chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 606852) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications included antidepressant, orthotricyclen and patient could not recall the other names. On 29-SEP-2015 the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L007560, dose 1, intramuscularly in the left arm for prophylaxis. On 29-SEP-2015, 1 hour after vaccination, the patient experienced injection site pain and injection site swelling and continued throughout the day. This was reported to Co. Health department on 26-OCT-2015. Reports indicated that the patient did not follow up with the provider and no analgesics, cold pack or warm pack to comfort site or symptoms were given. The outcome of injection site pain and injection site swelling were reported as not recovered/not resolved. 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 culture, Culture throat, Oropharyngeal pain, Pharyngeal oedema, 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 # 606975) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 02-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # K026245, (lot expiry date, dose number, dose, frequency, route and site of administration were not reported) for prophylaxis. Other suspect therapies included ADACEL (vaccinated date: 02-NOV-2015, lot # C4714AA, lot expiry date, dose number, dose, frequency, route and site of administration were not reported) and MENACTRA (vaccinated date: 02-NOV-2015, lot # U4986AA, lot expiry date, dose number, dose, frequency, route and site of administration were not reported) for prophylaxis. On the same day, the patient underwent ultrasound scan, blood culture and throat culture were performed and also experienced rash, pharyngeal oedema and oropharyngeal pain. The patient was taken to emergency room. The outcome of all the events 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 606975) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 02-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # K026245, (lot expiry date, dose number, dose, frequency, route and site of administration were not reported) for prophylaxis. Other suspect therapies included ADACEL (vaccinated date: 02-NOV-2015, lot # C4714AA, lot expiry date, dose number, dose, frequency, route and site of administration were not reported) and MENACTRA (vaccinated date: 02-NOV-2015, lot # U4986AA, lot expiry date, dose number, dose, frequency, route and site of administration were not reported) for prophylaxis. On the same day, the patient underwent ultrasound scan, blood culture and throat culture were performed and also experienced rash, pharyngeal oedema and oropharyngeal pain. The patient was taken to emergency room. The outcome of all the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, PPV
Symptoms: Seizure
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 # 608112) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient's medical history included aortic valve disorder, aortic valve regurgitation, eosinophilic oesophagitis and major cardiovascular surgery. Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 15-OCT-2015 the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot# 1019287, dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included PNEUMOVAX 23 (dose, frequency and lot expiration date were not reported) (dose number: 1, vaccinated date: 15-OCT-2015, lot# K007826; dose and expiration date unknown) intramuscularly in the right arm, MENACTRA (dose number: 2, vaccinated date: 15-OCT-2015, lot# U5026CA; dose and expiration date unknown) and FLUVIRIN dose, frequency and lot expiration date were not reported) (dose number: 3, vaccinated date: 15-OCT-2015, lot# 157703; dose and expiration date unknown) intramuscularly in the right arm. On 04-NOV-2015, the patient underwent seizure. The outcome of seizure 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
Symptoms: Crying, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-614191). This spontaneous report refers to a 11 year old female patient. On 03-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L016428, dose 1 (unknown dosage regimen), in the left arm for prophylaxis. Other suspect therapies included MENACTRA dose 1 in the right arm. The patient started to feel sore last evening, worse on awakening in the next morning. Went to school but wound up in clinic, crying and arm pain. The patient's parents were called to pick her up early. Her dad stated that the child had a similar reaction, though less severe, to her Tdap in July. The patient was 11 year, 7 month old female who presented with a complaint of skin problems. The onset of the skin problems has been sudden and they have been occurring in an intermittent pattern for 1 day. The course has been increasing. The problem was characterized as a change in skin color. Lesions are described as red. There has been no associated fever (Child received 11yr injections on yesterday (HPV, and MENACTRA vaccine) and is now have returned to office as his right arm was red, swollen and hot to touch. It was reported that Child received the MENACTRA in right arm "yesterday". The patient required emergency room visit. The outcome of the events was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Skin discolouration, Skin lesion, 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 ID-614191). This spontaneous report refers to a 11 year old female patient. On 03-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L016428, dose 1 (unknown dosage regimen), in the left