chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
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 94 year old patient. Weight: not provided; Height: not provided. Concomitant medications: 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-2-16, 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 to 23-Set-2016.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 41-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 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Age: 68.0
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 68 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 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.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pharyngeal oedema
Clinical narrative: This spontaneous case, initially received on 12-Oct-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56007. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date 3.5hrs after her AFLURIA flu injection, the patient felt her throat swelling (medically significant) and she was turning red (outcome: recovered / resolved, stop date: 12-Oct-2016). The patient went to the ER (Emergency Room) and was given steroids and antihistamines which brought the reaction under control. No problems now.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: This spontaneous case initially received on 11-Oct-2016, was reported by a health professional and concerns a(n) 45-year-old female patient. Weight: not provided; Height: not provided. She had administered FLUVIRIN in the previous years with no issues. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016 Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 149221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Oct-2016 less than 24 hours after receiving the vaccine, the patient experienced flu-like symptoms (malaise, fever, fatigue) (outcome: recovered / resolved), swollen glands and sinus congestion (outcome: not recovered / not resolved). She stated that flu-like symptoms have resolved to date but sinus congestion and swollen glands persisted. Reporter comments: The patient who was also a nurse assessed the events as non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: This spontaneous case initially received on 11-Oct-2016, was reported by a health professional and concerns a(n) 45-year-old female patient. Weight: not provided; Height: not provided. She had administered FLUVIRIN in the previous years with no issues. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016 Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 149221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Oct-2016 less than 24 hours after receiving the vaccine, the patient experienced flu-like symptoms (malaise, fever, fatigue) (outcome: recovered / resolved), swollen glands and sinus congestion (outcome: not recovered / not resolved). She stated that flu-like symptoms have resolved to date but sinus congestion and swollen glands persisted. Reporter comments: The patient who was also a nurse assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: This spontaneous case, initially received on 11-Oct-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Oct-2016 a couple of hours after vaccination, the patient started to feel very tired. That night the patient felt like she had a fever, with sweating and chills and achiness to her joints. She could not sleep very well. The next day the patient had no energy and felt lightheaded with a mental 'fogginess' (start date: 08-Oct-2016). Her muscles were very weak and she felt achy all over (start date: Oct-2016). Today, day number 2, the patient still feels tired with muscle fatigue in particular (outcome: not recovered/not resolved, start date: Oct-2016). Though the patient states this may not be a severe adverse reaction, she is concerned about this sudden drop in energy (start date: Oct-2016). Outcome for all other events: unknown. Reporter comments: The reporter states that set-backs like this are not acceptable and she will never have another vaccination again. The reporter thinks that the symptoms that she just described go underreported and wishes she could take it back and let her immune system deal with the flu the way it should.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hyperhidrosis, Muscle fatigue, Muscular weakness, Pain
Clinical narrative: This spontaneous case, initially received on 11-Oct-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Oct-2016 a couple of hours after vaccination, the patient started to feel very tired. That night the patient felt like she had a fever, with sweating and chills and achiness to her joints. She could not sleep very well. The next day the patient had no energy and felt lightheaded with a mental 'fogginess' (start date: 08-Oct-2016). Her muscles were very weak and she felt achy all over (start date: Oct-2016). Today, day number 2, the patient still feels tired with muscle fatigue in particular (outcome: not recovered/not resolved, start date: Oct-2016). Though the patient states this may not be a severe adverse reaction, she is concerned about this sudden drop in energy (start date: Oct-2016). Outcome for all other events: unknown. Reporter comments: The reporter states that set-backs like this are not acceptable and she will never have another vaccination again. The reporter thinks that the symptoms that she just described go underreported and wishes she could take it back and let her immune system deal with the flu the way it should.
