chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pain, Pain in extremity, Vaccination complication
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659190) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 9 year old male patient. The patient's medical history included allergy to bee sting. Patient's other medications included gummy bits vitamins. Information on prior vaccinations were not reported. The patient had no concurrent illnesses. On 10-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M018810 (dose, frequency and lot expiration date were not reported), via unknown route in the left arm for prophylaxis. Other suspect therapies included FLUZONE Quadrivalent (dose number: 1, vaccinated date: 10-OCT-2016, intramuscularly in the right arm, lot# UI657AA; dose and expiration date unknown). On 11-OCT-2016, the patient experienced cellulitis, pain in extremity, pain, oedema, musculoskeletal pain, vaccination complication and erythema. Patient's right arm/shoulder developed cellulitis which was a possible reaction to the vaccine. The outcome of erythema, cellulitis, pain in extremity, pain, oedema and musculoskeletal 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: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Fatigue, Headache, Injection site erythema, 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 # 659343) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included autism and attention deficit/hyperactivity disorder. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 10-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M013636 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced back pain, neck pain, nausea, injection site erythema, fatigue and headache. Patient also experienced slight erythema around immunization site. The outcome of back pain, neck pain, nausea, injection site erythema, fatigue and headache 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: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659343) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included autism and attention deficit/hyperactivity disorder. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 10-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M013636 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced back pain, neck pain, nausea, injection site erythema, fatigue and headache. Patient also experienced slight erythema around immunization site. The outcome of back pain, neck pain, nausea, injection site erythema, fatigue and headache 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: 56.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous case initially received on 14-Oct-2016, was reported by a health professional and concerns a 66-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received ALFURIA on 06-OCT-2016. Dose regimen: 0.5mL, Route of administration: Intramuscular, Batch number: WT54106. Non-company suspect drugs: The patient also received PREVNAR on 06-OCT-2016 in the same arm as AFLUIRA administration (special circumstances: drug administration error not explicitly reported). Adverse reactions/events and outcomes: On an unknown date, the patient's arm was sore and red (outcome: unknown). As of 14-OCT-2016, the patient's arm was still sore and red. Reporter's comments: The reporter considered the events as non-serious.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, 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 # 660057). This spontaneous report refers to a 5 year old male patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 07-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L036301, dose 1, route: unknown in the left arm for prophylaxis. Drug was administered to patient of inappropriate age and patient had no adverse event or symptoms. Patient's mother was informed as a part of treatment. A call was made to patient's family the next day to check on child and was reported that he was fine without symptoms of fever or redness in left arm. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
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 # 660413). This spontaneous report refers to a 23 year old female patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 11-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L036301, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient passed out and she required emergency room visit. The outcome of the event was reported as recovered. The causality assessment for the event 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: 13.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain lower, Blood creatine phosphokinase normal, C-reactive protein normal, Full blood count normal, Metabolic function test 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 # 660692). This spontaneous report refers to a 13 year old patient of unknown gender. Information on patient's current illnesses, other medications and prior vaccinations was not reported. The patient's medical history included asthma. On 09-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M026306, dose 1, intramuscularly in the left arm and VAQTA lot # M018644, dose 2, intramuscularly in the left arm for prophylaxis. On 21-SEP-2016, the patient developed lower abdominal pain radiating to right thigh. On 29-SEP-2016, patient complained of myalgia in left arm and both legs on visit. Examinations done on 30-SEP-2016, complete blood count (CBC), comprehensive metabolic panel (CMP), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine kinase were normal. By 03-OCT-2016, patient marked improvement and was back to normal activities. 