arm for prophylaxis. Other suspect therapies included MENACTRA dose 1 in the right arm. The patient started to feel sore last evening, worse on awakening in the next morning. Went to school but wound up in clinic, crying and arm pain. The patient's parents were called to pick her up early. Her dad stated that the child had a similar reaction, though less severe, to her Tdap in July. The patient was 11 year, 7 month old female who presented with a complaint of skin problems. The onset of the skin problems has been sudden and they have been occurring in an intermittent pattern for 1 day. The course has been increasing. The problem was characterized as a change in skin color. Lesions are described as red. There has been no associated fever (Child received 11yr injections on yesterday (HPV, and MENACTRA vaccine) and is now have returned to office as his right arm was red, swollen and hot to touch. It was reported that Child received the MENACTRA in right arm "yesterday". The patient required emergency room visit. The outcome of the events was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Injection site reaction, Injection site urticaria, Rash, Rash erythematous
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 # 614314) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient had no medical history or concurrent conditions. The patient's concomitant therapies, lab data and other medications were not reported. On 10-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L017407 dose 1, intramuscularly (dose and lot expiration date unknown) in the left arm for prophylaxis. Other suspect therapies included VARIVAX (dose number: 2, vaccinated date: 10-DEC-2015, subcutaneously in the left arm, lot# L024250; dose and expiration date unknown), M-M-R II (dose number: 1, vaccinated date: 10-DEC-2015, subcutaneously in the right arm, lot# K024036; dose and expiration date unknown), BOOSTRIX (dose number: 1, manufacturer: Glaxosmithkline, vaccinated date: 10-DEC-2015, intramuscularly in the right arm, lot# 45MHS; dose and expiration date unknown), MENVEO (dose number: 1, manufacturer: Novartis, vaccinated date: 10-DEC-2015, intramuscularly in the left arm, lot# M15065; dose and expiration date unknown) and FLUMIST Quadrivalent (manufacturer: Medimmune,  vaccinated date: 10-DEC-2015, intranasal, lot# FL2013; dose and expiration date unknown) for prophylaxis. On the same day post vaccination, patient experienced injection site reaction, dyspnoea, urticaria, rash erythematous, rash and injection site urticaria. There were hives and rash surrounding the torso, followed by difficulty breathing and the patient visited the emergency room. The outcome of events 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: FLUN4, HPV9, MMR, MNQ, TDAP, VARCEL
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 # 614314) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient had no medical history or concurrent conditions. The patient's concomitant therapies, lab data and other medications were not reported. On 10-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L017407 dose 1, intramuscularly (dose and lot expiration date unknown) in the left arm for prophylaxis. Other suspect therapies included VARIVAX (dose number: 2, vaccinated date: 10-DEC-2015, subcutaneously in the left arm, lot# L024250; dose and expiration date unknown), M-M-R II (dose number: 1, vaccinated date: 10-DEC-2015, subcutaneously in the right arm, lot# K024036; dose and expiration date unknown), BOOSTRIX (dose number: 1, manufacturer: Glaxosmithkline, vaccinated date: 10-DEC-2015, intramuscularly in the right arm, lot# 45MHS; dose and expiration date unknown), MENVEO (dose number: 1, manufacturer: Novartis, vaccinated date: 10-DEC-2015, intramuscularly in the left arm, lot# M15065; dose and expiration date unknown) and FLUMIST Quadrivalent (manufacturer: Medimmune,  vaccinated date: 10-DEC-2015, intranasal, lot# FL2013; dose and expiration date unknown) for prophylaxis. On the same day post vaccination, patient experienced injection site reaction, dyspnoea, urticaria, rash erythematous, rash and injection site urticaria. There were hives and rash surrounding the torso, followed by difficulty breathing and the patient visited the emergency room. The outcome of events 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, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis
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 # 614341) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses.  On 10-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L013429, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 10-DEC-2015, intramuscularly in the right arm, lot# U5187AA; dose and expiration date unknown) and ADACEL (dose number: 1, vaccinated date: 10-DEC-2015, intramuscularly in the right arm, lot# U5279AA; dose and expiration date unknown). On 10-DEC-2015, the patient experienced dizziness and hyperhidrosis. The outcome of dizziness and hyperhidrosis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 614775) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 24 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 14-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246, dose 1, intramuscularly in the left arm for prophylaxis. On 14-DEC-2015, the patient experienced nausea. Patient's doctor was contacted and doctor recommended that she visited the ER (emergency room). However, after 10-15 minutes, patient felt better and went home. Patient was encouraged to contact