chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Gastrointestinal disorder
Clinical narrative: Case number PHEH2014US020800 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. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Headache, Vision blurred
Clinical narrative: Case number PHEH2014US020803, is an initial spontaneous report from a health care professional received on 13 OCT 2014. This report refers to a patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly at a dose of 0.5 ml on an unknown date. On an unknown date after vaccination, the patient experienced blurred vision, lightheadedness, headaches and severe abdominal pain. The final outcome of the events was unknown. Seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2014US020652, is an initial spontaneous report from a physician received on 13 OCT 2014. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date. It was reported that during administration some of the vaccine dripped down his arm. No adverse event was reported following this medication error (vaccine under dose).
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US020583 is an initial spontaneous report from the pharmacist received on 09 OCT 2014. This report refers to a 72-year-old male patient. On 08 OCT 2014, he was inadvertently vaccinated with an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 14554P) instead of FLUZONE high dose (influenza vaccine, other manufacturer). No adverse event reported following this medication error (wrong vaccine administered).
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020661 an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 02 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601) intramuscularly on 13 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020669, is an initial spontaneous report received from a pharmacist on 10 OCT 2014. This report refers to a 25 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) intramuscular on 10 OCT 2014. Pharmacist reported that unopened and opened multi dose vials of FLUVIRIN reached 33-35.9 F overnight and this is the second temperature excursion. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US020681 is an initial spontaneous report received from a pharmacist on 13 OCT 2014. This report refers to a 25 year old female patient. She was going through fertility treatment. On an unspecified date, she received seasonal influenza vaccine (manufacturer and batch number: not reported) and a month later, on 12 OCT 2014, she received FLUVIRIN 2014/2015 (batch number: 1413301) intramuscularly. No adverse events were reported following this medication error (inappropriate schedule of vaccine administered).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020713 is an initial spontaneous report received from a medical assistant on 14 OCT 2014. This report refers to a 55 years old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with expired FLUVIRIN 2013/2014 (batch number: 1309501) intramuscularly on 11 OCT 2014. No adverse events reported after the maladministration (expired vaccine used).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020729, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 65 year old male patient. His medical history and concomitant medication was not reported. He 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 gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020730, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 71 year old female patient. Her medical history and concomitant medication were 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 gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020733, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 47 year old male patient. His medical history and concomitant medication were not reported. He 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 gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020734, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 56 year old male patient. His medical history and concomitant medication were not reported. He 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 gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020736, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 76 year old female patient. Her medical history and concomitant medication was not reported. Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. 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). No adverse event was reported. No further information was provided.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020737, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 39 year old male patient. His medical history and concomitant medication was not reported. Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 0403201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). No adverse event was reported. No further information was provided.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020739, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 73 year old male patient. His medical history and concomitant medication was not reported. Nurse stated that the person who opened the cooler stated the gel packs were still mushy, but temperature unknown. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). No adverse event was reported. No further information was provided.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020741, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to an 87 year old male patient. His medical history and concomitant medication was not reported. He 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 the gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Corrective lens user, Exposure via direct contact, Eye irrigation, Eye irritation
Clinical narrative: Case number PHEH2014US020749 is an initial spontaneous report received from a pharmacy technician on 14 OCT 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was inadvertently exposed to FLUVIRIN 2014/2015 (batch number: 1411001) splashed in her eyes on 14 OCT 2014 when she was drawing up a dose of FLUVIRIN for a patient. It was reported that her affected eye burned, experienced hurt causing some swelling. She was wearing contact lenses at the time of vaccine splash then removed her contacts and used the eye wash on the affected eye. After eye wash, she noted that her eye was puffy and warm under the eye. Her vision had not been impaired and she was wearing her glasses. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Eye swelling
