesses and other medications. On 20-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (Expiration date: 19-OCT-2017) dose 1 (unspecified dosage) via needle and syringe (not specified), in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5180AA dose 2 (unspecified dosage) via needle and syringe (not specified), in the right arm for prophylaxis. On 07-JUN-2016, the patient experienced intermittent cough, swollen lymph nodes in the groin, pain in the testicles, nausea, diarrhoea and painful lymph nodes in the groin. The patient required an emergency room visit and he also underwent blood test and 2 ultrasound scans. The patient had consulted three different specialists and a pediatrician. The patient's mother enquired on who would be reimbursing her, for the costs incurred due to the forced toxic immunization and also stated that the toxic vaccine, was making the patient sick. The outcome of the events was reported as not 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, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644326) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient's medical history included inflammatory dermatitis. Information on the patient's prior vaccinations and the other medications were not reported. On 19-JUL-2016, the patient was vaccinated with the first dose GARDASIL 9 (batch/lot # 1024993 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5247AA, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5228BA, dose 1, intramuscularly in the right arm for prophylaxis. On 19-JUL-2016, the patient's right arm was red, swollen, warm and experienced cellulitis. The patient was treated with Clindamycin for cellulitis but possibility of reaction was still there. The outcome of skin warm, peripheral swelling, erythema and cellulitis was unknown. The 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: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Seizure, 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 # 644450) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 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 21-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # M005714 with expiration date : 03-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX lot # 943Z5, Manufacturer: GlaxoSmithkline and MENVEO, Lot # M15079, Manufacturer: Novartis, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day, 15 minutes post vaccination the patient experienced syncopal episode, hit back of head on wall and had seizure activity. The patient lab tests included computerized tomogram head negative and electrocardiogram normal. The patient required an emergency room (ER) visit. The outcome of computerised tomogram head normal, electrocardiogram normal, head injury, seizure and syncope was reported as recovered/resolved.  Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644455) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no medical history. Information on the patient's prior vaccinations, lab data, current illnesses and other medications were not reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 with needle and syringe in the right arm (reported as right deltoid), lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-JUL-2016, the patient experienced large local reaction, redness, swelling at injection location on right deltoid. The outcome of injection site erythema, local reaction and injection site swelling 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: 9.0
Sex: M
Vaccine: HEPA, HPV9, MMRV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, 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 # 644504) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 9 year old male patient. Information on the patient's prior vaccinations, lab data, current illnesses, medical history and other medications were not reported. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M011117 with expiration date: 07-DEC-2017 and second dose of PROQUAD subcutaneously in the right arm, lot # M004895 with expiration date: 26-JUL-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included first dose of HAVRIX, lot # 595MR and BOOSTRIX lot # GS5BR, intramuscularly in the left arm, Manufacturer: GlaxoSmithKline (dose, frequency and lot expiration date were not reported) for prophylaxis. On 22-JUL-2016, while bathing the patient the patient's mother was noticed that the patient had 2 inch wide and 4 inch long reddened, warm area on the back of right arm with complaint of mild itching and denied pain. No treatment was received. The outcome of erythema, pruritus and skin warm was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644842) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. The patient had no concurrent illnesses, other medications and medical history. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018) dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced headache, nausea, lightheadedness and impairment in activities of daily living. The patient did not experience syncope and emesis. The symptoms resolved on its own (self-limited), several hours after the vaccine administration. 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.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Lethargy, Nausea, Pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient. The patient's medical history, current illnesses and prior vaccinations were not reported. The patient's other medications included ADDERALL. On 25-JUL-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L026602 and expiration date: 19-OCT-2017, (route of administration reported as needle and syringe (not specified)) in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BEXSERO dose number 1; vaccinated date: 25-JUL-2016, (route of administration reported as needle and syringe (not specified)) in the left arm, lot # 157501, (dose, frequency and lot expiration date unknown). On 25-JUL-2016, the patient had pain down left side of the body (side of injection), lethargy, nausea, headache and fatigue. The outcome of lethargy, nausea, headache, fatigue and pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
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 # 645139) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's medical history included asthma. The patient's current illnesses included seasonal allergic rhinitis. Information on concomitant medications, lab data and prior vaccinations were not reported. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764, Expiry date: 30-JAN-2018, dose number 1 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, Vaccinated date: 20-JUL-2016, lot # UI568AA, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm and MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 20-JUL-2016, lot # U5282BD, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On an unknown date, the patient experienced injection site erythema and injection site induration on right lateral deltoid measuring 15cmx8cm. The outcome of injection site erythema and injection site induration were unknown. The patient required an emergency room visit. The 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, MENB, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea, 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 # 645201) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 17 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764, Expiry date: 30-JAN-2018, dose number 1 (dose and frequency unknown) via intramuscular route in the right arm and VARIVAX lot # M004329, dose number 2 (dose, frequency and lot expiration date unknown) via subcutaneous route in the left arm for prophylaxis. Other suspect therapies included BEXSERO (Manufacturer: Novartis, Vaccinated date: 19-JUL-2016, lot # M15124, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day, approximately 10 minutes after immunizations given patient became very pale, dizzy, diaphoretic and complained of nausea. Patient transferred to bed via wheelchair and lied down in darkroom. Ammonia inhalant was used prior to patient being transferred to wheelchair. Patient required a very cool compress and was applied. H20, bed monitored for 20 minutes with no further complains. Patient left facility with no issues or complaints and accompanied by his mother. The outcome of all 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: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Pain, 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 # 645292) 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 concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 27-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L037554 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included first dose ADACEL intramuscularly in the right arm, lot # U5378AA and MENACTRA intramuscularly in the left arm, lot # U5228BB, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On 28-JUL-2016, the patient experienced body ache, fever 101.8 and headache. The outcome of headache, pain and pyrexia was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 645729) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder (ADD), scoliosis, Lyme disease in 2012 and language disorder. The patient had no concurrent illnesses. Information about the patient's other medications and prior vaccinations were not reported. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (Expiration date: 03-OCT-2017) dose 3 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 30-JUL-2016, the patient experienced urticaria. The outcome of urticaria was reported as unknown. The causality assessment for urticaria was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Electrocardiogram, Full blood count, Head injury, Loss of consciousness, Metabolic function test
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 # 646065) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on the patient's prior vaccinations, current illnesses, medical history and other medications were not reported. On 01-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M011117 with expiration date: 07-DEC-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included first dose of TRUMENBA intramuscularly in the right arm, lot # M68769, Manufacturer: Pfizer/Wyeth (dose, frequency and lot expiration date were not reported) for prophylaxis. After few seconds of vaccination, the patient complained that she couldn't see and she passed out. She hit her head on a chair. The patient was picked up and laid her on exam table. The patient was given an ice pack, her blood pressure (BP) and pulse were checked. The patient went for labs and electrocardiogram (EKG). The patient's lab data included complete blood count (CBC), comprehensive metabolic panel (CMP). The outcome of events electrocardiogram, full blood count, head injury, loss of consciousness, metabolic function test and visual impairment was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
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 # 646065) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on the patient's prior vaccinations, current illnesses, medical history and other medications were not reported. On 01-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M011117 with expiration date: 07-DEC-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included first dose of TRUMENBA intramuscularly in the right arm, lot # M68769, Manufacturer: Pfizer/Wyeth (dose, frequency and lot expiration date were not reported) for prophylaxis. After few seconds of vaccination, the patient complained that she couldn't see and she passed out. She hit her head on a chair. The patient was picked up and laid her on exam table. The patient was given an ice pack, her blood pressure (BP) and pulse were checked. The patient went for labs and electrocardiogram (EKG). The patient's lab data included complete blood count (CBC), comprehensive metabolic panel (CMP). The outcome of events electrocardiogram, full blood count, head injury, loss of consciousness, metabolic function test and visual impairment was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient had no current illnesses. The patient's medical history included seasonal allergies and asthma. The patient's other medications included Zyrtec and Astelin (for seasonal allergies) and Advair. It was reported that Xopenex was not taken. The patient's prior vaccinations was not reported. On 01-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M009116, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included MENVEO dose number 1; vaccinated date: 01-AUG-2016, intramuscularly in the left arm, lot # M15149, (dose, frequency and lot expiration date unknown). The patient did not look at injection site unless it was tender the next day on 02-AUG-2016, the same day she noted and marked red area at 2 pm noon when she felt the soreness. Initially red area measured 6 x 6.5 cm and red area enlarged in size, now noted to be 11 cm in length. The patient had no induration and heat. The outcome of injection site erythema and injection site pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
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 # 647067) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L027282, intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 09-AUG-2016, intramuscularly in the right arm, lot# U5185BA; dose and expiration date unknown). On the same day, the patient experienced syncope. Patient was placed in supine position with legs elevated. The outcome of syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Amnesia, Fall, Head injury, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647085) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 08-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011117, Expiry date: 07-DEC-2017 dose number 1 (dose and frequency unknown) via intramuscular route in the left arm and VAQTA lot # M003011, expiry date: 15-NOV-2017, dose number 1 (dose and frequency unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 08-AUG-2016, lot # U5272AA, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On the same day, post vaccination with GARDASIL 9 patient was fine immediately after shots and walked to the checkout counter with no issues. About 5 minutes after vaccination, patient experienced a syncope episode at the checkout window. When nurse checked on patient he was coming back around and responsive. Patient was able to follow commands and sit up on his own. Patient drank a cup of water and ate a granola bar without difficulty. Patient was moved into an exam room where Doctor examined him. She noted no abnormalities at that time, but his mother was concerned because he hit his head when he fell. Patient stayed for 15 minutes longer and then was reassessed. His mother was concerned at that point because patient could not remember anything around the time of the syncopal episode. Patient's mother stated that she wanted to take patient to the Emergency room to be further evaluated. Doctor informed her that loss of memory is common with syncope, but she could take him to the Emergency room if that would make her more comfortable. The outcome of fall, syncope and head injury was 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 26-JUL-2016 at the pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 02-AUG-2016, the female patient was treated by physician for a vesicular outbreak that was diagnosed as severe shingles. The female patient was prescribed ZOVIRAX and acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.