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: 13.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate 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 # 660692). This spontaneous report refers to a 13 year old patient of unknown gender. Information on patient's current illnesses, other medications and prior vaccinations was not reported. The patient's medical history included asthma. On 09-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M026306, dose 1, intramuscularly in the left arm and VAQTA lot # M018644, dose 2, intramuscularly in the left arm for prophylaxis. On 21-SEP-2016, the patient developed lower abdominal pain radiating to right thigh. On 29-SEP-2016, patient complained of myalgia in left arm and both legs on visit. Examinations done on 30-SEP-2016, complete blood count (CBC), comprehensive metabolic panel (CMP), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine kinase were normal. By 03-OCT-2016, patient marked improvement and was back to normal activities. 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: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 660852) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's other medications included guanfacine, methylphenidate and medical history included Attention deficit/hyperactivity disorder (ADHD), tic disorder, communication disorder and anxiety. The patient had no concurrent illnesses. On 28-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # L036301 dose 3, intramuscularly in the right arm and VAQTA lot # M001815 dose 2, intramuscularly in the right arm for prophylaxis. On 20-OCT-2016, the patient experienced injection site redness, injection site swelling and injection site pain over the right shoulder. The outcome of injection site erythema, injection site swelling and injection site pain was 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: Cellulitis, Erythema, Hypersensitivity, 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 # 661463) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. The patient's other medications was reported as unknown. On 18-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M017983 dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # M15166 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. The patient's mother reported that, the next morning after the day of vaccine administration, she noticed that the patient's left arm had turned red and swollen. Due to which, the patient required an emergency room visit on 19-OCT-2016. The patient was diagnosed with allergic reaction and cellulitis. The patient was treated with prednisone and Bactrim. 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: FLU4, 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 # 661580). This spontaneous report refers to a 15 year old male patient. The patient's concurrent illnesses and medical history were reported as none. Other medications included Multivitamin (MVI). On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M020103, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included FLUZONE (lot # UI62AC, dose 12, intramuscularly in the right arm). Within 2 minutes after vaccination, patient had syncopal event that lasted approximately 1 minute. The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pain in extremity, Pyrexia, 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 # 661814). This spontaneous report refers to a 16 year old male patient. The patient's concurrent illnesses and medical history were reported as none. On 11-OCT-2016, the patient was vaccinated with GARDASIL 9, lot# L014458, dose 2, intramuscularly in the left arm for prophylaxis. On 12-OCT-2016, approximately 24 hours after vaccination, the patient experienced dizziness, swelling, pyrexia and pain in extremity (arm). Patient had an emergency room visit. On 13-OCT-2016 and 14-OCT-2016, the patient called office to report complaints. The outcome of dizziness, swelling, pyrexia 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: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Influenza virus test, Myalgia, Oropharyngeal 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 # 661902). This spontaneous report refers to a 12 year old male patient. The patient's history included evaluation for attention deficit/hyperactivity disorder (ADHD) and current illnesses include decreased appetite. On 12-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUZONE QUADRIVALENT lot # UT5673JA, intramuscularly in the left arm. On 13-OCT-2016, the patient had muscle aches, sore throat and felt feverish. On the same day, the patient underwent flu test (influenza virus test) and he required emergency room visit. The outcome of the events was reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLUX, HPV9, MEN, TDAP, FLUX, HPV9, MEN, TDAP
