chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 an 75 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 07-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 07-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: 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 an 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not provided. 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 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: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case initially received on 17-Oct-2016, was reported by a health professional and concerns a(n) 58-year-old female patient. Weight: not provided; Height: not provided Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA PFS from 09-OCT-2016 to 09-OCT-2016 Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: WT52305. Action taken with suspect drug: discontinued. No additional suspect drugs. Adverse reactions/events and outcomes: The patient returned the next day (10-Oct-2016) because the injection site was red, warm and swollen. The patient was given an ice pack and ibuprofen and a recommendation to take diphenhydramine that night. The nurse mentioned perhaps the injection was too low on the arm, about 3 inches lower on the arm than idea. Special circumstances: Drug administered at inappropriate site. The outcome not reported Reporter comments: The reporter considered all events as non-serious. Follow-up was received on 20-Oct-2016: The outcome of the events was reported as recovered.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave AFLURIA to a 4 year old [Drug administered to patient of inappropriate age] This spontaneous case initially received on 04-Nov-2016, was reported by a health professional and concerns a 4-year-old patient of unknown gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 04-NOV-2016 to 04-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13149212A. No additional suspect drugs. Adverse reactions/events and outcomes: On 04-Nov-20126, the pharmacist gave AFLURIA to a 4 year old (outcome: unknown, special circumstances: drug administered to patient of inappropriate age). Reporter comments: The healthcare professional classified the event as a medication error.
Age: 58.0
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 58 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 01-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 01-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: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous case initially received on 15-Nov-2016, was reported by a health professional and concerns a 63-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 11-NOV-2016 to 11-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54206. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Nov-2016, the patient experienced an injection site reaction (outcome: Not recovered / Not resolved). On an unknown date, a knot developed this same day at the injection site (outcome: Not recovered / Not resolved), the knot became itchy (injection site) (outcome: Not recovered / Not resolved), the knot became red (injection site) (outcome: Not recovered / Not resolved) and the vaccine stung after injection (outcome: Not recovered / Not resolved). Symptoms were still occurring on 14-Nov-2016. The patient was referred to a medical doctor by the pharmacist. Reporter comments: The healthcare professional considered all events as non-serious and related (probable) to AFLUIRA. Case correction (31-Jan-2017): The event 'injection site reaction' was removed as the injection site reactions were specified.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 51 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 29-Aug-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 29-Aug-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: 71.0
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 71 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: Not reported. 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). 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: 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 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). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Eczema, Eosinophilia
Clinical narrative: This spontaneous case initially received on 03-Nov-2016, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 2014 to 2014 Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non -company suspect drugs: ZOSTAVAX. Adverse reactions/events and outcomes: On 2014, shortly after receiving the vaccine, the patient experienced Eczema (outcome: Not Reported), Eosinophilia (outcome: Not Reported).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 29-Nov-2016, was reported by a health professional and concerns a(n) 59-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 19-NOV-2016 to 19-NOV-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. On 19-Nov-2016, the patient was administered AFLURIA vaccine that underwent first excursion. It was stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received on 23-Nov-2016, was reported by a health professional and concerns an adult female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56507. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the plunger rod stuck when trying to administer AFLURIA (outcome: not reported, special circumstances: medication error) and only a partial dose (AFLURIA) was given (outcome: not reported, special circumstances: underdose). The patient did not want to be given another dose. Reporter comments: The healthcare professional considered all events as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypersomnia, Migraine, Ocular hyperaemia, Vomiting
Clinical narrative: This spontaneous case, initially received on 28-Nov-2016, was reported by a health professional and concerns a(n) 49-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: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On an unspecified date in Nov-2016, the patient experienced Bloodshot eyes (outcome: Recovered / Resolved), Excessive sleep (16 hours) (outcome: Recovered / Resolved), Migraine (outcome: Recovered/ Resolved), Sweats (outcome: Recovered / Resolved), Vomiting (outcome: Recovered / Resolved). Follow-up information received 30-Nov-2016: This case concerns a 49 year old non-pregnant female patient. Concomitant medications: omeprazole, alprazolam, dicyclomine, diphenhydramine, metronidazole and hydrocodone / acetaminophen. This was the patient's first flu shot.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Nausea, Vomiting
Clinical narrative: This spontaneous case initially received on 06-Dec-2016, was reported by a health professional and concerns an adult 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 AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52005 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within a week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Device leakage, Exposure via skin contact
Clinical narrative: This spontaneous case, initially received on 29-Nov-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): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration: Not reported. Batch number: 12849211A. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the vial leaked onto RN (registered nurse) finger when withdrawing doses (outcome: not reported, special circumstances: occupational exposure to product), started leaking after 3rd puncture (outcome: not reported, special circumstances: medication error). Reporter comments: The healthcare professional classified the report as occupational exposure and quality defect.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Nausea, Palpitations, Vomiting
Clinical narrative: This spontaneous case, initially received on 06-Dec-2016, was reported by a health professional and concerns an adult 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 AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52005 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within one week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), heart palpitations (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
Age: 86.0
Sex: M
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 and 86-year-old male patient. Weight: not provided; Height: not provided Administration of company suspect drug(s): The patient received AFLURIA from 01-Sep-2016 to 01-Sep-2016. Dose regimen: 0.5 ml 1 time dose, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Special circumstances: 01-Sep-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).
