chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 84 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 09-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case , initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 12-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, route of administration: not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-206, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 12-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Age: 92.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 92 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 12-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 12-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Age: 85.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 84 year old patient. Weight: not provided; height: Not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: not reported, route of administration: not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered in the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions form 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 51 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 90.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 90 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 10-Feb-2017, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regiment: Not reported, Route of administration. Batch number: Not reported. No additional suspect drugs. Adverse event description: It was reported that the patient had already received 2 shots this flu season (outcome: not reported). There was no information about any adverse events an no reaction was reported. Special circumstances: extra dose administered without adverse event. Reporter's comments: The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case, initially received on 16-Feb-2017, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. The patient had no other known allergies. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 2015 to 2015. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 2015, the patient experienced an anaphylactic reaction (Medically Significant, outcome: Not Reported).
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns a 64 year old female patient. Weight: not provided; Height: not provided. Concomitant medication refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13749221A. No additional suspect drugs. On 03-Jan-2017, the patient was administered AFLURIA from a multi dose vial that was punctured over 28 days. No adverse effects were noted. Special circumstances: Drug administration error without adverse event.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Lip swelling, Swelling, Swollen tongue
Clinical narrative: This spontaneous case, initially received on 20-Jan-2017, was reported by a health professional and concerns a 46-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 19-JAN-2017 to 19-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT53706. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-JAN-2017, the patient experienced swelling (medically significant, outcome: not recovered / not resolved), swelling around her eyes (medically significant, outcome: not recovered / not resolved), swelling around her lips (medically significant, outcome: not recovered / not resolved), swelling around her tongue (medically significant, outcome: not recovered / not resolved). Patient took an antihistamine for the reaction and the swelling has reduced. Patient is still taking the antihistamine until the swelling completely subsides. Reporter comments: The healthcare professional considered all events as serious and related to AFLURIA vaccination. Follow-up received from 26-Jan-2017: The overall outcome was reported as recovered on 23-Jan-2017. Intervention was required to prevent permanent impairment/damage. Reporter comments: The healthcare professional considered all events as related (probable) to the administration of AFLURIA.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 26-Jan-2017, was reported by a non-health professional and concerns a 62-year-old male patient. Weight: not provided; Height: not provided. Concomitant mediation: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 03-JAN-2017 to 03-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse event description: On 03-Jan-2017, the patient received AFLURIA vaccine following temperature excursion (outcome: unknown). Special circumstances: incorrect product storage without adverse event, drug administration error without adverse event).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 57-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 23-NOV-2016 to 23-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 23-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 43-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 23-NOV-2016 to 23-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number; WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 23-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous case, initially received on 09-Nov-2016, was reported by a health professional and concern a(n) 65-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 08-NOV-2016 to 08-NOV-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT53306. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Nov-2016, the patient received partial dose of AFLURIA -No adverse effect (outcome: Not Reported). Special circumstances: Underdose. Follow-up information received 06-Jan-2017: The product (AFLURIA) had been stored correctly and the indication for use was as per the Product Information Leaflet. On 08-Nov-2016, the syringe leaked (outcome: not reported, special circumstance: poor quality drug administered) and could not be certain that the patient got very much of the vaccine. A second dose was given that following day (outcome: not reported). The patient said that she appreciated the second dose to make sure she got enough dose to be protected. The events 'partial dose of AFLURIA was administered to a female patient' and 'second dose AFLURIA was given the following day' combined to 'partial dose of AFLURIA was administered to a female patient / second dose AFLURIA was given the following day - no adverse effect' (outcome: not reported, start date: Nov-2016, special circumstances: underdose without adverse event, extra dose administered).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Exposure during pregnancy, Foetal disorder, Hypoaesthesia oral, Hypoaesthesia teeth
