chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Donor called today 01/07/15 at 13:30 PM He stated about 23:55 PM 01/05/15 after his tetanus injection on 01/05/15 his arm (L deltoid) started hurting and he became short of breath for a brief period of time, but it subsided. He went today to the doctor 01/07/15 and told he had possible cellulitis and was offered antibiotics and pain medication, which he declined. Requested donor to come to facility. He stated he could not had to be at work at 14:30. He ask if I could write an excuse for work then said he was going to another doctor today, he proceeded to say he might come in later today.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial report received from a health care professional on 09 October 2014. Additional information received 02 January 2015 resulted in the case being upgraded to serious. A 37-year-old female patient had received second intradermal dose of FLUZONE ID (lot number-UT4993AA, expiry date 05 May 2014), in left deltoid region, on 06 October 2014. The patient had no illness at the time of vaccination or any pre-existing physician diagnosed allergies and birth defects. The patient had medical history of hyperlipidemia. On 07 October 2014 i.e. 1 day after vaccination, the patient experienced redness, swelling, warm to touch area around injection site up to shoulder of her left arm. On 08 October, the patient came for a MD visit since symptoms became worse. The patient had received FLUZONE ID last year, but did not develop any reaction. The patient was treated with Clindamycin. The patient's laboratory investigations were not reported. At the time of reporting the outcome of the event was unknown. Follow-up information for this unsolicited case was received from a physician on 02 January 2015. The patient had received prior doses of Influenza vaccine, however the reporter noted that this "may be first intradermal flu shot". She presented to the physician on 08 October 2014 with a 4x5 cm area of erythema and warmth along the lateral left shoulder, with a 1x1 cm area of induration along the central area. The area was tender to palpation, and the redness was extending beyond a line which had been drawn around the border. No fever or chills were noted. Physical findings revealed the following: blood pressure 120/80, pulse regular, respiration rate 18/minute, oral temperature 98 degrees F, height 64 inches, weight 256 pounds, body mass index 43.9 kg/m2, body surface area 2.17 m2. The patient was well developed, well-nourished, and in no acute distress. She was diagnosed with local Influenza reaction vs cellulitis, and prescribed clindamycin Hcl 300 mg caps, three times a day for five days. She was instructed to use ice and ibuprofen for discomfort and swelling, and to take probiotics while on antibiotics. She was also instructed to call the physician's office with any worsening of symptoms, including fevers or chills, and to call the doctor's office with an update on Friday (2 days) with an update. Outcome was not reported. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Initial report received from a health care professional on 09 October 2014. Additional information received 02 January 2015 resulted in the case being upgraded to serious. A 37-year-old female patient had received second intradermal dose of FLUZONE ID (lot number-UT4993AA, expiry date 05 May 2014), in left deltoid region, on 06 October 2014. The patient had no illness at the time of vaccination or any pre-existing physician diagnosed allergies and birth defects. The patient had medical history of hyperlipidemia. On 07 October 2014 i.e. 1 day after vaccination, the patient experienced redness, swelling, warm to touch area around injection site up to shoulder of her left arm. On 08 October, the patient came for a MD visit since symptoms became worse. The patient had received FLUZONE ID last year, but did not develop any reaction. The patient was treated with Clindamycin. The patient's laboratory investigations were not reported. At the time of reporting the outcome of the event was unknown. Follow-up information for this unsolicited case was received from a physician on 02 January 2015. The patient had received prior doses of Influenza vaccine, however the reporter noted that this "may be first intradermal flu shot". She presented to the physician on 08 October 2014 with a 4x5 cm area of erythema and warmth along the lateral left shoulder, with a 1x1 cm area of induration along the central area. The area was tender to palpation, and the redness was extending beyond a line which had been drawn around the border. No fever or chills were noted. Physical findings revealed the following: blood pressure 120/80, pulse regular, respiration rate 18/minute, oral temperature 98 degrees F, height 64 inches, weight 256 pounds, body mass index 43.9 kg/m2, body surface area 2.17 m2. The patient was well developed, well-nourished, and in no acute distress. She was diagnosed with local Influenza reaction vs cellulitis, and prescribed clindamycin Hcl 300 mg caps, three times a day for five days. She was instructed to use ice and ibuprofen for discomfort and swelling, and to take probiotics while on antibiotics. She was also instructed to call the physician's office with any worsening of symptoms, including fevers or chills, and to call the doctor's office with an update on Friday (2 days) with an update. Outcome was not reported. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Patient received immunizations immediately after leaving room to wait in lobby, pt's mom informed us she was near fainting. Applied ice packs to forehead and base of neck, had pt lay down, elevated legs.  Patient recovered w/in 20 minutes to be able to go home with mother.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Large red rash lasted 1 1/2 wks itching. Swollen. Hot to the touch.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Severe headache, slight fever, shakiness, pain around injection site, swelling around injection site, redness, pain through entire arm.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Severe headache, slight fever, shakiness, pain around injection site, swelling around injection site, redness, pain through entire arm.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Electromyogram, Eyelid ptosis, Immunoglobulin therapy