Symptoms: Dizziness, Feeling hot, Insomnia, Lethargy, 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 # 662082) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included allergies to pollen. The patient had no concurrent illnesses. Information on the patient's other medications and prior vaccinations were not reported. On 25-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (site: left arm; route, lot# and expiration date were not reported). On the same day, the patient was also vaccinated with MENOMUNE (manufacturer: Sanofi Pasteur, dose number, route, site, lot# and expiration date were not reported), BOOSTRIX (manufacturer: GlaxoSmithKline, dose number, route, site, lot# and expiration date were not reported) and influenza virus vaccine (unspecified) (manufacturer: unknown, dose number, route, site, lot# and expiration date were not reported) for prophylaxis. On the same day, the patient had nausea, dizziness, insomnia and was feeling hot and lethargic. The outcome for the events feeling hot, nausea, dizziness, lethargy and insomnia were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case, initially received on 01-Nov-2016, was reported by a health professional and concerns a 60 years old female patient. Weight: not provided: Height: not provided. Past medical history includes breast cancer. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 22-OCT-2016 to 22-OCT-2016. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non-company suspect drugs: ZOSTAVAX, batch number: M019646, expiry date: 18-Jul-2017. Adverse reactions/events and outcomes: In Oct-2016, the patient experienced Itching about 4 inches in diameter at the injection site (outcome: Not recovered/Not resolved), Redness about 4 inches in diameter at the Injection site (outcome: Not recovered/Not resolved), Warmth about 4 inches in diameter at the injection site (outcome: Not recovered/Not resolved). The patient reported that the size of the affected area was now decreased to a 3 inch area as of 26-Oct-2016.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 01-Nov-2016, was reported by a health professional and concerns a 60 years old female patient. Weight: not provided: Height: not provided. Past medical history includes breast cancer. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 22-OCT-2016 to 22-OCT-2016. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non-company suspect drugs: ZOSTAVAX, batch number: M019646, expiry date: 18-Jul-2017. Adverse reactions/events and outcomes: In Oct-2016, the patient experienced Itching about 4 inches in diameter at the injection site (outcome: Not recovered/Not resolved), Redness about 4 inches in diameter at the Injection site (outcome: Not recovered/Not resolved), Warmth about 4 inches in diameter at the injection site (outcome: Not recovered/Not resolved). The patient reported that the size of the affected area was now decreased to a 3 inch area as of 26-Oct-2016.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test negative, Facial paralysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 663083) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 22-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M018810 dose 1 in the left arm (route: unknown) for prophylaxis. On 23-SEP-2016, 1 day after vaccination, the patient experienced facial paralysis and underwent Borrelia test which was negative. The patient's Lyme titer was negative. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, IPV, TD, VARCEL
Symptoms: Rash
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 # 663185). This spontaneous report refers to a 17 year old female patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 29-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L038503, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VARIVAX lot # M000760 (expiry date: 06-JAN-2018), dose 2, via subcutaneous route in the right arm; TENIVAC lot # C4736CA, dose 1, intramuscularly in the right arm and IPOL lot # M13531M, dose 2, via subcutaneous route in the right arm. On the same day, the patient had rash on left arm and neck and was not sure if rash was present prior to vaccination. The patient was given Benadryl intramuscular (IM) 25 mg, Zyrtec oral (po) 10 mg and 30 minutes later Benadryl 12.5 mg, IM and Depo-Medrol 40 mg, IM were given. Patient was not in distress and pulse oximetry was 99%, room air. The outcome of the event rash was reported as recovered. The causality assessment of the event rash with respect to GARDASIL 9 and VARIVAX was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Radiculitis brachial
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 # 663208) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old female patient. The patient's other medications, concurrent illnesses, prior vaccination details and pertinent medical history were not reported. On 11-DEC-2015 the patient was vaccinated with GARDASIL 9 dose 2, intramuscularly in the left arm for prophylaxis. On an unknown date the patient experienced brachial neuritis. The outcome of the event was 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: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, 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 # 663392). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and the patient's medical history was not reported. Other medications included ALLEGRA. On 28-OCT-2016, the patient was vaccinated with GARDASIL 9, lot# M0323BD, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included ADACEL (lot# U5486AB, dose 1, intramuscularly in the left arm), FLUZONE Quadrivalent (lot# UT669AB, dose 2, intramuscularly in the right arm) and MENACTRA (lot# U5513AA, dose 1, intramuscularly in the right arm). On 29-OCT-2016, the patient's left arm was swollen and had redness down the arm. The outcome of erythema and peripheral swelling 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, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 663461). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses and other medications were reported as none. The patient's medical history included asthma. On 10-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # L040054, dose 1, via unknown in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included BOOSTRIX (lot # 2729X, dose 1, via unknown in the right arm) and MENACTRA (lot # U5180AA, dose 1, via unknown in the left arm). On the day of vaccination, patient became lightheaded, nauseated, sweaty, and pale after receiving TDAP, MENACTRA, and HPV vaccine. Patient complained of tingling in his left arm after receiving MENACTRA. These events were notified to the doctor. Patient observed in office for 30 minutes. Symptoms subsided after 10-20 minutes. The outcome of dizziness, paraesthesia, pallor, nausea and hyperhidrosis 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: U