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 34 year old female, pregnant patient. The last menstrual date was 29-Dec-2014 and the expected date of delivery was 10-Jul-2015 (ultrasound confirmed dates). Ultrasound was performed during the pregnancy and the result was normal nuchal translucency. There was no failure in contraception. Weight: 66 kilograms, Height: 170 centimeters. Linked Case ID(s): US-BEH-2016060371 (Mother-child pair). Concurrent medication condition(s), medical and drug history: The patient has a medical history of Smoking, G2P1 and a missed abortion. Concomitant medication included prenatal vitamins only. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA in early pregnancy on 11-Feb-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: not provided, site: left deltoid. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Numbness in throat (non serious, outcome: Recovered / Resolved), Metallic taste (non serious, outcome; Recovered / Resolved), Numbness in her mouth (non serious, outcome; Recovered / Resolved), Numbness radiated down the right side of her teeth (non serious, outcome; Recovered / Resolved), Pregnant patient was vaccinated (non serious, outcome; Recovered / Resolved), Tingling in mouth (non serious, outcome; Recovered / Resolved), Tingling in throat (non serious, outcome; Recovered / Resolved). The mother delivered a baby boy (weight 3.85 kg) via the normal vaginal delivery at full term. The Apgar score was 9 at 5 minutes and 9 at 10 minutes. The mother had no maternal complications or problems related to birth. On an unspecified date, the infant patient developed bilateral fetal pyelectasis (mild) on ultrasound. The patient was seen by urology after birth and was reported normal. In Feb-2016, the patient was seen by urology and no further follow-up was needed. The 'innocent heart murmur' was to be evaluated by paediatic-cardiology in March 2016 (see case 2016060371). Reporter's assessment: non-serious, did not require hospitalisation, not life threatening and not medically significant. Causality - not suspected in relation to AFLURIA. The Health Professional considered the event(s) Numbness in throat, Metallic taste, Numbness in her mouth, Numbness radiated down the right side of her teeth, Pregnant patient was vaccinated, Tingling in mouth, Tingling in throat as non-serious and unrelated. 23-JUN-2016 (System Update): Linked Case ID(s): US-BEH-2016060371 (Parent-Child Link).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Ultrasound antenatal screen normal
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 34 year old female, pregnant patient. The last menstrual date was 29-Dec-2014 and the expected date of delivery was 10-Jul-2015 (ultrasound confirmed dates). Ultrasound was performed during the pregnancy and the result was normal nuchal translucency. There was no failure in contraception. Weight: 66 kilograms, Height: 170 centimeters. Linked Case ID(s): US-BEH-2016060371 (Mother-child pair). Concurrent medication condition(s), medical and drug history: The patient has a medical history of Smoking, G2P1 and a missed abortion. Concomitant medication included prenatal vitamins only. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA in early pregnancy on 11-Feb-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: not provided, site: left deltoid. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Numbness in throat (non serious, outcome: Recovered / Resolved), Metallic taste (non serious, outcome; Recovered / Resolved), Numbness in her mouth (non serious, outcome; Recovered / Resolved), Numbness radiated down the right side of her teeth (non serious, outcome; Recovered / Resolved), Pregnant patient was vaccinated (non serious, outcome; Recovered / Resolved), Tingling in mouth (non serious, outcome; Recovered / Resolved), Tingling in throat (non serious, outcome; Recovered / Resolved). The mother delivered a baby boy (weight 3.85 kg) via the normal vaginal delivery at full term. The Apgar score was 9 at 5 minutes and 9 at 10 minutes. The mother had no maternal complications or problems related to birth. On an unspecified date, the infant patient developed bilateral fetal pyelectasis (mild) on ultrasound. The patient was seen by urology after birth and was reported normal. In Feb-2016, the patient was seen by urology and no further follow-up was needed. The 'innocent heart murmur' was to be evaluated by paediatic-cardiology in March 2016 (see case 2016060371). Reporter's assessment: non-serious, did not require hospitalisation, not life threatening and not medically significant. Causality - not suspected in relation to AFLURIA. The Health Professional considered the event(s) Numbness in throat, Metallic taste, Numbness in her mouth, Numbness radiated down the right side of her teeth, Pregnant patient was vaccinated, Tingling in mouth, Tingling in throat as non-serious and unrelated. 23-JUN-2016 (System Update): Linked Case ID(s): US-BEH-2016060371 (Parent-Child Link).
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns an 11 year old male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 08-Dec-2015 - unknown stop date, Batch no: U56606, Dose no: 3, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): MENACTRA, Batch no: U5082AA, Dose no: 0, Site: Left arm (LA). Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Oedema (non serious, outcome: Recovered/Resolved), Edema (pitting 2+) in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Erythema in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Warmth in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Pain in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved). Lab date: None. Reporter's assessment: Non serious. The health authority reported the symptom: oedema.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 64 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Asthma. The patient had no illness and was not on any concomitant medication at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 19-Dec-2015 - unknown stop date, Batch no: U56006, Route of administration: not provided, Dose: 0.5 ml, route: SYR, site: Left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced the Injection site reaction of pain (non serious, outcome: Unknown). The patient called on 12-Jan-2016 and complained about an injection site reaction of pain since the date of administration. The pharmacy suggested to the patient to see their personal doctor. Reporter's assessment: The health authority assessed the event as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 23-Mar-2016. The case was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing, and conditions surrounding the onset of reaction(s)/event(s): The patient received Unspecified flu vaccine. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, the patient developed unspecified pain on an unspecified part of their body. The outcome was not reported. For relevant test results see appropriate report section.