Clinical narrative: Case number PHEH2014US020749 is an initial spontaneous report received from a pharmacy technician on 14 OCT 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was inadvertently exposed to FLUVIRIN 2014/2015 (batch number: 1411001) splashed in her eyes on 14 OCT 2014 when she was drawing up a dose of FLUVIRIN for a patient. It was reported that her affected eye burned, experienced hurt causing some swelling. She was wearing contact lenses at the time of vaccine splash then removed her contacts and used the eye wash on the affected eye. After eye wash, she noted that her eye was puffy and warm under the eye. Her vision had not been impaired and she was wearing her glasses. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020303 is an initial spontaneous report received from a pharmacist on 07 OCT 2014. This report refers to a 23 year old female patient. Her medical history and concomitant medications were not reported. On 07 OCT 2014, she was vaccinated  with a dose of FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly. The pharmacist was suspicious that the vaccine was frozen or stored below recommended temperature administration. No adverse event was reported following this administration error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: Case number PHEH2014US020032 is an initial spontaneous report received from a pharmacist on 02 OCT 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) on 01 OCT 2014. On the same day, she had a little bit of bleeding when FLUVIRIN was administered. She was not on any blood thinners. She was okay last night (unspecified). The final outcome was reported as unknown. Causality and seriousness were not reported. But reporter "did not think this was a big deal". Reporter refused to provide any more details.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US020042, is an initial spontaneous report from a pharmacist received on 03 OCT 2014. This report refers to a patient of unknown identifiers. Past medical history and concomitant medications were not reported. On an unknown date, the patient received one dose of FLUVIRIN 2014/2015 (batch number: unknown) from a multiple dose vial (MDV) intradermally. No adverse event was reported following this medication error (wrong route of administration).
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Feeling abnormal, Injection site pain
Clinical narrative: Case  number PHEH2014US020050 is an initial spontaneous report received from a pharmacist on 03 OCT 2014. This report refers to a 45 year old male patient. His past medical history and concomitant medications were not reported. On 03 OCT 2014, he was vaccinated with FLUVRIN 2014/2015 (batch number: 1411301) intramuscularly. On the same day after 15 minutes of vaccination, the patient noticed a funny taste in his mouth and had pain at the injection site. The reporter also stated that the patient felt a little disconnected. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019677 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 33 years old female patient.  Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Malaise, Rhinorrhoea
Clinical narrative: Case number PHEH2044US019679 is an initial spontaneous report received from a healthcare professional (physician assistant) on 30 SEP 2014 with a follow up report received from the physician assistant on 27 OCT 2014. This report refers to a 64 year old male patient. His current conditions included hypertension, hyperlipidemia, allergic rhinitis and peripheral vascular disease. His concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) intramuscularly at a dose of 2.5 mg (o.5 mg x 5) (whole vial) on 30 SEP 2014 (overdose). He was monitored for 01 hour in the office and was told to take Benadryl. On 30 SEP 2014, the patient had fatigue, malaise, runny nose and cough. The patient completely recovered from the events four days after the onset on 07 OCT 2014. The seriousness and causality of the events were not reported.   Follow up report was received from the physician assistant on 27 OCT 2014: Updated current conditions and dose of vaccination. New events (fatigue, malaise, runny nose and cough) were added.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019684 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 61 years old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019684 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 45 years old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019687 is an initial spontaneous report received from a medical assistant on 28 SEP 2014. This report refers to a 43 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2014 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019688 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 57 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019691 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 65 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2044US019693, is an initial spontaneous report from a medical assistant received on 29 SEP 2014. This report refers to a 32-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001, 141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 and 23 SEP 2014. IT was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse event reported after the maladministration (incorrect storage of drug).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019765 is an initial spontaneous report received from a nurse on 30 SEP 2014. This report refers to a 03 years old male patient. His medical history and concomitant medications were not reported. On 30 SEP 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 145405) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019829 is an initial spontaneous report received from a pharmacist on 29 SEP 2014 with a follow up report received from the pharmacist on 28 OCT 2014. This report refers to a 16 years old male patient. His concomitant medication was none. His past vaccination was well tolerated (unspecified vaccine). On 28 SEP 2014, he received initial application of FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly at a dose of 0.5 ml. It was reported that the patient received FLUVIRIN after excursion below recommended temperature but not frozen. No adverse event was reported following this administration error (incorrect storage of drug).   Follow up report received from the pharmacist on 28 OCT 2014: Updated past vaccination details (unspecified vaccine well tolerated)., vaccination details (initial application) and vaccine does (0.5 ml).
