chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on an unknown date. The subject's estimated date of delivery was 19th January 2015. The subject received BOOSTRIX at week 38 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: A pharmacist was considering administering BOOSTRIX in a pregnant patient who is currently 38 weeks pregnant. She knows it is recommended between 27 and 36 weeks but was wondering if it would be okay at 38 weeks. The patient was at the pharmacy but an administration had yet to occur.
Age: 24.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, Wrong drug administered
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female patient who received KINRIX (batch number F43Z7, expiry date 31st October 2016). On 6th November 2014, the patient received KINRIX (unknown) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 24th February 2015. The patient received KINRIX at week 24 of the pregnancy and during the second trimester of pregnancy. On 6th November 2014, an unknown time after receiving KINRIX, the patient experienced vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing. Additional details provided: KINRIX was administered inadvertently instead of BOOSTRIX. KINRIX was not indicated for use in adults.
Sex: U
Vaccine: HEPA, HIBV, HPV4, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of GARDASIL (dose number, lot# and expiration date was not reported). LIQUID PEDVAX HIB dose number, lot# and expiration date as not reported, VAQTA dose number, lot# and expiration date was not reported, MMR II dose number, lot# and expiration date was not reported, ROTATEQ dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Age: 0.57
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Injection site dryness, Injection site rash, Rash, Rash erythematous
Clinical narrative: Mom of pt concerned about possible reactions to 2nd flu vaccine 12/26/14 at nurse visit apptmt. Rash occurred approximately 2-3 days after immunization given. Mom presented to HC with pictures taken by her cell phone . According to photos, reddened rash to cheeks, BLE and BUE noted. Current today assessment (1/5/2015) reveals no redness to cheeks. BLE/BUE skin dryness/roughness noted. denies fever. No SOB or acute distress noted. No treatment necessary at this time, as mom stated that she is applying lotion to site for the dryness. Advised mom to contact HC in the morning at 8:30am if rash re-appears.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Muscle strain, Pain
Clinical narrative: Pain. Limited shoulder movement. Feels like pulled muscle.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Soreness where shot was given.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Rhinorrhoea
Clinical narrative: Pt had large red/warm to touch injection site reaction from shoulder to elbow. Pt had fever and runny nose. Pt saw physician. Exact cause of fever and runny nose undetermined. No infection in arm.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Pyrexia, Rash papular
Clinical narrative: Erythematous papules to bilat. upper thighs with 3 lesions on chest x 3 days with intermittent fever.
Age: 63.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Rash, Skin reaction
Clinical narrative: Patient has redness and rash on both forearms and legs. Skin reaction.
Age: 40.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Eosinophil count increased, Pyrexia, Rash maculo-papular, Rash vesicular, Rhinorrhoea
Clinical narrative: Vaccine was given on 12/11/2014. Pt developed a maculo papular rash, centripetal over her chest wall, abdomen, and back resembling varicella, and fever 102 degrees F. Itchy throat and runny nose on 12/23/2014.
Age: 40.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Throat irritation
Clinical narrative: Vaccine was given on 12/11/2014. Pt developed a maculo papular rash, centripetal over her chest wall, abdomen, and back resembling varicella, and fever 102 degrees F. Itchy throat and runny nose on 12/23/2014.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 1/8/15 arm swollen in area of injection, warm, and hot. Size of 50 cent piece vaccine was given on 1/5/15 (Monday).
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Skin warm
Clinical narrative: 8 x 5 cm erythema and warmth. Denies dyspnea no swelling noted. No systemic symptoms noted. Advised to ice site and take BENADRYL and go to ER for difficulty breathing. VS WNL.