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Erythema, 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 # 642096) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. Information on the patient's lab data, medical history, other medications and prior vaccinations were not reported. Information on patient's current illness was reported as none. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M009362, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with BEXSERO lot/batch # 151501, dose 1, intramuscularly in the left arm, MENVEO lot/batch # M15122, dose 1, intramuscularly in the right arm and VAQTA lot # M022531, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On 23-JUN-2016, the patient had minimal redness and swelling. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Headache, 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 # 642320) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's other medications, lab data and prior vaccinations were not reported. Patient had no concurrent illness. Information on patient's medical history was reported as none. On 08-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L023230, dose 1, intramuscularly in the left arm for prophylaxis (dosage unspecified). On 10-JUN-2016, the patient had vomiting, headache, stomach, cramps and weakness and all lasted for three days. The outcome of the events were reported as 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: F
Vaccine: HPV9
Symptoms: Dysgeusia, 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 # 642516) on 02-MAY-2017. This spontaneous report refers to a 20 year old female patient. The patient had no concurrent illnesses. The patient was diagnosed with heart murmurs in the past and had no allergies. Information on the patient's prior vaccinations were not reported. The patient's other medications included Lutera and Paxil. On 05-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. On 07-JUL-2016, the patient complained of severe headaches (which was considered to be a common side effect to vaccine) and also complained of metallic taste in mouth (dysgeusia) for which she was monitored for changes in taste and was recommended with Tylenol and Ibuprofen for controlling headaches. The patient was not introduced to any new medications or new foods and no changes in diet. The outcome of dysgeusia and headache was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643794) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 14-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L024993 (expiration date: 17-OCT-2017) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included VAQTA lot # M009377 (expiration date: 17-JUN-2017), dose 1, intramuscularly in the left arm for prophylaxis. On 14-JUL-2016, the patient reported redness and itching at and around the injection site. The outcome of injection site erythema and injection site pruritus was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644259). This spontaneous report refers to a 14 year old male patient. The patient had no concurrent illnesses or medical history. Information on the patient's prior vaccinations and other medications were not reported. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (expiry date: 03-OCT-2017), dose 1, intramuscular route in the left arm for prophylaxis. On 21-JUL-2016, at 03:00 the patient broke out into hives all over. The patient was given Benadryl with good effect. The outcome of urticarial was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Insomnia, Malaise, Pallor, 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 # 644461) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 19-JUL-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the unknown site, lot # L043214 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient could not sleep at all the first night after he received the vaccine. On 20-JUL-2016, the patient slept all day and experienced low grade fever, became pale and generally felt sick. The outcome of insomnia, malaise, pallor and pyrexia was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Gait disturbance, Nausea, Pallor, 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 # 644638) on 02-MAY-2017. This spontaneous report refers to a 14 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 25-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M014929 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included VARIVAX lot # M003440, dose 2, (dose, frequency and lot expiration dates were not reported), subcutaneously in the left arm, HAVRIX batch/lot # 4P9M9, dose 2, intramuscularly in the left arm, BOOSTRIX batch/lot # 73D7R, dose 1, intramuscularly in the right arm and MENVEO batch/lot # M15078, dose 1, intramuscularly in the left arm for prophylaxis. On 25-JUL-2016, the patient had pale skin with uneasy gait. The patient sat down in a chair. He also complained of nausea and light headedness. The patient asked for water. Approximately after 4 minutes of vaccination the patient started to vomit. 30 minutes later the patient stated he was feeling good. The outcome of vomiting, pallor, nausea, gait disturbance and dizziness was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Presyncope
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 # 644802) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 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 26-JUL-2015 at 11:00, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M014929 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day at 11:05 the patient experienced a vasovagal episode  and lost consciousness for approximately 5 seconds. The outcome of loss of consciousness and presyncope was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Induration, Mass, Pain, Tenderness, 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 # 645140) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 26 year old female patient. Patient had no current illness. Patient's medical history included bee sting allergy and multiple sclerosis. Information on the patient's prior vaccinations were not reported. Patient's other medication included Avonex. Patient's lab data included ultrasound, soft tissue right upper arm, pending. On 24-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048237, unknown dose number, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On 28-JUN-2016, the patient had pain, hard lump, it was tender to touch with radiating pain in the lump. Radiating pain and tenderness continued for one month. No real treatment was done at this time. Patient was seen for evaluation. 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: HEPA, HPV9, MNQ