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2014US019871, is an initial spontaneous report from a medical assistant received on 01 OCT 2014. This report refers to a 20-year-old female patient (nurse). Historical conditions were not reported. No concomitant medication was reported. It was reported that the FLUVIRIN 2014/2015 (batch number: 141901) vaccine leaked onto patient (nurse) skin with no reaction noted on 30 SEP 2014. No adverse reaction reported following the inadvertent exposure to vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US019884, is an initial spontaneous report from a health care professional received on 01 Oct 201. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN, (batch number: 1413101) intramuscularly on 29 Sep 2014. It was reported that the patient received FLUVIRIN that was at room temperature for 48 hours. No adverse reaction reported following the maladministration (incorrect storage of drug).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Axillary pain, Chills, Fatigue, Full blood count normal
Clinical narrative: This spontaneous report as received from a father reporting on his 17 years old daughter. The patient had no pertinent medical history and no drug reactions or allergies. The patient's mother had a breast cancer history. On an unknown date the patient was vaccinated with GARDSAIL (dose, route, lot # not reported). There was no concomitant medication. On an unspecified date approximately in August 2014 (reported as prior to start school in August 2014 or September 2014) the patient experienced swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". The patient was seen by physician assistant and was prescribed unspecified antibiotics. Swollen and painful lymph nodes resolved after treatment. However on unspecified date in 2014 (reported as "approximately one month after receiving the unspecified antibiotics") the patient experienced two more episodes of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". Initial ultrasound showed swollen lymph nodes (on an unspecified date in 2014). The reporter stated that since his daughter experienced a third episode of swollen and painful lymph nodes in her armpits (on an unspecified date) and with the patient's mother having a breast cancer history, a mammogram was planned. The outcome of first episode of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit" was reported as recovered/resolved. However the outcome of next episodes of swollen and painful lymph nodes in armpits" was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a father reporting on his 17 years old daughter. The patient had no pertinent medical history and no drug reactions or allergies. The patient's mother had a breast cancer history. On an unknown date the patient was vaccinated with GARDSAIL (dose, route, lot # not reported). There was no concomitant medication. On an unspecified date approximately in August 2014 (reported as prior to start school in August 2014 or September 2014) the patient experienced swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". The patient was seen by physician assistant and was prescribed unspecified antibiotics. Swollen and painful lymph nodes resolved after treatment. However on unspecified date in 2014 (reported as "approximately one month after receiving the unspecified antibiotics") the patient experienced two more episodes of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". Initial ultrasound showed swollen lymph nodes (on an unspecified date in 2014). The reporter stated that since his daughter experienced a third episode of swollen and painful lymph nodes in her armpits (on an unspecified date) and with the patient's mother having a breast cancer history, a mammogram was planned. The outcome of first episode of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit" was reported as recovered/resolved. However the outcome of next episodes of swollen and painful lymph nodes in armpits" was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a father reporting on his 17 years old daughter. The patient had no pertinent medical history and no drug reactions or allergies. The patient's mother had a breast cancer history. On an unknown date the patient was vaccinated with GARDSAIL (dose, route, lot # not reported). There was no concomitant medication. On an unspecified date approximately in August 2014 (reported as prior to start school in August 2014 or September 2014) the patient experienced swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". The patient was seen by physician assistant and was prescribed unspecified antibiotics. Swollen and painful lymph nodes resolved after treatment. However on unspecified date in 2014 (reported as "approximately one month after receiving the unspecified antibiotics") the patient experienced two more episodes of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit". Initial ultrasound showed swollen lymph nodes (on an unspecified date in 2014). The reporter stated that since his daughter experienced a third episode of swollen and painful lymph nodes in her armpits (on an unspecified date) and with the patient's mother having a breast cancer history, a mammogram was planned. The outcome of first episode of swollen and painful lymph nodes, beginning in the "left armpit and then in the right armpit" was reported as recovered/resolved. However the outcome of next episodes of swollen and painful lymph nodes in armpits" was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2014YS019928, is an initial spontaneous report from a pharmacist received on 02 OCT 2014. This report refers to a 28 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145303) intramuscularly on 30 SEP 2014. Post vaccination she experienced redness, swelling, itching, inflammation and a knot at the injection site. She has not seen a physician for this reaction and has not taken any measures to help alleviate these reactions. Outcome of the events was reported as unknown. Seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020026 is an initial spontaneous report received from a pharmacist on 03 OCT 2014. This report refers to a 66 years old female patient. Her medical history and concomitant medications were not reported. It was reported that she received a dose of expired FLUVIRIN 2013/2014 (batch number: 1309601) intramuscularly on 03 OCT 2014. No adverse events were reported after the medication error.