Sex: U
Vaccine: RV1
Symptoms: Depressed level of consciousness, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician and described the occurrence of consciousness decreased in a infant patient who received ROTARIX. On 11th December 2014, the patient received ROTARIX. On 11th December 2014, less than a day after receiving ROTARIX, the patient experienced consciousness decreased (serious criteria GSK medically significant). On an unknown date, the outcome of the consciousness decreased was unknown. It was unknown if the reporter considered the consciousness decreased to be related to ROTARIX. Additional information was provided: This case was reported by another manufacturer (Pfizer) and described an infant who stopped responding after receiving ROTARIX; therefore the other vaccines were not given.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX TETRA. On an unknown date, the patient received FLURARIX TETRA. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema and injection site swelling to be probably related to FLUARIX TETRA.  Additional information received on 22 OCT 2014: A handful of employees receiving the FLUARIX Quadrivalent vaccine experienced increase site reaction described as redness and swelling. There were no informations about the concomitant medications and the relevant medical history. It was also unknown if the patients received other vaccines on the same date, if they had previously received flu shots and if they had adverse events following previous vaccinations.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site rash, Rash
Clinical narrative: Case number PHEH2014US022261 is an initial spontaneous report from the consumer received on 05 NOV 2014. This report refers to a 37-year-old female patient She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 24 OCT 2014. On the same date, after vaccination she experienced a rash on her abdomen , back and on arm at the injection site. She also had loss of pigment at the injection site. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Facial pain, Feeling hot, Nausea
Clinical narrative: Case number PHEH2014US022262, is an initial spontaneous report from a nurse received on 05 Nov 2014. This report refers to a 33-year-old female patient. Historical conditions were not reported. No concomitant medications was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On 04 Nov 2014, she experienced dizziness, nausea, pain on the left side of face and felt heat spreading over neck and shoulders. The final outcome of the events was unknown. Seriousness and causality was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2014US022268, is an initial spontaneous report received from a pharmacist on 05 Nov 2014. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. It was reported that the pharmacist unintentionally vaccinated the patient with FLUVIRIN (batch number: unknown) PFS intramuscular which was stored at room temperature fpr 45 minutes on 04 Nov 2014. No adverse event was reported. No further information was provided.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022103, is an initial spontaneous report received from a nurse on 31 Oct 2014. This report refers to a 3 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 145705) intramuscular on 29 Oct 2014. No adverse event was reported. No further information was provided.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US022114, is an initial spontaneous report from a nurse received on 03 NOV 2014. This report refers to a 71-year-old male patient. Medical history and concomitant medications were not reported. On 03 NOV 2014, the patient inadvertently received FLUVIRIN 2014/2015 (batch number: 1413401) intravenously. NO adverse event was reported following this medication error (inappropriate route of vaccination).
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site extravasation, Underdose
Clinical narrative: Case number PHEH2014US022248 is an initial spontaneous report received from health care professional (infection control manager) on 03  NOV 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly in her arm on an unknown date (vaccination date was reported as 2 weeks ago). The patient thought that the vaccine leaked out at the injection site, but the nurse did not think so. The nurse had to put the needle way into the muscle due to her large arm. It was reported that the patient had a bruise due to hitting a blood vessel or something as per reporter. The patient did not  think she was protected. The events outcome was unknown. The seriousness and causality were not reported.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2014US022024 is an initial spontaneous report from the nurse received on 29 Oct 2014. This report refers to a 70-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1411401) intramuscularly at a dose of 0.5 ml on 19 Oct 2014. On the same date, after vaccination he experienced muscle pain in the arm that received the FLUVIRIN injection. He also experienced soreness, discomfort and limited motion in the left arm. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020726, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 47 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). Nurse stated that the person who opened the cooler stated that the gels packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 3.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US022028 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a three years and two months old patient of an unspecified gender. The past medical history and concomitant medications of the patient were not reported. On an unspecified date, the patient received FLUVIRIN (batch number: not reported) in error but the patient should have received FLUZONE (other manufacturer, batch number: not reported). No adverse events were reported following this medication error (wrong vaccine administered).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Sleep disorder
Clinical narrative: Case number PHEH2014YS022091, is an initial spontaneous report from a consumer (patient) received on 03 NOV 2014. This report refers to a 58-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with intramuscular dose of FLUVIRIN 2014/2015 on 15 OCT 2014. On the same day, after vaccination, he experienced lower back pain. It was reported that the pain was tolerable during the day because he was otherwise preoccupied, however it worsens at night and he was unable to sleep well because of it. It has been persistent since the vaccination. Final outcome of the event of lower back pain was reported as condition unchanged and sleep disturbance as unknown. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US022092, is an initial spontaneous report from a physician received on 31 OCT 2014. This report refers to female patient of unknown age.  Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that the patient received FLUVIRIN that was mixed in the same vial with Provera Depo. No adverse event reported. No further information provided.