Clinical narrative: June 20th Red rash all over over my body. June 21st woke up with ptosis of the eye and muscle weakness and blurry vision. It continued to get worse until a doctor diagnosed me with Myasthenia Gravis and started me on medicine. 6 months later I underwent a Thymectomy and IVIG to try to go into remission. It has only been 3 weeks since surgery and no change yet.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Muscular weakness, Myasthenia gravis, Nuclear magnetic resonance imaging, Rash erythematous
Clinical narrative: June 20th Red rash all over over my body. June 21st woke up with ptosis of the eye and muscle weakness and blurry vision. It continued to get worse until a doctor diagnosed me with Myasthenia Gravis and started me on medicine. 6 months later I underwent a Thymectomy and IVIG to try to go into remission. It has only been 3 weeks since surgery and no change yet.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Thymectomy, Vision blurred
Clinical narrative: June 20th Red rash all over over my body. June 21st woke up with ptosis of the eye and muscle weakness and blurry vision. It continued to get worse until a doctor diagnosed me with Myasthenia Gravis and started me on medicine. 6 months later I underwent a Thymectomy and IVIG to try to go into remission. It has only been 3 weeks since surgery and no change yet.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient experienced 3-4 daily episodes of forearm numbness from Sept 18 until Sept 28 or 29. After first few days, the episodes were also followed by numbness on left side of his mouth. On the last day, he developed about 1 minute of expressive aphasia.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Hypoaesthesia, Hypoaesthesia oral, Laboratory test normal, Ultrasound Doppler
Clinical narrative: Patient experienced 3-4 daily episodes of forearm numbness from Sept 18 until Sept 28 or 29. After first few days, the episodes were also followed by numbness on left side of his mouth. On the last day, he developed about 1 minute of expressive aphasia.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ultrasound scan normal
Clinical narrative: Patient experienced 3-4 daily episodes of forearm numbness from Sept 18 until Sept 28 or 29. After first few days, the episodes were also followed by numbness on left side of his mouth. On the last day, he developed about 1 minute of expressive aphasia.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Posture abnormal, Tremor
Clinical narrative: Pt with eyes open, slumped in chair and was not responsive, breathing and HR still present. Pale and diaphoretic. Slight shaking, color returned to pt face then pt awoke stating " What happened." Pt was given juice and observed for 15 minutes with no other reactions.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt with eyes open, slumped in chair and was not responsive, breathing and HR still present. Pale and diaphoretic. Slight shaking, color returned to pt face then pt awoke stating " What happened." Pt was given juice and observed for 15 minutes with no other reactions.
Age: 1.04
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Febrile convulsion, Full blood count normal, Metabolic function test normal, Pyrexia
Clinical narrative: 12-20-14 fever to 103.3 febrile sz x2 seen ER and admitted to hospital. 12-15-14 diarrhea.
Age: 1.0
Sex: U
Vaccine: FLU3, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician and registered nurse refers to a 12 month old patient of unknown gender. On 29-DEC-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (lot# and dose/frequency were not reported), subcutaneous instead of VARIVAX (Merck) due to a human error. And the patient also received M-M-R and FLUZONE on the same day on 29-DEC-2014. No adverse effect reported. This was one of two cases reported from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Fever and lump R upper thigh.
Sex: F
Vaccine: FLU4
Symptoms: Hypokinesia, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 30th June 2015). On 17th October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, several days after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm and movements reduced were not recovered/not resolved. The reporter considered the pain in arm and movements reduced to be possibly related to FLUARIX QUADRIVALENT. Additional information: Patient reporting 10 days after flu vaccination, she is having intense pain in her upper left arm. She also is reporting limited range of movement in left arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Patient states area of/around flu shot was immediately itchy and has continued to itch intensely since vaccination. Patient has used hydrocortisone cream on area and has not beet seen by MD.