Vaccine: HPV9
Symptoms: Incorrect product storage
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 # 663465) on 02-MAY-2017. This spontaneous report refers to a 11 year old patient (gender: unknown). Information on the patient's medical history, concurrent illnesses, other medications, lab data and prior vaccinations were not reported. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (route and site: unknown; dose number, lot # and expiration date were not reported). The medical clinic was part of the VFC program and one of the VFC refrigerators malfunctioned and created a too low temperature for vaccines to be viable. The patient received vaccination due to human error in not pulling the non-viable vaccines from refrigerator when it was reported that all non-viable vaccines were pulled correctly and transferred correctly. After speaking with all pharmaceutical companies regarding the patient receiving non-viable vaccines, the patient was recalled and was told that the patient would received the vaccine as soon as possible. Age of the patient at the time of event: 11 years 6 months. The outcome of the event was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature, Cough, Mobility decreased, Muscular weakness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 663554). This spontaneous report refers to a 14 year old male patient. The patient had no current illnesses and other medications. The patient's medical history included penicillin allergy. On 17-OCT-2016 at 16:00, the patient was vaccinated with GARDASIL 9 lot # M026306, dose 3, intramuscularly in the left deltoid for prophylaxis and later that evening, patient had left arm pain which persisted but he slept fine. On the day of report, pain persisted with nausea and temperature: 100.5 (units not reported) at 17:30. The patient was unable to raise his arm above shoulder level and had symptoms of cough and legs weakness. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664006). This spontaneous report refers to a 13 year old male patient. Currently the patient was well child and had no known allergies (NKA). On 19-OCT-2016, the patient was vaccinated with GARDASIL 9, lot# M009328, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included FLUARIX (lot# 2994A, dose 5, intramuscularly in the left arm). On 20-OCT-2016, 1 day following HPV vaccine, the patient experienced headache. The outcome of headache 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: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, 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 # 664301). This spontaneous report refers to a 18 year old female patient. The patient was well child when checked. The patient's medical history included asthma and depression/anxiety. Historical drugs included Azithromycin. On 26-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M017983 (expiry date: 30-MAY-2018), dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included MENVEO (lot # M16006, intramuscularly in the left arm). On the day of vaccination, the patient experienced diarrhoea, abdominal pain upper, vomiting and hyperhidrosis. The outcome of abdominal pain upper, vomiting, hyperhidrosis and diarrhoea 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: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling, Interchange of vaccine products
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 # 664316). This spontaneous report refers to a 15 year old female patient. The patient's concurrent illnesses was reported as none and medical history was not reported. On 10-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M030380, dose 2, via unknown route in the left arm for prophylaxis. On the same day, the patient experienced pain, injection site erythema, injection site mass, injection site paraesthesia and injection site swelling. Patient's bump measures 2 x 1.5 cm when lifts up arm up. The outcome of injection site erythema, pain, injection site swelling, injection site paraesthesia and injection site mass 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: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site paraesthesia, Injection site swelling, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664316). This spontaneous report refers to a 15 year old female patient. The patient's concurrent illnesses was reported as none and medical history was not reported. On 10-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M030380, dose 2, via unknown route in the left arm for prophylaxis. On the same day, the patient experienced pain, injection site erythema, injection site mass, injection site paraesthesia and injection site swelling. Patient's bump measures 2 x 1.5 cm when lifts up arm up. The outcome of injection site erythema, pain, injection site swelling, injection site paraesthesia and injection site mass 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: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Crying, Dyskinesia, Eye movement disorder, Fatigue, Hypersomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 665679) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and lab data were not reported. The patient's first HPV was the quadrivalent vaccine. On 11-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm (dose number 2; lot # and expiration date was not reported) and FLUZONE QUADRIVALENT (intramuscularly in the left arm; dose number, lot # and expiration date were not reported) for prophylaxis. On the same day, the patient was nervous at the immediate time period right before the shots were administered. She then said that it hurt a lot. Approximately 1-2 minutes later, the patient said that she felt sick. She was white as a sheet and fainted leaning forward. The patient was caught and laid her down across her sister who was seated on the exam table. The patient's eyes rolled back, she started smacking her lips and then had small jerking movements of all four extremities. This lasted approximately for 10 seconds. The patient then woke up and complained of not being able to hear and she started crying. She calmed down after several minutes and she was laid down for 15 minutes after which she was given juice. She had fatigue and was subdued for the next 36 hours. That night, the patient slept for 11 hours which was atypical and then stayed in bed the next day until the evening. The outcome of the events was reported as recovered. 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: FLU4, HPV9
Symptoms: Hypoacusis, Malaise, Pain, Pallor, Posture abnormal
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 # 665679) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and lab data were not reported. The patient's first HPV was the quadrivalent vaccine. On 11-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm (dose number 2; lot # and expiration date was not reported) and FLUZONE QUADRIVALENT (intramuscularly in the left arm; dose number, lot # and expiration date were not reported) for prophylaxis. On the same day, the patient was nervous at the immediate time period right before the shots were administered. She then said that it hurt a lot. Approximately 1-2 minutes later, the patient said that she felt sick. She was white as a sheet and fainted leaning forward. The patient was caught and laid her down across her sister who was seated on the exam table. The patient's eyes rolled back, she started smacking her lips and then had small jerking movements of all four extremities. This lasted approximately for 10 seconds. The patient then woke up and complained of not being able to hear and she started crying. She calmed down after several minutes and she was laid down for 15 minutes after which she was given juice. She had fatigue and was subdued for the next 36 hours. That night, the patient slept for 11 hours which was atypical and then stayed in bed the next day until the evening. The outcome of the events was reported as recovered. 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: FLU4, HPV9
Symptoms: Syncope, Tardive dyskinesia
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 # 665679) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and lab data were not reported. The patient's first HPV was the quadrivalent vaccine. On 11-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm (dose number 2; lot # and expiration date was not reported) and FLUZONE QUADRIVALENT (intramuscularly in the left arm; dose number, lot # and expiration date were not reported) for prophylaxis. On the same day, the patient was nervous at the immediate time period right before the shots were administered. She then said that it hurt a lot. Approximately 1-2 minutes later, the patient said that she felt sick. She was white as a sheet and fainted leaning forward. The patient was caught and laid her down across her sister who was seated on the exam table. The patient's eyes rolled back, she started smacking her lips and then had small jerking movements of all four extremities. This lasted approximately for 10 seconds. The patient then woke up and complained of not being able to hear and she started crying. She calmed down after several minutes and she was laid down for 15 minutes after which she was given juice. She had fatigue and was subdued for the next 36 hours. That night, the patient slept for 11 hours which was atypical and then stayed in bed the next day until the evening. The outcome of the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 21-Oct-2016, was reported by a health professional and concerns a 63-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 18-OCT-2016 to 18-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Oct-2016, the patient experienced 2x2 circle erythema around injection site (outcome: Unknown), 2x2 circle raised around injection site (outcome: Unknown), Warm to touch (injection site) (outcome: Unknown).
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous case initially received on 21-Oct-2016, was reported by a health professional and concerns a 37-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s). The patient received AFLURIA from 18-OCT-2016 to 18-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57308. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Oct-2016, the patient felt feverish (outcome: unknown), however, they did not have a fever, and experienced symptoms of malaise (outcome: unknown).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous case initially received on 21-Oct-2016, was reported by a health professional and concerns a(n) 41-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 18-OCT-2016 to 18-OCT-2016 Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57308. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-OCT-2016, the patient experienced Felt feverish (outcome: Unknown), however did not have a fever and developed Malaise (outcome: Unknown).