Age: 1.15
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022099, is an initial spontaneous report from a medical assistant received on 03 NOV 2014. This report refers to a 14 months old male infant. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 145303) intramuscularly on 27 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US021970, is an initial spontaneous report received from a medical assistant on 30 OCT 2014. This case refers to a 41 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601), intramuscularly on 30 OCT 2014, which was reached 33 F for 16 hours. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US021983 is an initial spontaneous report received from a pharmacist on 29 OCT 2014. This report refers to a 58 year old female patient. Her past medical history and concomitant medications were not reported. On 29 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) at a dose of one ml intramuscularly. No adverse events were reported following the administration of overdose.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Case number PHEH2014US021995, is an initial spontaneous report received from a nurse on 29 OCT 2014. This report refers to a male patient of unknown age. Patient was sick with a severe cole 2 weeks prior to receiving the vaccine. The patient received FLUVIRIN 2014/2015 (batch number: 1413401) intramuscular on 28 OCT 2014. Two hours after vaccination he stated that he was feeling a little bit better. He went to bed at 07:30 PM the day of vaccination and woke up at 08:00 AM, the next day, which was not usual for him. Final outcome of the events, seriousness and causality assessment was not reported. No further information was provided.   Following an internal review on 10 NOV 2014, of the information received on 29 OCT 2014 significant correction was done. The coding of the event "started to feel run down" was changed to tiredness.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Case number PHEH2014US021747, is an initial spontaneous report received from health care professional on 27 OCT 2014. This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412801) intramuscular on an unknown date. On an unknown date post vaccination he experienced similar reaction but not as strong. He experienced arthralgia, it burned when injection went in, arm was little sore and by the next day it was bad. Reaction continues feels like a rotator cuff injury. Final outcome of the events was unknown. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2014US021825 is an initial spontaneous report received from a nurse on 29 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413101) via intradermal route on 28 OCT 2014. It was reported that on 28 OCT 2014 after vaccination, she had a red bump at the injection site. The event outcome was unknown. The seriousness and causality was not reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US021633 is an initial spontaneous report received from a medical assistant on 13 OCT 2014. This report refers to a 44 years old male patient. His medical history and concomitant medications were not reported. it was reported that on 13 OCT 2014 he was due for PPD (other manufacturer, batch number: not reported), but he might have received FLUVIRIN 2014/2015 (batch number: 1412901, expiry date: JUN 2015) intradermally instead of PPD. No adverse events were reported following the maladministration.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US021653 is an initial spontaneous report received from a health care professional (receptionist) on 24 OCT 2014. This report refers to a 54 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) subcutaneously on an unknown date (reported as 2 weeks ago). No adverse events were reported following the maladministration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Case number PHEH2014US021659 is an initial spontaneous report received from a nurse on 24 OCT 2014. This report refers to  48 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410801) intramuscularly from a multi-does vial (MDV) on 17 OCT 2014. It was reported that during vaccination, the needle separated from the syringe and the patient did not receive full dose of vaccine. No adverse events were reported following the medication error.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021541 is an initial spontaneous report received from a nurse on 24 OCT 2014. This report refers to a 15 months old female infant. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411601) via intramuscular route on 09 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Anxiety, Blood test normal, Burning sensation, Nausea
Clinical narrative: Case number PHEH2014US021611, is an initial spontaneous report received from a consumer on 27 OCT 2014. This report refers to a 43 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) on unspecified date (reported as 2 years ago) and was well tolerated without any problems. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 15 OCT 2014. Approximately one hour after vaccination he experienced feeling of burning sensation to his arm, legs, stomach and chest. IT was reported that he felt nauseated and has stomach pain; he feels the symptoms like a rash under his skin. He also experienced tingling sensation in the legs like something affected the sheath in the nerves. It was reported that symptoms of feeling like a rash and tingling increases with any physical activity. He visited emergency room. H had urine test and blood test done and stated that everything was normal. On the paper it states paresthesia. He also had extreme anxiety and brain problems. He was treated with Ativan. It was reported that  he was advised to take an appointment with a neurologist. The outcome, seriousness and causality of the events were not reported.  Upon internal date review performed on 12 NOV 2014 of date received on 27 OCT 2014. Burning sensation in stomach, stomach ache and nausea were taken separate events.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder, Paraesthesia, Rash, Urine analysis normal