Sex: F
Vaccine: FLU3
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: This spontaneous case, initially received on 11-Oct-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Oct-2016 a couple of hours after vaccination, the patient started to feel very tired. That night the patient felt like she had a fever, with sweating and chills and achiness to her joints. She could not sleep very well. The next day the patient had no energy and felt lightheaded with a mental 'fogginess' (start date: 08-Oct-2016). Her muscles were very weak and she felt achy all over (start date: Oct-2016). Today, day number 2, the patient still feels tired with muscle fatigue in particular (outcome: not recovered/not resolved, start date: Oct-2016). Though the patient states this may not be a severe adverse reaction, she is concerned about this sudden drop in energy (start date: Oct-2016). Outcome for all other events: unknown. Reporter comments: The reporter states that set-backs like this are not acceptable and she will never have another vaccination again. The reporter thinks that the symptoms that she just described go underreported and wishes she could take it back and let her immune system deal with the flu the way it should.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, initially received on 21-Sep-2016, was reported by health professional and concerns a 3-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 21-SEP-2016 to 21-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: reported as 12649221A. Site: Left leg. No additional suspect drugs. Adverse reactions/events and outcomes: On 21-Sep-2016, AFLURIA was inadvertently given to a 3 year old (special circumstances: drug administration error). The doctor is aware. Currently the child is not showing any adverse reaction. Outcome for all events: unknown. Reporter comments: The reporter considers the event non-serious (medication error).
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 20-Sep-2016, was reported by a health professional and concerns a male patient. Weight: not provided, Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT53606. No additional suspect drugs. On an unknown date, the patient was administered AFLURIA vaccines that were out of range at 50.1F for 1 hour and 27 minutes - no adverse event (outcome: not reported, special circumstances: drug administration error without adverse event). Reporter comments: The reporter considered the event as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case initially received on 20-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): On an unknown date, the patient received AFLURIA. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT53606. No additional suspect drugs. On an unknown date, the patient was administered AFLURIA vaccines that were out of range at 50.1F for 1 hour and 27 minutes - no adverse event (outcome: not reported, special circumstances: drug administration error without adverse event). Reporter comments: The reporter considered the event as non-serious.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 59-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 54-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a health professional and concerns a 56-year-old female patient. Administration of company suspect drug(s): The patient received AFLURIA on 06-SEP-2016. Dose regimen: Not reported, Route of administration: Subcutaneous, Batch number: WT54206. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Sep-2016, the patient thinks the vaccine was given subcutaneous (outcome: not reported, special circumstances: incorrect route of drug administration). On an unknown date (by 08-Sep-2016), the patient experienced erythema in the area where the injection was given (outcome: not reported).
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case initially received on 07-Sep-2016, was reported by a Non-health Professional and concerns a patient of unknown age/gender. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Unknown. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced anaphylactic reaction (medically significant, outcome: not reported).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 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 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case initially received on 26-Aug-2016, was reported by a health professional and concerns a 65-year-old female patient. Administration of company suspect drug(s): The patient received AFLURIA on 26-Aug-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number WT53106. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Aug-2016 during AFLURIA PFS (pre-filled syringe) administration, the vaccine was leaking through the barrel of the plunger and not through the needle (outcome: not reported) and the patient only received some vaccine into the tissue (outcome: not reported, special circumstances: underdose). The RPh (registered pharmacist) believes that when the needle was screwed onto the PFS it was crooked, but he did not inspect it closely and was not sure what the problem was. Additional information received on 02-Sep-2016: PTC number added QA investigation results: The QA investigation for Lot number WT53206 (PRD-18098) was also extended to the sister lot WT53106. Bothe 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: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Vaccination complication
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a non health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Past medical history included Surgeries for the melanoma, Needle biopsy, Cold sores, LEEP (loop electrosurgical excision) procedure. Drug history/allergy included Opioids (Reaction: Drug Reactions/Allergies). At the time of the event the patient had Chronic fatigue syndrome, Malignant melanoma on legs and chest. Concomitant medications: pembrolizumab, dexamethasone, valacyclovir and corticosteroids. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Drug reaction/allergies to flu shots (outcome: Not Reported).