doctor. Patient's sister also got the same shot at the same time and also claimed she had similar symptoms (nausea and couldn't see well). The outcome of nausea was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, 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 # 615024) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included attention deficit disorder (ADD) and fatigue. The patient's concomitant therapies, concurrent illness and prior vaccinations were not reported. On 14-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L036245, dose number 1 (dose, frequency and lot expiration date were not reported), intramuscularly in the right arm for prophylaxis. On the same day, the patient experienced pyrexia and vomiting. The body temperature was reported as 101.2 (units unspecified). The outcome of pyrexia and vomiting was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Skin discolouration
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 # 616298) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male (also reported as 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 23-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L020015, via intramuscular route for prophylaxis (dose number, dosage, anatomical location of vaccination and expiry date unspecified). Other suspect therapies included FLUZONE QUADRIVALENT batch # UI1444AA, via intramuscular route for prophylaxis (dose number, dosage, anatomical location of vaccination and expiry date unspecified). On 23-DEC-2015, the nurse prepared flu vaccine and administered to patient. The patient lost consciousness within a minute of the second vaccine. The patient's legs were elevated and ice was put on his (also reported as female patient) neck and forehead. Blood pressure was checked at 2:25 was 112/62 after the patient regained consciousness, LOC was 1-2 seconds. The patient's mother reported that he (also reported as female patient) had done this in the past. Blood pressure at 2:30, when the patient was sitting was 108/52. The patient drank juice and color became pink again. The patient reported that he (also reported as female patient) was feeling normal, laughing and joking with medical personnel for 20 minutes before leaving the office. The outcome of loss of consciousness and skin discoloration was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Injection site pain, Mobility decreased
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 # 616731) on 04-APR-2017. This spontaneous report was 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 and other medications were not reported. On 15-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L027282, via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included BOOSTRIX, batch # 43MP2, dose 1, via intramuscular route, in the left arm, MENVEO batch # M15019, dose 1, via intramuscular route, in the right arm and FLUMIST QUADRIVALENT batch # FL2112, dose 2, via intranasal route in unknown anatomical location, for prophylaxis (dosage and expiry date unspecified). On 15-DEC-2015, the patient had pain at injection site, right deltoid, which lasted for 3 days. The pain resolved approximately after 1 week and returned 3 to 4 days later. The patient reported that, the pain was severe and with limited mobility. The outcome of injection site pain and mobility decreased was unknown. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Nausea, Tinnitus
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 # 616958). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses. Information on the patient's medical history and other medications were not reported. On 30-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L013429, dose 1, intramuscular route in the left deltoid (arm) for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENVEO lot/batch# M150665, dose 1, intramuscular route in the right arm, BOOSTRIX batch/lot# 9N74F, dose 1, intramuscular route in the right arm and FLUMIST Quadrivalent batch/lot# FL2117, intranasal route for prophylaxis (dosage unspecified). On 30-DEC-2015, the patient experienced dizziness, tinnitus, nausea and hypotension. The patient develop hypotension, blood pressure (BP): 62/31 (units unspecified) within 3-5 minutes after vaccination of GARDASIL 9 over left deltoid. The patient was closely observed and monitored, BP improved to 72/35 (units unspecified) after 10 min. Further improved to 95/50 (units unspecified) after 5 min and heart rate was 64-70/min. The patient completely felt better after 20 minutes in total and was discharged after. The outcome of dizziness, tinnitus, nausea and hypotension was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Erythema, Hyperventilation, Hypoaesthesia, Muscle spasms, 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 # 617589). This spontaneous report refers to a 16 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 05-JAN-2016, at 11:50 AM, the patient was vaccinated with GARDASIL 9 lot # L016428 dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with M-M-R II lot# K022284, dose 2, subcutaneous route in the right arm, HAVRIX lot/batch# 294X9, dose 1, intramuscular route in the right arm, TD ADSORBED batch/lot# U4852AA, dose 1, intramuscular route in the left arm, IPOL batch/lot# L10011, dose 1, subcutaneous route in the left arm and ENGERIX-B lot/batch# 475PE, dose 2, intramuscular route in the left arm for prophylaxis (dosage unspecified). On 05-JAN-2016, patient experienced hyperventilation, rash, muscle spasms and hypoaesthesia. After