Clinical narrative: Case number PHEH2014US021611, is an initial spontaneous report received from a consumer on 27 OCT 2014. This report refers to a 43 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) on unspecified date (reported as 2 years ago) and was well tolerated without any problems. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 15 OCT 2014. Approximately one hour after vaccination he experienced feeling of burning sensation to his arm, legs, stomach and chest. IT was reported that he felt nauseated and has stomach pain; he feels the symptoms like a rash under his skin. He also experienced tingling sensation in the legs like something affected the sheath in the nerves. It was reported that symptoms of feeling like a rash and tingling increases with any physical activity. He visited emergency room. H had urine test and blood test done and stated that everything was normal. On the paper it states paresthesia. He also had extreme anxiety and brain problems. He was treated with Ativan. It was reported that  he was advised to take an appointment with a neurologist. The outcome, seriousness and causality of the events were not reported.  Upon internal date review performed on 12 NOV 2014 of date received on 27 OCT 2014. Burning sensation in stomach, stomach ache and nausea were taken separate events.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: Case number PHEH2014US021415 is an initial spontaneous report from the health care professional received on 22 OCT 2014. This report refers to a 56-year-old female patient. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 14582P) from a prefilled syringe, intramuscularly on 21 OCT 2014. It was reported that the syringe used for vaccination was malfunctioned  and it caused the patient to not receive the full dose of FLUVIRIN. No adverse event reported following this medication error (under dose).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US021072 is an initial spontaneous report from the nurse received on 17 OCT 2014. This report refers to a 59-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) on 17 OCT 2014. It was reported that FLUVIRIN was administered via subcutaneous route into her arm by the pharmacist. Nurse believed that the pharmacist inserted the one inch needle only a quarter of an inch into  her arm which did not penetrate the muscle. The pharmacist stated to the nurse the "needle inserted partially into her arms because she was too thin". No adverse event reported following this medication error (inappropriate route of vaccination).
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Case number PHEH2014US021435 is an initial spontaneous report received from a medical assistant on 23 OCT 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 14582P, expiry date: 21 MAY 2015) pre-filled syringe (PFS) on 23 OCT 2014. The medical assistant reported that when the nurse administered vaccine, the syringe malfunctioned and the patient did not receive full dose of FLUVIRIN. No adverse events were reported following the maladministration.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US021537, is an initial spontaneous report from a pharmacist received on 23 OCT 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The pharmacist reported that the safety needle was not tightly screwed to the syringe prior to the vaccination with FLUVIRIN. When the FLUVIRIN 2014/2015 (batch number: 145404) was administered on 23 OCT 2014 all the vaccine fell down the side of the patient arm. The pharmacist reported that the leaking was caused by the technique (drug administration error) only and not due to FLUVIRIN. No adverse event was reported.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Case number PHEH2014US019247, is an initial spontaneous report from a pharmacist received on 23 SEP 2014. This report refers to a 77-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) intramuscularly into left arm below the deltoid side on an unknown date. On 12 SEP 2014, the patient experienced bruise on her arm at the injection site. It was reported that the event was not getting worse but was not healing (at the time of this report). Seriousness and causality of the event was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US021403, is an initial spontaneous report received from a consumer on 23 OCT 2014. This case refers to a patient of unspecified age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported), intramuscularly on 23 OCT 2014, which was stored at 60 F for 24 hours. No adverse event was reported following this administration error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Case number PHEH2014US021411 is an initial spontaneous report from the pharmacist on 23 Oct 2014. This report refers to a female adult patient who was in her 30s-40s age. She was vaccinated with FLUVIRIN, (batch number: not reported) via subcutaneous route from a nurse on an unknown date. On an unknown date, the patient experienced more sore in the arm compared to the intramuscular injections which she had received in the past. The outcome, seriousness and causality of the event were not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2014US021412, is an initial spontaneous report from a pharmacist received on 22 OCT 2014. The report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: 1412401) intramuscularly on 21 OCT 2014. It was reported that after the vaccine was administered to the patient and before placing the band aide at the injection site, vaccine was dripping from the injection site. No adverse event was reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US021379 an initial spontaneous report received from a nurse on 21 OCT 2014. This report refers to a 67 years old female patient. Her medical history and concomitant medications were not reported. It was reported on 21 OCT 2014, she was administered FLUVIRIN 2014/2015 (batch number: not reported) pre-filled syringe (PFS) which was at room temperature from 11 AM to 12:30 PM. The pharmacist stated that they leave their flu shots out at room temperature prior to administration. No adverse events reported following the inadvertent administration.