Age: 0.27
Sex: M
Vaccine: RV5
Symptoms: Infantile vomiting, Oral administration complication
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 3 month old male patient. Medical history and concurrent conditions were not reported. On 22-DEC-2014, the patient was vaccinated with a first dose of ROTATEQ oral, 2 ml, (lot number and expiry date were not reported). There was not concomitant medication provided. On 22-DEC-2014, the patient vomited most of ROTATED dose right after dose was administered. The outcome of vomited most of ROTATEQ dose was unknown. Additional information is not expected because reporter refused additional contact.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 7-year-old male patient who received KINRIX (batch number 23MJ17, expiry date 22nd October 2015). On an unknown date, the patient inadvertently received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch at injection site. 5 cm induration. Itchy R arm Subq-MMR.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthropathy, C-reactive protein normal, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Pain in extremity
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Red blood cell sedimentation rate normal, Rotator cuff syndrome, Vaccination site swelling
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Hypersensitivity, Mobility decreased
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Musculoskeletal pain, Myalgia, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Surgery, X-ray
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthropathy, C-reactive protein normal, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Osteoarthritis
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Rotator cuff syndrome, Vaccination site swelling
Clinical narrative: Severe arm pain and swelling at vaccine site was minimal but pt reported severe pain and arm ROM was limited but also has DJD.
Age: 30.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called on 1-4-15 stating arm that pneumonia vaccine was given in has been sore since injection was given so painful she could not lift arm. Today a red ring developed about 3 inches. 1-7-15 arm has improved, did not call doctor.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation
Clinical narrative: Inflammation at injection site about the size of a golf ball. No other apparent distress. Area was iced for about one hour. Inflam. decreased to 1/4 or 1/3 of original size before pt. left.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm/shoulder since administration on 11/6/14.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increased redness, slight swelling to right thigh. Area tender to touch x 4 days. Skin intact. Treatment ice applied to affected area. Ibuprofen prescribed for pain.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023736 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 74-years-old male patient. His medical history and concomitant  medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reporting following maladministration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023739 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 66-year-old female patient. She was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 06 NOV 2013. No adverse event was reported following this medication error (expired vaccine used).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023742 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 77-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023743 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 71-years-old  male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Gout, Pain in extremity, Swelling
Clinical narrative: Case number PHEH2013US023712 is an initial, spontaneous report received from a pharmacist (who is also the patient) on 12 NOV 2013. This report refers to a 32-years old female patient. Her medical history and concomitant medications were  not reported. On 28 OCT 2013,, she was vaccinated with FLUVIRIN 2013/2014 (batch  number: 1309701) intramuscularly. Later, on the night of vaccination she experienced gouty attack on her large toe. It was reported that the toe was very painful and swollen. She did not have history of gout or risk factors for gout which could have precipitated the events. She took ibuprofen to reduce her pain. The reaction had lessened but did not completely go away. The causality and seriousness of the case were not assessed.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US023423 is an initial spontaneous report received from a pharmacist on 06 NOV 2013. The report refers to a 24-year-old male patient. He received FLUZONE (other manufacturer and batch  number unknown) in SEP 2013. He was further vaccinated with FLUVIRIN 2013/2014 (batch number: 13372P) intramuscularly on 06 NOV 2013. No adverse event was reported following medication error (inappropriate schedule of vaccine administered).
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2013US023496 is an initial spontaneous report received from health care professional on 07 NOV 2013. This report refers to a female patient of an unknown age and gender. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307901) intramuscularly on 07 NOV 2013. It was reported that she had received only a partial dose of vaccine because after that the needle displaced from the syringe during administration. Reporter explained that needle was not screwed in tight enough by the administrator. No adverse event was reported following medication error.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Case number PHEH2013US023518 is an initial spontaneous report received from a pharmacist on 07 NOV 2013 with follow-up received on 13 DEC 2013. This report refers to a 40-year-old female patient. Her medical history and concomitant medication ws not reported. The previous vaccinations were well tolerated. She was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number 13392P) intramuscularly on 03 OCT 2013 and experienced bursitis on the arm the day after her flu shot. The affected arm was the same arm that had the site of injection and the pain continued at the time of reporting. On 06 OCT 2013, she experienced pain in upper arm and was unable to lift the arm. She was treated with prednisone, Benadryl and heat patches. Final outcome of the events was recovered. No further information about seriousness and causality was available.  Follow-up received on 13 DEC 2013: New events (vaccination site pain and injected limb mobility decreased) and vaccination dose was updated.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US023706 is an initial spontaneous report received from a physician on 12 NOV 2013. This report refers to a 64-years-old male patient. On an unknown date, he was vaccinated with FLUVIRIIN 2013-2014 (batch number: 1309201) intramuscularly. But the vaccine had been exposed to temperatures up to 51 Fahrenheit overnight on 11 NOV 2013. No adverse reaction was reported following this administration error (incorrect storage of drug).