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Nausea, Vomiting
Clinical narrative: This spontaneous case, initially received on 06-Dec-2016, was reported by a health professional and concerns an adult 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 AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52006 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within a week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Nausea, Vomiting
Clinical narrative: This spontaneous case, initially received on 06-Dec-2016, was reported by a health professional and concerns an adult 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 AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52005 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within one week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), nausea (outcome: not reported, vomiting (outcome: not reported).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 10-Dec-2016, was reported by a health professional and concerns a(n) 58-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 09-DEC-2016 to 09-DEC-2016. Dose regiment: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event. AFLURIA was administered following a temperature excursion of 46.6 F maximum temperature with maximum excursion of 11 hours 45 minutes. Follow-up information received 13-Dec-2016: The patient was not pregnant at the time of vaccination. The temperature excursion of 46.6 maximum temperature with maximum excursion time of 11 hours 45 minutes was the first excursion.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous case initially received on 02-Nov-2016, was reported by a company representative and concerns an a 4-year-old 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 AFLURIA. 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, gave AFLURIA to a 4 year old (outcome: not reported, special circumstances: drug administered to patient of inappropriate age).
Sex: F
Vaccine: FLUX, MMR
Symptoms: Asthenia, Bone pain, Chills, Night sweats
Clinical narrative: This spontaneous case initially received on 28-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Drug history includes MMR (reaction: night-sweats, rigors, bone aches and body weakness). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On an unknown date, the patient received MMR. Dosage regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Adverse reactions/events and outcomes: On an unknown date, the patient experienced night-sweats, rigors, bone aches and body weakness for over a month (outcome: not reported). The patient reported having a similar reaction as a child to MMR vaccine. Reporter comments: The healthcare professional considered all events non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: 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. Dose 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 comment: The healthcare professional classified the event as a medication error.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous case initially received on 19-Dec-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Past medical history included high blood pressure. Drug history includes penicillin, sulfonamide, mycin (reaction: drug reactions/allergies). Concomitant medication: refer to appropriate report section. 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: ZOSTAVAX. Dose regimen: Not reported, Route of administration: Subcutaneous. Batch number: Not reported. Adverse reactions/events and outcome: On an unknown date, the patient experienced blisters breaking out around the injection site (outcome: not recovered / not resolved), they (blisters breaking out around injection site) are really itchy (outcome: not recovered / not resolved).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Feeding disorder, Malaise, Nervousness
Clinical narrative: This spontaneous case initially received on 06-Oct-2016, was reported by a health professional and concerns a 48-year-old female patient. Weight: not provided; Height: not provided It is unknown whether AFLURIA has been tolerated by the patient in the past. Administration of company suspect drug(s): The patient received AFLURIA from 16-SEP-2016 to 16-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: WT53106. The product has been stored correctly. No additional suspect drugs. Adverse reactions/events and outcomes: In Sep-2016 two to three days after receiving the vaccine, the patient experienced malaise and anxiety, stating that she felt nervous, couldn't eat, and felt on edge (outcome: not recovered / not resolved). Adverse reactions have not resolved to day. No additional information is known. Reporter comments: The healthcare professional considered all events as non-serious. Additional information received on 24-Jan-2017: QA investigation for Lot number WT53206 (PRD-18098) was also extended to the sister lot WT53106. Both batches WT53206 and sister dispensed batch WT53106 are derived from the same formulated bulk lot (0906USF284). Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT53206 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Sex: M
Vaccine: FLUX
Symptoms: Headache, Influenza like illness
Clinical narrative: This spontaneous case, initially received on 05-Oct-2016, was reported by a company representative and concerns a male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced flu-like symptoms (outcome: not recovered/not resolved). Associated symptoms included: headache.
Age: 61.0
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 health professional and concerns a(n) 61-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 AFLUIRA 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 the underwent temperature Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Sex: U
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: This spontaneous case, initially received on 05-Oct-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. 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 following vaccination, the patient experienced seizures that lasted for an unspecified amount of time (medically significant, outcome: not reported).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased
Clinical narrative: This spontaneous case initially received on 05-Oct-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 30-SEP-2016 to 30-SEP-2016. Dose regimen: 0.5 ml, single dose, Route of administration: Intramuscular. Batch number: not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a limited range of motion in the left shoulder (outcome: not recovered / not resolved). Reporter comments: The reporter assessed the event as non-serious. Follow-up information received 07-Oct-2016: This report concerns a 51-year-old female non-pregnant patient. On 30-Sep-2016, the patient received AFLURIA (batch number: WT52305), no other applicable suspect products. The product was stored correctly. Treatment of the adverse event included the patient being seen by a doctor, no treatment at this time.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: This spontaneous case initially received on 05-Oct-2016, was reported by a health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided Administration of company suspect drug(s): The patient received AFLURIA from 26-SEP-2016 to 26-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Not reported. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2016, the patient experienced a local red raise warm reaction size of half dollar, lasted several days, reaction did subside (outcome: recovered / resolved). Reporter comments: The healthcare professional considered all events as non-serious.