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US021383, is an initial spontaneous report from a nurse received on 23 OCT 2014. This report refers to a female patient of an unknown age. Her medical history and concomitant medications were not reported. She had been administered with FLUVIRIN 2014/2015 (batch number: 1412701) intramuscularly  twice in this flu season on 20 OCT 2014 and 23 OCT 2014. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021396 is an initial spontaneous report received from a health care professional on 22 OCT 2014. This report refers to a 12 months old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 22 OCT 2014. No adverse events reported after the maladministration (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Influenza like illness, Malaise
Clinical narrative: Case number PHEH2014US021271, is an initial spontaneous report from a pharmacist on 21 Oct 2014. This report refers to a female patient of unknown age. Her concurrent condition included allergies to formaldehyde and arsenic. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on unknown date. She began to feel ill with flu-like-symptoms immediately after vaccination. The patient was completely recovered now and the pharmacist suspects that she already had the flu prior to FLUVIRIN administration. Seriousness and causality assessment was not reported. Final outcome of the event was recovered.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US21282 is an initial spontaneous report received from a pharmacist on 22 Oct 2014. This report refers to a 65 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated twice with FLUVIRIN (batch number: 1414101) from mutil-dose vial (MDV); once subcutaneously and then intramuscularly in the deltoid on 22 Oct 2014. No adverse events were reported following the inadvertent administration.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue
Clinical narrative: Case number PHEH2014US021298 is an initial spontaneous report received from a pharmacist on 20 OCT 2014, with the follow-up information received from Quality Assurance Department (reference number: 332248) on 19 NOV 2014. This report refers to a patient of unknown age and gender. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145201) from a pre-filled syringe (PFS) on an unknown date. It was reported that while injecting the vaccine into the patient the vaccine is not  coming out of the needle instead it was running down the patient's arms. It was reported that his was the second PFS that was not manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified for the complaint. The most probable root cause is user handling. The complainant stated that vaccine leaded at the needle connection site and that the needle is self-contained in the syringe; however, Novartis do not supply syringes for this batch. It is probable that the needle was not adequately attached to the syringe.   Follow-up information received from the Quality Assurance Department  (reference number: 332248) on 19 NOV 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US021304, is an initial spontaneous report from a pharmacist on 21 Oct 2014. This report refers to a 65 year old male patient. He received a FLUVIRIN (batch number: 146404) pre filled sryinge on 21 Oct 2014, after it reached an unknown temperature during a power outage for fours hours. Pharmacist mentioned that the documented temperature for the refrigerator was 40 degree F before the power outage and immediately after the power was restored. No adverse event was reported. No further information was provided.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019158, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 29-year-old female patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US020793 is an initial spontaneous report received from a health care professional on 13 Oct 2014. This report refers to a 2 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly at a dose of 0.5 ml on 10 Oct 2014. No adverse events reported after the maladministration.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020647 is an initial spontaneous report received from a pharmacist on 10 OCT 2014. This case refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported), intramuscularly on an unknown date, which had been at 33.7 for 30 minutes twice over a 10 hour period on 23 SEP 2014. No adverse event was reported following this administration error.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US020949, is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to a 70 year old female patient. Her medical history and concomitant medication was not reported. Pharmacist reported that she received 2 dose of FLUVIRIN 2014/2015 (batch number: unknown) on the same day. No adverse event was reported. No further information was provided.
Age: 1.33
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2014US020849, is an initial spontaneous report received from a pharmacist on 16 OCT 2014, with a follow up received from pharmacist on 12 NOV 2014. This report refers to a 16 months old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) intramuscularly on 16 OCT 2014. Outcome of the event was unknown. Seriousness and causality assessment was not reported. The pharmacist would like to follow up from resent via fax. No further information was provided.  Non significant follow up received from pharmacist on 12 NOV 2014: updated pharmacist fax number and pharmacist comment (pharmacist would like follow up from resent via fax).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021090, is an initial spontaneous report from a physician received on 17 OCT 2014. This report refers to a 3 years and 4 months old male patient. His medical history and concomitant medications were not reported. On 16 OCT 2014, the patient inadvertently received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 1464603). No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2014US020771, is an initial spontaneous report received from a pharmacist on 14 OCT 2014. This report refers to a 46 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145204) on 09 OCT 2014. Pharmacist reported that two needles after attaching to the top of the syringe snapped off and a small amount of vaccine leaked on her skin. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020066, is an initial spontaneous report from a health care professional received on 02 OCT 2014. This report refers to a patient under 4 years of age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly sometime in the last week. No adverse reaction reported following the maladministration (inappropriate age at vaccine administration).