Symptoms: Erythema, Fall, Head injury, Headache, Swelling face
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 # 645373). This spontaneous report refers to a 15 year old male patient. The patient had no current illnesses and medical history. Patient's other medication include ALLEGRA. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M009116, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX lot # 4P9M9, dose 1, intramuscularly in the left arm and MENVEO lot # M15123, dose 1, intramuscularly in the left arm. On 25-JUL-2016, after receiving immunizations patient had syncopal episode and fell, striking his head on the floor which was witnessed by two medical assistants (MA). Vital signs were assessed and ice pack was placed on his left forehead for redness and swelling. Patient was awake after 30 seconds with headache. He was moved to chair after 10 minutes and was examined by the doctor. The patient was assisted to car with his mother and was scheduled for follow up visit the next day with the doctor. The outcome of the events was reported as 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: HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 645373). This spontaneous report refers to a 15 year old male patient. The patient had no current illnesses and medical history. Patient's other medication include ALLEGRA. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M009116, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX lot # 4P9M9, dose 1, intramuscularly in the left arm and MENVEO lot # M15123, dose 1, intramuscularly in the left arm. On 25-JUL-2016, after receiving immunizations patient had syncopal episode and fell, striking his head on the floor which was witnessed by two medical assistants (MA). Vital signs were assessed and ice pack was placed on his left forehead for redness and swelling. Patient was awake after 30 seconds with headache. He was moved to chair after 10 minutes and was examined by the doctor. The patient was assisted to car with his mother and was scheduled for follow up visit the next day with the doctor. The outcome of the events was reported as 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: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 645723). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses or other medications and had no known drug allergies. Information on the patient's prior vaccinations not reported. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (expiry date: 03-OCT-2017), dose 1, intramuscular route in the left arm, BOOSTRIX batch/lot# E735A, dose 1, intramuscular route in the right arm, HAVRIX batch/lot# 2427S, dose 3, intramuscular route in the right arm and MENACTRA batch/lot# U5259AA, dose 1, intramuscular route in the left arm for prophylaxis. On an unknown date, the patient experienced an unevaluable event. The outcome of the unevaluable event was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site urticaria, Lip swelling
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 27-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L020015 and expiration date: 16-AUG-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included MENVEO dose number 2; vaccinated date: 27-JUL-2016, intramuscularly in the left arm, lot # M15124; (dose, frequency and lot expiration date unknown) and HAVRIX dose number 2; vaccinated date: 27-JUL-2016, intramuscularly in the left arm, lot # P3A42; (dose, frequency and lot expiration date unknown). On 30-JUL-2016, the patient reported that he developed hives on his left upper arm and trunk and upper lip became swollen. The patient reported that he took 1 Benadryl pill and symptoms subsided. On 31-JUL-2016 afternoon, the patient reported that hives returned. The patient again took 1 dose of Benadryl and symptoms subsided and have not returned. The patient denied shortness of breath, syncope or other symptom. The outcome of lip swelling and injection site urticaria was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. It was reported that the patient denied of other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 03-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M007764 and expiration date: 30-JAN-2018, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included MENVEO dose number 1; vaccinated date: 03-AUG-2016, intramuscularly in the left arm, lot # M15097; (dose, frequency and lot expiration date unknown) and BOOSTRIX dose number 1; vaccinated date: 03-AUG-2016, intramuscularly in the right arm, lot # 7RJ9B; (dose, frequency and lot expiration date unknown). On the same day, after 15 minutes of vaccinations the patient fainted. The patient recovered quickly with no troubles noted. The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: 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 # 647666) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no medical history and concurrent illnesses. Information about the patient's other medications and prior vaccinations were not reported. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M003659 (Expiration date: 20-SEP-2017), dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient fainted. The outcome of syncope was reported as recovered. The causality assessment for syncope was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.