chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 an 74 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 19-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 19-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 patient's will be contacted for revaccination.
Age: 47.0
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 47 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 or 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 and 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: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 16-Nov-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received ALFURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse event description: On an unknown date, AFLURIA vaccine was administered from the multi-dose vial more than 28 days after it had been punctured (outcome: not reported). Special circumstances: drug administration error without adverse event. Reporter comments: The healthcare professional considered the event as non-serious.
Age: 56.0
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 56 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 or 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 74 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-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 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-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: Erythema, Incorrect route of drug administration
Clinical narrative: This spontaneous case was initially received on 12-Apr-2016. The case report 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 AFLURIA on 11-Apr-2016 - unknown stop date, Batch no: U58808, Route of administration: Subcutaneous, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 12-Apr-2016, 1 day after starting / treatment with AFLURIA the patient's arm is very red (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment: Seriousness criterion/criteria: Non serious. Case correction (05-Jul-2016): AE as reported term 'received one subcutaneous dose of AFLURIA 'recoded to LLT' inappropriate route of vaccination'. Listedness for the AE as reported term 'arm is very red' corrected to unlisted.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous consumer report (initial receipt 15-Apr-2016) concerns a female patient. On an unspecified date a few years ago, the patient received AFLURIA injection (batch number not provided). On an unspecified date a few years ago, following the administration of AFLURIA, the patient was evaluated at an unspecified ER (emergency room) and was diagnosed with an anaphylactic reaction. No further information available. The outcome was recovered.
Sex: F
Vaccine: FLU3
Symptoms: Drug hypersensitivity
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 15-Apr-2016. The case report was received from a Non Health Professional and concerns a female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza vaccine on an unknown date. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Influenza vaccine the patient experienced Drug allergies (non serious, outcome: Unknown). Reporter's assessment. Listedness: According to the Reference Safety Information, the event Drug allergies is a listed event of Influenza vaccine. Case Causality: Unassessable/unclassifiable due to insufficient information.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Authority and concerns a 49 year old female patient who had no current illness and no medical history. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-Oct-2015 - unknown stop date, Batch no: U55906, 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 unknown date, after starting / treatment with AFLURIA, the patient experienced Numbness and Pain occurred in left arm (non serious, outcome: Not Recovered / Not Resolved) shortly after vaccination and continued to present (at the time of reporting). The patient did not report this to the pharmacist until 16-Feb-2016. Patient has yet to visit her physician to determine what might be the problem. Reporter's assessment: Non serious.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case initially received on 01-Nov-2016, was reported by a non health professional and concerns a 65-year-old female patient. Weight: not provided; Height: not provided. Current conditions include COPD (chronic obstructive pulmonary disease). Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA for the prevention of seasonal influenza from 25-OCT-2016 to 25-OCT-2016. Dose regimen: 0.5 ml once, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: The patient states the technician gave her the shot in the back of the arm and she did not feel the injection at all. The next day on 26-Oct-2016, she had pain in the triceps area (outcome: recovered / resolved). The pain is gone now. The patient thinks the injection was subcutaneous instead of intramuscular. Special circumstances: Incorrect route of drug administration. Reporter comments: The reporter considered the event non-serious and reports that it is unclear if the patient received AFLURIA or FLUVIRIN.
Age: 83.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse effect This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 83 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 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 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 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 an 82 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 ALFURIA. 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). 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.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, initially received on 21-Nov-2016, was reported by a health professional and concerns a(n) adult unk 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 Oct-2016 to Oct-2016. Dose regimen: 0.5 ml, Site: Deltoid area, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Significant pain that lasted 2 weeks or longer at the injection site (outcome: Not recovered / Not resolved). Follow-up information received 13-Dec-2016: The patient did not receive any other concomitant vaccination on the same arm. The patient was recommended to rest arm and use ice or heat for pain. The patient experienced no other associated symptoms. The outcome was reported as complete recovery. All doses were administered by a RN (registered nurse) or a Certified Medical Assistant who is also a paramedic. Both have been administering flu vaccines for years. A 22 gauge 1 inch or 1.5 needle was used. The RN is certain that the dose was administered correctly in the deltoid muscle of the arm as trained. Case correction 23-Feb-2017: Follow-up information received on 13-Dec-2016 missing the following information: QA investigation results (final assessment): Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Headache, Mouth swelling, Swelling face
Clinical narrative: This spontaneous case, initially received on 22-Nov-2016, was reported by a health professional and concerns a(n) 62-year-old female patient. Weight: not provided; Height: not provided. Past medical history included Soy allergy. Drug history included Penicillin (Reaction: Penicillin allergy). Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 18-NOV-2016 at 2:30 pm to 18-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Nov-2016, 3 to 4 hours after receiving AFLURIA, the patient had a reaction. About 5pm, the patient developed headache (Medically Significant, outcome: Recovered/Resolved). About 8 pm, her mouth/face began swelling (Medically Significant, outcome: Recovered/Resolved). The reaction progressed and the patient went to emergency room and received prednisone and EPIPEN. The patient had recovered from the anaphylactic reaction. Reporter's comments: The pharmacist reported the case as serious as it required intervention to prevent permanent impairment/damage.