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a 41-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 12-OCT-2016 to 12-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse event description: On 12-Oct-2016, the individual was given AFLURIA subcutaneously (special circumstances: incorrect route of drug administration without adverse event).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 26-Oct-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): The patient received AFLURIA from 26-OCT-2016 to 26-OCT-2016. Dose regimen: 1 ml, Route of administration: Intramuscular. Batch number: 13249221A. No additional suspect drugs. Adverse event description: On 26-Oct-2016, the patient was accidentally given a 1 ml dose of the vaccine instead of a 0.5 ml (outcome: unknown, special circumstances: accidental overdose without adverse event).
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 14-Oct-2016, was reported by a health professional and concerns a 44-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received AFLURIA (thimerosal containing) from 13-OCT-2016 to 13-OCT-2016. Dose regimen: 0.5 mL, Route of administration: Intramuscular, Batch number: 12849211A. No additional suspect drugs. Adverse event description: On 13-Oct-2016, AFLURIA was administered to one patient that had some particulate material floating in the vial (outcome: not reported, special circumstances: poor quality drug administered without adverse event).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 14-Oct-2016, was reported by a health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 14-OCT-2016. Dose regimen: 0.5 single dose, Route of administration: Intramuscular. Batch number: 10949221A (expiry date: 05-Jun-2016). No additional suspect drugs. Adverse event description: On 14-Oct-2016, gave expired dose to employee, no reaction noted (outcome: not reported, special circumstances: expired drug administered without adverse event). Reporter's comment: The reporter classified the event as a medication error and considered it non-serious.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: 15 minutes after getting immunizations got generalized hives.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 41-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 24-NOV-2016 to 24-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 24-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 1 day after- injection site hard, swollen, hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 3 inch area of erythema and mild edema surrounding site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient's injection site was swollen the size of a baseball and warm to touch according to mom. She declined appointment and used ice pack. Swelling and pain gone.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient complained of initial swelling at injection site; then gradual pain of the entire arm.
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Not an adverse reaction. Only vaccine error.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Chapped lips, Lip discolouration, Paraesthesia oral
Clinical narrative: Patient called pharmacy with complaint regarding vaccine received 5/15/17. Said she feeling tingling in/on her lips, also said lips turned black and cracked. Using VASELINE to moisten lips; will take BENADRYL at night and stay hydrated- MD notified.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Injection site discharge, Injection site erythema, Injection site vesicles
Clinical narrative: Patient was given immunization in right upper thigh. Parent stated it was red at the site for about one week and then blistered and drained over last few days. Given BACTROBAN for 7 days.
Age: 69.0
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 69 year old patient. Weight: not provided. Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 83.0
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 an 83-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 77.0
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(n) 77-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 12-JAN-2017 to 12-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event. On 12-Jan-2017, the patient received vaccine following temperature excursion. The outcome was reported as unknown.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns an 84-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 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(n) 27-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 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 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.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degree 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.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 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: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns a(n) 54-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration. Batch number: 13749221A. No additional suspect drugs. On an unspecified date, the patient was administered AFLURIA from a multi dose vial that was punctured over 28 days. No adverse effects were noted. Special circumstances: Drug administration error without adverse event.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 44-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 22-NOV-2016 to 22-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 22-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous case, initially received on 15-Mar-2017, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Past medical history includes egg allergy. Concomitant medication: Not reported. Administration of company drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported, Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced severe nausea and vomiting after receiving an unspecified influenza vaccine. Reporter's comments: The pharmacist reported that the patient felt that this was due to the egg content of the unspecified influenza vaccine as the patient felt she had an egg allergy.
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 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Sex: U
Vaccine: FLUX
Symptoms: Nodule
Clinical narrative: This spontaneous case, initially received on 15-Dec-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 Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a "knot" in the unspecified vaccinated arm (outcome: not reported).
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 78 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was 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: 86.0
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 86 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: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, initially received on 27-Jun-2016, was reported by a health professional and concerns a patient of unknown age/gender. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date, the patient received unspecified Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Unspecified allergic reaction (outcome: Not Reported).
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, initially received on 11-Jul-2016, was reported by a health professional and concerns a female patient. Weight: 62.58 kg; 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 allergies (outcome: not reported). Linked Case ID(s): US-BEH-2016071024 (same patient).
Age: 86.0
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 86 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.