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US021091, is an initial spontaneous report from a physician on 17 OCT 2014. This report refers to a 2 year old male patient. Physician reported that this patient had received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: unknown) on 17 OCT 2014. No adverse reaction was reported. No further information was provided.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021197, is an initial spontaneous report from a nurse received on 20 OCT 2014. This report refers to a 60-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of expired FLUVIRIN 2013/2014 (batch number: 1308901) in error on 20 OCT 2014. No adverse reactions have occurred following this medication error (expired vaccine used).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injected limb mobility decreased, Muscular weakness, Pain in extremity, Tenderness
Clinical narrative: Case number PHEH2014US021227 is an initial spontaneous report received from a consumer on 20 OCT 2014. This report refers to a 57 years old male patient. Her medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml intramuscular FLUVIRIN 2014/2015 (batch number: not reported) in his arm on 14 OCT 2014. Three days later on 17 OCT 2014, he started feeling weakness and tiredness in his legs. On the same day he also had soreness in his legs that lasted a full day. There was no fever. The feeling of weakness and tiredness in his legs was followed by tenderness on 18 OCT 2014 (the fourth day after vaccination) and he experienced tenderness and soreness in thighs (Symmetrical, inner aspect and up to top and around hips). His arms were fine except that he had soreness in his vaccination site which was expected. Soreness at vaccination site lasted about 2 to 3 days. He had difficulty in lifting his arm which went away. The event outcome of weakness and tiredness of legs, tenderness, soreness in thighs and  legs and vaccination site pain was reported as condition unchanged. The seriousness and causality were not reported.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHEH2014US021227 is an initial spontaneous report received from a consumer on 20 OCT 2014. This report refers to a 57 years old male patient. Her medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml intramuscular FLUVIRIN 2014/2015 (batch number: not reported) in his arm on 14 OCT 2014. Three days later on 17 OCT 2014, he started feeling weakness and tiredness in his legs. On the same day he also had soreness in his legs that lasted a full day. There was no fever. The feeling of weakness and tiredness in his legs was followed by tenderness on 18 OCT 2014 (the fourth day after vaccination) and he experienced tenderness and soreness in thighs (Symmetrical, inner aspect and up to top and around hips). His arms were fine except that he had soreness in his vaccination site which was expected. Soreness at vaccination site lasted about 2 to 3 days. He had difficulty in lifting his arm which went away. The event outcome of weakness and tiredness of legs, tenderness, soreness in thighs and  legs and vaccination site pain was reported as condition unchanged. The seriousness and causality were not reported.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020828 an initial spontaneous report received from a consumer (patient's mother) on 15 OCT 2014. This report refers to a 02 year old female patient. Past medical history and concomitant medication were not reported. It was reported that, her mother went to military base to get the flu shot and some administered FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 15 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US020854 is an initial spontaneous report received from a medical assistant on 08 OCT 2014. This report refers to a 45 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601, expiry date: Jun 2015) at a dose of 1.0 ml from a 3CC syringe on 08 OCT 2014. No adverse events reported after the maladministration (overdose).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020994 is an initial spontaneous report from the patient received on 17 OCT 2014. This report refers to a 42-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 16 OCT 2014. The patient felt that the FLUVIRIN vaccine received by her was not kept in the refrigerator. No adverse event reported following this medication error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Underdose, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Case number PHEH2014US021048 is an initial spontaneous report received from a nurse on 17 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601) intramuscularly on an unknown date. It was reported that she did not receive any vaccine because it ran down her arm when it was administered. The nurse stated that on 09 OCT 2014, the patient had a knot at the vaccination site and it was warm to touch. The outcome of the events was unknown. The seriousness and causality of the events was not reported.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020755 an initial spontaneous report received from a pharmacist on 14 OCT 2014. This report refers to a 03 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 13 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case  number PHEH2014US020756 an initial spontaneous report received from a pharmacist on 14 OCT 2014. This report refers to a 24 year old female patient. Her medical  history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly on 13 OCT 2014, which was stored approximately 30 minutes before administration (syringe was pre-drawn from multi-dose vial). No adverse event was reported following this administration error (incorrect storage of drug).
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US020779 is an initial spontaneous report received from a nurse on 14 OCT 2014. This case refers to a 37 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412601), intradermally on 14 OCT 2014. No adverse event was reported following this administration error (inappropriate route of vaccination).
Sex: U
Vaccine: FLU3
Symptoms: Gastrointestinal disorder
Clinical narrative: Case number PHEH2014US020798 is an initial spontaneous report received from a health care professional on 13 OCT 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly at a dose of 0.5 ml on unspecified date. It was reported that the patient experienced intestinal issues lasting for 2 days. The final outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.