vaccines were administered to the patient, she was advised to wait for 30 minutes for monitoring. The patient was speaking to the nurse for about 5 minutes and the patient started hyperventilating and complaining of numbness of both arms and cramping on both hands. The patient remained alert and oriented. The nurse remained with the patient and measures were done to attempt to calm the patient down. The patient calmed down and was breathing normally and minutes later started hyperventilating again and rashes were observed on the patient's upper chest. Telephone call was made for emergency intervention. The outcome of hyperventilation, rash, muscle spasms and hypoaesthesia was reported as recovered. The causality assessment for the events with respect to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was not reported.   Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: FLU4, HEP, HPV9, MMR, TDAP, VARCEL
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 ID-617947). This spontaneous report refers to a 25 year old female patient. On 07-JAN-2016 the patient was vaccinated with GARDASIL 9 (lot # J015378), (unspecified dosage regimen) intramuscular in the right arm for prophylaxis, M-M-R II (lot # K005431) subcutaneously in the right arm, VARIVAX (lot # K015994) subcutaneously in the left arm. Other suspect therapies included ENGERIX-B in the right arm, ADACEL in the left arm and FLUZONE Quadrivalent in the left arm intramuscularly for prophylaxis. Patient received vaccinations. She then asked questions about other medical services and next appointment. About 5 minutes after the immunizations she arose and walked towards the waiting room. In the hallway, she walked into a wall and fainted. Clinician was behind her and caught her and kept her upright and with her aunts help carried her to a padded chair and instructed her to bend forward and put her head between her knees. The aunt tried to keep patient's head up. With translation and by clinician demonstrating, patient bent forward on the chair and put her head down near her knees. Clinician demonstrated for her to take some deep breaths. After about 10 breaths clinician helped her to sit upright and had a drink of water brought to her which she drank after monitoring her for another 5 minutes, clinician put a chair next to patient and had her relative sit by her and hold her hand and watch her for fainting for another 15 minutes. Clinician checked on her and after 15 minutes with patient stating she felt fine now, clinician let her leave with her relatives. 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.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Heart rate increased, Pallor
Clinical narrative: Dizziness; Heart rate increased; Pallor; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-619545). This spontaneous report refers to a 17 year old female patient. The patient had no concurrent and historical conditions. No other medications were reported. On 18-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L014415 dose 1 (unspecified dose and frequency), intramuscular in the left arm for prophylaxis. Other suspect therapies included MENVEO (dose 2, via intramuscular route in the right arm). On the same day, the patient experienced dizziness, pallor (pale coloring around lips) and increased heart rate. On an unknown date, Blood pressure: 129/81, Respiratory rate: 20, Pulse: 95, T (Temperature): 97.7 and blood oxygen saturation was 99%. The outcome of dizziness, pallor and heart rate increased 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: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Bradycardia, Contusion, Face injury, Fall, Heart rate decreased
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 ID-620052). This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. On 31-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L016429 dose 1 (unspecified dose and frequency) in the right arm for prophylaxis.  Other suspect therapies included MENVEO dose 2 in the right arm and FLUMIST Quadrivalent, dose 1 via nasal route for prophylaxis. The patient fainted after injection, low blood pressure, low heart rate. After 15-20 min, the patient was fine. The had an episode of syncope with brief loss of consciousness, fell and hit face with no lac/mild contusion only and vital signs following syncope showed bradycardia to the 50s and hypotension to 80s over 40s which persisted for approximately 8 minutes. The patient's neurological examination was normal. Hypotension/bradycardia initially concerning for vaccination triggered anaphylaxis but given its full resolution within 10 minutes and blood pressures and heart rate increasing back to the 130s over 80s with heart rate in the 80s to 90s with none of the other accompanying features of anaphylaxis in including no wheezing, no lip swelling, no vomiting, no rashes, that was much more likely to be vasovagaI reaction to a painful stimulus like vaccination. Patient had a similar episode of syncope when he had a splinter removal several years prior, lending further evidence to this being a vasovagal reaction. However given family concern it was happy to refer to Allergy and Immunology to see whether a skin test for HPV vaccine produces any local reaction that would indicate patient has an allergy to this important vaccine. We recommended that the patient have any painful procedures like splinter removal, vaccination, suturing etc done sitting or lying down in a safe position. The outcome of the events 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: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Hypotension, Loss of consciousness, Neurological examination normal, Presyncope, 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 ID-620052). This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. On 31-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L016429 dose 1 (unspecified dose and frequency) in the right arm for prophylaxis.  