Age: 0.51
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHEH2013US023964 is an initial spontaneous report received from a pharmacist on 12 NOV 2013. This report refers to a 6-months-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: boy vomited 2-3 times after the flu shot was administered) intramuscularly on 12 NOV 2013. It was reported that he vomited two to three times after the flu shot was administered. The outcome of the event was unknown. No further information was provided.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2013US023798 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 33-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of FLUVIRIN 2013/2014 (batch number: 1309601) intramuscularly in the arm on 17 OCT 2013. It was reported that she received only a part of the dose as some of the vaccine ran down her arm during administration. No adverse event was reported following the maladministration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023745 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 66-year-old female patient. She was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccinated used).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023747 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 71-year-old female patient. She was vaccinated with expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023749 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 74-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US023750 is an initial spontaneous report received from a pharmacist on 12 NOV 2013. This report refers to a patient of unknown age and gender. On 12 NOV 2013, the patient ws vaccinated with FLUVIRIN 2013-2014 (batch number: 1309201) intradermally, instead of PPD (other manufacturer, batch number unknown). No adverse reaction was reported following this administration error (wrong vaccine administered).
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023753 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 73-year-old male patient. He was vaccinated with expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023756 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 54-year-old male patient. He was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US023757 is an initial spontaneous report received from a pharmacist on 11 Nov 2013. This report refers to a 42-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 Oct 2013. No adverse event was reported following the maladministration.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2013US024113, is an initial spontaneous report received from a nurse on 14 Nov 2013. This report refers to a 27-year-old patient of unspecified gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi-dose vial at once (10 doses) on 14 Nov 2013. No adverse events were reported following this maladministration (overdose). No additional information was available.
Sex: F
Vaccine: FLU3
Symptoms: Device issue, No adverse event, Underdose
Clinical narrative: Case number PHEH2013US024036 is an initial spontaneous report received from a pharmacist on 13 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: unknown) on 10 Nov 2013. It was reported that during withdrawal of the needle, some of the vaccine ran down the patient's arm, therefore she did not receive the full dose. No adverse event was reported following medication error. The pharmacist commented that it was because of misuse or malfunction of the device (which was supplied by Vanish Point). Follow-up received from the pharmacist on 16 Dec 2013: Updated comment from the reporter regarding syringe of the vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Case number PHEH2013US023973 is an initial spontaneous report received from a consumer on 12 Nov 2013. This report refers to a 66-year-old male patient. His medical history included eye migraines 2 to 3 times a year and concomitant medications were not reported. He was vaccinated with an intramuscular dose of FLUVIRIN (batch number: not reported) on 06 Nov 2013. It was reported that 15 minutes after vaccination, he experienced migraine headache and since then he had it daily. He reported that his doctor told him that he experienced eye migraine of unknown cause. The event outcome was reported as condition unchanged.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023969 is an initial spontaneous report received from a medical assistant on 12 Nov 2013. This report refers to a 2-years-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1308101) on 12 Nov 2013. No adverse event was reported following the maladministration.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Oral pain
Clinical narrative: Case number PHEH2013US023968 is an initial spontaneous report received from a pharmacist on 12 Nov 2013. This report refers to a 74-years-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1309301) on an unknown date. It was reported that 8 hours after vaccination, on 11 Nov 2013, he experienced pain inside his mouth. The event outcome was reported as condition unchanged.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024168 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to an 18-months-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1309801) on 15 Nov 2013. No adverse events were reported following the maladministration.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US024159 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to a patient of unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 15 Nov 2013. It was reported that this vaccine was previously exposed to temperature of 62 Fahrenheit overnight. No adverse event was reported following medication error.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2013US024155 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to a female patient of an unknown age. The patient's medical history and concomitant medications was not reported. The nurse reported that one of her co-workers while withdrawing a dose of FLUVIRIN (batch number: not reported) from a multi-dose vial into a syringe, some of the vaccine sprayed into the patient's eye on 15 Nov 2013. No adverse event was reported following the maladministration.