Age: 88.0
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 88 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 (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. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 27.0
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 27-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA not reported 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: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Lymphadenopathy
Clinical narrative: This spontaneous case, initially received on 04-Oct-2016, was reported by a health professional and concerns a 51-year-old female patient. Weight: not provided; Height: not provided. Medical history was not provided. Administration of company suspect drug(s): The patient received AFLURIA from 01-Oct-2016 to 01-Oct-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 14249211A. Action taken with drug: reported as 'discontinued'. No additional suspect drugs. Adverse reactions/events and outcomes: On 01-Oct-2016 later in the day, the patient experienced soreness at the injection site. On 02-Oct-2016, the patient noticed a small, circular rash at the injection site and a swollen lymph node underneath her armpit in the arm she received AFLURIA. Outcome of all events: not recovered/not resolved. Report's assessment: The healthcare professional considered all events as non-serious and believes that the rash is from receiving AFLURIA, but suspects that the swollen area under her armpit is not a lymph node, but may be due to the patient shaving her armpit the night before.
Age: 63.0
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 63 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 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. The patients will be contacted for revaccination.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: This spontaneous case, initially received on 23-Sep-2016, was reported by a health professional and concerns a 49-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 23-SEP-2016 to 23-SEP-2016. Dose: 0.5 ml single dose, Route of administration: Intramuscular. Batch number WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On 23-Sep-2016, the patient experienced small wet spot on (skin) site from leur lok, not from injection site (outcome: recovered / resolved). The patient had no adverse effect from vaccine on skin at site (outcome: recovered / resolved). Reporter comment: The healthcare professional considered the events as non-serious and reported the classification: quality defect. Follow-up received 21-Oct-2016: The patient had no concomitant medications. The patient has not previously received AFLURIA. Indication for use was approved as per the Product Information Leaflet. The product was not stored correctly. Action taken with drug: None, dose was administered and empty syringe was discarded into sharps container. On 20-Sep-2016 (also reported as 23-Sep-2016), the patient may not have received full dose (outcome: recovered / resolved, special circumstances: underdose) as luer lock may be defective at connection causing fluid to leak. The patient does not report any adverse reactions. No treatment needed. Cleaned fluid and area where fluid leaked. Reporter comments: The healthcare professional considered the event unassessable. The as reported term 'Small wet spot on (skin) site from leur lok, not from injection site' changed to 'Small wet spot on (skin) site from leuk lok, not from injection site / Patient may not get full dose - no adverse effect' (special circumstances: exposure via skin contact without adverse event, underdose without adverse event) and coded to preferred term: no adverse event. Additional information received on 24-Jan-2017: 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'.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 13-Oct-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 on 12-OCT-2016. Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced "Nothing is moving" (outcome: Not Reported), complained of stomach problems/Stomach did not feel good (outcome: Not Reported), Whole body is weak (outcome: Not Reported). No other information was available.
Age: 78.0
Sex: F
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 78-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 01-SEP-2016 to 01-SEP-2016. Dose regimen: 0.5 ml 1 time dose. Route of administration: Intramuscular, Batch number: WT54006. No additional suspect drugs. Special circumstances: On 01-Sep-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: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, initially received on 12-Oct-2016, was reported by a health professional and concerns a 16-month-old patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 12-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: WT56908. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Oct-2016, a 16 month old patient received AFLURIA vaccine (special circumstances: drug administration error). No adverse reaction noted after administration. The outcome was reported as unknown. Reporter comments: The healthcare professional considered all events non-serious.
Age: 87.0
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 87 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.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case initially received on 12-Oct-2016, was reported by a health professional and concerns an unk patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 12749211A. No additional suspect drugs. Adverse event description: On an unknown date, the reporter stated that there was a temperature excursion with unopened AFLURIA MDVs (multi-dose vials). Maximum temperature reached between 74-76 degrees F for an unknown amount of time but the reporter estimates over 24 hours and less than 7 days. Vaccines were warm to touch upon discovery, 1 employee has received the vaccine (outcome: unknown, special circumstances: drug administration error without adverse event). This is the first excursion according to the nurse. Reporter comments: The healthcare professional classified the event as a medications error.
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: This spontaneous case, initially received on 19-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 13-SEP-2016 to 13-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 13-Sep-2016, the patient experienced severe bruising (outcome: unknown, special circumstances: wrong technique in drug usage process) after receiving the AFLURIA from the pre-filled syringe that had air bubble (the reporter wondered if the air bubble should have been removed). Reporter's assessment: The reporter considered the event(s) bruising as non-serious and related to the administration of AFLURIA.