Age: 79.0
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 79 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). 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: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Received AFLURIA that reached 47F for 8 hours - no adverse event This spontaneous case initially received on 01-Sep-2016, was reported by a health professional and concerns a 22-year-old female 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 (special circumstances: drug administration error without adverse event). The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
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 an 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sept-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 74 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). 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: 79.0
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 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sept-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 46.0
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 46-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 (thiomersal-containing) from 12-JAN-2017 to 12-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse event description: On 12-Jan-2017, the patient received vaccine following temperature excursion (outcome: unknown). Special circumstances: incorrect product storage without adverse event, drug administration error without adverse event.
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 08-Sept-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: This spontaneous case initially received on 31-Jan-2017, was reported by a Non-Health Professional and concerns a(n) 70-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 for Flu vaccination from 12-JAN-2017 to 12-JAN-2017 Dose regimen: Not reported, Route of administration: Not Reported. Batch number: 14049222A. No additional suspect drugs. Adverse reactions/events and outcome: On 12-Jan-2017, immediately after administration, the patient acquired a big welt on his arm. Ice was used on the reaction site and the swelling subsided that day before the patient left the clinic.
Age: 32.0
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 32 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, stated that another excursion occurred on 15-Sep-2016. The doses arrived 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: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 77 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 81.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 81 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Local reaction
Clinical narrative: This spontaneous case was initially received on 05-Feb-2016. The case report was received from a Health Professional and concerns a 63 year old female patient. Weight: 228 pounds, Height: not provided. Linked Case ID(s): US-BEH-2016062594 (Same patient). Concurrent medical conditions(s), medical and drug history: At the time of the event the patient concomitantly suffered from Drug Allergy to AVELOX, Drug Allergy to Sulfa, Drug Allergy to AUGMENTIN, Drug Allergy to IVP dye, Depression, Post Traumatic Stress Disorder reported as PTSD, Anxiety, Short term memory loss and Attention deficit/hyperactivity disorder reported as ADD. The following drug history information was reported: AVELOX (Indication:-, Reaction: Drug Allergy), Sulfa (Indication: -, Reaction: Drug Allergy), AUGMENTIN (Indication: -, Reaction: Drug Allergy) and IVP dye (Indication: -, Reaction: Drug Allergy). 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 Influenza Vaccine on an unknown date. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unspecified date in Dec-2015, the patient had a local reaction after the flu shot. The patient missed doses of HIZENTRA due to the local reaction after the flu shot. The medication was stopped for 2 weeks. On an unspecified date, the patient had bronchitis. The outcome was resolved. Reporter's assessment:
Age: 100.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 100 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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: 70.0
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 70 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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.
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event
Clinical narrative: Administered influenza vaccine with a 5/8 inch needle - no adverse event This spontaneous case initially received on 30-Sep-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided Administration of company suspect drug(s): The patient received AFLURIA from 20-SEP-2016 to 20-SEP-2016. Dosage regimen: 0.5 ml as one single dose, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse event description: On 20-Sep-2016, the patient was administered influenza vaccine with a 5/8 inch needle (special circumstances: drug administration error without adverse event). The reporter is concerned that it may have not reached the muscle in the patient. Reporter comments: The healthcare professional classified the event as a medication error.
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 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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.
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: This spontaneous case initially received on 18-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date, the patient received 'high dose' Influenza Virus Vaccine (INN) for indication not reported. 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 following vaccination, the patient experienced allergic reaction, lightheadedness and dizziness. Outcome for all events: Not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Mass
Clinical narrative: This spontaneous case initially received on 11-Nov-2016, was reported by a health professional and concerns a 53-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 09-NOV-2016 to 09-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57108. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Nov-2016, the patient experienced an egg size lump on side of neck by collar bone (outcome: unknown).
Age: 40.0
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 40 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-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 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). 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.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Muscle swelling, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case initially received on 23-Aug-2016, was reported by a health professional and concerns a(n) 67-year-old female patient. Weight: 73.02 kg; Height: 65 cm. Administration of company suspect drug(s): On an unknown date, the patient received and injection of 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 08-Oct-2015, the patient experienced (L) arm pain/[swelling and (L) bicep swelling (outcome: not recovered / not resolved). On an unknown date, the patient experienced erythema "S/P" flu shot, pain on bicep, pain on shoulder and swelling for 2 to 3 weeks (outcome: not reported).
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling, Swelling
Clinical narrative: This spontaneous case initially received on 23-Aug-2016, was reported by a health professional and concerns a(n) 67-year-old female patient. Weight: 73.02 kg; Height: 65 cm. Administration of company suspect drug(s): On an unknown date, the patient received and injection of 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 08-Oct-2015, the patient experienced (L) arm pain/[swelling and (L) bicep swelling (outcome: not recovered / not resolved). On an unknown date, the patient experienced erythema "S/P" flu shot, pain on bicep, pain on shoulder and swelling for 2 to 3 weeks (outcome: not reported).
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 16-Dec-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 31-OCT-2016 to 31-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT56407, Site: Left arm. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient developed arm pain a number of weeks after the event, the patient had symptoms right away and it continued to get worse. The patient experienced left arm pain and shoulder pain that has persisted since administration of the vaccine. Outcome for all events: unknown.