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US024967, is an initial spontaneous report from a physician received on 25 Nov 2013 with the follow-up received on 07 Jan 2014. This report refers to a 62-year-old male patient. His medical history included coronary artery disease, sleep apnea, hypercholesterolemia, asthma, shoulder pain right, right knee pain, abnormal weight gain, hypertension, herpes labialis, peripheral edema, lung nodule found during imaging, rotator cuff tear, tonsillectomy, bypass surgery, tumor removed from bladder, partial prostatectomy and aortic valve replacement. He was a social alcohol user (3 times a month). His family history included father deceased at 76 years due to heart disease and esophageal cancer and mother deceased at 78 years due to colon carcinoma. Concomitant medication included long term use of anticoagulant. He was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature, at a dose of 0.5 ml intramuscularly into left deltoid on 20 Nov 2013 at 15:54. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) at 6 hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. No more information was available. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, family history, concomitant medications, site and time of vaccine administration.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US024966, is a spontaneous report from a physician received on 25 Nov 2013 and a follow up received from physician on 07 Jan 2014. This report refers to a 57-year-old female patient. Past medical history included cerebrovascular accident, stroke with residual left hemiplegia, hypertension, chronic pain, bipolar I disorder, rhinitis allergic, obstructive sleep apnea, irritable bowel syndrome, needs flu shot, insomnia, urinary frequency, ganglion cyst, knee pain, yeast infection of the skin, knee effusion, leg edema, deep venous thrombosis after surgery, obsessive-compulsive disorder, depression, degenerative disc disease, arthritis, total knee replacement, B total hip, cholecystectomy, tubal ligation and attempted hand wrist tendon repair-multiple. She had no known drug allergies. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1309081) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into the right deltoid on 30 Nov 2013 at 13:28. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for six hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for six hours. No adverse reaction was reported following the medication error. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, concomitant medications, date of vaccination, site of vaccine administration, batch number and event onset date.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US024965, is an initial spontaneous report received from a physician on 25 Nov 2013 with follow-up received on 07 Jan 2014. This report refers to an 81-year-old polymedicated female patient. Her medical history included hypertension, hypercholesterolemia, gastrooesophageal reflux disease, seasonal allergic rhinitis, diabetes mellitus type 2, arthritis, dementia due to traumatic brain injury, thyroid nodule, chin laceration, dizziness, impacted cerumen of both ears, pre-ulcerative corn or callous, orthostasis, neurological deficit present, glaucoma and elevated liver enzymes. She was hospitalized in 2010 due to intracranial hemorrhage and recurrent fall. She was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into left arm on 20 Nov 2013. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for 6 hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. No more information was available. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, concomitant medications and site of vaccine administration.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US024964, is a spontaneous report from a physician received on 25 Nov 2013 and a follow up received from a physician on 07 Jan 2014. This report refers to a 71-year-old male patient. Past medical history included allergies to PERCOCET, hypertension, hypercholesterolemia, coronary artery disease, current use of long term anticoagulation, clotting disorder, arthritis, unspecified heart disease, stroke, appendectomy, tonsillectomy and cardiac catheterization. He was a former smoker and he quitted smoking in 2001. He was a non-alcoholic and not a drug abuser. His family history included heart disease to his father and mother. Concomitant medications included LIPITOR, warfarin, aspirin, COUMADIN and metoprolol succinate. He was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs which were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into the left deltoid on 18 Nov 2013 at 16:37. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursions. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for 6 hours on 14 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. It was further reported that he was vaccinated with one dose of FLUZONE (other manufacturer, batch number: unknown) on 18 Nov 2013. No adverse reaction was reported due to the medication errors. Follow-up received from physician on 07 Jan 2014: Updated medical history, family history, patient demographics, vitals before vaccination, concomitant medications, co-suspect vaccination with FLUZONE, site of FLUVIRIN administration and event.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US024962, is an initial spontaneous report received from a physician on 25 Nov 2013 with the follow-up received on 07 Jan 2014. This report refers to a 71-year-old polymedicated female patient. Her history conditions included chronic pain, coagulopathy, hypertension, dyslipidemia, insomnia, gastrooesophageal reflux disease, eczema, multiple allergies, osteoarthritis, chronic obstructive pulmonary disease, hypothyroidism, depression, factor V Leiden heterozygote, acute vomiting, hypoxia, dehydration, pneumonia, elevated liver enzymes, atrial fibrillation, peripheral edema, hypercholesterolemia, acute renal insufficiency, itching, headache, allergic rhinitis, osteopenia, deep vein thrombosis, fibromyalgia, cholecystectomy, hernia repair, hysterectomy, tonsillectomy and B cataracts. She was an ex-smoker. Her family history included father alive with heart disease. She was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature 0.5 ml intramuscularly into left deltoid on 18 Nov 2013 at 16:32. The reporter stated that the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for 6 hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. Vital signs which were performed on 02 Dec 2013 were normal. No more information was available. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, family history, concomitant medications, site and time of vaccine administration.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US024953 is an initial spontaneous report received from a pharmacist on 26 NOV 2013 and a follow up report from the pharmacist received on 11 FEB 2014. This report refers to a 59-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with two doses of 0.5 ml FLUVIRIN 2013/2014 (batch number: 1307601, expiry date: MAR 2014) intramuscularly in the left arm on the same day (20 NOV 2013, at 7:00 PM). No adverse event was reported following this administration error.  Follow up report from the pharmacist received on 11 FEB 2014: Age of patient amended. Updated FLUVIRIN batch number, expiry date, vaccination site and dose.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Nausea
Clinical narrative: Case number PHEH2013US024876 is an initial spontaneous report received from a pharmacist on 26 NOV 2013. This report refers to a 39-year-old adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013-2014 (batch number: 131001, expiry date: MAY 2014) intramuscularly at a dose of 0.5 ml on 24 NOV 2013. On 25 NOV 2013, after vaccination she experienced nausea and complained of a metallic taste. She did not visit any physician or sought medical care from a health care professional at the time of reporting. The outcome of the event was condition unchanged. The seriousness and causality of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US024861, is an initial spontaneous report received from a medical assistant on 25 NOV 2013. This case refers to a male patient of unknown age. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401) intramuscularly on 25 NOV 2013 which was not stored under the recommended temperatures. Reporter stated that, their power went out sometime over the weekend and may have reached room temperature. Duration of excursion was not known. When the power came back on, the refrigerator malfunctioned and some of the liquid in the fridge froze and it was not known if FLUVIRIN froze. No adverse event was reported following this administration error.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US024858, is an initial spontaneous report received from a pharmacist on 25 NOV 2013. This case refers to a male patient of unknown age. Past medical history and concomitant medication were not reported. It was reported that, the patient had received FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly on unknown date in OCT 2013 and then again vaccinated with FLUVIRIN 2013/2014 intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US024301, is an initial spontaneous report received from a nurse on 18 NOV 2013. This case refers to a female patient of unknown age. Past medical history and concomitant medication were not reported.  She was vaccinated with expired  FLUVIRIN 2013/2014 (batch number: 1207101 expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 15 NOV 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US024970 is an initial spontaneous report from a health care professional on 26 NOV 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. IT was reported that the patient received a dose of expired FLUVIRIN 2012/2013 (batch number: 1205301, expiry date: not reported) intramuscularly on 14 OCT 2013. No adverse event was reported following the maladministration.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US024852, is an initial spontaneous report received from a nurse on 26 NOV 2013. This report refers to a patient of unknown gender of unknown age Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308301) intramuscularly on an unknown date, which was exposed to temperatures down to 1C on 25 NOV 2013. No adverse reaction was reported following this administration error.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024644, is an initial spontaneous report from a nurse received on 21 NOV 2013. This report refers to a 3-year-old male patient who was accidentally vaccinated with FLUVIRIN 2013/2014 (batch number: 131001) intramuscularly on 20 NOV 2013. No adverse reaction reported following this medication error (inappropriate age at vaccine administration).
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024625 is an initial spontaneous report received from a pharmacist on 21 NOV 2013. This report refers to a 03-year-old female child. Past medical history and concomitant medications were not reported. On 12 NOV 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) intramuscularly. No adverse event was reported following this administration error.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US024308 is an initial spontaneous report received from a nurse on 18 NOV 2013. This case refers to a 35-years-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly a month ago (date unspecified) and received another intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1309001) on 18 NOV 2013. No adverse event was reporting following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US024300 is an initial spontaneous report received from a nurse on 18 NOV 2013 and a follow up report from the nurse received on 10 DEC 2013. This case refers to female patient of unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN 2012/2013 (batch number: 1207101 and expiry date: JUN 2013) at dose of 0.5 ml in the right arm intramuscularly on 15 NOV 2013. No adverse event was reporting following this administration error.   Follow up report from the nurse received on 10 DEC 2013., Patient initials and site of vaccination was updated.