Other suspect therapies included MENVEO dose 2 in the right arm and FLUMIST Quadrivalent, dose 1 via nasal route for prophylaxis. The patient fainted after injection, low blood pressure, low heart rate. After 15-20 min, the patient was fine. The had an episode of syncope with brief loss of consciousness, fell and hit face with no lac/mild contusion only and vital signs following syncope showed bradycardia to the 50s and hypotension to 80s over 40s which persisted for approximately 8 minutes. The patient's neurological examination was normal. Hypotension/bradycardia initially concerning for vaccination triggered anaphylaxis but given its full resolution within 10 minutes and blood pressures and heart rate increasing back to the 130s over 80s with heart rate in the 80s to 90s with none of the other accompanying features of anaphylaxis in including no wheezing, no lip swelling, no vomiting, no rashes, that was much more likely to be vasovagaI reaction to a painful stimulus like vaccination. Patient had a similar episode of syncope when he had a splinter removal several years prior, lending further evidence to this being a vasovagal reaction. However given family concern it was happy to refer to Allergy and Immunology to see whether a skin test for HPV vaccine produces any local reaction that would indicate patient has an allergy to this important vaccine. We recommended that the patient have any painful procedures like splinter removal, vaccination, suturing etc done sitting or lying down in a safe position. The outcome of the events 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: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, VARCEL
Symptoms: Chills, Dyspnoea, Fear, Speech disorder, Throat tightness
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 ID-620243). This spontaneous report refers to a 14 year old female patient. On 20-JAN-2016, Wednesday at 20:00 the patient was in clinic for immunization with GARDASIL 9 lot # L018351 dose 2 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis, VARIVAX (L034369) dose 2 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis, HAVRIX, intramuscular in the left arm and FLUVIRIN intramuscular in the left arm for prophylaxis. She denied reactions to previous vaccine, heart and lungs sounds were normaI, and she was afraid. Approximately 15 minutes after giving the four vaccines patient started shivering, she was covered. Provider asked mother to stay at her side, and provider checked on her approximately 4 times inn the 15 minutes. Patient started complaining of shortness of breath, throat tightness and difficulty speaking. Provider then administered oxygen via nasal cannula at 4 LPM. Symptoms improved somewhat but patient was still shivering and complaining of constriction in her throat. Provider asked medical assistant to call 911 at approximately 20:55. Fire paramedics arrived approximately 21:05, assessed patient, and they gave her Benadryl 50 mg, loaded patient on Gurney, transported to hospital. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP
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 ID-620690). This spontaneous report refers to a 12 year old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 25-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L020015 dose 1 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis. Other suspect therapies included ADACEL dose 1 in the left arm, MENACTRA, HAVRIX dose 1 in the left arm and FLUMIST Quadrivalent dose 1 via nasal route for prophylaxis vaccinated on the same date. GARDASIL 9 was the final immunization. On the same day, the patient had momentary loss of consciousness. Blood pressure was measured as 110/76. The patient recovered spontaneously. 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: FLU3, HPV9
Symptoms: Fatigue, Hypersomnia, Loss of personal independence in daily activities, 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 ID-621422). This spontaneous report refers to a 11 year old female patient. The patient's medical history included ankle sprain. patient's concurrent condition also included ankle sprain. The patient's other medications included Advil, Muilti vitamin and Fiber gummi. On 25-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L019297, dose 2 (unknown dose and frequency) in the left arm for prophylaxis. Other suspect therapies included FLUZONE, dose 2 in the right arm (unknown dose and frequency) for prophylaxis. On 26-JAN-2016, the patient experienced peripheral swelling, hypersomnia and fatigue. The patient's activities of daily living were also impaired. The patient was sleeping 16 hours daily for 3 days. The patient was sent home. He was sleeping 16 hours for 2 days. The outcome of events was reported as not recovered. The patient was not examined on 29-JAN-2016. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (622793) under the Freedom of Information Act, referring to a 14 year old female patient. The patient did not have medical history, concurrent conditions or concomitant medications. On 15-FEB-2016, the patient was vaccinated in her right arm with the second dose of GARDASIL 9 (strength, route, lot number and expiration date were not reported) for prophylaxis. On the same date (15-FEB-2016), the patient experienced light headedness, dizziness, shaking, quivering and passed out after receiving GARDASIL 9; the outcome of all the events was reported as recovered. The reporter did not assess the relatedness between the events and the vaccination with GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report has been received from a patient's mother and referred to a 13-year-old male patient. The patient did not have pertinent medical history and his concurrent conditions included allergy to penicillin. The patient did not have concomitant therapies. On an unknown date in approximately November 2016 (reported as "roughly six months before the second one", the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (route of administration, lot number, and expiration date were not reported) for the prevention of human papillomavirus (HPV). The reported stated that on an unknown date after the first vaccination, the patient experienced a really sore arm. On 20-APR-2017, the patient received the second dose of GARDASIL 9 0.5 ml (route of administration not provided; lot number M035486 with an unknown expiration date). On 22-APR-2017, it was noted that the patient had developed three swollen lymph nodes behind his ear however it was unknown when the swelling began. The patient's mother called a physician and the patient received unspecified treatment for the events. There were no laboratory diagnostic tests performed. It was unknown if the patient still had the sore arm after getting the second dose of GARDASIL 9. At the time of the report, the patient had not recovered from lymphadenopathy. The primary reported did not specify if the patient would continue with the series of vaccination of if the therapy would be discontinued. The causality assessment between lymphadenopathy and pain in extremity with GARDASIL 9 was unknown. Additional information is not expected as there was no contact consent.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous report has been received from a patient's mother and referred to a 13-year-old male patient. The patient did not have pertinent medical history and his concurrent conditions included allergy to penicillin. The patient did not have concomitant therapies. On an unknown date in approximately November 2016 (reported as "roughly six months before the second one", the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (route of administration, lot number, and expiration date were not reported) for the prevention of human papillomavirus (HPV). The reported stated that on an unknown date after the first vaccination, the patient experienced a really sore arm. On 20-APR-2017, the patient received the second dose of GARDASIL 9 0.5 ml (route of administration not provided; lot number M035486 with an unknown expiration date). On 22-APR-2017, it was noted that the patient had developed three swollen lymph nodes behind his ear however it was unknown when the swelling began. The patient's mother called a physician and the patient received unspecified treatment for the events. There were no laboratory diagnostic tests performed. It was unknown if the patient still had the sore arm after getting the second dose of GARDASIL 9. At the time of the report, the patient had not recovered from lymphadenopathy. The primary reported did not specify if the patient would continue with the series of vaccination of if the therapy would be discontinued. The causality assessment between lymphadenopathy and pain in extremity with GARDASIL 9 was unknown. Additional information is not expected as there was no contact consent.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Unable to move right arm without much pain. Even then could only move it a few inches from my side. Hurt to walk, as I couldn't hold my arm still enough. Difficult to dress and button my jeans. 100.6 fever on Sat. Swelling covering 75% of my upper arm. Hard Lump. By Sunday the hard lump went away. Monday the swelling had reached 2" below my elbow, and the skin was red. Wed and Thurs some yellow bruising below shot administering site. Finally able to use arm on Monday. Swelling disappeared Tuesday evening. I saw the pharmacist Sat afternoon and showed him the problem. I saw him again Sunday. He said the hard lump was gone, and that he had reported this to the CDC. I had to lay down, or sit and support my arm Sat afternoon and all day Sunday. I used TYLENOL extra strength, and a heating pad. Very tired, but could only sleep on left side. Basically lost two days to this. Wish I'd known it would be this bad. I was unable to fulfill previous engagements for two days.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Unable to move right arm without much pain. Even then could only move it a few inches from my side. Hurt to walk, as I couldn't hold my arm still enough. Difficult to dress and button my jeans. 100.6 fever on Sat. Swelling covering 75% of my upper arm. Hard Lump. By Sunday the hard lump went away. Monday the swelling had reached 2" below my elbow, and the skin was red. Wed and Thurs some yellow bruising below shot administering site. Finally able to use arm on Monday. Swelling disappeared Tuesday evening. I saw the pharmacist Sat afternoon and showed him the problem. I saw him again Sunday. He said the hard lump was gone, and that he had reported this to the CDC. I had to lay down, or sit and support my arm Sat afternoon and all day Sunday. I used TYLENOL extra strength, and a heating pad. Very tired, but could only sleep on left side. Basically lost two days to this. Wish I'd known it would be this bad. I was unable to fulfill previous engagements for two days.