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020321, is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number:  not reported) intramuscularly that was stored at room temperature for three days on 06 OCT 2014. The reporter was not aware of any side effects/complaints by the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020336 is an initial spontaneous report received from a pharmacist on 07 OCT 2014 with the follow-up received on 14 OCT 2014. This report refers to a 65 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly at a dose of 0.5 ml on 06 OCT 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within the total duration. No adverse event was reported following this administration error (incorrect storage of drug).   Follow-up received on 14 OCT 2014:  Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within that total duration).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020345 is an initial spontaneous report received from a pharmacist on 07 OCT 2014 with a follow-up received on 14 OCT 2014. This report refers to a 63-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly at a dose of 0.5 ml on 06 OCT 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within that total duration. No adverse event was reported following this administration error (incorrect syringe of drug).   Follow-up received on 14 OCT  2014: Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within the total duration).
Sex: U
Vaccine: FLU3
Symptoms: Syringe 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 an 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 this was the second PFS that was not functioning properly (initial report did not involve a patient). The investigation determined that, FLUVIRIN batch number: 145201 was 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 leaked 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: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020348 is an initial spontaneous report received  from a pharmacist on 07 OCT 2014 with a follow-up received on 14 OCT 2014. This report refers to a 66-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly at a dose of 0.5 ml on 06 OCT 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. IT was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within that total duration. No adverse event was reporting following this administration error (incorrect storage of drug).   Follow-up received on 14 OCT 2014. Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within that total duration).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020575, is an initial spontaneous report from a nurse received on 10 OCT 2014. This report refers to a 52-year-old female patient. Past medical history and concomitant medications were not reported. On 10 OCT 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN 2014/2015 (batch number: 1412121) intramuscularly. It was reported that the patient received FLUVIRIN from open multiple dose vial (MDV) that reached 72 F overnight. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019192 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 30 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Age: 0.28
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Skin warm
Clinical narrative: Case number PHEH2014US020437, is an initial spontaneous report from a medical assistant received on 08 OCT 2014. This report refers to a 3 months old female neonate. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411401) intramuscularly on 06 OCT 2014. On 07 OCT 2014, the patient began experiencing burning down the left side of her body and it was reported almost her body was warm. Outcome of the events was reported as ongoing at the time of this report. Seriousness and causality of the event was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Case number PHEH2014US020441, is an initial spontaneous report from a consumer (patient) received on 08 OCT 2014. This report refers to a 72 year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) intramuscularly on 08 SEP 2014. On the same day, within 40 to 45 minutes after vaccination, he felt a click in his head and got really dizzy. It was stated that it was not a heavy nausea but his stomach was not doing well and had a dull headache. His doctor thought that it was viral and then tried Z-pack. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Case number PHEH2014US020441, is an initial spontaneous report from a consumer (patient) received on 08 OCT 2014. This report refers to a 72 year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) intramuscularly on 08 SEP 2014. On the same day, within 40 to 45 minutes after vaccination, he felt a click in his head and got really dizzy. It was stated that it was not a heavy nausea but his stomach was not doing well and had a dull headache. His doctor thought that it was viral and then tried Z-pack. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020442, is an initial spontaneous report from a physician received on 08 OCT 2014. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUVIRVIN 2014/2015 (batch  number: unknown) intramuscularly on 07 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014YS020445, is an initial spontaneous report from a pharmacist received on 08 OCT 2014. This report refers to a 53-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1413401) subcutaneously on 07 OCT 2014. No adverse event was reported following this medication error (inappropriate route of vaccination).