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Crying, Depressed mood, Emotional disorder, Inappropriate affect
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 # 668338). This spontaneous report refers to a 14 year old female patient. The patient had no current illnesses, medical history and other medications. On 27-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M018810 (expiry date: 28-MAY-2018), dose 1, route: needle and syringe (not specified further) in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUZONE QUADRIVALENT lot # UI678AA, dose 1, intramuscularly in the left arm. On 27-OCT-2016, patient's parents stated that she became overwhelmed with emotion, both sadness and happiness, was uncontrollably sobbing and then laughing. She acted as if she was under the influence of drugs and it subsided about one and half hours later and she appeared to be crashing from a high. At bedtime, she had further episodes and the next night, she was more sad at bedtime but not as intense. To patient's parents it seemed like the vaccination effected her "affect" or maybe serotonin. The patient also had the flu vaccine at the same time and same arm but she has had flu vaccines before without any incident. The outcome of the event was reported as recovered. The causality assessment for the event 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: 27.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Hypersomnia, Myalgia, Neck pain
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Drug history included Penicillin (Reaction: Drug reactions/Allergies: penicillin). Concomitant medication: not reported. Administration of company suspect drug(s): The patient received Influenza Vaccine (INN) on 10-OCT-2016. Dose regimen: Not reported, Route of administration: not reported, Batch number, Not reported. Non-company suspect drugs: On 10-Oct-2016, the patient also received VARIVAX, Route: intramuscular, Batch number: L021211. This was the fourth time she received VARIVAX vaccine as she was already vaccinated on unspecified dates in 2001, 2009 and 2011. Patient stated that on an unspecified date in 2015 she had blood work drawn to 'check varicella titers' and stated she 'was still protected but was told that my titers were right on the border of not being protected. That is why I received another dose on 10-Oct-2016'. Adverse reactions/events and outcomes: On the next morning, the patient experienced Muscle aches (outcome: Not Reported), Sleeping a lot more than normal (outcome: Not Reported), and Sore neck (outcome: Not Reported). No treatment was given. No further information provided.
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal discomfort, Blindness, 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 # 670359). This spontaneous report refers to a 10 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M009362, dose 1, via unknown route in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included MENACTRA (lot # U5392AA, dose 1, via unknown route in the left arm). On the day of vaccination, the patient experienced dizziness, stomach discomfort and intermittent blindness for 3 days. The patient had an emergency room visit. The outcome of abdominal discomfort, dizziness and blindness 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: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-Dec-2016, was reported by a non health professional and concerns a 66-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Site: Left arm. Non-company suspect drugs: PNEUMOVAX 23, Indication: Immunisation for the prevention of pneumococcal disease. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. Site: Right arm. Adverse reactions/events and outcomes: On 09-Nov-2016, the patient experienced Could not open car door or raise right arm past hips (outcome: Not recovered / Not resolved), Pain in right shoulder / Pain circling to shoulders (outcome: Not recovered / Not resolved), Right arm was extremely painful (outcome: Not recovered / Not resolved), Right arm was red (outcome: Not recovered / Not resolved), Right arm was swollen (outcome: Not recovered / Not resolved).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 05-Dec-2016, was reported by a non health professional and concerns a 66-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Site: Left arm. Non-company suspect drugs: PNEUMOVAX 23, Indication: Immunisation for the prevention of pneumococcal disease. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. Site: Right arm. Adverse reactions/events and outcomes: On 09-Nov-2016, the patient experienced Could not open car door or raise right arm past hips (outcome: Not recovered / Not resolved), Pain in right shoulder / Pain circling to shoulders (outcome: Not recovered / Not resolved), Right arm was extremely painful (outcome: Not recovered / Not resolved), Right arm was red (outcome: Not recovered / Not resolved), Right arm was swollen (outcome: Not recovered / Not resolved).
Sex: U
Vaccine: DTAPIPVHIB, HPV9
Symptoms: Wrong drug 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 # 671415) on 02-MAY-2017. This spontaneous report refers to a 3 months old patient (gender unknown). Information on the patient's medical history, concurrent illnesses, other medications, lab data and prior vaccinations were not reported. On 07-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot # L016429; route and site: unknown; lot expiration date: 09-AUG-2017; dose number was not reported) and PENTACEL (manufacturer: Sanofi Pasteur; route and site: unknown; dose number, lot # and expiration date were not reported) for prophylaxis. The patient was administered a wrong drug (GARDASIL 9) thinking it was PENTACEL. The outcome of the event was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 671719) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient's medical history and concurrent illnesses were reported as none. The patient's other medications and prior vaccinations were not reported. On 26-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L036301 (dose number and lot expiration date were not reported) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (intramuscularly in the left arm, lot # M37315, manufacturer: Pfizer/Wyeth; dose number and lot expiration date were not reported) and HAVRIX (intramuscularly in the left arm, lot # 9554N, manufacturer: GlaxoSmithKline; dose number and lot expiration date were not reported) for prophylaxis. Since the evening of vaccination, the patient experienced intermittent tingling in the right arm and referred to a neurologist. The patient's lab data was reported as none. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.