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site mass, Injection site swelling, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Unable to move right arm without much pain. Even then could only move it a few inches from my side. Hurt to walk, as I couldn't hold my arm still enough. Difficult to dress and button my jeans. 100.6 fever on Sat. Swelling covering 75% of my upper arm. Hard Lump. By Sunday the hard lump went away. Monday the swelling had reached 2" below my elbow, and the skin was red. Wed and Thurs some yellow bruising below shot administering site. Finally able to use arm on Monday. Swelling disappeared Tuesday evening. I saw the pharmacist Sat afternoon and showed him the problem. I saw him again Sunday. He said the hard lump was gone, and that he had reported this to the CDC. I had to lay down, or sit and support my arm Sat afternoon and all day Sunday. I used TYLENOL extra strength, and a heating pad. Very tired, but could only sleep on left side. Basically lost two days to this. Wish I'd known it would be this bad. I was unable to fulfill previous engagements for two days.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Unable to move right arm without much pain. Even then could only move it a few inches from my side. Hurt to walk, as I couldn't hold my arm still enough. Difficult to dress and button my jeans. 100.6 fever on Sat. Swelling covering 75% of my upper arm. Hard Lump. By Sunday the hard lump went away. Monday the swelling had reached 2" below my elbow, and the skin was red. Wed and Thurs some yellow bruising below shot administering site. Finally able to use arm on Monday. Swelling disappeared Tuesday evening. I saw the pharmacist Sat afternoon and showed him the problem. I saw him again Sunday. He said the hard lump was gone, and that he had reported this to the CDC. I had to lay down, or sit and support my arm Sat afternoon and all day Sunday. I used TYLENOL extra strength, and a heating pad. Very tired, but could only sleep on left side. Basically lost two days to this. Wish I'd known it would be this bad. I was unable to fulfill previous engagements for two days.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Dizziness, Laboratory test
Clinical narrative: ALL SEVERE AND STILL EXIST TODAY. Fevers, mouth ulcers, body stiffness, full body pain, dizziness, heart palpitations, nausea, diarrhea, stomach cramps, stomach bloating, fainting spells.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Mouth ulceration, Musculoskeletal stiffness, Nausea, Pain, Palpitations
Clinical narrative: ALL SEVERE AND STILL EXIST TODAY. Fevers, mouth ulcers, body stiffness, full body pain, dizziness, heart palpitations, nausea, diarrhea, stomach cramps, stomach bloating, fainting spells.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pyrexia, Syncope
Clinical narrative: ALL SEVERE AND STILL EXIST TODAY. Fevers, mouth ulcers, body stiffness, full body pain, dizziness, heart palpitations, nausea, diarrhea, stomach cramps, stomach bloating, fainting spells.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Within a few days, i noticed unusual pain in upper arm near injection site. I still have it, 7 months later. Cannot fully extend arm without pain. This never happened with any previous flu shot over many decades.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 17-APR-2017 from a medical assistant, which refers to unspecified patients (age and gender not reported). The patients' pertinent medical history, current conditions and concomitant medications were not reported. The medical assistant reported that improperly stored doses of vaccines were administered to unspecified patients on unspecified dates. The names of the vaccines involved (including Lot # and expiration date) are GARDASIL 9 (Lot number N00270, expiration date 12-MAY-2019), PEDVAXHIB (Lot number M036057, expiration date 18-MAY-2019), ROTATEQ (Lot number M016238, expiration date 07-DEC-2017) which were administered to unspecified patients on unspecified dates. No adverse events reported. The vaccines were exposed to Temperature 35F (35 degrees Fahrenheit) for the time frame of 4 hours. There were no previous excursions reported. The call was because of a data logger. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report was received from a 53 year-old female licensed practical nurse referring to herself. There were no concurrent conditions or medical history reported. The patient presented an amoxicillin (+) clavulanate potassium (AUGMENTIN) and sulfonamide (SULFA) allergy/reaction. Her concomitant medication included an unspecified eye lubricant. On 17-APR-2017, the patient was twisting off a cap of a ROTATEQ when the vaccine splashed into her right eye, so she flushed her eye out right away. The patient's eye felt irritated but she did not sought medical attention and no laboratory diagnostic studies were performed. It was reported that the patient has been working at facility and "no other eye history" was noted. At the time of the report, she had not recovered from the adverse event. The causality between the adverse event and ROTATEQ was unknown.  Additional information is not expected, as no consent to contact the reporter was granted.