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Case number PHEH2014US020510 is an initial spontaneous report received from a consumer on 13 OCT 2014. This report refers to a 47 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly on unknown date . On OCT 11 2014 he experienced swelling in his arm pit to the left side only. The outcome of the event was reported as resolving. The seriousness and causality of the event was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020573, is an initial spontaneous report from a nurse received on 10 OCT 2014. This report refers to a 20-year-old-female. Past medical history and concomitant medications were not reported. On 10 OCT 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN 2014/2015 (batch number: 1412121) intramuscularly. It was reported that the patient received FLUVIRIN from open multiple dose vial (MDV) that reached 72 F overnight. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020576, is an initial spontaneous report from a nurse received on 10 OCT 2014. This report refers to a 57-year-old male patient. Past medical history and concomitant medications were not reported. On 10 OCT 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN 2014/2015 (batch number: 1412121) intramuscularly. It was reported that the patient received FLUVIRIN from open multiple dose vial (MDV) that reached 72 F overnight. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2044US020130 is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 46 years old male patient. Past medical history and concomitant medications were not reported. On 07 OCT 2014, the patient received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 146401) which had been stored at 55 degrees Fahrenheit for 2 hours. No adverse event was reported following this medication error (incorrect storage of drug).
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020168 is an initial spontaneous report received from a pharmacist on 06 OCT 2014. This report refers to an adult patient of an unspecified gender. Past medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an expired FLUVIRIN 2014/2015 (batch number: 1310301) intramuscularly. No adverse events were reported following this medication error (expired vaccine used).
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019193 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 73 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014 he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US020305 is an initial spontaneous report received from a nurse on 07 OCT 2014. This report refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly which was stored above refrigeration temperature so that the patient experience less sore. No adverse event was reported following the administration error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Case number PHEH2014US020206 is an initial spontaneous report from a pharmacist received on 06 OCT 2014. This report refers to an adult female patient. Past medical history and concomitant medications were not provided. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145203) into her arm intramuscularly on an unknown date. On the same day, a little bit after vaccination, she experienced arm pain and muscle spasms in her arm. The outcome , seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHEH2014US019417 is an initial spontaneous report received from a consumer on 25 SEP 2014. This report refers to a 51 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported0 intramuscularly on 14 SEP 2014. On the same day after vaccination, she experienced pain and swelling in her arm. It ws reported that her arm was very sore and she could not use it. She tried  heat, ice, Aspirin and ibuprofen, but nothing helped her. The events outcome was unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020230 is an initial spontaneous report from a health care professional (allergy technician) received on 08 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medication were not provided. It was reported that on 03 OCT 2014, she received a dose of expired FLUVIRIN (batch number: unknown) intramuscularly on 03 OCT 2014. No adverse events were reported following maladministration.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2014US020308, is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 51-year-old female patient. Past medical history and concomitant medications were not reported. On 06 OCT 2014, the patient received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 1413401) from a multidose and some of the vaccine dripped out of the injection site. It was reported that some of the vaccine ran down her arm and was not sure how much dripped out. No adverse event was reported following this medication error (drug administration error).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain
Clinical narrative: Case number PHEH2014US019382 is an initial spontaneous report received from a pharmacist on 25 SEP 2014. This report refers to  a 51 year old female patient. Her medical  history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) intramuscularly on 19 SEP 2014. On the same day after vaccination, she experienced an orange sized swelling in her armpit which was painful and palpable. Outcome for swelling was reported as complete recovery (subsided). Outcome for pain was not reported. The seriousness and causality were not reported.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US019197 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 23 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).