chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
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 71 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 (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: 75.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 75 year old patient. Weight: not provided; Height: not provided. Concomitant medications: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA for protection against influenza virus. 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 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 remained 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 44.0
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 44 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: 30.0
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 30 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: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, initially received on 30-Dec-2016, was reported by a health professional and concerns a 3-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 29-DEC-2016 to 29-DEC-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT53606. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Dec-2016, administered AFLURIA to a 3 year old child (outcome: not reported, special circumstances: drug administered to patient of inappropriate age), no adverse effects were noted (outcome: not reported). Reporter comments: The healthcare professional considered all events as non-serious.
Sex: U
Vaccine: FLUX, TTOX
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 06-Jul-2016, was reported by a health professional and concerns a patient of unknown age and gender. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: Tetanus Vaccine. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced arm swelled, "blew up" (outcome: not reported).
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: This health authority case was initially received on 09-May-2016. The case report was received from a(n) Health Professional and concerns a(n) 58 years old male patient. 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 AFLURIA on 19-Sep-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unspecified date, the patient experienced intermittent numbness, burning and tingling since receiving the vaccine in Sep-2015. The outcome was not recovered. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was initially received on 11-May-2016. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received an unspecified Influenza Vaccine, (brand and batch number unknown) on an unknown date. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after treatment with an Unspecified influenza vaccine the patient experienced an Unknown reaction to unspecified influenza vaccine (non serious, outcome: Unknown). Reporter's assessment:
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product container issue
Clinical narrative: This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns a(n) 27-year-old male 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 04-JAN-2017 to 04-JAN-2017. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13749221A. No additional suspect drugs. On 04-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: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 73-year-old male patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 13049221A. Suspect product tolerated in the past: Unknown. Product stored correctly: Yes. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time (special circumstances: poor quality drug administered without adverse event). The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
Age: 82.0
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 82 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, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator 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 patient 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: 59.0
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) 59-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 21-NOV-2016 to 21-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 21-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: 67.0
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 67 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 reading 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: 34.0
Sex: M
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) 34-year-old male 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 22-NOV-2016 to 22-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 22-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: 64.0
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 64 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not provided. 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: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 56-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 78.0
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 78 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: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This spontaneous case, initially received on 09-Aug-2016, was reported by a health professional and concerns a female non-pregnant patient. The patient's medical history is unknown. Administration of company suspect drug(s): The patient received AFLURIA from 04-AUG-2016 to 04-AUG-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Unknown. The product had been stored correctly. No additional suspect drugs. Adverse reactions/events and outcomes: In Aug-2016 following vaccination, the patient experienced severe body aches (outcome: not recovered / not resolved). No additional information is available. AFLURIA dechallenge: N/A for the event(s) body aches. AFLURIA rechallenge: N/A for the event(s) body aches. The pharmacist considered the event non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, initially received on 13-Jul-2016, was reported by a non health professional and concerns a 67-year-old male patient. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced drug reactions/allergies (outcome: not reported). Follow-up receive 15-Jul-2016: The patient has had allergic reaction to flu shots in the past and now refused to get them. No information on which flu shot was received in the past.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 11-May-2016. The case report was received from a(n) Health Professional and concerns a 20 year old male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA, on 09-May-2016 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml and on 11-May-2016 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 09-May-2016, the patient received AFLURIA (batch number not reported). On 11-May-2016, the patient received second administration of AFLURIA (batch number U55306) at a dose of 0.5 ml once (overdose). The patient did not report any side effects. The outcome was unknown. Reporter's assessment: Non serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Scan
Clinical narrative: This spontaneous case was initially received on 11-May-2016. The case report was received from a Non Health Professional and concerns a 63 year old female patient. Linked case: US-BEH-2016062653 (same reporter). Weight: 135 pounds, Height: 5 feet 6 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Fibromyalgia and Migraines. 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 AFLURIA on 26-Sep-2015 - 26-Sep-2015, Batch no: 11549221A, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 27-Sep-2015 (the next morning), the patient woke up extremely dizzy. Dizziness comes and goes. The patient underwent a sinus scan and was going for a brain scan. The outcome was not yet recovered.
Age: 75.0
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 75 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: 74.0
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 67 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 excursions 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: 59.0
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 59 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: 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 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: 23.0
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) 23-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 27-NOV-2016 to 27-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 21-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: 56.0
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) 56-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 26-NOV-2016 to 26-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 26-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: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 01-Sep-2016, was reported by a health professional and concerns a 53-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 31-AUG-2016 to 31-AUG-2016. Dose regimen: 0.5 ml 1 time dose, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Special circumstances: On 31-Aug-2016, the patient was administered AFLURIA that reached 47F for 8 hours - no adverse event. The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Sep-2016, was reported by a health professional and concerns a patient of unknown age/gender. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 12-SEP-2016 to 12-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54507. No additional suspect drugs. On 12-Sep-2016, the patient received AFLURIA PFS (which had been) exposed to fluorescent light for an unknown duration of time - no adverse event (special circumstances: drug administration error without adverse event, outcome: unknown). The reporter considered the event non-serious (medication error).
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: This spontaneous case, initially received on 20-Sep-2016, was reported by a non health professional and concerns an 81-year-old patient (gender not reported). Weight: not provided: Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 10-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Sep-2016, the symptoms began. The patient's arm hurt and he experienced pain at injection site (outcome: recovered / resolved). On 12-Sep-2016, the symptoms became acute and the patient experienced redness, swelling / swelling between shoulder and elbow and then it reached to below the elbow. The symptoms lasted for a total of 7 to 8 days. The patient took diphenhydramine. The outcome was reported as recovered / resolved.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 28-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 50-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 79-year-old male patient. Weight: not provided: Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA (trivalent influenza vaccine thiomersal) on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049331A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 74-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Skin warm, Swelling, Urticaria
Clinical narrative: This spontaneous case, initially received on 12-Sep-2016, was reported by a health professional and concerns a 56-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 10-SEP-2016 to 10-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2016, the patient experienced welting, bruising, painful, heat (outcome: not recovered/not resolved) and swelling (outcome: recovering/resolving) 3-4 inches below the injection site within 1 hour after received AFLURIA. On 12-Sep-2016, the swelling has gone down now, improving, much better today. Reporter's assessment: The reporter considered the events bruising 3-4 inches below the injection site, heat 3-4 inches below the injection site, painful 3-4 inches below the injection site, swelling 3-4 inches below the injection site and welting 3-4 inches below the injection site as non-serious and related to the administration of AFLURIA. The reporter did not know the cause of the event, but speculated that the needle may not have been deep into the muscle tissue.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue
Clinical narrative: This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 46-year-old male patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. It is unknown if the suspect product (AFLURIA) was tolerated in the past. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 13049221A. The product was stored correctly. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time. The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 74-year-old female patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. It is unknown if the suspect product (AFLURIA) was tolerated in the past. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular, Batch number: 13049221A. The product was stored correctly. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time. The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
Age: 78.0
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 78 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 for indication not reported. 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 (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.
Age: 55.0
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 55 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-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 14-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.
Age: 78.0
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 78 year old patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 14-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 14-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 of, 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.